cyrilzakka/clinical-trials huggingface dataset:
Safety, Efficacy and Cost-effectiveness of Racecadotril in Children With Acute Diarrhea in Mexico

Rationale: Acute diarrhea (AD) is still a significant morbidity-mortality problem worldwide. Although oral rehydration therapy is the cornerstone, its anti-diarrheal effect is a controversial subject. Since ten years ago, Racecadotrilo´s safety and efficacy had been proved. However, a pharmacoeconomics analysis on this therapeutics has not been published yet.

Objective: Evaluate the efficacy, safety, tolerability and costs associated with Racecadotril administration in comparison to a placebo in infants up to 24 months of age with AD in a hospital (mildly or moderately dehydrated) and ambulatory (no dehydrated) settings at the National Institute of Pediatrics in Mexico.

Material and Methods: Randomized, double-blind, placebo controlled, clinical trial (RDBCCT) with pharmacoeconomics analysis (cost minimization) to realize in 454 infants with AD (270 hospitalized and 184 outpatients), 1 to 24 months of age who concomitantly will receive ORT and Racecadotril (1.5mg./Kg./t.i.d. doe 5 days) (ORT-Rac Group) or placebo (ORT-Placebo Group). The clinical outcomes in the hospitalized infants to measure will be a) Stool output rate at 48hs. and at the end of the study; b) duration of diarrhea; c) percentage of intravenous (IV) needs and d) percentage of adverse events. The outcome variables in outpatient infants to measure will be a) total liquid and semi-liquid bowel movements during the study; b) duration of diarrhea and c) percentage of adverse events. The pharmacoeconomics analysis will involve a cost minimization analysis (CMA). Results will be analyzed through bi and multivariate analysis using STATA 11.0 for Mac, considering a p value \< 0.05 as significant. The pharmacoeconomics model will made through decisions trees using TreAge Pro Healthcare v 1.2.0, 2009.


Eligibility Criteria:
Inclusion Criteria:

* children ≥ 1 month of age and ≤ 24 months of age
* Acute diarrhea (defined as three or more watery or semi-watery bowel movements for at least one day lasting no more than 5 days before being admitted)
* For in hospital group: mild or moderate dehydration
* Signed informed consent letter

Exclusion Criteria:

* previous use of oral antibiotics for more than 48 hours (during the two weeks before the trial
* previous use of anti-diarrheal medication (e.g.: bismuth subsalicylate, adsorbents, Loperamide, combinations)
* chronic pathologies (e.g.: cardiopathies, nephropathies, chronic gastrointestinal pathologies, endocrinopathies)
Laryngeal Adaptation for Speech and Swallowing

This study will test laryngeal adaptation in speech and swallowing function in healthy adults, in patients with cerebral stroke, and in patients with spinocerebellar ataxia type 6. The findings from this proposal will be the first step toward implementing rehabilitation techniques that help patients to prevent speech and swallowing errors before they occur.


Eligibility Criteria:
Patient Inclusion Criteria:

All stroke and ataxia

Ataxia

* DNA diagnosis of SCA6 and phenotype consistent with the DNA diagnosis
* No recessive, X-linked or mitochondrial

Stroke

* Bilateral or unilateral middle cerebral artery (MCA) stroke
* No structural abnormalities (i.e. nodules)
* Dysphagia involving laryngeal dysfunction

Stroke and ataxia with speech and swallowing disorders

* no structural abnormalities
* dysphagia involving laryngeal dysfunction

Patient Exclusion Criteria:

* Montreal Cognitive Assess. \<24
* Moderate to severe hearing loss
* Barium allergy
* Other confounding speech disorder (i.e. stuttering)
* Chemo-radiation, surgical head and neck treatment
* Smoking Hx in the past 5 yrs or \>5 years at any one time
* Twenty one years of age or older
* Breathing disorders or diseases
Clinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation

Clinical outcome of extended-depth-of-focus trifocal intraocualr lens (Triumf) implantation


Eligibility Criteria:
Inclusion Criteria:

1. Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye
2. Age-related cataract
3. A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
4. A patient want presbyopia correction at the same time as cataract surgery
5. A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
6. Written informed consent to surgery and participation in the study

Exclusion Criteria:

1. Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
2. Pregnant woman and lactating woman
3. A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
4. A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye
5. If expectations for presbyopia correction are too high
6. Those who are not able to read and understand the informed consent (illiterate or foreigners)
The PSIQS Study - User Experience With Pro-Set

Open label, randomized 2-period cross-over study comparing two continuous subcutaneous insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed® Quick-set®


Eligibility Criteria:
Inclusion Criteria:

* Must be between 13 and 70 years of age (inclusive)
* Must have been previously diagnosed with type 1 diabetes mellitus
* Must be using one of the following Medtronic insulin pumps with the Paradigm connector (note 670G excluded) for at least 6 months prior to enrollment. These pumps must have the ability to upload data to Medtronic CareLink Therapy Management software.

