cyrilzakka/clinical-trials huggingface dataset:
Single and Multiple Dose Study to Explore the Safety and Pharmacokinetics of JNJ-39758979 In Healthy Male Volunteers of Either Caucasian or Japanese Descent

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single doses of JNJ-39758979 in healthy Japanese volunteers and multiple doses of JNJ-39758979 in healthy Japanese and Caucasian volunteers.

This study will assess the safety and pharmacokinetics of JNJ-39758979 or placebo (which looks like the drug being studied but has no active ingredients) in healthy volunteers. This study is being conducted in two parts. Part 1 is a randomized (study drug will be assigned by chance), double-blind (neither the physician nor volunteer knows the identity of the assigned drug) study evaluating the safety, tolerability and pharmacokinetics of single doses of JNJ-39758979 and placebo in 36 healthy Japanese male volunteers. Part 2 is a randomized, double-blind study evaluating the safety, tolerability, and pharmacokinetics of multiple doses of JNJ-39758979 and placebo in 24 healthy Japanese males and 24 healthy Caucasian males. For Part 1, the participation period is a maximum of 56 days, including a screening visit, a 7-day in-clinic period and two follow-up visits. For Part 2, the participation period is a maximum of 202 days, including a screening visit, a 17-day in-clinic period and two follow-up visits. For both parts of the study, safety evaluations, which will include ECG (a cardiac function test), vital signs and monitoring of side-effects will be performed. Additionally, blood and urine samples will be collected for evaluation. Part 1: volunteers will receive a single oral (by mouth) dose of JNJ-39758979 (50, 100, 300, or 600mg) or placebo; Part 2: volunteers will receive an oral dose of JNJ-39758979 (300 mg) or placebo once a day for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Must be generally in good health
* If japanese, must have lived outside of Japan for no more than 5 years and whose parents and grandparents are Japanese
* Have negative result for HIV, hepatitis B, and hepatitis C
* Must be willing to use an acceptable method of birth control for 6 months after the last dose and to not donate sperm during the study and for 6 months after the last dose
* Must have a negative test for alcohol and drugs of abuse at check-in

Exclusion Criteria:

* History of alcohol or drug abuse within the last 5 years (consuming more than 14 drinks per week)
* Average consumption of more than 3 cups of caffeinated beverages (tea/coffee/cocoa/cola) per day
* Use of vitamins, herbal supplements, energy drinks or St.John's Wort (hypericin) for 14 days before first dosing
* Receipt of an experimental drug or medical device within the last month
Balance Effects of Morton´s Extension in Flat Foot

The aim of this study is to simulate the orthopedic treatment called Morton's extension on flat foot patients to check balance effects in standing position.

The objective of this study is to perform an assimilation of the orthopedic treatment called morton extension on flat foot patients to verify the balance with stabilometry study.

Eligibility Criteria:
Inclusion Criteria:

* Women and men aged 18 to 30 with flexible flat feet.

Exclusion Criteria:

* Participants who have had any previous limb surgery, and/or previous lower limb trauma within the last year
* Uncorrected hearing or visual impairment.
* Lumbar pathology with radicular involvement.
* Pregnancy.
* Healthy participants performing strenuous exercise.
* Diagnosed active or inactive rheumatic or inflammatory disease.
* Participants consuming alcohol within 24 hours prior to recording or stimulants 6 hours prior to testing (e.g. caffeine).
* Participants who have a history of injury with residual lower extremity symptoms within the past year.
* Participants with evidence of a leg length discrepancy (difference in distance from the anterior superior iliac spine to the superior iliac spine at the surface of the most prominent aspect of the medial malleolus) of more than 1 cm 19
* Having at least 15 degrees of ankle dorsiflexion.
* Participants with evidence of balance deficit, as determined through oral questioning about falls and by use of the Balance Evaluation Systems Test (BESTest).
* Participants with neurological pathology with lower limb deformities, sensory-motor disturbances, neuromuscular pathology, or neurovascular disease.
Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics

The study investigates effects related to muscle protein metabolism at provision of Parenteral or enteral nutrition

Randomized study investigation alterations in muscle protein metabolism at provision of parenteral or enteral (oral drink) nutrition. The study uses a genomic/transcriptomic/proteomic approach to evaluate factors related to activation of skeletal muscle protein synthesis and protein degradation. Patients scheduled for major gastrointestinal surgery are included. Muscle specimens are collected during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Major gastrointestinal surgery.
* Assumed need of post-operative nutrition support.

