cyrilzakka/clinical-trials huggingface dataset:
Treatment of NLP Method in Women Who Have Experienced Postpartum Post Traumatic Stress Dissorder

The purpose of this interventional study is to evaluate the effectiveness of the NLP PTSD protocol in the event of PPPTSD. The study's main hypothesis is that the implementation of the NLP protocol will be effective and result in reduction of the overall PTSD level.

Post Traumatic Stress Disorder (PTSD) is considered to be a major Public Health disorder in the Western world with 8% prevalence. When including partial/Sub-clinic PTSD, prevalence rises dramatically. Studies examining the common intervention methods indicate certain clinical effectiveness although none presents sweeping efficiency. Therefore, this syndrome is still a significant clinical problem in Public Health.

This study focuses on women population who have experienced trauma in childbirth. Such women experience full post traumatic symptoms (Full PTSD) or Partial/Subclinical PTSD. This syndrome is defined in professional literature as PPPTSD (Post-Partum Post Traumatic Stress Disorder). While childbirth is a healthy part of the cycle of life, birth itself is an event that may involve a risk to the mother and child life. PPPTSD prevalence ranges between 1%-6% and is expressed in at least two of the criteria listed in the DSM. 8.3%-28% of women suffer from partial PPPTSD.

Neuro Linguistic Programming (NLP) is a "one-on-one" intervention method, connecting Neurological processes (N), Linguistic (L) and learned behaviors (P), in order to allow conceptual/perceptual, mental and behavioral changes. Even though NLP is used since the 1970's and field testimonies report its effectiveness, there are only few studies regarding its effectiveness in the field of PTSD.

This study's main objective is to examine the effectiveness of the NLP PTSD protocol.

The study population will include approx 30 women, up to 2 years after birth, with PPPTSD. The women will be treated in 5 individual sessions implementing the NLP PTSD protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Women
2. Age: 18-40
3. 2 years from the date of birth;
4. PTSD or PTSD symptoms (indicating partial PTSD) diagnosed as a leading problem in the participant's life
5. Hebrew speaking
6. Insured by Maccabi Health Services

Exclusion Criteria:

1. Presence of one of the following:

   (A) Mental retardation; (B) Schizophrenia or other mental illnesses;
2. Changes in medication dose during the study or during the three prior months;
3. Suicide attempts or self-harm;
4. Alcohol or drug use;
5. Postpartum depression;
6. Incompetent
7. Stillbirth
Low Intensity Exercise in Different Normobaric/Hypobaric Normoxic/Hypoxic Conditions.

The main goal of this project is to investigate how low intensity cycling exercise (1.5W/kg, for 6 minutes) influences cerebral functions, such as: Cerebral blood flow, oxygenation, and other physiological variables in different normobaric and hypobaric hypoxic conditions.

Subjects will bike at 1W/kg for 6 minutes at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Concentration performance also will be measured to better understand how hypobaric and hypoxia conditions may affect physiological responses, cerebral and cognitive functions.

Eligibility Criteria:
Inclusion Criteria:

* Study Indication
* Male and Female subjects from 18 years to 40 years of age
* Healthy volunteer
* Signed Informed Consent after being informed

Exclusion Criteria:

* Contraindications to the study intervention.
* Define drugs, treatments or interventions not allowed during the study or for specific periods of time prior to the intervention,
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study,
* Known or suspected non-compliance, drug or alcohol abuse,
* Previous problem with hypoxia or altitude exposure,
* Known pathologies/diseases
* Relevant medical disorders
* Anemia or poor health
* History of flight sickness
Treatment of Influenza in Routine Clinical Practice

This study evaluates the statistics of influenza and acute respiratory viral infections (ARVI) management in outpatient sites in Russia, Armenia, Moldova and Georgia (epidemiology: disease severity and bacterial exacerbations; patients demography; treatment duration and timelines; safety; quality of treatment) in routine clinical practice with focus on drug therapy and usage of interferons' inducers.

This non-interventional study covers more than 15000 patients from outpatient sites in Russia, Armenia, Moldova and Georgia.

Influenza and acute respiratory viral infections (ARVI) diagnosis validate according to "World Health Organization (WHO) Guidelines for Pharmacological Management of Pandemic Influenza A (H1N1) 2009 and other Influenza Viruses". All patients' examinations are carried out according to the local routine clinical practice and local and international standards of care.

