cyrilzakka/clinical-trials huggingface dataset:
The Effect of Bitter Taste Receptor Agonists on The Gastrointestinal Tract, Hunger and Food Intake

In this study, the investigators aimed at evaluating the role of bitter taste receptors in the gastrointestinal tract (GIT). Intragastric or intraduodenal administration of denatonium benzoate (DB) or quinine hydrochloride were compared with placebo administration for their effects on lingual sensitivity, gastrointestinal motility (both in the fasted and fed state), gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and cholecystokinin (CCK)) and food intake. Differences between lean and obese subjects will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>30 kg/m² for the obese volunteers
* BMI\<30 kg/m² for the lean volunteers
* Subject is capable and willing to give informed consent
* Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception

Exclusion Criteria:

* Female volunteer is pregnant or breastfeeding
* Gastrointestinal diseases, major abdominal surgery
* Major psychiatric illnesses
* Volunteers that use drugs affecting the GIT or the central nervous system (CNS)
* Volunteers that suffer from diabetes mellitus
* Volunteers suffering from an endocrine disease such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor...
* Volunteers that have undergone surgical procedure for weight loss
Changes in Trans Tibial Amputee Running Asymmetry During Prolonged Effort

The purpose of this study is to determine the effect of prolonged effort in long distance running on the biomechanical bilateral asymmetry in the lower limbs of trans tibial amputee running with running specific prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral traumatic trans tibial amputee.
* Experience in running with running specific prosthesis.
* Ability to run for at least 20 minutes.

Exclusion Criteria:

* Injury or other orthopedic or neurologic issue that compromises the gait.
An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses

Triamcinolone acetonide is a mid-potency, class 4/5 topical corticosteroid that is available in a spray formulation (Triamcinolone Acetonide Spray, T Spray). It is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Unlike more potent steroid products, T Spray has no time limitations on its use; therefore, it is commonly used to treat flares in psoriasis, atopic dermatitis, seborrheic dermatitis, and contact dermatitis.

In contrast to creams and ointments, T Spray can easily cover large and hard-to-reach areas of the body. Its optional nozzle directs application of the medication to precise areas without affecting nearby areas. Patients requiring a mid-potency corticosteroid for lesions on the scalp, back, intertriginous folds, large areas, or areas that require precise application would benefit from the T Spray formulation. In the time since the introduction of T Spray to dermatology, other topical corticosteroids have entered the market, but T Spray remains the only mid-potency corticosteroid available in a spray formulation.

In a recently published open-label, non-comparator study involving 42 patients with chronic steroid-responsive dermatoses, T Spray was used up to four times a day for 28 days. Improvement of lesions after one week of treatment was experienced by 85% of patients, and 95% of subjects preferred the spray over creams and ointment. Most importantly, 56% of patients reported an anti-pruritic cooling effect which was experienced upon application.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be at least 18 years old and in good general health, as confirmed by a medical history
2. A clear diagnosis of the chronic steroid-responsive dermatosis (i.e. psoriasis, atopic dermatitis) or acute steroid-responsive dermatosis (i.e. contact dermatitis, first-degree burn) must have been previously established and patients must have a target lesion that can be assessed for severity of inflammation
3. Females of childbearing potential must have a negative urine pregnancy test to participate in the study
4. Subjects must be able to understand the requirements of the study and sign an informed consent prior to study procedures

Exclusion Criteria:

1. Subjects who are pregnant and/or nursing
2. Subjects with a known hypersensitivity to any component of the T Spray
3. Subjects who are using any medication or have a disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study
4. Subjects with any of the following pathologies: cold urticaria, cryoglobulinemia, Raynaud's phenomena, or Paroxysmal cold hemoglobulinuria
Incidence of Hyperpigmentation in Black Patients With Multiple Myeloma Treated With Immunomodulatory Drugs

The purpose of this study is to measure the incidence of hyperpigmentation in Black participants with multiple myeloma (MM) treated with immunomodulatory drugs (IMiDs) compared with Black participants with MM not treated with IMiDs. The study will use de-identified data from electronic medical records in the Flatiron Health database.


