cyrilzakka/clinical-trials huggingface dataset:
Ghrelin Suppression by Octreotide in Prader-Willi

The purpose of this study is to learn more about how octreotide (Sandostatin LAR® Depot) affects levels of ghrelin, hunger, and body weight in people with Prader-Willi Syndrome.

After baseline tests, a nurse will administer monthly injections of Sandostatin LAR® or placebo for 6 months. At the end of this initial 6-month treatment period and a 4-month washout period, study subjects will then crossover to receive the alternative therapy (placebo or octreotide) for an additional 6 months. Subjects will be followed for 16 months total at scheduled visits: 0, 2, 6, 10, 12, and 16 months (Table 2).

Eligibility Criteria:
Inclusion Criteria:

* o Diagnosis of PWS confirmed by chromosome analysis (i.e. interstitial deletion of paternally-derived chromosome 15Q, uniparental maternal disomy or other chromosome 15 abnormalities)

  * Age 18 years and older
  * Written informed consent obtained (by subject or guardian) and willingness to comply with the study schedule and procedures
  * Free T4, TSH values in the normal range (with or without thyroxine replacement)
  * Subjects with confirmed hypogonadism who are corrected with adequate doses of sex steroid replacement, will have been treated for at least 6 months prior to entry and have no change in dosages over the study period.
  * Patients with confirmed growth hormone deficiency who are corrected with adequate doses of replacement, will have been treated for at least 6 months prior to entry and have no change in dosages over the study period.

Exclusion Criteria:

* Symptomatic gallstones.
* Smokers.
* Alcohol consumption \> 2 drinks per day.
* Exercise \> 30 minutes 3 times a week.
* Weight \> 500 lbs (exceeds the limit for the BODPOD).
* Active pulmonary infection.
* Sleep disorder.
* Subjects will be excluded if they have clinically significant disease that would have an impact on metabolic outcomes or body composition including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease, heart disease, cancer, symptomatic gallstones, or neurological disorders
* history of hepatic disease (patients with minimal, i.e., \<3Xs the upper limit of normal for LFTs indicative of hepatic steatosis, MAY participate)
* pregnant or lactating
* known hypersensitivity to Sandostatin acetate or other related drug or compound
* subjects who exhibit symptoms indicative of intolerance following the 100 mcg test dose of Sandostatin Injection, SC
* subjects who have previously received Sandostatin® (octreotide)
* subjects who have received other investigational drugs administered or received within 30 days of study entry
Pharmacologic Modulation of Hippocampal Activity in Psychosis

The purpose of this study is to test whether administration of levetiracetam (LEV), a commonly used anti-epileptic that alters neurotransmitter release, can reduce hippocampal hyperactivity. Specifically, we will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood oxygen level dependence (BOLD) contrast will assess activity with a visual scene processing task that engages the anterior hippocampus and 2) arterial spin labeling (ASL) will assess baseline activity. This study will also assess whether patients have improvement in their symptoms after receiving LEV. Previous studies in people with psychotic disorders have shown that the hippocampus is hyperactive and more activity correlates with worsening of clinical symptoms. Therefore, the aim of this study is to use an intervention to further understand the underlying mechanisms of the hippocampus in psychosis.


Eligibility Criteria:
Inclusion criteria for psychosis subjects:

1. Men and women age 18 - 65.
2. Communicative in English.
3. Provide voluntary, written informed consent.
4. Physically healthy by medical history.
5. BMI \> 17.5 and \< 45.
6. Diagnosis of a psychotic disorder confirmed by Structured Clinical Interview for DSM-V (SCID) or diagnostic interview with a trained clinician.
7. Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
8. For females, no longer of child-bearing potential, or agreeing to practice effective contraception during the study; and,
9. For females of child-bearing potential, must have negative urine pregnancy test at time of screening visit and before each testing day.
10. Not breastfeeding/nursing at time of screening or at any time during the study.

Inclusion criteria for healthy controls All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.

