cyrilzakka/clinical-trials huggingface dataset:
MRI Study of the Distal Radius Bone Marrow Fat Fraction in Osteoporotic and Healthy Women

The aim of the study is to test whether the distal radius bone marrow show significant difference in the fat fraction in young women compared to post menopausal women with and without osteoporosis.

Patients of the Department of Endocrinology, who routinely perform bone density tests, DXA (Dual Energy X-ray absorpiometry) test on the lumbar spine, proximal femoral and distal radius, will be invited for a visit, and after signing the informed consent form, the following data will be collected: age, BMI, first menstrual period and last menstrual period, family history of osteoporosis, history of osteoporotic fractures, smoking, alcohol use and exercise habits. In addition, blood tests will be performed: calcium phosphate, albumin, alkaline phosphatase, vitamin D level, thyroid function, LH (Luteinizing Hormone) FSH (Follicle Stimulating Hormone), Estradiol, and serum bone turnover index (CTX P1NP). Amount of blood taken: 12 ml The patients will then be sent to the Alfredo Federico Strauss Center for Computerized Neuroimaging at Tel Aviv University for an MRI study of the distal radius. The study results will be analyzed by an expert bone radiologist from the Sourasky Medical Center to reject any kind of pathology (such as a fracture, inflammation, tumor), and further analyzed for bone marrow fat fraction by Tel Aviv University researchers. In the case of abnormal findings, they will be mentioned in the report and the participants will receive recommendations from the appropriate expert.

Eligibility Criteria:
Inclusion Criteria: Women over the age of 45 with regular menstruation should be included in group 1, women over the age of 55 without menstruation for at least one year should be included in groups 2 or 3 according to the results of the bone density test. If T-Score\> -2.5 will be included in group 2 and if T-Score \<-2.5 they will be included in group 3.

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Exclusion Criteria: Women with metabolic bone disease, thyroid or pre-thyroid disease, diabetes, chronic steroid use, use of osteoporosis drugs, hormonal therapy, BMI below 20 or over 27, pregnant women and tattooed women in the area under study will not be included in the study.

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Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women

The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.

Urge Urinary Incontinence affects 30% of postmenopausal women. The etiology is unknown therefore treatment is symptomatic. For that purpose the nerval stimulation of the bladder muscle is interfered by several drugs, e.g. solifenacin.

We observed that the surgical repair of critical pelvic structures, i.e. the uteri-sacral ligaments (USL) can restore continence in a considerable number of patients.

In this study the surgical treatment is compared with the solifenacin treatment. According to outcome after three months patients who are still incontinent are referred to the opposite treatment group.

Outcome will be differentiated in cure (primary aim) and improvement of symptoms (secondary aim).

Eligibility Criteria:
Inclusion Criteria:

* urge urinary incontinence

Exclusion Criteria:

* stress urinary incontinence
* cancer disease of the females genital tract
* pregnancy
* neurologic/psychological reasons for incontinence
* body weight \>100kg
* previous urogynecological surgery (TVT)
* syndrome of dry overactive bladder (\>20 micturitions within 24 hours)
HAPH Registry: Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.

The purpose of the current study is to evaluate the clinical and physiologic course of Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal cohort study. To this end, the investigators will invite the same highlanders who participate din the study in 2017 to undergo follow-up examinations in 2024, in order to allow comparisons of current results with baseline data from 2017.


Eligibility Criteria:
Inclusion Criteria:

* Permanently living \>2500 m
* Written informed consent

Exclusion Criteria:

* Highlanders who cannot follow the study investigations,
* Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, heavy smoking \>20 cigarettes/day or \>20 pack-years.
* Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
* Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
Gastrointestinal Tolerance of Infant Formula

The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.


Eligibility Criteria:
Inclusion Criteria:

* Infant is judged to be in good health.
* Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
* Infant's birth weight was \> 2490 g (\~5 lbs 8 oz.).
* Infant is between 0 and 8 days of age at enrollment.
* Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) as the sole source of nutrition for the duration of the study.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.