Exclusion Criteria:

* Insulin dependent diabetes.
* Steroid medication.
Normal Tension and Chronic Open Angle Glaucoma and Cerebrospinal Fluid Composition

Normal tension glaucoma (NTG) and chronic open angle glaucoma (COAG) occurring progressively with optimal conventional or intraocular pressure reducing surgery are still unsolved problems in ophthalmology. The investigators would like to investigate whether or not the composition of cerebrospinal fluid (CSF) surrounding the optic nerve (ON) in these patients is pathologic under certain conditions. They therefore compare the CSF taken during optic nerve sheath fenestration with the CSF taken during a lumbar puncture. The investigators' hypothesis is that, in patients with NTG and COAG, the composition of CSF surrounding the affected ON plays an important role in promoting progressive visual function loss.

We will recruit 30 patients with progressive visual function loss, due to Normal tension glaucoma (NTG) or chronic open angle glaucoma (COAG), despite optimal conventional or intraocular pressure reducing surgery treatment so far. We will proceed with an optic nerve sheath fenestration (ONSF) (according to the studies in the literature, e.g. Wax MB, Barrett DA, Hart WM Jr, Custer PL. Optic nerve sheath decompression for glaucomatous optic neuropathy with normal intraocular pressure. Arch Ophthalmol. 1993;111(9):1219-28.) and compare the cerebrospinal fluid (CSF) taken from the subarachnoid space (SAS) of the optic nerve (ON) with the CSF taken during a lumbar puncture, on the same day. Concentrations of neurobioactive substances will especially be studied. Visual acuity and visual field development before and after ONSF will be studied. Quality of life assessment will be done before and several times after ONSF.

Eligibility Criteria:
Inclusion Criteria:

* Documented progressive visual function loss over 2 years (visual field or visual acuity)
* Intraocular pressure measured as a maximum of 25 mmHg
* Possibility of receiving general anaesthesia and optic nerve sheath fenestration.

Exclusion Criteria:

* Secondary glaucoma
* Oral medication to lower intraocular pressure (carboanhydrase inhibitor)
* Visual acuity worse than 20/400
* Any other type of glaucoma (pseudoexfoliation, narrow or closed angle).
A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.

The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide® collagen membrane either sutured or glued compared to microfracture alone in the treatment of symptomatic cartilage defects of the knee.

* Prospective, randomized, active treatment-controlled, open-label multicenter study (up to 40 sites in the US and EU).
* All subjects that meet preoperative screening eligibility criteria will be randomized to treatment with Chondro-Gide® either sutured or glued or Microfracture alone.
* Eligible and consenting subjects are randomized in a 1:1:1 ratio using centralized randomization list to receive one of the following treatments: Group I: Microfracture alone; Group II: Microfracture covered with a Chondro-Gide® membrane glued with fibrin glue (AMIC glued); Group III: Microfracture covered with a Chondro-Gide® membrane sutured (AMIC sutured)
* All subjects will be assessed at intervals post-procedure (6 weeks, 3 months, and 1,2 and 5 years).
* Subjects will be required to follow a strict pre-specified post-surgery rehabilitation protocol specific to the defect location.
* Measures to assess effectiveness and safety will be conducted at all follow-ups.
* Safety will be assessed by the collection of adverse events at all timepoints.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 50
* One or two cartilage defects Grade III or IV according to Outerbridge classification
* Defect size between 2 and 10 cm2 (inclusive)
* Intact normal surrounding cartilage to suture the Chondro-Gide® membrane
* Informed consent
* Patient willing to fulfill a strict postoperative physiotherapy scheme