The following data will be collected and analyzed after the end of treatment:

* demography
* disease severity
* body temperature
* chills and fever (no/mild/severe)
* weakness (no/mild/severe)
* muscle or joint pain (no/mild/severe)
* rhinitis (yes/no)
* throat irritation (no/mild/severe)
* headache (no/mild/severe)
* cough (no/mild/severe)
* conjunctivitis (no/mild/severe)
* timelines: disease onset, first visit to physician, start of treatment
* therapy (drug name, dose, with focus on interferons' inducers)
* bacterial exacerbations (yes/no)
* therapy of bacterial exacerbations (drug name)
* adverse events
* results of treatment satisfaction questionnaire for medication (TSQM-9), if completed by patient

Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 18 years old,
* patients diagnosed with influenza or influenza-like illness caused by a different type of virus,
* patients to whom anti-flu treatment administered,
* patients who have signed informed consent for management of their personal data.

Exclusion Criteria:

* no exclusion criteria except participating in a current clinical trial because of non-interventional sudy design
Post-Myocardial Infarction Remodeling Prevention Therapy

The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI) in patients at highest risk for adverse myocardial remodeling.


Eligibility Criteria:
Inclusion Criteria:

* Myocardial Infarction (MI) within the past 10 days
* Peak Creatine Phosphokinase (CPK) greater than 3000 Units/Litre (U/L) at time of MI, or a troponin T (TnT) greater than 10 micrograms/Litre (mcg/L)
* At least 18 years old
* Willing to comply with the protocol

Exclusion Criteria:

* Documented MI greater than 10 days
* Chronic renal disease, as defined by estimated glomerular filtration rate (eGFR) less than 30 milliliters/minute/1.73 square meter
* Life expectancy less than 18 months, as determined by a physician
* Existing pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) device
* QRS duration greater than 120 milliseconds (ms)
* Coronary Artery Bypass Graft (CABG) within 30 days prior to MI, or CABG procedure planned
* Third degree atrioventricular (AV) block or symptomatic bradyarrhythmia
* Persistent atrial fibrillation (AF) that is not self terminating within 7 days or is terminated electrically or pharmacologically
* Permanent AF that is non self terminating, with cardioversion failed or not attempted within the past year
* New York Heart Association (NYHA) Class IV
* Non-ischemic cardiomyopathy
* Pregnant or planning to become pregnant during the study
* Enrolled or planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from Medtronic, documenting that there is not a concern that co-enrollment could confound the results of this trial.
* Breast feeding
* Of a vulnerable population as determined by local law or requirement, or a physician
Duchenne Muscular Dystrophy Tissue Bank for Exon Skipping

We will utilize the Cooperative International Neuromuscular Research Group (CINRG) network to collect and store tissue and blood from patients with Duchenne muscular dystrophy (DMD) with specific genetic mutations within the dystrophin gene that could be treated by antisense oligonucleotide (AO) drugs.

The purpose of this tissue bank is to collect blood and skin samples from participants who are diagnosed with Duchenne muscular dystrophy (DMD) and carry one of nine specific changes in the dystrophin gene. The specific dystrophin changes that we are interested in studying are those that would work with exon-skipping therapies in patients with DMD, specifically deletions of the follow exons: 10-52, 13-50, 29-50, 43-52, 44, 43-50, 45-50, 45-52, 46, 46-47, 46-48, 46-49, 46-51, 46-53, 46-55, 46-60, 47-50, 47-52, 48-50, 49-50, 50, 52, 52-63, 48-52, 49-52, 50-52.

These blood and skin samples will be held in a tissue bank at Carolinas Medical Center for future DMD research.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 and above
* Diagnosis of DMD with a confirmed out-of-frame dystrophin gene deletions that could be corrected by skipping exon 45, 51, or 53 based on past genetic testing.

Exclusion Criteria:

* Investigator assessment of inability to comply with blood and skin sample collection
Effectiveness of Cognitive Therapy for Suicide Attempters With Drug Dependence Disorder

This study will examine the effectiveness of combining cognitive therapy with enriched usual care for preventing subsequent suicide attempts in people with a drug dependence who have recently attempted suicide.

Suicide attempts involving drug abuse are a major public health problem. Development of interventions that focus on reducing the suicide attempt rate among drug abusers is a necessity. There is a strong connection between drug abuse and both suicide attempts and completed suicide. As much as 45% of drug abusers have attempted suicide at least once. The rate of completed suicide among drug abusers has been reported to be as much as 30 times the rate for the general population. Unfortunately, there is a lack of empirically supported treatments for reducing suicidal behavior in drug abusers. This study will develop and evaluate the effectiveness of a cognitive therapy intervention for people with a drug dependence disorder who recently attempted suicide.

Participants in this single-blind study will be randomly assigned to one of two treatment groups: cognitive therapy combined with enriched usual care; or enriched usual care alone. An initial baseline assessment will occur within 7 days following the participant's suicide attempt and subsequent medical evaluation at a hospital emergency department. Suicide behavior and ideation, depression, hopelessness, and addiction severity will be assessed. Following the baseline assessment, treatment will begin. The cognitive therapy treatment will be specifically developed to prevent suicide attempts. It will involve the identification of proximal thoughts, images, and core beliefs that were activated prior to the suicide attempt. Cognitive and behavioral strategies will be applied to address the identified thoughts and beliefs. Patients will also learn adaptive ways of coping with stressors. The enriched usual care will entail standard treatments for suicide prevention. Study visits will occur 1, 3, 6, 12, 18, and 24 months following enrollment. Baseline measurements will be repeated at each study visit to evaluate participants' improvement. Participants receiving cognitive therapy will attend approximately 10 weekly or bi-weekly outpatient study visits. Participation will last for 2 years.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00149773

Eligibility Criteria:
Inclusion Criteria:

* Recent suicide attempt with an emergency department visit within 48 hours of the attempt (suicide attempt is considered to be a potentially self-injurious behavior with a nonfatal outcome for which there is evidence, either explicit or implicit, that the individual intended to kill himself or herself)
* Current DSM-IV diagnosis of a current drug dependence disorder within the past 6 months

Exclusion Criteria:

* Self-mutilating behavior without intent to commit suicide
* An acute, unstable, or severe Axis III disorder that may affect participation
A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma

The purpose of this study is to determine the safety and tolerability of CC-90010 when combined with standard of care treatment, temozolomide (TMZ) with or without radiotherapy (RT) in the newly diagnosed WHO Grade IV glioblastoma (ndGBM).


Eligibility Criteria:
Inclusion Criteria:

* Primary isocitrate dehydrogenase (IDH)-wild type newly diagnosed World Health Organization (WHO) Grade IV Glioblastoma
* O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status must be available prior to randomization
* Karnofsky performance status of ≥70

Exclusion Criteria:

* Indeterminate MGMT promoter methylation status
* Biopsy only of glioblastoma (GBM) at surgery, defined as \< 20% resection of enhancing tumor
* Any known metastatic extracranial or leptomeningeal disease

Other protocol-defined inclusion/exclusion criteria apply
Pressure Ulcer-associated Osteomyelitis: Evaluation of a Two-stage Surgical Strategy With Prolonged Antimicrobial Therapy

Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe complication with a poorly known management, and is associated with a high rate of relapse, leading to a high-burden in hospital bed-days, financial cost, surgical intervention, antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone and joint infection management, the medical and surgical strategies are systematically discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to evaluate this complex approach and to determine risk factors of treatment failure in order to improve patient management, focusing on optimization of empirical antimicrobial therapy after each surgical stage, delay between the two surgical stage, and duration of antimicrobial therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (i.e age ≥ 18 year-old) with a osteomyelitis complication following a pressure ulcer who benefited from a two-stage surgical strategy

Exclusion Criteria:

-
Fitbit Pilot Study in Post-operative Lumbar Degenerative Spinal Stenosis Patients

Spinal stenosis is a common orthopedic spine condition that limits individuals ability to walk and stand because of nerve compression. Surgical treatment can alleviate leg pain and improve function such as increasing physical activity. This study will use Fitbit technology to monitor patient's post-operative physical activity. It will evaluate the efficacy of a Fitbit incentive based walking program on improving post-operative physical activity and rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* 60 years of age and older
* diagnosed with neurogenic claudication or radiculopathy secondary to central or lateral recess stenosis between L3-L5 confirmed by CT or MRI
* consent for surgical treatment

Exclusion Criteria:

* traumatic stenosis from a pathologic fracture
* inflammatory spine disease
* peripheral arterial disease
* hip or knee arthritis or pulmonary or circulatory diseases for which exercise is contraindicated
* severe or progressive neurologic deficit effecting ambulatory ability
* cancer
* no access to a computer or mobile device
* inability to complete the questionnaires or provide follow-up (i.e. lack of permanent address, substance abuse, interfering psychiatric illness).
Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator

The primary objective of this pilot study is to document the percentage achievement in effective HR control (average nighttime HR \< 70 bpm) during WCD use in a cohort of female patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends data from the WCD to optimize BB/ivabradine dosage, as compared to a prior historical control.

