cyrilzakka/clinical-trials huggingface dataset:
Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)

The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and improving overall veteran function.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

1. Veterans 18-55 years of age
2. Diagnosis of subthreshold PTSD (at least one symptom in PTSD symptom clusters B, C, and D by structured interview; with or without functional impairment exposure to war zone stressors)
3. Written informed consent; and
4. A negative serum pregnancy test for women of childbearing potential.

Exclusion Criteria:

1. Lifetime history of DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition
2. History of substance dependence within the last 3 months
3. Significant suicide risk or serious suicide attempt within the last year
4. Clinically significant medical condition or laboratory or EKG abnormality
5. Women of childbearing potential who are unwilling to practice an acceptable method of contraception
6. Subjects needing concurrent use of psychiatric medications
7. History of hypersensitivity to paroxetine
8. HADS depression subscale score \> 12
9. Failure to respond to an adequate trial of paroxetine (20 mg/day x 8 wks).
Heparin Versus Taurolidine to Bloodstream Infection Prevention Related in Central Venous Catheter in Children

Clinical trial, that aim is evaluation of the use of taurolidine and heparin in the prevention of bloodstream infection in venous catheter in children with intestinal failure.

Will be collected data about sociodemographics : date of birth, hospitalization and which is use (taurolidine or heparin), sex, underlying disease and associated co-morbidities.

About central venous catheter will be collect: catheter type in each period, the number of lumens, date of insertion of each catheter usage time, reason for removal of the catheter insertion site and catheter material (silicone or polyurethane ).

Data relating to parenteral nutrition will also be collected: osmolarity of parenteral nutrition, infusion time every 24 hours and concentration of glucose parenteral nutrition bag.

It will be used for aseptic handling technique of the solutions, as well as for handling the connections of the central catheter. For preparation and administration of taurolidine and heparin is used an operations manual that was made for the authors. Patients are divided into two groups: taurolidine or heparin.

Eligibility Criteria:
Inclusion Criteria:

* The population will consist of patients 30 days of life to fourteen years old, admitted to the pediatric inpatient units, with intestinal failure receiving parenteral nutrition through a central venous catheter and at least eight weeks of use forecast.

Exclusion Criteria:

* Children will be excluded other associated diseases that occur with frequent use of antibiotics, for example, cystic fibrosis, primary or acquired immunodeficiency. Also excluded are the children admitted that they are not accompanied by a responsible family recognition, or accompanied by responsible under the age of 18 years. Children with allergic reactions to the use of some of the solutions (taurolidine or heparin) will be suspended medication and receive appropriate treatment. Although these children have stopped the use of medication, will be followed according to the assessment protocol by the end of the study.
Effects of Carvedilol on Cocaine Use in Humans - 11

The purpose of this study is to examine carvedilol effects in response to cocaine.

The purpose of this study was to determine whether carvedilol, and alpha and beta adrenergic blocker, would inhibit the priming effect of cocaine in a laboratory model. A total of 12 subjects were enrolled in this double blind, placebo controlled, outpatient study. After an adaptation session, three experimental sessions were held, 2-9 days apart. On each of 3 experimental sessions, a single oral dose of low (25mg) or high dose of carvedilol (50mg) or placebo were administered. Two hours following carvedilol or placebo treatment, subjects received a priming dose of smoked cocaine, 0.4 mg/kg. during the second part of the session, subjects had the option to earn up to 2 tokens by working on a computer task that could later be exchanged for money or deliveries of cocaine. We proposed that blockage of adrenergic receptors by carvedilol would significantly alter the subjective and physiological effects of cocaine.

Eligibility Criteria:
Inclusion Criteria:

Male/Female between 20 and 55. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. current history of good health and normal EKG. Not pregnant as determined by pregnancy screening nor breast feeding, using acceptable birth control methods (e.g. birth control pills diaphragm, condoms plus foam)

Exclusion Criteria:

Current problems with major psychiatric illnesses including bipolar disorder, schizophrenia, or anxiety disorders. History of major medical illnesses including asthma and chronic obstructive pulmonary disease. Currently on a drug related parole or probation. Treated for chemical dependency withing the past 6 months.
2-year Mortality After COVID-19 in Nursing Home Residents

This was a retrospective study conducted in three Nursing Homes (NHs). Residents who had survived the 1st CoPW (March to May 2020) were included. The diagnosis of COVID-19 was based on the results of a positive reverse transcriptase-polymerase chain reaction test. The collected data also included age, sex, length of residence in the NH, disability status, legal guardianship status, nutritional status, need for texture-modified food, hospitalization or Emergency Department visits during lockdown and SARS-COV2 vaccination status during the follow-up. Non-adjusted and adjusted Cox models were used to analyse factors associated with 2-year post-1stCoPW mortality.


