cyrilzakka/clinical-trials huggingface dataset:
Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.

The study objective is to assess Efficacy and safety of Reparixin treatment as compared to placebo (both on top of standard treatment) in adult patients with severe COVID-19 pneumonia.

This is a phase 3 clinical trial designed as a randomized, double-blind, placebo-controlled, multicentre study to evaluate the efficacy and safety of Reparixin in hospitalized adult patients with severe COVID-19 pneumonia.

Patients will be screened for the participation in the study and eventually randomized based on an unbalanced randomization scheme (2:1) to Reparixin oral tablets (2 x 600 mg TID) for up to 21 days or to placebo.

An unequal randomization is justified by the need to gain experience and more safety data with the investigated treatment and by an expected better acceptability of the trial by patients.

The placebo control arm is justified by the unavailability of a well-defined standard of care for subjects with COVID-19 pneumonia who are candidates for this study.

All patient will receive the standard supportive care based on the patient's clinical need. Follow-up information on the patient's clinical condition will be collected until day 90.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 90, male and female subject of any race
2. Reverse transcriptase Polymerase Chain Reaction (rt-PCR)-confirmed COVID-19 infection based on a nasal / oropharyngeal swab within 10 days before randomization
3. At least one of the following: 1) Respiratory distress with tachypnea (RR ≥ 24 breaths/min without oxygen); 2) Partial arterial oxygen pressure (PaO2) / Fraction of inspiration O2 (FiO2), P/F \>100 and \<300 mmHg (1mmHg = 0.133kPa), 3) SpO2 ≤ 94% while breathing ambient air.

   Calculation through validated Sat/FiO2 scales is allowed. P/F value of reference if the last available before the signature of consent.
4. Need of supplemental oxygen (i.e. new use of supplemental oxygen, or increased oxygen requirement if on chronic oxygen) requiring low- or high-flow oxygen or non-invasive mechanical ventilation (7-point WHO-OS category 4 or 5).
5. Radiological chest imaging (X-rays, CT scan) confirms lung involvement and inflammation.

Exclusion Criteria:

1. Cannot obtain informed consent.
2. Hepatic dysfunction with Child Pugh score B or C, or ALT or AST\> 5 times the upper limit.
3. Renal dysfunction with estimated glomerular filtration rate (MDRD) \< 50 mL/min/1.73 m2 or patient receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
4. Bacterial sepsis (besides COVID-19 sepsis).
5. Known congenital or acquired immune deficiency.
6. Positive or missing pregnancy test before first drug intake or day 1; pregnant or lactating women; women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study.
Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally

This is a Phase l double-blind, placebo-controlled, randomized study to investigate the safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of APX001 administered intravenously and orally, followed by an evaluation of the safety, tolerability, pharmacokinetics and drug-drug interaction potential of multiple doses of APX001 administered orally.


Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing potential must agree to avoid pregnancy during the study and to use contraception at least 2 weeks before the start of the study until 3 months after the last dose of study drug.
* Males with partner(s) of childbearing potential must agree to use appropriate barrier contraception from the screening period until 3 months after the last dose of study drug.
* Screening hematology, clinical chemistry, coagulation and urinalysis consistent with overall good health.
* No significantly abnormal findings on physical examination, ECG and vital signs.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.
* History or presence of malignancy within the past year. Subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
* Use of prescription medication within 14 days prior to the first dose of study drug and throughout the study.
* Use of non-prescription or over-the-counter medications within 7 days prior to the first dose of study drug and throughout the study.
* Positive results on any of the following Screening laboratory tests: serum pregnancy test, urine alcohol test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder

Menopausal syndromes includes somatic symptom, psychosomatic symptoms, sexual dysfunction and even urinary symptoms. Hormone therapy (HT) is widely used for controlling menopausal symptoms. Common HT for menopausal syndrome with intact uterus includes tibolone, estradiol valerate (E2V) 1mg \& medroxyprogesterone acetate (MPA) 2.5 mg, and conjugated equine estrogens \& MPA.

