cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled Trial of the Effects of Reactive Neuromuscular Training on Balance

Falls are a major concern for the geriatric population and represent a significant public health problem. Various interventions are being explored to improve balance and decrease falls in the elderly. Success has been shown in some programs; various exercise interventions place emphasis on strength, balance, or endurance exercises. Results reported in the literature are still equivocal. Controversy exists as to optimal types of exercise, and the optimum frequency, duration, and intensity of exercise. It is believed that the SpineForce device, which places a unique combination of strength and balance demands upon the user, can result in rapid increases in balance as compared to other rehabilitation programs. Gains in balance have implications for geriatric populations as well as those seeking enhanced sports performance and injury prevention. The Purpose of this study is to assess the SpineForce device as a novel intervention in the treatment of balance disorders.


Eligibility Criteria:
Inclusion Criteria:

* Young, healthy adults between the ages of 20 - 30, asymptomatic with respect to any balance specific disorder, and who are currently enrolled at Logan College.

Exclusion Criteria:Exclusion criteria include:

* A previous lower extremity injury;
* Previous lower extremity surgery;
* A visual or vestibular condition with accompanying balance difficulty;
* A diagnosis of Knee osteoarthritis;
* Currently receiving spinal manipulative therapy;
* Current participation in a regular exercise program;
* Use of any prescription medication, or herbal substance that may affect balance;
* Pregnancy
Remote Ischemic Conditioning and Platelet Dysfunction

The purpose of this study is to evaluate the effects of remote ischemic conditioning on platelet function during off-pump coronary artery bypass surgery.

Remote ischemic conditioning (RIC) may affect platelet function. However, little is known about effect of RIC on platelet function during off-pump coronary artery bypass surgery. In this study investigators are going to perform RIC after anesthesia induction (remote ischemic pre-conditioning) and after completion of coronary anastomoses (remote ischemic post-conditioning), and compare platelet function parameters with control group.

Eligibility Criteria:
Inclusion Criteria:

* 20 - 80 years of adult patient undergoing elective off-pump coronary artery bypass surgery

Exclusion Criteria:

* Acute Myocardial Infarction
* Recent (\<1 month) coronary angioplasty (percutaneous coronary intervention, PCI)
* Acute cerebrovascular ischemia (\<6 months)
* Preoperative LV EF \< 30%, mechanical ventricular support (IABP, VAD, ECMO)
* Peripheral vascular disease
* Poorly controlled diabetes mellitus
* Alzheimer's disease
* NSAIDs within 3 days
* iv heparin within 6 h
* low molecular weight heparin within 24 h
* platelet inhibitor within 24 h
* known thrombocytopenia
* renal failure / hemodialysis
* active infection
* preoperative bleeding diathesis
* redo-operation
* pregnancy
Effect of Bioptron on Primary Dysmenorrhea

This study will be conducted to determine the effect of bioptron on PD through the assessment of serum progesterone level, and pain level measured by pressure algometry in addition to evaluation of the symptoms of PD and its effect on girl's quality of life through valid and reliable questionnaires which will be of valuable benefits in the women's health fields.

All females will be randomly divided into two equal groups:

Group A (control group):

lt will include 28 participants suffering from PD taking vitamin D (vitamin D) supplements for three consecutive menstrual cycles.

Group B (study group):

lt will include 28 participants suffering from PD who will take vitamin D (vitamin D) supplementations as in group A in addition to Bioptron for 20 min daily for 7 days before the menstrual cycle along with the first three days of menstrual flow for three consecutive menstrual cycles.

All females will be given a full explanation of the study protocol and a consent form will be signed by each female before entry in the study

Eligibility Criteria:
Inclusion Criteria:

All females will be clinically diagnosed by the gynecologist with primary dysmenorrhea.

* Self-reported history of PD, at least moderate pain due to menstrual cramps (\>4 on VAS)
* They have moderate symptoms of PD on the WaILDD questionnaire, (5-12) Teheran et al., 2018).
* Their ages will be ranged from 18-24 years old.
* Their BMI will be less than 30 kg/m².
* Being a virgin.
* Having regular menstruation for the last 6 months (every 28-30 days with no intermittent bleeding).
* Voluntary acceptance to participate in the study.

