cyrilzakka/clinical-trials huggingface dataset:
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders

OBJECTIVES:

I. Assess the efficacy of dichlorphenamide in the treatment of episodic weakness attacks in patients with hyperkalemic periodic paralysis, paramyotonia congenita with periodic paralysis, and hypokalemic periodic paralysis.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and diagnosis.

The weekly attack rate is determined during an 8-week assessment prior to therapy initiation and at crossover.

Patients are randomly assigned to oral dichlorphenamide (DCP) or placebo for 9 weeks and then cross to the alternate treatment. Patients on DCP at baseline continue on the same dose; those on acetazolamide (ACZ) at baseline receive a DCP dose equivalent to one fifth of the ACZ dose.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Hypokalemic periodic paralysis Typical clinical profile Normal serum thyroxine Hypokalemia during spontaneous or glucose-induced paralytic attack in subject or affected family member

Periodic paralysis associated with sodium channel 17q alpha-subunit, e.g.:

* Hyperkalemic periodic paralysis with or without myotonia
* Paramyotonia congenita with periodic paralysis

Distinct, regular episodes of weakness at least once a week and no more than 3 times a day

No history of worsening symptoms with carbonic anhydrase inhibitor

No history of life-threatening weakness episodes prior to treatment

No atypical periodic paralysis without demonstrable 17q alpha-subunit defect

--Prior/Concurrent Therapy--

No requirement for the following agents, unless for periodic paralysis:

* Diuretics
* Antiepileptics
* Antiarrhythmics
* Magnesium supplements
* Steroids
* Calcium supplements
* Beta-blockers
* Potassium supplements
* Calcium channel blockers

--Patient Characteristics--

Hepatic: No hepatic disease

Renal:

* No renal failure
* No nephrolithiasis

Cardiovascular:

* No heart disease
* No cardiac arrhythmia

Pulmonary: No restrictive or obstructive lung disease

Other:

* No active thyroid disease
* No pregnant women
Efficacy of Direct Selective Laser Trabeculoplasty in Clinical Practice in Patients with Glaucoma

Prospective, single-arm, single-center, non-randomized, non-comparative study including naïve patients attending our center diagnosed with glaucoma, who have been recommended treatment with direct selective laser trabeculoplasty (DSLT) by their ophthalmologist and who are under no hypotensive medication. DSLT treatment will be performed with the Voyager DSLT system; it will consist of the application of 120 laser pulses of preset 3 ns and a preset 400 μm spot size, with an energy of 1.8 mJ delivered to the limbus through a full 360 degrees.

The study will evaluate the effect of DSLT on intraocular pressure (IOP). Baseline IOP will be the IOP measured with Goldman applanation tonometry by the investigator on the day of treatment, prior to the application of DSLT. Patients will be seen one week (±2 days), one month (±7 days), three months (±15 days), six months (±30 days) and 12 months (±40 days) after DSLT treatment. In each of these visits, the attending ophthalmologist will measure IOP with Goldmann applanation tonometry and record the presence of any relevant ocular signs and query patients regarding potential adverse events. The study´s main end-point will be percentage reduction in IOP six months after DSLT compared to baseline.


Eligibility Criteria:
Inclusion Criteria: • Age over 18 years

• Diagnosis of open angle glaucoma in eye study and scheduled for both eyes being treated after bilateral laser indication. The diagnosis of glaucoma will be based on the presence of optic nerve damage that is compatible with glaucoma in the absence of any other cause that could have produced this damage, with an IOP value\>21 mmHg.

Exclusion Criteria:

* Patients diagnosed with uveitis, angle closure or congenital glaucoma.
* Presence of anterior peripheral synechiae
* Patients unable to complete three, six- and 12-months follow-up.
* Patients having undergone intraocular surgery, save for uneventful phacoemulsification (performed at least 6 months prior to inclusion)
Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series

The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)

Stage 1 (Dose-level Finding;Phase 2)

1. To compare the immunogenicity and safety of three LBVD vaccine candidates, varying at different dose levels, to the Control vaccines at 4 weeks after a three-dose primary series of vaccination and thereby, select an optimal vaccine dose level for Stage 2

Stage 2 (Evaluation of Safety, Immunogenicity, and Lot-to-lot Consistency;Phase 3)

1. To demonstrate the non-inferiority and lot-to-lot consistency in the immunogenicity of three separate lots of LBVD to the Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age
2. To demonstrate the safety and immunogenicity of LBVD at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

