cyrilzakka/clinical-trials huggingface dataset:
CoolSculpting of the Distal Thigh Study

Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a small area applicator for non-invasive subcutaneous fat reduction in the distal thigh.

This study will investigate the use of a Small Area Applicator with the CoolSculpting device for reducing subcutaneous fat in the distal thigh. The study will evaluate the safety and effectiveness of treatments.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects \> 22 years of age and \< 65 years of age.
* Subject has clearly visible fat on the distal thigh, which in the investigator's opinion, may benefit from the treatment.
* Subject has not had weight change exceeding 10 pounds in the preceding month.
* Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
* Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.
* Subject has read and signed a written informed consent form.

Exclusion Criteria:

* Subject has had a surgical procedure(s) in the area of intended treatment.
* Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
* Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
* Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
* Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
* Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
* Subject is taking or has taken diet pills or supplements within the past month.
* Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
* Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
* Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
* Subject is lactating or has been lactating in the past 6 months.
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
* Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
A Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Low Systolic Blood Pressure

The investigators thus propose to use an innovative randomized effectiveness trial design to test the theory that early automatic identification of a ¡ Low Systolic Blood Pressure¡± clinical condition and decision-support alerts will prompt earlier hemodynamic support and a consequently reduce the duration of such conditions. Specifically, the investigators will test the hypothesis that providing DSS alerts in regards to hypotension reduces the duration of hypotensive episodes. The core of the investigators study will be an existing electronic anesthesia record and smart-alarm decision-support system. All patients undergoing surgery at Hillcrest will be randomly assigned to routine care or to DSS support. In patients assigned to DSS support, a systolic blood pressure less than 80 mmHg will generate a warning within three minutes after detection. Clinicians will be free to act on the alert, ignore the alert, or to consider the provided information without acting on it. The randomization, complete anesthesia record, detailed record of hypotensive events, alerts provided, clinician responses, and SAP response, will be captured by the investigators electronic record-keeping system. The investigators primary outcome will be the duration of time the patient has a systolic blood pressure less than 80 mmHg. Secondary outcome will be duration of hospitalization. The investigators will assess the effect of the alert on the primary outcome of time to SBP returning to above 80 mmHg using survival analysis, with time to event censored (and considered a non-event) at either the end of surgery or end of monitoring if patient did not return to above 80 mmHg.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be enrolled in the study if systolic blood pressure (SBP) is measured to be below 80 mmHg for at least 3 minutes, either with the arterial line or cuff (non-invasive blood pressure, NIBP).
Psychosocial Needs of YMSM

The proposed study will use both qualitative and quantitative research methods (mixed methods) to gather data that will support the eventual development of interventions for young men who have sex with men (YMSM) living with behaviorally acquired HIV infection. The overall goal of the study is to gain an understanding of the psychosocial/developmental needs of YMSM by focusing on two critical developmental issues-identity development and future life goals.


Eligibility Criteria:
Inclusion Criteria:

Potential participants must meet all of the following inclusion criteria in order to participate in the study:

* Biologically male at birth and identifies as male at time of study participation;
* HIV-infected as documented by medical record review or verbal verification with referring professional;
* Between the age of 16 years, 0 days to 24 years, 364 days at the time of informed consent/assent;
* HIV infection occurred through sexual or substance use behavior of the participant;
* Ability to understand both written and spoken English; and
* History of at least one sexual encounter involving either anal or oral penetration (either receptive or insertive) with a male partner during the 12 months prior to enrollment.

Exclusion Criteria:

* Acquired HIV through perinatal infection;
* Transfusion acquired HIV infection;
* Presence of serious psychiatric symptoms (active hallucinations, thought disorder) that would impair participants' ability to complete the study measures;
* Visibly distraught (suicidal, homicidal, exhibiting violent behavior); or
* Intoxicated
A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.

This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.


Eligibility Criteria:
Inclusion Criteria:

* Disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment)
* And/or patients who have discontinued sunitinib treatment at any point due to toxicity
* Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks
* Memorial Sloane Kettering Cancer Centre (MSKCC) prognostic score low or intermediate
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%).

