cyrilzakka/clinical-trials huggingface dataset:
Metformin and Oral Contraceptives in PCOS

Background: PCOS is a common condition with a prevalence of 5-8 % in premenopausal women. More than 50% of PCOS patients are insulin resistant and have a diabetes risk 5-8 times higher than age- and weight-matched controls. Studies using insulin sensitizers in PCOS found increased insulin sensitivity and decreased insulin levels to be followed by decreased androgen levels and improved ovulatory function. No studies however, evaluated the long term effects of insulin sensitizing treatment.

Oral contraceptives normalize menstrual cycles and suppress androgen levels in PCOS, however no long-term studies evaluated the effects of combined treatment with metformin and oral contraceptives in PCOS.

Design: Randomized open study in 3\*30 PCOS patients. Patients are randomised to 24 months of treatment with 1: metformin, 2: metformin and oral contraceptives or 3: oral contraceptives.

Primary outcome measures: fasting insulin, AUC insulin. Secundary endpoints: BMI, WHR, LH, FSH, total and free-testosterone, c-peptid, urinary cortisol, AUC for insulin, glucose and c-peptid during OGTT.

Inclusioncriteria:

1. Irregular menses or anovulaty cycles
2. High free testosterone \> 0,035 nmol/l or hirsutism
3. PCO in vaginal US Criteria 1 and 2 OR 2 and 3.

Design:

90 patients are included and randomized to 12 months of treatment with metformin (1000+1000 mg/d) or OCP (150 mg desogestrel 30 microgram ethinylestradiol) or combined treatment (metformin+OCP).

Patients attend a biochemical and physical examination at study inclusion and at 12 months. Patients attend for registration of side effects and compliance after 6 months of study duration. Safety tests are performed at all three visits and include weight, blood pressure, HbA1c, liver enzymes, electrolytes, and white blood cell count. Pregnancy tests are performed by the participants each month. Patients are given general advice on lifestyle intervention. Patients are excluded if they initiated medical treatment with possible hormonal and metabolic effects during the intervention period. Lifestyle intervention is allowed. Laser treatment is offered to patients with moderate or severe facial hirsutism and patients are allowed to shave/wax. The patients accept not applying cosmetic treatment 3-4 days before attending for evaluation at the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Irregular menses or anovulaty cycles
* High free testosterone \> 0.035 nmol/l or hirsutism
* PCO in vaginal US Criteria 1 and 2 OR 2 and 3

Exclusion Criteria:

* Age \> 18 years
* Postmenopausal
* Diagnosis diabetes mellitus
* Use of medicine known to affect hormones measured in the project
* Pregnancy or planned pregnancy during study period
* Non-Caucasian
* Previous tromboembolic disease
* Heavy smoker \> 35 years and BMI \> 35 kg/m2
Evaluation of Vestibular Dysfunction or Visuospatial Perception in Individuals With Idiopathic Scoliosis

This study was planned to investigate whether there is a visual-spatial perception disorder in individuals with idiopathic scoliosis and also to reveal its dependent/independent relationship with vestibular dysfunction.

Vestibular dysfunction is thought to be associated with the etiology of patients with idiopathic scoliosis. However, there is limited data on this in the literature. However, visuospatial ability has been evaluated in the literature regarding vestibular dysfunction independent of scoliosis. In the study, it was first requested to investigate vestibular dysfunction in patients with scoliosis. However, as far as is known, there is no study in the literature on visuospatial perception investigated for vestibular dysfunction in patients with scoliosis. This study was planned to investigate whether there is a disorder related to visuospatial perception and to reveal its dependent/independent relationship with vestibular dysfunction. Based on the studies, it is planned to evaluate visuospatial (visual-spatial) perception performance in the presence/absence of vestibular dysfunction in individuals with idiopathic scoliosis. The hypothesis of the study is that vestibular function and related visual-spatial perception may be affected in individuals with idiopathic scoliosis.

