cyrilzakka/clinical-trials huggingface dataset:
Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome

In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity. At that time wedge resection of the ovaries was introduced on an empirical basis and proved a successful treatment for the associated anovulation and infertility. In the ensuing fifty years the limitations of a purely surgical approach to therapy have become recognized and the importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary Syndrome: The prevalence of polycystic ovary syndrome in any specified population is dependent upon the diagnostic criteria used, but does have some regional and ethnic variation. While most reports on the prevalence of polycystic ovary syndrome range between 2 and 20%, the chosen diagnostic criteria are recognized to influence the determined prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been done to use the level of anti-mullerian hormone as a factor for planning the number of ovarian drills in each ovary.


Eligibility Criteria:
Inclusion Criteria:

1. Infertility more than 2 years.
2. Age between 20-35 years.
3. clomiphene resistant patients: Patients received clomiphene 150 mg from day 3 to 7 of the menstrual cycle for 6 months and non-ovulatory (with failure of conception). They were followed up in the outpatient clinic.
4. No contraindications for laparoscopy.
5. Normal Hysterosalpingography

Exclusion Criteria:

1. Contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect....
2. Women's age less than 20 years or more than 35 years.
3. Previous Laparoscopic surgery.
4. Previous ovarian surgery.
5. Women with Antimullerian hormone level less than 4 ng/ml.
6. Tubal factor infertility as diagnosed by Hysterosalpingography .
Study of Daclizumab in Patients With Chronic, Persistent Asthma

The purpose of the study is to evaluate an investigational medication to treat chronic persistent asthma. The research is being conducted at up to 22 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site over a 10-month period. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.


Eligibility Criteria:
Inclusion Criteria:

* History of asthma for 6 or more months
* History of chronic persistent asthma requiring daily high dose inhaled corticosteroid for 3 or more months prior to enrollment

Exclusion Criteria:

* Patients with 10 or more pack years of smoking history or smoking within 12 months of study enrollment
* No significant disease other than asthma
Non-invasive Left-sided Cervical Vagus Nerve Stimulation for Atrioventricular Reentrant Tachycardia

The goal of this Interventional clinical trials in atrioventricular reentrant tachycardia patients. The main question it aims to answer whether non-invasive vagus nerve stimulation could be effective in restoring rhythm.

Patients will receive non-invasive vagus nerve electrical stimulation under catheter evoked and cardiac monitoring to observe their heart rhythm changes.

Participants will be treated with non-invasive electrical stimulation of the left vagus nerve in the neck. After routine induction of atrioventricular reentrant tachycardia prior to radiofrequency ablation, the electrode patch was placed on the patient's left cervical vagal body surface localization, i.e., between the sternocleidomastoid muscle and the trachea where the left common carotid artery pulsation could be palpated, and resuscitation was performed using non-invasive electrical stimulation.

Eligibility Criteria:
Inclusion Criteria:

1. The relevant diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Supraventricular Tachycardia (svt) need to be met.
2. All need to be free of psychiatric abnormalities, verbal communication disorders, and have good compliance.
3. The patients and their families gave informed consent and signed the informed consent form.

Exclusion Criteria:

1. Does not meet the relevant diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Supraventricular Tachycardia (svt).
2. Mental anomalies, verbal communication disorders, poor adherence
3. Those who do not consent to participate in this clinical trial
A Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease

The purpose of this study is to examine the relationship between depressive symptoms and markers of inflammation, two predictors of heart disease.

Depressive symptoms and inflammatory markers have both been proposed as measures that indicate/precede coronary artery disease (CAD). However, no controlled research study has tested the impact of these two candidate CAD risk factors within the same design to see the directionality of their influence. This study will explore if simvastatin reduces depressive symptoms and if sertraline reduces C-Reactive protein (CRP). Additionally, the recruitment process will help determine the feasibility of a larger trial, powered for significance testing. Three hundred and seventy-five participants will be consented and screened for this study. We expect forty-two otherwise healthy outpatients to have both elevated symptoms and high CRP levels, and be willing to be randomly assigned to sertraline, an antidepressant, simvastatin, a drug with anti-inflammatory properties, or a placebo for 8 weeks. Depressive symptoms and inflammatory indicators will be assessed before treatment (screening and baseline), mid-treatment (after 4 weeks), post-treatment (after 8 weeks), and a follow-up visit (after 12 weeks), using blood tests and depression interviews. We expect that both inflammation and depressive symptoms may be reduced by both medications, but the number of subjects needed to test this hypothesis is not yet known. Hence, this pilot study will be conducted. Knowledge about the inter-dependency of these two CAD risk factors allows the most promising future observational/intervention studies to be designed and conducted.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 60
2. Mild depression
3. Inflammatory markers: CRP \> 2