  1. MiniMed Paradigm Revel™ Insulin Pump - models 523 (1.8 mL reservoir) and 723 (3 mL reservoir)
  2. MiniMed 530G Pump - models 551 (1.8 mL reservoir) and 751 (3 mL reservoir)
  3. MiniMed 630G System
* Must have been using the Medtronic Enlite CGM for at least 3 months prior to enrollment, and are currently doing so
* Must routinely insert their own infusion set (may be inserted manually or with an inserter or with an integrated set/inserter, i.e. Mio)
* If instructed, must be willing to insert all assigned infusion sets with a mechanical inserter
* Must have another form of insulin delivery available (i.e. vial and syringe or pen and pen needle)
* Must agree to continue using current Medtronic Enlite CGM throughout the study
* Willing to have insulin pump, BGM and CGM data downloaded into Medtronic CareLink Therapy Management Software (requires subject CareLink logon ID and password)
* In stable health status with no acute or significant illness, in the opinion of the investigator or designee
* Able to read, write and follow instructions in English
* Able and willing to provide informed consent
* Able and willing to comply with study procedures

Exclusion Criteria:

* Pregnant (self-attestation) or nursing
* Currently using a body-worn patch insulin infusion pump, e.g. Omnipod or V-Go
* Currently using the Medtronic Model 670G pump and associated CGM
* Current or past participation in previous BD Study DBC-16SCARL21
* History of bleeding disorder or easy bruising.
* Currently taking anti-platelet therapy or anticoagulants (use of up to 81 mg per day of aspirin is permitted).
* Known blood borne infections.
* History of recurrent dermatological condition or skin disorder (e.g. psoriasis, eczema, pre-existing dermatitis).
* Skin abnormalities, anomalies or conditions (e.g. sunburn, tattoos, extensive scarring, lipohypertrophy) located at or very close to the intended insertion site.
* Physical condition that restricts dexterity and may limit ability to perform study procedures (i.e. severe neuropathy or arthritis of the hands; self-reported)
* Currently participating in any other clinical investigation that conflicts with this study
* Employed by, or currently serving as a contractor or consultant to BD, Medtronic or study site
* Any other condition the investigator or designee deems to pose an unacceptable risk to the subject in the study
A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers

The purpose of the study is to assess the pharmacokinetics of both AZD9056 (steady state) and simvastatin (single dose) when co-administered in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Male or female healthy subjects. Females should not be of childbearing potential
* Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
* Known allergy to simvastatin (or other statins) or previous complications to simvastatin therapy.
* Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).
Type 2 Diabetes and Exercise - A Pilot Study

A randomised, cross-over trial targeting a small sample of older (age 45-65 years) overweight adults with type 2 diabetes the aims of this pilot study are to:

1. Determine the feasibility of investigating the acute effects of prolonged sedentary behaviour (sitting) in this target group.
2. Compare the acute effects of a single prolonged (8 hour) bout of sedentary behaviour (sitting) on glucose and triglyceride concentrations and key muscle and adipose regulatory enzymes to a similar bout of sedentary behaviour combined with intermittent bouts of light-intensity activity.

The proposed study will involve a randomised cross-over experimental trial conducted in the laboratory setting in older overweight adults with type 2 diabetes. Participants will receive both of the acute testing conditions in a randomised manner.

Study design: Randomised cross-over pilot trial of 20 overweight/obese older adults with diet-controlled type 2 diabetes involving 2 acute treatment conditions, with a one-week wash-out period between testing conditions (Figure 1 a).

Setting: Acute, supervised laboratory setting within the Alfred and Baker Heart Institute Medical Unit.

Outcomes: We will measure acute responses in laboratory-measured plasma glucose \& triglyceride levels (every 60 mins) and glucose concentrations determined from continuous glucose monitoring (CGMS).

Eligibility Criteria:
Inclusion Criteria:

1. Diet controlled Diabetes
2. Overweight (BMI \> 27 kg/m2 but \<50 kg/m2)

Exclusion Criteria:

1. Hypoglycaemic Agents
2. Lipid Lowering Agents
The Establishment of the Early Intervention Program for Patients With Schizophrenia

Schizophrenia is a severe mental illness, which has a prodromal phase of 1-2 years prior to the onset of the illness. During the prodromal phase, patients might show maladaptation and/or poor social functioning. However, these early symptom of schizophrenia might be overlooked by patients and their families. At that period, patients might strive to improve their social interactions and social functioning. However, the efforts might further create their stress level on everyday life, which can actually accelerate the illness onset of schizophrenia. In other words, the efforts would worsen the pathophysiologic changes in the brain, which can result in the positive symptoms of schizophrenia.