Exclusion criteria for psychosis subjects

1. Age less than 18 or greater than 65.
2. Not communicative in English.
3. Unable to provide written informed consent.
4. Current medical or neurological illness.
5. History of severe head trauma.
6. BMI \< 17.5 or \> 45.
7. Meets criteria for diagnosis of substance or alcohol use disorder within the past month.
8. Positive urine pregnancy test at time of screening, before each testing day, or any potential concern for pregnancy at any time during the study.
9. Breastfeeding/nursing at time of screening or at any time during the study.
10. Conditions that preclude MR scanning
11. Conditions that preclude study drug administration

Exclusion criteria for healthy controls

All of the above and in addition:

1. Current use of psychotropic or potentially psychoactive prescription medication.
2. Major psychiatric disorder as determined by DSM-V (major depression, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, etc)
Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation

To assess the feasibility and preliminary effectiveness of a Cardio-Oncology Prehabilitation program in patients at high-risk of developing Cardiovascular (CV) events in improving Cardiorespiratory fitness (CRF) and reducing acute CV complications in Hematopoietic stem cell transplant (HSCT) recipients.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years or older
* Referred for HSCT evaluation
* Presence of least one CV risk factor at enrollment (hypertension, hyperlipidemia, atrial fibrillation, obesity, heart failure, history of coronary artery disease, diabetes)
* Able to ambulate unassisted
* Ability to understand and the willingness to sign a written informed consent
* Ability to use Polar Flow heart rate application

Exclusion Criteria:

* Severe anemia (hemoglobin \<7 gm/dl)
* Untreated high-risk coronary artery disease (left main, triple vessel disease)
* Severe aortic stenosis
* Recent fracture as assessed via self-report
* Gross balance deficits
* Severe pain with basic movement
* Unable to ambulate unassisted or exercise
* NYHA class IV heart failure
* Adults unable to give consent, pregnant women, and prisoners are excluded from this study.
Fecal Microbiota Transplantation in Decompensated Cirrhosis

Cirrhosis of the liver is the culmination point of long-standing chronic liver disease hallmarked by the cardinal features of liver fibrosis and portal hypertension. The prognosis of patients with cirrhosis is punctuated by the onset of complications which denote the stage of decompensation characterized by ascites, hepatic encephalopathy (HE), and variceal bleeding.

Patients with cirrhosis have been demonstrated to have significant changes in their gut microbiota characterized by alteration in the intestinal microbiome (gut dysbiosis) as well as small intestinal bacterial overgrowth (SIBO). Gut dysbiosis has been closely linked to the complications associated with decompensated cirrhosis. Several studies have documented the alteration of gut microbiota in patients with hepatic encephalopathy.

Therapeutic modalities that restore normal gut flora and stabilize the gut liver axis are being extensively studied in the management of cirrhosis and its complications. Antibiotics, probiotics, and long-chain fatty acid supplementation are being evaluated as methods to restore the gut dysbiosis and consequently limit progressive liver damage.

Fecal Microbiota Transplantation (FMT) involves the infusion of intestinal microorganisms by the transfer of stool from a healthy individual into a diseased individual for restoration of normal intestinal flora.The ultimate goal of FMT is to replace aberrant native microbiota with a stable community of donor microorganisms. The treatment is based on the premise that an imbalance in the community of microorganisms residing in the gastrointestinal tract (i.e., dysbiosis) is associated with specific disease states. FMT has been well-established as a treatment modality to stably modify the gut microbiome and has been shown to be safe and efficacious in several disease states resulting from gut dysbiosis.

With this background, a trial is proposed to determine whether an FMT from a healthy donor to a patient with advanced cirrhosis improves overall survival and prognosis.


Eligibility Criteria:
Inclusion Criteria:

Age 18-65 years Decompensated cirrhosis (of any etiology) based on clinical, radiological, or histological criteria Model for end-stage liver disease (MELD scores) between 12-21 were included.

Exclusion Criteria:

Ongoing bacterial infection requiring antibiotics Antibiotics/pre-pro biotics within the last 14 days, t Significant alcohol intake in the previous two months, Recent (\<14 days) history of spontaneous bacterial peritonitis, HE or variceal bleed, History of substance abuse or psychiatric illness, HIV infection, Pregnant patients, Hepatocellular carcinoma or other known malignancy, t Prior liver transplantation or bariatric surgery, Immunosuppression, Inflammatory bowel disease Celiac disease, History of allergy to food substances
Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)

The aim is to determine the frequency of RBC transfusion in patients with metastatic "poor prognosis" germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa


Eligibility Criteria:
Inclusion Criteria:

* Poor prognosis" according IGCCCG-criteria:
* Primary mediastinal tumor
* Gonadal/retroperitoneal germ cell tumor with visceral metastases except of lung
* Poor marker: AFP \> 10.000 ng/ml or beta-HCG \> 10.000 ng/ml (50.000 IU/l) andd LDH \>10 x upper normal limit
* No previous chemotherapy
* Age \> 18 years
* Performance-Status: WHO =\< 2
* Written informed consent
* Ability to give informed consent

Exclusion Criteria:

* Hemolysis
* Hematological disease with insufficient erythropoiesis
* Patients without sufficient treatment of sideropenia, folate deficiency or vitamin B12 deficiency
* Uncontrolled arterial hypertension
* Treatment with rh-Erythropoetin during trial
* Creatinin clearance \< 50 ml/min
* Insufficient bone marrow function (WBC count \< 3.000/ml or platelets \< 100.000/µl)
* Other major symptomatic or uncontrolled illnesses not allowing to complete treatment protocol with the exception of symptoms caused by the primary disease
* Second malignancy, except of completely resected basal cell carcinoma of the skin
EXecution of Trans-Esophagus Echo Cardiogram in CardioPulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest

The purpose of this single center, randomized clinical control trial is to determine that changing chest compression site during cardiopulmonary resuscitation according to the examination of the TEE could increase the level of end-tidal CO2, which represents the quality of cardiopulmonary resuscitation, or not in adult patients with non-traumatic out-of-hospital cardiac arrest while comparing to those who don't receive examination of transesophageal echocardiography during cardiopulmonary resuscitation.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 20 years-old
2. Out-of-hospital cardiac arrest
3. Non-trauma

Exclusion Criteria:

1. Obvious signs of death appears, such as separation of head and body, rigor mortis, livor mortis, cankered corpse......etc.
2. Family members clearly express the willing of do not attempt resuscitation or patients who have registered advance care planning not to attempt resuscitation.
3. Patients not suitable for transesophageal ultrasound, such as patients with esophageal tumor, those whose probe cannot be placed......etc.
4. Received Extracorporeal CPR.
5. Achieving sustained ROSC before ED arrival
Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients

This study will determine if autologous platelet gel (APG) on sternal incision and conduit sites will improve wound healing and decrease infection in coronary artery bypass grafting surgery patients.

The purpose of this study is to determine if the use of autologous platelet gel (APG) on sternal incision and conduit sites will improve wound healing and decrease the incidence of infection in patients undergoing coronary artery bypass grafting surgery

Eligibility Criteria:
Inclusion Criteria:

* Any patient who meets criteria and consents to undergo a CABG procedure involving conduit sites and consents to this study.

Exclusion Criteria:

* Any patient, after inclusion, whom is later determined to have had on-going therapy that could influence wound healing such as radiation or chemotherapy, extensive steroid use, or accidental trauma such as burns, etc.
Phase 3 Papulopustular Rosacea Study

The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
2. The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.

Exclusion Criteria:

1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne,
2. The subject has rosacea with more than two nodules on the face.
Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

Purpose:

To establish whether there is a correlation between dry eye symptoms, age and gender, a difference in symptom intensity in different times of the day, which test (Schirmer or TBUT) better correlates with dry eye symptoms, whether it is possible to reliably use cheap, easy to use hygrometer in everyday clinical setting, and finally whether there is statistically significant correlation between applied tests (TBUT, Schirmer and evaporimetry).

Methods:

Subjects: 45 in group without dry eye related symptoms, and 45 in group with symptoms.

Examination included structured case history (questionnaire), slit lamp examination with fluorescein staining, periocular evaporimetry, TBUT test and Schirmer test.

Purpose:

The purpose of this study was to establish whether there is a correlation between dry eye symptoms, age and gender, any difference in symptom intensity in different times of the day, which test (Schirmer or TBUT) better correlates with dry eye symptoms, whether it is possible to reliably use cheap, easy to use hygrometer in everyday clinical setting, and, finally, whether there is statistically significant correlation between applied tests (TBUT, Schirmer and evaporimetry).

Methods:

Subjects were divided in two groups: 45 in group without dry eye related symptoms, and 45 in group with symptoms.

Examination was performed in the following sequence:

1. structured case history (questionnaire),
2. evaporimetry
3. slit lamp examination with fluorescein staining,
4. TBUT test and
5. Schirmer test I (without anesthetic, closed eyes)

Case history consisted of the following questions:irritation more pronounced on wind? irritation during reading and/or watching TV or computer? irritation more pronounced during winter? gritty sensation in the eyes? irritation more pronounced in the morning or evening? All answers, except to the last question, were graded from 0 (no complaints) to 3 (severe).

Evaporimetry was performed using commercially available hygrometer from HYGROTEC (Titisee-Neustadt, Germany), installed in swimming goggles with its front part sawn off.

First measurement was performed by measuring for 5 minutes with eyes closed. Second measurement also lasted 5 minutes, with eyes kept open, normal blinking, and with subject fixating at one point in distance, with no eye movements.

