louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03854786: Aerobic Fitness in Overweight and Obese Individuals
Official title: A Randomized, Placebo-controlled, Multi-blind Study to Assess the Effect of Oxyjun on Aerobic Fitness in Overweight and Obese Individuals.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-26
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Oxyjun is known for improving cardiovascular endurance. Overweight and obese individuals are at increased risk of cardiovascular complications. To lower the risk, these individuals need to remain physically active with acceptable aerobic fitness.

Hence, the objective of the study is to investigate the effect of Oxyjun on aerobic fitness in physically active overweight and obese individuals. All subjects in the study will be tested for maximum aerobic capacity , body composition, and serum biomarker for fitness.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index ≥ 25 - ≤ 34.9 kg/m2.
* Waist Circumference ≥ 80 cms.
* Non-smoker.
* BP ≤ 140/90 mm Hg
* FBS ≤ 125 mg/dl
* Hb ≥ 11 g/ dl
* Can abstain from strenuous exercise and alcohol for at least 48 hours.
* Can abstain from caffeine for at least 24 hours.

Exclusion Criteria:

* Participants with history of regular (≥2 times a week) structured exercise (gym, walking, yoga, etc).
* Inter-arm blood pressure is ≥10 mm Hg.
* Known cases of type II Diabetes Mellitus.
* Known cases of hypertension with or without anti-hypertensive medication.
* Visual or balance problems, or who cannot walk on a treadmill without using the handrails.

Primary outcomes:
measure: To investigate the effect on Oxyjun on aerobic fitness in overweight and obese individuals
timeFrame: From baseline to Day 56
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Vedic Lifesciences Pvt. Ltd
state: Opp Infinity Mall
Study officials:
References:
Clinical trial NCT00864786: Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study
Official title: A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalating Study To Investigate The Safety, Toleration, Pharmacokinetics, And Pharmacodynamics Of Multiple Inhaled Doses Of PF-03635659 In Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Multiple dose safety and pharmacokinetics study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-19
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple dose safety and pharmacokinetics in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
* Any condition possibly affecting drug absorption (eg, gastrectomy).

Primary outcomes:
measure: Safety and toleration: Adverse events, vital signs measurements (supine and standing), 12-lead ECGs, spirometry (FEV1, FVC), laboratory safety tests, physical examination, and subject-reported dry mouth assessment.
timeFrame: 3 Weeks
measure: Pharmacokinetics: Plasma: Cmax, Tmax, AUCinf, AUCτ, t½, accumulation ratio, linearity ratio.
timeFrame: 3 Weeks
measure: Pharmacodynamics: Salivary flow rate
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT07012486: Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia
Official title: A Pilot Study to Evaluate the Therapeutic Effect of Dihydroartemisinin on Female Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Androgenetic Alopecia (AGA)
Keywords: androgenetic alopecia
dihydroartemisinin
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if dihydroartemisinin (DHA) works to treat Androgenetic Alopecia (AGA) in female adults. The main question it aims to answer is:

• Does DHA increase terminal hair follicles in the vertex area. Researchers will compare oral DHA plus topical minoxidil to topical minoxidil alone in female patients with AGA to see if DHA works to alleviate AGA.

Participants will:

* Receive oral DHA every day plus topical minoxidil or use topical minoxidil alone for 6 months.
* Visit the clinic once every month for checkups and tests.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with androgenetic alopecia (AGA)
* No pregnancy plans within the next 6 months

Exclusion Criteria:

* Patients who received systemic medications for hair loss within the past 2 months
* Use of topical medication for hair loss within the past 2 weeks
* Pregnancy or lactation
* Patients with known severe diseases of vital organs (e.g., heart, liver, kidney) or malignancies.

Primary outcomes:
measure: Improvement in terminal hair follicles in the vertex area
timeFrame: Baseline and 180-day of treatment
Secondary outcomes:
measure: Change of terminal hair follicle density in the vertex area from baseline to the end of treatment
timeFrame: Baseline and 180-day of treatment
measure: Change of hair density in the vertex area from baseline to the end of treatment
timeFrame: Baseline and 180-day of treatment
measure: Change of terminal hair follicle density in the frontal area from baseline to the end of treatment
timeFrame: Baseline and 180-day of treatment
measure: Change of hair density in the frontal area from baseline to the end of treatment
timeFrame: Baseline and 180-day of treatment
measure: Change of serum total testosterone from baseline to the end of treatment
timeFrame: Baseline and 180-day of treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jingjing JIANG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05521386: The Effects of Caffeine on Heart Rate and Heart Rate Variability
Official title: The Effects of Caffeine Supplementation on Heart Rate and Heart Rate Variability at Rest and During Submaximal Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caffeine
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In previous research we have shown that an acute caffeine dose of 5 mg/kg body mass reduces heart rate at rest and during low intensity exercise, with the effect dissipating as exercise intensity increases. If, as suspected, the effect at rest and at low intensities is due to an effect of caffeine on parasympathetic activity, this is likely to be reflected in an increase in heart rate variability (the beat-to-beat fluctuation in heart rate). The aim of this study is therefore to investigate the effect of caffeine on heart rate and heart rate variability at rest and during submaximal exercise.