However, only a few literatures mentioned about the therapeutic effect of tibolone, but lack of comparison research about their therapeutic effect on somatic symptoms, psychosomatic symptoms, sexual dysfunction and even urinary symptoms. The knowledge of the above therapeutic effects should be important for choosing a suitable medication. Therefore, the aim of this study is to assess the therapeutic effect on somatic symptoms, psychosomatic symptoms, sexual dysfunction and even urinary symptoms between tibolone and E2V/MPA.


Eligibility Criteria:
Inclusion Criteria:

* All female patients with intact uterus who seek for medical treatment for menopausal syndrome

Exclusion Criteria:

* patients with gynecologic or breast cancers
Vitiligo Skin Transplantation

In vitiligo, the melanocytes are lost from the skin in certain areas. One treatment for vitiligo takes the melanocytes from areas of normal skin and places them on areas of that same person's body which have lost their color. This is called the melanocyte-keratinocyte transplantation procedure (MKTP). This procedure has been used successfully in over 3000 cases in India and Saudi Arabia. The purpose of this study is to see if it is effective when performed at the investigators' institution.


Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years old
2. Have a diagnosis of vitiligo with no news lesions or growth of old lesions in the past 6 months
3. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
4. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

1. Female patients who are breastfeeding, pregnant, or planning to become pregnant
2. Patients with a history of developing vitiligo or keloids at sites of trauma
3. Patients self-reported as having HIV or Hepatitis C
4. Patients self-reported as having uncontrolled Diabetes Mellitus
5. The investigator feels the patient should not participate in the study for any reason
PRenatal Video-Based Education and PostPARtum Effects

The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. AME involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among women with higher BMI, including impaired breastfeeding self-efficacy, insufficient milk supply (critical period endocrine modulation of milk volume), and early formula supplementation in the context of a medically complex birth (availability of banked antenatal milk).

Participants will be enrolled in their third trimester of pregnancy and allocated into one of two study arms: 1) AME instruction delivered by remote, live International Board Certified Lactation Consultants via an innovative app-based telelactation platform; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). Video-based education for both groups will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing AME 1-2 times per day at home.

Measured outcomes of interest will include short and long-term breastfeeding practices (e.g., breastfeeding duration, exclusivity) and participants' experiences with and perceptions of AME.

The purpose of the PREPARE Trial is to examine the impact of an antenatal milk expression (AME) intervention among women with pre-pregnancy BMI 25 or more on breastfeeding outcomes, including breastfeeding self-efficacy, breastfeeding duration and exclusivity, and perception of insufficient milk supply. Specifically, the investigators will:

1. Determine the effect of the AME intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum.
2. Explore the sustained effect of the AME intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum.
3. Examine participants' experiences with and perceptions of AME.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who:

  1. have a pre-pregnancy BMI ≥ 25
  2. are ≥ 18 years
  3. are English-speaking
  4. are 34 0/7-36 6/7 gestational weeks
  5. are nulliparous
  6. intend to/have interest in breastfeeding after birth
  7. are having a singleton pregnancy
  8. plan to receive prenatal care and deliver at select hospital/birth facility systems (access to EMR data)

Exclusion Criteria:

1. contraindications to breastfeeding as specified by the American Academy of Pediatrics
2. history of breast reduction surgery or radiation
3. indication for delivery by 37 weeks gestation
4. gestational or pre-existing diabetes
Clinical Curative Effect Evaluation Study of Treatment of Oral Deferiprone Tablets in Aceruloplasminaemia Patients

Aceruloplasminemia is an autosomal recessive disorder characterized by iron deposition in the brain and visceral organs. Deferiprone was used to treat aceruloplasminemia in previous study. In this study, we will assess the clinical curative effect evaluation of oral deferiprone in Chinese aceruloplasminemia patients.

Diabetes is one of the most severe symptom in aceruloplasminemia. In this study, we use R2\* of pancreas MRI to evaluate the effect of deferiprone treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Diagnosed with aceruloplasminaemia
* Genetically confirmed diagnosis of aceruloplasminaemia

Exclusion Criteria:

* Contraindications to deferiprone therapy
* Pregnancy was excluded in women of childbearing age
Alcohol Counseling for Telephone Quitline Callers

The goal of this study is to train phone counselors working for the New York (NY) State Smokers' Quitline to advise callers who drink at hazardous levels to limit or abstain from alcohol use to determine whether this improves smoking cessation outcomes so that we can establish effect size estimates for a full scale multi-site trial.

