louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05032885: Early Physiotherapy in Covid Patients
Official title: RANDOMIZED CLINICAL TRIAL OF PHYSIOTHERAPY IN COVID PATIENTS ON THEIR PHYSICAL CONDITIONING, ANXIETY LEVEL AND THEIR QUALITY OF LIFE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Anxiety State
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Based on the hypothesis that early physiotherapy in patients hospitalized for COVID-19 improves their functional capacity, perceived quality of life and decreases anxiety. Our main objective is to analyze the differences between groups with respect to functional deterioration, need for oxygen therapy and anxiety when implementing an early physiotherapy program.

We propose a randomized clinical trial with two arms and single-center, to be developed in hospitalization units and intermediate respiratory care units (IRCU), with patients diagnosed with COVID. The sample will consist of an experimental group of 66 admitted patients with COVID-19 to whom an early physiotherapy program will be implemented from 48-72 hours after admission. The control group will be made up of another 66 admitted patients with COVID-19 who will receive the treatment according to the usual procedure of the hospital center.

Sociodemographic and clinical variables will be collected, including: modified MMRC dyspnea scale, amount of oxygen therapy, MRC-SS, sit to stand test, hand grip, Tinetti, HADS anxiety and depression questionnaire, SF-12 quality of life questionnaire, clinical frailty scale (CFS) and FRAIL scale. Patients in both groups will be re-evaluated two months after hospital discharge with the above variables in addition to the PCFS post-COVID patient functional status scale.

A basic descriptive analysis and logistic regression will be performed to determine the effect of the intervention.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the hospitalization unit or intermediate respiratory care unit, diagnosed with COVID-19 pneumonia, of legal age and who consent to participate in the study. Pregnant patients or patients with dementia, terminal illnesses or those in which there are communication problems (language problems, comprehension ...) will not be included.

Exclusion Criteria:

* Patients who are transferred to another acute hospital due to impossibility of completing the follow-up period, exitus during hospital admission and those who revoke consent.

Primary outcomes:
measure: Respiratory competence
timeFrame: 4 months
measure: Motor competence
timeFrame: 4 months
Secondary outcomes:
measure: Anxiety state
timeFrame: 4 months
measure: Variation in the level of quality of life
timeFrame: 4 months
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Susana Arias-Rivera
state: Madrid
Study officials:
References:
Clinical trial NCT05656885: Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses
Official title: Clinical Evaluation of Proclear Monthly and Avaira Vitality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2022-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants received Lens A and then Lens B in fixed-sequence order.
Primary purpose: TREATMENT

Brief summary: This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

Detailed description: The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Eligibility criteria: Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and signed an information consent letter.
* Self-reports having a full eye examination in the previous two years.
* Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
* Has refractive astigmatism no higher than -0.75DC.
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)

Exclusion Criteria:

* Is participating in any concurrent clinical or research study.
* Has any known active ocular disease and/or infection that contraindicates contact lens wear.
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
* Has known sensitivity to the diagnostic sodium fluorescein used in the study.
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
* Has undergone refractive error surgery or intraocular surgery.

Primary outcomes:
measure: Lens Fit Acceptance Rating
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: University Complutense of Madrid
Study officials:
affiliation: University Complutense of Madrid
name: Juan G Carracedo Rodríguez, OD,MSc,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02766985: Rasch-analysis of Clinical Severity in FSHD
Official title: Rasch-analysis of Clinical Severity in FSHD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facioscapulohumeral Muscular Dystrophy
Keywords: FSHD
muscular dystrophy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-05-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Particpants with genetically verified FSHD types 1 and 2.

Brief summary: The purpose of this study is to make a standardized and scalable Rasch-built clinical severity scale to help in finding genetic and environmental modifiers of disease in Facioscapulohumeral muscular dystrophy (FSHD).


