cyrilzakka/clinical-trials huggingface dataset:
A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies

This study is researching an experimental drug called REGN10597 (called "study drug"). The study is focused on patients with certain solid tumors that are in an advanced stage.

The aim of the study is to see how safe, tolerable, and effective the study drug is.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Phase 1: Conducted in the United States Phase 2: Conducted globally

Eligibility Criteria:
Key Inclusion Criteria:

Dose-escalation cohorts:

1. Histologically or cytologically confirmed diagnosis of malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy
2. Participants are required to submit archival tissue with optional fresh biopsy

Dose-expansion cohorts:

1. Histologically of cytologically confirmed diagnosis of Melanoma or ccRCC tumors with criteria, as defined in the protocol
2. Participants are required to submit fresh pretreatment biopsy during screening

Key Exclusion Criteria:

1. Prior treatment with Interleukin 2 (IL2)/IL15/IL7
2. Prior treatment with anti PD-1/PD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol
3. Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs
4. Has had prior anti-cancer immunotherapy within 2 months prior to study therapy
5. Has ongoing immune-related AEs prior to initiation of study drug, as defined in the protocol
6. Has known allergy or hypersensitivity to components of the study drug
7. Has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study drug
8. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.
Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)

In patients with Relapsing Remitting Multiple Sclerosis (RRMS), the investigators observed a positive correlation between regulatory T cell (Treg) function and vitamin D status. The present goal is to assess whether Treg function improves on supplementation with vitamin D3.

In several studies, Multiple Sclerosis (MS) incidence and disease activity has been related with vitamin D status. We observed that RRMS patients who remained relapse free before blood collection had a better vitamin D status than patients who experienced relapses (Smolders et al. Mult Scler 2008;17:1220-1224). Since vitamin D3 is a potent promotor of T cell regulation in vitro (Smolders et al. J Neuroimmunol 2008;194:7-17), we hypothesised that a promotion of Treg function in MS patients might underlie its association with MS disease activity. In a cohort of RRMS patients, we observed a positive correlation of Treg function with vitamin D status (Smolders et al. PLoS ONE 2009;4:e6635). Furthermore, vitamin D status correlated positively with a Th1/Th2-balance which was more directed towards Th2. In the present study, we will assess whether treatment of RRMS patients with vitamin D3 promotes T cell regulation.

In the present study, RRMS patients will be supplemented with vitamin D3, and regulatory T cell tests will be performed before and after supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing Remitting MS (Revised MCDonald criteria 2005)
* Age \> 18 years

Exclusion Criteria:

* Progressive MS phenotype
* Abnormalities of vitamin D hormonal system other than low dietary intake or limited sun exposure
* Intake of drugs that influence vitamin D homeostasis other than corticosteroids
* Conditions with in increased susceptibility to hypercalcemia
* Alcohol or drug abuse
* Pregnancy or the intention to become pregnant within the study period
Safety and Effectiveness of High Frequency Electrocautery for Abdominal Fat Reduction

The goal of this clinical trial is to learn if the intervention of radiofrequency technology can help treat abdominal fat hypertrophy and skin laxity in adults. The main questions it aims to answer are

* Does radiofrequency technology lower the abdominal subcutaneous adipose tissue height by ultrasound measurement?
* Does radiofrequency technology improve abdominal circumference data and lower the number of times participants need to use a rescue inhaler.

Researchers will compare the treatment side to the non-treatment side to see if radiofrequency technology works to treat abdominal fat hypertrophy and skin laxity?

Participants will:

* Accept the treatment of radiofrequency technology every week for 10 weeks.
* Visit the clinic 1 month and 3 months after the treatment ends for checkups and tests.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign the informed consent form;
2. Age 18 to 65 years old (including 18 and 65 years old), male or female;
3. The body mass index (BMI) is in the range of 22 \~ 35 (kg/m2) (including the cut-off value);
4. Maintain a stable weight and lifestyle (including calorie intake and exercise) throughout the clinical study period and within 6 months after the end of the study;
5. Non-pregnant and breastfeeding women who have no pregnancy plan and voluntarily take effective contraceptive measures during the screening period and the whole trial period, and have no sperm or egg donation plan.

