cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues

The overall objective of this project is to evaluate, over a period of 1 year, the outcomes of either conventional free gingival graft (FGG) or mesh-FGG to increase the width of keratinized mucosa (KM) at implant sites.

The importance of the width of keratinized mucosa (KM) at implant sites remains a subject of ongoing debate. Reduced dimensions of KM (width \<2 mm) are associated with mucosal recession, biofilm accumulation, soft-tissue inflammation, marginal bone loss, peri-implantitis and patient discomfort. Surgical options to increase the width of KM include an apically positioned flap, either alone or in combination with an autogenous graft or a xenogeneic collagen matrix. The free gingival graft (FGG) is a well-established technique with a history of successful clinical use. The harvesting procedure for autogenous graft from the palatal mucosa, however, is usually associated with significant patient morbidity, especially when there is a need to graft extensive mucosal areas. To overcome this problem, various graft modifications have been proposed to limit the need for large-area autografts. Examples include the accordion technique, the strip gingival autograft technique, and a vertical modification of the strip gingival graft. The expanded mesh graft, another graft modification, has been used in the field of plastic surgery, especially in the treatment of large burn wounds. Recently, De Greef, Carcuac, De Mars et al. proposed this technique to be used in periodontal plastic surgery, more specifically, in the widening of KM at implant sites by means of a meshed free gingival graft (mesh-FGG). In this case series, initially inadequate width of KM in edentulous areas could be successfully increased prior to implant installation, without the need for any extensive autograft harvesting. Data from trials comparing mesh-FGG to conventional FGG and assessing the long-term efficacy of this novel technique, however, are missing.

The investigators hypothesize that the mesh-FGG technique will demonstrate similar clinical results (non-inferiority: increase in KM width) but improved patient-reported outcomes (superiority: post-surgical morbidity) compared to the FGG.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age,
* systemically healthy,
* presence of ≥2 adjacent implants in both sides of the mandibles showing \<2 mm of KM on the buccal aspects,
* subjects have to present with discomfort from brushing and/or difficulties in maintaining proper home care due to inadequate dimension of KM
* Full-Mouth Plaque Score (FMPS) \<20%,
* Full-Mouth Bleeding Score (FMBS) \<20%.

Exclusion Criteria:

* pregnancy or lactation,
* tobacco smoking,
* uncontrolled medical condition,
* medication that can affect gingival conditions.
Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

This study will evaluate the efficacy and safety of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe crow's feet lines
* Female or male, 18 to 65 years of age and in good general health
* Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active skin disease or irritation at the treatment area
* Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
* Treatment with botulinum toxin type A for crow's feet lines in the last 6 months
Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

The purpose of this study is to determine whether fully covered or partially covered metal stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a stent or tumour related cause in a 6-month follow-up


Eligibility Criteria:
Inclusion Criteria:

* Malignant stricture of the esophagus or cardia
* No curative treatment options available
* Dysphagia grade of at least 2 (i.e. swallow semi-solid foods or less)
* Informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Previous treatment with self-expandable metal stent for same condition
* Evidence of tumor within 2 cm of the upper esophageal sphincter.
* Presence of an esophago-tracheal or -bronchial fistula or both.
* Not able to undergo upper endoscopy
Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients

Voriconazole, a newer triazole-derivative, has become the drug of choice for many invasive fungal infections, including invasive Aspergillosis. Recently, therapeutic drug monitoring of voriconazole has been issued because of wide variations and unpredictability of voriconazole blood concentration. The objective of this study is 1) to characterize the pharmacokinetics of voriconazole in ICU patients on voriconazole prophylaxis or treatment, and 2) to develop and evaluate the prediction and adjustment models for voriconazole plasma levels.

