cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD)

Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS.


Eligibility Criteria:
Inclusion Criteria:

* long history of GERD symptoms
* persistent or recurrent symptoms despite optimal medical treatment
* persistent or recurrent complications of GERD
* reduced quality of life owing to increasing esophageal exposure to gastric juice
* pathological values in the preoperative evaluated functional parameters.

Exclusion Criteria:

* any distinct hiatal hernia detectable by gastroscopy or barium radiography
* dysphagia
* esophageal strictures
* poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy

The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who have an inadequate response or are intolerant to biologic disease-modifying anti-rheumatic drugs (DMARD) therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female participants who are 18-75 years of age (19-75 years of age at sites in Republic of Korea, 20-75 years of age at sites in Japan and Taiwan), on the day of signing initial informed consent
* Meet Classification Criteria for Psoriatic Arthritis (CASPAR)
* Have a history consistent with Psoriatic Arthritis (PsA) ≥ 6 months at Screening
* Have active PsA defined as ≥ 3 swollen joints (from a 66 swollen joint count \[SJC\]) and ≥ 3 tender joints (from a 68 tender joint count \[TJC\]) at Screening and Day 1; these may or may not be the same joints at Screening and Day 1
* Must have a documented history or active signs of at least one of the following at Screening

  * Plaque psoriasis
  * Nail changes attributed to psoriasis
* Have had inadequate response (lack of efficacy after ≥ 12 week duration of therapy) or intolerance to at least one and not more than 3 biologic DMARDs (bioDMARD) administered for the treatment of PsA or psoriasis, as per local guidelines / standard of care
* Prior to the first dose of study drug on Day 1, treatment with bioDMARD(s) should have been discontinued

Key Exclusion Criteria:

* Prior exposure to a janus kinase (JAK) inhibitor \> 2 doses
* Any active / recent infection
* Any chronic and / or uncontrolled medical condition that would put the individual at increased risk during study participation or circumstances which may make a individual unlikely or unable to complete or comply with study procedures and requirements, per investigator judgement
* Any moderately to severely active musculoskeletal or skin disorder other than PsA or plaque psoriasis that would interfere with assessment of study parameters, as per judgement of investigator

NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to PsA or additional diagnosis of PsA

* Any history of an inflammatory arthropathy with onset before age of 16 years old
* Active autoimmune disease that would interfere with assessment of study parameters or increase risk to the individual by participating in the study, (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of investigator
* Pregnancy or nursing females
* Active drug or alcohol abuse, as per judgement of investigator

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity

The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.

Brain emotional processing was determined with the Emotional Faces Assessment Task (EFAT). In this task, participants view a trio of faces and match one of the two faces (bottom) that expresses the same emotion as the target face (top). The faces display one of five expressions (angry, happy, fearful, sad, neutral) and the other (incongruent) probe face always displays a neutral (or happy if the target is neutral) expression. The paradigm consists of 20 face trials per expression and 20 shape trials, presented in pseudorandomized order, separated by a 3-7 sec intertrial blank screen with fixation cross.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for traumatic stress
* Normal or corrected to normal vision
* Right-handed
* Fluency in English
* Physically able to travel for study visit attendance

Exclusion Criteria:

* Significant chronic uncontrolled disease (e.g. uncontrolled diabetes, advanced liver disease, cancer, etc.)
* Severe hearing problem
* Intellectual disability or serious cognitive impairment
* Inability to tolerate enclosed spaces (e.g. the MRI machine)
* Ferrous-containing metals within the body
* Pregnant, trying to get pregnant, or breastfeeding
* Epilepsy
* Other research participation
* Frequent number of special events during study period (weddings, concerts, exams, etc.)
A Study to Estimate the Effect of Formulation on the Relative Absorption of SB-751689 Administered to Healthy Women

This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.


