louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03601936: User Testing of the Evivo Screening Test
Official title: User Testing Protocol to Evaluate Performance of the Evivo Infant Gut Bifidobacterium Screening Test
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gut Microbiome
Lead sponsor: Evolve BioSystems, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 231
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The study is an evaluation of the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens.

Detailed description: This is a prospective, multi-center clinical study of the Evivo Infant Gut Bifidobacterium Screening Test ("Evivo Screening Test").

Lower levels of bifidobacteria in the infant gut have been linked to increased incidence of metabolic and inflammatory disorders. This CLIA Waiver User Testing study is being conducted to evaluate the performance of the Evivo Infant Gut Bifidobacterium Screening Test, which was designed to differentiate between high and low levels of Bifidobacterium in infant stool. This study is intended to confirm the precision of results for this screening test, as well as its ease of use, in a setting that closely resembles the conditions of intended use, specifically the circumstances of sample collection, the location of test sites, and the potential operators.

Eligibility criteria: Inclusion Criteria:

* Infants aged 0-6 months.
* Generally healthy infants.

Exclusion Criteria:

* Infants should not have an acute infection.
* Not intended for use with stool containing meconium.
* Infants with jaundice should not be tested until it has resolved.
* This test should not be used for infants with carbohydrate malabsorption syndrome, which may present with one or more of the following persistent signs: abnormally foul-smelling, mucus-containing, and/or green frothy stools.

Primary outcomes:
measure: To evaluate the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens compared to molecular methods (quantitative PCR).
timeFrame: 2 - 6 weeks
Secondary outcomes:
measure: Ease of use of the Evivo Screening Test by operators.
timeFrame: 2 - 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Matrix Clinical Research, Inc.
state: California
city: Marietta
country: United States
facility: Breastfeed Atlanta LLC
state: Georgia
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Swarthmore
country: United States
facility: Swarthmore Pediatrics
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
Study officials:
affiliation: rflannery@evolvebiosystems.com
name: Robin Flannery
role: STUDY_DIRECTOR
References:
Clinical trial NCT05354336: A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers
Official title: A Randomized, Open-Label, Phase I Clinical Study on SHR6390 of Different Specifications After Process Modification in Healthy Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125 mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose of SHR6390 was given to each group, including 100 mg, 125mg and 150mg of SHR6390.


Eligibility criteria: Inclusion Criteria:

* Healthy Chinese male and female aged 18-45years with a minimum weight of 50 kg for male and 45 kg for female subjects and a body mass index (BMI) of 18-26 kg/m2 who provided written informed consent for participating in the study.
* Without history of cardiovascular, hepatic, kidney, pulmonary, endocrine, gastrointestinal, neurological, or psychiatric disease.
* No pregnancy plan during the trial or within 6 months after completion of the trial.
* Voluntarily signed the informed consent form and strictly adherence to the study protocol.

Exclusion Criteria:

* vital signs, physical examination, 12-lead electrocardiogram, and laboratory examination had results of clinical significance.
* Hepatitis B and C, human immunodeficiency virus (HIV) and syphilis antibody positive;
* Any history of allergy, alcohol and drug abuse;
* blood donation, massive blood loss (≥400mL).
* Participated in other clinical trials within three months. (6) Severe infection or surgery four weeks prior to screening;
* use of any drug that inhibits or induces hepatic metabolizing enzymes four weeks prior to screening;
* use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health care products fourteen days prior to screening;
* A history of dysphagia, gastrointestinal ulcers, or any gastrointestinal disease that interferes with drug absorption.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 12 days
measure: Area under the plasma concentration versus time curve (AUC)0-t
timeFrame: 12 days
measure: Area under the plasma concentration versus time curve (AUC)0-∞
timeFrame: 12 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 22 days
measure: Incidence of abnormal blood pressure
timeFrame: 22 days
measure: Incidence of abnormal temperature
timeFrame: 22 days
measure: Incidence of abnormal electrocardiogram waveform
timeFrame: 22 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase I Clinical Research Center
state: Shandong
Study officials:
References:
Clinical trial NCT02144636: Protein Supplementation and Weight Loss
Official title: Effect of Protein Supplementation on Weight Loss and Cardio Metabolic Profile of Overweight/Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized control trial of diet with protein supplementation is being conducted to test the hypothesis that in overweight/obese subjects high protein diet may lead to weight loss and improvement in cardio-metabolic profile.


