cyrilzakka/clinical-trials huggingface dataset:
Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients

The purpose of this study is to investigate the mean number of stimulation (high definition-transcranial direct current stimulation) sessions (up to 26) needed to achieve a clinical response with this response defined as a 50% decrease in Visual Analog Scale (VAS) for pain. These data will be important in defining the optimal number of sessions for future fibromyalgia subjects in Phase III trials.


Eligibility Criteria:
Inclusion Criteria:

* Providing informed consent to participate in the study
* 18 to 85 years old, both male and female
* Have a diagnosis of Fibromyalgia
* Existing pain for more than 3 months with an average of at least 4 on a 0-10 VAS scale
* Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex and Codeine.

Exclusion Criteria:

* Pregnancy
* Contraindications to tDCS: metal in the head or implanted brain medical devices
* History of alcohol or drug abuse within the past 6 months as self-reported
* Use of carbamazepine within the past 6 months as self-reported
* Severe depression (with a score of \>30 in the Beck Depression Inventory)
* Any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or severe migraines
* History of unexplained fainting spells as self-reported
* Neurosurgery as self-reported
Word-Retrieval Treatment for Aphasia: Semantic Feature Analysis

The purpose of this investigation is to further develop and test a treatment for word-finding problems in aphasia. The treatment is designed to strengthen meaning associations within categories of words (e.g., animals, tools, fruits). The treatment is also designed to be used as a search strategy in instances of word-finding difficulty. The study was devised to evaluate the extent to which treatment increases the ability to recall trained, as well as untrained, words.

The purpose of the proposed research is to examine the effects of a semantically-oriented treatment on word retrieval in persons with aphasia. The planned investigations are designed to further the development of semantic feature training so that it may serve as not only a mechanism for improving disrupted lexical semantic processing, but also as a compensatory strategy during word retrieval failures. The proposed research will also address the issue of exemplar typicality (Kiran \& Thompson, 2003) by examining the effects of training typical versus atypical exemplars of various categories with individuals with different types of aphasia. A series of 24 single subject experimental designs will be conducted in the context of a group design to address the following experimental questions:

* Will training atypical examples of living and artifact noun categories using semantic feature training result in a significantly different outcome\* than training typical examples of living and artifact noun categories?
* Will training of one category of nouns using semantic feature training result in improved retrieval of untrained categories of nouns?
* Will effects of semantic feature training vary across aphasia types?
* Will semantic feature training result in increased production of content during discourse?
* Will generalization to untrained typical examples vary across generalization lists that are repeatedly exposed and those that are limited in exposure? (i.e., Does repeated exposure appear to contribute to generalization?)

  * Outcome measure will reflect acquisition, response generalization within category, and response generalization across category effects of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Wernicke's, Broca's, or Conduction aphasia with significant word-retrieval deficits
* At least 6 months post-onset of single, left-hemisphere stroke
* Minimum of high-school education
* Visual and auditory acuity sufficient for experimental tasks
* Nonverbal intelligence within normal limits

Exclusion Criteria:

* Diagnosed mental illness other than depression
* Neurological condition other than that which resulted in aphasia
* History of alcohol or substance abuse
* Non-native English speaker
* Premorbid history of speech/language disorder
Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study

The objective of the study is to examine the effect of the addition of intravenous dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid consumption, pain scores, fatigue, and recovery in patients undergoing gynecological surgery with laparotomy under general anesthesia.

This is a dose finding study with two different doses (0.1 mg/kg vs. 0.2 mg/kg) of dexamethasone to find out the optimal efficacious dose of dexamethasone with minimal side effects.

Dexamethasone has anti-inflammatory, immunomodulatory, and analgesic effects; and is superior to placebo in providing post-operative pain control, lower analgesic consumption, prevention of postoperative nausea and vomiting, lesser post-operative fatigue, and better recovery profile. No dose response study has been done. The investigators hypothesize that a higher dose of dexamethasone may have an incremental beneficial effect.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be non-lactating
* 18-65 years of age
* ASA groups I-III for elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair)or myomectomy through a lower transverse or low midline incision under general anesthesia. Incidental appendectomy and /or abdominal lipectomy were allowed as collateral surgical procedures if the same incision was used

Exclusion Criteria:

* Emergent procedures
* Diagnosed malignancy
* History of allergy to dexamethasone
* Allergy or contraindication to drugs used in study and anesthesia
* Patients with uncontrolled diabetes mellitus, recent history of gastrointestinal bleeding or ulceration within 30 days before the study)
* Patients who have taken drugs in the 12 hours preceding the surgery that could confound the analgesic response (specifically analgesics, neuroleptics, corticosteroids, NSAIDs)
* Patients who have been on long term oral steroid therapy
* Patients with BMI\>40
* Serious organ disease/ dysfunction
* Chronic pain patients requiring \>30mg morphine per day or equivalent
* Severe psychiatric disease
* Drug Addiction
* Pregnancy
* Language barrier
* Inability to cooperate with the use of the intravenous PCA morphine pump
Myfortic Conversion Trial in OLT Recipients With GI Intolerance

Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of orthotopic liver transplant at least 8 weeks post transplant
* Mild and/or moderate GI complaints directly related to MMF

Exclusion Criteria:

* Multi-organ transplant recipients
* Evidence of graft rejection within 14 days prior to Baseline visit
Effect of the Mediterranean Diet in Patients Affected by CADASIL and Cerebral Amyloid Angiopathy.

The study is divided into two phases: Phase 1 (observational) and Phase 2 (dietary intervention). The goal of Phase 1 is to assess the nutritional status and dietary habits of two cohorts of patients with CADASIL and CAA. A specific aim is to evaluate adherence to the Mediterranean Diet. The objectives include analyzing patients' nutritional status, lean and fat mass, basal metabolism, and total energy expenditure. It also aims to assess the relationship between adherence to the Mediterranean Diet and the onset of stroke and cognitive decline, as well as examine stroke severity (ischemic or hemorrhagic) and its association with Mediterranean Diet adherence (MEDAS questionnaire). Additionally, the study will explore the link between diet adherence and cognitive deficits, and measure changes in biological and anthropometric parameters as a result of adopting the Mediterranean Diet.

Phase 2 is an interventional dietary study designed to evaluate the effects of the Mediterranean Diet, enriched with either extra virgin olive oil or walnuts, on stroke incidence and cognitive decline in patients with CAA and CADASIL.


Eligibility Criteria:
Inclusion Criteria:

* The study will include individuals of both sexes aged 18 years or older with a diagnosis of CADASIL (confirmed genetically by the presence of the NOTCH3 gene mutation) or possible/probable CAA (defined according to the Boston 2.0 criteria). All participants must provide informed consent for the use of demographic, clinical, and nutritional data for scientific purposes in an anonymous form

Exclusion Criteria:

* na
Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents

This study is a retrospective and prospective follow-up study of patients who were participating in a randomized comparative study (DETECT-OCT trial) to determine the duration of dual antiplatelet therapy for neointimal hyperplasia after Biolimus stent and Everolimus stent insertion . The primary objective of this study was to determine the duration of double antiplatelet therapy (DAPT) based on OCT results at 3 months after percutaneous coronary intervention with OCT guide and percutaneous coronary intervention with guided angiography. After that, patients who were enrolled in the previous DETECT-OCT study will be followed up for a 10 years follow-up.

This clinical trial will be followed for a long time until the 5th and 10th years of patients who have been registered for the DETECT-OCT study To assess the patient's status at 5- and 10-year, follow-up visits are scheduled at the outpatient visit if they are currently followed-up at the registry. However, if there is no follow-up observation at the current registrar, we will follow-up the telephone survey and visit as much as possible. Patients who have already passed the 5-year follow-up period from January 2, 2013, the first time to register, will be followed up by medical records to confirm the progress. To track the progress to the 10-year follow-up, we will conduct prospective observations by telephone survey.

Eligibility Criteria:
Inclusion Criteria:

* 1. patients who were enrolled in the previous DETECT-OCT study
* 2. Patients who agreed with informed consents

Exclusion Criteria:

* 1. Patients who disagreed with informed consents
A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease

The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)
* Memory complaint by subject or study partner
* CSF aβ42 levels \< 200pg/mL or Total Tau/aβ42 ratio of ≥ 0.39
* Score of ≤4 on the Modified Hachinski Ischemia Scale
* CT results consistent with Alzheimer's disease
* Medically stable
* 6 years education
* Reliable study partner
* Must be able to swallow capsules

Exclusion Criteria:

* Premenopausal women
* DSM-IV diagnosis of Dementia History of stroke
* Immunocompromised
* Active peptic ulcer, GI bleed, chronic inflammatory bowel disease, chronic diarrhea or past GI surgery that would impact drug absorption
* Unstable Vitamin B-12 deficiency
* Hematologic or solid malignancy within 5 years
* Geriatric Depression Scale ≥ 6
* Unstable medical condition
* Alcohol or drug abuse history with 12-months of study entry
* Significant drug allergy
* Prisoners, compulsory psychiatric patients, or residents of nursing home or skilled nursing facility at entry
* Any other experimental therapy with 30-days of study entry
Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum

This is a multicenter investigator-initiated trial between Baylor-Scotts \& White (BSW) and Methodist Health System (MHS). This study will be conducted via a retrospective review and a prospective patient registry. Patients who have undergone the ZPOEM procedure performed by the physicians listed in this protocol will be included, as well as patients who will have this procedure in the future. Data that will be collected at MHS will be entered into an Excel spreadsheet. Patient demographic information will be collected via a review of subjects' electronic medical records. Available patient outcomes will be collected via a review of electronic medical records. This review will be conducted from 1/1/2017 through 12/31/2025.

This is a multicenter investigator-initiated trial between Baylor-Scotts \& White (BSW) and Methodist Health System (MHS). This study will be conducted via a retrospective review and a prospective patient registry. Patients who have undergone the ZPOEM procedure performed by the physicians listed in this protocol will be included, as well as patients who will have this procedure in the future. Data that will be collected at MHS will be entered into an Excel spreadsheet. Patient demographic information will be collected via a review of subjects' electronic medical records. Available patient outcomes will be collected via a review of electronic medical records. This review will be conducted from 1/1/2017 through 12/31/2025.

To obtain the follow-up information, potential subjects will be identified using the same process described in the previous paragraph and will be contacted by a member of the institution's research team to answer questions about their symptoms post-surgery. These are listed in the ZPOEM Data Collection Sheet. These questions may be administered over the phone, via email, or by mail. Subjects enrolled in the patient registry will have follow-up data collected at 2-time points: 2 weeks post-op and 3 months post-op.

Primary endpoints and other variables to be collected are those listed on the ZPOEM Data Collection Sheet. Primary subject endpoints include, but are not limited to:

* Dysphagia score(s) - depending on what is available in EMR
* Weight gain following surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Any patient of the physicians listed in this study who has undergone the ZPOEM procedure to treat ZD at MHS
* For prospective registry: Ability to give informed consent

Exclusion Criteria:

* For prospective registry: Unable or not willing to provide informed consent
Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy

The purpose of this study is to determine the efficacy of high dose Erythropoietin to improve survival and neurologic outcome in asphyxiated term newborn undergoing cooling.

Hypoxic-ischemic encephalopathy remains the main cause of death or long term neurologic impairments in neonates. Yet, therapies for birth asphyxia are currently limited. Hypothermia when applied within 6 hours after birth demonstrate partial improvement in outcome of newborns specially those with moderate form. Erythropoietin and its receptors are upregulated after brain injury in ischemic conditions. Systemically administered erythropoietin is neuroprotective in animal models of birth asphyxia. To date, one study demonstrate improvement neurologic outcome in asphyxiated term newborn under erythropoietin treatment but no reports evaluating beneficial of erythropoietin associated with cooling. This is a large randomised controlled trial to evaluate the efficacy of high dose erythropoietin on outcome at two years of asphyxiated term newborns undergoing cooling.

Eligibility Criteria:
Inclusion Criteria:

* Term or near-term newborn (\> = 36 weeks gestational age)
* Moderate to severe encephalopathy
* undergoing moderate controlled hypothermia started within 6 hours after delivery : rectal or esophageal temperature maintained at 33.5 ° C + / - 0.5 ° C before H6
* Beneficiary of social security plan
* Informed consent parental authority

Exclusion Criteria:

* Impossibility of getting controlled hypothermia before H6
* Infant older than 12 hours of age
* Chromosomal or significant congenital abnormality
* Predictable surgery in the first 3 days of life
* Uncontrolled collapse
* Haemorrhagic syndrome unchecked
* Head trauma with or without skull fracture
Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone

The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).

This study includes a screening visit with several assessments, followed by an open-label medication trial of Allopregnanolone for 12 weeks and an end-point evaluation to assess for changes. Assessments include blood draws for genetic and safety laboratory testing, neurological and physical exam and medical history, cognitive testing, and motor testing.