Previous researches found that the critical period for treatment of schizophrenia is the early phase of illness onset, especially the first two or three years. Delay treatment would worsen the illness. To this extent, early treatment would bring to a better prognosis as well as minimize the costs of individuals, families and society. In other words, early interventions not only can prevent relapse, it also can benefit patients' psychosocial adjustments. However, researches found that the average duration of untreated psychosis is 25.2 months in Taiwan, which indicates the phenomena of delay treatment and this trend might result in missing the critical treatment period.

This is a two years study aiming to establish an early intervention program for patients with schizophrenia. In the first year, it aims to understand the phenomena of psychiatric care services utilization for patients with schizophrenia, special emphasis will be on the delay treatment and pluralistic health seeking process. In the second year, it aims to establish an early intervention program. The results of this research would contribute to in-service trainings, service providing, and policy making of psychiatric services.


Eligibility Criteria:
Inclusion Criteria:

* patients with schizophrenia
* capable to express in Chinese
* willing to cooperate with

Exclusion Criteria:

* patients with schizophrenia but not willing to cooperate with
Wheatgrass Juice / Lifestyle Recommendations / Cancer Patients' Quality of Life / Chemotherapy Treatment

This study is aimed to study the impact of wheatgrass juice and lifestyle recommendations (diet, physical activity and breathing exercises) on the well being, fatigue and hematological parameters of chemotherapy-naive patients with no evidence for symptoms of active oncological disease.The researchers hypothesize that both wheatgrass juice and lifestyle recommendations can improve patient's well-being during chemotherapy.

Chemotherapy-naive patients will be offered to participate in a two arms study. Following consent, patients will be randomized to one of two arms. Patients in both arms will be provided by booklet and audio-cassette that specify lifestyle recommendations (diet, physical activity and breathing exercises). Patients in one of the study arms will be provided in addition with frozen wheatgrass juice (recommended daily dosage of 55-110 CC daily). Patients in both arms will be asked to fill in a daily patient's diary monitoring the practice of the lifestyle recommendations.

Baseline assessment will include the following questionnaires: ESAS, MYCAW, FACIT- Fatigue. Evaluation will include weekly ESAS and FACIT-Fatigue questionnaire and subsequent evaluation (including ESAS, MYCAW, FACIT- Fatigue questionnaires) following 3 and 4 chemotherapy cycles of treatment. Follow-up evaluation will be performed at the completion of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cancer with no sign of active disease
* First-time treatment with chemotherapy

Exclusion Criteria:

* Treatment with per os administration of chemotherapy
Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

This study will evaluate the use of hydrogel electrode pads (rather than tap water baths) to deliver iontophoresis treatment using a traditional iontophoresis device. Participants will treat one hand with the hydrogel-based iontophoresis device and leave the other hand untreated.

Palmar hyperhidrosis affects 4.3 million Americans and results in substantial quality of life impairment. Treatment options for palmar hyperhidrosis include antiperspirants, systemic anticholinergic agents, botulinum toxin injections, and iontophoresis. Standard iontophoresis involves submerging the hands in tap water through which current is applied to the palms for 30 minutes per day up to 3 times per week. While effective, treatment adherence rates are low.

This study will evaluate the use of hydrogel electrode pads (rather than tap water baths) to deliver iontophoresis treatment using a traditional iontophoresis device. Hydrogel electrode pads permit improved mobility and hand functionality during iontophoresis treatment sessions.

Eligibility Criteria:
Inclusion Criteria:

* 13 years of age or older
* \>6 months self-reported history of primary palmar hyperhidrosis
* Initial gravimetry test: \>20mg/min on each palm
* No topical treatments for hyperhidrosis (antiperspirants) on the palms for 2 weeks prior to the start of the study
* No systemic treatments for hyperhidrosis (anticholinergics) for 4 weeks prior to the start of the study
* No tap water iontophoresis treatment for 6 weeks
* No Botox injections on the palms for 6 months (if single treatment session) or 10 months (if \>1 previous sessions) prior to the start of the study
* No history of cardiothoracic sympathectomy for hyperhidrosis
* Able to attend 3 office visits (Stanford Medical Outpatient Center located at 450 Broadway St, Redwood City, CA 94063; Lucile Packard Children's Hospital at 730 Welch Road, 1st Floor, Palo Alto, CA 94304) and one virtual visit in an 8 week time frame
* Capable of performing sweat level testing and hydrogel-based iontophoresis treatment at home, after training
* Hydrogel electrode pad fits on the hand (typically tip of middle finger to lower end of palm length of 6.5in (16.5cm) or greater)