Eligibility criteria: Inclusion Criteria:

1. Subjects aged between 21 -65 years
2. Subjects with BMI \> 23 Kg/m2

Exclusion Criteria:

* Inclusion Criteria:

  1. Subjects aged between 21 -65 years
  2. Subjects with BMI \> 23 Kg/m2

Exclusion Criteria:

1. Diabetes (type 1 and type 2)
2. Known or documented coronary heart disease (CHD) (including ECG consistent with prior myocardial infraction), cerebrovascular accident (including transient ischemic attack), peripheral vascular disease (including symptoms of claudication)
3. Angina or other chest pain that may indicate CHD by history
4. Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable) by history
5. Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, other investigational drugs within 30 days of study entry
6. Pregnancy or planning pregnancy during the study period by history
7. Uncontrolled hypertension
8. Uncontrolled hypothyroidism
9. Sensitivity or allergy to product by history
10. Subjects who had undergone bypass procedure
11. Any debilitating disease such as tuberculosis, HIV by history .
12. Unwillingness to give written informed consent for participation in the study

Primary outcomes:
measure: weight loss
timeFrame: baseline to 3 months
Secondary outcomes:
measure: improvement in lipid profile
timeFrame: baseline - 3 months
Other outcomes:
Locations:
city: Delhi
country: India
facility: Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology
Study officials:
References:
Clinical trial NCT01096836: Low Carbohydrate and Conventional Diets Associated to Resistance Training on Muscle Fitness and Health Markers
Official title: Combined Effects of Resistance Training and Low Carbohydrate or Conventional Diets on Strength, Muscle Mass, Body Composition, Blood Lipids and Endothelium Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: resistance exercise
body mass index
hypertrophy
endothelial function
blood lipids
Lead sponsor: Universidade Gama Filho
Sponsor class: OTHER
First posted: 2010-03-31
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the effects of two different diets (low carbohydrate - LCD and conventional - CONV) on body composition, strength performance, muscle mass and biomarkers of health in overweight adults submitted to resistance training (RT). It has been hypothesized that LCD would produce higher rates of weight loss and that both diets would be useful to maintain muscle mass and strength and biomarkers of health.

Detailed description: Overweight and obesity prevalence has increased worldwide. Current guidelines recommend health behavior modifications, including better eating habits and regular physical activity (including resistance training - RT) as a strategy to control and prevent the problem. Traditionally, diets poor in energy and fat (conventional diets - CONV) have been recommended to promote losses in body and fat masses; however, there has been recently a growing interest in the academic community to investigate the effects of low carbohydrate diet (LCD) on health outcomes, since this kind of diet appears to be more effective for reducing body mass as compared to CONV. Nevertheless, evidences are scarce regarding the effects of LCD associated to RT on body composition, strength performance, blood lipids, endothelium function and other markers of health, demanding the development of clinical trials aiming to determine the combined health effects of these interventions.

Eligibility criteria: Inclusion Criteria:

* BMI equal or over 25 kg/m2
* resistance trained at least 12 weeks

Exclusion Criteria:

* upper or lower limbs injury
* pregnancy
* diabetes
* use of ergogenics, stimulants or drugs
* history of dislipidemias
* arterial hypertension

