cyrilzakka/clinical-trials huggingface dataset:
Development and Validation of a Brief Food Noise Questionnaire

The purpose of the research is to develop and test the reliability and validity of a brief questionnaire to measure food noise.

Currently and to our knowledge, there are no validated questionnaires to assess food noise. The purpose of this study is to develop and validate a brief food noise questionnaire. A total of 400 participants will be asked to complete the new food noise questionnaire. A subsample will also be asked to complete the questionnaire a second time to evaluate test-retest reliability. A separate subsample will also complete additional questionnaires to test convergent and discriminant validity.

Eligibility Criteria:
Inclusion Criteria:

* This study is open to adults (aged 18 years and above) who reside in the United States.

Exclusion Criteria:

* Individuals who do not provide informed consent will not progress to the survey questions
* Individuals who are currently participating in a weight loss program
* Individuals who have a BMI lower than 18.5 kg/m2
Mucosal Impedance Balloon in Diagnosis and Treatment of Eosinophilic Esophagitis (EoE)

This study will evaluate the role the balloon mucosal impedance may have in diagnosing and monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.

The standard diagnostic evaluation for EoE includes upper endoscopy with esophageal biopsies. Recently we completed the study "Mucosal impedance in eosinophilic esophagitis and the effect of treatment" using a new technology allowing for direct assessment of mucosal impedance at the time of routine upper endoscopy to assess esophageal integrity and disease activity and alevate the need for biopsies.

For this study, Sandhill Scientific has customized a Mucosal Impedance balloon (MI) assembly to provide precise measurements over a broad area of esophageal epithelium, while eliminating the fluids and spanning across a 10 mm luminal area using the same direct assessment as the mucosal impedance at the time of routine upper endoscopy.

Eligibility Criteria:
Inclusion criteria:

* Adults ages 18-90 undergoing clinically indicated upper endoscopy
* Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy
* Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or GERD with normal appearing esophageal mucosa.

Exclusion criteria:

* Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
* Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma

The primary objective of this trial is to compare the survival of patients with metastatic malignant melanoma treated with Taxoprexin Injection to those treated with Dacarbazine. In addition, the response rate to each drug, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have malignant melanoma, and documented metastatic disease.
* Patients must have at least one unidimensionally measurable lesion.
* Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed provided there is documentation of disease progression.
* At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during immunotherapy.
* At least 4 weeks (28 days) since any prior radiotherapy.
* Lesions being used to assess disease status may not have been radiated.
* Patients must have ECOG performance status of 0 - 2.
* Patients must be \>= 18 years of age.
* Patients must have adequate renal and liver function
* Patients must have adequate bone marrow function.
* Life expectancy of at least 3 months.
* Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.

Exclusion Criteria:

* Patients who have received prior therapy with any taxane or dacarbazine.
* Patients whose primary site is the eye.
* Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers cured by surgery alone with a disease-free survival longer than 5 years.
* Patients with uncontrolled brain metastasis.
* Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
* Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
* Patients with current peripheral neuropathy of any etiology that is greater than grade 1.
* Patients with unstable or serious concurrent medical conditions are excluded.
* Patients with a known hypersensitivity to Cremophor.
* Patients must not have had recent major surgery within the past 14 days or large field radiation therapy, chemotherapy, endocrine therapy in the last 28 days, or biologic therapy in the last 42 days.
Bone Microarchitecture in Men With Hemophilia

Hemophilia A and B are hereditary sex-linked deficiencies of coagulation factors VIII and IX characterized by bleeding. Their modern therapy increases life expectancy and risk of age-related diseases, e.g., osteoporosis.

Hemophilia-specific risk factors impair formation of peak bone mass and accelerate bone loss. Fractures are more frequent in hemophilic men vs. age-matched men and induce bleeding which is aggravated by manipulations and surgical intervention.

The hypothesis of this study is that hemophilic men have poor bone microarchitecture (assessed by High-resolution peripheral quantitative computed tomography (HR-pQCT)) related to an imbalance between bone formation and resorption (assessed by bone turnover markers (BTM) and bone biomarkers).

The study aims to assess the difference in low trabecular number (Tb.N) at the distal radius between hemophilic men (cases) and age- height-weight-ethnicity and smoking-matched healthy men (controls). Correlation between BTM and Tb.N will be also studied.