Exclusion Criteria:

1. Non-English or Non-Spanish speakers
2. Active suicidal or homicidal ideation
3. Current alcohol or other substance abuse
4. Psychotic features
5. Current personality disorder
6. History of bipolar depressive disorder
7. Any current psychotic disorder
8. Current major depressive disorder
9. Current depression treatment or treatment within preceding 6 weeks
10. History of chronic liver and/or renal disease
11. Current use or contraindication to any of the tested medications
12. Absence of a response to a previous adequate trial of any of the tested medications
13. Pregnant or lactating women
14. History of coronary artery disease
15. Current use of statins
16. Current, regular aspirin use
17. Antibiotic use within the previous four weeks
18. History of diabetes
19. Inflammatory diseases
20. Meets NCEP guidelines for cholesterol lowering therapy
COS-P for Parents of Children Referred to Child Psychiatric Services

Background:The quality of attachment is greatly influenced by parental sensitivity. Attachment based interventions are designed to promote parental sensitivity, to change parental mental representations and to improve understanding of the developmental needs of the child. Very few studies have investigated the effect of attachment-based interventions on psychiatric symptoms in children. Targeting parental sensitivity and the parent-child interaction might have an important impact on psychiatric symptoms in a clinical sample of children referred to child psychiatric services.

Objectives: The primary objective is to investigate whether Circle of Security-Parenting (COS-P) has an effect on parental sensitivity in parents of children referred to child psychiatric services. The secondary objectives are to investigate the effect on children's behavioral and emotional symptoms and the parental stress and reflective functioning after 10 weeks of intervention and at the 24 week follow-up. The study is also exploring the effect of parental attachment style, parental stress and parental psychopathology on the effect of the intervention.

Methods: The trial will include 128 families of children (age 3-8 years) who are referred to child psychiatric services in a randomized and controlled design. Included families will be randomized to COS-P+ Treatment as Usual (TAU) or TAU only.

Perspectives: Considering the important impact of the quality of the parent-child relationship on the child's well-being, it is essential to target it in interventions and to investigate the relation with psychiatric symptoms. Generally there is a lack of interventions targeting parental sensitivity in psychiatric child populations. Working with the parents on the child-parent relation, might have an important impact on their children's current psychiatric symptoms and could additionally prevent future psychopathology.


Eligibility Criteria:
Inclusion Criteria:

* Children who score equal or above the 93d percentile on CBCL-total score
* Score above 93d percentile on the CBCL- ODD or aggression scale
* Informed consent from both custody.

Exclusion Criteria:

For children:

* autism spectrum disorders
* serious psychopathology requiring immediate clinical attention
* head injury or verified neurological disease
* intelligence quotient (IQ) \<80
* medical condition, requiring treatment
* no informed consent from custody

For parents:

* a diagnosis of schizophrenia
* bipolar disorder
* known substance abuse
* severe intellectual impairment
* suicide attempt in the past
Mobile Food Record on Recall Effects

Human dietary habits remain challenging to measure. Even the "gold-standard" interviewer-administered 24 hour dietary recall has established underreporting issues especially in high-risk populations, such as patients with obesity. Performance of precision nutrition research requires state of the art tools to capture individual dietary patterns. Given the widespread availability of smart phones, mobile-phone based food records present a prime opportunity to capture "in the field" dietary intake. Mobile food records, however, are not yet widely used in nutrition research. Several reasons exist. First, the mobile food record needs to be validated relative to the "gold standard" of dietary intake, the 24-hour dietary recall. Second, many available mobile food records are commercially based, with caveats about data availability and meeting research-quality data security practices (HIPAA compliance).

In response, this study includes using a freely available, research-focused, HIPAA compliant, mobile food record (mCC: my Circadian Clock app) actively used in research studies (including our own ongoing work) to test the hypothesis that a mobile food record can expand capture of dietary intake. The proposed aims include the following: Using a randomized, cross-over design, evaluation of augmenting interviewer-administered 24-hour dietary recalls by a mobile food record (Augmented Recall) results in less energy intake underreporting than a standard (un-augmented) interviewer administered 24-hour dietary recall (Standard Recall).