B) Exclusion Criteria:

Participants will be excluded if they have:

* Musculoskeletal or neurological disorders.
* Patients with a history of phototherapy allergy.
* Professional athletes (Jill et al., 2012).
* Secondary dysmenorrhea pathology such as (endometriosis, fibroids, adenomyosis, and pelvic inflammatory disease)
* Menstrual irregularity.
* Using hormonal contraception (such as contraceptives or injections).
A Study to Investigate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants

The primary objectives of this study are to investigate the relative bioavailability and PK (Pharmacokinetic) profile of 2 ALXN2050 MR (Modified Release) formulations in comparison with the IR (Immediate Release) formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
* BMI within the range of 18.0 to 30.0 kg/m2 (inclusive), with a minimum body weight of 50.0 kg at screening.
* Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.

Exclusion Criteria:

* History of clinically significant respiratory, cardiovascular, dermatological, hepatic, renal, GI, endocrinological, hematological, psychological, psychiatric, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
* History of meningococcal infection.
* History of clinically significant hypersensitivity reactions to commonly used antibacterial agents, including beta lactams, penicillin, aminopenicillins, fluoroquinolones (specifically including ciprofloxacin), cephalosporins, and carbapenems, which in the opinion of the Investigator would make it difficult to properly provide either empiric antibiotic therapy or treat an active infection.
* History of clinically significant hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
* History of significant multiple and/or severe allergies (eg, drug, latex allergy, band aids, adhesive dressing, or medical tape). Hay fever is allowed unless it is active.
* History of seizures including childhood seizures.
* History of significant head injury, or head trauma requiring medical evaluation.
* History of malignancy within 5 years of screening, with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
* Any previous procedure, including history of stomach or intestinal surgery or resection, cholecystectomy, gallstones, TIPS, or surgical shunt, that could alter absorption or excretion of orally administered drugs.
* Significant current or chronic history of liver disease.
* Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome).
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions

The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended release tablets (Sandoz) with Opana extended release oxymorphone hydrochloride tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, nonmedical history or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C
* Treatment for drug or alcohol abuse
* Allergy to opiates
Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen

A prospective, randomised, open-label phase IIb clinical trial assessing the effect of pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B

The primary objective of the trial is to investigate whether the add-on of pegylated interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48 weeks.

170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an oral antiviral regimen and having a nondetectable viral load for at least 12 months are included.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B, HBe antigen negative
* treatment with a stable oral antiviral treatment (not containing telbivudine) and a fully suppressed viral load for at least 12 months (below limit of detection in conventional HBV-PCR assays, i.e. \<116 IU / ml).
* 18-70 ys
* willingness and ability to give informed consent and to follow study procedures
* willingness to use adequate contraception

Exclusion Criteria:

* contraindications against treatment with pegylated interferon, e.g. depression, uncontrolled epilepsy, autoimmune diseases, pregnancy, leukocytopenia or thrombocytopenia at screening, etc.
* active alcohol or drug abuse
* preexisting polyneuropathy
Efficacy and Safety of Sirolimus in Combination With Tacrolimus

To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation

Basic randomized clinical trial (multicentre) in primary KTX to assess the safety and efficacy of a tac/rapa vs a tac/MMF regimen. Tac trough levels in accordance with current standards in both arms. Steroids to be used to individual centre protocol. Rapa trough levels will be adjusted to 5-10 ng/ml. Up to now only few data (primate and clinical) on tac/rap combinations available.

Eligibility Criteria:
Inclusion Criteria:

* first kidney transplantation
* re-transplantation
* non-related living donor transplantation
* patients \> 18 years
* patients have given their written consent after being informed
* female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test

Exclusion Criteria:

* related living donation
* patients with known HIV-anamnesis
* patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection
* patients with present malignant disease
* patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer
* patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority
* other reasons which depend on the assessment of the physician
Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men

This study is being done to understand how testosterone, the major male sex hormone, controls the pituitary gland's secretion of growth hormone (GH). GH is an important metabolic hormone, which controls sugar; fat and protein use in the body and maintains muscle strength and bone calcium content. Both testosterone and GH decline in older men. The age-related fall in these hormones probably contributes to relative frailty, reduced quality of life, bone loss, muscle wasting and impaired sexual function.

Repletion of testosterone in older men drives pulsatile GH secretion via conjoint facilitation of feedforward by the primary secretagogues GHRH and GHRP and repression of feedback by the dominant inhibitor, somatostatin; and, in corollary, testosterone acts via aromatization to estradiol and/or reduction to 5 alpha-dihydrotestosterone

Eligibility Criteria:
Inclusion Criteria:

* healthy men between the ages of 50 and 80;
* normal weight (within 30% of ideal body weight defined by New York Metropolitan Life tables); and
* normal hematocrit (greater than 38%);
* community dwelling; and
* voluntarily consenting

Exclusion Criteria:

* recent use of psychotropic or neuroactive drugs (within five biological half-live);
* obesity (outside weight range above);
* anemia (hematocrit \< 38%);
* drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
* acute or chronic organ-system disease;
* endocrinopathy, other than primary thyroidal failure receiving replacement;
* nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission);
* acute weight change (loss or gain of \> 2 kg in 6 weeks);
* allergy to administered compounds; and
* unwillingness to provide written informed consent.
Effect of Chorioamnionitis on Platelet Activation and Placental Vessel Among Preterm Infants by Wnt-Flt1 Signal Pathway

Objective:The purpose of this study was to explore the effect and mechanism of maternal chorioamnionitis on placental microvasculature and platelet activation among preterm infants by activating Wnt-Flt1 signal pathway .

Methods:With clinical randomized controlled trial (RCT), the cases were matched with 1:1 according to gestational age and divided into 2 groups according to the placental pathology result: chorioamnionitis group and control group. (1) To observe the platelet parameter, birth weight, thrombrocytopenia and hemorrhage complication, such as intracranial hemorrhage, retinal hemorrhage, pulmonary hemorrhage and gastrointestinal hemorrhage. (2) To observe the miscrovascular density (MVD) in placenta, platelet activating factor (CD62p,CD63) and thrombopotetin (TPO) in preterrn infants.The placental MVD was assessed by immunohistochemical method. The platelet activating factors were detected by flow cytometry. TPO was detected by ELISA. (3) To observe Wnt5a, Flt1 and VEGF in placenta and fetal circulation.The measurement data were analyzed by pair t test and conditional logistic regression. Pearson correlation analysis was used for relationship.

The exclusive criteria included :(1) born to mother with no any other maternal complications; (2) no congenital abnormalities and neonatal asphyxia; (3) died or discharged within 72 hours.

Eligibility Criteria:
Inclusion Criteria:

1. gestational age\<37weeks
2. admitted to the NICU at Guangdong Women and Children Hospital, with a date of birth from June 2016 to December 2016
3. whose mothers were diagnosed chorioamnionitis by placental histopathology

Exclusion Criteria:

1. born to mother with no any other maternal complications
2. no congenital abnormalities and neonatal asphyxia;
3. died or discharged within 72 hours.
Mesh Suture for Internal Load Bearing Closures

Determine whether Mesh Suture achieves an acceptable safety and efficacy profile in load bearing internal tissue approximations. Mesh Suture has a novel design that permits tissue ingrowth and limits suture pull-through--items important for internal high-tension repairs

Sutures are flexible linear elements that appose tissues and are "self-holding" with a surgically created knot. When tissues are under tension, such as the closure of an abdominal wall after laparotomy, the sutures cut through the tissues in what is known as "suture pull-through" and create incisional hernias. The hernia rate after primary laparotomy depends on the patient population, but is over 10%. In some high-risk populations, even with a small 3 cm laparoscopy incision, the hernia rate is over 30%. In primary hernia repair, use of sutures alone yields a 60% hernia recurrence rate at 10 years. Mesh has become commonplace in order to decrease incisional hernia recurrence rates in primary hernia repairs.

A novel mesh suture, designed at Northwestern University (Chicago, IL) by Dr. Gregory Dumanian, has shown improved outcomes in pre-clinical animal models and these results are included at the end of this document. Dr. Dumanian has employed the concept of using a mesh-like suture already in his clinical practice. He has cut strips from an FDA-approved piece of hernia mesh, and used them as sutures, tying them with knots.

Based on improved outcomes in pre-clinical and analogous clinical data in comparison to standard suture, Dr. Dumanian now proposes the use of a medical grade mesh suture of his design and fabrication in the load bearing internal tissue approximations. These are internal permanent sutures and will not be removed. They are made of the identical material (polypropylene) used in standard sutures.

Mesh Sutures are larger than standard sutures and they automatically flatten to help resist suture pull-through. Tissue ingrowth around the filaments and into the suture improves their hold.

