cyrilzakka/clinical-trials huggingface dataset:
Assessment of Efficacy of LightWalker (Nd:Yag, Er:Yag) Laser Therapy on Incidence, Severity and Duration of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT). Prospective Randomized Open-label Study

Oral mucositis (OM) is a common and debilitating adverse effect of conditioning regimens in patients undergoing hematopoietic cell transplantation (HCT). It is treated symptomatically with pain relief medications. The use of low-level laser therapy (LLLT) to prevent tissue damage has been postulated for almost forty years, however, there are only a few reports concerning old generation lasers in mucositis prophylaxis in HCT recipients. Here we hypothesized, that a new generation LLLT (Nd: YAG Fotona LightWalker®) laser may be an effective prophylaxis in shortening and reducing the severity of this complication.

This clinical trial is a prospective, randomized open-label study. All patients qualified to hematopoietic stem cell transplantation will be informed about possibility of taking part in this study. Patients who meet the inclusion criteria will be enrolled and randomized into two groups.

Patients in the first group will receive standard supportive treatment. Patients in the second group, except for the supportive treatment (as in the first group), will additionally receive prophylactic laser therapy of oral mucosa during high-dose chemotherapy conditioning before HSCT. Patients will undergo laser treatment daily from the first day of conditioning regimen till the second day after stem cell transfusion. The procedure will be carried out by trained staff at the bedside.

Severity of oral mucositis and pain will be measured in both groups on days 0, 4, 7, 11, 14, 18 and 21 after HSCT.

Severity of oral mucositis will be assessed according to five-point WHO scale Pain intensity will be measured on the basis of ten-point NRS scale.

In addition, the need for opioid analgesics and total parenteral nutrition will be evaluated.

Photographic documentation will be made on days -7, 0, 7, 14, 21. All obtained results will be collected in a database and subjected to statistical analysis. Additional analysis will be carried out during the study to evaluate whether the differences in results between studied groups reach statistical significance with less than a predetermined number of patients.

Eligibility Criteria:
Inclusion Criteria:

* written, informed consent for participation in the study
* oral sanation
* myeloablative conditioning

Exclusion Criteria:

* lack of patient's consent
* pathological lesions in oral cavity on the first day of conditioning regimen
* renal failure
* active infection
The SCCS Polypill Pilot Trial

In this study the investigators will examine the effect of the polypill on medication adherence, systolic blood pressure, and LDL cholesterol over a 12 month span.

The purpose of this study is to assess if a polypill-based approach to primary CVD prevention is feasible in a low socioeconomic status population. The study will assess whether a polypill approach is associated with better cardiovascular risk factor control compared with usual care.

The polypill will be supplied as a compounded pill containing atorvastatin 10 mg, amlodipine 2.5 mg, losartan 25 mg, and hydrochlorothiazide 12.5 mg. The medications in the polypill have been extensively evaluated individually and in combination. Each of the medications in the polypill is approved by the United States Food and Drug Administration (FDA) and widely administered in the US for the treatment of and prevention of cardiovascular disease. The doses of each component medication included in the polypill are low, which should minimize the chance of any potential side-effects.

In this study we assess medication adherence, systolic blood pressure, and LDL cholesterol over a 12 month span, in subjects taking the polypill versus subjects under usual care.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled at the SCCS site in Mobile, Alabama, obtain care at Franklin Primary Health Center, or live in the surrounding area.
* Aged 45-75 years
* Baseline systolic blood pressure ≥120 mm Hg. In this open-label trial, the study physicians are permitted to prescribe any additional medication deemed appropriate to achieve blood pressure control.

Exclusion Criteria:

* History of coronary heart disease or stroke
* History of cancer, except for basal cell skin cancer
* History of liver disease, not including chronic, clinically-stable hepatitis
* Laboratory evidence of hepatic dysfunction (an alanine aminotransferase level more than two times the upper limit of the normal range)
* Known renal disease, estimated creatinine clearance \< 60
* Current use of more than 2 anti-hypertensive medications
* LDL cholesterol ≥190 mg/dl
* Insulin-dependent diabetes
* Known intolerance to any of the components of the polypill
* Potassium \<3.4 or \>5.5 mEq/L
* Use of medications that interact with statins, including those affecting the cytochrome P450 system
* Current use of diuretics for indications other than hypertension
* Comorbidities that might be expected to limit lifespan during the 12-month follow-up period
* Inability to provide consent.
Effects of the Adjunctive Use of Hyaluronic Acid-based Gel in the Surgical Periodontal Treatment of Periodontitis

This study aimed to assess the effect of Hyaluronic Acid-based gel as an adjunctive chemotherapeutic agent in surgical periodontal treatment on clinical parameters and cytokine levels (IL-6, IL-8, IL-10, IL-17A, TOS, and TAS) in gingival crevicular fluid (GCF) among periodontitis patients.

The aim of this study is to evaluate the effects of adjunctive Hyaluronic Acid-Based Gel (HA) application in the surgical treatment of patients with moderate to severe stage III periodontitis (Grade B or C) on clinical parameters, as well as on IL-6, IL-8, IL-10, IL-17, TAS, and TOS levels in gingival crevicular fluid (GCF) to determine its anti-inflammatory and antioxidant efficacy.

This split-mouth study included 18 patients (mean age 43.44±8.12 years) diagnosed with Stage III Grade B or C periodontitis. Quadrants were randomly assigned to two groups: Group 1 (control: open flap debridement \[OFD\], n=18) and Group 2 (test: OFD + 0.8% HA gel, n=18). Baseline (T0) assessments included plaque index (PI), gingival index (GI), bleeding on probing index (BPI), probing pocket depth (PPD), clinical attachment level (CAL), and GCF collection. Following non-surgical treatment, patients underwent OFD; HA gel was applied to defect sites in the test group and saline in the control. Clinical parameters and GCF sampling were repeated pre-surgery (TS-1), and at 1 month (TS-2) and 6 months (TS-3) post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Stage III Grade B or C periodotitis
* over 18 years old
* signed the informed consent

Exclusion Criteria:

* pregnancy, or lactation,
* systemic problems that would contraindicate for periodontal surgery,
* prosthetic restorations in the test or control teeth,
* taking medications that affect wound healing (corticosteroids, anticancer agents, etc),
* using nonsteroidal anti-inflammatory drugs, using any antibiotics and anti-inflammatory drugs in the last 6 months,
* alcohol abuse and smoking use
Sensory Assessment and Regression Rate of Bilateral External Oblique Intercostal Block and m-TAPA Block

External oblique and m-tapa blocks are routinely performed on patients undergoing laparoscopic cholecystectomy in our clinic. In this study, sensory block and regression rates will be investigated in patients who underwent block.

External oblique block and m-Tapa blocks may be the key to provide adequate analgesia in patients undergoing abdominal surgery by blocking the abdominal nerves. In this study, the sensory dermatome block area calculation and the regression rate of the blocks will be evaluated in patients who underwent EOIB and m-Tapa.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing L/S cholecystectomy

Exclusion Criteria:

* patients who do not want to participate
RCT on Elderly Patients Undergoing Colorectal Cancer Surgery With Enhanced Geriatric Care

This study evaluates the effects of enhanced geriatric input on elderly patients undergoing colorectal cancer surgery. Half of the participants will received additional pre, peri and post-operative care from the geriatric team, while the other half will receive standard surgical care.

Additional geriatric care involves appropriate assessments and interventions by a multidisciplinary team involving geriatricians, physiotherapist, occupational therapist, surgical team, dietician and social worker. It is divided into three stages of care: 1) preoperative assessment, 2) perioperative care and 3) discharge or rehabilitation. In preoperative assessment, a comprehensive geriatric assessment will be carried out which encompasses patients medical and social backgrounds, cognitive status, nutritional assessment and risk factors identification. Perioperative care includes a joint care by surgical and geriatric teams aiming to prevent and treat any postoperative complications. Discharge and rehabilitation aim to identifies and facilities any potential discharge problem or accelerates patients for rehabilitation to the appropriate locations.

Standard surgical care will be given to patients who are undergoing colorectal cancer surgery but without the additional input mentioned above.

Eligibility Criteria:
Inclusion Criteria:

1. Consecutive colorectal cancer patients (aged 70 and over) undergoing elective colorectal cancer surgery at the Prince of Wales Hospital, Shatin, Hong Kong
2. American Society of Anaesthesiologists fitness score of I, II or III

Exclusion Criteria:

1. Colorectal cancer patients aged 69 or under undergoing colorectal surgery
2. Patients undergoing emergency colorectal cancer resection
3. Patients with benign pathology
4. Patients with evidence of locally advanced or metastatic spread of their primary disease
5. Patient who are unable to give informed consent
Iron Repletion in Chronic Cough and Iron Deficiency

Chronic cough is more frequent and severe in women than in men. Women often have decreased iron stores, due to menses and pregnancies. Aim of the study: to investigate if iron deficiency has a role in chronic cough by favouring airway hypersensitivity to inhaled irritants.

Women with chronic cough and iron deficiency, cough unresponsive to empiric treatment (suggested by cough guidelines) with antiH1-histaminic drug plus proton pump inhibitor.

Cough VAS (score from 1,best, to 5, worst). Histamine inhalation challenge, performed to assess bronchial, laryngeal, and cough thresholds, performed by delivering doubling concentrations, from 0.5 mg/ml up to 32 mg/ml, by a nebulizer. After each dose FEV1, as bronchial index, maximum mid-inspiratory flow (MIF50) as laryngeal index, and coughs number are assessed. Bronchial threshold is the concentration causing 20% decrease in FEV1, laryngeal threshold that causing 25% decrease in MIF50, cough threshold that causing 5 coughs. Histamine hyperresponsiveness of the bronchi (BHR), larynx (LHR) and cough (coughHR) are defined for thresholds equal or below 8 mg/ml.

Histamine thresholds and cough VAS obtained in baseline, after cough empiric treatment with antiH1-histaminic and proton pump inhibitor, and after iron supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Unexplained cough : no detectable trigger for chronic cough identified, such as persistent rhinitis, chronic sinusitis, gastroesophageal reflux disease and asthma.
* no benefit by prior treatment with antiH1-histaminic drug and proton pump inhibitor.
* iron deficiency.
* normal lung function tests and chest radiography no relevant systemic disease.
* no acute respiratory infection in the last eight weeks.
* no pharmacological treatment in the last two weeks.

Exclusion Criteria:
Vaginal Estradiol Use in Pessary Care

The primary outcome of this study compare the rate of pessary discontinuation at 6 months post-pessary fitting in women using vaginal estradiol versus those not using vaginal estradiol.

The purpose of the study is to investigate the effects of vaginal estradiol cream on pessary care. All patients presenting to the University of South Florida Urogynecology clinic for pessary fitting for pelvic organ prolapse and/or urinary incontinence are screened as potential study participants. After being informed of risks and benefits of participations and consent is obtained, patients that have been successfully fitted for a pessary and agree to participate will be separated into two groups: the control group or treatment group. The treatment group will be provided with a prescription for vaginal estradiol cream. Vaginal estradiol cream is FDA approved and is the first line treatment for vaginal atrophy, also known as dryness. The study will be unblinded and randomized, neither the participant nor the study doctor will choose which group the will be participant will be placed in. The participant will have an equal chance of being given either treatment. The treatment group will be asked to apply vaginal estradiol cream nightly for two weeks and then twice weekly thereafter. All participants will have 2 study visits over a 6-month period which is standard for pessary care: a regular follow up pessary check visit two weeks after pessary fitting and second visit 6 months later. At these visits, questions regarding symptoms including vaginal bleeding, vaginal discharge, and discomfort with pessary will be assessed and a physical exam will be performed as is standard for all pessary users.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Postmenopausal status
* Recent pessary fitting
* Office-based and home-based pessary care

Exclusion Criteria:

* Women \< 18 years old
* Women currently on hormone replacement therapy (pill, patch, pellet)
* Women currently using vaginal estradiol cream within the last 4 weeks
* Medical contraindications to vaginal estradiol including unevaluated vaginal bleeding
* Inability to apply vaginal estradiol cream
* Inability to provide informed consent
* Inability to comprehend written and/or spoken English or Spanish
* Inability to comply with study visit schedule
Effects of HQK-1001 in Patients With Sickle Cell Disease

The purpose of this study is to evaluate the effects of HQK-1001 on Hb F in subjects with sickle cell disease.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 12 and 60 years of age
* Diagnosis of SCD, type Hb SS or Hb S-B0 Thalassemia
* At least 1 episode of SCD pain crisis, acute chest syndrome, other acute SCD complications, or leg ulcers in the 12 months prior to screening
* Not being treated with Hydroxyurea (HU); if HU treatment has been previously administered and then discontinued, at least 3 months must have elapsed since last dose of HU
* If subject has been transfused in the 3 months prior to screening, then Hb A level \< 20% at screening
* Baseline Hb F level obtained within 14 days prior to randomization
* Able to swallow tablets
* Able and willing to give informed consent and/or assent
* If subject is a woman of child-bearing potential (WCBP), she must have a negative serum pregnancy test within 14 days of first dose of HQK-1001 and a negative urine pregnancy test prior to dosing on Day 1
* If a subject is a WCBP, she must agree to use an effective form of contraception starting at screening and for one month after HQK-1001 discontinuation
* Sexually active male subjects who have not had a vasectomy must agree to use latex condoms with WCBP partners or ensure that their partner(s) use an effective form of contraception starting at screening and for one month after HQK-1001 discontinuation.

Exclusion Criteria:

* Assigned to a regular transfusion program
* Use of erythropoiesis stimulating agents within 90 days prior to screening
* An SCD pain crisis or SCD-related acute complication within 3 weeks prior to randomization
* More than 5 SCD pain crisis or SCD-related acute complications within 12 months prior to screening
* Pulmonary hypertension requiring therapy
* ALT or AST \> 3x ULN
* Serum creatinine \> 1.5x ULN
* Serum amylase levels \> 1.5x ULN
* Serum lipase level \> 1.5x ULN
* A serious, concurrent illness that would limit ability to complete or comply with the study requirements
* An acute illness (e.g., febrile, GI, respiratory) within 72 hours prior to screening
* History of syncope, clinically significant dysrhythmias or resuscitation from sudden death due to SCD-related complication
* Symptomatic peptic ulcer, hiatus hernia, or gastroesophageal reflux disease (GERD)
* History of pancreatitis
* Chronic opiate use, which, in the view of the investigator, could confound evaluation of an investigational drug
* Current abuse of alcohol or drugs
* Use of another investigational agent within 4 weeks or 5 half-lives, whichever is longer, prior to screening
* Currently pregnant or breast feeding a child
* Known infection with HIV-1
* Infection with hepatitis B or hepatitis C, such that subjects are currently on anti-viral therapy or will be placed on therapy
A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD

This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.

The study will be performed in subjects with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of PXL770 exposure in plasma.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have given written informed consent
* Body mass index (BMI): ≥ 25 kg/m²
* Hepatic steatosis (CAP ≥ 300)
* Insulin-resistant but not diabetic subjects
* Fasting plasma glucose \<126 mg/dL
* Glomerular filtration rate (eGFR) ≥ 60 mL/\[min\*1.73 m²\]
* Alanine amino transferase (ALT) \> 20 IU/L in females and \> 30 IU/L in males
* Effective contraception

Exclusion Criteria:

* Evidence of another form of liver disease
* Evidence of liver cirrhosis
* Evidence of hepatic impairment
* Positive serologic evidence of current infectious liver disease
* History of excessive alcohol intake
* Acute cardiovascular disease with 24 weeks prior to screening
* Uncontrolled high blood pressure
* Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study
* Use of non-permitted concomitant medication
* Pregnancy or lactation
Perioperative Optimization With Enhanced Recovery

This is a randomized controlled trial examining the effect of a motivational interview and perioperative mobile-app based nutrition and exercise intervention on surgical outcomes. The hypothesis is that such an intervention will improve surgical outcomes. Patients who are planned to undergo major elective abdominal surgery will be randomized to standard care or the nutrition/exercise intervention. This intervention consists of a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.


Eligibility Criteria:
Inclusion Criteria:

* major abdominal surgery in 3+ weeks
* English or Spanish speaking

Exclusion Criteria:

* Unable to use smartphone
The Effect of Ozone Therapy for Lumbar Herniated Disc

The purpose of this study is to assess the efficacy (vs. placebo) of ozone infiltration and its effectiveness in comparison with micro discectomy in the treatment of lumbar herniated disc with criteria for surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of herniated disc by surgeons from participating hospitals
* Sciatic pain of 5 or more on Visual Analogue Scale
* Pain radiated to appropriate area according to herniated disc
* On waiting list for disc surgery at one of participating hospitals

Exclusion Criteria:

* Inability to fill out questionnaires (VAS, Roland Morris, SF12)
* Calcified or migrated herniated disc
* Herniated disc with indications for laminectomy or arthrodesis
* Clinically relevant partial paralysis
* Simultaneous cervical and dorsal symptomatic herniated discs
* Previous lumbar spine surgery
* Presence of other spinal pathology
* Significant glucose-6-phosphate-dehydrogenase deficit
* Allergy to ozone
* Treatment with oral anticoagulants
Value of Prothrombin Fragment F1+2 in the Diagnosis of Pulmonary Embolism in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

To access the clinical usefulness of F1+2 in the diagnosis of PE in patients with AECOPD who require hospitalization. Specifically, to determine whether F1+2 may have an additional value in the subgroup of patients with an abnormal D-dimer,to determine whether it may increase the proportion of patients in whom PE can be safely ruled out and to determine the sensitivity, specificity and NPV of F1+2 at various cut-off values.


Eligibility Criteria:
Inclusion Criteria:

* COPD exacerbation
* Able to give informed consent
* Able to perform spirometry

Exclusion Criteria:

* Known malignancy
* Known hypercoagulable state
* Receiving anticoagulant treatment
* Pregnancy
* Renal failure
* Allergy to iodine
Efficacy and Safety Study of a Modified SOX Regimen in First-Line Treatment of Unresectable Gastric Adenocarcinoma

This is an open-label, phase II study to evaluate the efficacy and safety of a modified regimen of oxaliplatin and S-1 on unresectable gastric adenocarcinoma in the first-line therapy.

Primary endpoint: Overall Response Rate

Secondary endpoint: Time to progression, overall survival, safety data

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent;
* Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2;
* Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination;
* At least 3 weeks since last major surgery;
* At least 12 months since last adjuvant chemotherapy;
* At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected;
* Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields;
* Patients with reproductive potential must use effective BC;
* Required Screening Laboratory Criteria:

  * Hemoglobin 90g/L
  * WBC 3.5 x 109/L
  * Neutrophils 1.5 x 109/L
  * Platelets 100 x 109/L
  * Creatinine 133 umol/L and creatinine clearance 60 mL/min
* A probable life expectancy of at least 6 months;

Exclusion Criteria:

* Brain metastases;
* Female of childbearing potential, pregnancy test is positive;
* Concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer;
* Active infection;
* Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk;
* Sexually active patients refusing to practice adequate contraception;
* Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator;
* History of grade 3 or 4 toxicity to fluoropyrimidines;
* Pre-existing neuropathy ≥ NCI CTC grade 2.