cyrilzakka/clinical-trials huggingface dataset:
Magnesium After Alcohol Withdrawal Treatment

The primary purpose is to see if magnesium tablet supplementation will decrease elevated GGT enzyme activity in alcoholic patients immediately after they had been treated for alcohol withdrawal. The secondary aims are to find out whether supplementation decreases the activity of ASAT and ALAT enzymes, increases muscle strength, decreases blood pressure and decreases depressive symptoms among these patients.

Magnesium (Mg) deficiency is common among alcoholics. Animal studies have shown that magnesium deficiency aggravates the hepatic damage caused by alcohol. One study on chronic alcoholics suggested that magnesium supplementation over six weeks decreases abnormally high activities of three enzymes related to liver function: serum gamma-glutamyltransferase (GGT), aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT), and increases muscle strength \[4\]. These results were, however, significant at the 5% level only when a 1-sided test was applied. It seems that magnesium supplementation may improve liver recovery after a drinking bout, but the evidence is not yet strong enough to warrant clear recommendations for clinical practice. Magnesium deficiency may also be one of the symptoms of depression and may aggravate hypertension. The primary purpose of the present randomized, parallel group, double blind trial is to see if oral magnesium supplementation will decrease elevated GGT enzyme activity in alcoholic patients immediately after they had been treated for alcohol withdrawal. The secondary aims are to find out whether supplementation decreases the activity of ASAT and ALAT enzymes, increases muscle strength, decreases blood pressure and decreases depressive symptoms among these patients.

Eligibility Criteria:
Inclusion Criteria:

* Admission to treatment because of an acute alcohol withdrawal
* Elevated serum GGT (men\>80, women \>50)
* Age 20-64 years
* Fixed address and a telephone to facilitate follow-up

Exclusion Criteria:

* Mg supplementation within the past two months ten 250 mg tablets or more
* History of heart rhythm disturbances
* Contraindications against Mg treatment
* Abnormally high serum creatinine
Docosahexaenoic Acid in the Treatment of Autism

The purpose of this study is to test the hypothesis that dietary supplementation with the omega-3 fatty acid docosahexaenoic acid (DHA) improves the behavior of children with autism.

Autism is a neurodevelopmental disability with an increasing prevalence. Traditional medicine does not offer any cures for autism; thus, many parents of children with autism are attracted to complementary and alternative therapies, one of which is dietary supplementation with the long chain polyunsaturated omega-3 fatty acid, docosahexaenoic acid (DHA). DHA is a critical structural lipid of brain cell membranes and differences in brain DHA content may influence synaptic function, particularly in nutritionally-sensitive areas of the brain, such as the cerebellum and hippocampus, which may be brain structures involved in the etiology of autism. This study is a randomized, double-blind, placebo-controlled trial investigating whether DHA supplementation is an effective treatment for children with autism. Eighty children with autism will be randomized to receive 200mg of DHA or placebo for 6 months. Outcome variables will include total plasma fatty acid patterns and scores on parent and investigator-completed behavioral and developmental rating scales at baseline and after 3 and 6 months of supplementation. Differences between groups after 6 months will be evaluated using regression methods. Regression analysis will be used to detect correlations between plasma total fatty acid DHA contents and scores on the various outcome measures. Results from this study will either provide evidence for a breakthrough biomedical treatment alternative for children with autism or evidenced-based advice to desperate parents in regard to their choices of potential treatments for their children with autism

Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-IV criteria for autistic disorder
* Age 3 to 10 years

Exclusion Criteria:

* Use of a dietary supplement containing DHA within 90 days of study inclusion
* Medical history of a disorder of lipid metabolism
Evaluation of TP US in Women With Prolapse

Many women suffers from uterine and vaginal prolapse Usually they suffer from these symotoms in menopause

The most common cause of pelvic organ prolapse is multiple pregnancy and multiparity

Eligibility Criteria:
Inclusion Criteria:

* Women with history of normal delivery Age between 25 to 75 years

Exclusion Criteria:

* women with cesarean deliveries
Heart Failure Management Program Versus Usual Care

Heart Failure (HF) patients discharged to Skilled Nursing Facilities have higher rehospitalization rates and mortality than patients discharged to home.

