cyrilzakka/clinical-trials huggingface dataset:
Establishment of Social Skills Training Group in Adults With Autism Spectrum Disorder and Effectiveness Analysis

This project aims to examine the effectiveness of social skill training group in adults with autism spectrum disorders.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 45 years
* having relational problems
* having motivation to participate
* good chinese speaking
* having a healthy cargiver join together
* IQ \> 70 (WAIS)
* Autism Spectrum Quotient \> 26

Exclusion Criteria:

* ever had psychosis and neurological diseases
* visual and hiring impairment
Aspirin and Clopidogrel Reactivity in Patients With Critical Limb Ischemia (CLI)

Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a major cause of death and disability (secondary to myocardial infarction, stroke and amputation). The mortality in patients with CLI approaches 25% and 50% at one and five years respectively. High on-treatment platelet reactivity (HPR) in patients treated with aspirin and clopidogrel (previously referred to as "resistance") is associated with an increased risk of recurrent cardiovascular events after percutaneous coronary interventions and acute coronary syndromes. The prevalence and significance of High on-treatment Platelet Reactivity (HPR) in patients with critical limb ischemia treated with aspirin and/or clopidogrel is not known.

The investigators project aims to investigate the prevalence of HPR (to aspirin and clopidogrel) in one hundred patients with diagnosis of critical limb ischemia encountered at University of Southern California (USC) affiliated hospitals (Los Angeles County Hospital and Keck Hospital of University of Southern California).

This prospective clinical study will investigate the prevalence of high on- treatment platelet reactivity (HPR) in one hundred patients with critical limb ischemia (CLI), at the Keck Hospital of USC and Los Angeles County Medical Center (LAC+USC). Platelet inhibition to aspirin will be evaluated with the VerifyNow® aspirin (ASA) test. Clopidogrel platelet inhibition will be evaluated with two different tests: the vasodilator-stimulated phosphoprotein (VASP) and the VerifyNow® purigenic receptor P2Y12 (VN-P2Y12) assays. All platelet function analyses will be performed once after a minimum of one week of uninterrupted dual antiplatelet therapy with aspirin and clopidogrel. High on-treatment Platelet Reactivity on aspirin treatment (HPRA) group will be defined as aspirin reaction units (ARU) ≥550 by the VerifyNow® ASA assay. High on-treatment Platelet Reactivity on clopidogrel (HPRC) group will be defined as P2Y12 reaction units (PRU) ≥208 by the VerifyNow® assay and Vasodilator-stimulated phosphoprotein-platelet reactivity index (VASP-PRI) ≥50% by the vasodilator-stimulated phosphoprotein (VASP) assay. All other patients will be assigned to the adequate platelet reactivity on therapy (APR) group. Prevalence of high on-treatment platelet reactivity will then be calculated for aspirin and/or clopidogrel

Eligibility Criteria:
Inclusion Criteria:

* EXPERIMENTAL GROUP: Patients with a diagnosis of critical limb ischemia (CLI) and uninterrupted treatment with aspirin and/or clopidogrel for at least one week before testing.
* CONTROL GROUP: 10 normal volunteers without any known co-morbidities

Exclusion Criteria:

* Chronic use of nonsteroidal anti-inflammatory drugs, thrombocytopenia (platelet count \<100 × 103/μl), use of an oral anticoagulant (warfarin), glycoprotein (GP) IIb/IIIa inhibitors, or fibrinolytic drugs within 30 days before testing. Any documented history of hypercoaguable states or history of medication non-compliance.
A Prospective Study to Collect High-Quality Documentation of Bleeds, Health-Related Quality of Life (HRQoL), and Safety Outcomes in Patients With Hemophilia A Treated With Standard-of-Care Treatment

This non-interventional study will prospectively collect detailed, high-quality documentation of bleeds, HRQoL, and safety in patients with hemophilia A with or without FVIII inhibitors treated according to local routine clinical practice (receiving FVIII replacement or bypassing agents as either episodic or prophylactic treatment). Actual patients will be enrolled from routine clinical practice in this observational study.