This is a developmental study to: 1) create and beta test an alcohol counseling protocol with 25 Quitline callers and 2) train Quitline Specialists to provide an alcohol intervention using at least 100 pilot Quitline callers to ensure that Specialists in the alcohol intervention + standard care condition provide counseling that addresses hazardous drinking with a high level of alcohol intervention strategies and skill. After this phase of the study is complete, a developmental randomized clinical trial will be conducted with 1,948 NY Quitline callers who drink at hazardous levels to compare practical counseling + smoking cessation print materials added to standard care (PC + SC condition) to alcohol intervention counseling + alcohol-focused print materials added to standard care (AI + SC condition). Efficacy data from this trial will be used to determine effect size estimates for both quitdate and 7-month self-reported point prevalence abstinence rates. Reduction in alcohol consumption and reduced drinking as a mediator of smoking cessation outcome will be secondary outcomes. Other mediators and moderators of alcohol intervention effects will also be examined as an exploratory outcome. If the effect size estimates are sufficiently large and medically important to pursue a definitive trial, these data will be used to propose a full scale multi-site large study. If an alcohol intervention is shown to enhance treatment outcome in a large-scale study, alcohol interventions with quitline counselors could be translated for use by the entire NY state quitline and other quitlines across the country. This may increase the effectiveness of quitline interventions and thus has the potential to reach millions of smokers, thereby bolstering tobacco and cancer control efforts across the United States.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18+ years)
* Cigarette smokers requesting assistance with quitting smoking
* Hazardous drinkers (per NIAAA criteria)

Exclusion Criteria:

* Eligible for Enhanced Services Program
Anlotinib In Combination With PD-1/L1 Inhibitor As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study

Anlotinib In Combination With PD-1/L1 Inhibitor As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study


Eligibility Criteria:
Inclusion Criteria:

1. The subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up;
2. Patients between 18-75 years old;
3. Extensive small cell lung cancer confirmed by histopathology (according to Veterans Administration lung study group, Valg stage) and did not progress after 4-6 cycles (21 days as a cycle) of first-line standard chemotherapy platinum combined with etoposide \[complete remission (CR), partial remission (PR) or stable (SD) according to recist1.1 standard\];
4. The time interval between the first TRT and the end of the last chemotherapy should be less than or equal to 6 weeks;
5. The life expectancy shall be at least 3 months;
6. ECoG score: 0-1

Exclusion Criteria:

1. Small cell lung cancer patients with other pathological types of tumor species;
2. Patients with pathological fracture in bone metastasis of small cell lung cancer;
3. Patients with central nervous system metastasis;
4. Patients who have received chest radiotherapy before;
5. Patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before;
6. Imaging (CT or MRI) showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a central tumor invading the local large blood vessel, or there was an obvious cavitary or necrotic tumor in the lung;
Use of the GARDEX™ Embolic Protection Device During Percutaneous Coronary Interventions of Saphenous Vein Graft

This is a multi center, prospective study designed to demonstrate the safety and performance of the GARDEX Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) interventions.


Eligibility Criteria:
Inclusion Criteria:

* Anticipated patient life expectancy of at least 1 year from enrollment.
* Patient (or their legal guardian) has provided a signed informed consent.
* Patient is willing to comply with the protocol requirements.
* Candidate for PCI, stenting and CABG.
* Total CK verified to be within hospital normal limits at the time of enrollment.
* Myocardial ischemia as evidenced by one or more of the following:

  * Diagnosis at time of enrollment of stable or unstable angina pectoris
  * Reversible 12 lead ECG changes consisted with ischemia
  * Positive function study (e.g. stress test)
  * Recent myocardial infarction (\>24 hours prior to enrollment with total CK verified to be within hospital normal limits at the time of enrollment).
* Lesions amendable to PCI.
* Lesion(s) is located within SVG and has ≥50% and \<100% stenosis (angiographic visual assessment).
* Only single SVG graft to be treated.
* Vessel has thrombolysis in myocardial infarction (TIMI) grade 1 or higher flow before the passage of a guidewire.
* Reference vessel diameter where the GARDEX™ system is to be placed is ≥ 3.5mm and ≤6.0mm in diameter by angiographic visual estimation.

Exclusion Criteria:

* A hypersensitivity or contraindication to heparin and bivalirum (Angiomax), aspirin, ticlopidine, clopidogrel, murine products, procedure equipment material, and a sensitivity to contrast dye which cannot be adequately pre-treated with diphenhydramine and/or steroids.
* Myocardial infarction with documented total CK\> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
* A stroke or transient ischemic attach (TIA) within the past 2 months.
* A history of bleeding diathesis or coagulopathy.
* Major gastrointestinal (GI) bleeding within 3 months of index procedure.
* Baseline creatinine ≥ 2.5 mg/dl.
* A planned invasive surgical procedure within 30 days.
* Undergone cardiac surgery within the past 60 days.
* The lesion is in a SVG that is less than 2 months post implant.
* Left ventricular ejection fraction \< 20%
* The lesion is an arterial conduit.
* Anatomical exclusions that preclude placement of the GARDEX™ system per the Instruction for Use.
* More than one SVG graft that need to be treated at the index procedure.
* Chronic occlusion of the target lesion/severe calcification.
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

This was a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study assessed primarily the safety and tolerability of PDR001 in combination with regorafenib.


Eligibility Criteria:
Key inclusion criteria:

1. Patients with metastatic colorectal adenocarcinoma.
2. Patients must provide a newly obtained or an archival tumor sample corresponding to CRC diagnosis (primary tumor) with sufficient tissue quality (qualified) for analysis
3. Patients must provide a newly obtained tumor tissue sample from a metastatic site
4. Patients with the presence of at least one lesion with measurable disease as per RECIST
5. Patients previously treated with two prior regimen as per standard of care and have experienced disease progression (including -VEGF and EGFR targeted therapies (if KRAS wild).
6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Key exclusion criteria:

1. Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
2. Patients with metastatic disease amenable to be resected with potentially curative surgery
3. Patients who have had chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study treatment
4. Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti- CTLA-4 antibodies, other checkpoint inhibitors
Study of Patient Navigation to Reduce Social Inequalities

Variations in participation to the colorectal cancer screening seems to reveal social and geographical inequalities. Our study will investigate whether patient navigation could increase the participation to the colorectal cancer screening and in the same time, reduce the social inequalities.


Eligibility Criteria:
Inclusion Criteria:

* Insured people invited to the national french colorectal screening program are from 50 to 74 years old.
* We select people who never do the screening test or are not compliant with it
* Among these people we select those living in the randomized geographical areas.

Exclusion Criteria:

* people who have already done the screening test at the two previous campaigns.
* people who have done a colonoscopy in the previous five years or people with a family history with colorectal cancer and people who are following outside of the screening program.
* people with other severe disease or in incapacity to realize the screening test
* people who have another exclusion criteria to realize the screening test.
Venclose RF Ablation System for the Treatment of IPVs

A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.


Eligibility Criteria:
Inclusion Criteria:

* Patient is \>= 18 years.
* IPVs to be treated have an outward flow duration of \>= 0.5 seconds immediately after release of manual distal compression with patient standing or in Reverse Trendelenburg.
* IPV(s) to be treated have a diameter of ≥ 3.5 mm located caudal edge of ankle.
* Has been diagnosed with refractory symptomatic disease attributable to the IPV to be treated.
* Is able to ambulate.
* Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study.
* Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.

Exclusion Criteria:

* Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
* Has thrombus in the vein segment to be treated.
* Has untreated critical limb ischemia from peripheral arterial disease.
* Is undergoing active anticoagulant therapy for Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
* Patients with known bleeding or clotting disorders or unwilling or unable to frequently ambulate post-operatively.
* Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
* Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.
* Has a condition, judged by the treating physician, that may jeopardize the patient's well-being and/or confound the results or the soundness of the study.
* Is pregnant or lactating at the time of the study procedure or is intending on becoming pregnant within 30 days following the study procedure.
* Is participating in another clinical study that is contraindicated to the treatment or outcomes of this investigation