Eligibility Criteria:
Inclusion Criteria:

For the patient and control group;

* Those who do not have any other joint deformity,
* Those between the ages of 10-25,
* Individuals with good mental status Only for the experimental group
* Individuals diagnosed with idiopathic scoliosis,
* Those who have not received physiotherapy and rehabilitation for idiopathic scoliosis in the last 6 months,

Exclusion Criteria:

* Those with severe hearing and visual impairment, any neurological, orthopedic, metabolic, rheumatological disorders other than idiopathic scoliosis
* Other types of scoliosis,
* Individuals with benign paroxysmal positional vertigo, meniere, primary pathologies of the ear and a history of serious infection (ear, internal organ) will be excluded
* In healthy individuals, shoulder height difference during scanning, visual impairment, dizziness in the last 1 year, glasses wearers and individuals with a history of middle ear infection
Ocular Allergy Treatment Practical Impact Trial

To study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.

To assess the impact of ocular allergy treatment on patients using an ophthalmic agent (or no treatment) versus alcaftadine(Lastacaft™)

Eligibility Criteria:
Inclusion Criteria:

1. patients age 18 and older with a history of seasonal or perennial forms of allergic conjunctivitis and skin test positive reactivity to seasonal aeroallergens
2. Total Ocular Symptom Score (TOSS) on the day of enrollment of 4 or more.
3. have allergic ocular symptoms for the past week for which they are either treating with ophthalmic agents or have had no treatment.
4. Are willing/able to follow instructions from the study investigator and his/her study staff.
5. Have signed infromed consent approved by Institutional Review Board or Independent Ethics Committee.

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Exclusion Criteria:

1. Active ocular infection;
2. History of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
3. Ocular surgical intervention within three (3) months prior to visit 1 or scheduled during the study.
4. History of unstable, or uncontrolled disease of any nature.
5. Pregnancy or lactation;
6. Have a known hypersensitivity tp LASTACAFT™ (alcaftadine) -
A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents

This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help establish voriconazole dosing recommendations for adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are expected to develop neutropenia following chemotherapy.
* Subjects who require treatment for the prevention of systemic fungal infection.

Exclusion Criteria:

* Subjects with a history of severe intolerance of azole antifungal agents.
* Subjects with documented bacterial or viral infection at the time of study entry who are not responding to appropriate treatment against the infection.
Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery

This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical prostatectomy. Side effects of green tea extract and quercetin in combination with green tea extract will also be evaluated. In preclinical studies, green tea polyphenols have anticancer and cancer preventative effects in a number of malignancies. Likewise, in preclinical studies quercetin was found to enhance the anticancer effects of green tea. This trial is designed to translate these findings forward in a short-term human intervention trial.

PRIMARY OBJECTIVES:

I. To investigate the prostate tissue concentration of epigallocatechin gallate (EGCG), epicatechin gallate (ECG) and quercetin and their methylated metabolites in men scheduled for prostatectomy and consuming green tea (GT)extract (N=15) or GTextract with quercetin (N=15) for 3 weeks prior to prostatectomy.

II. To determine the concentration of EGCG, ECG, epigallocatechin (EGC), epicatechin (EC) and quercetin and the methylated metabolites in plasma collected before (T=0) and two hours (T=2) after the intake of the morning dose of GTextract and placebo or GTextract with quercetin during the third week of intervention.

III. To determine the effect of GTextract/quercetin intervention on reducing the enzyme activity and protein and gene expression of catechol-O-methyltransferase (COMT) and deoxyribonucleic (DNA) (cytosine-5) methyltransferase 1 (DNMT1) as well as protein and gene expression of multidrug resistance transport protein 1 (MRP1) in prostate tissue collected in specific aim 1 and COMT activity in erythrocytes from blood collected at baseline and week 3.

IV. To determine the inter-individual variation in genotype of COMT in buffy coat DNA.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive GT extract orally (PO) twice daily (BID) and quercetin PO BID for 3-6 weeks before undergoing prostatectomy.