Eligibility Criteria:
Inclusion Criteria:

* Cohort A: Patients greater than or equal to (\>/=) 12 years of age at time of informed consent
* Cohort A: Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (that is, \>/= 5 Bethesda units \[BU\])
* Cohort B: Pediatric patients less than (\<) 12 years of age
* Cohort B: Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (that is, \>/=5 BU)
* Cohort C: Patients \>/=12 years of age
* Cohort C: Diagnosis of congenital hemophilia A and FVIII activity \<1 percent (%)
* Cohort C: No prior history of a positive inhibitor against FVIII

Exclusion Criteria:

* Prior RO5534262 (not applicable if patient agrees that prior RO5534262 will preclude participation in a future investigational RO5534262 study)
* Bleeding disorder other than congenital hemophilia A
* Ongoing (or planned during the study) immune tolerance induction therapy with FVIII or FVIII prophylaxis if currently/previously exposed to an inhibitor
* Previous or concomitant thromboembolic disease
* Known human immunodeficiency virus (HIV) infection with cluster of differentiation (CD) 4 count \<200 cells per microliter (cells/mcL)
IVF Versus LOD in Women With CC Resistant PCOS

The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).

Women will be randomly divided into two groups; IVF group and LOD group. Women in the IVF group will undergo one full IVF cycle. Women in the LOD group will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women with PCOS as defined by the Rotterdam criteria.
* CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion Criteria:

* Age \< 20 or \> 35 years.
* Presence of any infertility factor other than anovulatory PCOS.
* Previous history of ovarian surgery or surgical removal of one ovary.
* Previous exposure to cytotoxic drugs or pelvic irradiation.
* Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
* Metabolic or hormonal abnormalities.
Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations

In humans, surface electrophysiological recordings of the cochlear nerve in response to a sound stimulus provide information about the cochlear's ability to encode sound. Depending on the stimulus, the fine structure and temporal envelope of the signal will vary, allowing us to determine its characteristics. By phenotyping patients before surgery using subjective and objective audiometric tests, it will be possible to isolate for each patient the moment when the fine structure disappears and when the temporal envelope is effective.

During functional cerebellopontine angle surgery, a spherical electrode is placed on the human cochlear nerve to monitor hearing. Once the electrode is in place, clicks and speech signals with and without noise are delivered to analyze the cochlear electrophysiological signal produced. Depending on the characteristics recorded, this signal can be used to determine how fine structure and temporal envelope are encoded by the cochlea. Prior to surgery, each patient is evaluated by an audiologist to determine quiet and noise thresholds, tone and speech, electrocochleography, distortion testing, tympanometry, ABR and psychoacoustic testing.

Eligibility Criteria:
Inclusion criteria:

* The following will be included as hearing-impaired patients:

  * Male or female
  * Over 18 and up to 80 years of age
  * Normal otoscopic examination
  * Scheduled for surgery on the cerebellopontine angle (microvascular decompression)
  * With sensorineural hearing loss defined by average hearing thresholds between 21 dB HL and 40 dB HL at 0.5, 1, 2 and 4 kHz
  * Affiliated to a social security scheme
  * Having read the information note describing the study and having agreed in writing to participate by signing the informed consent form
* Will be included as normal-hearing patients:

  * Male or female
  * Over 18 and up to 80 years of age
  * Normal otoscopic examination
  * Scheduled for surgery on the cerebellopontine angle (microvascular decompression)
  * Free of sensorineural hearing loss, defined by average hearing thresholds of less than or equal to 20 dB HL in tonal air conduction audiometry, bilaterally on the side of the ear undergoing surgery and on the side not undergoing surgery, at 0.5, 1, 2 and 4 kHz
  * Affiliated to a social security scheme
  * Having read the information note describing the study and having agreed in writing to participate by signing the informed consent form

Exclusion criteria: patients will be excluded from the study if the auditory nerve is not accessible during surgery:

* Notably because of complete tumor invasion of the cochlear nerve (stage III and IV neuroma, advanced meningioma) ;
* Or because of a particular anatomical feature not identified during the preoperative examination, making its exposure for recordings impossible (protrusion of the posterior face of the rock).
Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)

The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women (\<5y since final menstrual period) with age between 50-60y
* Symptomatic (hot flashes, vaginal dryness) or asymptomatic
* BMI 26-45 kg/m2 (Overweight, Obesity I and Obesity II)
* Fasting glucose \<125mg/dl
* Triglycerides \<200mg/dl
* Normal mammogram within past 12 months
* Physician clearance

Exclusion Criteria:

* Amenorrhea from other causes (Hyperandrogenemia and anovulation)
* type 2 and type 1 diabetes
* Medications: diabetes or diabetic drugs, dyslipidemia, estrogen/progestin therapy, antidepressants and antipsychotics, antiretroviral (HIV), oral steroids, weight loss drugs
* ≤ 3 month washout of birth control pill (often prescribed for postmenopausal symptoms)
* Hysterectomy (partial or complete)
* Contraindications to estrogen treatment (unusual vaginal bleeding, blot clots, hepatic disease, bleeding disorder, past/present history of breast or uterine cancer, pregnant, breastfeeding)
Polarized Light Therapy in Patients With CREST Syndrome.

to evaluate the efficacy of the Polarized light therapy and Hand Grip Strengthening exercises in patients with CREST syndrome

Measurement of the skin thickness via the modified Rodnon skin score (RSS) and Hand Grip Dynamometer (HGD) . Methods:- Sixty patients, who had hand involvement of patients with CREST syndrome, were participated in the study. Their ages were ranged from 16 to 45 years. The participants were selected from the dermatology departments of Cairo university hospitals and Om El-Misrieen hospital, randomly distributed into three equal groups. Group A: (Study group): This group included 20 patients who had CREST syndrome with scleroderma in the dorsum of hands and who received the BLT with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months),time of session is 15 minutes. Group B: This group included 20 patients who have CREST syndrome with scleroderma in the dorsum of hands and who received resisted exercise with traditional physical therapy program (stretching, strengthening and active exercise) patients received 3 sessions per week for 12 weeks (3 months), time of session is 15 minutes and Group C:This group included 20 patients who had CREST syndrome with scleroderma in the dorsum of hands and who received combination of (BLT and resisted exercise) with traditional physical therapy program (stretching, strengthening and active exercise) exercise program (stretching, strengthening and active exercise).patients received 3 sessions per week for 12weeks (3 months), time of session was 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* The patients' ages ranged from 16 to 21 years.
* Patients who had hand involvement of patients with CREST syndrome particularly dorsum of the hand.
* All patients were conscious.
* All patients were randomly chosen (male and female).

Exclusion Criteria:

* Patients who are diabetic or hypertensive.
* Patients those familiar with the BLT and resisted exercise via the hand grip strengthener.
* Patients with hemorrhage specially hemorrhage of digestive system and those with bleeding per rectum.
* Patients with severe fungal diseases and acute viral diseases.
* Patients with active tuberculosis and tumors as well as those with peacemakers.
* Patients with polyneuropathy.
* Patients with thyroid problems
A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration

This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration


Eligibility Criteria:
Inclusion Criteria:

* 50 years or older with "wet" AMD as determined by an ophthalmologist
* decrease in visual acuity (20/40 to 20/640) in at least one eye

Exclusion Criteria:

* Uncontrolled systemic disease
* History of heart attack or stroke within one year of study entry
* Symptomatic coronary artery disease
* Cataracts that interfere with vision
Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng

This trial will assess the potential impact of a vaginal ring on condom use by comparing the performance (total clinical failure, clinical slippage, and clinical breakage) of a standard male lubricated latex condom when the female partner is wearing the vaginal ring and when the female partner is not wearing the vaginal ring.


Eligibility Criteria:
Inclusion Criteria:

1. Mutually monogamous heterosexual couples; current relationship ≥3 months; and who can give written informed consent;
2. Age ≥18 to ≤45 years (females) or ≥18 to ≤55 years (males) at time of the screening visit;
3. Healthy on the basis of medical history;
4. Not at risk of pregnancy, i.e., female is surgically sterile, using an IUD, or using effective hormonal contraception, or has a vasectomized partner. The use of vaginal contraceptive rings will not be allowed;
5. Sexually active and agree to have at least 8 acts of penile-vaginal intercourse using a study condom over 2 periods of up to 4 weeks each;
6. Agree to use only the condoms provided by trial personnel during the time of participation. Additional lubricant will be provided; use of non-study lubricants will not be allowed;
7. Agree to not use other vaginal products, except menstrual absorption products (e.g. tampons) and study lubricant during the trial;
8. Available for all visits and consent to follow all procedures scheduled for the trial;
9. At low risk for HIV infection.

Exclusion Criteria:

1. Males with untreated erectile dysfunction;
2. Female with positive pregnancy test;
3. Either partner allergic to natural latex or vaginal lubricants such as Astroglide ®;
4. History by self-report of recurrent or a recently-treated (within past 2 weeks) sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia) or HIV(+);
5. Currently using condoms for protection against sexually transmitted infection;
6. Either partner taking any topical or oral medication to treat a urogenital condition at enrollment, except medication for the male partner to treat erectile dysfunction (e.g., tadalafil, sildenafil);
7. Either partner with a self-reported or clinically diagnosed urogenital condition (e.g. itching, burning, irritation, etc.) that, in the opinion of the Investigator, could affect use of the study condoms or ability to interpret trial data;
8. Females, based on findings from a pelvic examination, who are not suitable candidates for wearing the vaginal ring (anatomical condition, current vaginal infection, etc.);
9. Current participation in a study or other research involving a drug, device or other product;
10. Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
Randomized, Controlled, Single-blind Exploratory Study of the Efficacy and Safety of Wrist and Ankle Acupuncture Intervention on Nausea, Vomiting and Pain After Sleeve Gastric Surgery in Women

PONV is the most common clinical presentation after surgical procedures beyond pain. A retrospective study of our center found that the postoperative incidence of LSG was 77.4%. PONV can not only cause postoperative discomfort, but also cause serious complications such as disturbance water and electrolyte balance, wound splitting, incisional hernia, and even residual gastric leakage and aspiration pneumonia, resulting in prolonged hospital stay and increased medical costs. Wrist and ankle acupuncture is a special kind of acupuncture therapy. Through subcutaneous stimulation, the electrical signal is fed back along the nerve fiber into the cerebral cortex, without dialectical treatment, and only needs the appropriate symptoms and signs of the patient. Although only in the wrist and ankle, it can solve a series of problems in the whole body, especially nausea, vomiting and pain symptoms.

Patients scheduled for female sleeve gastric surgery were selected, and the trial was designed into the control group (n=33) and the intervention group (33). The intervention group was based on the control group, combined with the intervention of the wrist and ankle acupuncture, namely, the wrist and ankle acupuncture treatment was started 1 day before the surgery. Take up and down 1,2 area as a needle point, use hua tuo brand sterile acupuncture needle (specification: 0.25mm 25mm), into the skin disinfection into the needle, keep 30 subcutaneous needle and skin, when the operator under the needle, patients without acid swelling, pain, close to the skin dermis, to about 1.5 inches, give tape fixed 24h, left under the skin, until postoperative 3 day.

Eligibility Criteria:
Inclusion Criteria:

* In accordance with the Guidelines for Surgical Treatment of Obesity and Type 2 Diabetes in China (2019 edition);
* ASA grades II-III; Age: 18-65 years old;
* Denial of smoking history;
* Denied any history of motion sickness or PONV;
* Female patients proposed to undergo laparoscopic sleeve gastrectomy under elective general anesthesia;
* Voluntary attended and signed informed consent.

Exclusion Criteria:

* With known drug allergies related to this study;
* Severe heart, respiratory, renal or liver diseases, and coagulation disorders;
* Psychiatric or neurological disorders;
* difficulties in communication;
* Premedication or premedical conditions limits target assessment, including use of antiemetics, opioids or corticosteroids (excluding anesthetic medication);
* Gastroesophageal reflux (GRED), clinically assessed as severe GRED or preoperative gastroscopy indicating grade B of oesophagitis or above;
* Patients undergoing combined cholecystectomy and gynecological surgery during the operation.
Intravenous Versus Subcutaneous Amifostine in Prevention of Xerostomia After RT for Head and Neck Carcinomas

Prospective randomized study in order to compare intravenous versus subcutaneous administration of amifostine in patients receiving radiotherapy for head and neck cancer. Salivary flow will be evaluated during few years after the treatment by a clinical evaluation, the measure of the weight of saliva and a patient benefit questionnaire cotation.

Prospective randomized study in order to compare intravenous (IV) versus subcutaneous (SC) administration of amifostine in patients receiving radiotherapy for head and neck cancer. IV administration of amifostine is 200 mg/m2/day in a short 3-min infusion 15 to 30 min before each fraction of radiotherapy. SC administration is 500mg/day in two slow 1.25 ml injections at two different sites 20 to 60 min before each radiotherapy fraction. Procedure requires antiemetic treatment and blood pressure monitoring in both arms.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed squamous cell head and neck cancer
* inclusion of at least 75% of both parotid glands within radiation fields that would receive at least 40 Gy
* Neutrophils ≥ 2000 / mm, Platelets ≥ 100,000 / mm3, Creatinine \< 130 / mmol.L-1, Transaminase ≤ 3 x upper limit

Exclusion Criteria:

* Distant metastases
* Prophylactic use of pilocarpine
* Concomitant chemotherapy