HF disease management programs have been shown to reduce rehospitalizations in community settings, no national guidelines have been set forth for Skilled Nursing Facilities (SNF).

This study will investigate the the effect of a heart failure-disease management program on the outcome of all-cause hospital readmissions, emergency room admissions and mortality for 30 days post-SNF admission using 7 component heart failure disease management program.


Eligibility Criteria:
Inclusion Criteria:

* Heart Failure is listed as the hospital discharge primary diagnosis
* Heart Failure is listed as the hospital discharge secondary diagnosis

Exclusion Criteria:

* Any life threatening condition which predicts mortality in 6 months or less
Water Oxygenation and Brain Activity

The primary purpose of this interventional, placebo controlled, crossover, double blind, basic science exploratory study is to investigate whether there is a difference in brain electrophysiological oscillatory activity in healthy adults before and after oral consumption of water containing very small bubbles of oxygen (electrokinetically modified water).


Eligibility Criteria:
Inclusion Criteria:

* Men or women of any ethnic background;
* living in New York tri-state area;
* fluent in English;
* normal or corrected to normal vision and hearing;
* willing to complete all study procedures; and
* capable of giving written informed consent.

Exclusion Criteria:

* A history of gross brain abnormalities such as stroke, severe ventriculomegaly or severe periventricular white matter abnormalities;
* a history of serious psychiatric or neurological disorders, including psychosis or major depression, alcohol or drug abuse, brain injury, seizure disorder, brain tumor, etc.;
* taking psychoactive medications, including antipsychotics, anxiolytics and antidepressants, or cognitive enhancers such as cholinesterase inhibitors;
* presence of contraindications for MEG or MRI recording, including any of the following: cardiac pacemaker, intracranial clips, metal implants, or external clips within 10 mm of the head, metal in eyes, claustrophobia, obesity and/or any other reason leading to difficulty staying in the MEG or MRI for up to one hour.
Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity

This is a randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. The study will be conducted in the U.S.A., approximately 128 adult subjects from approximately 30 study centers will be randomly assigned (1:1:1:1) to one of four treatment groups. The study consists of a 21-day screening period, a treatment visit and follow-up visits.

The protocol was amended and the study was completed with fewer subjects than described in the initial protocol due to impact of COVID-19 on enrollment.

Subjects will be randomly assigned to DAXI for Injection 250 U, DAXI for Injection 375 U, DAXI for Injection 500 U, or placebo group, respectively. Eligible subjects will have ULS characterized by a primary aggregate posture

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of age
* Written informed consent including authorization to release health information
* Focal upper limb spasticity (ULS) after a stroke (as defined by WHO criteria) or traumatic brain injury (TBI), last stroke or TBI \> 24 weeks prior to Screening
* ULS with the primary aggregate posture
* Moderate to severe ULS with a MAS score ≥ 2 at the elbow, wrist, and finger flexors
* Moderate to severe functional disability (Disability Assessment Score \[DAS\] score ≥2) on the principal target of treatment
* Has sufficient cognitive and communication ability to be able to give informed consent

Exclusion Criteria:

* Upper limb spasticity attributable to an etiology other than stroke or TBI.
* Bilateral upper limb paresis or quadriplegia.
* Initiated in physiotherapy of the upper extremities ≤ 30 days prior to Screening or planned to start physiotherapy of the upper extremities during the course of the study.
* Previous or planned treatment of the spastic upper limb with phenol, alcohol injection, or surgery
* Profound muscular atrophy or fixed contracture leading to marked limitation on range of motion
* Prior treatment with intrathecal baclofen
* Any neuromuscular neurologic conditions (amyotrophic lateral sclerosis, Lambert- Eaton, myasthenia gravis)
Comparison of Patient Controlled Analgesia (PCA) Versus Bolus Narcotic Therapy for the Treatment of Vaso-Occlusive Crisis (VOC)

This research is being done to find out the best way to give narcotics for pain relief in adults with sickle cell disease and painful crisis. This study is a comparison of two ways of giving narcotics. The first way is what occurs now in the Emergency Acute Care Unit (EACU) where patients are given a single intravenous (iv) dose of a narcotic which is repeated by the nurse as needed to control the pain. The second way is to provide a single iv dose of narcotic and then allow the patient to push a button and receive one or more additional doses of narcotic when he/she thinks it is needed. Our hypothesis is that PCA will be a more effective way of controlling pain.


Eligibility Criteria:
Inclusion Criteria:

* Documented sickle cell disease
* Signed consent in outpatient clinic or during a prior hospitalization
* 18+ years of age
* Seen in the ED with sickle cell pain crisis - this will be based on patients chief complaint that they are in a VOC.
* Requires IV administration of narcotics (has failed oral narcotic therapy at home)
* Must be 2 weeks since their last randomization on this study.

Exclusion Criteria:

* Contraindication to the use of IV narcotics
* Hypotension with systolic blood pressure (SBP) ≤ 90
* Respiratory rate ≤9
* Altered mental status
* Patient unable to understand how to use the PCA device
* Patient unwilling to use PCA device
* Pulse oximeter reading of ≤ 94% on room air
* Patient is allergic to IV morphine \& hydromorphone \& fentanyl.
* Patient is allergic to oral hydromorphone \& morphine \& oxycodone
* Patient has been randomized on this study 3 times before
DEFENDO Long Term Follow-up Study in Stage 1 NK Patients

The primary objectives are to evaluate the long-term safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in Stage 1 Neurotrophic Keratitis (NK) patients who enrolled in the DEFENDO Study.

This clinical study will be a multi-center, open label, long term follow-up study of the patients who were enrolled in the DEFENDO Study who had Stage 1 Neurotrophic Keratitis (NK) who were treated with OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution.

The DEFENDO Long-Term Follow-up Study will have follow-up with the patients at month 24-30 post-treatment in the DEFENDO Study: All patients will be evaluated in a real-world setting post the enrollment in the DEFENDO Study through 30 months. Patients will be treated per standard of care as determined by the Investigator and will document topical ophthalmic medications.

The original DEFENDO Study duration was for a total of 34 weeks: a screening period of 2 weeks, followed by enrollment in 8 weeks of OXERVATE™ treatment and an Off- Treatment Follow-Up of 6 months.

After completing enrollment in the original DEFENDO Study, patients will be invited to enter the DEFENDO Long- Term Follow-up Study (all standard of care is permitted).

Two additional long-term follow-up visits will occur at 24- and 30-months to evaluate long-term clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Previously enrolled in the DEFENDO Study.
2. Satisfy all Informed Consent requirements. The patient and/or his/her legal representative has read, signed, and dated the IRB approved Informed Consent document before any study-related procedures are performed.
3. Must have the ability and willingness to comply with study procedures.

Exclusion Criteria:

Participating in another study that involves treating the study eye.

a. Participation in non-ocular studies is acceptable provided that the treatment is not considered to be confounding with the DEFENDO Long-Term Follow-up Study, in the opinion of the Investigator.
Evaluation of IBI302 Injection in nAMD or DME

The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.


Eligibility Criteria:
Inclusion criteria

1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol;
2. Male or female patiensubjects ≥ 18 yrs. of age;
3. For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD;
4. For DME subjects, Type 1 or type 2 diabetes mellitus, decrease in vision determined to be primarily the result of DME in the study eye; the CST measurement of ≥ 280 μm in the study eye;
5. BCVA ETDRS letter score of 24-73 in the study eye;

Exclusion criteria

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
2. Presence of uncontrolled glaucoma in the study eye ;
3. Presence of active intraocular or periocular inflammation or infection;
4. Prior any treatment of following in the study eye:

   1. Anti-VEGF therapy or anti-complement therapy;
   2. Laser photocoagulation;
   3. History of vitreoretinal surgery;
   4. Glucocorticoid treatment(intravitreal or peribulbar) ;
5. BCVA score \<19 letters in the fellow eye;
6. Anti-VEGF therapy in the fellow eye within 30 days of day 0;
7. Presence of any systemic disease: including but not limited to active infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening; serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; uncontrolled clinical disease(such as diabetes mellitus, hypertension) or malignant tumor;
8. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
9. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
10. Participated in any clinical study of any other drug within 90 days of day 0, or attempted to participate in other drug trials during the study;
11. Other conditions unsuitable for enrollment judged by investigatiors.
Mechanical Stimulation of the Ovary for Infertility Treatment in Patients With Very Low Ovarian Reserve

Examine the possibility that mechanical stimulation and ovarian fragmentation in women with premature ovarian failure or low ovarian reserve intended for egg donation may cause early follicular recruitment and increase chances of achieving pregnancy through IVF.

The women will undergo a surgical laparoscopy during which one of the two technique will ensue.

1. One of the ovaries will be scratched ( 2 mm depth) with a knife. Simultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.
2. A piece of one ovary will be resected (up to one third of the ovary's volume, without harming the other ovary.

The resected ovarian tissue will be transferred immediately to the laboratory where the cortex will be divided from the medulla and sliced to small pieces of 1-2 square millimeters.

These pieces will be transferred back to the operation room in order for them to be transplanted under the serosa layer of the remaining ovary.

Any bleeding would be stopped using a stiches or hemostatic mesh (diathermy will not be used).

Simultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.

Post operational follow up ( up to two years) including: menstrual cycle surveillance, hormonal profile, AMH level, US of the pelvis and Antral Follicles Count (AFC).

A month after the surgery, an ovarian stimulation will commence following IVF while close monitoring the ovarian response and comparing the pre and post operation response.

Moreover, the treated ovary will be compared to the untreated one: using the US the ovarian volume and antral follicles size and count will be evaluated.

The preserved pieces of ovary will be histologically evaluated for ovarian reserve analysis.

Additionally, these pieces will be used for experiments for the evaluation of various methods for primordial follicles stimulation including mechanical stimulation like the laser or using substances like Akt Stimulators.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women, aged 21-40. with premature ovarian failure.
* Healthy women, with poor ovarian reserve, aged 38-45, undergoing IVF Low ovarian response: recruitment of up to three eggs in previous treatments.
* After the failure of at least 4 cycles.
* Two functioning ovaries, follicular and hormonal response of both ovaries in prior therapies.
* Women candidates for egg donation, and seeking further treatment before switching to egg donation.

Exclusion Criteria:

* Women with kidney disease.
* Women with infertility factors other than ovarian failure, such as endometriosis, PCOS, male factor.
* Women with one non-functioning ovary, or that was removed.
* Women with an intrauterine or pelvic pathology.
The Cost in Oxygen of Surgical Trauma

The investigators will examine the relationship between post-operative oxygen consumption (using non-invasive measurement technology ) and complications in patients having contemporary major abdominal surgery. The investigators hypothesis is that major surgery may trigger a physiological stress response that results in an increase in post-operative metabolic demand and oxygen consumption (V̇O2) which must be met by an increased oxygen delivery (DO2).