Eligibility Criteria:
Inclusion Criteria:

* Living in one of the Nursing Homes during the fiorst COVID-19 pandemic wave
* Having survived the first pandemic wave

Exclusion Criteria:

* Residents who died during the first pandemic wave
* Refusal for articipation to the study
Tissue Repository for Studies of Myasthenia Gravis

This is a study during which the investigators collect plasma and cells from patients with myasthenia gravis for the purpose of finding new antibodies.

This is a bio-specimen collection study. The investigators will collect plasma and peripheral lymphocytes. Plasma will be collected either when the patient undergoes plasma exchange, a decision independent of this study, or through a scheduled blood draw.

Patient plasma will be screened for novel antibodies which may cause myasthenia gravis. Subjects that are found to be positive for candidate antigens for myasthenia gravis will have a clinical evaluation which will consist of several disease rating scales will be performed (QMG score, MG-composite, Myasthenia Gravis Foundation of America (MGFA) clinical classification, MG-Quality of Life (QOL)15, MGFA Therapy Status).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Clinical Diagnosis of MG with supporting evidence either from antibody testing, repetitive nerve stimulations study (RNS) or Single Fiber Electromyography (EMG) (SFEMG).

Exclusion Criteria:

* Significant medical condition that would make participation in diagnostic and research part of evaluation impossible or risky. Acute or unstable medical condition.
* Inability to provide informed consent, either directly or via appointed power of attorney.
* Unwillingness to consent for collection of biological samples or their cryopreservation.
* Unable to provide evidence of previous antibody testing or neurophysiology confirming the diagnosis of Myasthenia Gravis.
* Any bleeding disorder that would prevent or present any danger during blood extraction.
Statins, Cholesterol and Cognitive Decline in Alzheimer's

Disturbances in brain cholesterol homeostasis may be involved in the pathogenesis of Alzheimer's disease (AD). Lipid-lowering medications could interfere with neurodegenerative processes in AD through cholesterol metabolism or other mechanisms. The investigators aim to estimate the causal effect of statins on cognitive function measured by MMSE and to identify the mediating or modifying effect of cholesterol between statins and cognitive function in patients with Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

All patients with AD and mixed dementia registered in SveDem and from SCREAM.

Exclusion Criteria:

* All patients with a missing MMSE score at diagnosis date will be excluded from the analyses.
* Patients with at least one measurement of low-density lipoprotein cholesterol (LDL-C) within 1 year before dementia diagnosis.
Prep Plus: Upper Limb Stroke Rehabilitation in the Community

PREP Plus aims to create support for those who have survived stroke(s) and are still experiencing weakness in the upper limbs. In conjunction with the PREP programme, and based on the GRASP programme, the aim is to evaluate the feasibility, acceptability, and efficacy of an upper limb intervention support for survivors. Integration of an evidence based upper limb programme to an established physical activity programme will be a feasible method to support long term upper limb rehabilitation to community dwelling stroke survivors.

The main objectives for overall study is to assess acceptability of the demand of the trial as well as the PREP Plus intervention placed on survivors and their carers. Within this mixed methods study, the investigators aim to recruit participants in a total of three waves. Each site will deliver 6 weeks of the intervention / control with a new set of participants before post intervention qualitative measures (focus groups and 1:1 interviews) are used to inform the design of the next wave. With having the trial in three waves, their objective is to optimise the design of upper limb rehab and the delivery by therapists with preparing them with adequate training and resources aimed toward upper limb rehab in survivors of stroke.

Participant recruitment will integrate into the current PREP programme design.

All participants will complete one hour of circuit-based exercises followed by one hour of education. The exercise stations will focus on lower body/cardiovascular fitness station and upper limb strength exercises. Each week the amount of time spent at each station will be increased by 30 seconds resulting in a final 3 minutes at each station. Those in the intervention group, will have an additional five exercises that focus on upper limb stretching, arm stretching, hand stretching, coordination, and hand skills.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of stroke

Have completed statutory rehabilitation

Able to follow two part written or spoken commands

Are medically fit to complete exercise, as determined by their GP

Having an impairment of their upper limb, as identified by the participant and/ or their community stroke team.

