cyrilzakka/clinical-trials huggingface dataset:
Cognitive Rehabilitation in Alzheimer's Disease

This study aims to proof the efficacy of a cognitive rehabilitation program for patients with mild dementia in Alzheimers Disease with respect to activities of daily living.

This prospective randomized, single blind intervention study aims to proof a cognitive rehabilitation program for patients with mild dementia in Alzheimers Disease (AD). The investigators modified a manualized and established German behavioural therapy program (KORDIAL) to use in a group context. The respective modules contain multimodal and multiprofessional approaches to improve capabilities relevant to activities of daily living (external memory support, compensation strategies, training of everyday competence, communication training). The intervention group receives this therapy for 12 weeks. Age and gender matched participants with AD serve as active control sample receiving a standardized cognitive training in the domesticity. The primary outcome are measurements of skills in activities of daily living prior the intervention as well as at the end of the intervention (after 3 months) and after 6 months (Follow up).

Eligibility Criteria:
Inclusion Criteria:

* mild dementia in Alzheimer's disease (NINCDS-ADRDA)
* Mini Mental State ≥ 17

Exclusion Criteria:

* severe psychiatric disorder
* severe brain disorder (epilepsy, tumor, stroke)
* contraindication for MRI examination
DPP Feasibility Study of Breastfeeding - eMOMS 2.0

The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application.

This study is a randomized controlled trial designed to determine the feasibility and efficacy of a combined breastfeeding, diabetes prevention-based program (DPP) in a cohort of overweight or obese women to be followed during pregnancy through 3 months postpartum. The trial will have two study arms: DPP + breastfeeding (Tx1) and Usual Care (Tx2).

Aim 1: Quantify interest in use of the DPP-lactation mobile health (mHealth) application among target population. To accomplish this, we will: (1) measure research engagement including rates of screening, recruitment, and retention among users, especially rural and racially/ethnically diverse women; (2) assess barriers/facilitators to enrollment/retention through surveys and semi-structured in-depth interviews or focus groups; and (3) evaluate intervention uptake, delivery, and adherence via tracking/measuring use of the mHealth app.

Aim 2: Measure weight loss and duration of lactation through 3 months postpartum among target population. To accomplish this, we will measure pre-pregnancy weight, weight at study entry, weight immediately prior to and after delivery, and weight at specific postpartum time points. Lactation and infant feeding practices will be measured at similar postpartum time points.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* In second trimester or early third trimester
* BMI \>/= 25 and \< 35
* At least 18 years old or older
* Able to read and understand English
* Able to learn and use a video platform

Exclusion Criteria:

* Complications related to pregnancy that require emergency care
* Thyroid disease
* Multiple gestation
* Substance abuse within last 3 years
* Assisted reproductive technology (ART)-related pregnancy
* Current smoker
* Prior bariatric surgery
* In weight-loss program within 3 months of conception
* BMI \>/= 35
* Unable to attend intervention/ follow-up visits
* Unwilling to self-monitor data collection
* Unable to complete intervention
* Presence of any condition that limits walking
* Presence of any condition that limits following diet recommendations
* Pregnancies complicated with fetuses diagnosed with lethal malformations/conditions
Fracture Recovery for Returning to Duty (Teriparatide STRONG)

The project goals are to improve combat readiness of U.S. Soldiers and sustain the availability of the military to deploy by, 1) decreasing the number of days not physically ready for duty after diagnosis of a diaphyseal tibial stress fracture, 2) decreasing the need for a physical profile or medical discharge board after bone stress injury, and 3) decreasing the recurrence rates of bone stress injuries.

The study will examine the utility of a novel, non-operative, anabolic bone agent in the treatment of diaphyseal tibial stress fractures (DTSF). Teriparatide has been well studied in basic science and clinical studies to conclude its positive effects on building bone mass and preventing fractures in post-menopausal women. This allowed the medication to gain it an FDA indication for treatment in these groups. The investigators seek to explore additional uses for this anabolic agent in an at risk study population that has an imbalance of bone stress and bone formation resulting in a bone stress injury (BSI).