Exclusion Criteria:

* More than 2 defects
* Defects on both knees
* X-ray signs of osteoarthritis
* Bone lesion \> 0.7 cm in the defect
* Knee instability, varus or valgus deformation, status after complete meniscus resection, status after mosaicplasty, patella dysplasia
* Rheumatoid, infectious disease
* Skin lesion on the operated knee
* Treatment with cartilage building medication
* Drug and alcohol abuse
* Chronic heart disease, endocrine or metabolic disease, Haemophilia A/B
* Pregnancy or lactation
* Collagen allergy
* Participation in other Trials
Gastro Intestinal Tele Endoscopy Project

Synchronous Tele-Endoscopy: A clinical feasibility study of gastrointestinal tele-endoscopy by implementing and evaluating synchronous tele-endoscopy using ENDOALPHA in a hospital based endoscopy unit. EndoAlpha will be used on the hospitals existing Intranet/LAN and the possibilities of tele-endoscopy on WAN through existing network, on separate dedicated line or through new established transmission lines, will be evaluated. The EndoAlpha system will be integrated in a highly advanced endoscopy procedure room. The system will integrate through LAN with doctor office, clinic conference and lecture room and GI pathologist room. Through either LAN or WAN, connection will be establish to a referral GI center in Denmark. Through WAN, connection will be established to doctor home and to an expert Spanish center.

Evaluate the potential network (LAN +WAN) limitations for video transmission image quality and audio transmission (two-way) quality. Validate the tele-endoscopy technology for consulting and second opinion in diagnostic endoscopy and therapeutic endoscopy (teaching, training and supervision of basic and advanced therapeutic procedures).

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective gastrointestinal endoscopic procedures

Exclusion Criteria:

* Age \< 18 years or \> 90 years
* Unwilling to participate (no informed consent)
* Not able to understand and read Danish
* Emergency endoscopic procedures
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers

This is a prospective, single site, randomized, double masked, comparator-controlled study designed to evaluate the efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in soft contact lens wearers as compared to control. We hypothesize that there will be a significant improvement in dry eye symptoms in contact lens wearers using lifitegrast as compared to those being treated with control (lifitegrast vehicle).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must read, understand and sign the Statement of Informed Consent
2. Subjects must be at least 18 years of age
3. Subjects must be habitual soft contact lens (CL) wearers, with a daily, weekly, bi- weekly or monthly replacement schedule
4. Habitual contact lenses must have a suitable fit as determined by the investigator
5. Subjects must report a history of dry eye symptoms, for which they have used rewetting drops or Artificial Tears (ATs) in the past 30 days
6. Subjects must be willing to discontinue the use of Artificial Tears (ATs) and rewetting drops for the duration of the study
7. Subjects must have a score of 12 or higher on the CLDEQ (Contact Lens Dry Eye Questionnaire-8) at baseline
8. Subjects must have at least 2 of the following signs of dry eye disease:

   1. High tear osmolarity \> 308 mOsm/L, (milliosmoles per liter) or a difference greater than 8 mOsm/L between eyes
   2. Any corneal staining
   3. Any bulbar conjunctival staining
   4. Low TBUT (tear break up time) (\<10s)
   5. Schirmer \<10mm in either eye
9. Subjects must be able to read at least half of the 20/25 (via entrance Snellen visual acuity) or better in each eye in their current contact lens prescription.
10. Subjects currently wearing reusable contact lenses must be willing to use Clear Care solution for cleaning and disinfecting throughout the study.

