cyrilzakka/clinical-trials huggingface dataset:
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but \< 85 years of age at the time of informed consent.
* Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures.
* Subject is willing and capable of complying with all required follow-up visits.
* Subject and/or Care Team agree that the distance and transportation resources from the patient's home to the clinic are reasonable for study participation and compliance.
* Subject has an estimated life expectancy \> 18 months.
* Subject is ambulatory (cane or walker are acceptable).
* CKD Stage 5 (eGFR less than 10) or ESRD subjects presenting for upper arm autologous arteriovenous fistula creation that is not transposed for hemodialysis access.
* Subjects who are currently on dialysis through a CVC or who imminently require dialysis (GFR \<10).
* Vein diameter ≥ 2.5 mm at the antecubital fossa per vein mapping.
* Artery diameter ≥ 2.5 mm per vein mapping.
* Subject is not participating in another investigational clinical trial that has not met its primary end point. Participation in post-market registry is acceptable.

Exclusion Criteria:

* CKD Stage 1-4 or subjects that do not require upper arm autologous arteriovenous fistula creation for hemodialysis access.
* Subject has history of Steal Syndrome.
* Subject who is immunocompromised or immunosuppressed.
* Subject has had three previous failed AV fistulae for hemodialysis access.
* Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.
* Known or suspected active infection on the day of the index procedure.
* Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula.
* Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count \<50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access.
* Subjects with active malignancy.
* Subjects with a history of poor compliance with the dialysis protocol.
* Subjects with a known or suspected allergy to any of the device materials.
* Subjects with an existing fistula or graft.
* Subjects who are anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months.
* Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.
Home or Office Visit for the Insertion of Implantable Birth Control

This is a pilot study in which women who desire an etonogestrel implant will be randomized to either a home or office insertion visit. The purpose of this research is to study the interest in, feasibility of, and rates of insertion for implantable birth control (Implanon®/Nexplanon®) when inserted at home visit appointments compared to standard office visit appointments.

The ultimate goal of the study is to reduce barriers to insertion of the etonogestrel implant and increase consistent and correct contraception use by introducing a previously unexplored method of access, the home visit.


Eligibility Criteria:
Inclusion criteria

* Women aged 18 and over
* Was pregnant within the last 10 weeks
* Interested in using the etonogestrel implant for contraception
* Willing to have investigators come to the home for an insertion visit
* Presenting to University Hospitals for delivery or contraception.
* Has running water and a working bathroom in the home
* Has a safe and private location in the home for the implant to be inserted

Exclusion criteria

* Current or history of thrombosis or thromboembolic disorders
* Liver tumors or active liver disease
* Undiagnosed abnormal genital bleeding
* Known or suspected breast cancer or history of breast cancer
* Allergic reaction to components (ethylene vinylacetate, etonogestrel, barium sulfate) of etonogestrel implant or local anesthetics
* Women currently taking hepatic enzyme inducers including but not exclusive to barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenylbutazone, phenytoin, rifampin, topiramate, protease inhibitors, and St. John's wort
* Uncontrolled hypertension
* Housing located greater than 10 miles from University Hospitals Center for Women's Health
* The location of the home is in a place that would not be safe for investigators
* Participant is homeless
Study of Clinical, Biological Characteristics and Quality of Life of Patients With Hereditary or Acquired Non Drug-induced Bradykinin-mediated Angioedema, Monitored in Besançon's Partner Site Reference Center for Studies of Kinin-mediated Angioedema (CREAK)

This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires


Eligibility Criteria:
Inclusion Criteria:

* Clinically documented angioedema due to C1 inhibitor deficiency, hereditary (type I et II) or acquired
* Clinically documented angioedema with normal C1 inhibitor activity (hereditary type III)

Exclusion Criteria:

* Acquired angioedema with normal C1 inhibitor activity (former "drug-induced")
* Minor subjects
* Vulnerable subjects (under guardianship/curatorship/tutorship)
* Pregnant women
Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes

Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Has type 2 diabetes treated with either: \*A stable regimen of metformin for a minimum of 3 months, and/or \*Diet modification and exercise for a minimum of 3 months.
* Has HbA1c of 7.1% to 11.0%, inclusive.
* Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.