Eligibility Criteria:
Inclusion Criteria:

* Infants in stable health
* Male or female 6 to 8 weeks of age
* Signed informed consent by the infant's parent(s) or legally acceptable representative(s)

Exclusion Criteria:

* Known or suspected Hib, HepB, diphtheria, tetanus, pertussis, or poliomyelitis
* Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration
* Known or suspected immunodeficiency
* Previous use of blood or blood-derived products
* Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination
* Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration
* Any history of allergy (hypersensitivity) to any of the vaccine components
* Participation in another interventional clinical trial simultaneously
Longitudinal Observation of NHS Staff Wellbeing Following Introduction of the I-care Peer Support App

The coronavirus pandemic has had demonstrable impact upon healthcare workers. For healthcare workers this has meant disruption to vital access to peer support networks. In May 2020 the United Nations (UN) published a policy brief highlighting the importance of supporting mental health and wellbeing for communities affected by coronavirus. There is a need to find innovative solutions to facilitate support in the post-COVID-19 era and some innovations are emerging to fill this void but an evidence, long-term, sustainable, solution is yet to be proposed. In response, a digital app has been co-developed by UK researchers and healthcare staff with the intent to facilitate a virtual peer support mechanism for National Health Service (NHS) staff.

Rationale: The coronavirus pandemic has had demonstrable impact upon healthcare workers. For healthcare workers this has meant disruption to vital access to peer support networks. In May 2020 the United Nations (UN) published a policy brief highlighting the importance of supporting mental health and wellbeing for communities affected by coronavirus. There is a need to find innovative solutions to facilitate support in the post-COVID-19 era and some innovations are emerging to fill this void but an evidence, long-term, sustainable, solution is yet to be proposed. In response, a digital app has been co-developed by UK researchers and healthcare staff with the intent to facilitate a virtual peer support mechanism for National Health Service (NHS) staff.

Aim: The main aim of this research is to determine the acceptability and efficacy of the newly developed I-care app to facilitate peer-support for NHS staff wellbeing.

Methods: A mixed methods study with concurrent process evaluation will be conducted to explore the acceptability and efficacy of an app-based peer support platform for use by anyone working within Solent NHS Trust with access to an android mobile phone device. Data will be generated from quantitative app usage, binary survey responses, and qualitative interviews.

Populations: All staff within Solent NHS Trust with an android mobile phone will be considered eligible to use the app.

Duration: Data will be collected at one, three, six, and 12-months post app launch.

Expected outcomes: As the innovation developed has spanned biomedical, behavioural and computing science a range of exploratory methods are proposed to establish the reach and uptake of the innovation, early indication of a potential causal model explaining how the innovation could lead to benefit, identification of key components of the innovation as identified by end users, and estimation of overall acceptability and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* All staff within a single UK Health Trust with an android mobile phone will be considered eligible to use the app

Exclusion Criteria:

* Not employed within the designated Trust
* Under 18 years of age
* Unable or unwilling to provide informed consent
A Safety and Tolerability Study of Jaktinib

This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.

This study is a Phase 1, single-arm, open-label, dose escalation trial, to evaluate the safety and tolerability of Jaktinib in patients with PMF or Post-PV/ET MF and who are relapsed/refractory to a marketed JAK inhibitor

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia).
* Relapsed/refractory to a marketed (FDA approved) JAK inhibitor.
* At least 18 years of age.
* ECOG PS 0, 1, or 2.
* Expected life expectancy is greater than 24 weeks.

Exclusion Criteria:

* Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
* Major surgery or radiation therapy within 28 days prior to initiation of study drug.
* With suspected allergies to jaktinib or its excipient.
* Another clinical trial of a new drug or medical instrument within 3 months before screening.
* Females who are pregnant, currently breastfeeding, planning to become pregnant.
* Unable to adopt effective contraceptive methods during the study.
Comparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.

The purpose of this study was to compare the pain relieving action of the lornoxicam and diclofenac in patients of OA knee.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patient aged between 25 to 65 yrs of either gender suffering from osteoarthritis of knee according to criteria given by American College of Rheumatology
* Informed consent obtained from the patient.

Exclusion Criteria:

* Patients with any other systemic llness,
* Patients with pregnancy and lactation,
* Patients taking other drugs like lithium\[4\], digoxin, methotrexate, anticoagulants, antidiabetics, diuretics,
* Patients with H/O hypersensitivity to NSAIDs,
* Patients who had consumed any analgesics in last 1 month
The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.