Eligibility Criteria:
Inclusion Criteria:

* Participants ≥18 years of age at index date
* Participants with new diagnosis of MM as defined by:

  * ICD-9-CM: 203.0x and/or ICD-10-CM: C90.0x or C90 during the study period
  * At least two documented clinical visits for MM on different days and occurring on or after January 1, 2011
* Participants who received at least one systemic MM therapy on or after initial MM diagnosis
* Participants who did not receive clinical study drug at any time during the observation period
* Participants with race information

Exclusion Criteria:

* Exclusion Criteria
* Patients with less than 6 months of medical data during the prior or follow-up period
* Patients in more than one race category (mix race), missing race, unknown race, and "other" race
* Patients diagnosed with the following hematological cancers on or prior to the index date:

  * myelodysplastic syndromes (ICD-9: 238.74, 238.75; ICD-10: D46.xx)
  * mantle cell lymphoma (ICD-9: 200.4x, ICD-10: C83.1x)
  * follicular lymphoma (ICD-9: 202.0x, ICD-10: C82.xx)
  * marginal zone lymphoma (ICD-9: 200.3x, ICD-10: C83.4x)
* Patients with evidence of skin hyperpigmentation (ICD-9: 709.00, 709.09; ICD-10: L81.0, L81.1, L81.4, L81.8) on or prior to the index date

  * 709.00 Dyschromia, unspecified
  * 709.09 Other dyschromia
  * L81.0 Post inflammatory hyperpigmentation
  * L81.1 Chloasma/melasma
  * L81.4 Other melanin hyperpigmentation
  * L81.8 Other specified disorders of pigmentation
Pilot Testing a Novel Approach to Pediatric Obesity Treatment

The goal of this clinical trial is to learn if an emotion regulation and self-monitoring intervention can help treat overweight and obesity in teens. The main question it aims to answer is:

* Does emotion regulation and self-monitoring help reduce biases in teens with overweight and obesity?
* Do changes in biases relate to changes in health functioning and health behavior?

Researchers will compare the intervention to the provision of educational handouts about overweight and obesity to see if the intervention is more effective.

Participants will:

* Complete self-report questionnaires, an fMRI scan, and have their blood drawn
* Received educational handouts or attend weekly telehealth group sessions weekly for four weeks and be asked to self-monitor their mood and behavior between sessions
* Return to complete the same questionnaires, fMRI and blood draw procedures


Eligibility Criteria:
Inclusion Criteria:

* Being English-proficient
* Ages 11-14
* At or above the 85th BMI percentile based on age and sex norms
* Having access to WIFI or cellular data to attend the telehealth groups
* Living in a home in Lubbock County (TX) or surrounding areas.

Exclusion Criteria:

* Having a psychiatric or medical diagnosis that interferes with participation (e.g., significant developmental delay; pregnancy)
* Current enrollment in overweight/obesity treatment.
* Because the study will include entering an MRI scanner, additional standard exclusion criteria will be considered (e.g., having immovable medical devices with batteries, body piercings on the head/face, and having substantial visual impairment that cannot be corrected with staff-provided glasses)
Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors

This study will begin to fill a knowledge gap by determine whether changes in kynurenine metabolism occur following Resistance Training (RT) and relate to reductions in inflammation and improved behavioral and physical function as this may identify potential targets for interventions to promote cancer recovery.

Interventions that reduce pro-inflammatory cytokines with resultant stimulation of kynurenine metabolism may be increasingly important in Breast Cancer Survivors (BCS) to prevent susceptibility to cancer associated fatigue, depression, and declines in muscle mass and function.

There is emerging evidence that supports exercise as a non-pharmacological therapy to prevent cancer recurrence, sedentary behaviors, and obesity during cancer survivorship . It seems that interventions that include resistance training (RT) are most efficacious at reducing fatigue in BCS This study will begin to fill a knowledge gap by determine whether changes in kynurenine metabolism occur following RT and relate to reductions in inflammation and improved behavioral and physical function as this may identify potential targets for interventions to promote cancer recovery.

Eligibility Criteria:
Inclusion Criteria:

1. within 6 months to 10 years post active breast cancer therapy (i.e. surgery/chemotherapy) for stage I-III invasive breast cancer,
2. at least 6 months post breast reconstruction (if applicable),
3. lack of menses for at least one year,
4. BMI 20-35 kg/m2,
5. fatigued (subjective reporting ≥3 on a 1-10 scale),
6. untrained with regard to structured resistance training (no more than 3x/week).

Exclusion Criteria:

1. plans for surgery (e.g., breast reconstruction) during the study period,
2. taking an anticoagulant medication (i.e. heparin, apixaban, rivaroxaban),
3. allergic to lidocaine,
4. orthopedic or chronic pain condition restricting exercise,
5. Mini-Mental Status Examination (MMSE) scores below education-specific cut-points (less than 23 for more than 9th grade education and less than 17 for less than 8th grade education),
6. unable to receive physician medical clearance.
Lanreotide as Treatment of Polycystic Livers

To assess the efficacy of lanreotide in controling total liver volume in patients with polycystic livers this study will be performed. A minimum of 38 patients will be recruited and randomized (1:1) to receive either verum or placebo. Lanreotide is already used in other disease states and found to be safe and non-toxic.


Eligibility Criteria:
Inclusion Criteria:

* 18 yrs-of age
* Multiple cysts \> 20
* Cooperating patient
* Is willing and able to comply with the study drug regimen and all other study requirements
* Willingness to give written informed consent

Exclusion Criteria:

* Use of oral anticonceptives or estrogen suppletion
* Females who are pregnant or breast-feeding
* History or other evidence of chronic pulmonary disease associated with functional limitation
* History of severe cardiac disease
* History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
* Symptomatic gallstones
* Renal failure requiring hemodialysis
Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis

The investigators hypothesize that an increase in the duration of dialysis session in thrice weekly center hemodialysis may provide better outcome, less morbidity, higher quality of life, lesser requirement of medications, and lower total cost.

The proposed prospective and controlled clinical trial aims to compare 4-hour and 8-hour dialysis sessions in thrice weekly center HD regarding mortality, hospitalization rate, several clinical and laboratory parameters, and total cost. Four hundred and ten HD patients will be taken into the study. The study will last for 12 months. The patients will be placed in two groups:

1. Four-hour dialysis session, blood flow rate 300-400 ml/min
2. Eight-hours dialysis session, blood flow rate 200-250 ml/min

Sample size is estimated with following hypotheses: twelve months duration of follow-up; twelve months survival of the control group 85%; a bilateral alpha risk equal to 5%; an expectation that 12-months survival to be 95% by 8-hours dialysis; a 85% power to detect the decrease in annual mortality by 8-hours dialysis comparing to 4-hours dialysis; a 10% of dropout rate. The required sample is total 410 patients.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18-years
* On maintenance bicarbonate HD scheduled thrice weekly 12 hours/week; achieved mean single pool Kt/V above 1.2
* Willingness to participate in the study with a written informed consent

Exclusion Criteria:

* To be scheduled for living donor renal transplantation
* To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
* Pregnancy or lactating
* Current requirement for HD more than three times per week due to medical comorbidity
* GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
* Use of temporary catheter
* Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
* Mental incompetence
Psychological Effects of the Pandemic on the Health Personnel Working in the Filiation Team

Purpose of Research: This study; It will be done in order to determine the psychological effects of the Covid-19 pandemic process on the health personnel working in the filiation team and to examine the possible effects in depth.

This research was planned as a mixed methods research. Research Questions

1. What are the psychological effects of the pandemic process on the healthcare personnel working in the filiation team?
2. Do the socio-demographic characteristics of the healthcare personnel working in the injection team affect their psychological status?
3. What are the opinions of the health personnel working in the filtering team about the psychological effects of the pandemic?

Type of Research This research was planned as a mixed methods research. Mixed methods research is a type of research that allows us to obtain in-depth information from the data collected by quantitative and qualitative data collection techniques. It also defines it as a research approach in which quantitative and qualitative data are collected in order to understand research problems and two data sets are integrated with each other. In this approach, a better understanding of the problem is provided by combining statistical trends with stories and personal experiences (Yıldırım \& Şimşek, 2011).

Research Pattern The design of this research was determined as an explanatory sequential mixed design, one of the mixed methods research designs. Creswell (2009) states that deciding on a mixed method design depends on four factors: timing (simultaneous-sequential), weight (qualitative-quantitative), when and how it is mixed (connected-integrative-embedded), and theorizing. In this study, the explanatory sequential mixed design, which is dependent on the timing factor, was adopted from the designs determined by Creswell and Plano Clark (2011). The purpose of adopting this design in the research is to explain the quantitative data to be collected in more depth with qualitative data. According to the exploratory sequential mixed design, in the research, first of all, the "Effect of Events Scale" will be applied to determine the psychological effects of the pandemic process on the healthcare personnel working in the filiation team, and then "Semi-Structured Interviews" will be conducted with questions to be prepared with the data obtained from the scale in order to investigate the reasons for the results from this scale. The exploratory sequential mixed pattern is shown as NIC nit. This pattern is expressed as a useful pattern when qualitative data are needed to explain quantitative results (Creswell \& Guetterman, 2018).

Eligibility Criteria:
Inclusion Criteria:

* Worked in the filiation team,
* Open to communication and cooperation, and
* Healthcare personnel who agree to participate in the study will be included in the study.

Exclusion Criteria:

* Healthcare personnel who worked during the filiation process but resigned due to various reasons such as retirement will be excluded from the study.
Optimal Dog Visits

The aim of this project is to study how an the intensity of dog contact during dog visits in nursing homes can affect the immediate response to, and the general effect of the visits, and whether the residents' level of cognitive impairment affects the response and benefit of dog visits.

The participants are randomly assigned to receive one type of visits (12 visits in total) out of three possible visit types (1: visit with a dog; 2: visit with a dog, including a planned activity, 3 visit without a dog, including a planned activity). The residents received 2 visits per week for 6 weeks. The behaviour of the participants during visits is recorded. Before and after the intervention period, participants are scores on psychometric scales for cognitive impairment level, daily function level and symptoms of depression.


Eligibility Criteria:
Inclusion Criteria:

• Being able to sit up during the visits

Exclusion Criteria:

* Dog allergy
* Fear of dogs
* Health problems that make participation unadvisable
ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas

This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
* Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion Criteria:

* History of another primary invasive malignancy that has not been in remission for at least 3 years
* Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides
* History of progressive multifocal leukoencephalopathy (PML)
* Cerebral/meningeal disease related to the underlying malignancy
Effectiveness of Internet-based Depression Treatment

Care for people suffering from depressive symptoms should be given in a step-wise approach. One first step can be the provision of self-help material. Online self-help is an innovative way of providing self-help. The investigators want to study the effect of an interactive online self-help-program (Deprexis) in the treatment of mild to moderate depressive symptoms. Participants will be randomised to either twelve weeks of online-self help or a waiting-list control. Symptoms of depression and other aspects will be assessed over a one year period. Thereafter the controls will also receive online-self help. The investigators hypothesise that online self-help is superior to the control condition in alleviating depressive symptoms and preventing full blown depression.

This study is supported by the German Ministry of Health (BMG) and is a collaborative project of Universität Bern (PD Dr. Thomas Berger), Charité Berlin (PD Dr. Matthias Rose), Universität Bielefeld (Prof. Dr. Wolfgang Greiner), Universität Hamburg (Prof. Dr. Steffen Moritz, Prof. Dr. Bernd Löwe), GAIA AG Hamburg (Dr. Björn Meyer), Universität Tübingen (Prof. Dr. Martin Hautzinger) and Universität Trier (Prof. Dr. Wolfgang Lutz).

Eligibility Criteria:
Inclusion Criteria:

* PHQ\>4 and \<15

Exclusion Criteria:

* acute suicidality
* psychotic d/o, bipolar d/o or other severe psychiatric d/o
Endoscopic Trigger Finger Release

The purpose of this study is to compare recovery, scar, and patient satisfaction after retrograde endoscopic trigger finger release versus the standard open surgical treatment.

Consecutive patients presenting with trigger finger interested in surgical release of the A1 pulley will be prospectively treated with endoscopic versus open surgical release of the A1 pulley. Study measures will include scar assessment based on the Patient and Observer Scar Assessment Scale (POSAS) administered at 1 week, 1 month, and 6 months post-operatively, overall satisfaction (scale of 1 to 10), days before return to work, duration of post-operative occupational therapy, pain medication use, operative time, and complication and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Trigger finger diagnosis, recommended for surgical release
* Be in good health other than the trigger finger
* Have realistic expectations of surgical results
* Be willing to undergo surgical or endoscopic treatment
* Understand and be willing to follow all aspects of the study protocol and have signed and dated the Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed

Exclusion Criteria:

* Collagen-vascular, connective tissue, or bleeding disorder
* Pregnancy
* Regional sympathetic dystrophy
* Abscess or infection at time of planned surgery
* Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Effect of Alveolar Recruitment Maneuver on Postoperative Pain

Control group: no additional procedure Low ARM group : recruitment maneuver of 30cmH2O High ARM group: recruitment maneuver of 60cmH2O

After random assignment of group, Control group: no additional procedure apply, Low ARM group : after surgical trocha out after bariatric surgery, applying 30cmH2O recruitment maneuver 5 times every 5 seconds, High ARM group: after surgical trocha out after bariatric surgery, applying 60cmH2O recruitment maneuver 5 times every 5 seconds

Eligibility Criteria:
Inclusion Criteria:

* Patients who scheduled for elective bariatric surgery

Exclusion Criteria:

* uncontrolled cardio-vascular disease, active pulmonary disorder