Exclusion Criteria:

* Received any investigational drug within 3 months prior to screening.
* Is currently treated with any of the following excluded medications: \*Thiazolidinediones within 3 months of screening; \* Sulfonylureas within 3 months of screening; \* Insulin within 1 year of screening.
* Participated previously in an exenatide clinical study.
Post-operative Radiation With IMRT in the Management of Stage IIB-III Breast Cancer

Research has shown that treatment with conventional radiation techniques and chemotherapy following mastectomy or breast conserving surgery has resulted in better rates of locoregional control and overall survival in stage IIB-III breast cancer. The current feasibility trial using the most recent advance in radiation therapy, namely helical tomotherapy intensity modulated radiation therapy (HT-IMRT), hopes to improve on the results of conventional radiation by decreasing the amount of radiation-induced toxicity in patients with stage IIb-III breast cancer.

The role of locoregional radiation therapy in the management of stage IIB and III breast cancer has evolved and continues to evolve. The exact role of locoregional radiation, including axillary, supraclavicular and internal mammary nodes is, however, not clear. Radiation-induced toxicity remains a limiting factor to expanding the indications for radiation therapy to axillary and internal mammary nodes in the treatment of stage IIB and III breast cancer. Excellent target coverage and normal tissue sparing of IMRT has been previously demonstrated dosimetrically and clinically. In this feasibility study, patients will receive 50 Gy of radiation therapy in 25 fractions to the chest wall and supraclavicular, axillary and IM nodal areas using HT-IMRT following breast conserving surgery or mastectomy and chemotherapy. Patients will also be eligible for a radiation boost to 12 Gy by HT-IMRT or HDR brachytherapy. It is expected that treatment with HT-IMRT will result in appreciably fewer side-effects following locoregional irradiation due to a reduction in normal tissue irradiation, as compared to conventional radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Surgery with either mastectomy or breast conserving surgery
2. Presence and association of any of the following high risk pathological features present at time of surgery: stage pT3-4 and pN0 and central/medial location of tumour or any pT and pN2 (stage IIB-stage III)
3. All patients will have been treated previously with chemotherapy prior to radiation therapy
4. ECOG performance status of 2 or less

Exclusion Criteria:

1. Prior chest wall/breast or nodal radiation for other malignancies (i.e. Hodgkin disease)
2. HER2+ positive patients
3. Patients with diagnosis of metastatic disease
4. Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of breast cancer
Effect of Abdominal Massage on Bowel Movements in Patients with Subarachnoid Hemorrhage

The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit.

The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit. The sample of the study will consist of a total of 64 patients, 32 in the experimental group and 32 in the control group, hospitalized in the tertiary neurosurgery intensive care unit. Data collection tools are the "Descriptive Characteristics Form" and the "Patient Follow-up Form".The statistician will determine whether the patients who meet the sampling criteria will be assigned to the experimental or control group through randomization. The stratified randomization method will be used in the study. In this context, patients who meet the inclusion criteria from the start date of the study in the Neurosurgery Intensive Care Unit will be randomized by assigning them to the control group and abdominal massage groups, respectively. Patients will be assigned to the control and abdominal massage groups in this order until the sample size is reached. The CONSORT diagram will be used in the randomization of patients.

Eligibility Criteria:
Inclusion Criteria:

* • 18 years of age or older

  * Underwent neurovascular surgery
  * Received general anesthesia
  * Have no wounds, surgical intervention, or radiotherapy in the abdominal region
  * Have no bowel obstruction, irritable bowel syndrome, inflammatory bowel disease, abdominal herniation, or bowel cancer
  * Began oral feeding at the 6th hour post-surgery
  * Stayed in the intensive care unit for 3 or more days
  * Have a Glasgow Coma Scale (GCS) score of 9 or above
  * Have no signs of acute abdomen
  * Have no intra-abdominal infection
  * No mechanical ventilation
  * Mobilezed in the preoperative period
  * Unable to mobilize after surgery
  * Evaluated by the intensive care physician with no contraindications for abdominal massage
  * Have a first-degree relative who has given consent

Exclusion Criteria:

* Patients with the following conditions will be excluded from the sample:

  * Those with chronic constipation, fecal incontinence, or diarrhea
  * Those fed with a fiber-enriched nutritional solution (e.g., Nutrison Protein Plus Multifibre®, Fresubin Original Fibre®, Isosource Fiber®, Jevity Plus®)
  * Those fed via nasogastric enteral tube
  * Those receiving parenteral nutrition
  * Patients with a BMI \> 40 (morbid obesity)
European Deep Brain Stimulation (DBS) Depression Study

To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for treatment resistant Major Depressive Disorder (TR-MDD), single or recurrent episode on mood as measured by the MADRS.