Study record was updated in October 2018 to include adverse events and outcome measure reporting. Study record was updated in November 2018 in response to requests to (1) specify time frame of reported outcome measures, (2) clarify that the RASS was a safety monitoring tool, not a prespecified outcome measure, and as such will not be reported as an outcome measure, and (3) upload a version of the study protocol and statistical analysis plan with the required title page and statistical analysis plan information.

Eligibility Criteria:
Inclusion Criteria

* Fragile X premutation carrier status (55 to 200 CGG repeats in FMR1),
* Diagnosis of FXTAS including an intention tremor and/or ataxia and/or deficits on the BDS-2 demonstrating executive function deficits.

Exclusion Criteria

* other genetic problems in addition to the premutation
* a history of significant brain trauma
* significant substance abuse
* inability to follow the protocol
* liver or kidney disease
* heart failure
* active cancer
* other serious systemic disease
* current use of phenytoin
Acute Bronchitis in Korea:Associated Microorganisms and Clnincal Findings.

The investigators hypothesized that acute bronchitis will be associated with various bacteria and viruses.

The investigators will investigate various bacteria and viruses from colleced specimens from patients with acute bronchitis, and also investigate an assoication of the miroorganims with clinical findings

Eligibility Criteria:
Inclusion Criteria:

* Adults patients aged over 18 years.
* Patients who complain of recent sputum and cough.

Exclusion Criteria:

* Patinets who took antibiotics within 7 days.
* Patinets whose symptoms last for \< 5 days.
* Patients who have definite cause of acute cough such as pneumonia, allergic rhinnits, sinusitis, GERD and drug.
* Immunocompromised patients.
Canadian Oxygen Trial (COT)

Study Question: In infants who are born at gestational ages of 23 0/7 to 27 6/7 weeks, does lowering the concentration of supplemental oxygen to target an arterial oxygen saturation by pulse oximetry (SpO2)of 85-89% compared with 91-95%, from the day of birth until the baby's first discharge home, increase the probability of survival without severe neurosensory disability to a corrected age of 18 months?

Most extremely preterm babies require supplemental oxygen for several weeks or even months after birth. The goal of oxygen therapy is to achieve adequate oxygen delivery to the tissues without causing oxygen toxicity and oxidative stress. At present, this goal is elusive in very immature infants. Although it is standard practice in modern neonatal intensive care units to monitor arterial oxygen saturations via pulse oximetry, there is insufficient evidence to guide the choice of the upper and lower alarm limits. A rigorous trial with long-term follow up is urgently needed and long overdue to determine whether oxygen exposure can be reduced safely in extremely preterm infants without increasing the risk of hypoxic death or disability.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 23 0/7 - 27 6/7 weeks
* Postnatal age \< 24 hours

Exclusion Criteria:

* Infant not considered viable (decision made not to administer effective therapies)
* Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
* Known or strongly suspected cyanotic heart disease
* Persistent pulmonary hypertension, e.g. associated with pulmonary hypoplasia
* Unlikely to be available for long-term follow-up
Effect of Head-neck Rotation on I-gel™ Insertion

According to previous studies, head and neck rotation reduces the tongue from being rolled back by gravity, which resulted in increasing patency of the upper airway. Therefore, the purpose of this study is to verify whether head and neck rotation increases the first attempt success rate of i-gel™.

I-gel™ insertion has been reported that the success rate of insertion on the first attempt is 78.5%. There may be several causes of insertion failure. Tongue folding is a major obstacle preventing appropriate i-gel™ placement. To solve this problem, the previous study has proven the efficacy of the rotational technical for I-gel™ insertion and reported a success rate of 97%.

However, the rotation of i-gel™ in the oral cavity may be limited, and it may take some learning curve to get used to it. According to previous studies, head and neck rotation increases the cross-sectional area of the upper airway, which resulted in increasing patency of the upper airway. Therefore, the purpose of this study is to verify whether head and neck rotation increases the first attempt success rate of i-gel™.

Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status Classification Grade 1-3
* Patients who can provide written consent to participate in clinical trials
* Patients requiring the I-gel™ during surgery

Exclusion Criteria:

* Outpatient surgery
* Patients who have the neurologic disease or cognitive impairment
* Patients who take antipsychotic drugs
* Body mass index \> 35 kg/m2
* Mouth opening \< 2.5 cm
* Limited neck extension or cervical mobilization (Ex: Atlanto-axial subluxation, History of cervical spine surgery or head and neck surgery)
* Those with a recent sore throat
* Those with weak dentation
* Patients at risk of aspiration (Ex: Pregnancy, Gastroesophageal reflux disease or hiatus hernia)