1. To determine the feasibility of non-invasive measurement of oxygen consumption (V̇O2) using indirect calorimetry in a cohort of patients
2. To determine the feasibility of non-invasive measurement of oxygen delivery (DO2) in the same cohort using non-invasive measures of cardiac output, oxygen saturation and haemoglobin (pulse wave transit time and co-oximetry techniques)

Prospective observational study of non-invasive measurements of V̇O2 and DO2 pre-operatively and at 8 time points in the 48 hours postoperatively in a cohort of 40 patients undergoing elective major abdominal surgery (both open and laparoscopic) with a pre-operative cardiopulmonary exercise testing (CPET).

As pilot work examining the relationship between post-operative oxygen consumption and complications in patients having contemporary major abdominal surgery , the investigators need to define and grade the severity of complications. The Post-Operative Morbidity Survey (POMS) is a simple outcome scale designed to record the incidence of clinically important complications - specifically complications likely to keep a patient in hospital. A POMS score performed on Day 5 is likely to be discriminative between patients who are recovering well, and those who are developing complications. POMS is easily performed, has good internal validity and is predictive of a prolonged length of stay. POMS is not a simple additive scale; however patients with POMS score of 1 or greater are highly likely to remain in hospital, whereas those with a score of 0 are likely to be able to go home.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 or over.
* Undergoing elective major open or laparoscopic abdominal surgery.

Exclusion Criteria:

* Refusal to participate
* Requirement for post-operative ventilation
* Requirement of inspired oxygen concentrations (FiO2) \> 28% to maintain oxygen saturations ≥ 90%.
The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations

This is a randomized double-blind controlled trial，aiming to investigate the hypoglycemic effect of Cyclocarya paliurus extract and Cyclocarya paliurus compounds on hyperglycemic populations without modifying their original treatment plans.


Eligibility Criteria:
Inclusion Criteria:

* pre-diabetic or type 2 diabetic patients who are treated with only one oral antidiabetic agent and whose fasting plasma glucose is lower than 8.4 mmol;
* age:20-65 years;
* BMI :20-35kg/m2.

Exclusion Criteria:

* type 1 diabetic patients;
* type 2 diabetic patients with insulin treatment；
* pregnant or lactating women；
* adverse effect on intervention；
* acute or chronic inflammatory conditions;
* severe hepatic,kidney or other complications;
* other situations ineligible to intervention.
Effect of Exercise Mode in Breast Cancer-Related Lymphedema

Gaining a greater understanding of how each exercise mode affects lymphedema, as well as other health-related outcomes will improve exercise prescription guidelines relevant to this specific lymphedema. Therefore, the purpose of this work was to compare the effects of Xbox kinect rehabilitation and resistance exercises on limb volume, symptoms severity, physical function, and quality of life in women with Breast cancer-related lymphedema.

Breast cancer-related lymphedema is a common and debilitating side effect of cancer treatment. This study compared the effect of Xbox kinect rehabilitation and resistance exercises on breast cancer-related lymphedema volume and severity, as well as participant's physical function and quality of life. Women diagnosed with unilateral breast cancer related lymphedema were randomly divided into two groups: the kinect based rehabilitation group KBRG and resistance exercise group REG. woman in The KBRG received virtual reality therapy using Xbox Kinect-based games, the REG received resistance training in addition both groups received complex decongestive physiotherapy. The intervention was five sessions per week for 8 weeks. The outcome measures included limb volume, symptoms severity, physical function (muscle strength and range of motion) and quality of life. All these outcomes were assessed at pretreatment (baseline) and after the end of treatment at week eight (W8).

Eligibility Criteria:
Inclusion Criteria:

* Age more than 30.
* Histological diagnosis of breast cancer at least 1 year prior to the study.
* Clinical diagnosis of unilateral Breast cancer-related lymphedema and obtained medical clearance from their medical oncologists or surgeons.
* Clinical diagnosis of lymphedema was defined as having at least a 5 % inter-limb discrepancy in volume or circumference.

Exclusion Criteria:

* Unstable lymphedema, receiving intensive therapy within the previous 3 months.
* A musculoskeletal, cardiovascular and/or neurological disorder that could inhibit them from exercising.