Eligibility criteria: Inclusion Criteria:

* Trained cyclists

Exclusion Criteria:

* Injured or a contraindicative medical condition

Primary outcomes:
measure: Heart rate variability
timeFrame: From baseline to completion, up to 31 days
Secondary outcomes:
measure: Heart rate
timeFrame: From baseline to completion, up to 31 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04170686: Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome
Official title: Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: cognitive behavioral therapy
self-help
irritable bowel syndrome
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Bold Health Inc.
First posted: 2019-11-20
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to assess if a new self-help app for IBS is an acceptable and effective intervention for improving the overall quality of life in patients with Irritable Bowel Syndrome.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of IBS. Own a smart phone. Speak English

Exclusion Criteria:

* Under age of consent (18) Diagnosed with another GI disorder (e.g. celiac disease, inflammatory bowel disease)

Primary outcomes:
measure: Irritable Bowel Syndrome Quality of Life
timeFrame: 8 weeks
measure: Gastrointestinal Symptom Rating Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Visceral Sensitivity Index
timeFrame: 8 weeks
measure: GI Cognitions Questionnaire
timeFrame: 8 weeks
measure: Fear of Food Questionnaire
timeFrame: 8 weeks
measure: Patient Health Questionnaire
timeFrame: 8 weeks
measure: Depression Anxiety and Stress Scale - Depression Subscale
timeFrame: 8 weeks
measure: Depression Anxiety and Stress Scale - Stress Subscale
timeFrame: 8 weeks
measure: Depression Anxiety and Stress Scale - Anxiety Subscale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Melissa G Hunt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hunt M, Miguez S, Dukas B, Onwude O, White S. Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 20;9(5):e26152. doi: 10.2196/26152.
Clinical trial NCT02205086: Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology
Official title: Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatology
Lead sponsor: SimulConsult, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study compares the ability of clinicians to make diagnoses with or without the assistance of diagnostic decision support software. The area of clinical focus is primarily rheumatology.

Detailed description: The study uses written case vignettes, not decisions about patients seeking care from the study subjects (i.e., clinicians).

Eligibility criteria: Inclusion criteria: Clinicians in various medical specialties

Exclusion criteria: Non-clinician

Primary outcomes:
measure: Measures of Diagnostic effectiveness
timeFrame: Completion of each case vignette (typically ½ hour)
Secondary outcomes:
measure: Measures of Patient workup effectiveness
timeFrame: Completion of each case vignette (typically in the same ½ hour as measure 1)
Other outcomes:
Locations:
city: Brookline
country: United States
facility: SimulConsult
state: Massachusetts
Study officials:
affiliation: SimulConsult, Inc.
name: Michael M Segal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Segal MM, Williams MS, Gropman AL, Torres AR, Forsyth R, Connolly AM, El-Hattab AW, Perlman SJ, Samanta D, Parikh S, Pavlakis SG, Feldman LK, Betensky RA, Gospe SM Jr. Evidence-based decision support for neurological diagnosis reduces errors and unnecessary workup. J Child Neurol. 2014 Apr;29(4):487-92. doi: 10.1177/0883073813483365. Epub 2013 Apr 10.
citation: Segal MM, Schiffmann R. Decision support for diagnosis: co-evolution of tools and resources. Neurology. 2012 May 15;78(20):1546-7. doi: 10.1212/WNL.0b013e3182563c36. Epub 2012 Apr 18. No abstract available.
citation: Segal MM, Athreya B, Son MB, Tirosh I, Hausmann JS, Ang EY, Zurakowski D, Feldman LK, Sundel RP. Evidence-based decision support for pediatric rheumatology reduces diagnostic errors. Pediatr Rheumatol Online J. 2016 Dec 13;14(1):67. doi: 10.1186/s12969-016-0127-z.
Clinical trial NCT06981286: Oral Health Parameter-Based Diabetes Type 2 Indication Using Machine Learning
Official title: Oral Health Parameter-Based Diabetes Type 2 Indication Using Machine Learning in Older Individuals With Mild Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes
Keywords: Oral Health
Machine Learning
Diabetes Type 2
Lead sponsor: Blekinge Institute of Technology
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data collected from the Swedish National Study on Aging and Care (SNAC-B) will be analyzed. Participants aged 60 years or older will be included in the analysis

Brief summary: This study aims to explore the potential of using machine learning (ML) algorithms to predict Diabetes type2, based on oral health and demographic data. The objective is to evaluate the effectiveness of various ML models and identify the most relevant oral health indicators for predicting type 2 diabetes in individuals with mild cognitive impairment aged 60 and above.

