cyrilzakka/clinical-trials huggingface dataset:
Determination of the Incidence of Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome, or the Incidence of Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis

The study was designed as a multicenter, prospective cross-sectional cohort study. The research population will consist of patients under the age of 40, diagnosed with endometriosis and/or adenomyosis and polycystic ovary syndrome, who applied to the obstetrics and gynecology outpatient clinics in 13 centers. According to the results of the sample size analysis, it was planned to terminate the study when 1225 patients with polycystic ovary syndrome and 1225 patients with endometriosis and/or adenomyosis were recruited.

For the diagnosis of polycystic ovary syndrome, Rotterdam Criteria will be used. Hyperandrogenism will be determined clinically by Ferriman-Gallwey scoring, and biochemically by serum total testosterone and sex hormone initiating globulin (SHBG). 21-24 and 28-31 of menstruation in patients with ovulatory dysfunction, oligomenorrhea (cycles lasting longer than 38 days). It will be determined by measuring the serum progesterone level between days Polycystic ovarian morphology will be determined by transvaginal ultrasonography (8 mHz probe) by calculating the number of antral follicles and ovarian volume. Serum Anti Mullerian Hormone (AMH) will be requested from patients being investigated for polycystic ovary syndrome.

In order to exclude other conditions during the investigation in patients with suspected polycystic ovary syndrome, serum thyroid stimulating hormone (TSH), prolactin (PRL) and 17-hydroxyprogesterone (17-OHP) levels will be checked in the first 7 days of menstruation.

The diagnosis of endometriosis will be made by the presence of ovarian endometrioma and/or a deep infiltrating endometriosis nodule determined by transvaginal ultrasonography or by palpation of the endometriotic nodule on pelvic examination or surgical confirmation.

The diagnosis of adenomyosis will be made by transvaginal ultrasonography or surgical confirmation.

For polycystic ovary syndrome in patients diagnosed with endometriosis and/or adenomyosis; For endometriosis and/or adenomyosis in patients diagnosed with polycystic ovary syndrome, the above-described diagnostic investigations will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with endometriosis by ultrasound or surgery(after diagnosed)
* Being a newly diagnosed endometriosis patient
* Not using any hormones or additional drugs
* Not having undergone ovarian surgery
* Patients diagnosed with PCOS according to the Rotterdam diagnostic criteria

Exclusion Criteria:

* Previously diagnosed with endometriosis, medically or surgically patients receiving treatment
* Patients who have undergone ovarian surgery
An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea

the study will measure the decrease in redness on the face of rosacea subjects


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant, non-lactating female, 18 years of age or older.
2. Signed informed consent form that meets all criteria of current Food and Drug Administration regulations.
3. Females of childbearing potential must not be pregnant or lactating.
4. Females of childbearing potential must agree to the use of a reliable method of contraception throughout the study.
5. Have clinical diagnosis of rosacea with persistent (non-transient) facial erythema.
6. Have \< 3 inflammatory lesions on the face.
7. Have an erythema score of 3 (moderate) or 4 (severe) for both the CEA and the PSA that is reflective of the overall targeted areas.
8. Willing to minimize external factors that might trigger rosacea flare-ups (e.g., spicy foods, hot drinks, hot environments, prolonged sun exposure, strong winds, emotional stress and alcoholic beverages) during the study.

Exclusion Criteria:

1. Forms of rosacea that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of study endpoints
2. Patient has a skin condition that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of rosacea
3. Patients with active sunburn or excessive facial hair such as beards, sideburns, moustaches, etc.
4. Patients with moderate to severe telangiectasial masses
5. History of blood dyscrasia.
6. Significant history or current evidence of any uncontrolled chronic or serious disease or medical condition that would, in the judgment of the Investigator, would put the subject at undue risk or compromise the study assessments.
7. History or current evidence of Raynaud's syndrome, severe, unstable or uncontrolled cardiovascular disease, orthostatic hypotension, uncontrolled hypertension or hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, renal or hepatic or renal impairment, scleroderma, Sjögren's syndrome, depression, or narrow-angle glaucoma to an extent that, in the opinion of the Investigator, would place the subject at undue risk.
8. Female patients taking hormonal contraceptives or oral estrogen for less than one month or those that plan to change the dosage regimen during the course of the study.
9. Previous participation in this study.
10. Employees of the Investigator or research center or their immediate family members.
11. Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
Dose Response Study in Japanese Patients

This is a 12-week study to determine the effect on glucose and lipids, safety, and tolerability of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) compared with placebo in patients with type 2 diabetes. Improvement in dyslipidemia will be evaluated. The study comprises a 2-week screening period, 4-week placebo run-in, a 12-week randomized, double blind, parallel group, multi-center, placebo-controlled treatment period, and a 3-week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are \>=18 years of age
* Female patients: postmenopausal, hysterectomized
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral anti-diabetic agents

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants

The purpose of this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a body mass index of 18.0 to 32.0 kg/m2, inclusive.
* Participants will be required to always use a latex or other synthetic condom with spermicide during any sexual activity
* Participants must refrain from donating sperm during the entire study and for at least 90 days from dose of study drug.