Patients will be randomly assigned into 2 groups: conventional adjustment group (CA group) and early adjustment group (EA group). Voriconazole plasma levels will be measured on day 1 (both peak and trough levels), day 3, day 5, day 10, and day 14 (all trough levels). For CA group patients, voriconazole dosage will be adjusted according to the trough levels of day 5 (steady-state level). Predefined dose adjustment protocol will be used (\< 1 µg/ml: 50% increase, 1\~5.5 µg/ml: no change, \> 5.5 µg/ml: 50% decrease). For EA group patients, voriconazole dosage will be adjusted according to the each measurements of voriconazole levels from day 1. Adjusted dosage will be calculated using the NONMEN software. The target range of trough level is between 1.0 µg/ml and 5.5 µg/ml. The appropriateness of voriconazole level (day 5, day 10, and day 14), mortality, ICU stay, and the frequency of voriconazole-related adverse events will be compared. CYP2C19 polymorphism will be analyzed for all patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received voriconazole

Exclusion Criteria:

* Patients allergic to azole(s)
G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients

The purpose of this study is to describe the activity and toxicity of gemcitabine combined with four different drugs (carboplatin or cisplatin or etoposide or vinorelbine) as first line treatment of elderly patients with extensive small cell lung cancer.

Four treatment arms are planned.

* GEMVIN: gemcitabine 1000 mg/m2 and vinorelbine 25 mg/m2 on days 1 \& 8, every 21 days
* GEMCAR: gemcitabine 1000 on days 1 \& 8 and carboplatin AUC 3.5 or 4 or 4.5 on day 1, every 21 days
* GEMCIS: gemcitabine 1000 mg/m2 on days 1 \& 8 and cisplatin 50 or 60 or 70 mg/m2 on day 1, every 21 days
* GEMETO: gemcitabine 1000 mg/m2 on days 1 \& 8 and etoposide 60 or 70 or 80 mg/m2 on days 1,2,3 every 21 days

For the study of the GEMVIN combination a two-stage minimax flexible design will be applied. For the remaining 3 combinations (GEMCAR, GEMCIS, GEMETO) a phase 1/2 design aimed at looking for optimal dose within a Bayesian framework will be applied.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of SCLC
* Extensive disease
* Measurable disease
* Performance Status (ECOG) \< o = 2
* Age \> o = 70 years.
* Written informed consent.

Exclusion Criteria:

* Previous chemotherapy.
* Previous or concomitant malignancies (with the exception of adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix)
* •Neutrophils\<2.000/mm3;platelets\<100.000/mm3; hemoglobin \< 10 g/dl
* Creatinine \> 1.5 time the upper limit
* AST, ALT \> 2.5 times and/or bilirubin \> 1.5 time the upper limit of normal if liver metastases are absent or AST, ALT ³5 times and bilirubin \> 3 times the upper limit of normal if liver metastases are present
* Symptomatic brain metastases
A Non-interventional Study With Advanced Lung Squamous Cell Carcinoma

This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥18 years.
* Provision of fully informed consent prior to any study specific procedures.
* Advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology.
* According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

* None
Assessment of Potential Interactions Between Methamphetamine and Selegiline - 1

The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral selegiline.

To determine the safety of the selegiline concurrent with d-methamphetamine challenges of 15mg \& 30mg i.v. with the focus being on cardiovascular responses (HR,BP) to the i.v. methamphetamine challenges. This is a randomized, single-blind, placebo-controlled, two-arm study design to evaluate the safety of selegiline treatment, compared to placebo treatment, concurrent with i.v. methamphetamine challenges.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers who meet DSM-4 criteria for methamphetamine abuse or dependence; non-treatment seeking individuals
* Be able to verbalize understanding of consent form; provide written informed consent

Exclusion Criteria:

* Please contact site for more information
Diuretic Versus Placebo in Pulmonary Embolism

