cyrilzakka/clinical-trials huggingface dataset:
Use of High Cost Monitoring During Letrozole Ovulation Induction

The purpose of this study is to investigate monitoring methods during ovulation induction cycles with letrozole and their effect on pregnancy rates. Monitoring ovulation induction cycles with letrozole can be done with a variety of methods, the two most commonly utilized are home-based urinary LH kits (or ovulation predictor kits) and office-based midcycle follicular ultrasound. Letrozole coupled with follicular monitoring by ultrasound may add extra cost per cycle with no improvement in fecundability (pregnancy rates per cycle).

The study will be a randomized controlled trial of adult women with primary and secondary infertility seen at the University of Michigan Health System undergoing ovulation induction (OI) with letrozole as part of their standard clinical care. Patients who are undergoing OI with letrozole as per standard clinical care will be randomized to urinary luteinizing hormone (LH) ovulation predictor kit use versus mid-cycle ultrasound with administration of hCG when appropriate for timing of intercourse or intrauterine insemination. Patients who have been prescribed letrozole as per routine clinical care will be approached to determine willingness to participate in this study. Study period involves up to three ovulation induction cycles or until pregnancy occurs.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 21-39 undergoing letrozole ovulation induction (as part of routine clinical care) at a single academic-infertility center.
* Normal uterus and evidence of at least tubal patency on one side (as assessed by saline-infusion sonography or hysterosalpingogram per clinical care).

Exclusion Criteria:

* Current pregnancy
* Nursing mothers
* Prior hypersensitivity to hCG preparations
* Primary ovarian failure or menopausal levels of FSH (\>12 mIU/mL)
* Patients with abnormal uterine bleeding of undetermined origin or ovarian cyst of undetermined origin, sex-hormone dependent tumors, documented bilateral tubal obstruction, uncorrected uterine anomalies,
* Previous letrozole or gonadotropin use and/or previous treatment with in vitro fertilization
* Other uncorrected medical condition that would be a contraindication to attempting elective ovulation induction (e.g., uncontrolled diabetes, intracranial lesion, thyroid or adrenal disease).
Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects

To assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of lecozotan SR in healthy young and elderly subjects.


Eligibility Criteria:
Inclusion Criteria: -Young subjects: Men aged 18 to 45 years. -Elderly subjects: Men and women ≥ 65 years of age. -Body mass index in the range of 18 to 30 kg/m2 and body weight ≥ 50 kg. -Healthy as determined by the investigator.

Exclusion Criteria: -History of any neuropsychiatric disorder. -History of drug or alcohol abuse.
Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.

The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.

The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic HCV-infected, treatment-naive and treatment-experienced adolescent and pediatric individuals aged 3 to \< 18 as determined at Day 1.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Transcutaneous Direct Current Stimulation of the Spinal Cord for Treatment of Spasticity in Multiple Sclerosis

The current research is aimed at using Transcutaneous Spinal Direct Current Stimulation (tSDCS) as complementary therapeutic tool in the treatment of spasticity in multiple sclerosis. Patients will be randomized into two groups (tSDCS-anode vs. tSDCS-sham) according to the detailed protocol. Main outcome will be measured by the change in walking speed using the Timed 25-Foot Walk (T25FW).

A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes will assess functional improvement through Multiple Sclerosis Walking Scale (MSWS) Short Form - 36 (SF-36), Expanded Disability Status Scale (EDSS) and Ashworth scale.

Spasticity is experienced in around 80 % of patients with multiple sclerosis resulting in quality of life impairment. Transcranial direct current stimulation has been proven effective for the treatment of spasticity in patients with chronic stroke or cerebral palsy. The effect of transcutaneous spinal direct current stimulation (tSDCS) has been applied in spasticity but not in patients with spasticity due to multiple sclerosis. The study aims to assess the efficacy of anodal tSDCS on spasticity in multiple sclerosis patients through several assessment tools. The investigators hypothesize that anodal tSDCS will reduce spasticity in multiple sclerosis patients.

The study will be double blind sham-controlled crossover. The patients will be examined by the described assessment tools (T25FW, MSWS, SF-36, Ashworth, EDSS) before receiving tSDCS. The sessions of tSDCS will be applied 1 session per day in 5 consecutive days. Assessment using the scales and questionnaires will be performed at the end of the 5 days of stimulation, 1 week after the last day of first block of sessions and 2 weeks later. The group will be crossed and another block of 5 consecutive days of stimulation will follow. Assessment will take place again on first day and last day of the stimulations followed as well by assessment 1 week after the last day of second block of stimulation and 2 weeks after.