ARM II: Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects consent to participate in the trial
* The subject has a diagnosis of adenocarcinoma of the prostate
* The subject is scheduled to undergo radical prostatectomy
* The subject agrees to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention

Exclusion Criteria:

* History of hepatitis or liver dysfunction
* Ongoing alcohol abuse
* Significant medical or psychiatric conditions that would make the patient a poor protocol candidate
* Prior sensitivity or allergic reaction to tea, tea products or tea and quercetin supplements
* Allergies to multiple food items or nutritional supplements
* Taking luteinizing hormone-releasing hormone (LHRH) agonists, androgen receptor blocking agents, finasteride, or has undergone bilateral orchiectomy
A New Supplement for the "Metabolic Syndrome"

This study evaluates the effect of a combination of glycirrhizic acid, Cinnamomun Zeylanicum and corosolic acid for the treatment of metabolic syndrome. Participants receive the supplement or a placebo.

The supplement is composed by of a combination of glycirrhizic acid, Cinnamomun Zeylanicum and corosolic acid. They act in different way reducing insulin resistance, which is the main cause of metabolic syndrome. It was a randomized, controlled study involving 60 women with the metabolic syndrome following the criteria proposed by ATP III in 2015. Main outcomes were the improvement of the parameters that characterizes the metabolic syndrome, such as glucose and insulin levels, triglycerides, HDL-cholesterol and blood pressure.

Eligibility Criteria:
Inclusion Criteria: Postmenopausal women affected by Metabolic Syndrome, diagnosed by ATP 2015 criteria.

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Exclusion Criteria: treatment with steroids or with hypoglycemic or anti-cholesterol drugs

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Retrospective Study of the Impact of Drug Eluting Stents

The purpose of this study is to determine whether the use of drug eluting stents is associated with higher rates of death, myocardial infarction, and major bleeding. In addition, the overall economic costs of implanting drug eluting stents compared to bare metal stents will be assessed.

A major limitation of percutaneous coronary stenting compared to coronary artery bypass grafting surgery has been the significantly higher need for repeat revascularization due to restenosis occurring at or near the stent site. By eluting a potent anti-proliferative agent from a polymer coated stent in a time-controlled manner, it has been possible to markedly inhibit intimal proliferation that results from implantation of a bare metal stent, dramatically reducing the need for future target lesion revascularization.

Recent angioscopic and autopsy studies have demonstrated markedly delayed and incomplete endothelialization following drug-eluting stent implantation. These events are rarely observed following bare metal stent implantation. In addition, drug-eluting stents have been associated with hypersensitivity reactions, which may predispose patients to subacute thrombosis. Finally, serial intra-coronary ultrasound studies demonstrate late stent mal-apposition, which is believed to create a possible nidus for thrombus formation.

By means of examining several extensive administrative databases, this study will retrospectively examine approximately 9,800 consecutive patients who underwent either bare metal or drug eluting coronary artery stenting at Sacred Heart Medical Center, Spokane, WA between March 1, 2001 and March 30, 2006. Time frame of follow-up is at least 18 months.

Comparison: The strategy of implanting stents during three time periods will be compared to each other. In the first study period which occurred prior to commercial release of the Cypher drug eluting stent, all patients received bare metal stents. The second study group will include all patients from the time frame between release of the Cypher stent and the Taxus drug eluting stent (approximately one year) after which a contractual decision was made to only utilize Taxus stents. During second time frame of corresponding to availability of the Cypher stent, about 30% of total stent cases received drug eluting stents predominately for "on label" indications. The third study group occurred during a time-frame when Taxus drug eluting stents were implanted in about 90% of overall patients including many with "off label" indications.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery stenting between March 1, 2001 and March 30, 2006

Exclusion Criteria:

* Implanted investigational drug eluting stents
An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of rheumatoid arthritis
* Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy
* Patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed

Exclusion Criteria:

* Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
* Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
* Patients whose first biologic is rituximab, abatacept or anakinra.
* Patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit
Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care reduces the incidence of moderate (32-36° C) or severe (\<32.0° C) hypothermia in term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling) reduces the incidence of moderate hypothermia (32-36° C) or severe (\<32.0° C) in term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care, as practiced. The investigators are proposing two trials, one protocol for infants 32-36 6/7 weeks and one for infants who are ≥37 weeks gestational age (this one). This term infant trial will address the effectiveness of KMC in combination with plastic bags in decreasing hypothermia in preterm infants. The proposed trial will determine whether KMC with plastic bags prevents hypothermia in neonates born in a healthcare setting with limited resources where a high risk for hypothermia has been reported. Any intervention that decreases morbidity during the neonatal period has the potential to impact health beyond the neonatal period,and one that is highly cost-effective and easy to use is more likely to be implemented in the developing world.