Exclusion Criteria:

Pain score of 5/more in their impaired upper limb. Not participating in any other trial
COUREUR Study Myocardial Inflammation in Cyclist Part 1

The study will evaluate myocardial inflammation in cyclists after high intense and sustained exercise. Our hypothesis is that strenuous exercise in recreational cyclists may be associated with myocardial inflammation. Myocardial fibrosis in asymptomatic athletes is associated with life-threatening arrhythmic events and sudden death. Although myocarditis seems to be the most likely underlying cause, it remains unclear if strenuous and sustained physical exercise can cause myocardial inflammation with development of myocyte necrosis and possibly myocardial fibrosis in athletes.

Nineteen recreational cyclists performing "L'ETAPE DU TOUR (EDT) de France" a cycling ride (175 km, 3600 m of positive altitude difference) on July 4 2021 will be included in this study.

In part 1 of the study, each participant will complete a detailed questionnaire detailing their training history and an echocardiography at rest will be performed. All participants will have exercise testing approximately 1 week before the EDT stage to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.


Eligibility Criteria:
Inclusion Criteria:

* Recreational cyclists performing the 'étape du tour (EDT) de France 2021 ride

Exclusion Criteria:

* presence of pre-existing cardiovascular or pulmonary diseases, hypertension, diabetes, peripheral vascular diseases, any inflammatory or auto-immune diseases and the intake of anti-inflammatory drugs.
Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis

The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria included, but were not limited to the following:

1. Male or female, 18 years or older;
2. Chronic Atopic Dermatitis (AD) for at least 3 years;
3. History of inadequate response to a stable (\>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.

Exclusion Criteria:

1. Prior treatment with REGN668;
2. Presence of certain laboratory abnormalities at the screening visit;
3. Treatment with an investigational drug within 8 weeks ;
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
5. Certain treatments and medical procedures, undertaken within a particular time-frame prior to the baseline visit, preclude eligibility for participation in the study;
6. Known history of human immunodeficiency virus (HIV) infection;
7. History of malignancy within 5 years before the baseline visit, with certain exceptions;
8. Planned surgical procedure during the length of the patient's participation in this study;
9. History of clinical parasite infection;
10. Any medical or psychiatric condition which in the opinion of the investigator or the sponsor's medical monitor, would place the participant at risk, interfere with participation in the study, or interfere with the interpretation of study results;
11. Pregnant or breast-feeding women.
Cervical Orthosis Versus no Orthosis Following Multi-level Posterior Cervical Fusion

Use of cervical orthosis after instrumented posterior cervical spinal surgery is still widely practiced even though modern fusion techniques likely do not require additional stabilization from an external orthosis. This is a single, centre randomized, non-blinded equivalence trial. Patients undergoing multi-level posterior cervical fusion will be randomized to cervical orthosis (CO group) or no orthosis (NO group). Immediately following surgery patients in the CO group will be fitted with a Philadelphia collar prior to being transferred to the recovery room. On the patient ward a physiotherapist will fit the patient with a Cervimax/Aspen/Miami J collar which will be worn at all times for 6 weeks according the standard of care. The NO group will have no specific precautions applied to their neck range of motion. Outcomes will be assessed prior to surgery, on the second day after surgery, and at 2, 4, 6 and 12 weeks after surgery. The primary outcome will be neck pain score on the numerical rating scale (ranging from 0-10 with higher scores indicating more severe pain) during the first 4 weeks after surgery with an equivalence margin of 2.0 points. Secondary outcomes will be neck disability, general health, treatment satisfaction, pain medication use, adverse events, neck range of motion, time meeting discharge status, and compliance in wearing the collar.


Eligibility Criteria:
Inclusion Criteria:

1. Undergoing multi-level (2- or more level), open, posterior cervical fusion which may extent into the second thoracic vertebrae (C1-T2)
2. Able to consent to inclusion in the study
3. 18 years of age and older

Exclusion Criteria:

1. Spinal cord injury
2. Primary cervical spine infection
3. Cervical spine tumor
4. Inability to comprehend patient rated outcome instruments
5. Substance abuse
6. Dementia
7. Psychosis
8. Previous surgery at same level
Drug-Drug Interaction of Pyrotinib With a Moderate CYP3A Inducer

This drug-drug interaction (DDI) study had been designed to investigate the effect of a moderate CYP 3A inducer efavirenz on the pharmacokinetics of maleate pyrotinib in Chinese healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
* Ability to complete the study as required by the protocol;
* Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
* Body weight ≥ 50 kg for male and female, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
* In females, documented surgical sterilization, postmenopausal status for at least 1 year (follicle stimulating hormone \[FSH\] \> 40 mIU/mL serum at Screening), or agreement to use an approved form of contraception
* In males, agreement to avoid sperm donation for 6 months days after the dose of pyrotinib
* Liver function test results must be below the upper limit of normal.
* Participants must agree to refrain from donation of whole blood and other blood products from 90 days prior to Screening,

