cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Immunomodulator Drug Thalidomide in Multi-transfused Thalassemia Patients

This study aimed to determine the safety and efficacy of thalidomide in multi-transfused thalassemic children.

Given the significant burden of transfusion dependency, an effective and safe inducer is needed that could improve quality of life and reduce the healthcare costs associated with frequent transfusions and iron chelation therapy. If this study could establish the safety of thalidomide in terms of teratogenicity along with its efficacy, it would be a great support to multi-transfused thalassemic children.

Eligibility Criteria:
Inclusion Criteria:

* Children of both genders
* Aged 2-5 years
* With transfusion-dependent thalassemia (TDT)
* Whose parents/guardians showed willingness to adhere to follow-up visits

Exclusion Criteria:

* Children with uncontrolled infections
* Significant hepatic or renal dysfunction
* Malignancy
* Known contraindications to thalidomide
Adult Sexual Risk Behavior Among Women With a History of Childhood Sexual Abuse

This study will evaluate whether childhood experiences are related to current sexual behavior of adult women.

Adverse childhood events, including physical and sexual abuse, can cause significant distress for those affected, during both childhood and adulthood. Childhood abuse appears to increase the risk of a number of negative outcomes later in life, including psychiatric disorders, substance abuse, and HIV and sexually transmitted infections. Previous research has consistently found an association between childhood sexual abuse and greater rates of adult sexual risk behavior. However, improved understanding of how childhood sexual abuse relates to adult sexual risk behavior is needed. The Information-Motivation-Behavioral Skills and Traumagenic Dynamics models are theories used to investigate determinants of sexual behavior and effects of childhood abuse. Using these models to examine the relationship between childhood sexual abuse and adult sexual risk behavior may help in creating effective sexual risk reduction interventions for women abused during childhood. This study will evaluate whether childhood experiences are related to current sexual behavior of adult women. The study will also evaluate which theory, the Information-Motivation-Behavioral Skills model or the Traumagenic Dynamics model, better mediates the relationship between childhood sexual abuse and adult sexual risk behavior.

Participation in this study will include one study visit. Participants will first complete a 45-minute computerized survey that includes questions about childhood experiences; family environment; current health and behavior; attitudes, knowledge, and thoughts about sex and relationships; control over life circumstances; and substance use. Participants will then engage in two brief role plays in which they will either make a request of their partner or must stand up for themselves. For the last part of the visit, participants will be asked questions about condoms and condom use and will be asked to place a condom on a model used in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Understands English

Exclusion Criteria:

* Impaired mentally
Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

The main objective of the study is to demonstrate the safety and efficacy of the Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects Age \> 18 years and ≤ 55 years
* Male or Female
* Subjects with Type 2 Diabetes who have been treated for ≤10 years and are on oral diabetic medications
* Subjects with an HbA1C \> 7.5 and ≤ 10.0%
* Subjects with a BMI \> 26 - \< 50
* Subjects willing to comply with study requirements
* Subjects who have signed an informed consent form
* Women who are post-menopausal, surgically sterile or on oral contraceptives and agree to remain on oral contraceptives for at least twenty-four (24) weeks after being implanted or the duration of their trial participation and agree not to become pregnant during the trial.

Exclusion Criteria:

* Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
* Subjects requiring insulin
* Subjects with probable insulin production failure (fasting C Peptide serum \<1ng/mL)
* Subjects that have autoimmune disease as evidenced by a positive anti-GAD blood test
* Subjects with a weight loss of \> 4.5 Kg (10 lbs) within the 12 Weeks of screening
* Subjects requiring prescription anticoagulation therapy
* Subjects with or a history of iron deficiency and/or iron deficiency anemia
* Subjects with or a history of abnormalities of the GI tract
* Subjects with symptomatic gallstones or kidney stones at the time of screening
* Subjects with a known infection
* Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
* Subjects mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the Investigator, makes the Subject a poor candidate for device placement or clinical trial participation
* Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
* Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
* Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated)
* Subjects receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
* Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
* Subjects with active and uncontrolled GERD
* Subjects with a known history of substance abuse
* Subjects participating in another ongoing investigational clinical trial
* Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
FAAH Availability in Psychiatric Disorders: A PET Study

The aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in humans, including healthy individuals and across a spectrum of psychiatric disorders in which alterations in the endocannabinoid system are observed.

This study involves in vivo examination of FAAH availability, implicated both in the pathophysiology and therapeutics of disorders including PTSD, substance use disorders (e.g., alcohol use disorder, cannabis/cannabinoid use disorder, nicotine use disorder), psychotic disorders including schizophrenia, and mood disorders. The endocannabinoid system is a neuromodulatory system that has been implicated across a wide range of psychiatric disorders and may be implicated in the regulation of mood, appetitive behaviors, sleep, and cognition. Thus, alterations in the ECS have wide ranging implications. Finally, the ECS is being explored as a novel therapeutic target for several psychiatric disorders. Additionally, the test/retest reliability of the radiotracer, \[11C\]MK-3168, will be studied in up to 10 healthy control individuals.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65 years, inclusive
* Good physical health as determined by history, physical and laboratory examinations, ECG, and vital signs

PTSD Inclusion Criteria:

* Diagnosis of Post-Traumatic Stress Disorder

AUD Inclusion Criteria:

* Diagnosis of Alcohol Use Disorder

Psychosis Inclusion Criteria:

* Diagnosis of psychotic disorder such as Schizophrenia, Schizoaffective disorder

Exclusion Criteria:

* Presence of ferromagnetic metal in the body or heart pacemaker
* Women with a positive pregnancy test or women who are lactating
Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation

To examine radio frequency ablation as a treatment supplement to stimulate immunogenicity and improve survival for patients undergoing curative-intent surgery for colorectal liver metastases.

PURPOSE:

To investigate the impact of immunostimulation using radio frequency ablation (RFA) on survival in patients undergoing curative-intent surgery for colorectal liver metastases (CRLM).

HYPOTHESIS:

RFA-mediated partial destruction of CRLM will stimulate the immune system to recognize otherwise hidden cancer antigens, which in turn will improve survival by inhibiting micrometastases and recurrence.

BACKGROUND:

CRLM affects around 1,600 individuals in Denmark each year. State-of-the-art treatment includes liver resection, RFA treatment, radiation therapy, and chemotherapy. Of all individuals undergoing surgery, 50% will experience local or distant recurrence of the disease within five years. Although liver resection is the gold standard, RFA treatment has evolved considerably in recent years. RFA is a parenchymal-sparing treatment for hepatic malignancies, inducing a localized coagulation necrosis of the tumor. This leads to release of tumor antigens, which activates the patients' immune system. However, many cancer cells, including those from CRLM, have the ability to hide their antigens to the patients' immune systems. Using RFA as immunostimulation prior to surgery, these antigens may become visible to the immune system, which in turn can help eradicating all tumor cells and decrease the risk of tumor recurrence. Combined, this likely improves survival.

METHODS:

220 patients with CRLM planned for surgery will be enrolled in this study. Patients will be randomized to +/- RFA treatment before surgery. Under guidance of ultrasonography, a single-electrode RFA-needle is placed in a CRLM with a diameter of at least 3 cm, which is later going to be resected. In 20 of the patients, we will draw blood samples for determination of immune status both pre- and postoperatively. All patients will be part of a work-up with regular CT-scans.

ENDPOINTS:

Disease free survival and overall survival. Secondarily, we will examine the effect of RFA treatment of tumors on the innate and adaptive immune system in 20 patients

Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal liver metastases planned for resection
* At least one tumor size \>=3cm
* Performance status 0-1

Exclusion Criteria:

* Liver cirrhosis
* Extrahepatic metastases that can not be addressed curatively
* Other malignant diseases within 5 years prior to diagnosis
* Prior RFA treatment
Plethysmographic and Acoustic Respiration Rate Clinical Data Collection

The objective of this clinical investigation is to collect high-resolution pulse oximetry, RRp, and RAM data in pediatric subjects for the purpose of algorithm optimization and to build a database of representative pulse oximetry and respiratory signal profiles for patients in this population.


Eligibility Criteria:
Inclusion Criteria:

* Age: 0 to 5 years old
* Fully developed skin

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that would interfere with sensor application.
* Subjects with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
* Subjects deemed not suitable for the study at the discretion of the investigator
DASH Diet, Quality of Life and Cardiac Parameters of Patients With Acute Coronary Syndrome

The clinical trail study aimed to determine effect of DASH eating plan on cardiac parameters and quality of life in hypertensive individuals diagnosed with acute coronary syndrome.

The main questions it aims to answer are:

1. DASH diet improve quality of life?
2. DASH diet improve cardiac parameters?

The researchers assessed the results of 12 weeks of the DASH diet.

Patients will apply the DASH diet prepared individually by the researchers for 12 weeks.

The study period was 12 weeks. Patients' food consumption (3 day), anthropometric measurements, blood pressure measurements, physical activity levels, biochemical and cardiac parameters, adherence to DASH eating plan and the MacNew Heart Health-Related Quality of Life Scale were recorded at the beginning of the study and at the end of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with acute coronary syndrome within the last month
* with a measured blood pressure above 140/90 mmHg or using antihypertensive drugs
* not obese (body mass index \< 30)
* not diagnosed with a disease requiring a different medical nutrition therapy (chronic renal failure, diabetes, cancer, etc.)
* volunteered to participate in the study

Exclusion Criteria:

* Acute coronary syndrome diagnosed more than 1 month ago
* obese (body mass index \> 30 )
* without hypertension
* receiving different medical nutrition therapy
A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides

The researchers are doing this study to test the safety of combining bexarotene with TSEB radiotherapy in people who have a common form of CTCL called mycosis fungoides (MF).