Biologic markers of bone remodeling (C-terminal telopeptide of type I collagen (PINP), N-terminal propeptide of type I procollagen (CTX-I), periostin) will be studied.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Men aged 20 to 60 years
* Severe hemophilia A or B (FVIII or FIX\<1%)
* Regular followed up in Lyon Hemophilia Center
* Ability to give free and informed consent
* Person capable of actively participating in radiological examinations

Healthy Mens:

* Aged 20 to 60 years

Exclusion Criteria:

* Women
* Not covered by health system
* Vulnerable (adults unable to consent, protected under guardianship, prisoner)
* Any blood coagulation abnormality other than severe hemophilia A or B
* Having one of the following treatments against osteoporosis of more than 6 months : bisphosphonates, denosumab, teriparatide
* With a chronical disease having a high impact on bone structure and no related to hemophilia disease, such as Cushing or Crohn diseases.
Effects of MAT Pilates Versus Functional Training on Mechanical Low Back Pain

This study will be a randomized clinical trial. Total 44 Subjects with mechanical low back pain will be assigned randomly by using non probability convenient random sampling in to two groups with 22 subjects in each group. Subjects in one group will be treated with mat Pilates training and the other group with the functional training. NPRS, Inclinometer and urdu version of Modified Oswestry Disablility questionair would be used to measure the outcome of pain, Range of Motion and Disability respectively. After data collection from defined study setting, data will be entered and analyzed at Riphah International University lahore.

Mechanical low back pain refers to back pain that arises intrinsically from the spine, intervertebral disks, or surrounding soft tissues. This includes lumbosacral muscle strain, disk herniation, lumbar spondylosis, spondylolisthesis, spondylolysis, vertebral compression fractures, and acute or chronic traumatic injury. Repetitive trauma and overuse are common causes of chronic mechanical low back pain, which is often secondary to workplace injury. Pilates focus is improving the core strength, it trains the body as an integrated whole. Functional training involves the daily life activities that also targets on core stability and strength.

The aim of the study is to present the current state of knowledge concerning the application of pilates and functional training in terms of duration, frequency and specific exercises in the management of mechanical low back pain in terms of pain, ROM and disability improvement.

Effects of Mat Pilates and functional training on mechanical low back pain are checked individually before but their effects are not compared previously.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Age group 25-40
* Patient having mechanical low back pain for more than 12 weeks

Exclusion Criteria:

* Pregnancy
* Previous spinal surgery
* Orthopedic and neurological diseases
* Patients with serious spinal pathologies( tumor, fracture and autoimmune conditions)
Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product

Subjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. No investigational product or treatment will be administered in this study. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.


Eligibility Criteria:
Inclusion Criteria

* Willing to provide informed consent for participation in the study
* Received at least 1 dose of an ACTR T cell product in an investigational or other treatment setting, such as compassionate use, named patient IND, expanded access program, or equivalent settings
* Has completed study assessments and follow-up visits in the prior study or other investigational setting to the extent willing and able to do so
* Able to comply with study requirements

Exclusion Criteria

* None
An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine)

This study identify prescription patterns of Lodient Tab and evaluate the changes of the hypertension symptoms (BP pressure) who are first prescribed and taking Lodient Tab.

This study aims to observe changes in symptoms according to the treatment effect of hypertension for 6 months after Lodient Tab prescription.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over 19 years of age
2. A person diagnosed with hypertension
3. A person who has been first prescribed Lodient Tab within the past 4 months as of the IRB approval date or is scheduled to be prescribed Lodient Tab
4. A person who voluntarily agreed in writing to this study

Exclusion Criteria:

1. Pregnant women or nursing mothers
2. Persons subject to prohibition according to the permission of the Lodient Tab
3. Patients who in the judgement of the investigator, were inappropriate to participate in the study
Effects of Health and Wellness App on Employee Productivity

The purpose of this study is to test the effects of using the Calm app + coaching concierge (one 20-min session) and/or Calm Coaching for sleep program on sleep, mental health, and work productivity outcomes in employees.

Employees (N=5,000) will be randomized into one of two groups for 8-weeks.

Workplace stress is highly prevalent and is linked to poor health outcomes including depression and anxiety. Depression impacts a person's physical ability to complete job tasks about 20% of the time while reducing cognitive performance 35% of the time. Mental health issues are not often properly identified and less than half of people receive treatment.

The Calm app is a mindfulness meditation mobile app and has been evidenced to reduce stress, improve sleep, and reduce anxiety/depressive symptoms in a range of populations (e.g., college students, cancer patients, sleep-disturbed adults). The Calm app provides daily, 10-minute, guided meditations grounded in mindfulness-based stress reduction (MBSR) and Vipassana meditation. Uniquely, the Calm app also offers "Sleep Stories", narrated fictional tales that use mindfulness- inspired techniques to help users sleep. However, the effects of the Calm app in employees among worksites has not yet been explored.

The purpose of this study is to test the effects of using the Calm app + coaching concierge (one 20-min session) and/or Calm Coaching for sleep program on sleep, mental health, and work productivity outcomes in employees.

Employees (N=5,000) will be randomized into one of two groups for 8-weeks.

The research team will randomize the employee sites into one of two groups

1. Intervention group (N=2,500): Calm app + concierge (one live 20-minute coaching session)

   a. Calm Coaching for sleep Subsample (N=100): Participants with elevated sleep disturbance (determined as a score of \>10 with the ISI) AND interest in Calm Coaching for sleep will be assigned to the Calm Coaching for sleep Program in addition to having the Calm app + concierge
2. Waitlist control group (N=2,500): Following 8-weeks from the study start date, employee receives access to the Calm app a. Calm Coaching for sleep Subsample (N=100): Participants with elevated sleep disturbance (determined as a score of \>10 with the ISI) AND interest in Calm Coaching for sleep will be assigned to the Calm Coaching for sleep Program in addition to having the Calm app + concierge

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Employee of company
* Only English speakers
* Willing to download the Calm app to their smartphone

Exclusion Criteria:

• Greater than 60 minutes/month of meditation for the past six months
The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED)

This study will test the relationship between CBP (central blood pressure) and PBP (peripheral blood pressure) effects after single and multiple doses of Isosorbide mononitrate extended release (ISMN ER) or Amlodipine besylate in participants with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Participant is a male or female between 30 and 65 years of age (inclusive) at the pre-study (screening)
* Female participant of childbearing potential must have a negative pregnancy test
* Participant has a brachial systolic blood pressure \>130 mm Hg

and \<180 mm Hg

* Participant has a Body Mass Index (BMI) that is \>20 kg/m\^2 and \<35 kg/m\^2
* Participant has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

* Female Participant is pregnant or lactating
* Participant anticipates the use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) other than acetaminophen
* Participant is currently a user (including "recreational use") of any illicit drugs, has a history of drug or alcohol abuse within approximately 2 years, or has a positive prestudy urine drug screen
* Participant has a condition for which there is a warning, contraindication, or precaution against the use of ISMN ER including: acute myocardial infarction or congestive heart failure, hypotension, volume depletion, and pregnancy
* Participant has a history of significant drug allergy or any clinically significant adverse experience of a serious nature related to the administration of either a marketed or an investigational drug, including nitrates, nitrites, Amlodipine, and ISMN ER
Glucose Meter Study

The purpose of this study is to evaluate if the meal marker and reminder feature of the Contour meter along with education maintains or increases frequency of testing blood sugar after meals and enables behavioral changes that may lead to improvement in glycemic control.


Eligibility Criteria:
Inclusion Criteria:

1. Persons with type 1 or type 2 diabetes
2. Persons who are on a pump or are taking at least 1 mealtime injection of insulin a day
3. Persons at least 21 years of age
4. Persons willing to complete all study visits and study procedures including:

   * Using the meal-marker + reminder feature regularly (Group 2 subjects only)
   * Using the paper logbook provided (both Groups)
5. Testing their BG at least 3 times a day during the entire study.
6. Persons who are able to speak, read and understand English
7. Persons who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more

Exclusion Criteria:

1. Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months
2. Persons who test over 6 times/day regularly
3. Persons who wear a BG sensor 2 weeks or more during each month.
4. Persons with home heath aides who assist with their BG testing.
5. Persons with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:

   * Significant visual impairment
   * Significant hearing impairment
   * Cognitive disorder
   * Significant unstable co-morbidity (with notable change within the past 3 months)
6. Any other condition as per investigator's discretion
Endocrine Regulation of Energy and Fluid Supplies in Alcoholic Patients

This study is about the endocrine regulation of energy and fluid supplies in alcoholic patients. A large proportion of energy and fluid is supplied by alcohol beverages in alcoholic patients. In this study, we evaluated the importance of these supplies with a detailed questionnaire, a nutrition software that evaluated the importance of each macro- and micronutrients and correlated these values with several hormones such as Leptin, Insulin, Cortisol, Ghrelin, and PYY involved in the regulation of energy balance or AVP involved in the regulation of plasma osmolality

This study was conducted in a stepwise manner : study of the energy supplies first, of water supplies next.

Interviews and samples were performed or collected at two times of alcohol withdrawal to evaluate the possibility of parallel changes in craving for alcohol, supplies and endocrine function.

Eligibility Criteria:
Inclusion Criteria:

* Alcoholic patients still under the effect of alcohol at entry

Exclusion Criteria:

* Other type of addiction
Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients

Based on antitumor activity of statin, we designed a phase III study of capecitabine/CDDP chemotherapy plus a low-dose simvastatin that is equivalent to cardiovascular dose in advanced gastric cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with \> 50% extension in the stomach)
2. patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
3. measurable or evaluable disease according to RECIST
4. age, 18 years or older
5. ECOG performance status 0 - 2
6. adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 3.0 mg/dL
7. signed written informed consent

Exclusion Criteria:

1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. active CNS metastases not controllable with radiotherapy or corticosteroids
4. active and uncontrollable bleeding from gastrointestinal tract
5. known history of hypersensitivity to study drugs
6. patients who are already on statin treatment for hyperlipidemia control (if ≥ 1 year interval from the last statin dose, the patient is eligible for study entry)
A Study of LY2409021 in Healthy Participants

The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of the drug after the dose. This study will last approximately 28 days, not including screening. Screening can occur within 30 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females as determined by medical history
* Satisfactory clinical laboratory and physical examination tests
* Have a body mass index (BMI) of 18 to 32.0 kilograms per meter squared (kg/m\^2)

Exclusion Criteria:

- Abnormal electrocardiograms (ECGs)