Exclusion Criteria:

* Loss of more than 400 mL blood during the 3 months before the trial (eg, as a blood donor)
* Allergic constitution;
* History of drug use, or drug abuse screening positive;
* Alcoholic or often drinkers;
* A smoker with 5 cigarettes per day for more than 90 days;
* Positive serology for hepatitis B surface antigen (HBsAg) and HCV (healthy participants), anti-treponema pallidum virus (TP), or antihuman immunodeficiency virus (HIV) Type 1 and Type 2 (all subjects)
* Use of any drugs or substances known to be inhibitors or inducers of CYP3A4/5 within 90 days from the first dose or 5 half-lives, if known, of the drugs or substances, whichever is greater, prior to pyrotinib administration and during the study.
* A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
* Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
HRD Status Reference Standard Based on WGS

When evaluating the analytical performance of homologous recombination deficiency (HRD) status testing, there is currently no widely accepted reference standard. Therefore, a collaborative project was initiated to establish a HRD status reference standard for the industry. Although there is no genotyping strategy that is universally recognized as the most accurate for evaluating HRD status, whole-genome sequencing (WGS) is one of the best candidates.

* Primary objective: To establish a HRD status reference standard based on WGS.
* Secondary objective: To validate the analytical performance of panel HRD status using WGS HRD status as reference standard.
* Exploratory objective 1: To explore how methylation of selective genes correlate with WGS HRD status and efficacy.
* Exploratory objective 2: To explore how HRR gene mutations correlate with WGS HRD status and efficacy.
* Exploratory objective 3: To set up a harmonized bioinformatic analysis workflow for WGS HRD status.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at diagnosis
* Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
* High-grade serous or high-grade endometroid histological type
* FIGO stage II, III, or IV
* Complete response or partial response following completion of first-line adjuvant chemotherapy
* PARPi administered as first-line maintenance therapy

Exclusion Criteria:

* First-line surgery not conducted
* Total round of first-line chemotherapy (neoadjuvant and adjuvant) less than 5
* First-line PARPi maintenance therapy initiated beyond 12 weeks after last dose of chemotherapy
* Genotyping quality-control failed
The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder

The investigator would like to investigate the impact of intermittent theta burst stimulation over left dorsolateral prefrontal cortex on emotion regulation in autism spectrum disorder


Eligibility Criteria:
Inclusion Criteria:

* autism spectrum disorder, confirmed by ADOS

Exclusion Criteria:

* Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment
* Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection
* Previous or current severe brain injury
* Implementation of metal materials such as pacemaker or medication pump
* Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse
* Pregnancy
* Individuals with a significant brain abnormality such as intracranial space occupied lesions
* Individuals with a family history of epilepsy
* Previous febrile seizures
* Current taking antiepileptic drugs
* Concurrent use of medications which increased the risk of seizure attack
* Individuals suffering from sleep deprivation during rTMS procedures
* Skin trauma on application site
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study
* Participate another clinical trial within one month
Self-Management Assistance for Recommended Treatment (SMART) Portal

The purpose of the study is to develop, evaluate, and optimize an interactive website (the SMART portal). The SMART portal will use IBD-specific and general assessments and interventions to reduce the burden of common barriers to treatment adherence and enhance self-management skills. This study aims to build and revise the SMART portal according to feedback and testing from participants.

The study consists of three phases for development and evaluation of the SMART portal. Phase 1 is the development of online assessments and intervention components. There will be no participant interaction with the portal during Phase 1. Phase 2 will consist of one, individual interview with patients, caregivers, and clinicians/nurses to interact with a portal prototype and provide feedback. Phase 3 will contain an open trial for patients and caregivers with baseline, 2-6 months interacting with the portal and progressing through applicable intervention components, and post-treatment. Patient test data will also be loaded into the portal during Phase 3 for clinicians/nurses to interact with for 2-6 months. Feedback from all users will be collected at post-treatment for optimization of the portal.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis (collectively known as IBD)
* Patient between 11 and 18 years of age
* Patient prescribed at least one oral medication used to treat IBD
* Access to the internet whether public (example, library) or private (example, home, personal)
* English fluency for patient, caregiver, and clinician/nurse
* Clinician/nurse currently providing medical treatment to patients diagnosed with IBD through the IBD Center at Cincinnati Children's Hospital Medical Center

Exclusion Criteria:

* Diagnosis of pervasive developmental disorder in patient or caregiver
* Diagnosis of serious mental illness (example, schizophrenia) in patient or caregiver