cyrilzakka/clinical-trials huggingface dataset:
Efficiency of Hypervolt Device Application in the Treatment of Shoulder Impingement Syndrome

The aim of this study is to compare the effects of exercise and Hypervolt Device on pain, muscle strength and normal joint movement in the treatment of shoulder impingement syndrome.

The study was planned as a randomized controlled trial. The study sample will be divided into two groups by simple randomization method. Only exercise will be applied to 30 individuals diagnosed with shoulder impingement in the first group of the study. In the second group, 30 individuals with shoulder impingement diagnosis will be given a Hypervolt Device in addition to the exercise. Disabilities of the Arm, Shoulder and Hand Questionnaire, Visual Analog Scale and Lawton Daily Living Activities Questionnaire will be applied to the participants before and after the treatment. The obtained data will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-50.
* Having a Visual Analogue Scale (VAS) value of 5 or higher.
* Having a history of shoulder pain for at least 1 month.
* Volunteer to participate in research.
* Having been diagnosed with Shoulder Impingement.

Exclusion Criteria:

* Having cognitive, mental or psychological problems.
* Having a condition that prevents him from exercising.
Mobile Phone-Based Motivational Interviewing in Kenya

The primary objective of this study was to test whether motivational interviewing (MI) provided over the mobile phone would reduce alcohol use among adults, including people living with HIV/AIDS, visiting primary care in Kenya. Heavy alcohol users voluntarily consented to being randomized to one of three study arms: standard in-person MI, mobile MI, or waitlist control receiving no intervention for 1 month followed by mobile MI. Alcohol use problems were assessed using validated screeners and changes in alcohol use were assessed at 1 month and 6 months after receiving the intervention. The investigators hypothesized that alcohol use would reduce after MI treatment compared to waitlist control, there would be no difference between standard in-person MI and mobile MI, and these reductions would be sustained out to six months following the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Adults visiting the primary care clinic and screening positive for potential alcohol use problems.

Exclusion Criteria:

* Persons younger than 18 years old, with severe psychiatric morbidity, or cognitive impairment were not eligible for the study
MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time

Compartment syndrome can result from extremity trauma. It can also be caused by procedural cases that involve lower or upper extremity surgery. This condition results in muscle death, chronic pain, infection, and possible amputation. Early diagnosis is essential to institute interventions that can avoid complications. Subjective pain of the patient remains the mainstay for diagnosis. A method or device is needed that would improve our accuracy in diagnosing compartment syndrome. Ideally, this would be suited for single and/or continuous pressure read-outs. The aim is to reduce the incidence of missed compartment syndrome and diminish delays that would lead to significant disability.

Despite awareness, delayed diagnosis and treatment occurs in modern orthopaedic practice. As noted in many studies, once a diagnosis has been made, immediate fasciotomy is necessary to provide the best chance for a favourable clinical result. Therefore, there is a need for improved devices in order to obtain an early and reliable diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, aged 18 years of age and older
* Any tibial, foot, femoral, forearm or fracture that is felt by the surgeon to have a reasonable indication that elevated ICP could occur in the patient
* Mentally fit to provide informed consent

Exclusion Criteria:

* Patients with fractures that are not felt to be at risk of developing compartment syndrome based on serial clinical evaluation
* Infected wounds; infected fractures
* Patients who present with ACS requiring urgent surgical fasciotomy
* Patients who cannot consent to trial
* Pregnant women
Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions

The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to montelukast or any comparable or similar product.
Gene Expression in Tumor Tissue From Women Undergoing Surgery for Breast Cancer or Core Biopsy of the Breast

RATIONALE: Studying samples of breast tissue in the laboratory may help doctors learn more about the genes and proteins found in breast tissue.

PURPOSE: This phase I trial is studying genes and proteins in breast tissue from women undergoing surgery for breast cancer or core biopsy of the breast.

OBJECTIVES:

* Assess tumor gene expression information from women undergoing surgery for breast cancer or core biopsy sampling of the breast.

OUTLINE: This is a pilot study.

Tumor tissue is collected and analyzed for tumor gene expression by DNA microarray analysis for research studies.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Undergoing surgery for breast cancer OR core biopsy sampling of the breast

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
How Environmental Interventions Influence Behavior in School Lunchrooms

The investigators hypothesize that the new United States Department of Agriculture (USDA) regulations for lunches served as part of the National School Lunch Program will decrease the percentage of enrolled students purchasing lunch, increase the percentage of children taking fruit and vegetables, decrease the percentage of fruit and vegetable servings being thrown away, and increase the total number of fruit and vegetable servings eaten.