Primary outcomes:
measure: body mass
timeFrame: eight weeks
Secondary outcomes:
measure: Muscle strength
timeFrame: eight weeks
measure: Endothelial function
timeFrame: eight weeks
measure: muscle thicknesses
timeFrame: eight weeks
measure: markers of renal function
timeFrame: eight weeks
measure: body composition
timeFrame: eight weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Laboratory Crossbridges
state: RJ
Study officials:
affiliation: Universidade Gama Filho
name: Paulo Sergio C Gomes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04196036: Day 3 Fresh Transfer Followed by Day 3 or Day 5 Vitrification of Supernumerary Embryos
Official title: Cumulative Pregnancy Rates and Direct Healthcare Cost Analysis of Two Different Strategies: Fresh Cleavage-stage Embryo Transfer (ET) on Day 3 With Vitrification of Supernumerary Embryos on Day 3 Versus Day 5
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subfertility
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This monocenter academic study aims to evaluate the effectiveness and cost effectiveness of two different strategies: fresh Embryo Transfer (ET) on day 3 followed by cryopreservation of cleavage-stage (Day 3) embryos versus blastocyst-stage (Day 5) embryos.

The primary outcome is the cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles which might take about 1 year), up to two sequential cycles. The secondary outcome concerns a cost analysis of both strategies from the healthcare payer's perspective.


Eligibility criteria: Inclusion Criteria:

* subfertile women planned for the first or second oocyte retrieval for in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) treatment
* who are older than 18 and less than 38 years old
* who have normal Follicle Stimulating Hormone (FSH) and normal Anti-Mullerian Hormone (AMH) levels

Exclusion Criteria:

* treatment with donor oocytes or donor embryos
* patients planned for Pre-implantation Genetic Diagnosis (PGD)
* Patients with BMI\>30
* patients with endometriosis grade III-IV

Primary outcomes:
measure: cumulative pregnancy rate
timeFrame: Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
Secondary outcomes:
measure: cost analysis
timeFrame: Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Leuven University Fertility Center
Study officials:
References:
Clinical trial NCT05012436: A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects
Official title: A Study to Evaluate the Pharmacokinetics and Safety Following a Single Oral Dose of YHD1119 in Subjects With Renal Impairment and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Renal Impairments
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2021-08-19
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to compare the pharmacokinetic characteristics and safety of YHD1119(Pregabalin SR 75mg) and YHD1119(Pregabalin SR 150mg) in subjects with renal impairment and healthy subjects. YHD1119 is sustained-release (SR) formulation which is made by Yuhan Corporation. Primary endpoints are Cmax and AUClast and secondary endpoints are AUCinf,Tmax, t1/2, CL/F and V/F.


Eligibility criteria: Inclusion Criteria:

* 19\~75 years old, healthy volunteers and renal impairments
* eGFR \>= 60mL/min/1.73m2
* 60 mL/min/1.73m2 \> eGFR \>= 30mL/min/1.73m2
* written informed consent

Exclusion Criteria:

* AST or ALT \> 1.5 \* Upper normal range
* Total bilirubin \> 1.5 \* Upper normal range
* Blood CPK \> 1.5 \* Upper normal range
* Total Cholesterol \>1.5 \* Upper normal range
* Woman who is pregnant or lactating
* Patients who are difficult to participate in cinical trials judged by Investigators
* have participated in other clinical trials within 180 days before IP intake

Primary outcomes:
measure: Cmax
timeFrame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
measure: AUClast
timeFrame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
Secondary outcomes:
measure: AUCinf
timeFrame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
measure: Tmax
timeFrame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
measure: t1/2
timeFrame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72hour
measure: CL/F
timeFrame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
measure: V/F
timeFrame: 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: SeungHoon Han
role: PRINCIPAL_INVESTIGATOR
affiliation: CHA University
name: Hyounggyoon Yoo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00124436: Follow-up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis
Official title: Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hand Dermatoses
Keywords: Patients who have been enrolled in study protocol BAP089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2005-07-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Patients who have been treated in study protocol BAP089 may have responded to treatment, and subsequently relapsed to \>75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. Also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.


