cyrilzakka/clinical-trials huggingface dataset:
Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)

The purpose of this study is to determine the effects of stress reduction on glucose, blood pressure, quality of life and overall health and well-being in overweight or obese women, either with Polycystic Ovary Syndrome (PCOS) or without PCOS (non-PCOS). Stress reduction treatment sessions will include one or more of the following activities: breathing exercises, meditation, stretching exercises or health education activities.


Eligibility Criteria:
Inclusion Criteria:

1. Women, age 18 years or older
2. Body mass index (BMI) ≥ 25 kg/m2 (overweight or obese)

Exclusion criteria:

1. Current pregnancy
2. Secondary causes of hyperandrogenemia, such as known or suspected androgen secreting tumors, Cushing's syndrome, or hyperprolactinemia (prolactin \>30)
3. Untreated hypothyroidism or hyperthyroidism (defined as TSH \<0.2 or \>5.5 mIU/mL)
4. Severe active neuropsychological disorder such as psychosis or suicidal ideation
5. Severe untreated depression or anxiety. Women with severe depression or anxiety will be allowed to participate if they are under the care of a mental health specialist as long as they have permission to do so from their mental health specialist and will continue to follow-up with their mental health specialist during the study.
6. History of an inpatient admission for psychiatric disorder within the past two years
7. Active alcohol or drug abuse
8. Inability to read, speak or write English
9. Inability to commit to the intervention and follow-up
10. Current enrollment in a stress reduction program
11. Mindfulness practice within the past 6 months (regular formal practice at least once a week)
12. Current enrollment in other investigative studies
13. Type 1 diabetes
EQUIC-CC: Enhancing Quality of Informed Consent - Customized Consent

Patients in 'parent' cooperative study projects are interviewed about their experiences in the informed consent process.

Intervention: (1) Cognitive stratification (obtained by a test of cognitive ability, followed by a tailored IC process); (2) Pre-recruitment video (a patient-activation video designed to prevent several common misconceptions; (3) Provide prospective research volunteers with a sense of the purpose and methods of controlled research); and (4) Evaluation of the informed consent process using the Brief Informed Consent Evaluation Protocol (BICEP) developed in EQUIC-DP.

Primary Hypothesis: The validity of informed consent can be improved, as measured by an independent interview of patients (BICEP), by at least one of three interventions described above.

Primary Outcomes: The quality of the informed consent process, as measured by the BICEP (Brief Informed Consent Evaluation Protocol). The BICEP also offers a method to certify informed consent in routine use.

Study Abstract: Customized Consent will develop and test an innovative, supplemental method of disclosing information to patients in the informed consent process. This disclosure strategy is intended to increase patients' understanding and satisfaction with the consent process. This study has two goals:

* to evaluate the effectiveness of an intervention to improve comprehension during informed consent; and
* to identify those patients for whom this intervention is most effective.

The primary goal of EQUIC-CC is to determine whether an intervention, added to usual procedures for obtaining informed consent, is able to improve comprehension. The second goal of EQUIC-CC is to identify those patients for whom an augmented consent intervention is most effective, as well as to determine which subgroups of patients, if any, are most likely to benefit from visual information added to the usual disclosure phase of obtaining informed consent.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Depends on 'parent' study

Exclusion Criteria:

Exclusion Criteria:

* Depends on 'parent' study
Electromagnetic Interference and Automobile Remote Keyless Entry in Cardiovascular Implantable Electronic Device (CIED) Patients

Cardiovascular Implantable Electronic device (CIED) is a evolution therapy and number of patients with it are growing rapidly. Electromagnetic interference causing device malfunction is not uncommon, Radiofrequency Identification system is among its plausible source. Patients with CIEDs are at risk of exposure to this novel product in their daily living especially automobile keyless access system. Only informal studies have been conducted and not be published. Formal and systemic evaluation and tests are crucial.


Eligibility Criteria:
Inclusion Criteria:

1. Age more than 18 years old
2. Able to give informed consent
3. Implanted with functioning pacemakers or AICD more than 3 months
4. Adequate and stable all device parameters
5. Able to operate self triggering event recorders (at least 30 seconds)

Exclusion Criteria:

1. Patient with single chamber (Atrial) pacemaker (AAI or AAIR)
2. Presence of unstable hemodynamic or conditions
3. Presence of sustained or ongoing arrhythmia, besides atrial fibrillation/atrial flutter in single (ventricle) chamber device or Atrio-ventricular block
4. Documented of over-sensing episodes under regular sensitivity threshold (0.25 mV or more in the atrial channel and 0.75 mV or more in the ventricular channel, for permanent pacemaker device, and manufacture default setting in Automatic Implantable Cardioverter-Defibrillator, AICD)
5. Lack of noise oversensing detection/trigger and Electrogram (EGM) storage capability
6. Lack of tachyarrhythmia detection and episode storage capability
Functional Magnetic Resonance Imaging and 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Treating Patients With Newly Diagnosed Brain Tumors

RATIONALE: New imaging procedures, such as functional magnetic resonance imaging and 1H-nuclear magnetic resonance spectroscopic imaging, may improve the ability to detect the extent of cancer in the brain.

PURPOSE: Phase II trial to study the effectiveness of functional magnetic resonance imaging and 1H-nuclear magnetic resonance spectroscopic imaging in treating patients who have newly diagnosed brain tumors.

OBJECTIVES: I. Determine the definable topospecific relationship between functional neuroactivation measured by functional magnetic resonance imaging (fMRI) and chemostructural tissue measurements made with 1H-nuclear magnetic resonance spectroscopic imaging (1H-NMRSI) in patients with newly diagnosed brain tumors situated in the vicinity of the brain's language and motor regions. II. Determine if clinical improvement correlates with stronger imaging signatures of neuroactivation on fMRI in this patient population. III. Determine if functional loss during tumor recurrence or progression correlates with increases in choline and decreases in N-acetylaspartate on 1H-NMRSI in regions that previously displayed activation on fMRI or in associated underlying white matter regions in these patients.

OUTLINE: Patients undergo preoperative functional magnetic resonance imaging (fMRI), 1H-nuclear magnetic resonance spectroscopic imaging (1H-NMRSI), and conventional contrast MRI over 2 hours followed by neurofunctional motor and/or language neurofunctional testing. Intraoperatively, patients undergo corticography consisting of awake language mapping and motor cortex stimulation. Patients undergo repeat imaging and neurofunctional evaluation at 2 weeks following surgery and prior to any radiotherapy or chemotherapy. Patients also undergo neurological and neuropsychological testing consisting of basic gait, motor coordination, reflexes, hand motor, tongue motor, and language evaluation to measure baseline, preoperative, and postoperative clinical status and outcomes. Patients are followed every 4 months for 1 year.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Newly diagnosed brain tumor Neuroradiological and clinical evidence of probable glioma Lesion in close proximity to language and motor areas No prior resection

PATIENT CHARACTERISTICS: Age: 18 to 55 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other medical or psychiatric disorder No contraindications to MRI scanning (e.g., metal implants, dental prostheses other than fillings, contrast allergies)

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Study of Cancer Peptides Vaccine Plus GM-CSF as Adjuvant Treatment for High Risk (TXN2-3M0) or Metastatic Breast Cancer With No Evidence of Disease

This study will evaluate the safety and feasibility of administering a peptide vaccine consisting of twelve different tumor-rejection antigens to patients with high risk (TxN2-3M0) or metastatic breast cancer with no evidence of disease following their completion of systemic therapy. The vaccine is designed to elicit immune responses against twelve different pathways that are essential to tumor growth, survival and metastasis.

The primary endpoint will be to determine the safety and feasibility of administering cancer peptides to patients with high risk (TxN2-3M0) or metastatic breast cancer with no evidence of disease following their completion of systemic therapy, with the secondary objectives of evaluating immune response disease relapse survival. Two cohorts of 9 patients each will be treated with different doses of the vaccine. They will receive the peptide vaccine subcutaneously on weeks 0,1,2,4,5, and 6 and then receive the immunizations every 1 month for 6 months or disease recurrence. Toxicity will be assessed at each dose level using CTCv3 toxicity criteria.

Eligibility Criteria:
Inclusion Criteria:

* HLA-A2 patients with histologically confirmed, TxN2-3M0 or metastatic breast cancer with no evidence of disease who have completed their adjuvant systemic chemotherapy or trastuzumab
* Subjects will not be treated until 4 or more weeks after any prior chemotherapy, radiation therapy or immunotherapy, but they may be receiving hormonal therapy

Exclusion Criteria:

* History of autoimmune disease
* Serious intercurrent chronic or acute illness
* Active hepatitis
* Serologic evidence for HIV, splenectomy
* Receiving steroid or immunosuppressive therapy
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer

This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression.

Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.

Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC

Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)

Eligibility Criteria:
Inclusion Criteria:

* Performance status 0-1.
* Weight Loss \< 10% in preceding 3 months
* Age 18 years and older.
* Adjuvant chemotherapy allowed if \> 6 months from protocol entry
* Adequate Organ Function
* Liver enzymes \< 2X normal, bilirubin = normal
* Oxygen saturation\> 89% on room air unless chronically oxygen dependent (not cancer related)
* Creatinine \<2.0 mg

Exclusion Criteria:

* Not pregnant or lactating.
* No Clinical Brain Metastases
* No prior chemotherapy for systemic disease
* Imminent need for chemotherapy for impending organ dysfunction is not allowed
The Power of Curiosity: Leveraging Curiosity to Motivate People to Complete Health Risk Assessments

The investigators will work with one of Vitality's partner corporations to test whether curiosity can motivate employees to follow through on their virtuous intentions and complete their annual health risk assessment (VHR). Employees will receive email messages that contain either a curiosity-inducing question or a standard encouragement message. The investigators predict that presenting people with curiosity-arousing questions will make them more likely to complete a health risk assessment, as compared to standard messages.

The vast majority of adults express the desire and intention of engaging in healthy behaviors-exercising, losing weight, getting a colonoscopy-but then fail to do so. This has massive individual and societal costs. This research tests a promising intervention to increase the likelihood that an adult will follow through on their health-related intentions. Curiosity can be a powerful motivator and can cause people to engage in new behaviors (Tomkins 1962; Silvia 2006); however, curiosity has not yet been used as an intervention to help people follow-through on their intentions. In this project, the investigators target employees who have failed to complete their annual Vitality Health Review (VHR) and test whether curiosity can be used to induce the employees to complete their VHR. The VHR is a medical questionnaire that can help individuals understand medical risk factors they may be prone to. The investigators provide employees with a question and inform them that they will see the answer upon completion of their VHR. The investigators hypothesize that the curiosity-inducing messages will cause employees to follow through on their intention to complete their VHR.

Eligibility Criteria:
Inclusion Criteria:

* Employees at Vitality's partner's worksites that are in Vitality database
* Must have email address on file

Exclusion Criteria:

* Employees that have already completed their VHR by June 11, 2013
Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis

Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage during PD still remain unclear, generation of Endoplasmic reticulum (ER) stress may be responsible for progressive membrane dysfunction. Ursodeoxycholic acid (URSA) is a powerful inhibitor of ER stress to protect peritoneal fibrosis in peritoneal dialysis in the investigators in-vitro study. In this study the researchers investigated the hypothesis that URSA protect peritoneal membrane damage.

Ursodeoxycholic acid (URSA) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 300 mg per day. Patients will be randomly assigned to URSA and placebo group and prescribed according to the protocol. At 2 and 6 month, Peritoneal equilibrium test (PET) will be performed with blood sampling.

Eligibility Criteria:
Inclusion Criteria:

* Maintenance peritoneal dialysis at least 3 months
* Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information

Exclusion Criteria:

* Episode of peritonitis at least 3 months
* Episodes of admission due to other disease at lease 3 months
* Liver disease
* Allergic history with Ursodeoxycholic acid
* Nausea or vomiting after Ursodeoxycholic acid
A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.


Eligibility Criteria:
Inclusion Criteria:

* Male or female with age ≥ 18 years.
* Progressive or new metastatic melanoma, stage III or IV.
* Measurable disease by CT / MRI
* Failure of no more than 1 line of prior cytotoxic therapy.
* Adequate bone marrow, renal and hepatic function

  * Leukocytes ≥ 3000/mm3, ANC ≥ 1,500 cells/mm3, Platelets ≥ 100,000/mm3
  * Hemoglobin ≥ 10 g/dL (transfusion allowed)
  * Total bilirubin ≤ 1.5 x upper normal limit (UNL)
  * AST (SGOT), ALT (SGPT) ≤ 3.0 x UNL (≤ 5.0 x UNL may be acceptable)
  * Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance \> 45 mL/min/1.73 m2
  * PT/aPTT \< 1.5 x UNL or within therapeutic range via anti-coagulation therapy
* Karnofsky PS ≥ 70%.
* Estimated life expectancy \> 3 months.
* Signed informed consent approved IRB and ability to comply with the study or monitoring procedures.
* Subjects with evaluable disease are eligible in dose-escalation cohorts

Exclusion Criteria:

* Prior therapies for disease under study less than 4 weeks prior to enrollment.
* Major surgery or trauma within 4 weeks of enrollment.
* Active brain metastases
* Active chronic inflammatory, autoimmunity, immunodeficiency disease, and vascular or hemorrhagic disorders.
* History of allergic reactions to dolastatin, auristatin or compounds of similar composition.
* Significant cardiovascular disease
* Other malignancies
* Pregnancy or breast feeding
* Refusal or inability to use effective means of contraception (for men, and women with childbearing potential)
* History of or test-positive to HIV, or hepatitis B or C
Effects of Behavioral Interventions Based on Sensory Cues on FOG in PD After STN-DBS

The investigators aims to assess the effectiveness of behavioral interventions based on sensory cues on freezing of gait in patients with Parkinson's disease after bilateral subthalamic nucleus deep brain stimulation.

Freezing of gait (FOG) leads to falling and is one of the major determinants of quality of life and prognosis in Parkinson's disease (PD). Previous evidence suggests that subthalamic nucleus deep brain stimulation (STN-DBS) improve off-medication FOG but not on-medication FOG in patients with PD. Furthermore, off-mediation FOG persist or even worsen after STN-DBS in some PD patients.

Although visual and auditory cues are known to improve FOG in research setting, it is unclear whether these cues are effective for FOG in real clinical setting. Most previous studies have used wearable devices to use sensory cues, but such devices are difficult to apply in clinical practice.

Therefore, this study aims to investigate the effectiveness of behavioral interventions based on visual and auditory cues in patients with PD after bilateral STN-DBS. Participants undergo clinical evaluations including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Unified Parkinson 's Disease Rating Scale (UPDRS), Freezing of Gait-Questionnaire (FOG-Q), and the average number of falling over the last week. Then, participants receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice. To investigate the education effect, FOG-Q and the average number of falling over the last week are repetitively assessed at 2-week and 4-week follow-ups using a phone call.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's disease who are aged 30 years or older
* Patients who underwent bilateral subthalamic nucleus deep brain stimulation
* Patients who complain of freezing of gait

Exclusion Criteria:

* Patients who have already used sensory cues for freezing of gait in clinical practice
* Patients with MMSE scores of 18 or lower
* Patients with Hoehn-Yahr scale 5
* Patients who have neurological symptoms associated with neurological disorders other than Parkinson's disease
Study of the Impact on Survival of a Paradigm Shift in the Therapeutic Strategy of Patients With Advanced Ovarian Cancer

Ovarian cancer is the 8th leading cause of cancer-related death in women. Its prognosis is poor, with diagnosis often made at an advanced stage.

Patient management has evolved in recent years with more radical surgeries and the introduction of maintenance treatment following neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years old)
* Operated on at the HUS between January 1, 2010 and December 31, 2022
* Having undergone primary or interval cytoreductive surgery
* Suffering from stage FIGO IIIC or IV high-grade serous carcinoma of ovarian origin

Exclusion Criteria:

* Patiente ayant exprimé son opposition à la réutilisation de ses données à des fins de recherches scientifiques.
* Autres types histologiques de cancer de l'ovaire
* Stades de la maladie FIGO I, II, IIIA et IIIC
* Chirurgie de clôture.
Evaluation of Vitamin A and E Deficiency With Severity of SARS-COV-2 Disease: A Case-Control Study

Coronavirus disease 2019 (COVID-19) is a novel infectious disease that has been spreading worldwide Coronaviridae study group of the International Committee on taxonomy of viruses (2020). The clinical manifestation of COVID-19 can range from asymptomatic infection to critical illness with severe pneumonia, respiratory failure, and death.

Vitamin A is of special interest in the field of infectious diseases, especially for pulmonary infections. It is crucial for the development of normal lung tissue and tissue repair after injury due to infection. Therefore, it may play a role in recovery after severe COVID-19 pneumonia. Vitamin A has immune regulatory functions and positively affects both the innate and adaptive immune cell response.

The anti-oxidant Vitamin E, and trace element selenium, are major components of anti-oxidant defense. Epidemiological studies demonstrate that deficiencies in, either of these nutrients, alters immune responses and viral pathogenicity.

Data concerning vitamin A and E plasma levels in COVID-19 patients are lacking. Therefore, this study aims at characterizing vitamin A and E plasma levels in COVID-19 and analyzing the association of plasma levels with disease severity and outcome.

The aim of the current study is to evaluate the relation of plasma level of Vitamin A and E and their correlation with severity of SARS-COV2 disease.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 positive patients by PCR (polymerase chain reaction) test
* Patients aging 18 to 75 years

Exclusion Criteria:

* Patients with known immunodeficiency - Patients with known lung diseases