The European Study was a prospective, multicenter, double-blind, randomized study comparing high frequency stimulation (130 Hz) to low frequency stimulation (20 Hz). Subjects underwent 2 baseline evaluations by 2 separate psychiatrists and were implanted with the Libra DBS system. Subjects were randomized to receive either high or low frequency stimulation. The primary endpoint was evaluated after 6 months of stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Men and women (non-pregnant) age is 21-70 years;
* Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revision, 2000 (DSM-IV-TR) criteria derived from the Mini International Neuropsychiatric Interview (MINI);
* First episode onset before age 45;
* Current episode \> 12 month duration;
* In the current episode: Documented resistance to a minimum of 4 adequate depression treatments from at least 3 different categories;
* In adult lifetime (\>21 year of age) have experience a period of wellness as defined by DSM IV criteria;
* MADRS score ≥22 at 2 separate baseline visits, rated by 2 separate psychiatrists;
* Global Assessment of Functioning (GAF) score \<50;
* Mini-mental state examination (MMSE) score \>24;
* No change in current antidepressant medication regimen or medication free for at least 4 weeks prior to study entry;
* Able to give informed consent in accordance with institutional policies;

Exclusion Criteria:

* A diagnosis of bipolar I or bipolar II disorder by DSM-IV-TR criteria, derived from the MINI;
* Meets criteria for borderline or antisocial personality disorder in the last 12 months by DSM-IV-TR criteria, derived from the Cluster B Personality Disorders Sections 301.7 - 301.83, preferably screened via Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) at Baseline visit (optional);
* In the current depressive episode, has been diagnosed with General Anxiety Disorder (GAD) - as defined by the DSM-IV-TR, and GAD is the primary diagnosis;
Digital Imaging Aid for Assessment of Cervical Dysplasia

The overall objective of this study is to evaluate whether polarized or green filtered digital imaging can assist clinicians to screen for premalignant lesions in the cervix.

The specific aims of the study are:

* To compare polarized and green filtered digital images of the cervix, to standard white light images, colposcopic evaluation and to pathologic analysis of biopsied tissue.
* To develop algorithms to discriminate between normal and abnormal tissue based on digital images of the cervix.
* To analyze digital images to determine which types of optical information yield the most diagnostically useful data.

If you agree to take part in this study, digital imaging will be performed for research purposes, after your routine colposcopy of your cervix.

VISUAL DETECTION OF PRECANCEROUS LESIONS:

Reflectance (the ability of an area to reflect light) imaging helps doctors visually tell the difference between precancerous tissue, cancerous tissue, and normal tissue in the cervix. Researchers want find out whether a digital camera image can be as effective as colposcopy at screening for precancerous tissue.

STUDY PARTICIPATION:

You will be seen in the clinic during a routine visit. Your cervix will first be examined by the clinician using a standard white light headlamp, and the image will be recorded.

Your cervix will then be re-examined with the digital camera, which will involve the use of different types of light (standard white light, green filtered light, cross and parallel polarized light). These digital images will be taken before and after acetic acid (vinegar) is applied.

Researchers will use these images to make comparison studies with the colposcopy procedure.

LENGTH OF STUDY:

Your participation will be finished on this study once your cervix has been examined with the digital camera.

This is an investigational study. Up to patients 20 will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older who are referred to the University of Texas MD Anderson Cancer Center Colposcopy Clinic for colposcopy are eligible for this study.
* Patients must sign an informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria:

* Patients who are pregnant are not eligible for this study.
Laparoscopic Staging in Patients With Ovarian, Fallopian Tube, or Other Primary Abdominal Cancers

RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for ovarian, primary fallopian tube, and primary abdominal cancers.

PURPOSE: Phase II trial to study the effectiveness of laparoscopic staging in patients with ovarian, primary fallopian tube, or primary abdominal cancers who have not undergone complete staging.

OBJECTIVES: I. Determine the feasibility of laparoscopic staging of patients with incompletely staged ovarian, primary fallopian tube, and primary peritoneal cancers. II. Assess the adverse effects associated with this technique.

OUTLINE: Surgery. Laparoscopy with cytologic examination and lymph node sampling followed, if feasible, by surgical resection.

PROJECTED ACCRUAL: Up to 50 patients will be accrued over approximately 2 years. If more than 4 evaluable patients cannot complete surgery, the study will be closed.

Eligibility Criteria:
DISEASE CHARACTERISTICS: One of the following incompletely staged malignancies: Ovarian cancer of any cell type Primary fallopian tube carcinoma Primary peritoneal carcinoma No clinical evidence of metastases to abdominal organs, the adnexa, or retroperitoneal lymph nodes on CT with contrast or at prior abdominal surgery No metastases on chest x-ray No contraindications to laparoscopy, i.e.: No bowel obstruction No ileus No peritonitis No excessive obesity as indicated by a Quetelet Index over 35 (weight in kg/height in sqm) No diaphragmatic hernia on chest x-ray No grade 2 heart toxicity

PATIENT CHARACTERISTICS: Age: Adult Performance status: GOG 0 or 1 Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 mg/dL AST no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Other: No second malignancy except nonmelanomatous skin cancer Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concomitant chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior or concomitant abdominal or pelvic radiotherapy Surgery: No prior retroperitoneal surgery No more than 10 weeks since initial abdominal surgery
OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy)

This protocol is a multicentric interventional phase II study from the French CML Intergroup (FILMC).

The core of the protocol is to explore the efficacy and safety of an optimization strategy consisting in the modulation of the dasatinib daily dose according to the results of repeated plasmatic levels of dasatinib.

The objective of this strategy is to improve the overall results of the treatment of early CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase mutations.

The study will be conducted in selected FILMC and Canadian centers.

The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb. The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing authorization is granted in that indication.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient ≥ 18 years
2. ECOG Performance Status score 0-2
3. Philadelphia chromosome positive newly diagnosed (≤ 3 months) CP-CML
4. patients not previously treated except with hydroxyurea or imatinib (less than 4 weeks for imatinib)
5. Signed written inform consent
6. Adequate hepatic function defined as: total bilirubin ≤ 2.0 times the institutional ULN; ALT and AST ≤ 2.5 times the institutional upper limit of normal (ULN).
7. Adequate renal function defined as serum creatinine ≤ 3 times the institutional ULN.
8. Women of childbearing potential (WOCBP) must be using an adequate method of contraception.

Exclusion Criteria:

1. Patients with BCR-ABL positive, Philadelphia negative CML
2. Patient previously treated with a tyrosine kinase inhibitor (TKI) except with imatinib during less than 4 weeks.
3. Pregnancy
4. Active malignancy
5. Uncontrolled or significant cardiovascular disease
6. Patients with QTc \> 450 ms
7. Significant bleeding disorder unrelated to CML
8. Concurrent severe diseases which exclude the administration of therapy
Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.


Eligibility Criteria:
Inclusion Criteria:

* Treated with a statin.
* Fasting LDL-C \> 70 mg/dL and triglyceride \<=400 mg/dL.
* High or very high risk of incurring a cardiovascular event.

Exclusion Criteria:

* Pregnant or breastfeeding females.
* Cardiovascular or cerebrovascular event of procedures during the past 30 days.
* Congestive heart failure NYHA class IV.
* Poorly controlled hypertension.
Novel Prognostic Markers in Renal Cancer

The purpose of this project is to analyze tumour tissue from a group of subjects with renal cell carcinoma, who have been treated at the Royal Marsden Hospital.

Renal cancers have different clinical outcomes. The principal research objective is to study tumour tissue from renal cancer patients and try and understand why some cancers progress more rapidly than others. Further, another key aim of this study is to try and understand why some patients respond to treatment and others do not.

Eligibility Criteria:
Inclusion Criteria:

* The presence of histologically proven renal cell cancer
* The availability of paraffin embedded tissue
* Informed consent needed for tissue taken after January 2006 (date of enforcement of human tissue act)

Exclusion Criteria:

* Absence of histological tissue
* Absence of consent to study tissue after January 2006
Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).

This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be current cigarette smokers who have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit.
* mild to moderate COPD confirmed by spirometry
* Subjects must have a clinical diagnosis of COPD.

Exclusion Criteria:

* Subjects who have made a serious attempt to quit smoking in the past 3 months.
* Subjects who have been previously randomized in a study that has included varenicline.