cyrilzakka/clinical-trials huggingface dataset:
The Epidemiology of Acute Respiratory Distress Among Children, A Retrospective Cross-Sectional Study

l Respiratory distress is still a major concern in pediatric medicine. l In this study we evaluated the symptoms and causes of respiratory distress among children in a tertiary hospital.

l We found that tachypnea is the most common symptom and asthma is the most common cause of respiratory distress in children.


Eligibility Criteria:
Inclusion Criteria:

* patients older than one month
* signs or symptoms of respiratory distress, including tachypnea, bradypnea, cyanosis, respiratory muscle retraction, nasal flaring, tachycardia, and bradycardia

Exclusion Criteria:

* Patients older than 18 years old
* apnea
* known cardiac diseases
The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation

This study evaluates if the exclusion of left atrial low voltage areas / scars by ablation lines in addition to pulmonary vein isolation may improve the outcome in patients with persistent atrial fibrillation in comparison to stand alone pulmonary vein isolation.

This is a prospective, randomized multi center study comparing two catheter ablation strategies (pulmonary vein isolation (PVI) versus PVI plus low voltage areas (LVA) guided for ablation in patients with symptomatic persistent and long standing persistent atrial fibrillation (AF) who were unresponsive to at least one Class I or III antiarrhythmic agents, or it is the patient´s decision to receive ablation as first line therapy. Patients with documented persistent AF who are eligible for participation in the study, and gave a written informed consent, will be randomized between two groups prior to the procedure: PVI and PVI+LVAs guided radiofrequency catheter ablation.

All the patients will receive a high density voltage map in sinus rhythm (SR). All the patients will receive circumferential PVI. If LVAs are present, Patients randomized to the PVI+LVA group will get additional linear ablation lines to exclude these areas from normal voltage atrial myocardium. The patients will be followed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients with persistent AF documented by 12 lead ECGs (Persistent AF is defined as an AF episode which lasts longer than 7 days, Persistent AF which lasted longer than 12 months will be defined as long standing persistent AF.)
* Age 18 - 80 years, both genders
* Patient is willing to participate in the study (signed written informed consent)
* Patient is willing and available to perform all follow ups.

Exclusion Criteria:

* Atrial fibrillation due to reversible causes
* Any contraindication for AF ablation
* Contraindications to anticoagulation
* CVA/TIA in the past 6 months
* Previous left atrial catheter ablation
Exploratory Study to Evaluate 2 Acupuncture Methods for the Treatment of Headaches Associated With TBI

This study investigates whether acupuncture can help to decrease the number and severity of headaches in people who have Traumatic Brain Injury. The aim of this study is to compare two different types of acupuncture-either Traditional Chinese Acupuncture or ear acupuncture-to a group that receives no acupuncture at all. Acupuncture has been demonstrated to reduce pain, improve health-related quality of life, prevent migraine headaches, and improve tension and chronic daily headaches.

This is a 12 week study. If eligible, participants will be randomly assigned to 1of 3 groups: ear acupuncture, Traditional Chinese Acupuncture, or the usual care group.

Subjects receiving acupuncture will:

* meet with one of the acupuncturists who will conduct her first assessment
* come to Walter Reed Army Medical Center (WRAMC) 10 times over a 6-week period to receive acupuncture treatments from a licensed acupuncturist

Subjects in the usual care group will:

* not receive any acupuncture treatments
* continue usual treatment plan
* be given the option to receive 10 acupuncture treatments between the 6- and 12-week period

All subjects will also:

* complete questionnaires at 3 different times: baseline (beginning of study), after 6 weeks, and after 12 weeks. These questionnaires will assess headaches, overall health and quality of life
* complete a daily headache diary
* continue to be treated for their headaches
* continue taking prescription and over-the-counter medications for any conditions being treated

Eligibility Criteria:
Inclusion Criteria:

1. 18-69 years of age
2. Service Members with previous deployment to war zone
3. Non-acute mild to moderate traumatic brain injury as defined by:

   * Injury event (i.e., blast, fall, MVC, head impact) that occurred at least 7 days prior
   * Loss of consciousness (if present) for less than 24 hours and alteration of consciousness or posttraumatic amnesia for less than one week
4. Presence of headache or any etiology requiring self-medication or medical management with at least 4 headache days in the past 4 weeks
5. Rancho Los Amigos Cognitive Scale score of greater than or equal to 7
6. Able to provide informed consent

Exclusion Criteria:

1. Acupuncture treatment for any reason within the past month
2. Any active unstable psychiatric condition, including active psychosis, suicidal or homicidal ideation
3. Unwillingness on the part of the participant to complete all study visits and/or components of the intervention
4. Scheduled surgery during the treatment phase of the study
5. Pregnancy or breastfeeding at time of study enrollment or during study participation
6. Any medically unstable condition that in the opinion of the P.I. has the potential to warrant inpatient treatment in the medical or intensive care units
7. Inability to give informed consent or complete study measures
TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal

A multicentre, prospective, open-label, single arm study for 2 months, involving adult patients under poorly tolerated Home Enteral Nutrition (HEN). The study aims to analyse the evolution of tolerance and quality of life of HEN patients after switching from a High Protein High Energy (HPHE) polymeric Enteral Nutrition (EN) formula with or without fibre to Sondalis® HP 2kcal, with or without fibre. Eligible patients will give their written consent to participate before being included into the study.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged ≥18 years,
* Being under EN with polymeric HPHE product with or without fibre (=HPHE),
* Stable caloric prescription during HEN for at least one month,
* Patient with at least a score of 2 on at least 1 item of tolerance questionnaire,
* Investigators' judgement to change to HPHE concentrated,
* HEN is planned for ≥ 8 weeks,
* Life expectancy ≥ 3 months.
* Patient or his/her primary caregiver was required to be able to understand the study and to be fully free to participate in it,
* Patient having signed an informed consent,
* Patient registered with a social security scheme,
* Patient willing to adhere to study procedures,

Exclusion Criteria:

* Pregnancy or breastfeeding,
* Being either under PN or ONS,
* Acute intestinal disease such as gastric ulcer, gastritis, gastroparesis,
* Patient under prokinetic agents during the study phase,
* Patient receiving antibiotic, chemotherapy in the 7 days prior to inclusion,
* Patient receiving radiation treatment except head and neck location,
* Patient expected to receive chemotherapy or radiation treatment during the study except head and neck location ,
* Severe infectious disease and/or fever \> 38,5°C,
* Emergent hospitalization within last month,
* Known allergy or intolerance to any of the Sondalis® HP 2kcal with or without fibre ingredients,
* Previous treatment with HPHE concentrated at home (2kcal),
* Current participation in another intervention study or participation in a previous study for which exclusion period applies.
* Non-compliance with prescription and administration modalities as suspected by investigator and/or by home care provider dietitian
Visanne Post-approval Observational Study (VIPOS)

The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis.

Endometriosis is a common, chronic, gynecological disease characterized by pain and impaired fertility. It causes chronic inflammation, ovarian cyst formation, fibrosis and adhesions. Symptoms seem to respond to decreased circulating estrogen. The mainstay of medical treatment is hormonal induced anovulation and a reduction in endogenous estrogen production.

Medications for endometriosis such as Danazol and GnRH agonists have clinically relevant side-effects limiting treatment duration with these medications to 6-12 months.

Dienogest (DNG) is a 19-nortestosterone derivative progestogen. DNG 2mg/day is a reliable and effective treatment for dysmenorrhea, premenstrual pain, dyspareunia and diffuse pelvic pain associated with endometriosis.

Two important class effects of progestogens are the induction of bleeding disturbances and their influence on mood disturbance. It is not known what influence DNG will have on bleeding disturbances associated with endometriosis, particularly over a longer time frame.

In addition, women who suffer from endometriosis are at high risk of developing depressive symptoms. It is difficult to differentiate if depressive symptoms are causally associated with progestogen use or sequela of the disease process.

This study investigates the safety of DNG for endometriosis with regard to medical interventions for anemia and worsening of depressive symptoms associated with the disease. It is a prospective, controlled, non-interventional cohort study with two cohorts: users of DNG and users of other medications for the treatment of endometriosis. The study will be implemented in several European countries.

Eligibility Criteria:
Inclusion Criteria:

* Women using a newly prescribed regimen for endometriosis (first-time users or switchers or re-starters)
* Women who are willing to participate in this long-term follow-up study

Exclusion Criteria:

* Women who are not cooperative/available for follow-up
* Women with a language barrier
Ketamine Improves Post-Thoracotomy Analgesia

Thoracotomy for lung tumor or for minimally invasive direct coronary artery bypass (MIDCAB) surgery, may be associated with debilitating pain. Ketamine was shown to enhance opioid antinociception and prevent opioid resistance. We hypothesize that ketamine given with morphine would lower morphine consumption and narcotic related side effects after thoracotomy and provide superior analgesia to morphine given alone.

We planned a prospective, randomomized, double blind study of 2 pain management protocols in consecutive patients undergoing thoracotomy for MIDCAB or lung tumor resection over a 6 month period. After patients emerged from a standardized general anesthetic and when objectively awake and complaining of pain \>5/10 on a visual analogue pain scale, they were connected to an intravenous patient controlled analgesia regimen. The regimen was assigned randomly to be either morphine alone (1.5 mg per dose, lockout interval of 7 minutes) or morphine plus ketamine (1.0 mg morphine plus 5 mg ketamine per dose, same lockout interval). Rescue diclofenac was available to both groups. Follow-up lasted 4 hours.