Exclusion Criteria:

* Participant must not have had any clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months prior to admission to the clinic.
* Participant must not be currently employed in a job requiring radiation exposure monitoring.
* Participant must not have had any major surgery within 4 weeks of study drug administration that could impact upon the absorption of study drug
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B

This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia B.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects, younger than 12 years old.
* Severe hemophilia B (Factor IX \[FIX\] activity of ≤ 2%).
* Body weight ≥ 10 kg.
* Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for \> 150 exposure days (EDs) (6 to \< 12 years), and \> 50 EDs (\< 6 years).
* No history of FIX inhibitor formation, no detectable inhibitors at Screening and no family history of inhibitors against FIX.
* Written informed consent for study participation.

Exclusion Criteria:

* Known hypersensitivity to any FIX product or hamster protein.
* Known congenital or acquired coagulation disorder other than congenital FIX deficiency.
* Kidney or liver disease.
* Recent life-threatening bleeding episode.
"Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches"

The goal of this controlled clinical trial is to compare the effects of two distalization methods supported by inter-radicular mini-screw for maxillary molars distalization in 20 adult patients with skeletal class I or moderate skeletal class II malocclusion, dental class II molar relationship, and full permanent dentition. The participants were randomly selected according to inclusion / exclusion criteria from the outpatient clinic of the Department of Orthodontics and Dentofacial Orthopedics, Faculty of dentistry, Ain Shams University, Cairo, Egypt. Selectees age was ranging from 18 to 25 years old.

An informed consent has been signed by each patient before his / her enrollment in this study, where the aim , methodology, and possible complications were been clearly described in details. This research has been thoroughly reviewed by the Research Ethics Committee of the Faculty of dentistry, Ain Shams University.

This study is a two-arm, parallel group, prospective randomized clinical trial with the allocation ratio of 1:1. The Consolidated Standards of Reporting Trials (CONSORT statement) were used as a guide for this study.

After reviewing the study protocol, the ethical committee at the Faculty of Dentistry, Ain-Shams University approved the study.

Before treatment was carried out, a detailed written Arabic consent was signed by all the subjects of both groups after full explanation of the aim of the study and the procedures.

This prospective clinical study was conducted on a total of 24 maxillary first molars.

No financial competing interests: This study was part of a Masters' degree in Orthodontics, Faculty of Dentistry, Ain-Shams University.

No financial conflicts of interest were declared. The study was self- funded by the principal investigator.

A sample size of 24 distalizing sites was selected and divided into two groups twelve each:

Group 1: Single coil spring. Group 2: Double coil spring.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects are free from any dental anomalies as well as periodontal and systemic diseases that may influence orthodontic treatment.
2. Adult patients with age ranging from 18 to 25 years.
3. Full permanent dentition with exclusion of third molars.
4. Both first and second maxillary molars are in occlusion.
5. Skeletal class I, mild or moderate skeletal class II malocclusion.
6. Full cusp or end to end class II molar relationship.
7. Mild to moderate crowding in the upper dental arch and / or increased overjet.
8. Normal or horizontal growth pattern.
9. Non-extraction treatment plan.

Exclusion Criteria:

1. Previous orthodontic treatment.
2. Treatment planning requiring orthognathic surgery.
3. Severe molar rotation.
4. Poor oral hygiene.
MCAT Versus VISTA With Volume Stable Collagen Matrix in RT3 Gingival Recession

This study aims to compare MCAT technique (supraperiosteal approach with coronal advancement of flap) with VISTA technique(subperiosteal approach with coronal advancement of flap), Further, it may be hypothesized that supraperiosteal placement of graft material (in MCAT technique) may be better due to better blood supply, and MCAT technique utilizes a microsurgical concept, including microsurgical blades and suture material, which improves wound healing and establishes a better esthetic result and results in better outcome in terms of root coverage percentage compared to VISTA. Therefore, this study aims to compare minimally invasive technique MCAT and VISTA using VCMX as a graft in RT3 gingival recession in anterior teeth.