Exclusion Criteria:

1. Patients who gained or lost more than 2.5 kg of weight during the study;
2. Patients who have used weight loss drugs or participated in weight loss-related programs within 6 months of the start of the study;
3. Have received or are about to receive surgery or liposuction in the abdomen, or have received lipolytic drugs injected in the abdomen, or have received abdominoplasty or cryo lipolysis;
4. History of abdominal/waist-related trauma or scar;
5. Patients with excessive accumulation of abdominal skin affecting the operation;
6. Implantation of metal-related articles in the abdomen;
7. Patients suffering from severe systemic diseases that are life-threatening (such as cardiac insufficiency, renal insufficiency, etc.);
8. Those who are equipped with dentures, pacemakers, or other internal metal implants (such as metal IUD rings, etc.);
9. Local skin infection and open skin injury;
10. Have a history of eating disorder or eating disorder;
11. Pregnant or breastfeeding women.
Occult Paroxysmal Atrial Fibrillation in Patients With Non-cardioembolic Ischemic Stroke of Determined Mechanism

The aim of this study is to determine the yield of 3 weeks outpatient mobile cardiac monitoring for detection of atrial fibrillation in patients with history of stroke of known cause.

Patients will be recruited to wear a outpatient mobile cardiac monitoring device for detection of atrial fibrillation in patients with a history of stroke of known case. Their are not study treatments or interventions, this is an observational trial. Eligible patients must be \>50 years old, have a history of ischemic stroke or transient ischemic attack with a documented brain infarction within the prior 12 months. If patients are on anticoagulation therapies, they are eligible for enrollment if the long-term strategy for stroke prevention is anti-platelet therapy and not the oral anti-coagulant itself. Patients must not have an detection of AF and then must successfully activate the lifeStar device for enrollment. At the end of three weeks, the LifeStar device will be over-read and scored for the presence of AF and other clinically significant arrhythmias by the study electrophysiologist, who will determine the occurrence and burden of AF.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 50
2. Ischemic stroke, or transient ischemic attack with documented acute brain infarction, within prior 6 months.
3. Patient does not merit indefinite oral anticoagulation. (Patients requiring temporary OAC for purposes other than recurrent stroke prevention, such as treatment of a deep venous thrombosis, are eligible for enrollment if the long-term secondary stroke preventive strategy is anti-platelet therapy and not OAC).
4. Stroke mechanism is determined to be lacunar stroke, large vessel intracranial atherosclerosis, large vessel extracranial atherosclerosis, or a combination thereof.
5. Patient has been evaluated with at least a 12 lead EKG and at least one day of in-patient or out-patient cardiac telemetry, with no detection of AF or atrial flutter.
6. Detection of AF or atrial flutter would change secondary prevention antithrombotic strategy (eg to indefinite OAC).
7. Patient receives and successfully activates LifeStar ACT device.
8. Patient or legally authorized representative signs informed consent.

Exclusion Criteria:

1. Known history of AF or atrial flutter.
2. Patient has defibrillator or pacemaker capable of detecting AF.
3. Patient has indication for indefinite OAC.
4. Patient has indefinite contra-indication to OAC. (Patients with temporary ineligibility for OAC, for example due to the need for invasive medical procedures or large acute brain infarction, are eligible for enrollment).
5. Stroke due to known cause not listed in inclusion criterion 4.
6. Cardioembolic stroke.
7. Inability to comply with LifeStar ACT monitoring regimen.
Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.

The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children and adults with metastatic and refractory solid tumors. CELYVIR consists in bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. In addition to data on toxicities the investigators will evaluate clinical response.


Eligibility Criteria:
Inclusion Criteria:

* Children: Up to 18 yrs. Refractory to at least 2 previous therapy lines. Life expectancy more than 6 months. Measurable disease.
* Adults: 18-75 yrs. Refractory to at least 2 previous therapy lines. ECOG (Eastern Cooperative Oncology Group) \<2. Measurable disease.

Exclusion Criteria:

* Pregnancy.
* Central Nervous System metastasis.
* Experimental therapy during the previous month.
* Chemotherapy less than 3 weeks previous.
* Any organ functionally impaired.
* Concurrent infectious disease.
Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)

Dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of cutaneous bullous lesion arising spontaneously or after mechanical trauma.

These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no treatment available. Cares are consisting to dress lesions and to protect the skin.

The investigators have recently observed on patients having residual expression of collagen VII that phenotype severity is modulated by activation degree of dermic metalloproteinase. The investigators have also observed that epigallocatechin-3-gallate (Polyphenon E®) could be regulated this activity.

The primary purpose of this study is to assessing the efficacity of Polyphenon E to decrease the number of cutaneous bullosa after four month of treatment.

The primary outcome measure is the rate of patient presenting a decrease of 20% or more of the number of cutaneous bullosa.

Secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the average duration of cicatrisation and treatment tolerance.

This study foresees the inclusion of 22 patients older than 2 years old in 5 centers.

When patients are included, they will be randomized and receive the treatment (or placebo) for 4 months.


Eligibility Criteria:
Inclusion Criteria:

* known mutation of COL7A1

Exclusion Criteria:

* tea drinkers
* patient receiving induction treatment,protease inhibitor treatment
* liver failure
Follow-up of Pulmonary Radiotoxicity for Bronchopulmonary Cancer.

assess the consequences of low doses of radiation delivered by the volumetric radiotherapy, on the respiratory capacity of patients treated for bronchopulmonary carcinoma, by a follow up of functional respiratory exploration.

Radiation therapy with or without chemotherapy is a stable treatment in the management of patients with localized smack cell bronchopulmonary cancers, or not to small cells not metastatic but not operable. Radiation therapy results in changes in respiratory function, as measured by respiratory function tests and represented primarily by spirometry, total body plethysmography, and the diffusion capacity of the alveolar-capillary membrane.

Although these tests are minimally invasive, few studies have investigated the implications of radiation therapy on lung function in patients treated for pulmonary neoplasia, while these patients are often already carriers of respiratory diseases and will receive further chemotherapy during their illness, subject to their general good condition, including respiratory. No method has been recognized as superior for measuring the consequences of radiation therapy on respiratory function. After chest radiotherapy alone, the decline in diffusion capacity is estimated at 10-34%. New irradiation techniques have emerged over the last decade, in particular dynamic arc therapy. This innovative technology, combined with image-guided irradiation processes, ensures high-precision, short-term treatment, but exposes virtually all of the lungs to irradiation, although at very low doses, the objective consequences of which on respiratory functional explorations have never been reported.

The aim of this study is therefore to assess the consequences of low doses of radiation delivered by this recent technology, volumetric therapy, on the respiratory capacity of patients treated with radiotherapy within the framework of of bronchopulmonary carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* bronchopulmonary carcinoma histological proved
* OMS 0-2
* indication of radio(chimio)therapy alone approved by multidisciplinary comitee
* non opposition formular completed

Exclusion Criteria:

* SBRT indication
* history of thoracic surgery or irradiation
* unstable disease
* oxygenotherapy dependance
* severe chronic bronchitis
* collagen disease
* pregnancy
* contraception refusal
* refusal or incapacity to participate
Pilot Study of the HWL Program

The goal of the project is to test a remotely delivered, standalone behavioral weight loss intervention designed to help adults initiate the important dietary, physical activity (PA) and behavioral changes necessary to achieve weight loss.

The Weight Management Center currently offers a remotely delivered (smart phone, tablet, computer) program to assist patients with maintaining weight losses already achieved, which includes multi-channel self-monitoring and asynchronous individually recorded feedback from clinical staff. The goal of the presently proposed project is to build on this existing maintenance-focused program to create a remotely delivered, standalone behavioral weight loss intervention designed to help participants initiate the important dietary, physical activity (PA) and behavioral changes necessary to achieve weight loss. We recently developed the Home Weight Loss (HWL) program by repackaging existing clinical educational materials as instructional lifestyle change modules to be delivered remotely for participant weight loss

The aim of the proposed project are to pilot test the effects of the HWL program among a sample of overweight and obese adults (N=30). The digital platform currently used in the maintenance program will be used for the HWL program

Eligibility Criteria:
Inclusion Criteria:

* aged 18-70 years
* BMI = 25.0- 40 kg/m2
* Internet access via desktop or laptop computer
* valid email address
* smart phone ownership
* women of childbearing potential must agree to use effective contraception during the study

Exclusion Criteria:

* currently dieting (\>10-pound weight loss in past 3 months)
* another member of the household is participating in this pilot study
* inability to engage in physical activity
* inability to read and speak English
* diagnosis of diabetes (other than treated by diet alone),
* uncontrolled thyroid condition or other endocrine disorder
* major depressive disorder or other severe psychiatric disorder (e.g., bipolar disorder) within the past two years
* past suicide attempt
* current use of prescription or over-the-counter weight loss medications
* current/planned pregnancy
* drug and/or alcohol abuse
* use of steroid medication for more than 10 days in the past three months \*implanted electronic devices
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides

This is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of TTI-621 in subjects that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides.

The study will be performed in two different parts. Part 1 is the Dose Escalation phase and Part 2 is the Dose Expansion phase.

The purpose of this study is to characterize the safety profile of TTI-621 and to determine the optimal dose and delivery schedule of TTI-621. In addition, the safety and antitumor activity of TTI-621 will be evaluated in combination with other anti-cancer agents or radiation.

This is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of TTI-621 in patients that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides.

TTI-621 (SIRPα-IgG1 Fc) is a soluble recombinant fusion protein created by directly linking the sequences encoding the N-terminal CD47 binding domain of human SIRPα with the Fc domain of human immunoglobulin (IgG1). TTI-621 acts by binding human CD47 and preventing it from delivering an inhibitory "do not eat" (antiphagocytic) signal to macrophages.

The study will be performed in two different parts: Dose Escalation and Dose Expansion.

During the escalation part of the study, TTI-621 was studied at 3 different dose levels and at different dosing frequencies to characterize safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose (MTD).

During the expansion part of the study, TTI-621 will be studied in an expanded group of patients at the maximum feasible dosing regimen determined in the escalation phase. After completion of their initial assigned therapy, subjects may receive continuation with TTI-621. The expansion phase will further define safety and characterize efficacy of TTI-621 alone and in combination with other anti-cancer therapies.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented, injectable cancer lesion (limited to solid tumors and mycosis fungoides)
* Adequate renal function
* Adequate coagulation function
* Adequate hepatic function
* Disease that has progressed on standard therapy or for whom there is no other therapy option available

Exclusion Criteria:

* Central nervous system involvement
* Significant cardiovascular disease
* Active autoimmune disease
* Active hepatitis B or C or a history of HIV infection
* Uncontrolled infection
* History of hemolytic anemia or bleeding diathesis
Prediction of Acute Kidney Injury in Patients With COVID-19

The two biomarkers determined in urine, "Tissue Inhibitor of Metalloproteinases 2 (TIMP-2)" and "Insulin-like Growth Factor-Binding Protein 7 (IGFBP7)", can indicate the occurrence of Acute kidney injury (AKI) in cardiac surgery and critically ill patients at an early stage. However, no data are available whether these parameters can also predict the occurrence of AKI in the context of COVID-19 infection. An early prediction of AKI can be helpful for the optimisation of therapeutic management to improve patient outcome and for the triage of patients.

The aim of this observational study is to evaluate whether the biomarker \[TIMP- 2\]\*\[IGFBP7\] can predict the occurrence of AKI in critically ill patients suffering from SARS-CoV2 associated acute respiratory distress syndrome.

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is rapidly spreading around the world. The current outbreak of infections with SARS-CoV-2 is termed Coronavirus Disease 2019 (COVID-19). Two other coronavirus infections, SARS in 2002-2003 and Middle East Respiratory Syndrome (MERS) in 2012, both caused severe respiratory syndrome in humans. All 3 of these emerging infectious diseases are caused by β-coronaviruses.

Although COVID-19 primarily affects the lungs and may cause severe hypoxemia, other organs including the GI tract, heart and kidney are affected. Acute kidney injury secondary to COVID-19 (COV-AKI) is reported to occur in about 15-25% of patients hospitalized with COVID-19 infection. The majority of AKI cases are mild to moderate with renal replacement requirement in about 25%. However, AKI was much more common in non-survivors (\>50%). Although kidney failure appears to occur late in the course, patients may begin to develop AKI within the first 3 days of hospitalization. Similar to AKI in other settings,3 COV-AKI is likely to be of variable etiology. Thus, there may be a long window for treatment.

The two cell-cycle arrest markers, tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth-factor binding protein 7 (IGFBP7), have been shown to early predict the occurrence of AKI in cardiac surgical and critically ill patients. However, there is no data available whether (TIMP-2)\*(IGFBP7) can predict the occurrence of AKI in the COVID19 setting. Early prediction of AKI may be valuable to optimize therapeutic management in order to improve patient's outcome and might be helpful to triage patients.

The goal of this observational trial is to evaluate whether (TIMP-2)\*(IGFBP7) early predicts the occurrence of AKI in critically ill patients with SARS-CoV2 associated ARDS.

Eligibility Criteria:
Inclusion Criteria:

1. Moderate or severe ARDS according to the Berlin definition
2. SARS-CoV2 positive test
3. Age ≥ 18 years
4. Informed consent

Exclusion Criteria:

1. Pre-existing AKI
2. Severe CKD with eGFR\<20ml/min
3. Chronic dialysis dependency
4. Kidney transplant within the last 12 months
5. Pregnancy, breastfeeding
6. Persons with any kind of dependency on the investigator or employed by the sponsor or investigator.