Exclusion Criteria:

1. Currently pregnant or breastfeeding by self-report
2. Allergy to lifitegrast ophthalmic solution 5% (Xiidra)
3. Habitual extended wear contact lens schedule
4. Any active ocular disease that may affect the ocular surface other than dry eye (significant blepharitis, allergic conjunctivitis, lagophthalmos, chalazia, hordeolum etc.)
5. Any meibomian gland dysfunction, blepharitis, corneal neovascularization or papillary conjunctivitis that is grade 3 or higher using the Efron Grading Scale.
6. Excessive corneal staining, that in the opinion of the investigator, is a contraindication to contact lens use.
7. History of ocular surgery
8. Any active ocular infection
9. Use of any topical ophthalmic medications other than artificial tears or rewetting drops
10. Inability to perform necessary visual function assessments
11. Punctal plug insertion in the last 3 months, or presence of punctal plugs at the time of the exam.
Diabetic Macular Edema and Diabetic Retinopathy Screening (TeleMed) With Automated Retinal Photography

The purpose of this study is explore if a partnership and screening program put in place between a busy retina practice and their referring diabetes care offices can improve diabetic retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in patients with diabetic eye disease.

Retina Institute of Hawaii will place an infrastructure to screen for diabetic retinopathy/diabetic macular edema in 5 of the states largest Primary Care Clinics, General Medical and or Endocrine practices which re our primary referrals for diabetes patients. Each Sub-site will receive a DRS Automated Retinal Camera and our staff will train the sub-site's staff on taking images. The submission of these images to our practice will be administered by an automated job scheduler in the DRS Automated Retinal Camera removing the requirement of the locations to send images. Images will be electronically uploaded and sent to the Retina Institute of Hawaii for detailed interpretation and report sent back to the patients, their diabetes care MD's and their nurse practitioners/diabetic educators.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with diabetes that have not seen an Ophthalmologist in the past 1 year

Exclusion Criteria:

* Patients with diabetes already under the care of an Ophthalmologist.
* Patient not willing to give Consent for participation in the study
Effectiveness of a Crowdsourced Cognitive Reappraisal Intervention

This study evaluates a web-based, crowdsourcing platform to promote cognitive reappraisal. Half of participants will be granted access to the crowdsourced reappraisal platform. The other half will be provided a web-based expressive writing platform. The investigators hypothesize that the crowdsourcing reappraisal platform will be more effective than the expressive writing platform in promoting positive psychological outcomes.

There are many ways to manage stress and mood, including exercise, diet, and relaxation practices. Cognitive-based techniques are also extremely powerful. Simply changing how you think about stressful situations can dramatically affect the way you feel. Individuals who routinely use strategies like cognitive reappraisal exhibit an enviable affective profile: studies suggest these individuals generally have less stress, lower incidence of depression, and better social functioning than those who rely on less adaptive emotion regulatory techniques. Techniques like cognitive reappraisal are also integral to many evidence-based psychotherapeutic traditions, such as cognitive-behavioral therapy and rational-emotive therapy.

Unfortunately, cognitive techniques can be hard to learn. Thinking flexibly about stressful thoughts and situations requires creativity and poise, faculties that often elude us when we need them the most. In this study, the investigators evaluate a web-based technology that uses crowdsourcing and peer-to-peer interactions to help people learn cognitive-based techniques and apply them throughout their daily lives.

The goal of the proposed study is to see whether the investigators' technology is more engaging and more effective at reducing depression symptoms than a web-based expressive writing platform. While the investigators are most interested in how this intervention affects depression symptoms, the investigators will also assess other psychological variables and the investigators will open the study to the general population.

Participation in this study will last three weeks. Participants will be randomly assigned to receive either a crowdsourcing reappraisal platform or an expressive writing platform. All study procedures (subject recruitment, baseline and follow-up assessments, interventions) will be conducted online.

Eligibility Criteria:
Inclusion Criteria:

* An email account, a desktop computer, and broadband Internet access
* Access to modern web browsers (e.g., Chrome, Safari, Firefox)
* Native English speaker
* 18 to 35 years old

Exclusion Criteria:

* Planning to be without Internet access during the scheduled intervention time
Sequential Therapy Versus Quadruple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection

The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI + amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole + tetracycline ) as second line treatment of H. pylori .

a total of 101 patients were randomized to 2 groups : 50 in sequential group and 51 patients in quadruple group . mean age was 43 in both groups. In sequential therapy group 42 patients(84%) completed the treatment , 39 patients returned to follow up . In quadruple group only 33 patients (64.7%) completed the treatment , 29 of them returned to follow up.