Pulmonary Embolism (PE) is a frequent and severe disease with an annual incidence of about 75000 cases in France and a short-term mortality rate of about 10%. Death is usually related to an acute right ventricular (RV) failure due to the increase in right ventricular afterload. Treatment of PE with RV failure consists in fluid expansion and thrombolysis in case of shock. However several studies suggest that fluid expansion may worsen acute RV failure by increasing RV dilatation and ischemia and left ventricular compression by RV dilatation. Thus, current guidelines regarding PE treatment remain unclear about the use of fluid expansion. In a preliminary study published by our group, we showed that diuretic treatment in the setting of PE with RV dilatation is safe and is associated with an increase in urine output, a decrease in heart rate and an increase in SpO2 in normotensive patients with oliguria. This may be related to the decrease of ventricular interdependence and enhancement of both LV and RV function.

The main objective of the study is to evaluate the 24-hours clinical benefit of furosemide in patients referred for acute PE with RV dilatation compared to placebo. The combination of urine output and sPESI clinical parameters reflects hemodynamic status. It is relevant as it indicates the disappearance of pre-shock symptoms and is therefore associated with a lower event risk. Thus, it allows early discharge of the patients from the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 years and over with

1. Symptomatic acute pulmonary embolism with first clinical symptoms within 15 days, and objectively confirmed by CT scan
2. RV dysfunction (≥1 criterion) confirmed by elevated BNP value or echocardiography or spiral computed tomography of the chest:

   * Echocardiography

     o Right/Left ventricular end diastolic diameter \> 1(apical or subcostal 4-chamber view)
   * Computed tomography

     o Right/Left short-axis diameter ratio\>0.9 (transverse plane)
   * Positive Nt-proBNP (\>600) or BNP\>200 pg/mL
3. One abnormal following PESI criteria

   * Heart Rate\>110/min
   * Systolic blood pressure\<100mmHg
   * Arterial oxyhemoglobin level\<90% on room air or after 5 minutes of oxygen withdrawal.

Exclusion Criteria:

* Cardiogenic shock requiring thrombolysis
* Previous significant left ventricular insufficiency (LVEF\<45%)
* Systolic blood pressure\<90mmHg at admission
* Age ≤ 18 years
* Pregnancy
* No health insurance
* Patients deprived of liberty or under legal protection
* Creatinin clearance \<30mL/min/m²
* hypersensibility to furosemide or its excipients
* functional renal insufficiency
* Hepatic encephalopathy
* Urinary tracks obstruction
* Hypovolemia or dehydration.
* Sever hypokalemia (K+ \< 3mmol/L)
* Severe hyponatremia (Na+ \< 125mmol/L)
* Ongoing hepatitis and hepatic insufficiency severe in patients with renal insufficiency or dialysis
Screening of Helicobacter Pylori in Children of Positive Infected Mothers

Helicobacter pylori is aspiral shaped gram negative organism that colonized the gastric mucosa.it was showen that intra familial infection play role in transmission of H pylori and mother play the key role in transmission .

Prevelance of H pylori infection in children whose mother positive infected is different according to risks factors such as mother education,work out side or not , socioeconomic status, family size and breast feeding or not.H pylori in children can be represent with recurrent abdominal pain ,recurrent diarrhea,repeated vomitting ,pallor ,fulness,non variceal hematemesis,loss of appetite,reterded growth.complication of H pylori include gastric ulcer,duodenal ulcer,gastric atrophy may lead to gastric cancer and intestinal metaplasia.

Eligibility Criteria:
Inclusion Criteria:

Child with Dyspeptic symptoms

Exclusion Criteria:

malnutrition childs Patient with metabolic disorder
Reliability and Diagnostic Accuracy of an Alternate Lachman's Test Performed in a Prone Position

This study is investigating the reliability and diagnostic accuracy of a Lachman's test conducted in a prone position to detect the presence of a torn anterior cruciate ligament.