The primary objective of this pilot study is to document the percentage achievement in effective HR control (average nighttime HR \< 70 bpm) during WCD use in a cohort of female patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends data from the WCD to optimize BB/ivabradine dosage, as compared to a prior historical control.

Adult female patients (18 years or older) who are prescribed the wearable cardioverter defibrillator (WCD) for 3 months for ischemic or non-ischemic cardiomyopathy with a low ejection fraction.

Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row.

Based on this information, clinicians should follow guideline-directed medical therapy (GDMT) to add or titrate medication accordingly. The goal of these changes will be to achieve the average nighttime HR to recommended guidelines (\<70 bpm) by the end of WCD use.

Eligibility Criteria:
Inclusion Criteria for Screening Phase:

* Female patients with newly diagnosed (never hospitalized for HF in the last 30 days prior to enrollment) ischemic or non-ischemic cardiomyopathy and an EF ≤ 35% at the time of WCD prescription.
* Patients prescribed the WCD for an intended 90 ± 14 days of use.
* Patients have used the WCD for no more than 14 days from the day of consent.
* Patients 18 years of age or older at the time of consent.

Inclusion Criteria for Continuation Phase:

-After the first 2 weeks of WCD wear, only actively wearing patients averaging at least 105 hours of WCD wear per week (or 15 hours/day) are eligible to continue.

Exclusion Criteria for Screening Phase:

* Patients with a known contraindication or intolerance to beta-blocker therapy.
* Patients with permanent atrial fibrillation.
* Patients who have a pacemaker.
* Patients with a current or prior implantable cardioverter defibrillator (ICD).
* Patients who are self-reporting to be pregnant.
* Patients with known congenital or inherited heart disease.
* Patients participating in another interventional clinical trial.
* Patients not expected to live longer than 3 months.

Exclusion Criteria for Continuation Phase:

-Patients ending WCD use within the first two weeks of use.
Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Clinical Core

The goal of this project is to provide comprehensive longitudinal assessments of a cohort of PD patients before, during, and after DBS surgery, including neurological, neurophysiological, and neuropsychological data.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 years and older
* Diagnosis of Parkinson's disease
* Candidate for DBS

Exclusion Criteria:

* Diagnosis of dementia
* Pregnant women
Motor Signature, Falls Risk, and Home-Based Interventions in Older Adults With Mild Cognitive Impairment

A single-blinded, randomized controlled trial is designed to compare the effects of social interaction, computerized cognitive training, lower extremity strengthening, and tai chi chuan on improving cognitive functions and gait/mobility and reducing falls among 228 subjects with mild cognitive impairment, in which the influence of adherence to the intervention programs will also be examined.


Eligibility Criteria:
Inclusion Criteria:

* At least 65 years old
* Had a fall at least 3 months prior to the baseline assessment
* Can ambulate independently
* Has mild cognitive impairment

Exclusion Criteria:

* Cannot ambulate independently and communicate with researchers
* Have a major unstable cardiopulmonary disease (e.g., ischemic chest pain, shortness of breath, recurrent syncopal episodes, orthopnea, paroxysmal nocturnal dyspnea, palpitations, or tachycardia)
* Have a contraindication to physical exercise (e.g., severe osteoarthritis or severe pulmonary hypertension)
Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB

The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.

A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who underwent white light cystoscopy and TURB alone.

The present study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will also lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.

No safety data was collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients of study PC B305/04 with Ta or T1, that were followed for recurrence are eligible to be included in this study.

Exclusion Criteria:

* Patient died during clinical study PC B305/04
Cognitive Characteristics of PTSD Patients With OCD

Cognitive profile of patients who suffer both from PTSD and OCD, as compared to those who suffer from PTSD or OCD without other comorbidity.

Demographic data and cognitive data will be compared on PTSD, PTSD-OCD and OCD patients using a battery of computerized cognitive tests

Eligibility Criteria:
Inclusion Criteria:

* Patients suffer from current PTSD with no other co-morbidity
* Patients suffer from current OCD with no other co-morbidity
* Patients suffer from current PTSD and OCD

Exclusion Criteria:

* Patients suffer from PTSD and OC symptoms