Eligibility Criteria:
Inclusion Criteria:

* Estimated gestational age ≥37 0/7 weeks
* Delivery in the hospital

Exclusion Criteria:

* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder
* Clinically unstable mothers secondary to cardiovascular and pulmonary conditions
* Infants requiring respiratory support beyond 10 minutes after birth
* Infant requiring Neonatal Intensive Care Unit admission
* Cesarean section
* Multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant
Circumcision With a Novel Disposable Device in Chinese Children: a Hospital-based Randomized Controlled Trail

Circumcision, a removal of the foreskin, is performed commonly at any age in male worldwide. Globally over 25% of men are circumcised. In the Middle East, circumcision is even performed routinely in every male newborn. The benefits from it vastly outweigh the risks. Gradually, more and more Chinese male are willing to undergo it with themselves and their sons. But there are also some complications with circumcision, such as pain, edema, infection, and hemorrhage. Considering of that, physicians continually manage to improve their surgical methods and analgesic techniques.

In the study of Peng, a disposable minimally invasive circumcision anastomosis device named Shenghuan (China Wuhu Snnda Medical Treatment Application Technology Co. Ltd.) (ShD) was introduced to be applied in circumcision. And they concluded that method was quicker, safer and less pain than the conventional techniques of incision. In present study, we carry out a randomized controlled trail, using a different method as Peng introduced with this device in children's circumcision (Yan's), compared with the method as Peng used and the conventional technique in our hospital, and then observe the outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Children with phimosis or redundant prepuce

Exclusion Criteria:

* Children with genital tract infection or deformity,
* congenital diseases,
* hematological diseases,
* or other general diseases
Effect of an Enzyme-containing Lozenge on Dental Biofilm in Healthy Individuals.

The purpose of the study is to assess the effect of an enzyme containing lozenge on dental plaque accumulation in healthy adults.

The purpose of this study is to examine the clinical effects of a lozenge containing enzymes on dental plaque accumulation and oral microbiome composition after professional dental cleaning, as compared to a placebo lozenge without enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral hard and soft tissues. The null hypothesis is that the treatment with enzyme-containing lozenges do not affect plaque accumulation, as compared to a placebo control.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy males and females ≥18 years of age.
* Able to read, sign and receive a copy of the signed informed consent form.
* Have at least 20 natural teeth.

Exclusion Criteria:

* Clinically visible active caries lesions and/or periodontitis.
* Significant oral soft tissue pathology based on a visual examination.
* History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
* History of allergies to ingredients in the test product.
* History of allergies towards enzymes.
* Self-reported as pregnant or nursing.
* Self-reported serious medical conditions.
* Antibiotic or anti-inflammatory medication within 30 days of screening visit.
* Orthodontic appliances, including retainers, peri/oral piercings, or removable partial dentures.
* Acute sinusitis or severe oral-pharyngeal infections.
Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions

Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it with the individual drugs


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Age: 18 to 45 years (inclusive) at the first screening / examination visit
* Ethnicity: Caucasian
* Body mass index (BMI): \>/=18 and \</=29,9 kg/m²

Exclusion Criteria:

* Systolic blood pressure below 120 or above 145 mmHg
* Diastolic blood pressure above 95 mmHg
* Heart rate below 45 or above 95 beats / min
* Clinically relevant findings in the physical examination
* Suspicion of drug or alcohol abuse
* Regular daily consumption of more than 1 L of xanthin-containing beverages
* Intake of foods or beverages containing grapefruit within 4 weeks before the pre-study examination