Eligibility Criteria:
Inclusion Criteria:

* Adults between 18-65 years old
* BMI ≥30 kg/m2
* Without a 4 year (BS/BA) college degree
* Owns a smart phone
* Able to read and speak English

Exclusion Criteria:

• Pregnant or lactating women
Study of Everolimus in the Treatment of Advanced Malignancies in Patients With Peutz-Jeghers Syndrome

In this pilot study the investigators will treat all patients known with Peutz-Jeghers syndrome (PJS) who are diagnosed with advanced malignancies with everolimus 10mg daily until disease progression. Most patients with PJS have an inherited LKB1 mutation leading to aberrant m-TOR activity. Their risk to develop malignancies or intestinal polyps is probably related to this constitutive mTOR signaling. The hypothesis is that mTOR inhibition is an effective anticancer treatment in PJS patients with advanced malignancies.


Eligibility Criteria:
Tow cohorts of PJS patients will be included. Cohort 1: Advanced malignancy Cohort 2: High risk polyps

General inclusion criteria:

1. Known Peutz-Jeghers disease (with LKB1 mutation)
2. No concurrent systemic anti cancer treatment
3. No prior treatment with m-TOR inhibitor
4. Prior malignancies or concurrent second malignancies are allowed
5. Prior systemic therapy is permitted with a washout time of at least 4 weeks
6. ECOG/ WHO performance 0-2
7. Age \> 18 years
8. Adequate renal function (defined as creatinine \< 150 μmol/L)
9. Adequate liver function (bilirubin \< 1.5 times upper limit of normal, ALAT or ASAT \< 5.0 times upper limit of normal in case of liver metastases and \< 2.5 the upper limit of normal in absence of liver metastases
10. Adequate bone marrow function (WBC \> 3.0 x 10 9/L, platelets \> 100 x 10 9/L)
11. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
12. No pregnancy or lactating and ifof childbearing potential patients must agree to use a reliable contraceptive method throughout the study
13. No serious concomitant systemic disorder that would compromise the safety of the patient,at the discretion of the investigator
14. Signed informed consent according to ICH/GCP.
15. No uncontrolled symptomatic hyperglycaemia

Specific inclusion criteria for cohort 1:

1. Cytological or histological confirmed carcinoma
2. Metastatic or non-resectable disease
3. Patients with clinically and/or radiographically documented measurable lesion according to

RECIST criteria:

1. X-ray, physical exam \> 20 mm
2. Spiral CT scan \> 10 mm
3. Non-spiral CT scan \> 20 mm

Specific inclusion criteria for cohort 2:

1. Known high risk polyps (definition see page 19)
2. Ability to undergo endoscopies

Specific Exclusion criteria:

Symptomatic PJ-polyps, defined as polyps likely to be responsible/causal for the abdominal symptoms the patient presents with.
Slit Lamp Model SL-D-301 and DC-4 Digital Camera Attachment

The purpose of the evaluation is to confirm operability and usability of the SL-D301 Slit Lamp and the DC-4 digital camera attachment by conducting a usability evaluation and subsequently submitting a questionnaire and hold an interview with the operator.

Of special interest for the study is to confirm whether the illumination level of SL-D301 is enough to perform an eye exam since the maximum illumination level on the SL-D301 is lower than other existing Topcon digital ready slit lamps due to regulations that limit the maximum light intensity on the human eye. The SL-D301 will be compared against the predicate device SL-3G.

An eye care professional familiar with the use of slit lamps and experienced with other Topcon and other manufacturer's slit lamps will evaluate operability and usability of SL-D301 and DC-4 digital camera attachment instrument performing routine eye examinations and image capture on volunteer subjects using above mentioned instruments. Similar evaluations will be performed with the SL-3G Slit Lamp and a comparative evaluation will be drawn between the two instruments. At the end of the evaluation, the evaluator will be presented with a questionnaire on specific points regarding the performance and features of the instruments and interviewed. The responses will then be evaluated by Topcon.

Eligibility Criteria:
Inclusion Criteria:

* Any Willing Subject

Exclusion Criteria:

* Subjects unwilling to participate
Digital Radiography in Detection of Recurrent Caries Underneath Chlorhexidine Containing Adhesive Versus Conventional Adhesive After One Year Follow up: Randomized Clinical Trial

This study will be conducted to compare the effect of chlorexidine containing adhesive versus conventional one in prevention of secondary caries lesion underneath composite restoration over one year follow up null hypothesis

each patient will have at least 2 class II cavities.one will be restored using the intervention and the other using the control.

