cyrilzakka/clinical-trials huggingface dataset:
The Effect of Strain-counterstrain on Ankle Instability

This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of chronic ankle instability.

This study aimed to determine the effect of Strain Counterstrain (SCS) on dynamic balance and subjective sense of instability in individuals with chronic ankle instability (CAI). Although many studies have been published on CAI, the cause for this common clinical dysfunction remains inconclusive. No studies have assessed the effectiveness of SCS on CAI. Baseline information on all participants includes a demographic questionnaire, the Star Excursion Balance Test (SEBT), and the Foot and Ankle Ability Measure (FAAM). Participants were randomized into the SCS intervention group or the sham SCS control group. All participants received an intervention (as assigned) once a week for four weeks in addition to performing a prescribed home exercise program. At week four all participants repeated the outcome measures and completed a Global Rating of Change (GROC) form. The primary aim was examined with a 2-way analysis of variance (ANOVA).

Eligibility Criteria:
Inclusion Criteria:

* history of at least 1 ankle sprain, with pain and/or limping for more than 1 day, at least 3 months earlier
* 3 of more episodes of ankle giving way in the last 12 months
* chronic instability attributed to the original sprain injury
* age between 18-55

Exclusion Criteria:

* history of fracture or surgery in the affected ankle
* any other lower extremity musculoskeletal injury on the side of the involved ankle
* vestibular dysfunction or disorder
* history of balance dysfunction
* history of stroke or any other neurological pathology or disease
* history of ACL injury
* current participation in physical therapy or rehabilitation for the ankle injury
* evidence of CNS dysfunction
Psychological Treatment in Psychiatric Inpatient Care

This study aims to investigate the effect of a brief psychotherapeutic treatment intervention based on ACT, aimed specifically at the vulnerable group of patients in psychiatric 24-hour care treated according to LPT. The study aims to investigate whether a brief number of therapeutic sessions according to ACT during inpatient care produce positive effects on personally relevant life areas for a diagnostically mixed group of patients in a psychiatric intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older.
* Treated according to the compulsory psychiatric care act.
* Meet the criterion of informed consent.

Exclusion Criteria:

* Lack the cognitive ability to acquire the treatment intervention, such as impaired attention, memory, logic and reasoning, and also auditory and visual processing. This will be based on a clinical assessment by the ward team, including the attending psychiatrist and a clinical psychologist.
* Ongoing psychological treatment parallel to the admission.
Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

This is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX) and counseling on highly active antiretroviral treatment (HAART) medication adherence in a cohort of HIV-infected patients who report heavy drinking, or meet criteria for alcohol abuse and/or dependence, and inadequate (\< 95%) HAART adherence. All patients will receive a behavioral intervention, termed Medical Management/Medication Coaching or MM/MC. MM/MC incorporates the behavioral platform Medical Management (MM) from the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded COMBINE Study to reduce heavy alcohol use with Medication Coaching (MC), a manualized treatment designed to improve HAART medication adherence in HIV-infected patients with substance use disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Be HIV-infected.
2. Currently be prescribed HAART medication or be eligible to receive HAART medication.
3. Report less than 95% adherence to their HAART medication.
4. Report heavy drinking 4 or more times in the past 4 weeks, or meet current criteria for alcohol abuse or dependence. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on one occasion.
5. Be at least 18 years old.
6. Be able to understand English and provide informed consent.

Exclusion Criteria:

1. Be psychotic or severely psychiatrically disabled.
2. Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
3. Have medical conditions that would preclude completing or be of harm during the course of the study.
4. Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 times the upper limit of the normal range) or cirrhosis with a Child-Pugh classification greater than A or B.
5. Have a known contraindication to NTX therapy (e.g. requiring opioid medication for pain).
6. Be pregnant, nursing or unable to use an effective method of birth control (women).

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Multisensory Training in PD

People with Parkinson's disease (PD) were characterized by many motor symptoms, including rigidity, postural instability, bradykinesia, and resting tremor. These motor symptoms might cause gait dysfunction. Gait dysfunction represented a common sign of PD, including reduced gait velocity, reduced stride length, reduced arm swing, and increased gait variability. Poor postural control in people with PD might result to increase gait variability and then increase fall risk. Previous studies reported that proprioceptive-vestibular multisensory training improved postural stability in people with PD. However, no literature investigated the effects of proprioceptive-vestibular multisensory training on gait variability. Therefore, the purpose of this study is to examine the effect of proprioceptive-vestibular multisensory training on gait variability in people with PD.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD
* Hoehn and Yahr stage I to III
* Age 60\~80 y/o
* Mini-Mental State Examination (MMSE) ≥24
* Ability to ambulate independently (with or without walking aid)

Exclusion Criteria:

* Affecting the peripheral vestibular system
* Medical condition that substantially influenced their gait and balance performance
* People had joined any rehabilitation past 1 month
Biomarkers in Samples From Patients With Chronic Lymphocytic Leukemia Treated on Clinical Trial ECOG-2997

RATIONALE: Studying samples of cells in the laboratory from patients with cancer may help identify biomarkers related to cancer. It may also help doctors learn how patients respond to treatment.

PURPOSE: This laboratory study is analyzing samples of cells from patients with chronic lymphocytic leukemia who were treated on clinical trial ECOG-2997.

OBJECTIVES:

* To analyze the expression of a variety of informative molecules using a unique high-resolution flow cytometric immunophenotyping technology in samples from patients with chronic lymphocytic leukemia enrolled in clinical trial ECOG-2997.

OUTLINE: Cell samples are analyzed for the following prognostic biomarkers: ZAP-70, phospho-Syk, phospho-GSK-3β, phospho-Akt, phospho-ZAP-70, cyclin D1, cyclin D2, p21cip1, phospho-ReIA, IkappaBα, Bax, Mcl-1, PTEN, phospho-Erk1/2, and phospho-MEK1/2. Biomarker signals are amplified using enzymatic amplification staining to obtain high resolution detection of cell-surface markers on leukemic cells. Biomarker expression levels are measured using fluorescence activated cell sorting analysis. Relationships between clinical outcomes, standard flow cytometric analysis, cytogenetic studies, and high resolution immunophenotyping will also be assessed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Stored frozen viable cells from patients with chronic lymphocytic leukemia treated on clinical trial ECOG-2997

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
18F-DOPA-PET in Non-tumoral and Tumoral Brain Lesions

Background: 3,4-dihydroxy-6-\[18F\]-fluoro-L-phenylalanine (FDOPA) positron emission tomography (PET) can identify well low and high grade brain tumors. However, increased FDOPA uptake has been reported in non-tumoral brain lesions. The aim was to analyse FDOPA-PET in patients with non-tumoral brain lesions and to compare them with patients with (low and high grade) brain tumors.

Methods: retrospective analyse. Patients consecutively recruited with suspected primary brain tumor (based on clinical and MRI findings) referred for FDOPA-PET at Nimes university Hospital between June 2015 and June 2019. FDOPA-PET parameters (maximum and mean lesion standardized uptake values \[SUV\] and ratios comparing lesion with different background uptake SUV) and thresholds were analysed in search for those offering optimal discrimination between non-tumoral and tumoral lesions.


Eligibility Criteria:
Inclusion Criteria:

* presence of defined tumor (histology was required) or non-tumor (diagnosed by histological or other analyses) diagnosis,
* clinical and MRI follow-up of \>24 months,
* FDOPA-PET scan \<2 months before surgery or stereotactic biopsy (when performed)
Smoking Treatment and Anxiety Management Program

The Smoking Treatment and Anxiety Management Program (STAMP) is a treatment program focused on helping people manage their anxiety while quitting smoking. The study involves coming in to our clinic for 4 treatment sessions, with follow-ups for up to 2 years (a week 1, week 2, month 1, month 3, month 6, year 1, and year 2 follow-up). Participants will be paid $142.50 for their full participation as well as receive 6 weeks of free nicotine replacement patches.


Eligibility Criteria:
Inclusion Criteria:

* Anxiety Sensitivity Index greater than 15
* Daily smoker for at least 1 year
* Less than 45 years old
* Currently smoke at least 8 cigarettes per day
* Report a motivation to quit smoking

Exclusion Criteria:

* History of panic disorder
* Psychotropic medication use (if not stable for 3 months)
* History of significant medical condition
* Current use of smoking cessation pharmacology
* Use of other tobacco products
* Planning to move in the next 6 months
Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety

The objectives of this study were (a) to evaluate the pharmacokinetics and to evaluate and compare the pharmacodynamics of ilaprazole and esomeprazole following a single dose (Day 1) and once daily (QD) administration for 5 consecutive days each of 10-mg, 20-mg, and 40-mg ilaprazole tablets and 40-mg esomeprazole tablets; (b) to evaluate the safety of 10-mg, 20-mg, and 40-mg ilaprazole tablets following QD oral administration for 5 consecutive days; and (c) to characterize the plasma gastrin concentration profile on Day 1 and Day 5 following QD oral administration of 10-mg, 20-mg, and 40-mg ilaprazole and 40-mg esomeprazole tablets for 5 consecutive days.


Eligibility Criteria:
Inclusion Criteria:

* Prior to any study-specific procedures being performed, the subject voluntarily signed the approved informed consent/PIPEDA authorization form after having it fully explained and all questions answered.
* The subject was between 18 and 55 years, inclusive, and was generally in good health.
* Pregnancy test results for all females were negative in order to enter and remain in the study. A serum pregnancy test was performed on all females at Screening, Day -1 of each period, and Day 6 of Period 4 only, or if a subject prematurely discontinued. Results must have been negative in order for study drug to be administered.
* Female subject was using, and agreed to continue the use of, a double-barrier method of birth control. Oral, patch, implants, or injectable contraceptives were accepted as 1 method if the subject had been taking them for greater than 2 months at the Screening Visit. Subjects who had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy for a minimum of 6 months, or surgical sterilization of partner (vasectomy for 6 months minimum), or were postmenopausal (defined as the absence of menses for 2 years or the absence of menses for 12 months and follicle-stimulating hormone \[FSH\] level of \>40 IU/L) did not require the use of birth control.
* Subject had a negative breath test result for H pylori prior to enrollment.
* At the Screening Visit, subject had a body mass index (BMI) within the range of 18 to 30 kg/m2, as determined by the following calculation.
* Subject was in general good health as evidenced by a medical history, a complete physical examination, and ECG without clinically significant abnormalities.

Exclusion Criteria:

* Subject had current evidence of cardiovascular, central nervous system, hepatic, hematopoietic, renal, or metabolic dysfunction; serious allergy, asthma, history of significant sensitivity to any drug; or lactose intolerance that would contraindicate taking ilaprazole or esomeprazole or would interfere with the conduct of the study.
Animal Assisted Activity Program on Patients and Staff on an Inpatient Surgical Oncology Unit

The purpose of this study is to describe the effects of canine-assisted activity visits on patients and staff in a hospital setting. The Caring Canines program uses dogs who have been trained to be obedient, calm and comforting. It involves a visit by a volunteer (called the dog's handler) and the volunteer's dog that has been trained and tested to have a good personality and to follow commands. A visit typically lasts about 10-15 minutes with the patient interacting with the dog while the dog is supervised by the handler. Memorial Sloan Kettering currently has Caring Canine dogs visit patients but the investigators don't yet know the impact of these visits on patients and staff. The investigators would like to see how the Caring Canine visits impact a patients' mood, including anxiety, stress, and sense of well-being. Two groups of patients will take part in this study - the first group will receive standard post surgery care and will not receive a visit from the Caring Canines program and the second group will receive daily visits (Tuesday -Friday) from the Caring Canines program while they are on M15. The purpose of this study is to look at differences in well-being between patients who have the visits with the dogs and patients who do not.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Age greater than 21
* Admitted to M15 following a Monday or Tuesday surgery
* Ability to speak and read English.

Staff

* Age greater than 21
* Works at least one day shift a week on M15
* Ability to speak and read English

Exclusion Criteria:

Patients

* Self reported allergy to dogs
* Medical need to be in an isolation room
* Medical need to be in a Protective Environment room .

Staff

* Self reported allergy to dogs
Non-Op Management of Ventral Hernia Patients

Ventral hernias are among the most common surgical diseases among patients.The natural history of patients with ventral hernias who are managed non-operatively is unknown. The aim of this prospective trial is to document the natural history of patients who are undergoing initially non-operative management. The investigators hypothesize that 1) the risk of emergency ventral hernia repair is low, 2) the risk of elective ventral hernia repair is high, and 3) patients managed non-operatively will develop increasing hernia size and symptom progression. This is a prospective observational study of all patients undergoing non-operative management at LBJ General Hospital. Patients will be consented and then followed for 5 years. Phone interviews will be done with these patients yearly to assess surgical and medical history, information about their hernia, including pain level due to the hernia, as well as function and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing initial non-operative management as chosen by current practice patterns
* All patients who opt for non-operative management due to personal choice, lack of symptoms or concerns regarding surgical risks.
* Age 18 or older

Exclusion Criteria:

* Patient meets surgery criteria but elects for surgery within 1 year due to personal scheduling
* Patient smokes \< 1 pack per day, is actively quitting smoking, and desires to follow-up within 3 months upon smoking cessation
* Patient with BMI \< 35 kg/m2, is actively losing weight, and desires to follow-up within 3 months upon weight loss goals being met
* Patient is unlikely to be able to follow-up due to no personal or home phone
* Patient is enrolled in another trial
PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening

The purpose of this study is to collect blood specimens and clinical data from screening guideline eligible individuals designated by their physician to receive a screening colonoscopy, and to evaluate the performance of a colorectal cancer-specific DNA methylation biomarker for detection of colorectal cancer in this cohort. Based on the outcome of the colonoscopy, polypectomy, biopsy and surgical tissue histopathology, the clinical utility of Septin 9 as colorectal cancer screening test will be evaluated.

The study is designed as a prospective, open enrollment clinical investigation involving multiple clinical study sites in the United States and Germany. Subjects will be competitively enrolled at multiple sites until at least 50 invasive colorectal adenocarcinoma cases identified by screening colonoscopy and verified by clinical and histopathological examination have been enrolled. The primary objective of the investigation is to evaluate and describe the clinical performance of the Septin 9 Biomarker for detecting the 50 individuals with invasive colorectal adenocarcinoma identified in this population representative of the US screening guideline eligible population. Secondary objectives will be to evaluate and describe performance characteristics of the biomarker in individuals with adenomatous polyps 10 mm or larger, flat lesion (s) or non-invasive adenocarcinoma.

Collaborating sites will identify and contact patients scheduled for screening colonoscopy. These patients may be screened by the PI or designee to determine the patients' appropriateness for, and interest in, study participation. Study site personnel will meet with patients meeting eligibility guidelines and offer them participation. Patients interested in participation and who provide written informed consent will be enrolled as Subjects in the study.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent provided
* Capable of providing adequate health history
* Age 50 or older at time of colonoscopy (colorectal screening guideline eligible)
* Accessible for blood draw prior to start of bowel preparation for colonoscopy
* First large bowel endoscopy in lifetime

Exclusion Criteria:

* Anorectal bleeding or hematochezia within last 6 months for which patient sought medical attention
* Known iron deficiency anemia in the last 6 months for which patient sought medical attention
* Previous history of colorectal polyps or CRC
* High risk for colorectal cancer (2 or more 10 relatives with CRC; 1 or more 10 relative(s) \< 50 years with CRC; known HNPCC or FAP)
Salivary-based Bone Loss Marker Detection Platform for Point-of-care Screening - Phase II Study

The purpose of this study is to validate a human saliva sample analyzer technique designed to screen for low bone density and osteoporosis. The analyzer technique is meant to be a simple, noninvasive, easy-to-use, cost-effective, and routine means of diagnosing bone turnover using a point-of-care device that monitors salivary markers of bone turnover in a screening patient population that is at risk for low bone density or osteoporosis.

Primary objective: To validate the performance of human saliva sample analyzer LFA technique against bone density as measured by quantitative computed tomography (QCT).

Secondary objective: To validate the performance of human saliva sample analyzer LFA technique against salivary ELISA method (gold standard).

Number of sites: Single site at the University of Mississippi Medical Center

The purpose of this prospective Phase II observational study is to further refine a proprietary device and test it in a screening population composed of women 50 years of age or older who are at risk for low bone density or osteoporosis (N=200). After screening for inclusion and exclusion criteria and obtaining informed consent, participants will provide a salivary sample and will undergo quantitative computed tomography (QCT) at the same visit (Visit 1, Day 0). No additional visits are planned. Bone mineral density (BMD) will be measured by diagnostic radiologists using QCT techniques and serve as the gold standard for the study. Salivary samples will be analyzed by a lab at UMMC for concentrations of osteocalcin (OC) and deoxypyridinoline (DPD) using enzyme-linked immunosorbent assay (ELISA) techniques, while blinded to BMD measurements. De-identified and coded salivary sample will be shipped to IOS who will measure concentrations of OC and DPD using lateral flow assay (LFA), while blinded to BMD measurements.

Eligibility Criteria:
Inclusion Criteria:

* Female ≥50 years of age and referred for standard of care screening mammogram.
* Ability to provide salivary samples.
* Ability to lie flat on the CT scanner.
* Ability and willingness to provide signed and dated informed consent.

Exclusion Criteria:

* Any known bone metabolism disorder (other than osteoporosis or low bone density) including sickle cell disease, current neoplastic disease, metastatic disease or any neoplastic disease involving the bones (including leukemia), or Paget's disease.
* Body weight exceeds the weight limit (\>400lbs) of the CT table.
* Vulnerable subjects including pregnant women and prisoners.
* Subjects who have had prior QCT imaging to measure bone density.
Effects of Amorphous Calcium Carbonate Supplementation on Bone Health in Postmenopausal Women With Osteopenia

This research was designed in accordance to the Method for Efficacy Assessment of Health Food for Bone Heath. Changes to bone density were measured to evaluate the effectiveness of amorphous calcium carbonate in maintaining bone health.

Bone comprises organic matter, predominantly protein, and inorganic matter including various mineral salts. Inappropriate nutrition profile can affect the balance of bone metabolism and cause bone loss. Of all nutrients, calcium is considered the most important for bone structure and metabolism. It is the most common deficit that affects bone health. Low dietary calcium intake can lead to negative calcium balance. Low blood calcium (\< 10mg/dL) induces the release of parathyroid hormone (PTH), which activates the conversion process of 25-(OH)-D3 to physiologically active 1,25-(OH)2-D3 in kidneys. PTH and 1,25-(OH)2-D3 act jointly to change the ionic valence of hydroxyapatite, converting orthophosphate to pyrophosphate. This causes hydroxyapatite to easily dissociate and release calcium ion in order to compensate the blood calcium level. This is called bone resorption. While this physiological mechanism maintains blood calcium homeostasis, it also causes bone loss that can develop into osteoporosis. Negative calcium balance is not only caused by lack of dietary calcium, hormonal abnormality or vitamin D deficit may also lead to negative calcium balance and the development of osteoporosis. This study aims to assess the effects of UIC Amorphous Calcium on osteoporosis with "Bone Change Test" and "Calcium Bioavailability Test".

Eligibility Criteria:
Inclusion Criteria:

* Menopausal women were recruited (those who had just started menopause or less than 10 years post-menopause were preferred).

Exclusion Criteria:

* respiratory insufficiency,
* sleep apnea,
* gastroesophageal reflux,
* neurological or liver disease,
* malignant tumor, alcohol abuse,
* hysterectomy or hormonal therapy,
* and depressive symptoms.