We planned to monitor and compare pain scores, wakefulness scores, hemodynamic and respiratory parameters as well as total morphine consumption and incidence of side effects and complications. All monitoring and recording was done by blinded nurses and intensive care physicians.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients scheduled for elective minimally invasive direct coronary artery bypass (MIDCAB) or for lung resection via anterolateral thoracotomy during a 6-month period (Sep 2001-March 2002)

Exclusion Criteria:

Exclusion criteria were:

* American Society of Anesthesiologists (ASA) physical class ≥3, Emergency operations,
* Q-wave myocardial infarct occurring during the previous 3 weeks, or poor left ventricular function (e.g., ejection fraction \[EF\] \<30% by echocardiography or angiography).

Other exclusion criteria were:

* A body mass index \>35 kg/m2,
* Past or current neuropathy or psychological disturbances,
* The use of centrally active drugs,
* Chronic liver or renal failure requiring dialysis,
* A FEV1/FVC \<70%,
* Allergy to ketamine, morphine or non steroidal anti inflammatory drugs (NSAIDs),
* Clotting abnormalities,
* A platelets count \<70000/mm3,
* A white blood count \<3000\>14000/mm3,
* Uncontrolled diabetes mellitus or fasting blood glucose \>250 g/dl,
* Evidence of sepsis or infection up to one week prior to randomization.
Engaging Partners in Caring Communities

The goal of the EPICC observational study is to learn about capacity to implement evidence-based health promotion programs (EBPs) in congregations that are offered semi-structured technical assistance (TA). Congregational teams will complete an implementation capacity assessment survey before the TA is offered and 10 months later, after TA has been provided for up to 10 months. Participating congregations will be a convenience sample of congregations in Davidson County, TN that serve primarily African American communities.

The recruitment process is designed to provide a team of 3-5 volunteers from 40 congregations with information about five EBPs identified by the research team from which they are to choose one. The team completes one EPICC Survey for their congregation. The team is then offered up to 10 months of TA with the expectation that 2-3 months will be used for planning to launch the EBP, with 4-6 months for implementation. Each congregation will be asked to recruit a minimum of 8-10 members of the congregation to complete a brief report of health behaviors prior to launching of the EBP and repeating that report 6 months later to assess the impact of the EBP on their health behaviors.

Eligibility Criteria:
Inclusion Criteria: Adult (18 years and older) participants in the behavioral intervention (implemented health promotion program) in a congregation in Davidson County that has completed enrollment in the EPICC Project.

Exclusion Criteria:

* Individuals who are not enrolled in a health promotion program implemented in an EPICC congregation
Biological Implications of the Overlapping Phenomenon Between Childhood Schizophrenia and Autism Spectrum Disorders-Heterogeneity Approach Rather Than Diagnostic Boundary

Complex diseases such as schizophrenia and autism are heterogeneous in clinical presentation and etiology. This high heterogeneity constitutes the challenges for the clinical diagnosis and etiological research, resulting in that the majority of research findings cannot be replicated in the independent samples. For the high comorbid rate between the diagnoses of schizophrenia and autism spectrum disorders (ASD), and the shared neurocognitive deficits, genetic risks, and biological markers between the two disorders, a heterogeneity approach may probably be more promising than to arbitrarily split the two diagnostic categories apart or lump them together for etiological research. In schizophrenia, patients with a very early onset of disease and with preceding neurodevelopmental conditions may imply a different underlying etiology from those with typical onset and without neurodevelopmental conditions. Echoing the evidence that in early onset Parkinson's disease, PARK2 (encoding parkin protein) mutations are successfully reported to be as frequent as 49% with an autosomal-recessive mode of inheritance , representing a specific disease entity of Parkinson's disease. Therefore, it is critical to characterize the clinical phenotypes for this subpopulation of very early onset patients, including their clinical manifestation, disease course, and treatment response, as well as early developmental history and morphological characteristics. These may establish an important base for investigating the etiology and providing adequate clinical care for the heterogeneous syndrome of schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* SZ group: schizophrenia onset earlier than 12 years old
* COS group: schizophrenia onset later than 12 years old
* ASD group: diagnosed with autism spectrum disorder without schizophrenia
* Dual group: diagnosed with ASD and SZ

Exclusion Criteria:

* congenital disease
* major physical diseases
* neurodegenerative disorder
* chromosomal aberration
Pharmacogenomics of Antiplatelet Response

This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene expression in persons at high-risk of developing heart attacks due to family history of early-onset coronary artery disease

In this clinical trials we will select individuals from GeneSTAR cohort based o their platelet function. Equal number of individuals will be selected from each race and gender and from low or high platelet aggregation. We will have baseline platelet functions performed and baseline platelet gene expression examined. Participants will be given 2-week supply of aspirin(81 mg/daily) and will be examined at the end of 2-weeks with platelet aggregation studies and a repeat platelet gene-expression (using RNA-seq). The ultimate goal is to examine platelet gene expression differences due to aspirin and across different gender, race, platelet-aggregation groups.

