cyrilzakka/clinical-trials huggingface dataset:
Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol

Letrozole is a chemical compound, CGS 20267 which is a third-generation, nonsteroidal aromatase inhibitor.

Letrozole blocks estrogen synthesis by directly affecting the hypothalamic-pituitary-ovarian axis, subsequently, increases gonadotropins which increase pregnancy rates. Possible positive outcomes of aromatase inhibitors over selective estrogen-receptor modulators include a more physiologic hormonal stimulation of the endometrium which increases receptivity, a lower multiple-pregnancy through single follicle growth, a lesser side-effect especially vasomotor and mood symptoms, and more prompt clearance from blood, hence, reducing the probabilities of periconceptional exposure

The first pilot study for the clinical use of letrozole for ovarian induction in polycystic ovary syndrome (PCOS) patients was done in 2000.

In large randomized study, letrozole was superior to clomiphene as a treatment for anovulatory infertility in women with the polycystic ovary syndrome. Letrozole was also associated with higher live-birth and ovulation rates.

Ovulation induction with letrozole is associated with an ovulation rate of 70%-84% and a pregnancy rate of 20%-27% per cycle.

While in another study which Compare the Effect of Letrozole Alone with Letrozole Plus N-Acetylcysteine on Pregnancy Rate in Patients with Polycystic Ovarian Syndrome, the pregnancy rate was 7.5% in letrozole alone group .

Human chorionic gonadotropin (HCG) hormone will replace the naturally surging luteinizing hormone at mid-cycle, subsequently, will lead to full maturation of oocytes resulting in ovulation. Additionally, HCG will also enhance the endometrial quality by stimulating the corpus luteum. HCG is a hormone that is produced mainly by the placental syncytiotrophoblasts cells, it is also produced by other organs in minute amounts (Liver, colon and pituitary gland). HCG main function is maintaining pregnancy through stimulating the corpus luteum to produce progesterone.

This hormone is the cornerstone drug for inducing final maturation of follicles during a diversity of infertility treatment protocols.

In order to diagnose Polycystic ovarian syndrome two out of three Rotterdam criteria should be present. These criteria are: chronic anovulation, clinical and/or biochemical evidence of hyperandrogenism, and polycystic ovaries by ultrasound .

incidence of PCOS from 6% to 21% when the ESHRE/ASRM 2003 criteria were applied. Infertility (clinical definition) is currently defined as 1 year of unwanted non-conception with unprotected intercourse in the fertile phase of the menstrual cycles

Eligibility Criteria:
Inclusion Criteria:

* Infertile women with PCOS
* Normal hysterosalpingography
* Normal semen analysis according to WHO parameters are major prerequisites

Exclusion Criteria:

* Infertile women with causes other than PCOS,
* Ages \<18 or \>35 years
* women taken confounding medications like other infertility drugs
* Insulin sensitizers or hormones
* Abnormal hysterosalpingography
* Subnormal semen analysis
Epidemiological Study of Inflammatory Myopathies in a French Region

Knowledge of the descriptive epidemiology of MIs is very limited. The main objective of this study is to determine the prevalence of inflammatory myopathies in Alsace at the 1st January 2012 with "capture-recapture" design using several independent sources of case identification.

Inflammatory myopathies (MIs) are a group of muscle diseases with a significant heterogeneity, clinical, immunological and prognosis.

The old classifications, still currently used, highlight this heterogeneity. Therefore Troyanov and coll. and Hoogendijk and coll. have each recently proposed a classification based on clinical and serological - and immuno- histological examination.

The pathogenesis and prognosis of MIs is very different depending on the entity in question.

Knowledge of the descriptive epidemiology of MIs is very limited. In fact no epidemiological work using criteria consensual classification is actually started.

We propose an epidemiological study of MIs. The main objective of the study is to determine the prevalence of MIs in Alsace at 1stJanuary 2012 by means of a "capture- recapture" study using several independent sources of case identification. The secondary objectives of the study are:

* estimating the geographical distribution of the disease in the Alsace region and / or Auvergne
* demographic description of patients : age, sex, residence , occupation
* description of the disease: patient age at diagnosis, disease classification , main clinical manifestations and complications
* Identification of paraneoplastic forms will be for the Alsace region by crossing with Alsatian cancer registries. These records will be interviewed to identify cases of MIs associated with cancers.