Eligibility Criteria:
Inclusion criteria:

* Healthy postmenopausal women; 40 and 65 years of age, inclusive
* Non-smokers (as defined in exclusion criteria 6 below)
* Body weight \> or = 50 kg and BMI within the range 19-32 kg/m2
* Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form

Exclusion criteria:

* Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study
* A QTc interval of \> 450 msec at screening
* Positive urine drug screen at screening
* Positive urine test for alcohol at pre-dose
* Positive for HIV or hepatitis B or C virus at screening
* Urinary cotinine levels indicative of smoking at screening
* History of smoking or use of nicotine containing products within one year of the study or \>10 pack-year history of smoking overall
* History of regular alcohol consumption exceeding 7 units/week (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening
* History of drug abuse within 6 months of the study
* Participation in a clinical study and received a drug or a new chemical entity with 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of the current study medication.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Use of prescription or non-prescription drugs
* Consumption of red wine, grapefruit, grapefruit juice or grapefruit containing products within 14 days prior to the first dose of study medication
* Donation of blood in excess of 500 mL within 56 days prior to dosing
* Evidence of renal, hepatic or biliary impairment
* History of serious gastrointestinal disease
* History of sensitivity to any of the study medications or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
* History of clinically significant cardiovascular disease
* Medical conditions that might alter bone metabolism
* Serum parathyroid hormone (iPTH) test levels outside the reference range at screening
* Liver function tests, parathyroid hormone test or CPK outside the reference range at screening
Magnetoencephalography in Children

This study is a single-center observational clinical study, which evaluates the diagnostic value of magnetoencephalography (MEG) in the diagnosis of neurodevelopmental diseases in children, such as the localization of epileptic foci and brain functional areas, intracranial tumors, cerebrovascular diseases, autism, mental retardation, and neuropsychiatric disorders.

The purpose of this study is to observe the application of magnetoencephalography (MEG) in pediatric neurodevelopmental disorders

Eligibility Criteria:
Inclusion Criteria:

1. aged 1 month-18 years old (date of investigate minus date of birth)
2. epilepsy
3. intracranial tumors
4. cerebrovascular diseases
5. autism
6. mental retardation
7. ADHD
8. tic disorder
9. neuropsychiatric disorders

Exclusion Criteria:

1.Unable to cooperate with the exam of MEG
Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia

This study is designed to find the optimal (best) doses of GW679769 that promote sleep onset and maintain sleep during two consecutive nights of dosing without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Difficulty going to sleep and/or staying asleep for at least the past 3 months.
* Insomnia must result in significant distress or impairment in functioning at home, socially or at work.
* Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis.

Exclusion Criteria:

* History of other sleep disorders such as sleep apnea or restless leg syndrome.
* Regular sleep habits, including bedtime between 9 PM and midnight.
* Nightshift/rotating shift work, frequent napping or planned travel across \>2 time zones.
* Use to moderate use of nicotine, caffeine and alcoholic products.
Deficits in Emotion Regulation Skills as a Maintaining Factor in Binge Eating Disorder

The effectiveness of a systematic affect regulation training (ART; Berking, 2010) is evaluated with regard to reducing symptoms of binge eating disoder in a randomized controlled trial.

Evidence suggests that deficits in affect regulation play an important role in the development and maintenance of binge eating disorder (BED). Thus, we aim to clarify whether BED symptoms can be reduced with the help of a training of general affect regulation skills. For this purpose, we randomly allocated N = 99 individuals meeting criteria for BED either to an affect regulation training (ART) or to a wait list control condition (WLC). Primary outcome is the reduction of binges during the treatment-vs.-waiting period as assessed with the Eating Disorder Examination (EDE) interview. Secondary outcomes include BED symptom severity at follow-up and change in emotion regulation skills. To clarify whether potential differences between groups regarding change in binge eating result from a greater increase of affect regulation skills in ART, we will test whether potential group differences regarding binges will be mediated by differences between groups regarding change in affect regulation skills.