Eligibility criteria: Inclusion Criteria:

* Genetic confirmation of FSHD (either FSHD-1 or FSHD-2)

Exclusion Criteria:

* Do not understand English
* Unable to provide informed consent

Primary outcomes:
measure: FSHD Clinical Severity Scale
timeFrame: 1 day
Secondary outcomes:
measure: Brooks scale
timeFrame: 1 day
measure: Vignos scale
timeFrame: 1 day
measure: Iowa Oral Performance Instrument (IOPI)
timeFrame: 1 day
measure: Manual muscle testing
timeFrame: 1 day
measure: Quantitative strength testing
timeFrame: 1 day
measure: Functional testing
timeFrame: 1 day
measure: Reparatory function testing
timeFrame: 1 day
measure: Patient-reported outcome
timeFrame: 1 day
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Kansas Medical Center
name: Jeffrey Statland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04657185: Reducing Perioperative S. Aureus Transmission Via OR PathTrac
Official title: Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR PathTrac)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: S. Aureus Transmission
Surgical Site Infection
Keywords: transmission
surgical site infection
s. aureus
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: RDB Bioinformatics
name: University of Iowa
name: Trustees of Dartmouth College
First posted: 2020-12-08
Enrollment: 804
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing surgery requiring anesthesia and intravascular access.

Brief summary: Healthcare-associated infections (HAIs) occur frequently and are associated with patient harm. It is important that healthcare facilities take the necessary steps to prevent the spread of resistant bacteria. ESKAPE bacteria (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) are particularly pathogenic. Isolation of these pathogens from intraoperative reservoirs has been associated with postoperative infection development (i.e. surgical site infections). This project involves implementation of a software platform and bacterial collection system (OR PathTrac) that leverages the epidemiology of intraoperative bacterial transmission to guide dynamic, prospective improvements in perioperative infection control measures. We will assess the effectiveness of OR PathTrac feedback in optimizing an evidence-based, multifaceted, perioperative infection control program.

Detailed description: Our objective was to analyze the impact of surveillance feedback optimization of a multifaceted, perioperative infection control program on S. aureus transmission and SSIs. A multifaceted infection control program was implemented over 8 months (November 2018 to June 2019). A prospective cohort impact study was then conducted over 8 months (July 2019 to March 2020) to compare the incidence of within-case S. aureus transmission (primary outcome) and surgical site infection (secondary outcome) before (4.5 months) and after (3.5 months) implementation of surveillance feedback.

Eligibility criteria: Inclusion Criteria:

* Adult patients requiring anesthesia and intravenous catheter placement.

Exclusion Criteria:

* Pediatric patients, without requirement of anesthesia and/or intravenous catheter placement.

Primary outcomes:
measure: within-case S. aureus transmission
timeFrame: From patient entry into the operating room until case end, up to 6 hours
Secondary outcomes:
measure: surgical site infection
timeFrame: Up to 90 days following surgery
Other outcomes:
Locations:
city: Georgetown
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
References:
Clinical trial NCT02040285: Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC)
Official title: Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC). Comparison vs Laxative Free CTC.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Complication
Keywords: CT colonography
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate a low-dose of bowel preparation for Computed Tomography Colonography (CTC) versus free laxative CTC with regard to performance, feasibility, patient tolerability and acceptance.

Detailed description: Computed Tomography Colonography (CTC) is a valid alternative to colonoscopy in the detection of cancer, polyps and other colon lesions.

High volume cathartic preparations, low volume cathartic solutions with oral tagging agent and tagging agent only are the procedures available for CTC.

High volume preparations are a considerable burden for patients. Low volume cathartic solutions are more accepted by the patients, reduce the amount of tagging agent and the waiting time to the exam. Tagging agent only preparations represent a risk if they are taken without medical supervision.

Eligibility criteria: Inclusion Criteria:

* Out-patients undergoing a CTC
* Patient written informed consent

Exclusion Criteria:

* Pregnant or lactating women or at a risk of becoming pregnant
* Known or suspected gastrointestinal obstruction or perforation, toxic megacolon, ileo, major colonic surgery
* History of anaphylaxis to Iopamidol or allergic reactions to drugs

Primary outcomes:
measure: Efficacy
timeFrame: 20 min
Secondary outcomes:
measure: Efficacy
timeFrame: 20 minutes
measure: Efficacy
timeFrame: 20 min
measure: Safety
timeFrame: 2 days (the day before and the day of CTC)
measure: Safety
timeFrame: 2 days (the day before and the day of the exam)
measure: Acceptability
timeFrame: 2 days (the day before and the day of the exam)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Umberto I
Study officials:
References:
Clinical trial NCT03793985: Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337
Official title: Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemias
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-01-04
Enrollment: 45
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination


Eligibility criteria: Inclusion Criteria:

1. Between 19 aged and 45 aged in healthy male adult
2. Over 50 kg, BMI between 18.0-29.0 kg/m2
3. Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
4. Not abnormal or not clinically significant lab values.
5. Subjects who signed informed consent form with good understandings after explanations by investigators.