Eligibility Criteria:
Inclusion Criteria:

* Deep orthopedic soft tissue approximation

Exclusion Criteria:

* Pregnancy
* Age less than 1 year old
* Repair of skin or other epithelial surfaces
* Poor subcutaneous tissues
* Ongoing infection
Descriptive Study of Pain, Anxiety and Depression

The purpose of the study is to investigate pain, anxiety and depression in chronic pain patients with and without neuropathic pain compared with healthy volunteers

Primary outcome measures:

* Symptom checklist 92

Secondary outcome measures:

* Hamilton Depression and Anxiety Rating Scale
* Major Depression Inventory
* GAD-10 Anxiety Scale
* Health Survey SF-36
* McGill Pain Questionnaire
* Sweat test
* Heart rate variability testing
* Coping Strategy Questionnare
* Quantitative sensory testing
* Pain Catastrophizing Scale
* Pain rating (VAS)
* Interview

Eligibility Criteria:
Inclusion Criteria:

* Neuropathic pain patient or patient with fibromyalgia
* Daily pain in more than 6 months
* Weekly average pain score 4 or more (VAS)

Exclusion Criteria:

* Treatment with antidepressants, anticonvulsants or any other pain medication except paracetamol
* Serious or unstable medical disease
* Prior or present diagnosis of mania, bipolar or psychotic disorder, delirium, suicidal, drug and alcohol dependence, severe agitation
* Patients who cannot cooperate and do not understand Danish
Effects of Geriatric Inclusive Art Activity in Nursing Home Residents (GIA)

The study aimed to compare the changes in health and functional status between nursing home residents practicing GIA activity and a control group of residents, and to examine the changes in residents' abilities to participate in GIA activity.

Geriatric inclusive art (GIA) activity is a derived form of art therapy using painting to make older adults aware of their abilities through an improvement of emotional well-being (1). GIA protected against in-hospital mortality in demented older inpatients and has also been associated with shorter length of hospital stay in geriatric inpatients. These GIA-related positive effects suggest that GIA activity may improve health and functional status in the elderly. To date, effects of GIA on health and functional status in nursing home residents have not been examined.

Based on the previous positive effects reported in older inpatients practicing GIA activity, the investigators hypothesized that GIA activity could improve health and/or functional status of nursing homes residents.

Eligibility Criteria:
Inclusion Criteria:

* Being a resident in the nursing home "la Grande Providence" (Nantes - Loire Atlantique, France)
* Ability to answer questions
* Being affiliated to the French health insurance

Exclusion Criteria:

* Inability to understand and speak French
* Opposition to the use of information collected for research purposes
5G-based Telerobot-assisted Spine Surgery

This study retrospectively analyzed cases of remote robot-assisted spine surgery performed jointly by the Beijing Jishuitan Hospital Spinal Surgery and partner hospitals, with cases of local orthopedic robot-assisted spine surgeries performed by Beijing Jishuitan Hospital between April 2021 and December 2021.

Local orthopedic robot-assisted spine surgeries were performed according to the guidelines for thoracolumbar pedicle screw placement assisted by orthopedic surgical robots.

Based on the 5G network, the orthopedic robotic remote surgery platform is built at Beijing Jishuitan Hospital, providing primary hospitals with a platform for preoperative consultation, intraoperative communication and surgical robot teleoperation, and postoperative follow-up. With the support of the 5G network, equipment and surgical robots are integrated into the remote surgery service platform, building a high-speed transmission channel between Beijing Jishuitan Hospital and other hospitals.

Eligibility Criteria:
Inclusion Criteria:

* patients received remote robot-assisted spinal surgery or local orthopedic robot-assisted spinal surgery;
* patients had complete medical records and imaging data;
* patients provided informed consent.

Exclusion Criteria:

* revision surgery;
* more than four surgical segments;
* patients with severe comorbidities.
A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching

The aim of this study is to evaluate whether the targeted hemoglobin increment (2 grams per decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the control group, the prescribed number of red cell units will be transfused.

Hypothesis: By matching the hemoglobin dose to the individual needs of the patient the investigators will reduce the total usage of red cell concentrates.

This is a randomized clinical study on hemoglobin dose and patient matching. The aim of the study is to evaluate whether the targeted hemoglobin increment (2 grams per decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the control group, the prescribed number of red cell units will be transfused.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving red cell transfusions or expected to receive one or more red cell transfusions
* Patients over 16 years of age
* Patients for whom height and weight information is available
* Patients who have consented to participate

Exclusion Criteria:

* Patients who are hemodynamically unstable (ongoing bleeding or hemolysis)
* Patients with a known hemolytic anemia (congenital or acquired)
* Patients with a positive Direct Antiglobulin Test (DAT)
* Patients for whom informed consent has not been obtained
* Patients where the hemoglobin concentration increment target is above 2g/dl.
* Patients with auto- or alloantibodies against RBCs (red blood cells)..