cyrilzakka/clinical-trials huggingface dataset:
Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs

Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with PCOS.

Participants fulfilling inclusion and exclusion criteria will be divided into two groups, each group containing 300 participants;

Group (A):

300 participants will receive Clomiphene citrate oral tablets and placebo of Tamoxifen oral tablets.

Group (B):

300 participants will receive Tamoxifen oral tablets and placebo of Clomiphene oral tablets.

Participants with abnormal menstrual history will receive two tablets of norethisterone 5mg tab (Steronate nor ®, hi pharm/Egypt) every12 hours for 5 days to withdraw period before starting the procedure.

Then;

Group (A):

Women will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®, aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily), and one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle.

Group (B):

Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily), and one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.

Eligibility Criteria:
Inclusion Criteria:

* Primary infertility.
* Body mass index (BMI) between 25 and 30 Kg/m 2.
* Polycystic ovary syndrome (using ESHRE/ASRM criteria).

Exclusion Criteria:

* Secondary infertility.
* Patients with BMI under 25 or over 30 Kg/m 2.
* Hyper or hypothyroidism, or hyperprolactinemia.
* Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs.
* Intention to start a diet or a specific program of physical activity.
* Organic pelvic diseases.
* Tubal or male factor infertility.
* Interval of earlier treatment with any of the fertility drugs of less than 6 months.
* Contraindication to either:

  * Clomiphene citrate.
  * Tamoxifen.
  * HCG injection.
Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (\>20%)
* Women of childbearing potential
* Aged \>18 years
* Signed written informed consent form
* Willing to comply to the follow-up schedule

Exclusion Criteria:

* Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis
* Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amsel criteria (clue cells detection)
* Current genital malignancies
* Chemotherapy for any reason in last 6 months
* Radiotherapy in the genitourinary system in the last 12 months
* Use of antibiotics for any reason in the last 14 days
* Pregnancy or currently attempting to conceive
* Lactation
* Use of other treatment for vaginal conditions during the course of the clinical investigation
* Known allergies to ingredients of the product
* Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation
Identification of Biomarkers Predictive of Worse Prognosis in Henoch Schonlein Purpura

Henoch Schonlein Purpura (HSP), vasculitis of small vessels with deposits of IgA, is considered by many authors as the systemic form of Berger's disease (IgA-N). IgA-N is characterized by IgA1 deposits in mesangial areas associated with mesangial proliferation. These two diseases remain the leading cause of ESRD by primitive glomerulopathy in Western countries. In recent years, considerable progress has been made in understanding the pathophysiological mechanisms of IgA-N. However, only a high rate of proteinuria at one year or the presence of severe glomerular inflammation on renal biopsy remain predictors of long term renal function. Moreover, the high variability of HSP clinical expression, from few purpura skin lesions that evolve favourably spontaneously, to rapidly progressive renal failure, remains so far unexplained but suggests the existence of individual genetic susceptibility.

In the first part of the study, we will study key factors based on physiopathological data obtained by our laboratory as well as by other groups. The second part of the study concerns genetic factors. Although the candidate genes that may confer a particular susceptibility to the disease, to progress to ESRD or respond to treatment are many, the genes involved in inflammation or controlling renin-angiotensin system are of particular interest.

We will apply these results by studying patients with HSP showing three distinct phenotypes (HSP with isolated cutaneous purpura or associated with minimal or severe renal disease) at diagnosis and after clinical remission.

The purpose of this study is to assess whether the phenotype at diagnosis is associated with the physiological markers and if one of them predicts a pejorative evolution of renal disease at 1 year. Meanwhile, study of polymorphism of selected genes of interest could allow identification of patients with specific genetic susceptibility or with bad prognosis factors who would be thus eligible for specific treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with HSP whose diagnosis was confirmed by histology of an active skin lesion, who signed the informed consent form or for minors, signature of the holders of parental authority.

Exclusion Criteria:

* Patients who do not have skin lesions; Patients receiving immunosuppressive drugs or steroids for more than 2 weeks; Patients with another diagnosis (platelets\<100,000/mm3, bacterial purpura, other systemic disease);
* Patients unable to understand the protocol, refusing to sign the information form or unable to comply with regular follow-up consultation.
Levetiracetam for Neuroprotection Against Corticosteroid-induced Hippocampal Dysfunction: A Proof of Concept Study

The purpose of this research is to determine whether the memory impairment and manic symptoms (feelings of agitation, overexcitement or hyperactivity) typically seen in those on corticosteroid therapy is decreased with a seizure medication called levetiracetam compared to placebo (an inactive substance). Since increased levels of cortisol (the body's natural corticosteroid) in the body are frequently associated with memory impairment interventions that may prevent or reverse this are of great importance.