Exclusion Criteria:

* Patients with implanted electronic medical devices e.g. pacemaker, implantable cardioverter/defibrillator)
* Patients with metal implants in the extremity that will be treated
* Patients with larger skin defects (on the palm or arm of the extremity that will be treated) that cannot be covered by petroleum jelly
* Pregnant or nursing women, or looking to become pregnant
* Patients on medications that interfere with neuroglandular transmission
* Patients with active infection locally or systemically
* Patients with history of contact dermatitis to acrylates
* Patients with history of contact or systemic allergy to iodine
* Patients with a history of ischemic heart disease, cardiac arrhythmias, epilepsy or thyroid disease
Effects of Canagliflozin on C-peptide Clearance in Healthy Volunteers

The purpose of this study is to assess whether treatment with a single oral 300 mg dose of canagliflozin alters the kinetics (ie, clearance/removal from body) of serum C-peptide (a protein released from the pancreas during insulin secretion) in healthy adult volunteers.

This is a double-blind (neither the volunteer nor the study doctor/staff will know the identity of the assigned treatments) study to assess the effect of single oral (taken by mouth) dose of canagliflozin on clearance (removal from the body) of C-peptide in healthy adult volunteers. Healthy volunteers will be randomly (by chance) assigned to receive a single oral dose of canagliflozin followed by a single oral dose of placebo (inactive substance) or a single dose of placebo followed by a single dose of canagliflozin with a period of 7-10 days between treatments. Healthy volunteers will also receive intravenous (i.v.) infusion (injection in the vein) of somatostatin for 4 hours and a single dose i.v. injection of synthetic human C-peptide following administration of canagliflozin or placebo during each treatment period. Somatostatin will suppress the normal secretion of C-peptide, a protein that is released from the pancreas during insulin secretion, so that the human C-peptide administered to volunteers can be accurately measured. The total study duration for each volunteer will be approximately 44 days. During the study, blood and urine samples will be drawn (collected) for clinical laboratory evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy or clinically significant adverse reactions to canagliflozin or placebo or any of the excipients of the canagliflozin or placebo formulation
* Known hypersensitivity of synthetic human C-peptide, somatostatin preparation, or other structurally related peptides
Phase 2 Study of HL-009 Liposomal Gel to Treat Mild to Moderate Atopic Dermatitis

The objective of this phase 2 study is to evaluate the safety and efficacy of HL-009 Liposomal Gel in adult patients with mild to moderate atopic dermatitis (AD).

This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with mild to moderate AD. Following a 2-week screening period, subjects will be randomly assigned into one of four treatment arms. Placebo or HL-009 study treatments will be administrated to subjects twice daily for 8 consecutive weeks. After the randomization at Week 0 (Visit 2), subjects will visit their respective trial sites at Weeks 0.5, 1, 2, 4, 6, 8, and 10 (Visits 3, 4, 5, 6, 7, 8, and 9). All study drugs will be in identical laminated tubes to preserve double-blinding of the study.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 or older
* Clinical diagnosis of AD by a board certified/eligible dermatologist
* Subjects who have body surface area affected to at least 2% total body surface area (BSA)
* Subjects with IGA score 2 or 3 corresponding to mild to moderate AD at screening and baseline visits
* Subjects who can give written informed consent

Exclusion Criteria:

* Subjects who had topical treatment with corticosteroids within 2 weeks before screening
* Subjects who had systemic treatment with corticosteroids or ciclosporin and photopheresis treatment within 2 weeks before screening
* Subjects who had ultraviolet irradiation within 2 weeks before screening
* Subjects who participated in another drug trial within 4 weeks before screening
* Subjects who have an allergy to one of the excipients
* Female subjects who have a positive serum pregnancy test at screening, plan a pregnancy during study period, or are breast feeding
* Female subjects who don't meet one of the following criteria: Be surgically sterile,Post-menopausal for at least 12 months, or If sexually active, they should use oral contraceptives, double barrier contraception, intrauterine device, or other methods approved by the sponsor
* Subjects who have other topical treatment of the AD area
* Subjects who take any systemic anti-infective or antibiotic treatment
* Subjects who had eczema herpeticum
* Subjects who have any clinically significant presence of skin disease or pigmentation other than atopic dermatitis, or wide scar on atopic dermatitis area
* Subjects who have poorly-controlled chronic disease
* Subjects who have significant medical problems, including but not limited to uncontrolled hypertension and congestive heart failure
* Subjects who have clinically significant laboratory abnormalities at screening
* Subjects who have a marked prolongation of QT/QTc interval at screening
* Subjects who have a history of additional risk factors for TdP
* Subjects who use a medication that prolongs the QT/QTc interval
* Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule of study procedures