cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD).

Secondary objectives of the study are to:

* evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
* evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
* evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD

The total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study.
* Re-induction- Participants who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study

NOTE- Additional criteria may apply, please contact the investigator for more information

Exclusion Criteria:

* Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons)
* Participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician.
* Participant anticipates requiring major surgery during this study.
* Participant is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.

NOTE- Additional criteria apply, please contact the investigator for more information
Seric Calprotectine in Spondyloarthritis

To date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. A growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. In spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. Although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. Still others have shown that it could be a predictive factor of radiological evolution in the same disease key. These data support, despite the questionable results of the Klingberg study, the value of this dosage in spondyloarthritis. The objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. Difficulties classically encountered in common practice in rheumatology.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the active line of the rheumatology department with one of the following criteria:

  * active spondyloarthritis (BASDAI \>4),
  * or spondyloarthritis in low activity (BASDAI\<4),
  * or fibromyalgia without associated inflammatory rheumatism,
  * or healthy subjects (without inflammatory rheumatism and without fibromyalgia.
* Patients who have not objected to the use of their samples

Exclusion Criteria:

* Minor patient
* Subject not affiliated to the social security system
* Subject deprived of liberty
* Patient under guardianship or curatorship
Endometrial Scratching in Couples With Unexplained Subfertility

Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase pregnancy rate in women with unexplained infertility.


Eligibility Criteria:
Inclusion Criteria:

* women aged between 20 and 39 years with at least one year of infertility
* regular menstruation with the length of the cycle between 22-34 days and ovulation confirmed by appropriately timed mid-luteal progesterone
* fertile semen variables
* bilateral tubal patency (demonstrated by laparoscopy or hysterosalpingography).
Effect of Dexamethasone on Duration of Lower Extremity Blocks With Bupivacaine in Subjects Having ACL Repair

Anterior cruciate ligament reapair is a painful procedure. Single shot femoral and sciatic nerve block only last 12-16 hrs. Since dexamethasone prolongs brachial plexus block, using it in lower extremity blocks will prolong the analgesia to provide better outpatient pain relief after surgery at home.


Eligibility Criteria:
Inclusion Criteria:

* age 18-75, no contraindication to regional anesthesia

Exclusion Criteria:

* peripheral neuropathy
Estrogen for Triple Negative Breast Cancer

The purpose of this study is to determine the effectiveness of Estradiol treatment for advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study will also use tumor tissue from your original diagnosis or from a biopsy you may have had for your cancer to look at hormone receptors in the lab. The tissue left over from your previous surgery or a previous biopsy will be used for research tests to check whether a different estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen work better.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed breast cancer which is metastatic.
* A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from either a prior biopsy of the primary tumor or a metastatic site. .
* Primary tumor or metastatic biopsy lacking estrogen and progesterone receptor and Her2 negative
* Patients must have measurable disease.
* Eastern Cooperative Oncology Group performance status 0-1.
* Patients with bone metastasis at baseline must agree to treatment with intravenous bisphosphonates
* Subjects may have had 0-4 lines of prior systemic chemotherapy or targeted therapy regimens administered for treatment of their metastatic breast cancer.
* Age \>18 years
* Life expectancy of greater than 3 months.
* Patients must have adequate organ and marrow function as defined below:

Exclusion Criteria:

* systemic chemotherapies, targeted therapies or radiotherapy for their cancer within 2 weeks prior to entering the study
* Patients receiving any other investigational agents for breast cancer treatment.
* Patients with known brain metastases are excluded 3.2.4 History of allergic reactions attributed to compounds of similar chemical or biologic composition to estradiol.
* Patients with any condition of the gastrointestinal tract that is expected to result in an inability to take oral medication
* Dysfunctional or post-menopausal vaginal bleeding.
* Uncontrolled hypercalcemia/hypocalcemia
* Prior history of or active thrombophlebitis, cerebral vascular accident, myocardial infarction, deep venous thrombosis or pulmonary embolism.
* History of or active hepatic adenoma.
* Uncontrolled intercurrent illness
* Pregnant women are excluded from this study
* Patients with bone metastasis are excluded if they are unable to receive intravenous bisphosphonate therapy due to the risk for developing hypercalcemia.
Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.


Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of B-cell CLL, according to International Workshop on Chronic Lymphocytic Leukemia 2008
* Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ hybridization (FISH) testing
* No prior therapy for CLL other than corticosteroids for disease complications
* CLL that warrants treatment
* Presence of measurable lymphadenopathy
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Key Exclusion Criteria:

* Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
* Known presence of myelodysplastic syndrome
* History of a non-CLL malignancy except for the following:

  * the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment, or
  * carcinoma in situ of the cervix, or
  * adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or
  * asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to enrollment, or
  * ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or
  * other adequately treated Stage 1 or 2 cancer currently in complete remission
* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
* Ongoing liver injury
* History of noninfectious pneumonitis
* Ongoing inflammatory bowel disease
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing immunosuppressive therapy other than corticosteroids
* Received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment
* Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Randomised Controlled Trial Between Two Different HDR Brachytherapy Schedule in Locally Advanced Carcinoma of Uterine Cervix

The purpose of this study is to compare two different brachytherapy treatment option in locally advanced carcinoma of uterine cervix. Brachytherapy of two fractions of 9 Gy is effective in locoregional control and more convenient in terms of cost and time than 7 Gy brachytherapy of 3 fractions in management of locally advanced carcinoma of cervix.

Cervical cancer is the second most common cancer among women worldwide and is the commonest form of gynecolgic malignancy in Bangladesh.Radiotherapy in the form of external beam radiotherapy combined with intracavitary Brachytherapy is the accepted definitive mode of treatment.Limiting the number of high dose rate(HDR) Brachytherapy has the potential benefit of improving patient compliance and reducing treatment cost and duration.The aim of this study is to compare the treatment outcome and acute complications following treatment with 9 Gray (Gy) in two fractions of brachytherapy with standard EBRT in locally advanced carcinoma of cervix.

EBRT will be delivered by a cobalt 60 teletherapy unit to a prescribed dose of 50 Gy in 25 fractions of 2 Gy per fraction and 5 days a week over a period of 5 weeks concurrent with inj. Cisplatin 40 mg/meter square weekly for 5 weeks.The patients will be then randomised into two arms of HDR brachytherapy,either 9Gy in 2 fractions or 7 Gy in 3 fractions.All patients will be followed up as per guideline for 6 months.The treatment related toxicity will be measured by Common Toxicity Criteria(Common terminology criteria for adverse events v.3.0).

All the relevant collected data will be compiled on a master chart and then statistical analysis of the results will be obtained by using SPSS 17.The data will be analysed using Chi square test and T test.Significant value will be decided at a level of 0.05 in two tailed tests.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced carcinoma cervix (stage 2b - 4a)
* Histopathology squamous cell carcinoma

Exclusion Criteria:

* Previous history of malignancy
* Previously treated with radiotherapy
The Level of Knowledge and Awareness of Myofascial Pain Syndrome in the Turkish Population

This study aimed to assess the level of knowledge and awareness of myofascial pain syndrome (MPS) among the Turkish population.

The study will employ a cross-sectional design to assess the level of knowledge and awareness of myofascial pain syndrome (MPS) in the Turkish population. A representative sample of individuals will be selected for participation in the survey. A structured questionnaire will be developed specifically for this study, consisting of questions related to the understanding, recognition, and management of MPS. The questionnaire will be administered through face-to-face interviews. Data collected from the survey will be analyzed using appropriate statistical methods to determine the overall level of knowledge and awareness of MPS among the Turkish population.

Eligibility Criteria:
Inclusion Criteria:

* Giving consent.

Exclusion Criteria:

* Not giving consent.
* Any illness or disability that can prevent filling out the form or communicating.
Airway Epithelium Gene Expression: AEGIS IDE

The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.

Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and undergoing clinically indicated bronchoscopy
* All patients are required to be at least 21 years of age and be able to understand and sign the informed consent form
* Patient must be a current or former cigarette smoker

Exclusion Criteria:

* A pulmonary physician does not recommend that bronchoscopy be performed
* Inability to understand the written consent form and comply with requirements of the study
* History of prior primary lung cancer
* Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for \>24 consecutive hours.
The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)

The purpose of this study is to investigate the effect of percutaneous coronary intervention (PCI) on myocardial viability in coronary artery disease patients with single coronary total occlusion (CTO) lesions.

Patients with coronary artery disease might benefit from successful percutaneous coronary intervention (PCI). However, there is currently no consensus on an optimal treatment modality for single lesions resulting in coronary total occlusion (CTO). Since the other coronary arteries are often lesion-free, or with stenosis of less than 50%, patients often present with no symptoms. Although the expert consensus on CTO lesion suggests reducing the incidence of long-term adverse events via successful revascularization, there are few retrospective studies on single CTO lesions. To date, it is unclear whether successful PCI based on optimal medication treatment (OMT) can increase myocardial viability and the extent of myocardial viability related to prognosis of those CTO patients. Therefore, the aim of this multi-center, prospective, open labeled, non-randomized controlled study was to determine if the improvement to myocardial viability in single CTO patients with successful PCI plus OMT was superior to that of patients with only OMT.

Eligibility Criteria:
Inclusion Criteria:

* History of stable or unstable angina
* LVEF \> 35% on transthoracic echocardiography measurement
* Single lesion occluding the coronary artery detected by angiography or MSCTA, with or without stenosis of other coronary arteries (≤ 50% stenotic lesion)
* Availability for follow-up for up to 12 months
* No major barriers to provide written consent

Exclusion Criteria:

* Acute Q-wave myocardial infarction during the latest 3 months
* Revascularization in the non-culprit artery during the latest one month
* Unsuitable for PCI
* Unable to tolerate dual antiplatelet treatment (DAPT)
* Severe abnormal hematopoietic system, such as platelet count of \< 100×109/L or \> 700×109/L and white blood cell count of \< 3×109/L
* Active bleeding or bleeding tendency
* Severe coexisting conditions, such as severe renal insufficiency (GFR \< 60 ml/min•1.73m2), severe hepatic dysfunction \[elevated ALT (glutamic-pyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation\], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
* Life expectancy \< 12 months
* Pregnancy or planning pregnancy
* Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc.
* Participation or planning to participate in another clinical trial during the same period
* Refusal to comply with the study protocol
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass

It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. If this opening becomes too wide, food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating.

For some patients, doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine. Although this may help patients resume their weight loss, the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass.

The purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass. The procedure is designed to tighten the opening between the stomach pouch and the small intestine, which may slow down the passage of food to help patients feel full longer after eating.


Eligibility Criteria:
Inclusion Criteria:

* 6 months post primary RYGB with inadequate weight loss or weight regain
* BMI \>30 and ≤ 50
* Dilated gastrojejunal anastomosis
* Successfully completes screening process
* Signed consent

Exclusion Criteria:

* Recently quit smoking or plan to quit within the next year
* Pregnant or planning to become pregnant over the course of the next 9 months
* Mallampati score of 4
* Serious systemic disease or active disease of the gastrointestinal tract
* Gastric pouch abnormalities
* Significant movement limitations
* Use of weight-promoting or weight-reduction drugs during study period
* Severe eating disorders
* Uncontrolled depression or psychoses
* Ongoing severe complication resulting from initial RYGB or other condition that in the investigators' assessment would make the patient an unsuitable candidate for the study procedure
* History of significant cardiovascular, cerebrovascular or pulmonary disease
* Not a candidate for conscious or general sedation
* Anticoagulant therapies
* Active substance abuse
* Life expectancy \< 1 year
* Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's study endpoints
Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy

RATIONALE: Motivational counseling may help prevent pregnant women from smoking again after pregnancy.

PURPOSE: This randomized clinical trial is studying three different types of counseling to see how well they work in preventing smoking relapse after pregnancy in pregnant women who quit smoking during pregnancy.

OBJECTIVES:

* Develop and evaluate 2 "Motivational Relapse Prevention" (MRP) treatments of varying intensity for reducing postpartum smoking relapse among pregnant women who quit smoking during pregnancy.
* Assess MRP and Enhanced MRP (MRP+) effects on treatment mechanisms and the role of those mechanisms in mediating MRP and MRP+ effects on abstinence.
* Assess the cost-effectiveness of both the MRP and MRP+ treatments relative to each other and to usual care for reducing postpartum smoking relapse.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 intervention arms.

* Arm I (usual care \[UC\]): Participants receive self-help materials and brief relapse prevention advice based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.
* Arm II (motivational relapse prevention \[MRP\]): Participants receive the same intervention as in arm I. Participants also undergo telephone counseling over 30 minutes at 34 and 36 weeks gestation and then at 2, 4, 7, and 16 weeks postpartum.
* Arm III (enhanced MRP \[MRP+\]): Participants receive the same intervention as in arm I and telephone counseling as in arm II. Participants also undergo in-person counseling over 1 hour at 30-33 weeks gestation and then at 8 weeks postpartum.

Participants in all arms complete questionnaires at baseline, at 30-33 weeks gestation, and then at 8 and 26 weeks postpartum.

Participants are followed at 8 and 26 weeks postpartum.

PROJECTED ACCRUAL: A total of 450 participants will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 or older
2. former smoker who quit during pregnancy as assessed via self-report
3. smoked an average of greater than or equal to 1 cigarette per day during the year prior to the current pregnancy
4. gestational age \< 33 weeks and ability to attend an in-person visit at University of Texas MD Anderson Cancer Center (UTMDACC) between 30-33 weeks of gestational age
5. can speak, read and write in English.
6. must have a functioning home or personal cell phone

Exclusion Criteria:

1) high-risk pregnancy or known negative birth outcome