The role of gut microbiota in anastomosis insufficiency in patients operated for colorectal cancer and for peritoneal carcinomatosis is going to be investigated. This is a pilot study.


Eligibility Criteria:
Inclusion Criteria Colorectal group

* adenocarcinom in colon or rektum
* curative operation planed
* direct anastomose plan
* elective surgery

Inclusion Criteria HIPEC group :

* All patients with appendix, colon or rectal cancer accepted for CRS+HIPEC

Exclusion Criteria:

* Ongoing antibiotics treatment
* antibiotics treatment in the last 6 months
* acute surgery
* palliative surgery
* Ulcerös colitis or Crohns disease
* Prior colectomy
* Small intestine stoma before the operation
* neoadjuvant treatment
* Colon preparation
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.

Approximately 35 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.

Eligibility Criteria:
Key Inclusion Criteria:

* Genetically confirmed diagnosis of Alagille syndrome
* History of significant pruritus as measured by the Albireo Observer or Patient Reported Outcome instrument
* Elevated serum bile acid level

Key Exclusion Criteria:

* History or ongoing presence of other types of liver disease (eg. biliary atresia, progressive familial intrahepatic cholestasis, hepatocellular carcinoma)
* History of liver transplant, or a liver transplant is planned within 6 months of randomization
* ALT \>10× upper limit of normal (ULN) at screening
* Total bilirubin \>15 × ULN at screening
* Patient suffers from uncontrolled, recalcitrant pruritic condition other than Alagille syndrome
Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease

PRECISION-HD1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120101 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362307 (SNP1).


Eligibility Criteria:
Key Inclusion Criteria:

* Prescreened with targeted SNP on the same allele as the pathogenic CAG expansion
* Ambulatory, male or female patients aged ≥25 - ≤65 years
* Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4
* Early manifest HD, Stage I or Stage II based on UHDRS Total Functional Capacity Scores ≥7 and ≤13

Key Exclusion Criteria:

* Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years.
* Received investigational drug or implantable device in prior 3 months or investigational oligonucleotide in prior 6 months or 5 half-lives of the oligonucleotide, whichever is longer
* Clinically significant medical condition, unstable psychiatric symptoms, substance abuse, or pregnancy
* Inability to undergo brain MRI
* Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture
Smoking and Peptidoglycan Recognition Protein-1 and Initial Periodontal Therapy

A total of 40 patients with CP (20 smokers (S+CP) and 20 nonsmokers (S-CP)) and 40 periodontally healthy subjects (20 smokers (S+PH) and 20 nonsmokers (S-PH)), comprising 80 subjects, were included in this study. Baseline GCF samples were obtained from all subjects and clinical periodontal measurements, including probing depth (PD), clinical attachment level (CAL), plaque index (PI), and gingival index (GI), were recorded. In patients who had received initial periodontal therapy, GCF samples were obtained and all clinical periodontal measurements were recorded again during the 6th-8th weeks. GCF PGRP-1 levels were analyzed by enzyme-linked immunosorbent assay.

Peptidoglycan recognition proteins (PGRPs) are one of the antimicrobial peptides that play a role in innate immunity and act against the bacterial cell wall. Smoking is the most important environmental risk factor for periodontitis. This study determined the effect of smoking on PGRP-1 levels in gingival crevicular fluid (GCF) in smokers and nonsmokers with chronic periodontitis (CP) following initial periodontal therapy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of severe chronic periodontitis
* Clinical diagnosis of periodontal health

Exclusion Criteria:

* have any systemic disease,
* to be alcohol consumer,
* to receive any periodontal therapy in the past 6 months,
* to take any drugs regularly
* to be pregnant and/or lactate.
High-fat Yogurt and Plasma Lipids Profile

The goal of this clinical trial is to compare the effect of saturated fat intake from different source on cardiometabolic risk markers in healthy subjects. The main question it aims to answer are:

-Does intake of saturated fat in the form of high-fat yogurt have a different effect on cardiometabolic risk factors than intake of the same amount from butter? In this study, in two periods of 4 weeks, the effect of receiving saturated fat from high-fat yogurt compared to receiving the same amount of saturated fat from butter and low-fat yogurt on the plasma concentration of lipids, cholesterol, insulin, and some inflammatory factors will be studied in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy people who do not use lipid-lowering, blood pressure control or diabetes medications

Exclusion Criteria:

* Taking supplements of omega-3 fatty acids, or antioxidants
The Influence of Acute Myocardial Infarction Checklist on the Door-to-Balloon Time

This study was designed to investigate the influence of the acute myocardial infarction checklist on the door-to-balloon time in patients suffering from acute STEMI at Far Eastern Memorial Hospital


Eligibility Criteria:
Inclusion Criteria:

* all patients who presented to the emergency department of Far Eastern Memorial Hospital within 12 hours of the onset of ischemic chest pain
* patients with diagnostic criteria of acute ST-elevation myocardial infarction on electrocardiogram, e.g. at least 0.1 mV in two or more contiguous electrocardiographic leads or a new onset of bundle branch block
* patients were preparing for emergency cardiac catheterization

Exclusion Criteria:

* patients who did not fulfill the diagnostic criteria of acute myocardial infarction on electrocardiogram
* patients who were not eligible for cardiac catheterization
* patients who refused cardiac catheterization
* patients who suffered from acute myocardial infarction after admission to ward or intensive care unit for any reason
* patients who had an ambiguous diagnosis that the decision of emergency cardiac catheterization was made after admission to ward or intensive care unit
Exercise on Mitochondrial Functions of Lymphocyte in Hemodialysis

To improve aerobic capacity, muscular function and health-related quality of life in patients with end-stage renal disease (ESRD), regular exercise is recommended. Supervised intradialytic exercise with moderate intensity is an available approach to maintain patients' safety and compliance, and enhance physiological adaptations effectively. The exercise training effects of mitochondrial functions of lymphocyte in ESRD patients, like respiratory capacity, bioenergetic status and thrombosis/immunological regulation remained unclear.

Method: ESRD patients (anticipated n=180) would conduct supervised exercise training therapy for 3 days a week for 6 months in the hospital and 3 months at home. Cardiopulmonary exercise therapy would be performed before and after the intervention. A high resolution respirometer and a flow cytometer are used to determine the oxygen consumption rate/mitochondrial respiration in mitochondria and subtypes of lymphocyte, respectively.

Renal dysfunction results from cardiovascular-related comorbidities or metabolic disorders, accumulating excessive inflammatory products or damage mitochondrial bioenergetics health in platelet and lymphocyte, then lead to chronic kidney disease (CKD) eventually. End-stage renal disease (ESRD) is the highest level of CKD, patients at ESRD stage suffer from severe uremia and renal failure, preparing renal replacement therapy: dialysis.

Hemodialysis (HD) are the most common treatment for ESRD patients, especially in Taiwan, where reports the highest prevalence of HD globally due to related chronic diseases and comprehensive National Health Insurance program. Maintenance (long-term) HD results in physical inactivity and low quality of life; thus, exercise training is recommended to improve physiological adaptations and functional capacity for HD patients. With supervised condition and a safer progression, intradialytic exercise in clinical settings provides low dropout rate and superior compliance.

Mitochondrial dysfunction is one of the concerned issues in ESRD, impaired mitochondria also dysregulate circulating lymphocyte, leading to immunological senescence .

The purposes of the present study are to establish the measurements of mitochondrial functions of platelet and lymphocyte in HD patients, and determine cardiovascular and muscular fitness along with the effects of intradialytic exercise.

Eligibility Criteria:
Inclusion Criteria:

* All patients have been receiving hemodialysis and medication at least for 6 weeks, the Kt/V score must be above 1.2 to show that they were stable.

Exclusion Criteria:

* Under 20 years-old, hyperkalemia occurs within 3 month, orthopedic or muscular diseases, other medical, psychological or physiological diseases, pregnancy exercise contraindications.
Gut Microbiota and Antibiotics - Prevention of Side Effects by New Prebiotics

Antibiotics disturb the balance of gut microbiota causing dysbiosis. The purpose of this double-blind placebo controlled intervention study is to investigate whether a new prebiotic product could prevent the side effects of antibiotics.

Thirty children (2-6 years of age), who require antibiotic treatment assessed by a doctor, will be enrolled in the study. The children will be randomized to receive either the prebiotic product or placebo during the course of antibiotic treatment.

The children will give a faecal sample in the beginning and at the end of the study. The samples will be used for the analysis of microbiota and differences in the microbiota between the groups.

Eligibility Criteria:
Inclusion Criteria:

* An infection requiring antibiotic treatment assessed by a doctor

Exclusion Criteria:

* Coaeliac disease or allergy to cereals, use of other prebiotic/probiotic product during the study