It is hypothesized that patients who are scheduled to receive prescription corticosteroid therapy who are given levetiracetam pretreatment will show lesser memory impairment and manic symptoms than those receiving placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Scheduled to receive a corticosteroid "burst" of at least 10 mg of prednisone equivalents and for at least 5 days duration
* English- or Spanish-speaking

Exclusion Criteria:

* History of allergic reaction or other contraindication to levetiracetam therapy
* Other unstable medical conditions (e.g. recent myocardial infarction, renal failure, diabetes with poor glycemic control)
* Pregnant or nursing women
* History of mental retardation, dementia or other severe cognitive disorders
Controlled Trial of the I-PLAN Intervention

That is a need for intervention to promote hearing aid use among adult patients with hearing aids. The aim of the present study was, for the first time, to evaluate the efficacy of the I-PLAN intervention to promote hearing aid use.

The I-PLAN is a behaviour change theory-based intervention to promote hearing aid use. It consists of; 1. information on consequences of using and not using a hearing aid, 2. a physical prompt as a reminder to hearing aid use and 3. a behavioural plan to use a hearing aid. The aim of this study was to test efficacy of the I-PLAN intervention, delivered face-to-face by study audiologists. 160 first-time hearing aid users were recruited at the hearing aid fitting appointment. Adult patients were allocated either to the I-PLAN group or Standard Care group. Adult patients were allocated to the groups based on the clinic schedules of study audiologists.

Eligibility Criteria:
Inclusion Criteria:

* had no previous personal experience of using a hearing aid
* were aged 18 years old or above
* attended initial hearing aid fitting appointment with study audiologists
* were native English speakers or had good understanding of English
* had sufficient mental capacity to provide informed consent based on audiologist's opinion were eligible to take part in this study

Exclusion Criteria:

* inability to complete the questionnaires due to age-related problems (for example; dementia) based on audiologist's opinion
* presence of medical contraindications for hearing aids as described by the British Academy of Audiology (BAA 2007)
Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B

The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA \> 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 20-40 years old
2. HBsAg, HBeAg positive and HBV DNA \>6 log10 copies/ml
3. Gestational age: 26-28 weeks with normal fetus
4. Willing to consent for the study

Exclusion Criteria:

1. Elevated ALT
2. Antiviral treatment experience patients
3. Co-infection with HAV, HCV,HDV, HIV
4. Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
5. Clinical signs of threatened miscarriage in early pregnancy
6. Clinical evidence of cirrhosis and/or hepatocellular carcinoma
Role of Choline PET/CT in Predicting Survival in Patients With Hepatocellular Carcinoma

¹¹C-choline positron emission tomography/computed tomography (PET/CT) has been used in patients with some types of solid cancers, but few data are available in patients undergoing hepatectomy for hepatocellular carcinoma (HCC). The aim of this study was to analyze the prognostic value of metabolic imaging data by using ¹¹C-choline PET/CT in patients with HCC before hepatectomy.

Our prospectively maintained liver unit database was queried for patients with HCC preoperatively staged with ¹¹C-choline PET/CT. This metabolic imaging modality was performed in addition to standard abdominal CT or magnetic resonance imaging. Several PET/CT parameters were recorded and analyzed. Univariate and multivariate analyses were performed to identify whether those PET/CT parameters could be predictors of overall survival (OS) and disease-free survival (DFS) of HCC patients.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with HCC candidate to surgical resection preoperatively staged with ¹¹C-choline PET/CT

Exclusion Criteria:

* R2 resection;
* Intraoperative use of RFA/MWI
* Postoperative death (90-days)
Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection

Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the prevention of chronic thoracic pain after VATS lung resection surgery.

VATS lung resection is associated with a high incidence of persistent thoracic pain. To our knowledge, there is no study on the effect of cryoanalgesia on the incidence and severity of chronic thoracic pain 3 months after VATS lung resection.

Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. In a recent study by Ilfeld \& al, intercostal cryoanalgesia (combined with a single-injection paravertebral block) was able to drastically lower the incidence of chronic pain after total mastectomy compared to the use of the paravertebral block alone (3% vs 17%).

