cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Improving Effects of Visucomplex Plus on Quality of Life in Patients With AMD

This is an observational study in which patients affected by dry or wet AMD will be enrolled, after signing the Informed Consent, according to eligibility criteria.

Patients, after signing the Informed Consent, will enter into a screening phase during which the concomitant medication, clinical history, physical examination (including smoking habits) will be checked and the inclusion/exclusion criteria will be assessed.

Then, at the time of Baseline visit (V0) the eligible patients will be given Visucomplex Plus as monotherapy, 1 capsule daily after food, or for dry or wet AMD patients under treatment with a stable dose of an anti-VEGF drug, Visucomplex Plus, 1 capsule daily after food, upon physical decision.

Screening phase and the baseline visit (V0) could coincide.


Eligibility Criteria:
Inclusion Criteria:

* Patient Informed consent form (ICF) signed
* Adult male and female irrespective of their age at the time of the signature of ICF
* Patients affected by dry or wet AMD irrespective of the disease severity and including newly diagnosed patients
* Patients with no treatment for AMD or under treatment with stable doses of anti-VEGF
* Willing to follow all study procedures, including attending all site visits, tests and examinations.

Exclusion Criteria:

* Previously diagnosed optic neuropathies
* Decompensated diabetes or hypertension
* Retinal pathologies including hereditary forms
* Neurological, Neurodegenerative or Cerebrovascular conditions
* Patients with a significantly progressive opacity of lens in the previous 3 months prior to enrolment
* Surgical intervention for cataract in the previous 3 months prior to enrolment
* Previously diagnosed eye inflammatory conditions (uveitis) in the previous 3 months
* Refractive defects beyond the 5 spherical diopters, both positive and negative and over 3 cylindrical
* Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or hematological disease,
* Known drug and/or alcohol abuse
* Mental incapacity that precludes adequate understanding or cooperation
* Participation in another clinical study.
Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising

The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K, 1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist rated bruises in standardized photographs immediately after bruise creation and at week 2.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-60
* Subjects are in good health.
* Subjects have willingness and the ability to understand and provide informed consent for participation in the study.

Exclusion Criteria:

* Subjects who are currently using any anticoagulation therapy (Warfarin, Heparin, Aspirin)
* Subjects who have a history of bleeding disorders.
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness
* Subjects who are pregnant or nursing.
* Subjects who have active systemic or local infection
* Subjects with systemic or local skin disease.
* Subjects with systemic illness.
Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs

The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a protease inhibitor that is already commonly prescribed.

Patients are randomized to receive one of two drug regimens: BMS-232632, ddI, and d4T or NFV, ddI, and d4T. Three different doses of BMS-232632 are used in this study. Randomization is stratified for HIV RNA level (less than 30,000 copies/ml versus 30,000 or greater copies/ml). Patients remain on their drug regimen for 48 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have an HIV blood level between 2,000 and 200,000 copies/ml.
* Have a CD4 cell count of at least 100 cells/mm3.
* Are 18 years of age or older.
* Are available for follow-up for at least 48 weeks.
* Agree to use a barrier method of birth control (such as condoms) during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have ever received anti-HIV (antiretroviral) treatment.
* Have an HIV-related opportunistic infection or condition at the time of study entry.
* Have primary HIV infection, meaning they have recently been infected.
* Have had severe diarrhea within the 30 days before study entry.
* Have hemophilia.
* Have a history of pancreatitis, hepatitis, or a peripheral neuropathy.
* Are unable to tolerate oral medication.
* Are pregnant or breast-feeding.
* Abuse alcohol or drugs.
Study to Evaluate D-1553 in Subjects With Lung Cancer

This is a phase 1/2, open label study of D-1553 single agent treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic NSCLC with KRasG12C mutation


Eligibility Criteria:
Inclusion Criteria:

* Subject with histologically proven, locally advanced, unresectable and/or metastatic NSCLC for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment.
* Subject has KRasG12C mutation in tumor tissue or other biospecimens containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a central laboratory.
* Subject has measurable disease according to RECIST, v1.1