Change of randomization procedure: Over the course of the study, serious difficulties occurred with regard to recruiting participants as quickly as necessary to avoid drop-outs due to participants' unwillingness to wait until eight individuals were recruited for randomization. To solve the problem, we switched from the original block randomization to a procedure in which the next patient eligible for the study was allocated to the treatment condition until the minimum group size of four was reached.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of BED according to DSM-5 criteria
* age over 18 and below 69
* 25 \< BMI \< 45
* ability and willingness to provide informed consent

Exclusion Criteria:

* high risk of suicide
* co-occurring psychotic, bipolar disorders, alcohol/substance dependence within the past six months and/or borderline personality disorder
* medical disorders that would affect weight and/or the ability to participate
* insufficient German language skills (as assessments and treatment were conducted in German)
* current participation in psychotherapeutic treatment other than those offered in the study
* current participation in a weight control program
* taking medication that would affect weight
* pregnancy.
Evaluation of Silverlon Dressing for Autogenous Skin Donor Sites

The purpose of this study is to compare one type of dressing against the current standard dressing that is used to cover an unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned.

Hypothesis: The mean healing time for wounds treated with the Silverlon Dressing will be less than the mean healing time for wounds treated with Xeroform Dressing.

At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Silverlon dressing or Xeroform. The wound dressings will then be observed at least once a day beginning 72 hours after surgery until healed, defined as 90% or more of the wound surface being confluently re-epithelized.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older; male or female.
* Burn wounds of less than 30% total body surface area (TBSA) with no systemic abnormalities
* Burns do not involve the harvesting area
* Burn wounds require excision and grating of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas
* Scheduled excision and grafting procedures is the first such operation for subject during this hospitalization
* Subject agrees to participate in follow-up evaluations

Exclusion Criteria:

* Critical illnesses requiring ventilator support, systemic infection or hemodynamic instability
* Major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
* Subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). The use of anticoagulants does not include deep vein thrombosis (DVT) prophylaxis.
* Cellulitis or other infection of potential donor site
* Previously harvested donor site
* Subject with greater than 30% TBSA burns
* Subjects with sensitivity to silver or nylon
* Pregnancy
Muscle Strength Assessment in Patients With Chronic Ankle Instability

Patients with chronic ankle instability (CAI) show biomechanical and neuromuscular alterations during the performance of functional movements not only at the ankle joint level, but also in more proximal joints and segments. Few studies have been conducted to investigate the effects of chronic ankle instability on neuromuscular control at the knee joint level. The aim of this study is to investigate whenther abnormalities exists in maximal and sub-maximal isometric muscle strength expression in patients with CAI.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 40 years
* chronic ankle instability
* physically active individuals

Exclusion Criteria:

* sedentary behaviour
* previous injuries or surgeries to the lower limbs
* neurological disorders
The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. In addition, the hyaluronic acid was proved to decrease adhension of soft tissue and nerve during operation. The investigators design a randomized, double-blind, controlled trial to assess the effect after ultrasound-guided hydrodissection with hyaluronic acid in patients with CTS.

After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided hydrodissection with hyaluronic acid and control side received one-dose ultrasound-guided injection with normal saline. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 year-old.
* Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

* Cancer
* Coagulopathy
* Pregnancy
* Inflammation status
* Cervical radiculopathy
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid injection for CTS
A Dose-Finding and Exploratory Study of RO5323441 in Combination With Sorafenib in Patients With Hepatocellular Carcinoma