Bexarotene is a form of vitamin A that activates proteins called retinoid X receptors, which may stop the growth of cancer cells and kill them. TSEB radiotherapy is a type of radiation therapy that treats the entire surface of the skin with very low doses of radiation to kill cancer cells and shrink tumors. This type of radiation does not pass through the outer layers of the skin into the tissues and organs below the skin.

The study researchers think that giving bexarotene treatment at the same time as treatment with TSEB radiotherapy may be more effective against MF than either treatment given alone or in sequence (one after the other).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Pathologically confirmed cutaneous T-cell lymphoma consistent with mycosis fungoides (MF) based on biopsy done or reviewed at MSKCC
* Stage IB or higher MF per ISCL/EORTC criteria; concurrent diagnosis of Sézary syndrome permissible. Patients who have not had prior systemic therapies and refractory/relapsed patients are eligible.
* Baseline mSWAT score of at least 10
* Stable topical steroids or systemic antipruritic agent (e.g. antihistamines, doxepin, GABA analogs) preceding study entry is permissible, but no new prescribed or over the counter topical or systemic anti-pruritics started post-enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Ability to provide informed consent

Exclusion Criteria:

* Any oral retinoid therapy for any indication within 3 weeks of the first dose of study drug
* Prior TSEB (prior focal skin-directed RT acceptable)
* Concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL) or another non-Hodgkin lymphoma
* Concurrent diagnosis of additional non-skin malignancy
* Pregnancy
* Patients unwilling to use two forms of barrier contraception while taking study medication
* Receipt of treatment with another investigational device or drug (at present or within 2 weeks of enrollment)
* Familial hypertriglyceridemia or other medical conditions in which use of bexarotene would be contraindicated
* High likelihood of protocol non-compliance (in opinion of investigator)
* Systemic steroids within two weeks of first dose of study drug (patients on systemic steroids for non-disease related conditions will be permitted per investigator discretion)

Prohibited concurrent medications

* Gemfibrozil is contraindicated as may increase bexarotene concentrations
* Bexarotene is a minor CYP3A4 substrate: avoid strong/moderate CYP3A4 inducers and inhibitors, if possible, but concomitant use is not a contraindication Bexarotene is a moderate CYP3A4 inducer: avoid concurrent administration with CYP3A4 sensitive substrates, for which minimal concentration changes may lead to therapeutic failures of the substrate (e.g. cyclosporine, tacrolimus, sirolimus, quinidine, fentanyl), if possible
Total Motorized Spiral Enteroscopy Trial

Study design Prospective bicentric non-controlled clinical trial

Study purpose

- to evaluate the efficacy and safety of Novel Motorized Spiral Enteroscopy (NMSE) for total enteroscopy in patients with suspected small bowel diseases with an indication for direct visualization of the entire small bowel

Primary objective

Rate of total enteroscopy by means of NMSE with:

1. a complete anterograde approach
2. or a combined anterograde and retrograde approach

Secondary objectives

* Procedural success of anterograde and retrograde approach
* Procedural time (minutes)
* Depth of maximum insertion (cm)
* Diagnostic yield
* Therapeutic yield
* Adverse events


Eligibility Criteria:
Inclusion Criteria:

* Patients with small bowel disease with an indication for a total enteroscopy, e.g.:
* Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive Video capsule endoscopy (VCE) or negative VCE in patients who have ongoing bleeding shown by overt bleeding or continued need for blood transfusions
* Abdominal pain or chronic diarrhoea with positive findings of small bowel imaging examinations
* Noncontributory ileocolonoscopy and suspicion of Crohn's disease on small-bowel cross-sectional imaging modalities or small-bowel capsule endoscopy
* Further evaluation of known Crohn's disease or therapeutic indications in Crohn's disease
* Large polyps (\>10-15mm) in the jejunum and ileum discovered by radiological examination or small-bowel capsule endoscopy in patients with Peutz-Jeghers syndrome
* Nonresponsive or refractory coeliac disease

Exclusion Criteria:

* - Age under 18 years
* Health status American Society of Anesthesists Classification (ASA) 4
* Pregnancy
* Coagulopathy (INR≥2.0, Platelets \< 70/nl)
* Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
* Any medical contraindication to standard enteroscopy
* Presence of any intraluminal or extraluminal foreign body in the abdominal cavity
* Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable)
* Known or suspected bowel obstruction or stenosis or history of bowel obstruction
* Known coagulation disorder
* Known or suspected esophageal stricture or Schatzki ring
* Known gastric or esophageal varices
* Suspected perforation of the GI tract
* Known or suspected colonic or ileocecal valve (ICV) stricture
* Inability to tolerate sedation or general anesthesia for any reason
* Inability to tolerate endotracheal intubation
* Absence of a signed informed consent
Improving Dietary Behavior Through Tailored Messages

The aim of this study is to compare a Web-based system and a computer telephone system to determine their effectiveness in improving diet behaviors compared to each other and a control group.