Eligibility Criteria:
Inclusion Criteria:

-Patients diagnosed with Multiple Sclerosis according to the 2010 Mc Donald criteria with spasticity in the lower extremities

Exclusion Criteria:

* Cardiac pacemakers
* Patients with prior exposure to tDCS
* Metallic hardware in the spine
* Eczema or skin abrasion at the intended site of stimulation
* Currently pregnant or plan for pregnancy in the next 6 months
* Heart or respiratory failure resulting in activity impairment
* Walking impairment due to orthopaedics condition such as deformity or recent fracture.
Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma

The purpose of this study is to evaluate the efficacy and safety of Flamboyant 125/12 association in adults with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants aged 18 years or more;
* Diagnosis of uncontrolled moderate asthma;
* Participants with Forced expiratory volume in 1 second (FEV1) \> 60% of predicted;

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 12 months prior to Screening Visit.
* Current smoking or smoking history equivalent to "10 pack years"
* Participants with untreated oral candidiasis;
* Pulmonary disease history (e.g., chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis, tuberculosis);
* Participants with a history of acute asthma exacerbation, respiratory tract infection or hospitalization for asthma in the last 4 weeks;
* Known HIV-positive status or active hepatitis B or C virus test result
* Participants with current evidence or history of uncontrolled coronary artery disease, congestive heart failure, myocardial infarction or cardiac arrhythmia;
* Participants with current medical history of cancer and/or cancer treatment in the last 5 years;
* Participants using medications that would have an effect on bronchospasm and / or lung function.
Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression

The aim of this study was to evaluate the effect of n-3pufas on cognitive function in patients with depression

Depression is often accompanied by cognitive impairment. At present, there is no effective drug to improve the cognitive impairment in patients with depression, and the social function and quality of life of patients are affected in varying degrees. N-3 polyunsaturated fatty acids (n-3pufas) are food products with high safety and few adverse reactions. Previous clinical trials have also suggested that n-3pufas may help to improve cognitive impairment in patients with depression, but the reported results are different. We have developed a new generation of n-3pufas optimal proportion combination products and found good cognitive improvement effect in animal models of depression. Therefore, this clinical research project will screen out the depressive patients with cognitive impairment through the cognitive function battery test (MCCB) tool for schizophrenia. On the basis of routine treatment of depression, these patients will be added with the cognitive improvement formula n-3pufas capsule developed by us to explore the effect of n-3pufas formula on cognitive impairment of depression.

Eligibility Criteria:
Inclusion Criteria:① the patients met the diagnostic criteria of dsm-5 major depressive disorder; ② aged 18-55 years; ③ Hamilton Depression Scale score of 24 items ≥ 20 points; YMRS score \< 6 points; ④ the score of wms-ii spatial span (assessment of working memory) in MCCB tool was less than or equal to its mean half standard deviation; ⑤ antidepressant types had not been adjusted in recent 2 weeks; 6) right handedness; 7) primary school had no change in the types of antidepressants The patients or their family members are willing to participate in the study and sign the informed consent.

Exclusion Criteria:① Merge with any other mental disorder; ② Patients with history of brain organic disease or traumatic brain injury and physical diseases; ③ abusers of drugs, alcohol or other psychoactive substances; ④ pregnant, lactating women and postpartum women; ⑤ refractory depression; ⑥ severe suicide risk (c-ssrs assessment); ⑦ MECT treatment in recent three months; ③ continuous use of diazepam drugs in recent three months; Ⅸ long-term use of npufas in recent three months; ⑩ Long term use of anti-inflammatory drugs in the past three months.
Non-Pharmacologic Patient Centered Pain Control Adjuncts During First Trimester Abortion

This study will examine the use of non-pharmacologic pain control techniques and pain-management counseling as an additional tool for reducing pain during first trimester aspiration abortion.


Eligibility Criteria:
Inclusion Criteria:

* English speaking, able to read and understand consent form
* Age 18 + (minors eligible with parental consent)
* Seeking in-office aspiration termination of pregnancy
* Gestational age less than 14 weeks

Exclusion Criteria:

* Not able to read or understand English
* Unable to understand consent
* Minors without parental consent
* Requesting narcotic or sedative analgesics
* Currently incarcerated
* Gestational age greater than 14 weeks
* Seeking medication abortion
Study of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Participants With Early/Metastatic Breast Cancer in Saudi Arabia

This is a retrospective, multicenter study, consisting of chart review of Saudi Arabian participants diagnosed with breast cancer between 2007 and 2013 and with available human epidermal growth factor receptor 2 (HER2) testing. Data on survival will be collected through 2015.