Exclusion Criteria:

1. No history or presence of clinically significant diseases.
2. Subjects showing adverse reaction to investigational product
3. Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
4. History of myopathy
5. Subjects with abnormal lab values at least one below 1) AST or ALT\>2 fold of upper normal limit 2) Total bilirubin\>2 fold of upper normal limit 3) CK\>2 fold of upper normal limit 4) Estimated Glomerular filtration rate\<60mL/min/1.73m2
6. Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials
7. Smoke over 10 cigarettes per day or unable to stop smoking
8. Subjects who previously participated in other clinical trials within 90 days
9. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
10. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days.
11. Taking medications which induce or block medication metabolism
12. History of drug abuse
13. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
14. Disagree to contraception
15. Subjects who are in any conditions impossible participating in the clinical trials

Primary outcomes:
measure: Cmax
timeFrame: 0~72hours
measure: AUCt
timeFrame: 0~72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: INHA University Hospital
Study officials:
References:
Clinical trial NCT00654485: COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects
Official title: A 12 Week Randomized, Double-Blind, Force-Titration, Parallel Group, Multi Centre, Phase IIIb Study to Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects With Raised LDL-C and a 10 Year Risk of CHD >10%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Syndrome
Keywords: Cholesterol
hypercholesterolemia
low density lipoproteins
metabolic syndrome
Rosuvastatin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-08
Enrollment: 940
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Presence of 3 or more coronary heart disease risk factors as defined by the protocol.
* Fasting low density lipoprotein cholesterol level of \> 130 mg/dL.
* Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.
* Not previously taken statins.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood lipid levels above the limits defined in the protocol
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Primary outcomes:
measure: Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.
timeFrame: At 6 & 12 weeks
Secondary outcomes:
measure: Modification of other lipids and lipoproteins
timeFrame: At 6 & 12 weeks
measure: Modification of insulin resistance, inflammatory markers & glucose metabolism
timeFrame: At 6 & 12 weeks
measure: Safety: adverse events & abnormal laboratory markers
timeFrame: At 6 & 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Centre, The Netherlands
name: Prof. Anton Stalenhoef
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Russell Esterline
role: STUDY_DIRECTOR
References:
Clinical trial NCT04414085: The Clinical Significance of Biochemical 11 Deoxycortisol Levels
Official title: The Clinical Significance of Biochemical Polymorphism in the 11 Deoxycortisol Levels Before and After Stimulation With Adrenocorticotrofin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retrospective
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-06-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All referred to gynecology endocrinology adolescents clinic who underwent an ACTH stimulation test

Brief summary: data from charts regarding clinical characteristics and androgens levels from first to last visit were collected

Detailed description: data from charts regarding clinical characteristics and androgens levels from first to last visit were collected Female patients only ages 10-18 years who were referred to the combined gynecology endocrinology adolescents clinic

Eligibility criteria: Inclusion Criteria:

age 10-18 years referred to gynecology endocrinology adolescents clinic

Exclusion Criteria:

no data available in chart no blood work available

Primary outcomes:
measure: Presence of hyperandrogenism signs (1 to 3 categorized)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: galia barash, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00472485: Study of Eye Movement Testing and Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Saccadic Eye Movement Deficiency
Oculomotor Deficiency
Oculomotor Dysfunction
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2007-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the ability of several eye movement monitors, used in clinical practice, to identify children with poor reading eye movements. A second purpose of the study is to evaluate the effectiveness of eye movement therapy.


Eligibility criteria: Inclusion Criteria:

* Children ages 8 to 13 with saccadic eye movement deficit

Exclusion Criteria:

* Previous saccadic eye movement therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Marjean Kulp, OD, MS
role: PRINCIPAL_INVESTIGATOR
References: