cyrilzakka/clinical-trials huggingface dataset:
Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds

The study objectives are to evaluate safety and efficacy of topical administration of RPh201 oil solution (botanical extract) for treatment of patients with hard to heal chronic ulcerated wounds.

The study objectives are to evaluate safety and efficacy, of topical administration of RPh201 for treatment of patients with hard to heal wounds.

This is to include:

* Safety evaluation of RPh201 (botanical extract) formulated as an oil solution administered topically three times per week during an overall treatment period of up to 4 weeks in patients with hard to heal wounds.
* Efficacy assessment of wound improvement following the use of RPh201 oil solution (botanical extract) administered topically three times per week during an overall treatment period of up to 4 weeks and at the follow-up visit at 3 months after end of treatment in patients with hard to heal wounds

Eligibility Criteria:
Inclusion Criteria:

1. Participants, either men or women are ≥ 18 years of age.
2. Patients must have at least one hard to heal wound of different etiologies (venous insufficiency, lymphatic insufficiency, neuropathic wounds or diabetic ulcers, post- operative and post-traumatic chronic wounds) located on the leg shin or foot.
3. The wound is refractive to healing at least 4 weeks prior to treatment, although treated by routine practice.
4. Wound area size is in the range of: 3 - 36 square centimeters.
5. Patients defined as grade C or above on the granulometer scale (see section 6.5.1).
6. Participants understand the nature of the procedure and provide written informed consent prior to any study procedure.
7. Women of child bearing potential must use adequate birth-control precautions.

Exclusion Criteria:

1. Clinically significant arterial vascular disease with ABI index \<0.45 if the peripheral pulse is not palpable, or flatted PVR in case of non palpable arteries.
2. Clinical evidence for presence of infection in the soft tissue, joint and/or bone (osteomyelitis).
3. Wound has Non-viable tissue which covers more than 50% of the wound area.
4. Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound.
5. The wound penetrates into deep organs and involves bone, tendon or joint
6. Wound with sinus tracts
7. Patients are receiving, or have received within one month prior to enrollment any treatment known to impair wound healing, including but not limited to: immuno-suppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
8. Treatment with a dressing containing growth factors or other biological dressings within 15 days, prior to the screening visit.
9. Patients that have a history of alcohol or drug abuse within the last two years.
10. Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
11. Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
12. Clinically significant and/or uncontrolled condition or other significant medical disease
Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

The purpose of this study is to determine that a new drug called "Rivaroxaban®" is effective in preventing patients from forming clots after their heart rhythm has been reset by the cardiologist with an electrical device.

Patient who are electrically cardioverted require 1 month of anticoagulation (blood thinner). Rivaroxaban a Xa-inhibitor has been shown to be non-inferior to Warfarin (Vit K antagonist) the current standard of care in many treatment areas. Rivaroxaban will be compared to Warfarin historical control group studying the safety and efficacy in electrically cardioverted patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-valvular atrial fibrillation requiring electrical cardioversion o Atrial fibrillation of unknown duration

Exclusion Criteria:

* Patients requiring extended anticoagulation after cardioversion due to concomitant risk factors as defined by CHADS2 score ≥ 1
* Significant renal dysfunction (CrCl \<15mL/min)
* Significant hepatic dysfunction (Childs-Pugh Class B or C)
* History of coagulopathy
* Active bleeding
* Hypersensitivity to Rivaroxaban
* Concomitant use of anticoagulants
* Concomitant use of potent CYP3A4/P-gp inhibitors or inducers
* Interventions requiring interruption of therapy
* Pregnancy
* Age \<18 y/o
* History of GI Bleed
Dermal Tolerability of Dapsone Gel in Healthy Volunteers

This study will determine the cumulative irritation potential and sensitization potential of dapsone gel and vehicle after repeat applications on the skin of healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

-Healthy adults.

Exclusion Criteria:

* Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application
* Sensitivity to adhesive bandages or tape.
Suitability of Nitisinone in Alkaptonuria 2

This is a proposal to develop the orphan designated drug, nitisinone, for the treatment of a rare Mendelian disease, Alkaptonuria (AKU). Thanks to our existing successful fundamental and clinical research (cell models, animal models, natural history studies), we are now ready for this final stage of clinical development of nitisinone for AKU: a phase 3 clinical trial to prove efficacy. The results of DevelopAKUre will allow us to make the case to the European Medicines Agency for marketing authorisation of nitisinone for AKU, thereby contributing to the goal of the International Rare Diseases Research Consortium of developing 200 new therapies by 2020.


Eligibility Criteria:
Inclusion Criteria:

A patient must fulfil the following criteria in order to be included in the study:

1. Diagnosis of AKU Any Clinical manifestations of AKU, such as clinical ochronosis or chronic back/joint pain.

3. Age ≥25 years. 4. Willing and able to visit the investigational site for study visits. 5. Signed written informed consent given.

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Exclusion Criteria:

The presence of any of the following will exclude a patient from inclusion in the study:

1. Currently pregnant or lactating.
2. Female patient of child-bearing potential not using a reliable method of contraception.
3. Known allergy to nitisinone or any of the constituents of the investigational product.
4. Current malignancy.
5. Uncontrolled hypertension (blood pressure greater than 180 mmHg systolic or greater than 95 mmHg diastolic).
6. Unstable cardiovascular disease.
7. Serum potassium \< 3.0 mmol/L.
8. eGFR \< 60 mL/min .
9. ALT \> 1.5 x upper limit of normal.
10. Haemoglobin \< 10.0 g/dL.
11. Platelets \< 100 x 109/L.
12. Total white blood count \< 3.0 x 109/L or neutrophil count \< 1.5 x 109/L.
13. History of alcohol or drug abuse.
14. Participation in another clinical study within 3 months of randomization.
15. Treatment with nitisinone within 60 days of randomization.
16. Psychiatric or somatic illness that interferes with compliance or communication with health care personnel.
17. Foreseeable inability to cooperate with given instructions or study procedures.
18. Any other medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion.

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Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role?

This study aims at evaluating, in chronic kidney disease patients on dialysis, the effect of acute per- or pre-dialytic physical exercise on regional myocardial function and myocardial stunning, blood viscosity, arterial stiffness, variability of sinus rhythm, dialysis efficacy, inflammation, mineral and bone disorders, myokines and cardiac remodeling markers.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 20 to ≤ 79 years
* Undernourished patient according to the ARNOS score : ≥ 2
* No medical contraindication to physical activity
* Life expectancy greater than 6 months
* Patient on hemodialysis for more than 3 months
* Patients with relatively good echogenicity

Exclusion Criteria:

* Patient is participating in another Category I interventional study, or has participated in another interventional study within the past 3 months
* The patient is in an exclusion period determined by a previous study
* The patient is under legal protection or under guardianship or curatorship
* It turns out to be impossible to give the patient informed information, or the patient refuses to sign the consent
* Pregnant, parturient or breastfeeding patient
* Patient with a contraindication to retraining
* Patient with valvular heart disease, arteriopathy of the lower limbs stage III and IV, amputation or knee or hip prosthesis
* Patient with musculoskeletal problems
* Patient with severe respiratory failure
* Paired sleep apnea syndrome
* BMI\> 35
* Patient with automatic implantable defibrillator
* Heart transplant
* Uncontrolled high blood pressure
* Ejection fraction \<45%
* Unstabilized coronaries
* Non-contributory stress ultrasound
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R\^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R\^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed grade 1-3a FL or MZL
* Previously treated with ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy
* Need for systemic therapy for FL or MZL
* Measurable disease by computed tomography or magnetic resonance imaging
* Adequate bone marrow, liver and renal function

Key Exclusion Criteria:

* Transformation to aggressive lymphoma
* Requiring ongoing need for corticosteroid treatment
* Clinically significant cardiovascular disease
* Prior malignancy within the past 2 years
* Active fungal, bacterial, and/or viral infection that requires systemic therapy
* Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (\< 24 months)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Prevalence of Anal Sphincter Defects After Childbirth

The incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (AI) symptoms after childbirth may be as high as 40%. The present study aims to evaluate the prevalence of anal sphincter defects after childbirth in primiparous women-

The incidence of sphincter defect in women has raised in recently with current rates as high as 30% after vaginal deliveries. Fecal incontinence could be present at the time of the delivery but it is a real problem longtime after, in women older than 60 years.

It is of great importance not only an early detection but to indicates the best possible management as soon as posible.

The design is a prospective observational study including primiparous woman, without previous anal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous pregnant patients aged \>18 y, evaluated during pregnancy and after childbirth, including both vaginal and cesarean deliveries.

Exclusion Criteria:

* Non primiparous patients and patients with a history of anal surgery
Study to Assess an Anti-Trop2 Antibody Drug Conjugate in Relapsed or Refractory Solid Tumors

This is a phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors.

This is a Phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors including ovarian, breast, lung, esophageal, gastric, hepatocellular and urothelial cancers.

The study will determine any dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), assessing safety and preliminary efficacy using ascending dose cohorts and a conventional 3+3 study design.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced cancer that is relapsing or refractory to at least one prior treatment and not a candidate for other treatments or is intolerant to established treatments.
* At least one measurable disease per Response Evaluation Criteria in Solid Tumors v. 1.1 (RECIST 1.1).
* Eastern Cooperative Oncology Group Performance Status ≤ 2.
* Must have a life expectancy of ≥ 6 months.
* Must have adequate bone marrow, hepatic and renal function as assessed by specific laboratory tests.
* Must be recovered ≤ Grade 1 from acute toxicities from previous therapies, excluding alopecia and vitiligo.
* Has not had prior treatment within 2 weeks of screening with high dose corticosteroids.
* Be willing and able to comply with the study schedule and all study requirements.
* Willing to follow all contraception guidelines.

Exclusion Criteria:

* Previous treatment with any systemic therapy or investigational drug within 2 weeks of the first dose of study drug.
* Currently participating in any other interventional clinical study.
* Has a diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission.
* Has presence of bulky disease defined as any mass \> 7 cm in greatest dimension will trigger a discussion with the medical monitor.
* Has left ventricular ejection fraction (LVEF) \< 40%.
* New York Heart Association (NYHA) Class ≥ 3.
* Has prolonged QTcF interval on an electrocardiogram.
* Has spinal cord compression or clinically active brain metastases.
* Has a history of Sacituzumab govitecan treatment.
* History of anaphylactic reaction to irinotecan or ≥ Grade 3 toxicity to prior irinotecan treatment.
* Has active or prior COVID-19 infection, with symptoms presenting within 4 weeks of the first dose of study drug.
* Has an active bacterial, viral, or fungal infection.
* Is currently pregnant or breast feeding or planning on either during the study.
* Has chronic or moderate chronic obstructive pulmonary disease or other chronic respiratory conditions unless receiving treatment and stable for 3 months prior to screening.
* Has known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C.
* Has any significant medical condition, abnormality, or psychiatric illness that would prevent study participation.
L-arginine for Knee Osteoarthritis Patients

This study will examine the pain-relief efficacy and safety of L-arginine in knee OA patients.

Pain is the dominant symptom of knee osteoarthritis (KOA). The main management goal for people with KOA is to control pain without increasing treatment-related adverse effects (AEs). However, the commonly prescribed systemic analgesics have safety concerns, such as increased risk of cardiovascular and gastrointestinal AEs. Therefore, it is urgent to develop safe and effective treatment options.

L-arginine is one of the most commonly used oral nutritional supplements that has been widely used in patients with peripheral arterial disease, cystic fibrosis, and pregnant women with high risk of pre-eclampsia. The supplement has a high safety profile. Previous case-control and cross-sectional studies have found plasma L-arginine levels were lower in patients with knee OA than controls, suggesting that arginine deficiency may increase the risk of OA. The investigators previously observed an inverse dose-response relationship between levels of serum L-arginine and the risk of incident symptomatic KOA. Additionally, the investigators demonstrated that intra-articular injection of L-arginine solution relieved pain symptoms in a surgical rat model of OA. However, there is a paucity of high-quality clinical evidence on the effect of intake of L-arginine supplement on pain relief among patients with symptomatic KOA.

The investigators propose to conduct a randomized, double-blind, placebo-controlled trial to examine the efficacy and safety of oral L-arginine in patients with knee OA.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 and 80 years.
2. Knee OA according to the American College of Rheumatology (ACR) clinical criteria.
3. Knee pain lasting 3 months or longer and a score of 7 or greater on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (standardized to range from 0-20).
4. Kellgren-Lawrence (KL) grade 2 or 3.
5. Willing to and able to provide written informed consent.

Exclusion Criteria:

1. Any use of NSAIDs or other analgesics in the past two weeks.
2. History of injections of corticosteroids in the past three months or hyaluronic acid in the past 6 months in the index knee.
3. History of arthroscopy or open surgery in the index knee in the past 12 months.
4. History of a knee replacement in the index knee or planning to receive such a procedure within 3 months.
5. History of a severe injury in the index knee.
6. Pain in the index knee caused by inflammatory, autoimmune, neoplastic diseases or other diseases.
7. Abnormal liver or kidney functions, as defined by alanine transaminase or aspartate aminotransferase \>two times the upper limit of normal, or blood urea nitrogen or serum creatinine \>two times the upper limit of normal.
8. Severe respiratory diseases.
9. History of coronary artery disease and heart failure.
10. Uncontrolled hypertension or diabetes mellitus.
11. Diagnosis of malignant tumors.
12. Pregnant or contemplating pregnancy or breast-feeding.
Ceribell Delirium Data Collection Study

This study is designed as a prospective, non-randomized, observational clinical study. The study will collect clinical and rrEEG (Ceribell EEG) data when monitoring subjects for delirium subtypes. EEG and clinical data will be collected for the development of future software algorithms to assess the presence and severity of delirium.


Eligibility Criteria:
Inclusion Criteria: All must be present

* Age is 18 years or older
* Admitted to the Intensive Care Unit (ICU)
* Subject must be fluent in the language in which the delirium assessment is performed

Exclusion Criteria: All must be absent

- Any condition that prevents use of the Ceribell EEG system on the subject for the entire anticipated EEG monitoring period. Examples may include: Craniectomy with missing bone flap in an area where Ceribell EEG electrodes are placed. Expected use of continuous clinical EEG for the entire anticipated monitoring period.
Chidamide+Decitabine Plus Anti-PD-1 Antibody for Patients With R/R cHL Who Are Transplant-ineligible or Refused Transplant.

The prognosis for patients with relapsed/refractory classical Hodgkin lymphoma (cHL) who refuse or are ineligible for transplant is poor. This open label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus Anti-PD-1 Antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1 Antibody in transplant-ineligible or refused transplant diagnosed R/R cHL. The primary objective of the study is to evaluate progression-free survival.

The prognosis of refractory or early-relapsed lymphoma is poor, and it is even worse for those who are not eligible or refuse transplantation. Although many salvage regimens have been developed, there is no standard of care. Preliminary clinical observations have shown that Chidamide +Decitabine plus Anti-PD-1 Antibody might be beneficial for these patients. Brentuximab Vedotin or Bendamustine plus Anti-PD-1 Antibody are both standard regimens.The combination of Brentuximab Vedotin, Bendamustine and Anti-PD-1 Antibody may be another effective regimen. This open-label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus anti-PD-1 antibody and Brentuximab Vedotin + Bendamustine plus Anti-PD-1 Antibody, in patients with classical Hodgkin lymphoma who are transplant-ineligible or refused transplant .

The primary objective of the study is to evaluate the progression free survival. The key secondary end points are complete response rate, objective response rate and the safety.

Eligibility Criteria:
Inclusion Criteria: 1.18 to 75 years of age. 2.ECOG performance of less than 2. 3.Subjects must have histological confirmation classical Hodgkin lymphoma (cHL). 4. Patients must have at least two lines of antitumor therapy, those who were transplant-ineligible or refused transplant. 5.Life expectancy of at least 3 months. 6.Subjects with lymphoma must have at least one measureable lesion \>1cm as defined by lymphoma response criteria. 7. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to ≤ grade 1 toxicity. 8.Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. 9.Subjects must have adequate marrow, live, renal and heart functions.

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Exclusion Criteria:1. Subjects have received the combination therapy of Chidamide+Decitabine and anti-PD-1 antibody or Brentuximab Vedotin + Bendamustine Plus Anti-PD-1 Antibody. 2.Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 3. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. 4. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month. 5. Prior organ allograft. 6. Women who are pregnant or breastfeeding. 7. Women with a positive pregnancy test on enrollment or prior to investigational product administration. 8. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

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Dysphagia in Oculopharyngeal Muscular Dystrophy (OPMD)- Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up

The investigators aimed to review the natural history of dysphagia and dysphonia in OPMD in order to identify the best candidates and the proper timing to perform dysphagia alleviating procedures in both heterozygote and homozygote patients from the large pool of cases with this disease in Israel.

Clinical evaluation of patients suspected of having OPMD. Genetic confirmatory tests (diagnostic DNA test) at the genetic unit in Afula Hospital. Clinical follow-up with endoscopic fiber optic evaluation of swallowing. Pre-operative assessment. Crycopharyngeal myotomy intervention in selected patients. Nutrition follow-up.

Eligibility Criteria:
Inclusion Criteria:

* heterozygote and homozygote OPMD patients

Exclusion Criteria:

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