Eligibility Criteria:
Inclusion Criteria:

* current knee pain complaint in subjects between 15 and 60 years old

Exclusion Criteria:

* the inability to assume the prone testing position
* evidence of a fracture by application of the Ottawa Fracture rule
* previous knee joint arthroplasty
* suspicion of posterior cruciate involvement
* knee surgery in the previous six months
* presence of serious underlying non-mechanical pathology
* systemic illness
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness

The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness


Eligibility Criteria:
Inclusion Criteria:

* Subjects \>/= 12 years of age who reported occasional sleeplessness in month prior to screening

Exclusion Criteria:

* Females who were pregnant or breastfeeding
Therapeutic Effects of Monochromatic Infrared Energy Therapy on Patients With Chronic Low Back Pain

To investigate the effects of short-term and medium-term monochromatic infrared energy therapy on patients with chronic low back pain (LBP) according to the International Classification of Functioning, Disability and Health.

Methods：70 participants with chronic LBP will be included. Participants received six 40-min sessions of hot pack therapy combined active or placebo monochromatic infrared energy therapy over the low back (wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliwatt/cm2 for 40 min, total energy 83.2 J/cm2) followed by 20-min supervised therapeutic exercise, for 3 times per week for a 4-week duration. Patients will be assessed at before treatment and follow-up assessments, including after 2 week of treatment; after 4 weeks of treatment; and 1 and 3 months, respectively, after treatment is terminated.

Main Outcome Measures: Patients will be assessed periodically with pain, Multidimensional Fatigue Inventory, postural stability (using the postural stability evaluation system: Biodex Stability System), and Fear-Avoidance Behavior Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

participants with chronic low back pain

Exclusion Criteria:

1. low back pain accompanied by specific pathological conditions, such as an infection,inflammation, rheumatoid arthritis, fracture, or tumor;
2. a self-reported history of malignancy, vertigo, stroke, or other condition that may impair postural stability;
3. a history of low back surgery with an implant;
4. pregnancy or plans to become pregnant during the course of the study;
5. having received concurrent treatment for low back pain by another health care professional
Sodium-restricted Diets and Symptoms in End Stage Renal Disease: An RCT

Dietary sodium intake independently increases the risk of mortality in end stage renal disease (ESRD). It plays a significant role in hypertension, hypervolemia, and left ventricular hypertrophy (LVH), and blunts the effectiveness of hypertensive agents. In addition, the hypervolemia associated with excessive dietary sodium intake results in the need for more intense fluid removal during dialysis (ultrafiltration), resulting in symptoms such as pain, cramps, hypotension, nausea, and vomiting during hemodialysis (HD) treatment sessions. Although sodium restriction is a universal recommendation for ESRD management, the National Kidney Foundation (NKF) recommendation of 2400 mg/day is consensus-based per the Dietary Approaches to Stop Hypertension (DASH) studies, not an evidence-based recommendation from data derived from a dialysis population. In addition, The Dietary Guidelines for Americans 2010, recommend further restriction of dietary sodium intake to 1500 mg per day for persons with hypertension and/or kidney disease, middle-aged and older adults, and African Americans, though there is also little empiric evidence to support this recommendation in the general population and none in the dialysis population. Therefore, it remains to be demonstrated that a diet with such sodium restrictions is attainable, sustainable, safe or beneficial. The investigators propose a double blind randomized controlled design investigation to examine the feasibility of assessing the effects of three levels of sodium intake (ambient, 2400 mg/d, 1500 mg/d) on the hemodialysis (HD) participant symptom profile, and to compare the effect of hemodialysis-specific variables on participant symptom profile during dialysis as well as to explore the role of body fluid composition using bioimpedance (BIA) measurements among the three sodium-restricted groups as a marker of sodium restriction efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. persons ≥ 21 years of age
2. who have the ability to read and write,
3. who are undergoing maintenance HD
4. who are on therapy for at least 3 months.