Digital radiographs will be taken and the images will be processed using a digital system. Then the teeth will be evaluated by expert in dental radiology who had no awareness of the results of the visual inspection. The examiner will use a radiograph viewer and a radiographic film magnifier to determine the presence or absence of radiolucency underlying the restoration. The clinical and radiographic examination will be assessed according to the FDI World Dental Federation clinical criteria for the evaluation of direct and indirect restorations The aim of this equivalent trial is to examine if the chlorhexidine containing adhesive is effective as the conventional adhesive in prevention of recurrent caries under resin composite restoration after one year follow up in high caries risk patients with class II cavities. Based on the previous papers by Papagiannoulis et al .,1999 and kohler et al.,2000, the success rate reported was about 95% (absence of caries). If there is truly no difference between the standard and experimental treatment, then 37 patients are required to be 80% sure that the limits of a two-sided 90% confidence interval will exclude a difference between the standard and experimental group of more than 15 %. The sample size was calculated by sealed envelope online.

Data will be analyzed using IBM SPSS advanced statistics (statistical package for social sciences), version 21 ( SPSS Inc. Chicago , IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages. Comparisons between categorical variables will be performed using the chi square test. An equivalent limit will be tested. A P -value less than or equal 0.05 will be considered statistically significant. All tests will be two tailed

Eligibility Criteria:
Inclusion Criteria:

* Patients should be 20-25 years of age with high caries risk. Patients should have an acceptable oral hygiene level. Patients must have at least two proximal lesions to be restored.

Exclusion Criteria:

Patients with a compromised medical history. Severe or active periodontal disease. Heavy bruxism or a traumatic occlusion. Lack of compliance
An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress)

Exclusion Criteria:

* Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period
Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

Randomised doublet blinded study of the effect of tablet Magnesia (laxative) on post operative bowel ileus after open colonic resection. Material: 56 patients in two equal groups. Primary endpoint: Bowel function. Secondary endpoints: Intake of food and drinks.


Eligibility Criteria:
Inclusion Criteria:

* Patients with planned elective colonic resection

Exclusion Criteria:

* Previous extended abdominal surgery
* Pregnancy
* Opioid or alcohol abuse
Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients

The purpose of this study is to assess a possible predictor for weight loss seen in epilepsy patients treated with topiramate.

Topiramate has been shown to be an effective anti-epileptic medication with a good safety profile. In clinical trials, some patients have experienced substantial weight loss. This prospective single center, open, pilot study will investigate whether there is any metabolic predictor for the weight loss. The patients will receive daily oral dose of topiramate in addition to anti-epileptic medications already prescribed by their physicians. A battery of metabolic tests including Body Mass Index (BMI), lean body mass, blood lipids and fasting glucose in tandem with other examinations will be taken before dispensing of topiramate, after 3 months and at the final visit. The study hypothesis is metabolic test results will provide a predictor of weight loss with topiramate. Patients will receive between 25 to 400mg daily of topiramate by mouth in addition to current anti-epileptic medications for up to 1 year. Dose will be adjusted (up to 1000 mg daily) by the investigators depending on the patients' clinical response.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of partial onset epilepsy, with or without secondary generalization. Patients with a diagnosis of epilepsy characterized by primary generalized tonic-clonic seizures may also qualify
* Currently taking one or more anti-epileptic medications on a stable dose for one month
* Weight between 40 and 130 kg (88 to 286 lbs)
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test).

Exclusion Criteria:

* Patients with rapidly progressive disorders that may impair their weight or their reliable participation in the study
* Patients prone to severe malabsorption and/or metabolic disorders
* Patients who have mental retardation or impairment which would confound the interpretation of this study
* History (within the past six months) of a psychiatric or mood disorder requiring medical treatment
* History of poor compliance with past anti-epileptic drug therapy
* Suicide attempt in the past five years
Study of Enzastaurin Versus Placebo in the Treatment of Patients With Brain Metastases of Lung Cancer, After Whole Brain Radiation Therapy

This study is a multinational study to compare enzastaurin versus placebo in the treatment of patients with brain metastases of lung cancer. Approximately 108 patients will be randomly assigned to receive either enzastaurin or placebo after having completed whole brain radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Having radiologically proven brain metastases of lung cancer
* Having received whole brain radiotherapy with either 30 grays in 2 weeks or 20 grays in one week. Treatment with enzastaurin must start within 14 days after the last fraction of the whole brain radiotherapy
* No other previous radiotherapy to the brain except for radiosurgery at one occasion
* Adequate organ function as measured by appropriate laboratory tests.
* Age 18 years or older.

Exclusion Criteria:

* Inability to swallow tablets or show conditions which could interfere with oral medication intake (e.g. vomiting, partial bowel obstruction).
* Inability to discontinue use of certain anti-epileptic drugs such as, carbamazepine, phenobarbital or phenytoin.
* Concurrent administration of warfarin
* Hemophilia
* Having had any systemic anti-cancer treatment within the last 2 weeks prior to enrolment.