The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia for the prevention of chronic thoracic pain after VATS lung resection surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective anatomical pulmonary resection (anatomical segmentectomy, lobectomy or bilobectomy) by VATS for lung cancer
* American Society of Anesthesiologists (ASA) score 1-3

Exclusion Criteria:

* Contraindication to the paravertebral block (coagulopathy, discontinuous paravertebral space, impossible thoracoscopic visualization of the paravertebral space)
* Contraindication to intercostal cryoanalgesia (cold urticaria, cryoglobulinemia)
* Epidural analgesia preferred (high risk of thoracotomy, marginal lung function)
* Surgical criteria (conversion to thoracotomy, non anatomical wedge resection)
* Preoperative thoracic or shoulder pain on the operated side
* Known allergy to acetaminophen, celecoxib, sulfa, or both hydromorphone and morphine
* History of thoracic surgery on the operated site
* Regular use of opioids or medication with effects against neuropathic pain (tricyclics, gabapentinoids, duloxetine, venlafaxine)
* Inability to understand pain scales or to communicate clearly despite adequate teaching
* Contraindication to non-steroidal anti-inflammatory drugs (renal filtration rate \< 60 mL/min, active gastric ulcer)
* Pregnancy
* Patient refusal to participate
Tarceva and Capecitabine for Pancreatic Cancer

This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating patients with metastatic pancreatic cancer.

Patients will be treated once daily with Tarceva, twice daily with capecitabine for 14 consecutive days, followed by 7 days off of capecitabine (a cycle is 21 days). At week 1 of each cycle a physical exam and blood work will be performed. Reassessment of tumor size will be conducted at 6 weeks (2 cycles), 12 weeks (4 cycles) and then every 9 weeks thereafter. Patients will remain on treatment until one of the following occur: disease progression, illness that prevents further treatment or unacceptable adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors)
* Only patients with measurable disease
* ECOG performance status \< or equal to 1
* Life expectancy \>12 weeks
* Signed informed consent
* Failed or intolerance to first-line therapy for metastatic disease with a gemcitabine-containing regimen. Patients may have received adjuvant therapy in addition to one prior regimen for metastatic disease.
* \>4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities
* \>4 weeks must have elapsed from the participation in any investigational drug study
* Laboratory values:

  * ANC \> 1500/mm3;
  * Hemoglobin \> 9.0 gm/dl;
  * Platelets \> 100,000/mm3;
  * SGOT \<2.5 X upper limit of normal; or \<5 X upper limit of normal if evidence of liver metastases; Alkaline phosphatase \< 2.5 X upper limit of normal; or \< 5 X upper limit of normal if evidence of liver metastases; Total bilirubin \< 1.5 X upper limit of normal; Creatinine clearance \> 50 cc/min (by Cockroft - Gault or as determined from a 24-hour urine collection).

Exclusion Criteria:

* Prior therapy with capecitabine or epidermal growth factor receptor (EGFR) inhibitors
* More than one prior chemotherapy treatment regimen for metastatic disease
* Clinically apparent central nervous system (CNS) metastases or carcinomatous meningitis
* Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or heart attack within the last 12 months).
* Major surgery within 4 weeks of the start of study treatment, without complete recovery.
* Evidence of CNS metastases (unless CNS metastases have been stable for \> 3 months) or history of uncontrolled seizures, central nervous system disorders
* Uncontrolled serious medical or psychiatric illness
* Women must not be pregnant or lactating
* Concurrent radiation therapy
* Other active malignancy
* Inability to swallow tablets
* Patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome
* Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil
Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED)

The purpose of this study is to determine the safety and tolerability of ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Male Or Female Patient, 20 Through 79 Years Of Age
* Newly Diagnosed Dyslipidemia Patients Including: 1) Intermediate Risk (\>2 Risk Factors) With Total Cholesterol level above 200 mg/dL Or Low Density Lipoprotein-C (LDL-C) level\> 130 mg/dLwho failed a 3-Month diet control period, or 2) High Risk Patients with history of Coronary artery disease Or diabetes and having a total Cholesterol\> 200 mg/dL Or LDL-C level\> 130 mg/dL
* Willing To Follow An National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Changes (TLC) Or Similar Cholesterol-Lowering Diet For The Duration Of The Study
* Female Patients Receiving Hormone Therapy (Including Hormone Replacement Therapy, And Estrogen Antagonist/Agonist, Or Oral Contraceptives) If Maintained On A Stable Dose And Regimen For At Least 8 Weeks Prior To Visit 1 And If Willing To Continue The Same Regimen Throughout The Study

Exclusion Criteria:

* Women Who Are Pregnant Or Lactating
* Has A History Of Cancer Within The Past 5 Years (Except For Dermatological Basal Cell Or Squamous Cell Carcinoma)
* Patients Hypersensitive To Simvastatin Or Ezetimibe
* Any Condition Or Situation Which, In The Opinion Of The Investigator, Might Pose A Risk To The Patient Or Confound The Results Of The Study
* History Of Mental Instability, Drug/Alcohol Abuse Within The Past 5 Years, Or Major Psychiatric Illness Not Adequately Controlled By Pharmacotherapy
* Nephritic Syndrome Or Other Clinically Significant Renal Disease Resulting In Impaired Renal Function, Defined As Serum Creatinine ≧ 1.5 Mg/Dl
* Alanine Aminotransferase (ALT), And Aspartate Aminotransferase (AST) above 1.5 X Upper Limit Of Normal (Uln) Or With Active Liver Disease
* Congestive Heart Failure (New York Heart Association (NYHA) III Or IV), Uncontrolled Cardiac Arrythmias, Uncontrolled Hypertension (Systolic Blood Pressure (SBP) \>160 mm Hg Or Diastolic Blood Pressure (DBP) \>100 mm Hg), Unstable Angina Pectoris Or Severe Peripheral Artery Disease, Or Experienced Myocardial Infarction, Coronary Artery Bypass Surgery, Angioplasty Within 3 Months
* Unstable Diabetes Mellitus Patient (Hemoglobin A1c (HbA1c) \> 8.5%) Or Newly Diagnosed (Within 3 Months) Or A Change In Anti-Diabetic Pharmacotherapy Within 3 Months Of Screening
* Secondary Dyslipidemia (E.G., Hypothyroidism)
* Disorders Of The Hematologic, Digestive, Or Central Nervous Systems Including Cerebrovascular Disease And Degenerative Disease That Would Limit Study Evaluation Or Participation
* History Of Active Or Chronic Hepatobiliary Disease Or Cholelithiasis But Have Not Undergone Cholecystectomy
EULAR Impact of Rheumatic and Musculoskeletal Diseases Survey

The EULAR Impact of RMDs Survey collects first-hand information about the impact of rheumatic and musculoskeletal diseases (RMDs) among patients across and beyond Europe. Through periodic questionnaires, patients will provide information about their healthcare situation, and how the disease affects their social and occupational lives. This data will be an important resource for researchers, healthcare professionals, and patients alike, providing valuable insights into the burden of disease and helping improve the overall care for people living with these conditions.


Eligibility Criteria:
Inclusion Criteria:

* 18-year-old at time of baseline survey
* Living in a EULAR country at time of baseline survey
* Diagnosed with at least one RMD
* Valid personal e-mail address
* Being able to use an internet website

Exclusion Criteria:

* none
Study of Neoadjuvant Ipilimumab in Patients With Urothelial Carcinoma Undergoing Surgical Resection

The purpose of this study is to learn if ipilimumab can be given safely at two different doses given to patients with urothelial cancer who are going to have surgery as part of their treatment. The immunological effectiveness of ipilimumab will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated urothelial cancer requiring surgery for treatment
* Ineligible for chemotherapy
* Adequate hematologic, kidney and liver function

Exclusion Criteria:

* Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for the entire trial and up to 4 weeks after the study
* Women who are pregnant or breastfeeding
* Women with a positive pregnancy test on enrollment prior to study drug administration
* Prior treatment with ipilimumab or other anti-CTLA4 antibody, or a CD137 agonist
* Concurrent malignancy, with the exception of adequately treated and cured basal or squamous cell skin cancer, or carcinoma in situ of the cervix (previous malignancy without evidence of disease for 5 years will also be allowed to enter trial)
* Autoimmune disease: subjects with a documented history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], Systemic Lupus Erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome) are excluded from this study
* Patients deemed ineligible for surgery
* Any non-oncology vaccine therapy used for prevention of infectious diseased in the past month
* Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens, chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer related illnesses)
* Prior radiation therapy for urothelial cancer
* Positive screening tests for or any prior history of HIV, Hepatitis B or Hepatitis C