Gingival recession is the migration of the gingiva to a point apical to the cement-enamel junction and is considered one of the most common periodontal problems.Besides aesthetic complaints, GR may also cause root hypersensitivity, risk for development of caries or non-carious cervical lesions, and difficulties to achieve optimal plaque control. In modified coronally advanced Tunnel (MCAT) technique partial-thickness flap is created on the entire buccal aspect, no parts of the alveolar bone are exposed, and resorption of bony structures, which occurs when using a full-thickness flap can be avoided, also,it minimizes trauma and ensure a better blood supply for the graft.

Zadeh H. in 2011 introduced a conservative modification in tunnel technique; vestibular incision subperiosteal tunnel access (VISTA) which preserve the papillary integrity and enhances patients compliance. Vista technique allows gingival tissue regeneration through subperiosteal undermining of soft tissues using a vestibular incision instead of elevating the whole flap.VISTA offers broader access and maximum esthetic outcome because of placement of incision in the frenum region.

Eligibility Criteria:
INCLUSION CRITERIA-

* Patients with RT 3 isolated recession defects present Labially in Anterior teeth region,with vestibular depth\>=6mm
* Systemically healthy individuals.
* Age \>18 years old.
* A full mouth plaque score (FMPS) and full mouth BOP (FMBOP) \< 20%
* Patient showing adequate compliance and willing to participate in the study.

EXCLUSION CRITERIA-

* Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
* Previous surgical attempt to correct gingival recession.
* Crowding of affected teeth and tooth without adjacent contact teeth.
* Patients with active periodontal disease.
* Smokers and tobacco users.
* Pregnant and lactating women.
* Involved tooth with trauma from occlusion
* Involved tooth with prosthesis.
* Endodontically treated tooth.
* Tooth with cervical abrasion/undetectable CEJ/ caries.
Intraop Ventilation Management and Postop Pulmonary Complications in High Risk Patients for OSA

Lung protective ventilation (LPV) has been proposed to reduce the incidence of postoperative pulmonary complications (PPCs), and protect against ventilator induced lung injury (VILI).

LPV was first introduced in the intensive care units but has been recently adopted in the operating rooms. Obstructive sleep apnea (OSA) is a widely prevalent condition in obese patients and requires special attention in the operating room. Screening for OSA risk in surgical patients is a common practice. The STOP-BANG questionnaire is a common screening tool for OSA (Snoring, Tiredness, Observed apnea, high blood Pressure, BMI, Age, Neck circumference, and male Gender). The American Society of Anesthesiologists practice guidelines for the perioperative management of patients with OSA do not recommend any specific ventilation strategy to prevent PPCs in this population. To the knowledge of the investigators, the association between intraoperative ventilation strategies and PPCs in laparoscopic bariatric surgery patients, who have a high STOP-BANG score, has not been adequately investigated. The investigators propose a retrospective chart review of patients, 18 years of age and older, who underwent laparoscopic bariatric surgery, in reverse Trendelenburg position, using pressure controlled ventilation (PCV/PCV-VG) at the Ohio State University Wexner Medical Center, between January 01, 2012 and November 22, 2016, to determine whether intraoperative driving pressure is a predictor of postoperative pulmonary complications. No procedures will be done for the sake of conducting this study except for a retrospective review of patient charts. Preoperative and intraoperative variables will be collected to determine their predictive value of postoperative complications. No risks to the patients' health or well being are anticipated due to the conduct of the proposed study. No immediate benefits to the patients from whom data was collected is anticipated either. Results obtained from this study may provide valuable information on the preferred ventilation strategies in the operating room for future patients who have a high risk of postoperative lung complications.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age ≥ 18 y/o
* Patients who underwent laparoscopic bariatric surgery
* Surgery under general anesthesia with endotracheal intubation and pressure controlled mode of ventilation (PCV or PCV-VG)

Exclusion Criteria:

* Pregnant females, prisoners
* Short procedures: time of mechanical ventilation \< 60 minutes
* Patients who received volume controlled ventilation (VCV) mode
* Patients with past medical history of neuromuscular illnesses, pulmonary hypertension or CHF
Corticosteroids and / or Arthrographic Distention in the Treatment of Adhesive Capsulitis

Arthrographic distention of the shoulder joint is an increasingly popular treatment option in the management of patients with frozen shoulder. Most have included the intra-articular injection of a corticosteroid as part of the procedure, but it is not known if this is necessary. It is also not known whether arthrographic distention using steroid and saline is better than intra-articular steroid injection alone.