The investigators also hypothesize that when the regulations are in force, simple behavioral interventions can counteract the potentially negative impact on lunch sales and consumption. In other words, implementing the regulations and behavioral interventions together, the percentage of enrolled students taking a school lunch will increase at least back to baseline levels, the percentage of children taking fruits and vegetables will increase, the percentage of fruit and vegetable servings wasted will decrease, and the total number of fruit and vegetable servings eaten will increase.

This study was conducted in 43 schools in the New York City (NYC) School district in the spring of 2012. The new regulations for school lunches were scheduled to roll out nationally in the fall of the same year, so this study was designed to provide an indication of the impact the new regulations would have.

In addition to the regulations, the investigators also tested additional behavioral interventions, in conjunction with the regulations, to determine how the behavioral interventions might offset, or magnify, the impacts of the regulations.

Eligibility Criteria:
Inclusion Criteria:

* Public schools with any combination of grades K-12

Exclusion Criteria:

* No point of sale system in school
* Satellite school
* Feeder school
Changes in Body Composition Under Ustekinumab in PsA

There is not much body composition and bone mineral density data available for patients with psoriatic arthritis (rheumatoid arthritis) compared to control subjects.

The evaluation of the total fat mass and in particular of its abdominal distribution (visceral adiposity) is important because an excessive adiposity generates adverse effects on the health (hypertension, dyslipidemia, cardiovascular risk and resistance to the insulin).

In addition, data on changes in body composition and bone mineral density were not available under a new psA treatment, namely ustekinumab (anti-IL12 / 23 antibody).

It is proposed to conduct a pilot study to evaluate body composition, distribution (visceral adiposity) and bone mineral density in patients with psoriatic arthritis (versus control subjects) and their changes after 6 months of treatment with ustekinumab


Eligibility Criteria:
Inclusion Criteria:

* Psoriatic arthritis:

  1. Men and women ≥ 18 years
  2. Patients with PsA according to CASPAR criteria,
  3. Patients who do not have yet started ustekinumab,
  4. Patients who signed the informed consent.
* Healthy volunteers:

  1. Men and women ≥ 18 years
  2. Patients who signed the informed consent.

     Exclusion Criteria:
* Items 1 to 10 are applicable to healthy volunteers and PsA

  1. History of fragility fracture AND / OR T-score ≤-3 if ≥50 years AND / OR Z-score ≤-3 if \<50 years during the screening phase,
  2. Corticosteroids ≥10 mg / day,
  3. Diseases or treatments affecting bone metabolism (breast cancer with anti-aromatase, malabsorption, primary hyperparathyroidism, uncontrolled hyperthyroidism ...),
  4. History of radiotherapy on the lumbar spine or hip,
  5. Patients undergoing hormone replacement therapy (HRT) or patients already on anti-osteoporotic therapy (bisphosphonates, strontium ranelate, teriparatide or denosumab),
  6. Chronic kidney disease with creatinine clearance (CKD-EPI) ≤ 30 ml / min,
  7. Weight\> 160 kg,
  8. Patients under restrictive diet or considering a diet of this type during the study period,
  9. Patients who have an intense exercise program or plan to benefit from it during the study period,
  10. Pregnant or lactating women or having a pregnancy project,
Evaluation of Respiratory Motion-Corrected Cone-Beam CT in Radiation Treatment of Thoracic and Abdominal Cancers

Tumors must be seen clearly on CT scan to be radiated completely and safely. Breathing causes tumors to move. If the tumor moves during breathing, it can look blurred on the CT scan. This makes it difficult to see on CT scan. The investigators wish to investigate whether a new computer method makes tumors less blurry and easier to see on CT scan. Cone-beam CT is a type of CT scanner attached to the radiation treatment machine that produces 3D images of the patient. Since your tumor can move because of your normal breathing, it is often blurry and difficult to see accurately in a standard cone-beam CT scan. The investigators intend to use a computer method which processes the cone-beam CT data in a way that reduces the blurring and makes the tumor easier to see.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologic proof of a thoracic or abdominal malignancy, confirmed at MSKCC and suitable for radiation therapy, in order to be eligible for this study. Thoracic malignancies (study group 1) include those in lung and gastro-esophageal junction. Abdominal malignancies (study group 2) include those in liver and pancreas. Patients having both thoracic and abdominal malignancies will be placed in only one of the study groups, because the limited field-of-view of the CBCT precludes imaging of both malignancies in the same scan. Patients must be older than 18 years of age
* At least part of the tumor must be visible as observed in a diagnostic or planning CT. The tumor must exhibit at least 5 mm motion from respiration as observed in the respiration-correlated CT (RCCT) at simulation. The RCCT scan must be interpretable and not exhibit excessive motion artifacts caused by irregular patient breathing.
* Patients must have Karnofsky Performance Status ≥ 70%

Exclusion Criteria:

* Mesothelioma and other tumors of the pleura
* Pregnant Women
* Allergic to iodine or intravenous contrast agent (applies only to patients with a pancreas or liver malignancy)
* Renal impairment due to the use of a contrast agent
* Patients with pacemakers and defibrillators
Pharmacogenomic Study of Androgenetic Alopecia

Androgenic alopecia, the common form of hair loss is a highly heritable disorder of considerable social significance affecting around 40% of adult men and women. A variety of genetic and environmental factors are likely to play a role in androgenetic alopecia. Genetic variants in the human androgen receptor gene (AR) have been reported to be associated with AGA in Caucasians. Other genes involved with hair loss also have been found. One of them being a gene on chromosome 3 (3q26). A recent genome-wide association study in 296 individuals with male-pattern baldness and 347 controls had carried out and five SNPs on chromosome 20p11 were found to be highly significant association for AGA (rs2180439 combined P = 2.7 x 10(-15)). No interaction was detected with the X-chromosomal androgen receptor locus, suggesting that the 20p11 locus has a role in a yet-to-be-identified androgen-independent pathway.

The total number of evaluated patients with androgenic alopecia will be at least 300. All patients will be further grouped as good responders or poor responders to conventional medications, such as topical minoxidil and systemic finasteride. Candidate genes potentially involved in gout and its treatment response will be selected from the published literatures; specifically, two resources of candidate genes will be selected: (i) genes which are known to directly link with androgenic alopecia, and (ii) genes are potentially implicated in particular pathways of androgen/estrogen receptors, metabolism and downstream signals, and genes involved in anti-oxidants or hair growth. The SNP genotyping will be performed by MALDI-TOF Mass Spectrometry. Data analysis will be performed by comparing SNPs allele frequency between good responder and poor responder to conventional medications of patients with androgenic alopecia and further comparing to the allele frequency of SNPs in healthy controls. A functional study will also be done to prove the genetic association.


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign inform consent form
* Willing to received history taking by telephone or interview
* Diagnosed androgenetic alopecia by Hamilton-Norwood classification
* More than 20 year-old, both sex

Exclusion Criteria:

* Ever had trauma over alopecia area
* Cancer, infection, or other systemic disease that might interfere diagnosis
* Unconfirmed diagnosis clinically or pathologically.
Uterine Rupture After Hysteroscopic Septum Resection

To date, several studies have already confirmed a positive effect of hysteroscopic metroplasty on reproductive outcomes in primary infertile women affected by uterine septum, the most common uterine malformation. Nevertheless, very few data are available about the risk of uterine rupture in subsequent pregnancies after hysteroscopic septum resection (HSR). In order to shed about this element, we will retrospectively review the cases of uterine rupture in our setting in the last twenty years, identify which of them had previously undergone HSR, and evaluate the main clinical characteristics for each case.


Eligibility Criteria:
Inclusion Criteria:

* Previous hysteroscopic septum resection;
* Pregnancy;
* Uterine rupture.

Exclusion Criteria:

* Previous myomectomy (regardless of the surgical technique) or cesarean section.
Study to Develop a Tool to Estimate the Kidney Function in Databases Without Laboratory Data

Scientific analyses are frequently performed on e.g. health insurance databases to study the usage and effectiveness of drugs in real life.

Kidney function is known to have an influence on a patients disease development and/or drug levels in blood.

However, often direct measures for kidney function are not available in databases.

This study plans to develop tools to classify the renal function of patients, which helps scientists to identify patient cohorts (groups of patients sharing same characteristics) for scientific analyses.

Renal impairment is a common comorbidity in patients with diverse main underlying diseases and a pathology accompanying increasing age. Renal function might be an important modifier of treatment effects.

Population-based administrative claims databases are increasingly used in large-scale comparative outcomes studies of drug treatments. However, claims databases often lack information on laboratory tests results limiting their usefulness in Real-World Evidence(RWE) research of patients with renal impairment.

There is a need to develop methods for identification of patients with renal dysfunction from healthcare administrative claims-based proxies.

The main objective of this study is the development of algorithms/models to predict eGFR values and/or classes for patients at certain time point based on entries in claims database (demographic characteristics, clinical diagnoses, procedures and drug treatments) for a general population and a variety of use-cases (atrial fibrillation, coronary artery disease, type 2 diabetes mellitus patients sub-populations). To achieve this, modern data-driven machine learning techniques will be applied to discover relationships between renal status, measured by eGFR, and longitudinal patient-level data.

Evaluation of models' performance (out of sample validation, benchmark test, performance differences between eGFR value prediction algorithms and classification models tailored for the pre-defined eGFR classes) will be done as well.

Eligibility Criteria:
To be included in the eGFR-population, patients have to have at least one recorded eGFR value in the OPTUM CDM database between January 1, 2007 and December 31, 2016, be adults (\>18 years of age at the time of eGFR test) and have at least 370/180 days (180 days serves as sensitivity analysis) of continuous enrollment in medical and pharmacy insurance plans since eGFR test date.
Psilocybin and Depression

The main aim of the study is to investigate the possible long-term therapeutic effects of psilocybin on the symptoms of severe depression, as well as the brain mechanisms underlying these changes. Depression severity is assessed before and after (i.e., 1 week, 3 months and 6 months after) a single dose of psilocybin and compared to respective scores of a group receiving an active placebo, ketamine. Brain activity (using functional magnetic resonance imaging) is measured before and one week after drug administration in order to determine whether changes in brain networks related to emotional and self-referential processing correlate with any observed changes in depression scores. Further, blood samples will be obtained from the participants and analyzed in order to reveal gene expression and molecular level correlates underlying rapid antidepressant effects, and to identify biomarkers that predict treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Major depression of a moderate to severe degree (17+ on the 21-item HAM-D).
2. No health-related contraindications.

Exclusion Criteria:

1. Current or previously diagnosed psychotic disorder.
2. Immediate family member with a diagnosed psychotic disorder.
3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc.).
4. History of suicide attempts.
5. History of mania.
6. Current 5-HT2A antagonist antidepressant medication.
7. Blood or needle phobia.
8. Positive pregnancy test.
9. Current drug or alcohol dependence.
10. Lack of appropriate use of contraception.
11. Breast-feeding.
The Effect of Kinesio Taping Application for Dysmenorrhea

Dysmenorrhea is a common symptom in daily practice of gynecology. Different kind of treatment strategies are being held. But invasive and pharmacological therapies have good outcome with systemic side effects. Kinesio taping is being widely used in different pain conditions. Kinesio taping is a noninvasive and nonpharmacological, easy-to-use intervention method which can be used in outpatient practice without systemic side effects.

Dysmenorrhea is a kind of visceral pain that result of peritoneal irritation. It is so common in gynecological outpatient practice. Most of treatment is based pharmacological treatments as NSAIDs, oral contraceptives with many side effects. Kinesio taping is widely used for musculoskeletal parenchymal pain like sports related injuries. As in other complementary treatment methods like acupuncture and acupressure; pain carrying unmyelinated thin pain fibers are blocked by touch sensation carrying myelinated thick fibers which is stimulated by acupressure(gate control theory by Melzack), kinesio taping blocks the pain fibers that comes from same spinal level. So it can be used easily and instantly for dismenore

Eligibility Criteria:
Inclusion Criteria:

* Dysmenorrhea

Exclusion Criteria:

* pregnancy
* surgical abdominal emergency
* metabolic or inflammatory illnesses or cardiovascular diseases,
* endocrine disorders such as diabetes, thyroid disorders, androgen excess (hyperprolactinemia, uncontrolled thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumor),
* smokers
* using pharmaceutical agents such as anti-inflammatory agents that could possibly impact on endocrine and liver enzymes
* musculoskeletal pain
* inguinal hernia
Phamacokinetic and Pharmacodynamic Study of Ramosetron in Chemotherapy Induced Nasea and Vomiting

This study is designted to know optimal dose of Ramosteron to control for chemotherapy induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and clinilcal parameters using Rhodes Index.

Nausea and vomiting is a common adverse event during chemotherapy treatment. Even if preventive medicines such as dopamine receptor antagonist, corticosteroid, serotonin receptor antagonist, has been developed and used, there is residual nausea and/or vomiting in a significant percentage of patients treated for cancer. Serotonin receptor antagonist is the most potent antiemetic agent and has been used widely. However, the optimal dose of serotonin antagnosit based on individual symptoms is not defined. Therefore, this study was conducted to design standardization model for optiomal serotonin antagonist concentration using pharmacodynamic study and Rhodes Index as a suggogate marker for CINV.

Eligibility Criteria:
Inclusion Criteria:

* Patients who recevied moderate emetogenic chemotherapy
* Age between 18-75
* ECOG PS 0-2
* Adequate organ fuction including bone marrow, liver and kidney

Exclusion Criteria:

* Gastrointestinal obstruction or carcinomatosis peritonei
* CNS metastasis or disability in CNS
* Intractable medical illness
* Pregnancy or inadequate contraception