Exclusion Criteria:

1. unable to read or write
2. non-English speaking
3. intend to move out of the area or change HD centers within 6 months
4. have terminal illness or life expectancy of less than 12 months,
5. plan to receive a living donor transplant in the study period, have cognitive impairment
6. are unable to provide informed consent
7. have heart Failure Class III or IV
8. have an internal defibrillator or pacemaker, and/or are pregnant.
The Effect of Adding Pain Relievers to Local Anesthesia Before Preforming Drainage in Peritonsillar Abscess

The purpose of this study is to find if adding oral pain relievers as DYPIRON and TRAMADOL in addition to the local anesthesia injection, can help reducing the pain intensity in patients who diagnosed as Suffering from peritonsillar abscess (PTA)and treated by incision and drainage .

Control group: the patient will get local anesthesia injection with Lidocain. After 5 minutes- the DR will preform the incision and drainage of the abscess.

Then the patient will be asked by the vas score, the the pain intensity that he feels.

Intervention group:the patient will get dypiron 4 ml and tramadol 50 mg. after 40 minutes,the patient will get local anesthesia injection with Lidocain. After 5 minutes- the DR will preform the incision and drainage of the abscess.then the patient will be asked by the vas score, the the pain intensity that he feels.

Eligibility Criteria:
Inclusion Criteria:patients with PTA in ages 18-65, who agreed to join the research -

Exclusion Criteria:cave to dypiron and/or tramadol, pregnant women, mental illness,soldiers.

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IgA Nephropathy Registration Initiative of High Quality (INSIGHT)

The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients at recruited hospitals and developing a IgAN database in China. Patients will be follow-up every one year, and both baseline and follow-up information will be entered into the registration system. All-cause and cardiovascular mortality and a composite renal outcome of doubling of serum creatinine and end stage renal failure (ESRD, defined as initiation of dialysis or kidney transplantation) of IgAN patients will be compared using the IgAN database.

The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients, and developing a IgAN database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics (including systolic blood pressure, diastolic blood pressure, primary cause of ESRD, and lab measurements of serum and urine), complications, drug information at the baseline will be collected. Patients will be follow-up every one year, the demographic and clinical characteristics, complications and drug information of patients will be collected at each visit. The investigators also record the clinical events at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), ESRD (defined as initiation of dialysis or kidney transplantation) and hospitalization for any cause. All-cause and cardiovascular mortality and a composite renal outcome of doubling of serum creatinine and ESRD for IgAN patients will be compared using the IgAN database.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy-proven primary IgAN patients;
2. age ≥14 years old
3. Adequate biopsy sample containing ≥8 glomeruli.

Exclusion Criteria:

Secondary causes of mesangial IgA deposition, such as Henoch-Schonlein purpura nephritis, systemic lupus erythematosus, liver cirrhosis and et al; eGFR≤15ml/min/1.73m2 at biopsy.
Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery

RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict which patients will respond to treatment.

PURPOSE: This laboratory study is looking at prognostic factors in patients receiving tegafur-uracil for stage II colon cancer that was completely removed by surgery.

OBJECTIVES:

* Identify the prognostic factors in patients with curatively resected stage II colon cancer receiving adjuvant chemotherapy with tegafur-uracil.
* Identify predictive factors of chemosensitivity to this regimen in these patients.

OUTLINE: Available tumor tissue samples are analyzed by real-time reverse transcriptase-PCR for TS, DPD, TP, OPRT, VEGF, cyclooxygenase-2, and FPGS; by PCR for microsatellite instability and genomic deletions on chromosome arm 18q; and pathologically for tumor budding, Crohn's-like lymphoid reaction, category of extent of poor differentiation, and fibrotic cancer stroma. The candidate prognostic and predictive markers are analyzed for correlation with disease-free survival, relapse-free survival, and overall survival of patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the colon or rectosigmoid

  * Stage II disease
* Must be registered on clinical trial TMDU-BRI-CC-05-01
* Must have resected tumor tissue available
* No hereditary colorectal cancer

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1

PRIOR CONCURRENT THERAPY:

* Not specified