The only prior study to examine the effect of teriparatide on fracture healing demonstrated an absolute difference in the time to heal a fracture in the treatment groups, but was under powered to detect a difference. Given these positive results members of the research team have used these findings to administer teriparatide at the 20mg dose to young adult NCAA collegiate athletes who have DTSFs and other BSIs. The promising preliminary clinical observations have led the investigators to hypothesize that teriparatide will have a positive effect on bone healing and return to duty among service members with DTSFs.

A powered, prospective, controlled randomized study design will be utilized. Study subjects are to be recruited from the basic training corps at Fort Jackson via convenience sample. Soldiers who experience pain in the mid-shaft of the tibia during basic training will be evaluated and diagnosed according to the standard of care. Based on direct discussions with physical therapists stationed at Fort Jackson this diagnosis is often made by using a combination of bone scan and plain radiographs. After diagnosis, soldiers with a DTSF present to the physical therapy department for treatment and guidance for their progression of activities.

Eligibility Criteria:
Inclusion Criteria:

* Soldiers actively enlisted in the U.S. Army attached to basic training unit at Fort Jackson
* Soldiers diagnosed with a tibial diaphyseal BSI requiring convalescent leave
* Skeletally mature
* Willing to self-administer study medication
* Desire to continue their military commitment

Exclusion Criteria:

* History of any form of cancer
* Currently pregnant
* Paget's disease of bone
* Unexplained elevations of alkaline phosphatase (elevations in alkaline phosphatase may signal undiagnosed Paget's disease of bone)
* Pediatric and young adult patients with open epiphyses
* Prior external beam or implant radiation therapy involving the skeleton
* Recent (within the last 6 months) urolithiasis (kidney stones)
* Elevated serum calcium, alkaline phosphatase or uric acid
* Orthostatic hypotension
A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds

The purpose of this study is to evaluate the effectiveness of a honey-impregnated wound dressing at removing necrotic tissue in subjects with chronic foot or ankle wounds.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age
* Subject has a qualified chronic foot or ankle wound, sized 1cm2 to 25 cm2 for ≥ 4 weeks in duration
* Must have necrotic tissue at least 25% of wound area
* The wound type matches one of the indicated wounds listed on the product labeling:
* Leg ulcers
* Pressure ulcers
* Diabetic foot ulcers
* First and second degree burns
* Surgical wounds
* Trauma wounds
* Subject has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, consistent with adequate blood flow, within 3 months prior to study enrollment. If monophasic on exam, the non-invasive tests must display Ankle Brachial Index over 0.8 and no worse than mild disease on segmental pressures.
* Subject is likely to be compliant with instructions for case, such as following institutional standard of care directions, offloading, and keeping the wound area protected from environmental contaminants
* Type I/II diabetic subjects that meet the following criteria:
* Random blood glucose is less than 450 mg/dL within 30 days of the screening visit

Exclusion Criteria:

* Subject has a known sensitivity or allergy to honey based products, bee venom, or other ingredients in product
* The subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation
* Wound duration ≥ 52 weeks
* The subject has a prognosis that indicated unlikely survival past the study period
* The subject is currently receiving dialysis
* Gangrene is present in the target wound
* Patient's wound is infected
* The subject's diagnosis indicates third degree burns
* The subject has received any treatment prior to study enrollment that may, in the opinion of an Investigator, affect the outcome of the study
* In the opinion of an Investigator, the subject is otherwise not suitable for study participation, such as the subject is likely to be non-compliant with study requirements
A Prospective Study of Fortiva in Hernia Repair

The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years.

This is a post market, prospective, multi-center study of up to 120 participants at approximately 10 clinical study sites. Safety and performance will be measured after hernia repair for two years.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age at time of consent
* Undergoing hernia surgery in which Fortiva Tissue Matrix will be used
* Have no contraindications to the test material (s)
* Able to provide informed consent
* Able to read, understand and complete study questionnaires
* Able and willing to return for scheduled study visits

Exclusion Criteria:

* \<18 years of age
* American Society of Anesthesiologists (ASA) physical class of 4,5 or 6
* Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
* Hernia repairs involving active infection
IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study

Study to collect post-market safety data for HUD IBV Valve System, a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or LVRS. An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1)continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.