Eligibility Criteria:
Inclusion Criteria:

* All patient reported suffering from inflammatory myopathy
* Meeting the Hoogendijk, Troyanov and Griggs classification criteria
* Alive at 1st January 2012- Domiciled in Alsace (Bas-Rhin or Haut-Rhin counties of France)

Exclusion Criteria:

* All patient reported with a different or incomplete diagnosis of inflammatory myopathy (not meeting the Hoogendijk, Troyanov and Griggs criteria)
* All patient dead and/or non-domiciled in Alsace at 1st January 2012
Omega-3 Fatty Acid Dietary Intervention (O3DI)

Elevated cholesterol, including triglyceride levels, can lead to the development of cardiovascular disease in adulthood. A diet that is rich in omega-3 fatty acids (O3FA) can improve triglyceride levels in a way that is safe and does not require medication.

This is a single-center, prospective, unblinded, randomized-controlled dietary intervention study to assess the impact of an omega-3 fatty acid diet compared to a standard lifestyle intervention on serum triglyceride in patients with hypertriglyceridemia. The study consists of an 8-week dietary treatment period followed by an 8-week observation period.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients who are 10 -17 years of age
2. BMI greater than or equal to the 85th percentile
3. Clinical serum triglyceride level \>150 mg/dl and \< 500 mg/dl performed between 3 months and 1 week prior to study visit 1
4. Ability to follow the study procedures and adhere to the diet counseling recommendations
5. Written parental permission and assent are obtained prior to any research procedures

Exclusion Criteria:

1. Type 2 DM (hemoglobin A1C \>6.6%)
2. Isotretinoin use
3. Chronic kidney disease (CKD)
4. Uncontrolled hypothyroidism
5. Warfarin use
6. Liver disease (NAFLD is allowed)
7. Renal disease
8. Corticosteroid use
9. Omega-3 fatty acid use (prescription or supplement)
10. Allergy to fish and/or nuts
11. Currently pregnant or planning to become pregnant during the course of this trial - confirmed by date of LMP/querying family
12. Any significant medical condition which the investigator believes would interfere with participation in this study
Stereotactic Ablative Radiotherapy for Oligometastatic Hepatocellular Carcinoma

Oligometastasis is a definition that has been described in the past in the 1990s, and in some patients, metastases are not extensive and are limited to a small number of metastases. The local ablative treatment for oligometastasis is not a new concept. In case of liver metastasis from colorectal cancer, long-term survival can be expected if the liver resection is performed. Effectiveness has been demonstrated in studies of adrenal and brain metastasis from lung cancer as well as lung metastasis from sarcoma. A recent non-randomized study reported that patients with oligometastasis improved treatment outcomes with aggressive treatment. This study demonstrated that local ablative treatment for oligometastasis showed better treatment outcomes than expected. Also, the long-term outcomes in SABR-COMET trial showed that the overall survival were increased by 22 months. So far, the standard treatment for metastatic disease is systemic chemotherapy. However, based on these results from studies, active local treatment for patients with oligometastasis is currently being performed in the clinic. In this study, we aimed to apply this concept to patients with hepatocellular carcinoma. To confirm the efficacy and safety of stereotactic radiotherapy in patients with oligometastasis hepatocellular carcinoma


Eligibility Criteria:
Inclusion Criteria:

i. 19 years or older

ii. Patients who signed the informed consent form

iii. The clinical trial protocol can be complied with at the discretion of the investigator

iv. Performance status (based on ECOG) less than 2 (0, 1)

v. Patients with life expectancy greater than 3 months

vi. Condition in which primary cancer is controlled

• Definition: A condition that has not progressed at the time of review of clinical trials after curative treatment of primary cancer 3 months ago

vii. Number of metastatic lesions up to 5

viii. 3 or less metastatic lesions in one metastatic organ

ix. Those who are undergoing targeted therapy or chemotherapy can also be included (during radiation therapy, drug treatment is stopped)

Exclusion Criteria:

i. Serious medical complications that cannot proceed with radiation therapy

ii. Previous radiation therapy history at the location where radiation therapy is to be performed

iii. malignant pleural effusion

iv. When the spinal cord and the tumor are close (the tumor is located within 3 mm)

v. In case of brain metastasis requiring surgical intervention
Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil

The purpose of this study is to determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug.


Eligibility Criteria:
Inclusion Criteria:

* first trimester missed abortion

Exclusion Criteria:

* history or evidence of disorders that represent contraindication to the use of misoprostol:

  * severe pulmonary diseases
  * congenital or acquired heart diseases
  * glaucoma
  * prolonged use of corticosteroid
  * sickle cell anemia and adrenal insufficiency
  * smokers
  * known hypersensitivity to drugs
  * any evidence of infection
* patient's refusal to participate in the study
* patients with abnormal results of investigations
* patients with previous operations on cervix like conisation, cauterization, previous dilatation and curettage
* patients with complete abortion
* patients with severe bleeding that required emergency surgical evacuation of the uterus
* patients with partially dissolved tablets at the site of application in both groups
Study of Alpha-blockers Alone During Preoperative Preparation in Patients With Pheochromocytoma

Study of the relationship between hemodynamic stability and preoperative intravenous rehydration in patients with pheochromocytoma

All patients were subclassified into either the hemodynamic stability group (HS group) or the hemodynamic instability group (HU group) according to whether intraoperative hemodynamic instability occurred. Differences in data between the two groups were examined, and the risk factors for intraoperative hemodynamic instability were analyzed using logistic regression.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of adrenal pheochromocytoma Must be able to swallow tablets

Exclusion Criteria:

Bilateral or multiple pheochromocytomas. Ectopic pheochromocytoma
Assessment of Contrast Enhancement Boost for the Direct Identification of Pulmonary Emboli in Thoracic CT Angiography

Pulmonary embolism is a common cardiovascular disease and thoracic CT angiography is currently considered the gold standard for its non-invasive diagnosis. However, the diagnostic performance of CT angiography can be hampered by an insufficient enhancement of pulmonary arteries. Contrast Enhancement Boost (CE Boost) is a post-processing technique using an iodine density map to artificially improve pulmonary artery enhancement.

This retrospective study compares standard CT-angiography images with CE Boost images to assess the potential improvement of diagnostic performance for the detection of pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* Patient who underwent thoracic CT angiography for suspicion of pulmonary embolism in our institution between March and June 2018

Exclusion Criteria:

* None
Comfort Score During Ultrasound Guided Supraclavicular Brachial Plexus Block Placement in Elderly Patients

Results from our preliminary study accepted as e-poster presentation on ESRA (Bordeaux, September 2012.) showed significant difference in Comfort Score during Ultrasound Guided Supraclavicular Brachial Plexus block (US-SCB) between young and elderly population. However, it is unknown whether the difference in Comfort score (1) was associated with reduction of local anesthetic (LA) volume in elderly or it is attributed to elderly population by itself. The aim of the study is to compare the Comfort score during US-SCB placement in elderly patients undergoing upper limb surgery performed with two different volumes of local anesthetics (20 ml vs 32 ml).

Involutional changes of brachial plexus in elderly, assessed by measuring the cross-sectional area (CSA) of brachial plexus at the first rib, allowed a 35% reduction of LA volume for an effective US-SCB in comparison with the younger patients (2). Ultrasound-guided regional anesthesia becomes an increasingly popular technique and its performance must be as comfortable as possible. Therefore, Comfort score during block placement is extremely important. Comfort Score is consisted of maximum pain intensity (VAS), the satisfaction of the patient and the number of unpleasant events declared by the patients. It is calculated as the sum of each criterion, which was attributed a value of 0 or 1: VAS(\<or=30/100, 1; \>30/100, 0), number of unpleasant events (0, 1; \>or=1, 0) and satisfaction (satisfied or very satisfied, 1; acceptable or unsatisfied, 0). Comfort score of 3 or 2 is considered as comfortable while score 1 or 0 as uncomfortable block placement.

Eligibility Criteria:
Inclusion Criteria:

* age over 65 years (Elderly group)
* upper limb surgery

Exclusion Criteria:

* refusal of regional anesthesia
* any neurologic or neuromuscular disease
* clinical signs of cutaneous infection at the site of needle insertion
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTP-543 in Healthy Subjects

Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.

This two-part study will assess, in healthy volunteers, under fasted conditions, and in a sequential manner, the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses of CTP-543.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and females between 18 and 50 years of age, inclusive
* Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive

Exclusion Criteria:

* History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
* PR interval \> 220 msec or QRS duration \> 120 msec or QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug
* History of herpes zoster
* Hemoglobin, white blood cell, or platelet levels below the lower reference limit at screening or prior to the first dose of study drug
* Liver function tests greater than the upper limit of normal
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody
* Urinalysis positive for protein or glucose
* A positive screen for alcohol, drugs of abuse, or tobacco use
* Donation of blood, plasma or other blood products prior to screening
* A positive tuberculosis test
SPI-62 As a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome

This is a randomized, placebo-controlled, study of SPI-62 in subjects with ACTH-dependent Cushing's syndrome caused by a non-adrenal tumor. Subjects will receive each of the following 2 treatments for 24 weeks: SPI-62 and matching placebo with the option of long-term extension.

This is a multicenter, randomized, placebo-controlled, Phase 2 study to evaluate the pharmacologic effect, efficacy, and safety of SPI-62 in subjects with ACTH-dependent Cushing's syndrome. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in a screening period (Days -35 to -8), a baseline period (Days -7 to -1), and a treatment period (Day 1 of Week 1 to Day 168 ± 3 days of Week 24) and, the option of long-term extension. Subjects have the option to continue with the study on active study drug and return to the site every 3 months for blood tests and study drug dispensing. The visits may be conducted remotely if testing can be arranged.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-menstruating female
* 18 years or older
* Active and consistent cortisol excess
* Documented diagnosis of ACTH-dependent Cushing's syndrome including Cushing's disease, ectopic ACTH secretion, and ectopic CRH secretion.

Exclusion Criteria:

* Recent (within 6 weeks) surgery for Cushing's or surgery planned within 24 weeks of randomization.
* History of any fractionated radiation therapy for Cushing's within the past 2 years or conventional radiation therapy within 4 years.
* History of bilateral adrenalectomy or exogenous, pseudo, cyclic, or non-ACTH-dependent Cushing's syndrome (including certain inherited conditions).
* High risk of acute morbidity from corticotroph adenoma growth (similar to that which occurs with Nelson's syndrome) defined as current evidence of macroadenoma at risk of impingement of vital structures.
* Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results, including but not limited to poor venous access or recent receipt or donation of blood products.
* Women who are currently pregnant, lactating or planning fertility and unwilling to adhere to approved contraceptives or abstinence.
The Effect of an Interactive Video on Nursing Students' Learning in the Care of Anti-Embolism Stockings

This study will be conducted as a randomized controlled trial with a parallel design to determine the impact of an interactive video developed for the care of surgical patients wearing anti-embolism stockings on nursing students' learning outcomes. The research hypotheses are as follows: H0a: There is no significant difference in knowledge levels related to anti-embolism stocking care between the experimental and control groups. H0b: There is no significant difference in skill levels related to anti-embolism stocking care between the experimental and control groups.

The study will be conducted using a randomized controlled experimental design with third-year nursing students who have successfully completed their second year at a public university in a province of Turkey. The sample will include 60 students, with 30 in the experimental group and 30 in the active control group. Data will be collected using the Student Demographic Characteristics Form, the Perioperative Anti-Embolism Stockings Care Knowledge Assessment Form, the Perioperative Anti-Embolism Stockings Application Skills Assessment Form, and the Interactive Video Evaluation Form, all of which were developed by the researchers based on the literature. The study will evaluate the impact of the interactive video developed for the care of surgical patients wearing anti-embolism stockings on the knowledge and skill levels of nursing students.

Eligibility Criteria:
Inclusion Criteria:

* The student's academic average must be above 2.00.
* The student must own a smartphone, tablet, or laptop/desktop computer capable of downloading the video.
* The student must have internet access.
* The student must be willing to participate in the study voluntarily.

Exclusion Criteria:

* Graduates of health vocational high schools.
* Students who have failed the Surgical Diseases Nursing course.
* Students who have not participated in any of the stages of the study.
* Students who voluntarily decide to withdraw from the study.
Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs

The Partner Navigation Intervention Study is a randomized controlled study (RCT) to assess the efficacy and mechanism of action of the first behavioral intervention to increase hepatitis C (HCV) treatment initiation among adult people who inject drugs (PWID).

After an initial ramp-up phase to ensure intervention materials and protocols meet the needs of the target population and organizational setting, we will apply a stratified randomized design to enroll 250 adult PWID with recently diagnosed HCV infection ("index") and their primary injecting partner("partner") into a randomized control efficacy trial of a two-session partner navigation intervention, compared to standard of care. The primary endpoint is starting HCV treatment. Recruitment will over sample PWID between 18-30 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Self report injecting drugs in the past month
* Self report a primary injecting partner (currently inject drugs together)
* HCV infection identified at partnering community-based clinical site
A Study of Pertuzumab With Erlotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study will assess the safety and tolerability, and make a preliminary assessment of activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior chemotherapy regimen. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is less than 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients greater than or equal to 18 years of age
* Histological confirmation of non-small cell lung cancer (NSCLC)
* Locally advanced or metastatic disease
* Failure of at least one prior regimen of standard chemotherapy for locally advanced or metastatic disease
* Life expectancy of more than or equal to 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Baseline Left Ventricular Ejection Fraction (LVEF) of greater than or equal to 50%
* A negative pregnancy test one week prior to treatment and willingness to use contraception among women of childbearing potential
* Availability of histological Formalin-Fixed, Paraffin-Embedded (FFPE) tumor tissue

Exclusion Criteria:

* Prior chemotherapy, radiotherapy or immunotherapy within 4 weeks of study Day -8
* Prior treatment with any agent which targets growth factors or their receptors
* Patients who have not recovered from the acute reversible effects of chemotherapy and radiotherapy
* History of clinically significant cardiovascular disease
* History or evidence of central nervous system metastases
* Treatment with any investigational drug within 28 days of the start of the study (day -8)
* Prior cumulative doxorubicin dose of more than 360 mg/m2 or the equivalent