Eligibility Criteria:
Inclusion Criteria:

* Initially diagnosed with breast cancer
* Has a proven result of HER2 testing by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or any other in situ hybridization (ISH) method
* Alive or not alive

Exclusion Criteria:

- Inconclusive, equivocal or unavailable result of HER2/neu overexpression by IHC and FISH
Effects of Transcutaneous Acupoint Electrical Stimulation on Postoperative HRV and Hs-cTnT of Elderly With CHD

The aim of this study was to observe the effect of transcutaneous acupoint electrical stimulation (TAES) on postoperative heart rate variability and high-sensitive cardiac troponin T of elderly patients with coronary heart disease.

General anesthesia can inhibit sympathetic nerve activity and attenuate stress response, but it also inhibits vagus nerve activity. The decrease of vagus nerve activity can cause cardiovascular complications, especially ventricular arrhythmia in patients with coronary heart disease. Some study have shown that electrical stimulation of transcutaneous acupoints can regulate the function of autonomic nervous system and enhance the activity of vagus nerve so as to protect myocardial tissue. But the effect on autonomic nervous function and myocardial injury markers in elderly patients with coronary heart disease was not reported. Heart rate variability (HRV) is a noninvasive and reliable index reflecting cardiac autonomic nervous function. High-sensitive cardiac troponin hs-cTnT is the best myocardial injury marker.

The investigators plan to recruite 150 patients with coronary heart disease of both sexes, aged 65-80 yr, undergoing elective lumbar decompression and fusion internal fixation surgery. They will be randomly divided into 2 groups(n=75 each)using random number table : control group ( group C ) and TAES group (group T). Patients in group T receive TEAS (disperse-dense waves, frequency 4/20Hz) at the points of PC6 (Neiguan) and PC4 (Ximen) from 30 min before anesthesia induction to the end of surgery, the optimal intensity will be adjusted to maintain a slight twitching of the midfinger or ring finger (De-Qi response). Patients in group C receive electrode plate at the same acupoints without any electrical stimulation. Heart rate variability will be collected on 1 day before surgery, 1, 3 and 5d after surgery. 3mL of venous blood will be collected before the induction of anesthesia, 1, 3 and 5d after surgery, the serum will be isolated for the measurement of serum concentration of high-sensitive troponin T (hs-cTnT)、CK、CRP.

Eligibility Criteria:
Inclusion Criteria:

* Stable angina pectoris
* Slilent myocardial ischemia
* Remote myocardial infarction

Exclusion Criteria:

* Congenital heart disease
* Have a history of cardiac surgery
* Frequent ventricular / atrial premature beats, atrial fibrillation and other serious arrhythmia
* Heart conduction diseases
* Antiarrhythmic drugs used
* Temporary and permanent pacemaker used
* Intraoperative blood loss\>800ml
Impact of Metal Density on Deformity Correction for Adolescent Idiopathic Scoliosis

A retrospective analysis to ascertain the correlation between metal density and deformity correction among individuals with adolescent idiopathic scoliosis.

Posterior spinal fusion with pedicle screws has become the "gold standard" for the management of adolescent idiopathic scoliosis (AIS). Pedicle screws provide three column fixation through the strongest part of vertebra thereby enhancing surgeon's ability to do a 3-dimensional deformity correction. The higher pullout strength results in less long-term loss of correction, shorter fusions resulting in preservation of motion segments, lower pseudarthrosis rates and lower implant failures compared with these alternative posterior instrumentation systems. However, studies are contradictoryregarding the effect of metal density on coronaland sagittal curve corrections. Multiple factors including curve flexibility, instrumentation and rod types, reduction strategies and curve types, affect outcomes. Given this, intraoperative decisions regarding the number of anchorage points remain difficult, with considerable inter-surgeon variability.

The rationale for using a high implant density constructs is to obtain more rigid fixation and to limit potential stress concentration at any one screw. Furthermore, health-related quality of life instruments such as the SRS 22, 24, or 30 seem to show little correlation with curve correction. The placement of every additional pedicle screw is associated with increased operative time, risk of neurological deterioration and increased implant cost. If implant density can be lowered without compromising clinical results, reducing the number of screws may improve the efficiency and cost effectiveness of scoliosis surgery. Several authors have demonstrated successful results with low-density instrumentation for the treatment of scoliosis. The purpose of this retrospective review is to describe the demographics of our patient population and to ascertain correlation between metal density and correction achieved.

Eligibility Criteria:
Inclusion Criteria:

* Patients with adolescent idiopathic scoliosis
* Age more than 10 years at time of surgery
* Posterior instrumentation consisting of all pedicle screw construct except for bilateral hooks at the uppermost instrumented vertebra
* A major curve magnitude between 45 and 80 degrees.

Exclusion Criteria:

* Scoliosis patients with a diagnosis other than adolescent idiopathic scoliosis
* Previous spine surgery
* Use of spinal osteotomies in addition to posterior spinal fusion with pedicle screws
* ALenke 5 curve
* Patients with less than 2 years' follow-up
* Use of hooks or wires below the uppermost instrumented level
Laser Assisted ICSI; Has it Role Whatsoever?

laser-assisted ICSI (LA-ICSI) was described to be a new method combining a less invasive ICSI technique with assisted hatching.This procedure is usually used for MII oocytes possessing oolemma breakage difficulties, but why not using it for even normal Oocytes?!. Especially because data indicated that in addition to an improved oocyte survival, this new approach increases the hatching rate in vitro. But since it is still debatable that such a small opening might impair the hatching process, so modified zona thinning technique was proposed for more embryo safety.

This study aims to compare the LA- ICSI by drilling a micro hole (LAD-ICSI) and modified LA-ICSI by zona pellucida thinning (LAT-ICSI) with conventional ICSI in order to effectively assess whether this approach can be applied routinely to improve ICSI outcome.

One arm study divided into three interventions; Conventional ICSI (control group) was compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes.

The rates of maturation, fertilization, Devision, Blastulation and good quality blastulation rates were assessed in the three groups

Cases were randomly selected for embryo transfer from the three groups,Then chemical pregnancy and clinical pregnancy rates were compared between the three groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 20 years old to 37 years old
* good res-ponders
* gives more than 15 oocytes
* endometrial thickness more than 9 mm

Exclusion Criteria:

* poor res-ponders
* severe oligoasthinozoospermia of male partners
* testicular samples
* Poor quality oocytes
Detection of Visual-Auditory Reaction Rates in Individuals With Type 2 Diabetes

Background: The primary purpose of our study was to understand the damage in the peripheral nerves of patients with diabetes and to determine the change in patients' reaction rates and perceptions by the age groups, duration of diabetes, fasting plasma glucose and HbA1c values, and compare these with those of the healthy individuals.

Methods: This study was carried out at the Baskent University Hospital Endocrinology and Metabolic Diseases Outpatient Clinic. A total of 64 patients diagnosed with type 2 diabetes and 64 healthy controls were included in the study. Finger tapping, visual, and auditory reaction time tests were performed on the subjects, respectively. The subjects' fasting plasma glucose and HbA1c levels, and the duration of their diabetes were recorded. Analyses were performed using the SPSS version 25. Differences were considered statistically significant when the p-value is \<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed individuals
* Must be between 18-65 ages
* Must be Type 2 diabetics at least 6 months (for patient group)

Exclusion Criteria:

* use of alcohol-drug or similar substances,
* the use of any medication that may affect neurological functions,
* having color blindness,
* retinopathy,
* neurological disease,
* cancer,
* depression,
* a recent history of surgery,
* rheumatoid arthritis,
* osteoarthritis,
* and advanced osteoarthritis.
First-void Urine Samples for the Follow-up of Women Treated for High-grade Cervical Intraepithelial Neoplasia (CIN)

The aim of this study is to analyse biomarkers in first-void urine for improved follow-up of women treated for high grade cervical intraepithelial neoplasia (CIN).

In total 100 women, diagnosed with CIN2/3 and scheduled for LLETZ (Large Loop Excision of the Transformation Zone), will be included in this trial. These women are asked to collect two FV urine samples with the Colli-Pee device (Novosanis, Wijnegem, Belgium) prior to their treatment (one at home and one at the hospital) and at five additional time points post treatment (1-3-6-12-24 months) at home. In addition, five self-collected vaginal swabs will be taken, two before treatment (1 at home and 1 at the hospital) and three (6-12-24 months) after treatment at home. Qvintip devices are used for vaginal self-sampling.

During follow-up visits cervical samples and optional biopsies are collected by the physician and respectively send to the UZA anatomic pathology unit to determine the patient's HPV status, cytology and histology. For the study, one extra cervical sample will be taken by the physician just before treatment, that is not part of the normal standard procedure.

Eligibility Criteria:
Inclusion Criteria:

* Female (18 years and older)
* Scheduled for LLETZ treatment of diagnosed, histologically confirmed high grade CIN lesions
* Giving informed consent to the research team (CEV) to contact his/her GP and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy.
* Not participating in another clinical study where a drug or biological is administered.
* Able to understand the information brochure/what the study is about.