Compliance to the treatment was significant better in sequential group comparative to quadruple .Sides effects connected to gastro-intestinal tract were reported in 27(65.9%) of quadruple group patients and in 19(43.2%)of sequential group.

The H pylori was eradicated in 23 of 39 patients in sequential group(59%), and in 19 of the 29 patients in quadruple group(65.5%). no comorbidities like smoking, diabetes or other influenced the efficacy of eradication.

Sequential therapy showed the same eradication rate as second line treatment of H pylori as quadruple one, but was associated with better compliance and less adverse effects.

Both treatments protocols failed to show an appropriate eradication rate in population of Southern Israel .

Eligibility Criteria:
Inclusion Criteria:

1. signed informed consent
2. age at least 18 years
3. persisting H.pylori infection after at least one course of first-line standard triple therapy (Amoxycillin, Clarithromycin or Metronidazole based)

Exclusion Criteria:

1. history of gastrectomy
2. gastric malignancy, including adenocarcinoma and lymphoma
3. previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole, tetracycline) and proton pump inhibitors
4. Active upper gastrointestinal bleeding within the previous 1 week
5. contraindications to the treatment drugs
6. Pregnant or lactating women
7. Severe concurrent disease or malignancy
Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Wales

This study is aimed to establish the epidemiological chacacteristics and clinical outcomes of mechanically ventilated patients with acute hypoxemic respiratory failure admitted in a network of hospitals from Wales (U.K.).

The present study is aimed to establish the epidemiological characteristics and clinical outcomes of adult mechanically ventilated patients with acute hypoxemic respiratory failure \[defined as a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of 5 cmH2O or more and FiO2 of 0.3 or more\] admitted in a network of hospitals from Wales (U.K.). Although there are few previous published observational studies examining the incidence and mortality of patients with acute respiratory failure and ARDS, there are no studies specifically assessing the epidemiological characteristics, patterns of ventilation and clinical outcomes in patients with acute hypoxemic respiratory failure in the current era of lung protective ventilation. This study will be done simultaneously with the PANDORA (NCT03145974) in Spain.

The study is aimed to improve the knowledge on the epidemiology and outcome of ventilated patients, to identify the percentage of patients developing ARDS under the current definition, to validate a bedside scoring system for stratification of lung severity, and to examine the prognosis of hypoxemic respiratory failure, and risk factors associated with fatal outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18-year old.
* Endotracheal intubation and mechanical ventilation, independent of whether the need for ventilatory support is shorter or longer than 24 hours. Only patients receiving invasive mechanical ventilation can be included, although patients could have been on non-invasive ventilation before intubation.
* PaO2/FiO2 ≤300 mmHg on invasive mechanical ventilation with a PEEP of 5 cmH2O or more, and with a FiO2 of 0.3 or more.

Exclusion Criteria:

* No patients shhould be excluded (if they meet all the inclusion criteria), regardless of the underlying disease, estimated life expectancy, or duration of invasive mechanical ventilation.
Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time

When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.

ECT treatments are done under general anesthesia, and the induction is commonly done with methohexital. We will study whether using ketamine as an induction agent will result in a faster recovery time and quicker re-orientation time compared to using methohexital.

Eligibility Criteria:
Inclusion Criteria:

* All patients eligible for ECT with a primary mood disorder (bipolar disorder, major depressive disorder) will be eligible to participate in this study. - Patients must have decisional capacity and must be able to consent for this study.

Exclusion Criteria:

* patients with a primary psychotic disorder (schizophrenia, schizoaffective disorder); patients designated as having an American Society of Anesthesiologist (ASA) Status of greater than 3;
* patients with a known allergic reactions to methohexital , ketamine and succinylcholine;
* patients with current or previous history of aneurysms, intracranial bleeds, or intracranial hypertension;
* patients with uncontrolled severe hypertension.