This open-label study will assess the safety, efficacy and pharmacokinetics of RO5323441 in combination with sorafenib in patients with advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy. In the dose-finding Part I, cohorts of patients will receive escalating doses of RO5323441 intravenously (iv) every 2 weeks in combination with sorafenib 400 mg orally twice daily. In the exploratory Part II, patients will be randomized to receive either the previously established dose of RO5323441 iv every 2 weeks plus continuous oral sorafenib or sorafenib alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. For patients in the sorafenib arm with disease progression crossover to combination treatment with RO5323441 will be allowed.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/= 21 years of age
* Advanced or metastatic and/or unresectable hepatocellular carcinoma
* At least 1 measurable lesion according to RECIST criteria
* Primary tumor in situ (Expansion Cohort Part I, Part II)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Prior systemic treatment for metastatic hepatocellular carcinoma or patients who had tumor removed (Expansion Cohort Part I, Part II)
* Major surgery within previous 4 weeks or planned major surgical procedure during course of study
* Radiation therapy within 28 days prior to start of study treatment
* Serious non-healing wound, ulcer ore bone fracture
* History of uncontrolled seizures or encephalopathy within the last 6 months
* Current central nervous system (CNS) metastases or spinal cord compression
* History of gastrointestinal perforation or esophageal/gastric bleeding within 6 months prior to study enrollment
* History of another primary malignancy and off treatment for \</= 3 years, except for non-melanoma skin cancer and carcinoma in situ of the cervix
* Patients with prior liver transplant
* Inadequately controlled hypertension or prior history of hypertensive crisis or hypertensive encephalopathy
* Active bleeding diathesis
Establishing the Glycaemic Index of Fruit Drinks Using Different Measurement Methodologies

Glycaemic responses to carbohydrates ingested as fruit sugars may vary depending on factors inherent to the fruit and the type of sugar. The aim of this project is to investigate the glycaemic responses to a range of commercially available fruit drinks and to establish the glycaemic index for each product relative to a glucose reference. Differences in recorded responses could also be influenced by the sample type (capillary blood vs interstitial fluid) and participant characteristics. Participants will ingest 8 test drinks including 5 different fruit drinks (OJ, AJ, S\&B, ENERGISE, BLUE), each matched for carbohydrate to the glucose reference (CONTROL) which will be sampled two times, an additional sample of one of the smoothies (S\&B) will also be replicated. Fingerstick capillary blood sampling alongside dual sited continuous glucose monitors (CGM) will measure glucose and lactate concentrations, subjective appetite sensations will also be recorded. The tests will follow best practice guidelines for glycaemic index testing. These data will provide insight into how differing formulations can alter the glycaemic responses to fruit drinks, and whether sampling technique can affect the interpretations of measurement.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* Body mass index 18-30 kg/m2

Exclusion Criteria:

* diagnosis of any form of diabetes
* intolerances or allergies to any of the study procedures (e.g. fructose/inulin intolerance)
* Fructose malabsorption
* Inborn errors of fructose metabolism (e.g. fructokinase deficiency, aldolase B deficiency, fructose-1,6-bisphosphatase deficiency)
* pregnant or lactating
* any condition that could introduce bias to the study (e.g. diagnoses of lipid disorders, including cardiovascular disease, or therapies that alter lipid or glucose metabolism, such as statins or niacin).
To Compare Predictive Power of End-tidal Carbon Dioxide Between Different Time Line During Resuscitation

To analyze a multi-center observational study database. to select adult non-traumatic in-hospital cardiac arrest. Review and recored end-tidal carbon dioxide in per minute. Arrange them in different time line. one is in resuscitation time. The other is the time line which the beginning time is the time of starting appearing stable end-tidal carbon dioxide wave.To compare predictive power of end-tidal carbon dioxide between different time line during resuscitation.


Eligibility Criteria:
Inclusion Criteria:

adult non-traumatic in-hospital cardiac arrest patients Exclusion Criteria:1) surrogate decision of Do-Not-Resuscitate (DNR) during CPR; 2) out-of-hospital cardiac arrest (OHCA) patient; 3) trauma as the main reason for medical treatment; 4) child or adolescent patients; 5) Petco2 value was not recorded effectively; 6) delay from initial CPR to starting to record Petco2 exceeded 30 min; and 7) screening by qualified experts. More than three experienced physicians thought that the patient's Petco2 value was too extreme to agree with his/her medical history, and the value was seen as an error and was excluded