Exclusion Criteria:

* Patient should be excluded if they have unresolved chronic toxicity grade
* \> 1 and related to prior therapy with sunitinib.
Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)

Study to support the mental and physical well-being of US health care workers during the COVID-19 pandemic and ensure high-quality care for patients through Stress First Aid.

The goal of the project is to support the mental and physical well-being of U.S. health care workers (HCWs) during the COVID-19 pandemic to ensure high-quality care for patients, by establishing the effectiveness of a tailored Stress First Aid (SFA) intervention, compared to usual care (UC). The RAND Corporation will conduct a cluster randomized controlled trial (cRCT) with three cohorts containing matched pairs in approximately 40 diverse sites (hospitals and clinics) to evaluate whether SFA for HCWs improves mental and physical well-being compared to UC. Sequential roll-out of the intervention to three cohorts will allow investigators to quickly incorporate lessons learned and stakeholder feedback from each iteration into subsequent trainings, and share actionable findings given the urgency due to the pandemic. The end result will be an SFA toolkit tailored for HCWs that can be implemented and scaleable across multiple settings. The proposed SFA intervention addresses an important and compelling clinical care delivery challenge during COVID-19 by improving the mental well-being of HCWs, who will benefit directly and be better equipped to provide higher quality, more sustained, and more patient-centered care to patients. The specific aims of the project are to: (1) test the comparative effectiveness of SFA versus UC on mental and physical well-being (quantitative); (2) understand and document any UC activities to support HCW well-being prior to implementing SFA across sites; and (3) assess the experiences of HCWs and sites with SFA (acceptability, likelihood of uptake, lessons learned) and impact on HCW well-being (qualitative).

Eligibility Criteria:
Inclusion Criteria:

* Health care workers and patient-facing support staff (e.g., front desk staff)

Exclusion Criteria:

* Non-English speaking
Pilot Study of Safety and Efficacy of Sodium Phenylbutyrate in Spinocerebellar Ataxia Type 3

DESIGN: Pilot, Phase II, double-blind, placebo-controlled study

JUSTIFICATION: In the literature one does not find a pharmacological treatment that changes the natural history of Spinocerebellar ataxtia type 3 (SCA3). Patients with this disease invariably become dependent.

OBJECTIVES I. To determine safety and tolerability of phenylbutyrate in patients with SCA3.

II. To provide early subsidies on the efficacy of phenylbutyrate in SCA3.

DURATION: 12 months of a double-blind study.

PLACE OF REALIZATION: Hospital de Clínicas de Porto Alegre, Brazil.

NUMBER OF PATIENTS: 20 patients.

CONCOMITANT MEDICATIONS: There are no concomitant medications that are prohibited unless they affect safety parameters of this study (hemogram and platelets; fasting serum glucose, AST, ALT, Gamma-GT, Bilirubins, Prothrombin time, Creatinine, Urea, Na, K, chlorides and arterial gasometry; electrocardiogram and echocardiogram).

MEDICATIONS UNDER INVESTIGATION: Powdered sodium phenylbutyrate in sachets containing each 3g. At the start of the study, the dose will be 15g/day (five sachets) and may be reduced in case of mild adverse events.

OUTCOMES Primary safety outcome: The number of adverse events, interruptions and dose reductions in the two groups (cases and controls).

Efficacy outcomes: Efficacy outcomes are the following scores in both groups: NESSCA, SARA, Barthel, BDI, and WHOQol.


Eligibility Criteria:
Inclusion Criteria:

1. All patients shall have their molecular diagnosis confirmed and expanded polyglutamine tract (CAG) measures already determined.
2. Patients still able to walk with until 8 years of disease duration, and
3. Patients aged 16 years or over will be invited to participate in the study.

Exclusion Criteria:

1. they show electrocardiogram ou echocardiographic alterations suggestive of heart insufficiency at baseline;
2. their serum creatinine levels are higher than 1.2 mg/dL, with the confirmation of renal insufficiency due to the rate of glomerular filtration;
3. they show a history of hypersensibility to sodium phenylbutyrate, and if
4. they (men and women) do not agree to use a reliable contraceptive method during the entire study period and for three months after its end.
Selection of a Protective T Cell-based HIV-1/FIV Vaccine

The purpose of this research study is to develop a vaccine against Human immunodeficiency virus (HIV), a disease that causes AIDS in people,. The investigator will be looking at viruses similar to HIV in animals. Since these viruses are very similar to HIV, the blood from humans who have been exposed to HIV will be tested to see if the immune system will recognize the HIV and prevent infection.

HIV targets the immune system by attacking certain T cells called CD4+ T cells. There are parts on the AIDS viruses that help the virus infect these cells and other parts that help the immune system prevent viral infection by activating protective T-cells that fight HIV. Different T-cell populations are very important in most vaccines as they act as "effectors" that work as part of the immune system to recognize and fight off HIV infection. When effector T cells are activated by appropriate "protective" part(s) of the virus they either block HIV from reproducing or kill HIV infected cells. By finding these common protective parts of each of these human and animal AIDS viruses, the investigator hopes to make a vaccine that helps the immune system prevent HIV infection by avoiding parts that attack CD4+ T cells and may worsen HIV infection and selecting for parts that stimulate effector T cells that fight HIV infection.

As a participant in this study a blood drawn will performed.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between 18 and 65 years old who are HIV positive

Exclusion Criteria:

* Persons with other immune diseases that would result in autoimmunity or aberrant immune responses (such as subjects who have undergone chemotherapy within the past year).
Qigong For PPSP In Breast Cancer Pain In Breast Cancer Survivors

Studies have shown that on-going pain following breast surgery is common and may limit the ability to participate in physical activity, cause tiredness, difficulty in daily chores/activities as well as other problems.

This study is evaluating whether participating in a 12-week Qigong program (pronounced chee kung), an exercise program that involves gentle movements combined with breathing/relaxation techniques, also known as mind-body exercise, leads to improvement of pain, physical function, and quality of life among breast cancer survivors that have significant pain following surgery.

This is a pilot/feasibility study designed to look at the potential benefits of a 12-week program of Qigong mind-body exercise program. The study applies to women who have completed physical therapy treatment on symptoms such as pain, and difficulty moving/strength of arm in women who are experiencing on-going symptoms after breast cancer surgery. The results of this study will be used to help design future studies of the effect of Qigong programs in breast cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* History of Stage 0-III breast cancer;
* Persistent post-surgical pain at least 3 months after completion of surgery, chemotherapy, and/or radiation;
* Completion of a course of physical therapy

Exclusion Criteria:

* Unstable cardiovascular disease in the last 6 months
* Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder);
* Metastatic breast or other cancer;
* Participation in more than 240 minutes of moderate-intensity exercise per week (as determined by Leisure Score Index questionnaire)
* Pregnant or breastfeeding
* Recent history of attending regular QMBE or similar classes (e.g. yoga or tai chi classes), (i.e.20 or more classes in the past 6 months).
* Currently enrolled in a physical therapy course
Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes

This trial is conducted in South Africa. The aim of this trial is to investigate Long term safety of biphasic insulin aspart 30 in juveniles with type 1 diabetes previously treated in trial BIAsp-1240.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any trial-related activities according to local requirements. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
* The subject must have completed the trial BIAsp-1240
Amniotic Membrane for Recurrent Macular Hole

Macular hole surgery were tried by different surgeons using many techniques with different successes but still there were many recurrences. In this study the investigators try to close these distinct types including recurrent holes using pre-prepared amniotic membrane.

It is an interventional study of using amniotic membrane graft for closure of macular hole associated retinal detachment in patient who had a previous failed macular surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient with history of opened macular hole after previous pars plana vitrectomy and internal limiting membrane (ILM) peeling for treatment of myopic macular hole were included.
* Opened holes after 1 month of the surgery.
* Myopic macular holes only were included (Refraction of more than _6 D and/or axial length of more than 26 mm).

Exclusion Criteria:

* All other causes of macular hole (traumatic and idiopathic)
* Patients with diseases that can affect visual outcome (Diabetic retinopathy, choroidal neovascularization, age-related macular disease and advanced glaucoma patients.
Educational Strategy on a Vulnerable Population to Improve Cardiovascular Health and Food Insecurity

The purpose of this study is to demonstrate that an educational program on a healthy lifestyle which increases health literacy could improve long-term health and mitigate food insecurity.

A 24-month randomized clinical trial involving vulnerable families (460 participants) at risk of food insecurity to improve cardiovascular health, with an initial basic training workshop followed by randomization into three groups: 1. No further intervention; 2. A traditional advanced intervention model every three months; and 3. E-learning advanced intervention model every 15 days with YouTube videos and WhatsApp messages.

Primary objective:

- Improve cardiovascular health measured by Life's Simple 7, American Heart Association

Secondary objective

* Demonstrate whether the intervention improves the food safety score measured according to FAO
* Study which of the two models of advanced intervention, face-to-face or virtual, improves cardiovascular and food health literacy in the study population.

This project aims to transfer and offer to society this virtual educational strategy as a tool to improve cardiovascular health in other vulnerable populations, in a scientific, efficient, safe, and sustainable way.

Eligibility Criteria:
Inclusion Criteria:

* Participants from the general population without disabling diseases or whose severity implies a life expectancy of less than five years
* Informed Consent

Exclusion Criteria:

* Age less than 12 years or equal to or greater than 80 years, with a life expectancy, not less than 5 years.
* Patients with established cardiovascular disease
* Patients with limitations to follow the protocol
* Serious or difficult-to-control risk factors: Patients with hypertension and diabetes with organic involvement that limits their survival and disabling clinical manifestations of cerebral arteriosclerosis will be excluded.
* Chronic diseases not related to coronary risk: severe psychiatric diseases, chronic processes requiring treatment such as chronic renal failure, chronic liver disease, neoplasms undergoing treatment, severe and very severe chronic obstructive pulmonary disease, endocrinopathies susceptible to decompensation, and digestive tract diseases.
* Participants in other clinical trials at screening or within 30 days prior to start.
* Excessive alcohol and drug abuse
* Pregnant or lactating women.
A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy

The purpose as well as the aim of this project is to understand the effect of probiotics on gastrointestinal (GI) dysfunction such as nausea, vomiting, and constipation that are found during the first and second trimesters of pregnancy.

The primary objective of this project is to uncover whether probiotics have an effect on GI functional disorders.

The secondary objective is to identify the microbiota associated with probiotic intake.

The tested hypothesis is that gut microbiota influences the GI functions and may influence constipation, nausea, and vomiting during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* First and second trimester healthy or low risk pregnant women who report gastrointestinal disorders such as nausea, vomiting, and constipation

Definition of healthy or low risk pregnant women:

* Systolic blood pressure \< 140 mmHg and diastolic blood pressure \< 90 mmHg
* Hemoglobin ≥ 10.0 g/dL
* Have immunity against rubella (German measles)
* HIV negative
* Urine test shows no sign of kidney or urinary tract infection

  * 27 weeks 6 days gestation or less with confirmed fetal heart beat
  * Pregnant women age 18 and older

Exclusion Criteria:

* High risk pregnant women who have existing health conditions such as high blood pressure, Type 1 diabetes, HIV positive, or are infected with Hepatitis B, Syphilis, or other sexually transmitted diseases
* Pregnant women who have multiple gestations or a history of recurrent miscarriages (more than two consecutive miscarriages)
* Had prior bariatric surgery
* Conceived through IVF program
* Pregnant women who have had severe weight loss (more than 5 pounds) during pregnancy. \[Note: Mild weight loss (2-3 pounds) due to nausea, vomiting, or loss of appetite is considered normal.\]
* Medical history of irritable bowel syndrome or other non-pregnancy related GI dysfunction/disorder