The aim of this study is to compare a Web-based system (WEB-DIET) and a computer telephone system (TLC \[Telephone Linked Communications\]-DIET) for affecting dietary behavior change. These interventions will target the same dietary behaviors (consumption of fat and fruits and vegetables). The behavior change strategies and content will be derived from the same behavior change theory (the Transtheoretical Model \[TTM\]). A representative sample of \~1200 adults from a large urban area will be recruited through a list-assisted telephone list which will be bought by the University of Rhode Island so that subjects can be randomized into one of three groups: a Web-based system (WEB- DIET), a computer telephone system (TLC \[Telephone Linked Communications\]-DIET), or assessment only control. The study hypotheses, which will be evaluated both at the end of the 6-month intervention period and at the end of 18-month follow-up (post-baseline) observation period, are: 1. TLC-DIET\> Control 2. WEB-DIET\> Control 3. WEB-DIET\> TLC-DIET.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Be at risk with regard to saturated fat
* Have access to basic computer hardware and software
* Use the Internet regularly (defined as 1 times per week) and with basic proficiency
* Read and speak English at a fifth grade level
* Have access to a telephone and be able to use it independently.

Exclusion Criteria:

* Prescribed a diet that would conflict with a low saturated fat (e.g., a colectomy diet)
* Have a serious medical, psychiatric, or cognitive disease that would interfere with participation (e.g., cancer undergoing chemotherapy, psychotic disorder, Alzheimer's disease, etc.)
* If the individual does not use the Internet at least once a week
Percutaneous Electrical Stimulation, Education and Exercise Program in Patients With Knee Osteoarthritis

The purpose of this study is to compare the effectiveness of percutaneous electrotherapy treatment with transcutaneous and placebo.

There is evidence of the benefit of therapeutic exercise on pain intensity and functionality in patients with osteoarthritis of the knee. However, there is a lack of evidence of its effectiveness when applied in combination with new treatment strategies such as percutaneous electrostimulation and therapeutic pain education.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 45 years
* Have activity related joint pain
* Have morning stiffness ≤30 min
* Knee pain of at least 6 months duration
* OA diagnosis by physician
* Current levels of moderate/vigorous physical activity (MVPA) below physical activity guideline recommendations (\< 150 min/week of MVPA; assessed using the Active Australia Physical Activity Questionnaire)

Exclusion Criteria:

* Health conditions that prevent safe participation in physical activity interventions as listed in the American College of Sports Medicine Guidelines (e.g., cardiac or lung disease).
* Pain in other body areas that currently limits walking ability (e.g., back pain, foot pain, hip pain)
* Neurological disorders affecting lower limb movement (e.g., multiple sclerosis or stroke).
* Inflammatory arthritis (including rheumatoid arthritis)
* Fibromyalgia
* Previously operated knee is the most painful knee
* Any condition impacting decision-making/memory (e.g., Alzheimer's, dementia)
* Severe depression
* Current moderate/vigorous physical activity levels above guideline recommendations (≥150 min/week; assessed using the Active Australia Physical Activity Questionnaire)
* Currently undergoing regular, active intervention for the knee (e.g., seeing a physiotherapist)
* Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)
Acceptance-based Behavioral Treatment for Obesity: Maintenance and Mechanisms

The primary goal of this project is to determine if an innovative behavioral weight loss program that incorporates new developments from the field of behavior therapy produces superior weight control than standard behavioral treatment. A sample of 200 adults from the community are participating in this study.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 and 70
* Have a BMI between 27-50
* Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest).
* Agree to provide permission for the research team to regularly contact your physician throughout the study to share information on changes in your weight.
* Successfully complete all steps in the enrollment process

Exclusion Criteria:

* You have a medical condition or psychiatric condition that may limit your ability to comply with the behavioral recommendations of the program or pose a risk to you during weight loss.
* You are pregnant or plan to become pregnant in the next three years.
* Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain.
* You are participating in or plan to participate in another weight loss program in the next three years.
* The research team identifies any factors that would render you potentially unable or unlikely to follow the protocol, or unable to benefit from it.