Exclusion Criteria:

* Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
* Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
* Mother intends to use a combination of breast and formula feeding.
* Participation in another study that has not been approved as a concomitant study by AN.
A Retrospective Study of the iTotal CR Knee Replacement System

This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical condition included in the approved Indications For Use
2. Has signed the informed consent form to allow review of medical records and collection of data therein.
3. \> 18 years of age

Exclusion Criteria:

1. Treatment with iTotal in a manner inconsistent with Instructions for Use
2. Unwilling to sign then informed consent form
Treatment of Major Depressive Disorder With Psychotic Features.

The purpose of this study is to determine the safety and efficacy of risperidone monotherapy in the treatment of psychotic depression. We hypothesize that risperidone is as equally as effective as haloperidol plus sertraline for depression with psychotic features

Risperidone is a novel antipsychotic that is usually not associated with the adverse effects of neuroleptics. In addition, preliminary evidence suggests that it has additional mood stabilizing properties as compared with neuroleptics. We are examining the effect of risperidone alone for the treatment of psychotic depression. After providing written informed consent, subjects with major depression and psychosis will undergo a routine medical and neurological evaluation. If subjects qualify they will undergo a 3 to 7 day washout. Subjects will be randomly assigned under double-blind conditions to risperidone plus placebo; risperidone plus sertraline; or haloperidol (HPDL) plus sertraline in a prospective parallel design for a 6 week trial. Outcome measures include the Hamilton Rating Depression Scale, The Positive and Negative Symptom Scale and the Clinician Administered Ratings Scale for Mania and Simpson Angus Scale. Rating will be conducted on a weekly basis throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be men and women 18 to 70 years of age with major depression and psychosis that is either an initial episode or a recurrent episode (unipolar or bipolar).
* Subjects with an anxiety disorder or an additional mood disorder such as dysthymia are eligible.
* Baseline HDRS score of greater than 21.
* A baseline PANSS score of greater than 4 on at least one of the 5 psychosis items

Exclusion Criteria:

* Pregnant women Women of child-bearing age who refuse a urine pregnancy test or who refuse to use a contraceptive technique when sexually active.
* Persons with other psychotic disorders; a mood disorder due to a general medical condition or substance-induced; a current substance dependence disorder; or a dementing disorder are excluded.
* Persons with serious, unstable medical illnesses.
Evaluation of Effects of Clavicular Hook Plate on Subacromial Space

In this study, the investigators intend to demonstrate that the hook plate may have adverse effects on subacromial structures even with a short period of hardware retention. The investigators also sought to determine if musculoskeletal sonography could be used as a tool to demonstrate shoulder pathology such as subacromial impingement or rotator cuff tear in patients receiving hook plate fixation. The clinical results of patients receiving hook plate fixation, specifically bony union, pain relief, shoulder function and range of motion (ROM), were also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* The patient received surgical treatment for AC joint dislocation of unstable distal clavicle fracture in our hospital from December 2007 to January 2009.

Exclusion Criteria:

* The patient who was expired or the injured limb has preexisting injury or neurological deficit.
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets


Eligibility Criteria:
Inclusion Criteria:

* Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
* Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years

Exclusion Criteria:

* Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle
* Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study
* Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians

Congenital heart disease (CHD) affects approximately 1% of live births, and children with CHD often fail to meet WHO physical activity guidelines. Digital interventions to promote physical activity in CHD patients are limited. This study will develop and test a 12-week digital lifestyle intervention for children (ages 8-13) and their guardians, using a Garmin Vivofit Jr. 2 wearable to continuously monitor physical activity (PA). We will assess its impact on children's moderate to vigorous intensity physical activity (MVPA), daily activity (steps per day), quality of life, nutrition, and health literacy, as well as the quality of life and health literacy of their parents.


Eligibility Criteria:
Inclusion Criteria:

* Ages 8-14 years
* Presence of a congenital heart defect (must be moderate or complex according to ACC criteria)
* NYHA Class I or II
* Presence of written informed consent

Exclusion Criteria:

* Cognitive impairments that inhibit patients from understanding the tasks
* No sports clearance by paediatric cardiologists
Ocular Surface Syndrome Post-lasik, Outcomes of Treatment With Platelet Rich Plasma

To evaluate the efficacy of autologous platelet-rich plasma eye drops (E-PRP) for the treatment of chronic ocular surface syndrome (OSS) following laser in situ keratomileusis (LASIK).

Prospective interventional consecutive case series including 156 eyes of 80 patients affected by chronic post-LASIK OSS who were treated with autologous E-PRP 6 times a day as monotherapy for 6 weeks. Assessment after treatment with E-PRP included: dry eye symptoms, change in corrected distance visual acuity (CDVA), corneal fluorescein staining (CFS) and conjunctival hyperemia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients suffering from moderate to severe dry eye syndrome for 6 months or more after conventional treatments with artificial tears following LASIK.
* Tear break-up time (TBUT) between 4 and 9 seconds.

Exclusion Criteria:

* Ocular pathology needing topical treatments different than dry eye syndrome
* Trombocitopeny, associated pathologies to coagulation factors or any state of plaquets antiagregation (AAS and other AINES).
* Ocular tumours, corneal distrophies, history of ocular herpes.
* Pregnant or nursering women.
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504

This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age and older
* Patients scheduled to undergo ileostomy reversal
* Ability to provide informed consent, adhere to study visit schedule, and complete all assessments.

Exclusion Criteria:

* Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
* Patients who abuse alcohol or other drug substance.
* Patients with severe hepatic impairment.
* Patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at lest one month before and one month after dosing.
* Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
* Patients who have participated in an EXPAREL study within the last 30 days.
* Patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.

In addition, the patient will be ineligible if he/she meets the following criteria during surgery:

* Patients who have any concurrent surgical procedure.
* Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
* Patients who receive Entereg(R).
Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy

Radiofrequency (RF) could be technically feasible and effective in the treatment of lymph node metastases of differentiated thyroid cancer. It could constitute a minimally invasive and feasible therapeutic alternative in ambulatory, allowing a reduction of the tumoral volume sufficient to limit the symptoms even to induce a tumor remission, a normalization of the tumoral markers and a better quality of life.

The aim of this study is to evaluate the anti-tumor echographic efficacy at 12 months of radiofrequency on lymph node (LN) metastasis of thyroid cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients over age of 18 years
* with differentiated thyroid cancer (papillary, follicular) histologically confirmed, and absence of anaplastic component
* Previous treatment by total thyroidectomy and cervical lymph node dissection.
* Previous treatment by at least 1 therapeutic radioactive iodine (minimum activity 740MBq)
* Persistence on cervical ultrasound of at least 1 cervical metastatic lymph node, visible at ultrasound, small diameter between ≥10 mm and ≤30mm, volume maximum 20ml, spotted on a picture, and confirmed by cyto-punction
* Signed informed consent

Exclusion Criteria:

* Location of LN metastasis with significant risk of local complication (nervous, vascular) according baseline ultrasound assessment
* Patient carrier of a pacemaker or a defibrillator
* Congenital or acquired hemostasis abnormality, anticoagulant therapy or double platelet antiaggregatory (aspirin and clopidogrel)
* Hypersensitivity to local anesthetic
* Poor general condition (performance status Eastern Cooperative Oncology Group (ECOG) \> 1)
* Survival estimated less than 12 months
* Patient who can't follow the instructions of RF therapy or who can't be followed during 2 years in order to meet the objectives of the study
* Non affiliation to a social security
* Pregnant or breast feeding women at the time of RF
* Beta hormone chorionic gonadotrope (HCG) positive test (pregnancy) before RF therapy
* Baseline cervical ultrasound, by expert operator trained to RF, not fulfilling feasibility criteria for RF realisation because of the location of LN metastasis or the way to reach it
* Controlateral recurrent palsy on nasofibroscopy
Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy

The aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone for erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy Group 1: bupivacaine 0.25% + dexamethasone 8 mg

* Group 2: bupivacaine 0.25%
* Group3: control group A prospective Randomized Interventional double-blind study.

Optimal dynamic analgesia is recognized as the key to enhanced recovery following open abdominal surgery. In the last decade, there has been a significant shift away from thoracic epidural analgesia (TEA) that has been long considered as the gold standard. Various techniques have tried to replicate the analgesic efficacy of TEA. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and trans muscular quadratus lumborum analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries. Chin et al first described the erector spinae plane (ESP) block for providing analgesia following ventral hernia repair. The unique feature of the ultrasound-guided truncal blocks is that in all of these techniques, in contrast to peripheral nerve blocks, no nerve or plexus needs to be identified: Local anesthesia (LA) is injected in a particular muscle plane, in which the injectate spreads and reaches the intended nerves. This simple mechanism has made delivery of nerve blocks easy and versatile.

Eligibility Criteria:
Inclusion Criteria:

* Women ranging age between 30-60 years a who undergoing elective total abdominal hysterectomy

Exclusion Criteria:

* Participants had known sensitivity to bupivacaine
* Participants had difficulty in intubation
* Participants were on chronic pain medication or already on long-term opioids
* Participants smokers
* Participants with disabilities who were unable to communicate pain levels
* refuse to consent
Study on the Relationship Between Iodine Nutrition and Thyroid Diseases in the Elderly

The aging trend of China's population is intensifying. More than 50% of the elderly in China suffer from thyroid disease. Thyroid dysfunction in the elderly increases the risk of cardiovascular and metabolic diseases. Even if thyroid-stimulating hormone (TSH) is within the normal range, brain atrophy and infarction-like vascular damage in elderly males will be aggravated with the increased TSH level. Iodine is an essential component of thyroid hormones. Iodine deficiency or excess may lead to a series of thyroid diseases. The risk threshold of iodine intake in the elderly is unknown. The goal of this observational study is to clarify the relationship between thyroid diseases and iodine intake in the elderly. The aims are:

1. to clarify the differences in the prevalence of thyroid diseases in the elderly with different iodine nutrition backgrounds.
2. to analyze the effects of mild iodine deficiency and iodine excess on the thyroid health of the elderly.
3. to explore the hazard threshold of iodine intake for old people.
4. to compare the differences in thyroid disease and iodine nutritional status between young and middle-aged people and old people.

Part 1：A cross-sectional survey of thyroid diseases in adults in different iodine nutrition background areas.

Investigators will separately include adults ( middle-aged people and old people) in iodine-deficient, iodine-appropriate, and iodine-excessive areas. Venous blood will be collected to measure thyroid function and serum iodine. Thyroid volume and nodular disease were determined by B-ultrasonography. Drinking water, saliva and 24-h and spot urinary samples will be collected to precisely evaluate the daily iodine intake. Multiple indicators were used to accurately evaluate the iodine intake level of the subjects, and understand the differences in the prevalence of thyroid diseases in the elderly under different iodine nutrition backgrounds. Besides, the differences in thyroid disease and iodine nutritional status between young and middle-aged people and old people will be compared.

Part 2：A survey on the iodine nutrition status in the elderly with/without thyroid disease in iodine-appropriate areas.

Investigators will collect basic information (height, weight, age, other medical histories, etc.) and thyroid disease history information. Thyroid B-ultrasound and thyroid function tests were used to understand the current thyroid status of the elderly. The iodine dietary frequency questionnaire was used to assess the long-term iodine intake level of the survey subjects, and spot urinary iodine, 24-h urinary iodine and salivary iodine were used to assess the short-term iodine intake level of the survey subjects.

Eligibility Criteria:
Inclusion Criteria:

1. adults with at least 5 years of local residence;

Exclusion Criteria:

1. adults with family genetic diseases
2. adults with special dietary habits
3. adults taking iodine-containing drugs or supplements
4. adults with protein or nutritional deficiencies