Eligibility criteria: Inclusion Criteria:

* Previous participation in protocol BAP089
* Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease

Exclusion Criteria:

* Female patients who are pregnant or who want to become pregnant
* Female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception

Primary outcomes:
measure: Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24
Secondary outcomes:
measure: Patient's global assessment
measure: Extent of disease
measure: Time to respond
measure: Modified total lesion symptom score
measure: at week 12 or 24
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Thomas Ruzicka
Study officials:
affiliation: University of Düsseldorf, Dermatological Hospital, Germany
name: Thomas Ruzicka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453.
Clinical trial NCT05121636: Clinical Outcomes Following Total Joint Replacement With Corin Prostheses: Corin MetaFix Collared Stem
Official title: Clinical Outcomes Following Total Joint Replacement With Corin Prostheses : Trinity™ Cup and MetaFix™ Collared Stem
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis, Hip
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2021-11-16
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring a THR were identified and screened according to the Indications for use and the contraindications for implantation of the MetaFix™ collared femoral stem and the Trinity™ acetabular cup were invited to consent to the study. No specific exclusion criteria were defined for this study.

Brief summary: Assessment of the clinical performance and survivorship of the Corin Total Hip System with Trinity™ cup MetaFix™ Collared stem in a prospective study. The primary endpoint of the study is to evaluate the 3-year survivorship and clinical performance of the Corin Total Hip System using Trinity™ cup and MetaFix™ Collared stem. Additionally, the study follow up will continue until 10 years for subjects who consent to do.

Detailed description: The primary objective is the 3-year survivorship of the study devices.

The Secondary Objectives include:

* The improvement of clinical outcomes:

  * Oxford Hip Score (OHS) up to 10-year follow-up
  * Harris Hip Score (HHS) up to 10-year follow-up
  * Hip disability and Osteoarthritis Outcome Score (HOOS) up to 10-year follow-up
* Safety performance monitoring including hip- and device-related AEs and the revision rate up to 10-year follow-up

Eligibility criteria: Inclusion Criteria:

* Patients requiring a THR

Exclusion Criteria:

-

Primary outcomes:
measure: Post operative survivorship of MetaFix Collared Stem at 3-year follow-up
timeFrame: 3 years
Secondary outcomes:
measure: Harris Hip Score (HHS) up to 10-year follow-up
timeFrame: Baseline to 10 years
measure: Oxford Hip Score (OHS) up to 10-year follow-up
timeFrame: Baseline to 10 years
measure: Hip disability and Osteoarthritis Outcome Score (HOOS) up to 10-year follow-up
timeFrame: Baseline to 10 years
measure: Hip- and device-related adverse events up to 10-year follow-up
timeFrame: Baseline to 10 years
measure: Post operative survivorship of MetaFix Collared Stem at 10-year follow-up
timeFrame: Baseline to 10 years
measure: MetaFix Collared Stem radiographic performance up to 10-years
timeFrame: Baseline to 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Hoag Orthopedic Institute
name: Steve Barnett
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00860236: Giardia Induced Fatigue and Functional Gastrointestinal Diseases
Official title: Chronic Fatigue Syndrome and Abdominal Symptoms After Giardia Infection: Clinical Evaluation, Biomarkers, Risk Factors and the Effect of Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Fatigue Syndrome
Keywords: CFS
Giardia
Fatigue
Cognitive behavioural therapy
CBT
Chronic fatigue syndrome
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2009-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A giardiasis outbreak in Bergen has given us the opportunity to approach two basic research questions of national and global importance:

* Studying the pathoimmunology of giardiasis in a natural setting, and following the genetic and immunological responses leading to recovery or persistent disease and sequelae.
* Studying the two disease entities FGID and CFS when induced by acute giardiasi and their risk factors.
* Interventional cognitive behavioural therapy is the only intervention documented to have significant effect on CFS outcome, and conventional cognitive behavioural therapy will be compared to a psycho-educational programme in the format of a randomised controlled trial.


Eligibility criteria: Inclusion Criteria:

* Problems with fatigue of any severity after Giardia infection

Primary outcomes:
measure: Improvement minimum 6 points in Chalder Fatigue scale score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Skånevik
country: Norway
facility: Frihamnsenteret
Study officials:
affiliation: Frihamnsenteret
name: Bjarte Stubhaug, PhD
role: STUDY_DIRECTOR
affiliation: University of Bergen
name: Nina Langeland, PhD
role: PRINCIPAL_INVESTIGATOR
References: