cyrilzakka/clinical-trials huggingface dataset:
Exercise in Autoimmune Myasthenia Gravis and Myasthenic Syndromes

A few recent observational studies show that despite the lack of clear recommendations, many individuals with myasthenia participate in exercise. However, no link has been found between exercise and the severity of myasthenia symptoms, measured by the Muscle Myasthenia Score or the Myasthenia Gravis Composite Score. This suggests that there are other factors that may limit or prevent some individuals from being active, or factors which may facilitate participation in exercise.

Studies in other diseases have shown that there are internal (beliefs, motivation, etc.) and external (cost, accessibility, etc.) factors unrelated to the disease which may play a role in exercise participation.

The aim of this study is to identify factors that facilitate or limit exercise in individuals with autoimmune myasthenia gravis, congenital myasthenia syndrome and Lambert-Eaton syndrome.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* confirmed diagnosis of MG or SMC or LEMS
* Live in France or its territories
* Provide consent

Exclusion Criteria:

-
Delivery of Self Training and Education for Stressful Situations-Telephone Version

This study will evaluate a telephone-delivered cognitive-behavioral psychotherapy intervention designed for primary care treatment of combat-exposed service members with PTSD. The investigators will assess Posttraumatic Stress Disorder (PTSD) symptoms, mental health-related and occupational functioning, and symptoms of depression, anxiety, and somatization.

This is a randomized controlled trial that will compare DESTRESS-T to Optimized Usual Care (OUC). Optimized Usual Care is usual primary care PTSD treatment, plus a telephone care management program that includes: four outreach calls, feedback to the treating primary care provider (PCP), and care coordination.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* DSM-IV diagnosis of PTSD (derived from the CAPS) due to combat in OIF/OEF deployment
* Active duty personnel

Exclusion Criteria:

* Active suicidal or violent ideation within the past two months as assessed by the MINI and a supplementary form developed by the project team (see Appendices)
* Current participation in any active psychotherapy (e.g., psychoanalysis, CBT) for mood, anxiety or substance use disorders (as determined via service member self report and/or check of medical record)
* Recurrent PTSD treatment failure in psychotherapy, as determined via consensus of study team members (Dr. Charles Engel, Dr. Brett Litz, and Dr. Kristie Gore)
* Current alcohol dependence, as assessed by MINI
* Acute psychosis, psychotic episode, or psychotic disorder diagnosis within the past year, as assessed by the MINI
* Currently on an antipsychotic or mood-stabilizing agent for bipolar disorder or any disorder with psychotic features, as determined by medical record and/or self report
* Unstable administration schedule or dosing of any antidepressant, anxiolytic, or sedative-hypnotic (i.e., will exclude for any related medication changes in the month prior to randomization), as determined by medical record or service member self report
* Acute or unstable physical illness based on the judgment of the patient's primary care clinician and the study team.
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?

The purpose of this study is to determine whether treatment with Bismuth can reduce the toxicity of chemotherapy and radiotherapy in patients with malignant diseases of the blood.


Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 years or over referred to the Department of Haematology L, Herlev Hospital, with a view to 'cytostatic'? treatment of or radiotherapy for haematological malignancy

Exclusion Criteria:

* Pregnant women and nursing mothers
* No informed consent from patient
* Known hyper sensitivity to bismuth or other tablet content
* Severe renal insufficiency with creatinin clearance below 25 ml/min.
* Patients receiving other treatment for protection of the mucous membrane except cryo treatment of the oral cavity (lumps of ice in the mouth)
* Other experimental treatment within past four weeks.
Cognitive Behavioral Therapy (CBT) Study Evaluating the Updating of Persecutory Beliefs

The purpose of this study is to examine how Bayesian belief updating changes throughout psychotherapeutic treatment for persecutory delusions. Specifically, individuals with a psychotic disorder diagnosis who endorse both a current persecutory delusion with strong conviction and significant worry will be recruited and randomized to receive either a CBT-based worry intervention for persecutory delusions or an active control condition (befriending therapy). The investigators will examine: 1) whether belief updating parameters change as delusion severity changes, 2) whether CBT contributes to greater change in belief updating parameters than befriending therapy, and 3) whether neural correlates of belief updating parameters, as measured using functional magnetic resonance imaging (fMRI), predict treatment response.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women age 18 - 65.
2. Communicative in English.
3. Premorbid Intelligence \>79 (WTAR)
4. Provide voluntary, written informed consent.
5. Physically healthy by medical history.
6. Weight \<300 lbs
7. Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
8. Diagnosis of a non-affective psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief psychotic disorder, psychosis NOS) confirmed by Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-5 (SCID) or diagnostic interview with a trained clinician.
9. A persecutory delusion scoring at least a 3 on the conviction scale of the Psychotic Symptoms Rating Scale (PSYRATS) that had persisted for at least two weeks and that was not considered the direct result of substance use
10. A clinically significant level of worry, as shown by a score of at least 44 on the Penn State Worry Questionnaire (PSWQ).

Exclusion Criteria:

1. Age less than 18 or greater than 65.
2. Not communicative in English.
3. Premorbid IQ \< 79 (WTAR)
4. Unable to provide written informed consent.
5. Current medical or neurological illness.
6. History of severe head trauma.
7. Weight \>300 lbs
8. Primary diagnosis of alcohol or substance use disorder or personality disorder
9. Conditions that preclude fMRI scanning (as defined in the fMRI Screening Form)
10. Subjects who are actively involved with individual cognitive therapy (Past experience with individual therapy is not an exclusion)
Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO)

Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the incidence of clinically silent brain infarction is unknown. We will assess the rate of clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE) in relation to the presence or not of a PFO.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary embolism, informed consent signed, no-contraindication to MRI

Exclusion Criteria:

* contra-indication to MRI, informed consent not obtained
Postmarketing Clinical Study on AO-128

The purpose of open-label study is to evaluate the efficacy and safety of AO-128 (Voglibose) 0.6 mg/day in patients with impaired glucose tolerance (IGT) who had been non-responsive to diet therapy and exercise therapy, and follow up the progress after the end of treatment in patients who was assessed as normoglycemic.

The α-glucosidase inhibitor voglibose was developed by Takeda Pharmaceutical Co. Ltd and is one of the most commonly used oral antidiabetic agents in Japan. Voglibose is used as first-line treatment for improvement of postprandial hyperglycemia in diabetic patients with inadequate response to diet and exercise therapy and as add-on treatment to other oral antidiabetic drugs and insulin. In 2009, voglibose was approved in Japan for the management of prediabetes (IGT).

This study was a single-group, multi-center, open-label study. The study period consisted of a screening period of 1 week or less, a treatment period of 96 weeks or more, and a follow-up period of 48 weeks. However, if a patient was assessed as having type 2 diabetes mellitus or normoglycemia, the treatment period was to be ended, and only those assessed as normoglycemic were to proceed to follow-up. Follow-up was also to be terminated if patients were assessed as having IGT or type 2 diabetes mellitus during follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Patients on diet therapy and exercise therapy for 3 to 6 months prior to the start of screening, with baseline (fasting ) plasma glucose \< 126 mg/dL and 2-hour plasma glucose of 140 to 199 mg/dL (revised WHO criteria) during a 75 g oral glucose tolerance test (OGTT) in the screening period
2. Patients meeting any of 1 through 4 below:

   * 1) Comorbid hypertension or high normal blood pressure
   * 2) Comorbid dyslipidemia
   * 3) Comorbid obesity
   * 4) Patients with up to a second-degree family history of type 2 diabetes mellitus
3. Patients with HbA1c \< 6.5% in the screening period
4. Male or female patients at least 20 years of age at the time informed consent was obtained
5. Treatment category: Outpatient

Exclusion Criteria:

1. Patients previously diagnosed with diabetes mellitus.
2. Patients with apparent impaired glucose metabolism or with a disease or condition potentially involving impaired glucose metabolism.
3. Patients with serious hepatic impairment.
4. Patients with serious renal impairment.
5. Patients with serious cardiac, cerebrovascular, pancreatic, hematologic, or other disease.
6. Patients with a history of intestinal obstruction or a history of laparotomy within 6 months (24 weeks) before the start of screening.
Neural Therapy and Kinesio Taping Effectiveness in Fibromyalgia

The aim of this study; to investigate the effects of neural therapy and kinesio taping treatments on pain, functional status and quality of life in women with fibromyalgia.

Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep disturbance, cognitive impairment, and other physical symptoms that negatively affect physical and sensory functions and impair quality of life. Neural therapy and kinesio taping are treatments for musculoskeletal diseases. In this prospective, randomized controlled, double-blind, interventional study, 64 patients aged 18-55 years who met the eligibility criteria will be included in the study. Eligible participants will be randomly assigned to one of two groups using computer generated random numbers. Segmental neural therapy and sham kinesio taping will be applied to the first group. In the second group, kinesio taping with inhibition technique will be applied to bilateral trapezius and erector spina muscles and sham neural therapy will be added. Treatments will be applied once a week for a total of 6 weeks. Both groups will be given a home exercise program consisting of stretching exercises and will be checked every week. During the follow-up period, patients will be asked not to make changes to their current medical treatment. Participants will be evaluated for pain by Visual Analogue Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Central Sensitisation Inventory (CSI), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Health Assessment Questionnaire (HAQ), Short Form-36 (SF-36), manual algometer measurements and number of tender points, as well as post-treatment and post-treatment 3 month control data.

Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with fibromyalgia according to the ACR 2016 diagnostic criteria.
* Being a woman between the ages of 18 and 55.
* No change in the medical treatment he received for fibromyalgia syndrome during the study
* To be able to come to treatment 1 day a week for 6 weeks

Exclusion Criteria:

* Presence of known central nervous system or peripheral nervous system disease, progressive neurological deficit
* Peripheral venous insufficiency, coagulopathies and anticoagulant drug use
* Loss of sensation, loss of position sense, unhealed fracture or open surgical wound
* Uncontrolled hypertension and uncontrolled diabetes
* Be in major depression
* Cognitive impairment that causes difficulty following simple commands
* Pregnancy
* Be in menopause
* Allergy to local anesthetics and kinesio taping
* Open wound or infection at the application site
Prospective Study of Hormone Levels After Bariatric Surgery

This project will study the effects of surgery for obesity on bone metabolism and hormones that regulate appetite.

Subjects will be recruited from the outpatient obesity and surgical clinics at Columbia-Presbyterian Medical Center after they have chosen to undergo a surgical procedure. The groups will not be randomized. Rather, they will decide on their choice of surgery along with their physicians. The patients will be evaluated pre-operatively and followed post-operatively for 5 years.

Initial evaluation will include a complete history and physical examination, measurement of calcium, parathyroid hormone (PTH) and vitamin D, and assessment of skeletal health using markers of bone turnover and bone mineral density.

Eligibility Criteria:
Inclusion criteria:

1. Adult male or female \> 18 years of age
2. Scheduled to undergo bariatric surgery

Exclusion criteria:

1. Vitamin D deficiency
2. Primary hyperparathyroidism
3. Treatment with lithium or thiazide diuretics which may alter PTH levels
4. Osteomalacia
5. Untreated hyperthyroidism, liver disease, Cushing's syndrome, rheumatoid arthritis, myeloma or Paget's disease
6. Impaired renal function (serum creatinine \>2.0mg/dl) or history of renal osteodystrophy
7. Use of any anti-obesity medications for over 2 weeks 90 days prior to study
8. Participation in any research study 90 days prior to study
9. Any malabsorption syndromes such as celiac sprue
10. Previous bariatric surgery
An Observational/Non-interventional, Study of NS3/4a Protease and NS5A Protein of Hepatitis C Virus in Brazilian Participants With Chronic HCV Infection

The purpose of this study is to describe the genetic diversity of Hepatitis C virus (HCV) NS3/4a protease and NS5A protein of HCV in participants with chronic disease naive-drug or previously failed to double therapy (Peg-interferon and Ribavirin) and to identify the frequency of natural polymorphisms in HCV NS3/4a protease and NS5A protein that are associated with direct-acting antivirals (DAAs)-resistance.

This is a multicenter, observational/non-interventional, cross-sectional study to describe the genetic diversity of and to identify the natural polymorphisms in HCV NS3/4a protease and NS5A protein of hepatitis C virus in Brazilian participants with chronic HCV infection. Brazilian participants with Genotype 1 HCV infection treatment naive participants or previously failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the trial and will constitute the trial population.

Eligibility Criteria:
Inclusion Criteria:

* Participants mono infected with chronic Hepatitis C infection (genotype 1), including naive patients or previously failed to double therapy (Peg-interferon-α and Ribavirin)
* There is no restriction on fibrosis stage or clinical liver disease
* There is no restriction for comorbidities
* Male or female participants with age \>=18 years

Exclusion Criteria:

* Participants failed to triple therapy using protease inhibitors
* Participants with co-infections (i.e. Human immunodeficiency virus, Hepatitis B virus)
* Participants that are not agree to sign the written informed consent
* Participants is taking part in an interventional clinical trial with an investigational agent (i.e. non-commercialized agent) or in an interventional clinical trial sponsored by Johnson \& Johnson
Nurse Management of Neuromodulation Therapy

The central hypothesis is that the use of a DBS (Deep Brain Stimulation) clinical decision support system for individual patient management will enable considerable time savings compared to standard care. This hypothesis was formulated from pilot studies that showed dramatic decreases in DBS programming time compared to standard care for clinicians who used an iPad-based decision support system (99% time savings from over 4 hours to 2 minutes. Study group Parkinson's patients with DBS Systems

In most cases these subjects have failed to maintain adequate control of their symptoms on medications alone.

The Diagnosis of PD (Parkinson's Disease) and the decision to have DBS qualifies a subject for enrollment. Subjects would be selected because they will require DBS programming.

The investigators will prospectively enroll 20 PD DBS patients at the Froedtert Movement Disorders Center (surgical targets: subthalamic nucleus (STN) or internal segment of globus pallidus (GPi). Post-operative care, patients will be randomized 1/1 to standard care or using the clinical decision support system. The DBS RN will use ImageVis3D Mobile app on the iPad to program the DBS system, this software does not interact with Froedtert imaging systems. The study team uses identified images provided by the Froedtert PACS system, de identifies them, adds a study code. The images are loaded into the software system and used to identify the leads locations. The Patients will be assessed for 6 months starting with the initial DBS programming session. Importantly, the investigators do not anticipate that the clinical decision support tool will provide the final DBS settings, nor do we anticipate that this approach will obviate the need for motor exams. The clinical decision support system will help nurses choose good initial settings and then explore around those initial settings.

The investigators will measure the time spent on DBS programming for patients in each group. The investigators will capture programming session duration, number of programming sessions and total time spent on DBS programming. The investigators will compare total time spent programming for the standard care versus the intervention group.

Eligibility Criteria:
Inclusion Criteria:

Subjects 18 and older with a diagnosis of Parkinson's Disease that are scheduled for Deep Brain Stimulation for control of their symptoms and are seen at the Froedtert Neurology Outpatient Clinic.

Exclusion Criteria:

Patient's that are not candidates for Deep Brain Stimulation.
A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)

The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 40 years with COPD and chronic bronchitis
* Current or ex-smokers (history ≥ 10 pack years).
* Post-bronchodilator FEV1 \<60% of the subject predicted normal value and FEV1/FVC ratio \< 0.7.
* At least, one moderate or severe COPD exacerbation in previous year.
* CAT score ≥ 10
* Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit

Exclusion Criteria:

* Subjects with current asthma.
* Subjects with moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization.
* Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
* Subjects with COPD emphysema or mixed phenotypes.
* Subjects with known respiratory disorders other than COPD.
* Subjects with active cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy.
* Subjects under Roflumilast treatment within 6 months before study entry.
* Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
* Subjects with clinically significant cardiovascular.
* Subjects with a significant neurological disease.
* Subjects with clinically significant laboratory abnormalities.
* Subjects with moderate or severe hepatic impairment
Examining the Effect of Exogenous Ketone Supplementation on Glucose Control in Type 2 Diabetes

Ketone bodies are a fuel source and signaling molecule that are produced by the body during prolonged fasting or if an individuals consistently eats a low-carbohydrate "keto" diet. Blood ketones can be used as a source of energy by the body, but they may also act as signals that impact the functioning of different cells in the body. Recently, the availability of ketone supplements that can be taken orally allows for raising blood ketones without having to fast or eat a "keto" diet. The investigators' studies and those of other researchers have shown that ketone supplementation can lower blood sugar without having to make any other dietary changes. Oral ingestion of ketones may therefore be an effective strategy to improve blood sugar control and influence how cells function.

The main objective of this study is to determine if consuming a ketone supplement 3 times per day (before meals) for 14 days lowers blood sugar and impacts how the body's cells function. The results of this study will be used to guide future recommendations on the utility of ketone supplements for improving health in individuals with, or at elevated risk of, type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Have a type 2 diabetes diagnosis from a physician
* Have stable use of glucose-lowering medications for at least 3 months

Exclusion Criteria:

* Are a competitively trained endurance athlete
* Are actively attempting to gain or lose weight
* Have a history of mental illness or existing neurological disease(s), cardiovascular events (i.e., heart attack, stroke) in the last 2 years
* Have hypoglycemia, irritable bowel syndrome or inflammatory bowel disease
* Are currently using insulin or SGLT2 inhibitors
* Are using more than 2 classes of glucose-lowering medication
* Are currently following a ketogenic diet or taking ketone supplements
* Are unable to commit for a 29-day trial
* Are unable to follow a controlled diet