Exclusion Criteria:

* Subject with unstable or progressive central nervous system (CNS) metastases.
* Subjects with clinically significant cardiovascular disease
* Subject with interstitial lung disease (ILD) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
* Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
* Subject is pregnant or lactating.
Activity in Tourette Syndrome

Tics are brief repetitive movements or vocalizations. Gilles de la Tourette's syndrome (TS) is a disorder characterized by recurrent motor and vocal tics. Tourette syndrome and tic disorders affect up to 8% of children. Peak severity of tic disorders occurs between the ages of 8 to 12 years, therefore during childhood and adolescence the most significant impacts are felt. The quality of life of young people with tics is lower than their peers' and tic severity predicts lower quality of life. Studies have also shown negative social perception toward children with tics.

Approximately 50% of patients with Tourette syndrome will have other diagnoses including attention deficit hyperactivity disorder (ADHD), obsessive compulsive disorder, anxiety and depression. Studies have shown improvements in ADHD with physical activity. ADHD and tic disorders are thought to involve the same areas of the brain; thus it is possible that tics might also improve with physical activity. However, no studies to date have examined this. The investigators predict that by implementing a motivational physical activity program, in conjunction with physical activity counseling, the investigators will be able to increase levels of physical activity in children with tics and Tourette syndrome, with a positive impact on tic severity.


Eligibility Criteria:
Inclusion Criteria:

* Participants are between 8-16 years of age.
* Participants are required to have a diagnosis of either Tourette Syndrome or Persistent (Chronic) Motor of Vocal Tic Disorder as per the DSM V.
* Participants must be ambulatory.
* Participants and parents must understand English or French.
* Participants must be able and willing to complete the questionnaires.
* Participants cannot have any changes to their medication for tics, or any other psychotropic medications for 4 weeks prior to and for the entire duration of the study

Exclusion Criteria:

* Participants who cannot ambulate independently.
* Participants who are not permitted to participate in physical education class at school.
* Participants or families who are not willing to be randomly assigned to a study group.
Central Motor Mechanisms in AIS Via HD-sEMG, EEG and Neuromuscular Coupling Analysis

1. Verifying the Motor Control Effects of Spinal Manipulation on AIS Using outpatient and inpatient AIS patients from our department as the study subjects, standardized spinal manipulation treatment is applied. The efficacy is evaluated through a combination of clinical outcome measures, HD-EMG for paraspinal muscle function assessment, and Pro-Kin balance system for trunk stability analysis. This establishes an AIS efficacy platform to further clarify the effectiveness of spinal manipulation in motor control regulation of AIS.
2. Investigating the Central Motor Network's Response to Spinal Manipulation in AIS Utilizing high-density sEMG-EEG technology, synchronized brain and muscle electrical signals are collected before and after treatment. By employing a neuromuscular synchronization and coupling analysis approach that integrates linear and nonlinear methods, the characteristic indices of information interaction between the central system and muscles are identified. This further explores the motor control and response characteristics of the muscle-cortex network to spinal manipulation in AIS.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥10 years;
2. Risser sign grade 0-3;
3. Cobb angle between 10° and 40°;
4. No prior treatment;
5. Female patients within 1 year after menarche or before menstruation;
6. The patient's guardian signs the informed consent form for treatment.

Exclusion Criteria:

1. Those who do not meet the diagnostic criteria for AIS or inclusion criteria;
2. Patients with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system disorders, or those with mental illnesses;
3. Patients with thrombocytopenia, coagulation disorders, or a tendency to bleed;
4. Patients who are afraid of the treatment and cannot tolerate it;
5. Those who have already received other treatments that may affect the study's outcome measures.
Psychological Impact of the Health Measures Generated by the COVID19 in Adolescents

The lockdown of the French population is a health measure put in place in response to the pandemic linked to a new coronavirus, SARS-CoV-2 (Covid-19). After a health campaign to recommend hygienic "barrier gestures" and social distancing, the decision to confine the population at the national level was decided by the executive from Monday 16 March to Monday 11 May 2020. The national confinement implies the restriction of movement to the strict necessary, outings near the home and the closure of schools and communities. These decisions have led to an unprecedented state of stress for the entire French population, the consequences of which are unknown in the short, medium or long term. The objectives of this study are to evaluate the psychological impact of the confinement on adolescents with or without chronic disease and also the difficulties and fears engendered by deconfinement .


Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 11 to 18 years old
* Previous consultation in the Centre Hospitalier intercommunal de Creteil
* Agree to participate

Exclusion Criteria:

* Lack of computer equipment or internet connection
Impact of Mothers Touch Program to Improve Maternal Health After Birth

After the child birth most women experience major health issues such as depression, severe fatigue, back pain, perineal pain, mastitis, urinary or faecal incontinence, sexual problems and relationship problems with partners. That all lead to poorer emotional and mental health and factors contributing isolation, exhaustion and physical health problems.

'Sava Mahina (6-week period) is a traditional practice for postpartum women in India, which include special diet, lifestyle and supportive care. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes of Indian postpartum care on women.


Eligibility Criteria:
Inclusion Criteria:

* Primigravida
* Healthy pregnancy
* Consent to participate

Exclusion Criteria:

* Mental Health diagnosis
* Severe depression or psychosis
* Substance abuse
Safety Demonstration of Microneedle Insertion

Hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of humans and animals. Side effects of these needle injections are pain, bleeding, and anxiety in patients. An alternative drug and vaccine delivery method is the use of hollow microneedles, which are sub-millimeter needle-like structures. Microneedles are pain- and bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. As a result, they are better received by patients and do not induce needle anxiety. As the investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel, the purpose of this study is to observe their biocompatibility and inertness.


Eligibility Criteria:
Inclusion Criteria:

* Proven nickel allergy

Exclusion Criteria:

* Pregnancy
A Phase 1 Study of WVE-007 in Adults Living with Overweight or Obesity

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of WVE-007 when administered subcutaneously (SC) as single ascending doses in adults who are affected by overweight or obesity.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged 18 to 60 years
* BMI 28 to 35 kg/m2 which has been stable (±5%) for the previous 3 to 6 months (based on participant self-report or medical records)
* Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments

Exclusion Criteria:

* History or presence of CV disease, including heart failure (New York Heart Association \[NYHA\] Class III or IV), myocardial infarction, angina, or clinically significant abnormal laboratory assessments
* History or presence of thyroid disorders
* Medical history or diagnosis of causes of liver disease
* Use of any siRNA agent in the prior 12 months
* Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study
Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19

The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral solution when administered in combination with remdesivir in adult patients with advanced COVID-19.

This phase 2 randomized, double-blind, placebo-controlled study will enroll approximately 80 adult patients with advanced coronavirus disease 2019 (COVID-19). Approximately 80 patients will be randomized 1:1 to receive oral administration of MMPD + remdesivir or placebo + remdesivir. The first 40 patients will have a score of 3 or 4 on the National Institute of Allergy and Infectious Disease (NIAID) 8-point ordinal scale and at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion or symptoms of severe lower respiratory symptoms; the final 40 patients will have a score of 3 on the NIAID scale.

Study subjects will undergo screening evaluations prior to the first dose of study drug. Study drug treatment (MMPD or placebo) will continue for 10 days, unless the patient is discharged from the hospital before completing the 10-day randomized treatment period. Both treatment arms will also receive remdesivir per the Emergency Use Authorization labeling. Evaluations will be performed on Days 0-10 and every day thereafter until the subject no longer requires any form of respiratory support or they reach the last planned day of in-person study assessments and still require respiratory support. The final in-person study evaluations will be performed 4 weeks after completion of study drug (MMPD or placebo) treatment (Day 37). The final study evaluation will be a telephone call on Day 56.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Confirmed SARS-CoV-2 viral infection
* Advanced COVID-19 with score of 3 or 4 on NIAID scale (first 40 patients) or score of 3 on NIAID scale (last 40 patient
* Has at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath, confusion or severe lower respiratory symptoms
* Off antiviral medications at least 24 hours prior to first dose of study drug (except for remdesivir)
* Able to provide consent
* Agree to appropriate methods of contraception

Exclusion Criteria:

* In critical condition or has ARDS
* On invasive mechanical ventilation or ECMO
* Bacterial or fungal infection
* Pregnant or lactating (women)
* ALT \>5x ULN, bilirubin \>2x ULN, INR outside of normal limits at screening
* eGFR \<30 mL/min
* Clinically relevant serious co-morbid medical conditions
* Treatment with any immunosuppressive therapy within 30 days prior to screening
* Treatment with another investigational drug within 30 days or 5 half-lives of drug prior to screening
* Prior treatment with the study drug (MMPD) or treatment with remdesivir more than 24 hours prior to the first randomized dose of study drug
* Known hypersensitivity to the inactive ingredients in the study drug (MMPD or placebo) or any ingredient of remdesivir
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants

The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below:

* Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study.
* Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study.
* Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) ≥18.0 and ≤30.0 kg/m2

Exclusion Criteria:

* Clinically significant allergic reactions
* Gastrointestinal, renal, hematological, metabolic, neurologic or pulmonary diseases classified as significant by the Investigator
* Hepatic dysfunction upper limit of normal laboratory range
* Cardiac history or presence
* History or any concomitant active malignancy
* A known infection with human immunodeficiency virus, hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Inherited bleeding diathesis or coagulopathy with the risk of bleeding
* Hemoptysis, thrombotic or hemorrhagic event
* Cerebral vascular accident, transient ischemic attack, or subarachnoid hemorrhage
* History and/or sign/symptoms of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
* Lactose intolerance (lactase deficiency) and glucose-galactose malabsorption
Unmasking Right Ventricular and Pulmonary Derangements With Exercise and Oxygen in Early Stage Cardiopulmonary Diseases

Researchers are trying to develop innovative strategies that target the early identification heart and lung imbalances in patients with cardiopulmonary diseases.


Eligibility Criteria:
Inclusion criteria:

* Healthy controls (no known cardiac or pulmonary disease);
* PAH/HFpEF patients with known RV failure;
* PAH/HFpEF patients with known pulmonary failure
* Newly diagnosed PAH/HFpEF patients without any evidence of profound RV or pulmonary dysfunction.

Exclusion criteria:

* Persons unable to perform light exercise
* Persons pregnant or planning to be pregnant
A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-303 as a monotherapy and in combination with budigalimab, (ABBV-181).

ABBV-303 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-303 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 181 adult participants will be enrolled in the study across sites worldwide.

In Part A, ABBV-303 will be intravenously (IV) infused in escalating doses as a monotherapy in participants with relapsed (R)/refractory (R) solid tumors, R/R non-small cell lung cancer (NSCLC), R/R renal cell carcinoma (RCC), R/R head and neck squamous cell carcinoma (HNSCC), or R/R tissue agnostic participants with mesenchymal epithelial transition. In Part B, ABBV-303 in combination with budigalimab will be IV infused in participants with R/R solid tumors or NSCLC. The estimated duration of the study is up to 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Laboratory values meeting the protocol's criteria within the screening period (-28 days) prior to the first dose of study drug.
* Participants with a diagnosis of a malignant solid tumor by histology (World Health Organization \[WHO\] criteria).
* Participants with measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Exclusion Criteria:

* Unresolved Grade \> 1 adverse events (AEs) from prior anti-cancer therapy except for alopecia.
* Active systemic or uncontrolled local bacterial, fungal, or viral infection requiring antimicrobial therapy.
* History of hypersensitivity to the active ingredients or any excipients of ABBV-303 and budigalimab (ABBV-181).
* Body weight \< 35 kg.
Treatment of Leg Telangiectasias With Nd:YAG 1064nm

Studying the results of treatment of dilated vessels of the lower limbs with laser, and compare them to those obtained with sclerotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with leg telangiectasias

Exclusion Criteria:

* Arterial disease
* Varices
* Diabetes