Eligibility Criteria:
Inclusion Criteria:

* 45-75 years
* GeneSTAR participant
* No personal History of Coronary Artery Disease
* Women who are post-menopausal
* Women who are using a reliable method of contraception, such as history of tubal ligation, IUD or taking OCP

Exclusion Criteria:

* Taking aspirin prescribed by physician
* weight \< 60 kg
* History of recent or current bleeding
* allergy to aspirin or history of adverse events to aspirin
* serious comorbid conditions (such as AIDS, active cancer)
* high blood pressure (\>160/95)
* History of gastrointestinal ulcer/bleeding
* Mental incompetence to make decision to participate.
Test of Trans-cranial Magnetic Stimulation (TMS) Intervention on Unilateral Neglect

Problems in attention can affect around 40% of stroke survivors and are associated with poor recovery of function. This project will provide the largest scale and most detailed examination to date of whether problems in attention after stroke can be remediated through direct brain stimulation. In Part 1 of the project the investigators will use two forms of direct brain stimulation (neural inhibition) to try and balance activity across the two sides of the brain following a stroke to one side. The investigators will assess whether each form of stimulation leads to an improvement in attentional functions, as well as to wider improvements in other cognitive abilities and to activities of everyday living. Performance will be tested immediately post remediation and on longer-term follow-up, and performance of the two intervention groups will be assessed against data the investigators have collected from a large-scale screen of cognitive impairments and recovery of function under standard treatment conditions. In Part 2 of the project the investigators will take the most promising intervention from Part 1 and the investigators will use magnetic resonance imaging (MRI) to determine the brain changes that are linked to the recovery of attentional functions. The investigators will test whether recovery is linked to a change in the balance of activation within the two hemispheres of the brain, and whether there are associated structural changes in cortical tissue and fibre tracts. The project will evaluate whether neural inhibition can improve attentional functions in particular, and cognitive abilities and everyday activities more generally, in stroke survivors. It will also provide novel information on how recovery of function comes about within the brain.


Eligibility Criteria:
Inclusion Criteria:

* presence of left unilateral neglect after right hemisphere stroke

Exclusion Criteria:

* presence of epilepsy/family history of epilepsy
* insufficient comprehension to follow instructions
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan

The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients with SSc-ILD.


Eligibility Criteria:
Inclusion Criteria:

* Patients in Japan with SSc-ILD who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.

Exclusion Criteria:

* None.
Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder

A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.

The Marigold Study is a global, double-blind, placebo-controlled, Phase 3 clinical trial that will enroll approximately 70 patients between the ages of 2 and 21 with a confirmed disease-related CDKL5 gene variant. Patients will undergo a baseline period before being randomized to receive, in addition to their existing anti-seizure treatment, either ganaxolone or placebo for 17 weeks. Following the treatment period, all patients that meet certain eligibility requirements will have the opportunity to receive ganaxolone in the open label phase of the study. The study's primary efficacy endpoint is percent reduction in seizures. Secondary outcome measures will include non-seizure-related endpoints to capture certain behavioral and sleep disturbances that have been seen in previous clinical studies with ganaxolone.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed CDKL5 gene mutation, seizure onset by 1 year of age and lack of independent ambulation by 2 years of age
* Failure to control seizures despite 2 or more anti-seizure medications
* At least 16 seizures per 28 days of primary seizure types
* On a stable regimen of 0-4 anti-seizure medications (Vagus nerve stimulator, ketogenic diet, and modified Atkins diet do not count towards this limit)
* Additional Inclusion Criteria apply and can be discussed with study team

Exclusion Criteria:

* Previous exposure to ganaxolone
* West Syndrome with hypsarrhythmia pattern on EEG or seizures predominantly of Infantile Spasms type
* Use of adrenocorticotropic hormone (ACTH), prednisone or other glucocorticoid or use of moderate or strong inducers or inhibitors of CYP3A4/5/7 are prohibited
* Use of tetrahydrocannabinol (THC) or cannabidiol (CBD) is prohibited during the double-blind phase, unless patient has a prescription of Epidiolex®
* Exposure to any other investigational drug within 30 days or fewer than 5 half-lives prior to screening
* Plasma allopregnanolone-sulfate (Allo-S) levels greater than or equal to 6.0 ng/ml at screening visit
* Additional Exclusion Criteria apply and can be discussed with study team