Measured parameters included:

basal φ (%): relative environment humidity before measurement basal T: environment temperature before measurement closed eye φ (%): relative humidity in front of closed eye open eye φ (%): relative humidity in front of open eye C/O: ratio of φ (%) closed/open eye

Eligibility Criteria:
Inclusion Criteria:

* patients with or without dry eye symptoms

Exclusion Criteria:

* minors
* pregnant women
* patients with acute eye conditions (inflammation, allergy, trauma)
* patients with chronic eye diseases requiring continuous topical treatment (i.e.glaucoma)
* ocular surface scarring
* patients who did not sign informed consent.
A Randomized Controlled Trial to Evaluate the Efficacy of Acupuncture Versus Aromatherapy as Treatments to Lessen Nausea, Vomiting and Anxiety Associated With Adriamycin and Cytoxan

The overall goal of this study is to explore the effectiveness of using acupuncture versus aromatherapy, in conjunction with standard of care anti-emetics, to decrease chemotherapy induced nausea, vomiting, and anxiety in breast cancer patients undergoing Adriamycin and Cytoxan. This study also aims to determine if aromatherapy and anti-emetics is more effective than acupuncture and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan and if acupuncture and anti-emetics is more effective than aromatherapy and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan.


Eligibility Criteria:
i) Inclusion

* At least 18 years of age on the day of signing informed consent
* Patient has a diagnosis of breast cancer
* Patient is planned to start Adriamycin and Cytoxan chemotherapy

ii) Exclusion

* Patients who are unable to adhere to the protocol or treatment schedule
* Patients who have a concurrent illness or take medication that induces nausea independent of chemotherapy
* Patients undergoing radiotherapy or hormone therapy during chemotherapy treatments
* Patients who have a sensitive and/or poor sense of smell
* Patients who are allergic to essential oils, specifically peppermint, ginger, and/or lavender
* Patients who are already using essential oils or acupuncture for symptom management and are unwilling to stop while participating in this study
* Patients who are afraid of or unwilling to receive acupuncture stimulation
* Patients who are allergic to stainless steel needles
* Thrombocytopenia (Platelets \< 20,000)
* Patients who have received aromatherapy and/or acupuncture treatment within 1 week of starting treatment on this study
Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude

Introduction: Touching ensures physical, emotional and spiritual relaxation, confidence, peace, calmness and well-being, and increases self-esteem. The aim of this study is to determine the effect of therapeutic touch on labour pain, anxiety and childbirth attitude.

Methods: The sample of this randomized controlled experimental research consisted of 80 (intervention group: 40; control group: 40) women. Data were collected using a Personal Information Form, Visual Analogue Scale, State Anxiety Inventory and Childbirth Attitudes Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Having a first pregnancy
* Not having a high-risk pregnancy
* Having no health problems with the baby or herself
* Having a single foetus
* Being about to have a vaginal delivery
* Not receiving infertility treatment
* Not having a chronic physical or psychiatric diagnosis
* Agreeing to participate in the research

Exclusion criterion

-Multiparity
Validity and Reliability of the Community Integration Questionnaire-Revised in Lower Limb Amputees

The goal of this clinical trial is to determine the validity and reliability of the Community Integration Questionnaire-Revised (CIQ-R) scale in lower limb amputees. The main questions it aims to answer are:

* The Turkish version of the Community Integration Questionnaire-Revised is valid for lower extremity amputees.
* The Turkish version of the Community Integration Questionnaire-Revised is reliable for lower extremity amputees.

Participants will:

• Fill out general information, CIQ-R, TAPES, and ABIS forms.

The aim of this study is to determine the validity and reliability of the Community Integration Questionnaire-Revised (CIQ-R) scale in lower limb amputees. Lower limb amputees aged 18-65 years who used prostheses for at least 6 months and volunteered to participate in the study were included in the study. The adaptation of amputees to prostheses was evaluated with the "Trinity Amputation and Prosthesis Experience Scale" (TAPES), their perception of physical appearance with the "Amputee Body Image Scale" (ABIS), and their community integration with the CIQ-R. Correlation with TAPES and ABIS and confirmatory factor analysis were performed to determine the construct validity of the CIQ-R scale. The test-retest reliability of the CIQ-R scale was determined by the intraclass correlation coefficient (ICC) method. Internal consistency analysis was evaluated with Cronbach's alpha. 90 amputees were included in the study (mean age: 40.96±12.89 years; BMI: 25.55±5.5 kg/m2). The CIQ-R scale was reapplied to 18 of the participants 1 week later.

Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 18 and 65
* Lower extremity amputation
* Use of a prosthesis for at least one year
* Individuals who volunteered to participate in the research.

Exclusion Criteria:

* Have any known cognitive problems
* Illiterate individuals were excluded from the study.