The purpose of this study is to determine whether there is an additional benefit in the combination of arthrographic distention plus intra-articular corticosteroid injection compared to arthrographic distention or intra-articular corticosteroid injection alone.


Eligibility Criteria:
Inclusion Criteria:

* Pain and stiffness in predominantly 1 shoulder for 4 weeks or longer
* Restriction of passive motion of greater than 30° in 2 or more planes of movement (measured to onset of pain with goniometer)

Exclusion Criteria:

* Previous arthrographic distention and/or corticosteroid injection
* Systemic inflammatory joint disease
* Radiological evidence of osteoarthritis of the shoulder or fracture
* Signs of a complete rotator cuff tear
* Contraindications to arthrogram and/or distention
* Lack of written informed consent
A Study of the Efficacy and Safety of PerOx Quench on the Prevention of Oxaliplatin Treatment Induced Neuropathy

Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and often irreversible condition featuring pain, numbness, tingling and sensitivity to cold in the hands and feet (sometimes progressing to the arms and legs) that afflicts between 30 and 40 percent of patients undergoing chemotherapy.

American Society of Clinical Oncology (ASCO) guidance on The Journal of Clinical Oncology (JCO, 2014 April 14) does not recommend any prophylaxis regimen for CIPN.

PerOx Quench has unique membrane protection and anti-oxidative function as a special food, that's why to try to explore its preventive effects on CIPN prevention induced by Oxaliplatin for colorectal cancer or gastric cancer chemotherapy.

This study uses two stage group-sequential sampling design, based on current data, assumed the CIPN incidence rate is 50% in placebo arm, while 20% in PerOx Quench arm（60% reduction）, set a=0.05，80％ power, random allocation ratio is 1:1, obtained the subjects number is 41（total 82) by PASS 11 software for superior design; considering 10% drop out rate, final number of subjects totally is 90.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-80 years old, male and female
2. Without anti-cancer treatment before randomization, ECOG score 0-2
3. Estimate to bear at least 4 cycles chemotherapy treatment with normal function of heart, lungs, liver and kidneys.
4. Survival expectation ≥6 months
5. Signed Informed Consent Form, willing to follow all study procedures

Exclusion Criteria:

1. Received chemotherapy treatment within 4 weeks before randomization.
2. Current peripheral neuropathy(by chemotherapy, diabetes mellitus, alcoholic disease) and relative symptoms with relevant treatment.
3. Concurrent treatment within 30 days after randomization with the following drugs: Calcium-Magnesium injection, glutathione, and similar ingredients with PerOx Quench (such as polyene phosphatidyl choline).
4. Laboratory tests found not suitable for chemotherapy patients (Absolute neutrophil count \<2.0×10\*9/L\<2,000/mm3\>; or platelet count\<100× 10\*9/L\<100,000/mm3\>; or hemoglobin \<10/dl; or serum total bilirubin \>2 Upper Limit Of Normal (ULN), alanine aminotransferase (ALT)/aspartate aminotransferase (AST)\>3 Upper Limit Of Normal (ULN); or serum creatinine \>1.5 Upper Limit Of Normal (ULN) \<or creatinine clearance rate

   ≤60ml/min\>）.
5. Pregnancy, lactation and reluctant to using contraception women.
6. Patients with symptomatic brain metastases and other mental disorders could not be self assessment.
7. Alcohol and/or drug abuse or doctors determine compliance's claim.
8. Within a month in other clinical trial subjects.
9. Once into the group of this study, or random within eight weeks before using this product.
10. personnel involved this study.
11. Not completed independent self assessment of patients.
12. Other researchers determine does not fit to participate in this study.
ARTEMIS DIANE T790M (An Amino Acid Substitution at Position 790 in EGFR, From a Threonine (T) to a Methionine (M)) Mutation at Hospital Laboratories in Comparison With Central Laboratory

The study primary objective is to assess the concordance of T790M resistance mutation testing from hospital-based laboratories with T790M resistance mutation testing from a central laboratory.

This is a multi-center testing study. 800 patients from 80 different hospital sites will have local T790M testing by different molecular testing platforms and have central testing by Cobas platform. These two sets of data (local T790M testing and central T790M testing) will be analysed and compared to assess the concordance of these T790M testing platforms.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
2. Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy.
3. Patients who have progressed following prior therapy with an EGFR-TKI agent.
4. Patients who consent to provide tumour tissue and/or blood.

Exclusion Criteria:

1. Patients who disagree to participate this study.
2. Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.