Eligibility Criteria:
Inclusion Criteria:

* Subject has an air leak present on day 7 after lobectomy, segmentectomy, or lung volume reduction surgery (LVRS), or on day 5 if the air leak is 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise

Exclusion Criteria:

* Air leak only on force exhalation or cough
* Subject has significant active asthma, pneumonia, bacterial bronchitis or clinically significant bronchiectasis
* Subject is unable to provide informed consent and there is no designated authority to sign for the incapacitated patient
* Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures
* Subject has co-morbidities or factors that will prevent follow-up during the study period
The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance

The aim of this study is to evaluate the insulin-like growth factor (IGF) axis involvement in the immune tumor microenvironment in ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with epithelium ovarian cancer who have undergone surgery

Exclusion Criteria:

* Pregnant women
COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate

Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.

The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes including adverse events, scapular notching, and Constant Score.

All shoulders on which data will be collected are legally marketed and none of the devices are investigational or experimental. FDA has cleared this device via Premarket Notification 510(k) K080642. This data collection effort will document the clinical outcomes of the Comprehensive® Reverse shoulders. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Eligibility Criteria:
Inclusion Criteria:

Patients / cases to be included in this study shall utilize the following inclusion criteria:

1. Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse shoulder configuration.
2. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
3. Grossly deficient rotator cuff with severe arthropathy and/or

   1. Previously failed shoulder joint replacement with a grossly deficient rotator cuff.
   2. Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
   3. Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
   4. Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Exclusion Criteria:

* The exclusion criteria are the same as the indications stated in the cleared labeling for the device:

Absolute contraindications include infection, sepsis, and osteomyelitis.

Relative contraindications include:

1. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
2. Osteoporosis.
3. Metabolic disorders which may impair bone formation.
4. Osteomalacia.
5. Distant foci of infections which may spread to the implant site.
6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
The Femtosecond Laser in Residency Training (FLIRT) Pilot Study

This pilot study aims to primarily assess the rate of complication of anterior vitrectomy for patients undergoing femtosecond laser-assisted (FLA) cataract extraction and intraocular lens placement (CEIOL) compared to manual CEIOL, when performed by resident physicians under direct attending supervision. In this pilot study, the investigators aim to assess what the incidence of anterior vitrectomy is for each group, in order to better understand the sample size needed to assess whether there is a difference between these two groups. Secondarily, it will gather preliminary data on safety and refractive outcomes for patients undergoing these interventions.


Eligibility Criteria:
Inclusion Criteria:

* Patients of the Los Angeles County + University of Southern California Medical Center (LAC+USC) who are 40 years or older with visually significant cataracts asking for surgical intervention.
* Cataract must be visually and clinically significant on examination as determined by the resident surgeon and the attending physician.

Exclusion Criteria:

* Age less than 40
* Visual acuity 20/30 or better with refraction in the study eye
* Any previous ocular surgery
* Patient request for monovision or for correction at near at the expense of distance
* Patient and physician decision to use an IOL implant other than monofocal IOL
* Corneal pathology (e.g. Fuch's dystrophy, corneal opacity or scar, corneal ectasia)
* Posterior or anterior capsular plaque
* Posterior polar cataract
* White cataract
* Subluxated lens, weak zonules, or phacodonesis
* Pseudoexfoliation syndrome
* Failure of preoperative pupillary dilatation (\< 6 mm dilation)
* History of uveitis
* History of retinal detachment
* Untreated or active proliferative diabetic retinopathy
* Untreated or active diabetic macular edema
* Ocular diseases that may affect visual acuity or the operation (including and not limited to macular degeneration, retinitis pigmentosa, macular hole, advanced or end-stage glaucoma)
* Neurological or systemic diseases that may affect visual acuity or the safety of the operation
Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat

Submental fat (SMF) is a factor affecting beauty that makes people feel uncomfortable about themselves. In 2015, deoxycholic acid with the brand name KYBELLA® was approved by the American FDA for treatment of submental fat. The purpose of this study is to evaluate the safety and effectiveness of deoxycholic acid injection with the brand name Embella®, manufactured by Espad Pharmed Company, for treatment of this condition.

Research Objectives

Primary objective:

Effectiveness and safety of Embella® in reducing submental fat

Secondary objective:

Effectiveness assessment of Embella® in improving SMF grading Effectiveness assessment of Embella® in reducing submental fat diameter


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Individuals with unwanted submental fat of any severity.
* Ability to comply with visit schedules and study procedures.
* Signed informed consent form and agreement to a 3-month follow-up.

Exclusion Criteria:

* Any previous intervention for the treatment of submental fat (SMF).
* Specific anatomical features or previous damage to the intervention site (e.g., scars, liposuction, swallowing difficulties, enlarged thyroid or lymph nodes) that could interfere with the assessment of intervention outcomes.
* Evidence of submental enlargment due to reasons other than SMF.
* History of dysphagia.
* Body mass index (BMI) \> 30 kg/m².
* Individuals currently on a weight loss program.
* History of allergy to any components of the drug or local anesthetics.
* Presence of any inflammation, active infection, unhealed wounds, or skin lesions in the injection area.
* Use of any anticoagulants, NSAIDs, or any other medications that increase the risk of coagulation disorders within 7 days before injection.
* Unrealistic expectations.
* Pregnant or breastfeeding women.
* Individuals on sodium-restricted diets, such as those with uncontrolled hypertension.
The Tolerability , Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Adult Subjects

This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of HEC96719, in healthy subjects.This study is the healthy adult subjects single ascending-dose research

This study will evaluate the safety and tolerability of escalating single oral doses of HEC96719, and characterize the single-dose pharmacokinetics (PK) of HEC96719. Participants will receive either HEC96719 or HEC96719 placebo.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study.
* Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication.
* When signing the informed consent, 18 years old ≤the age≤45 years old(including the critical value), gender is not limited.
* Male body weight ≥50kg, female body weight ≥45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value).
* No clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results.

Exclusion Criteria:

* Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
* Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.
* Intemperant or regular drinkers within 3 months prior to the study, i.e., those who consumed more than 21 units of alcohol per week (1 unit =360mL beer or 45mL spirit with 40% alcohol or 150mL wine), or those who were positive on the alcohol breath test.
* Those who had a blood donation or blood loss of \>400mL within one month before taking the study drug.
* Those who have participated in clinical trials of other drugs within 3 months before randomization.
* Subjects considered by the investigator to have other factors unsuitable for participation in this study.
Allopurinol in Acute Coronary Syndrome

The pathogenesis of coronary heart disease is closely related to inflammation. IL-1 beta is an effective target for anti-inflammatory treatment of coronary heart disease. Allopurinol is a drug used for treating hyperuricemia and gout for many years. Recently, allopurinol has been proved to inhibit the production of NLRP3 in monocytes and reduce the level of IL-1beta, resulting in the decrease of TNF-alpha, IL-6 and CRP. Thus, in this study, the investigators aim to evaluate the efficacy and safety of allopurinol sustained-release capsules on improving the stability of coronary plaque in patients with acute coronary syndrome treated by conventional standardized therapy by the single-center, prospective, randomized, double-blind and controlled methods, which would provide new strategies for the treatment of coronary heart disease.


Eligibility Criteria:
Inclusion Criteria:

1. the people who understand and would sign the informed consent voluntarily;
2. Aged 18 to 80 years old;
3. hospitalized patients diagnosed as acute coronary syndrome in the past 1 months;

   1. hsCRP \> 2mg/L;
   2. allopurinol allergy gene HLA-B5801 was negative.

Exclusion Criteria:

1. history of coronary artery bypass grafting;
2. allergy to allopurinol or any excipient;
3. administration of allopurinol or other uric-acid-lowering drugs within 7 days before randomization;
4. abnormal liver function (ALT \>1.5 fold of the upper limit);
5. renal dysfunction (creatinine clearance rate \<45 ml/min);
6. thrombocytopenia (PLT\<100g/L);
7. gout patients;
8. uncontrolled infectious diseases in screening period;
9. Thyroid dysfunction, moderate to severe anemia (hemoglobin \< 90g/L), systemic lupus erythematosus, malignant hematopathy, leukopenia, asthma, inflammatory bowel disease and other immune diseases were found during the screening period;
10. Non-steroidal anti-inflammatory drugs, steroid hormone, immunomodulatory and chemotherapeutic drugs not included in the study protocol should be taken for a long time during the study period;
11. the history of surgery or interventional operation within 6 months before the screening period;
12. patients with mental disorders such as anxiety or depression;
13. pregnant women, lactating women or women of childbearing age who did not use effective contraceptive measures ;
14. patients who participated in other clinical trials 3 months before the screening period;
15. the researchers judged that patients were not suitable for this clinical trials.