cyrilzakka/clinical-trials huggingface dataset:
Titanium-Prepared Platelet Rich Fibrin in the Sinus Lifting Procedure

This study evaluates the radiographic, histological and clinical comparisons of the completely autologous T-PRF or allograft effectiveness at the maxillary sinus elevation procedure.

Participants randomly divided into 2 groups and the test group had a Schneiderian membrane elevation with using balloon lifting technique and after that sinus was filled with T-PRF produced from the patients' blood and 4 months waiting period has been entered. At the end of the 4th month, the bone samples were received from the implant slots and sent to histological evaluation. After 3 months, implant stability was measured and recorded. In the control group, the same procedures were followed and sinus was filled with only allograft. Waiting period was changed to 6 months for this group.

Eligibility Criteria:
Inclusion Criteria:

* Participants having been diagnosed to display a residual crest height of less than 5mm in posterior maxilla and non-smokers were included.

Exclusion Criteria:

* Participants with blood platelet disorders, infectious and metabolic diseases, ongoing chemotherapy or radiotherapy, history of chronic sinusitis associated with maxillary sinuses, taking any antibiotics and/or anti-inflammatory drugs were excluded.
Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis

The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.

This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. The study will be conducted in two phases. Hemodialysis patients treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these participants will be converted back to epoetin alfa administered TIW for 32 weeks. The primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.

Eligibility Criteria:
Key Inclusion Criteria:

* Receiving hemodialysis 3 times a week
* Receiving epoetin alfa IV 3 times a week
* Hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dL within 8 weeks of or during screening

Key Exclusion Criteria:

* Systemic hematologic disease
* Changes in Epoetin alfa dose by ≥ 50% within 8 weeks of or during screening
Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema

This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 or 2 diabetes mellitus
* Diagnosis of macular edema
* Visual acuity between 20/200 to 20/40

Exclusion Criteria:

* Eye surgery to the study eye within 3 months
* Use of Ozurdex® within 9 months
* Any active ocular inflammation and infection
* Diagnosis of glaucoma
* Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic use (e.g., Avastin®) within 6 months
CARG, VES13, G8 Scales in Predicting Drug Toxicity in Patients Receiving Nivolumab

The Geriatric 8 (G8), Vulnerable Elders Survey (VES-13), and Cancer and Aging Research Group (CARG) questionnaires are among the main tests whose purpose is to predict the risk of chemotherapy-induced toxicity (CRT) and allow treatment. Investigators aimed to investigate the effect of using the G8, VES13, and CARG scales in the geriatric age group in cancer patients receiving nivolumab treatment in predicting side effects.

Investigator aimed to examine whether the G8, VES13, and CARG scales can shed light on clinicians in predicting side effects during the use of nivolumab in geriatric cancer patients. In the chemotherapy unit, demographic information, diagnosis date of the disease, previous treatments, comorbidities, and CARG, VES13, and G8 questionnaires will be recorded face-to-face to the patients who meet the study criteria. In addition, routine hemogram and biochemistry tests, which were requested by the patient's follow-up physician before Nivolumab treatment and which will be requested by the patient's own physician during follow-up visits, will be recorded prospectively. Side effects that may occur during nivolumab treatment will be pursued at each visit. CTCA v.6. will be used for grading.

inclusion criteria

1-Advanced cancer patients whose nivolumab treatment was started by the physician followed up (independent of diagnosis) 2-60 years and over, 3-ECOG performance score 0-1 4-Patients who signed the informed consent form

exclusion criteria

1. Under 60 years old
2. Ecog score \>1

Eligibility Criteria:
Inclusion Criteria:

* Advanced stage cancer patients who have been treated with nivolumab
* be over 60 years old

Exclusion Criteria:

* be under the age of 60
Nonvisual Foot Examination for People With Diabetes and Visual Impairment

Because people who have both diabetes and visual impairment have high risk for foot problems, prevention of ulcers and amputation is a high priority. Usual care in diabetes self-management education (DSME) is to teach them to seek sighted assistance for regular foot examination, yet clinical experience suggests that this advice is seldom heeded. One possible solution is to teach use of the nonvisual senses of touch and smell for a systematic, thorough foot self-examination. The purpose of this pilot study was to compare the efficacy, acceptability, and feasibility of nonvisual foot examination with usual care (examination of the visually impaired person's feet by a sighted family member or friend).


Eligibility Criteria:
Inclusion Criteria:

* over age 18
* diagnosed with either type 1 or type 2 diabetes
* stated they had visual impairment

Exclusion Criteria:

* unable to pass a brief decisional capacity test
* had a score above 80 on the near vision scale of the National Eye Institute Visual Functioning Questionnaire
* had bilateral lower extremity amputations
* by self-report were unable to sense light touch on two or more fingers or either hand
A Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers

GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test the extent of the GW679769 affect on Warfarin levels in humans.


Eligibility Criteria:
Inclusion criteria:

* Healthy subjects
* non-smoking
* Females cannot be able to have children
* Must be able to swallow and retain oral medication
* Understand and sign the written consent
* comply with the requirements and restrictions involved in an overnight 30 day confinement in a healthcare setting

Exclusion criteria:

* cannot participate if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
* blood donation in excess of 1 pint within 56 days before dosing of medication
* iron deficiency
* history of drug or alcohol abuse or dependency within the past 6 months
* subjects cannot use any nicotine-containing products within the last 6 months
* positive for HIV, Hepatitis B or C
* use of prescription or non-prescription drug(s), herbal or dietary supplements or vitamins with 14 days prior to first dose of study medication
* consumption of any food or drink containing grapefruit, Seville oranges, kumquats, pomelos (or their juices) within 7 days of the first dose of study medication
* history of bleeding disorders or excessive bleeding
* female who has a positive pregnancy test
* female who is lactating
The Singulair® add-on Study Effectiveness of Adding Montelukast to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma (0476-384)

The purpose of this study is to evaluate the effectiveness of adding Montelukast Sodium (singulair®) 10 mg per day to inhaled corticosteroids in adult subjects with uncontrolled asthma.


Eligibility Criteria:
Inclusion Criteria:

* Patients Is 18 Years Old

Note 1: Regulatory Requirements Necessitate The Following Criterion. It May Not Be Appropriate For Your Patients. Female Patients Of Childbearing Potential Should Be Informed Not To Become Pregnant During The Study By Using The Appropriate Contraceptive Methods (Oral Or Long-Acting Contraceptive Injections (Depo Provera), Intrauterine Device (Iud), Or Barrier Methods (E.G. Condom Or Diaphragm Plus Spermicide) Or To Be Abstinent (No Sexual Intercourse)) Beginning At Least 7 Days Before Visit 1 And Continuing At Least 14 Days After Visit 4 Or A Discontinuation Visit

Note 2: For Alberta: Investigators Who Will Recruit In Private Office, No Patients Can Be Recruited In The Study Until Approval From The College Of Physicians And Surgeons Of Alberta Ethics Committee Is Obtained

Exclusion Criteria:

* Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy
Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment

The study is being conducted to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Confirmed histologic diagnosis of invasive adenocarcinoma of the breast
* ER, PR and HER2 testing, and
* TNBC patients （ HER2-neu 0-1+ by IHC or FISH-negative by ASCO CAP guidelines）
* ER-positive and HER2-negative breast cancer
* tumor measuring ≥2 cm in maximal diameter as measured by any available standard of care imaging (mammogram, breast ultrasound, breast MRI)
* Any nodal status
* ECOG Performance Status of 0 -1
* Screening laboratory values must meet the following criteria:

  i. Absolute neutrophil count (ANC) ≥1.5 × 109/L ii. Platelets ≥100 × 109/L iii. Hemoglobin ≥ 10.0 g/dl for TNBC, ≥ 10.0 g/dl for HR+/HER2-BC iv. Serum creatinine ≤1.5 x upper limit of normal (ULN) v. AST ≤ 2.5 xULN vi. ALT ≤ 2.5 x ULN vii. Total bilirubin ≤ 2.5 xULN viii left ventricular ejection fraction ≥ 50%.

Exclusion Criteria:

* Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on
* Inflammatory breast cancer
* Pregnant and lactating women;
* distant metastasis
* patients who have participated in other clinical trials.
Intrauterine Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions

Women undergoing operative hysteroscopy for removal of retained placenta after delivery will be randomized into two groups.

1. study group - immediately after operative hysteroscopy 5 ml hyaluronic acid gel will be injected into uterine cavity
2. control group - no injection

4-8 weeks after operative hysteroscopy, participants will undergo diagnostic hysteroscopy with no anesthesia , as a part of routine evaluation after removal of retained placenta in Israel.

during diagnostic hysteroscopy the uterine cavity will be evaluated and the presence of adhesions and severity of adhesions will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing hysteroscopic removal of retained placenta after delivery

Exclusion Criteria:

* Known adverse reaction or allergy to hyaluronic acid

History of intrauterine adhesions

Acute pelvic inflammatory disease
Effect of a Candy Flavoring Before Local Anesthesia on Anxiety and Pain Perception in Children

This is a randomized clinical trial that aimed to test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception when compared to a negative control group. Applying the flavor before injecting local anesthesia helped in distracting the child and reduced the associated pain.

Background: Distraction techniques can be very useful in managing children on the dental chair and to guide their attention away from a painful stimulus. No studies so far have used a sugar-free solution as a distraction method.

Aim: To test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group, using a split-mouth randomized study design.

Methods: A total of 84 children, aged 4-9 years with no previous dental experience and require the same treatment on the upper primary first or second molars bilaterally were included in this study. Each child received two injections. The children were randomly allocated into two groups, group 1 received the first injection after applying a flavor, and group 2 received the first injection after applying sterile water. The children received the first injection either on the right or left side, and switched sides on the next visit, resulting in (n=168) total injections. The observed pain perception was assessed using the SEM scale. Wong-Baker Faces pain rating scale will be used to assess the pain reported by the child. Pulse rate, BMI, and sweet taste preference were also recorded by an independent observer to ensure blinding.

Results: Using a sugar-free candy flavor before injecting local anesthesia helps in reducing pain accompanying local anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (ASA Grade 1 status) children
* First dental experience for the child including local anesthesia.
* Children with caries lesions that require restorative treatment.
* Children who require the same treatment on upper primary first or second molars bilaterally.

Exclusion Criteria:

* Children with poor behavior (unable to cooperate for dental treatment).
* Previous unpleasant dental experience (dental phobia).
* History of abscess, redness, fistula in the injection site (need for extraction).
* Presence of a systemic disease, mental, cognitive and intellectual disabilities.
Use of Faecal Calprotectin to Predict Enteropathy of the Preterm Neonates

This study aims to evaluate a clinico-biological predictive score, associating the faecal calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.

Enteropathy and necrotizing enterocolitis (NEC) are digestive emergencies in premature neonates which represent a major concern for the vital prognosis. It is therefore important to propose a tool for early diagnosis of these intestinal complications in order to avoid extended interruptions of enteral feeding at a period of life where growth (and digestive maturation) is in the foreground. Currently, the diagnosis of digestive impairment is based on classical clinical, biological (CRP, procalcitonin, fecal calprotectin, NFS) and radiological (abdomen without preparation) approaches, which induce on one hand a prolonged interruption of enteral feeding sometimes useless and even harmful for the intestinal maturation and, secondly, the establishment of a parenteral nutrition which is not risk-free. The study propose to dose the fecal calprotectin, a non-invasive marker of digestive inflammation, in order to validate the threshold decision proposed in a pilot study (350 µg/g of feces). Measurement of fecal calprotectin levels will be used as an integrated tool to build a powerful screening score combined to the usual parameters used in routine care for the diagnosis of and enteropathy and necrotizing enterocolitis (NEC) in premature neonates. A cohort of preterm infants born at a gestational age of 33 weeks or less will be included from birth. A stool sample will be collected from the diaper once a week, from birth until discharge from the hospital, and every day during gastrointestinal events (interruption of enteral feeding over 48 hours). The study will evaluate the performance of the rapid assay of fecal calprotectin by quantitative immunochromatography compared to the reference method by enzyme-linked immunosorbent assay (ELISA).

Eligibility Criteria:
Inclusion Criteria:

* Infants prematurely born at a gestational age of 33 weeks or less (or before the 7th month of pregnancy).
* Patient whose parents or holders of parental authority signed an informed consent.

Exclusion Criteria:

* Patient with a malformation.
* Lack of signature of the consent by parents or holders of parental authority.
Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Closure

Post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication.

The investigators will compare transvaginal versus laparoscopic closure of the vaginal vault at the end of a total laparoscopic hysterectomy, in order which of these two modalities of suturing is associated with a lower risk of dehiscence.

A post-hysterectomy vaginal cuff dehiscence is defined as a partial or total separation of the margins of the vaginal cuff closure, following hysterectomy.

The recognition of the complication is made on a clinical basis. The investigators will compare the percentage of dehiscence among women who had transvaginal vs. laparoscopic suture of the vault.

The investigators will also compare the two modalities in terms of:

* duration of the vaginal closure
* risk of bleeding from the vaginal cuff
* risk of post-operative pelvic infection
* risk of re-operation
* dyspareunia
* total vaginal length
* vaginal cuff prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy

Exclusion Criteria:

* Patients with gynecological malignancy (uterine and/or adnexal)
Predictive Factors and Outcome in Medical Thoracoscopy

Retrospective survey for factors predicting the outcome of medical thoracoscopy

Retrospective survey for factors predicting the outcome of medical thoracoscopy in patients with malignant pleuritis

Eligibility Criteria:
Inclusion Criteria:

* progressive malignancy
* pleuritis

Exclusion Criteria:

* respiratory failure
* unable to consent
High-fiber Diet on the Body and the Brain

The central research question aims to understand what drives individuals to make and maintain a vegan / vegetarian dietary decision, to investigate whether there are possible predictors that might influence such a decision and whether personality differences already exist or can only be measured after the change in diet. The investigators will examine the effects of a high-fiber diet on food wanting on a neural and on a behavioral level. The microbiome is suggested to mediate the expected changes in food wanting.


Eligibility Criteria:
Inclusion Criteria:

* body-mass-index 25-30kg/m\^2
* females on contraception only

Exclusion Criteria:

* current neurological or psychiatric illness
* daily consumption of more than 50 g of alcohol, more than 10 cigarettes or more than 6 cups of coffee
* use of antidepressants or other centrally acting drugs
* type 2 diabetes mellitus or other serious metabolic disorders
* MRI contraindication (e.g. cardiac pacemaker, drug pump, shunts)
* major untreated medical condition, including gastrointestinal organs, lungs, heart, cardiovascular system, liver and kidney)
* diet-related restrictions (food allergies, food intolerances, known nutrient deficiencies or a recent history of dieting or restrictive eating behaviour, including vegan, vegetarian diet)
* current pregnancy or lactation
Increased Expression of Adiponectin Receptor 2 in the Mononuclear Cells in Children With Prader-Willi Syndrome

The inflammatory process is involved in the pathogenesis of obesity. Prader-Willi syndrome (PWS) is a genetic model of syndromic obesity. Adiponectin is an adipokine with potent anti-inflammatory properties, and its effect is mediated through adiponectin receptors 1 (adipoR1) and 2 (adipoR2).

Objective of this study is to compare the expression of adipoR1, adipoR2, and adiponectin in peripheral blood mononuclear cells (PBMCs) in PWS children and obese control and to correlate receptor expression with insulin sensitivity and obesity-related parameters.


Eligibility Criteria:
Inclusion Criteria:

* children with Prader-willi syndrome
* children with simple obesity

Exclusion Criteria:

* subjects with diabetes mellitus (fasting plasma glucose \> 126 mg/dL with a 2-h oral glucose tolerance test value of \>200 mg/dl)
Correlates of Left Ventricular Global Longitudinal Strain and Surgical Intervention on Myocardial Bridges

To examine the changes in left ventricular (LV) global longitudinal strain (GLS), using two-dimensional speckle tracking analysis, after left anterior descending (LAD) unroofing, in myocardial bridges (MBs) refractory to optimal medical therapy (OMT).

The present study is enrolling all the MBs-patients who underwent angina surgical relief or medical treatment at the "Ospedali Riuniti" of Ancona, Italy, and the "University Hospital" of Chieti, Italy. All the participants will be examined utilizing echocardiography before and after the treatment. The two-dimensional speckle-tracking analysis will be performed with an off-line dedicated software from the apical 4-chambers-view. All the unroofing procedures will be performed under cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* Myocardial bridge of the anterior descending left coronary artery

Exclusion Criteria:

* Poor echocardiographic imaging quality
Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE)

The aim of this study is to determine the effect of Lanreotide on polycystic liver and kidneys in patients with autosomal dominant polycystic kidney disease.

The aim of this single center observational study is to assess the effect of lanreotide on polycystic liver and kidney. This is achieved by assessing total liver and kidney volume, and several urinary markers that could predict kidney damage or kidney dysfunction, such as GFR, blood pressure, and urinary tubular damage markers and serum biomarker FGF23.

The investigators aim to include 43 patients affected by a polycystic liver due to ADPKD. The duration of the trial will be 28 weeks. The treatment will be 24 weeks and the first screening visit will take place four weeks before start of treatment. Eligible patients will be invited to participate.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ADPKD with polycystic liver (\> 20 liver cysts)
* Renal function MDRD \>40 ml/hr
* Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements

Exclusion Criteria:

* Kidney transplantation
* Renal failure requiring hemodialysis
* Use of oral contraceptives or estrogen suppletion
* Women who are pregnant or breastfeeding
* History of cardiac/pulmonary disease; symptomatic gallstones, pancreatitis, etc
* Intervention (aspiration or surgical intervention) within three months from baseline
* Treatment with somatostatin analogues within three months from baseline
* Mental illness that interferes with the patient ability to comply with the protocol
* Drug or alcohol abuse within one year from baseline
* Abnormal liver function tests, as determined by blood test (except isolated elevated GGT and AP, which occurs frequently in PLD)
* Clinical diagnosis of pancreatitis
* Diagnosis of diabetes mellitus, as determined by blood test and medical history
* Use of drugs that can interact with lanreotide, such as cyclosporin