Detailed description: This cross-sectional study utilizes oral health and demographic data from the Swedish National Study on Aging and Care (SNAC-B). Participants aged 60 years or older with Mild Cognitive Impairment will be included in the analysis. The data will be used to develop and evaluate machine learning models for predicting type 2 diabetes.

Objectives:

1. Primary Objective: To assess the potential of oral health parameters for binary classification of type 2 diabetes or not.
2. Secondary Objective: To identify the most influential oral health parameters contributing to type 2 diabetes predictions.
3. Tertiary Objective: To compare the performance of Random Forest (RF), Support Vector Machine (SVM), and CatBoost (CB) classifiers in predicting type 2 diabetes using oral health data.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 60 years or older.
* Participants with recorded oral health parameters with or without Diabetes type2

Exclusion Criteria:

• Individuals with Diabetes type1

Primary outcomes:
measure: Detection perfomance
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karlskrona
country: Sweden
facility: Department of Health, Blekinge Institute of Technology
Study officials:
References:
Clinical trial NCT05328986: Kidney Disease After COVID-19
Official title: Multi-center Assessment of Survivors for Kidney Disease After COVID-19
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Acute Kidney Injury
Chronic Kidney Injury
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: New Jersey Medical School
name: University of Michigan
name: Yale New Haven Health System Center for Healthcare Solutions
name: Johns Hopkins University
First posted: 2022-04-14
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COVID-19.

Brief summary: To understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.


Eligibility criteria: Criteria:

Inclusion Criteria:

* Adults, age ≥18 years
* Confirmed diagnosis of COVID-19

Exclusion Criteria:

• No confirmed diagnosis of COVID-19

Primary outcomes:
measure: estimated Glomerular Filtration Rate (eGFR)
timeFrame: yearly for 4 years after COVID exposure
Secondary outcomes:
measure: Urine Albumin-to-Creatinine Ratio (UACR)
timeFrame: yearly for 4 years after COVID exposure
measure: Urine protein/creatinine ratio (UPCR)
timeFrame: yearly for 4 years after COVID exposure
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Newark
country: United States
facility: New Jersey Medical School - Rutgers University
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Evren U. Azeloglu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06758986: Is Gender a Factor in Patients With Subacromial Shoulder Pain?
Official title: Patients With Subacromial Shoulder Pain and Gender
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Subacromial Pain Syndrome
Keywords: Subacromial Shoulder Pain
functionality
disability
position sense
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted with patients who apply to Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center with complaints of shoulder pain and who meet the inclusion criteria.

Brief summary: This study aimed to investigate the effects of gender on pain, functionality, range of motion, disability level and position sense parameters in patients with subacromial shoulder pain.


Eligibility criteria: Inclusion Criteria:

1. Being between the ages of 18-65
2. Being diagnosed with unilateral subacromial impingement syndrome
3. Not having received steroid injections or physical therapy for shoulder problems in the last 6 months
4. Having painful shoulder pain for the last 3 months
5. Being willing to participate in the study

Exclusion Criteria:

1. Having a rheumatic, neurological, cardiovascular, psychiatric or systemic disorder
2. Having a surgical operation on the shoulder, cervical and thoracic region
3. Having a neurological deficit, fracture or history of fracture in the upper extremity
4. Having cervical radiculopathy
5. Having communication problems

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 20 weeks
Secondary outcomes:
measure: Quick DASH
timeFrame: 20 weeks
measure: SPADI
timeFrame: 20 weeks
measure: The laser-pointer assisted angle reproduction test
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kirsehir Ahi Evran University
state: Merkez
Study officials:
References:
Clinical trial NCT01989286: Postural Assessment in Plagiocephaly
Official title: Postural Assessment in Children With Non-synostotic Plagiocephaly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plagiocephaly
Keywords: Plagiocephaly
Posture
Spine
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 104
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who were diagnosed by plagiocephaly and a control group.

Brief summary: The positional plagiocephaly is a condition involving craniofacial asymmetry. The purpose of this study is to evaluate the spine, the posture and the psychomotor state in children who were diagnosed with infant plagiocephaly.

Detailed description: Positional infant plagiocephaly is a clinical entity in which the shape of an infant's head becomes altered as the result of external forces applied to the malleable bones of the cranium and can occur pre- or postnatally. It is characterized by asymmetric occipital flattening (one side or the central part of the occiput is flattened)with ipsilateral frontal bossing.Viewed from above, this results in a parallelogram deformity of the head. We hypothesize that children who had plagiocephaly when they were infants, they have postural and spine implications at 3-5 years old.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of infant positional plagiocephaly
* Aged 3, 4 or 5 years old.

Exclusion Criteria:

* Diagnosis of non synostotic plagiocephaly.
* Neurological concomitant condition.
* Problems in motor development.

Primary outcomes:
measure: Spine assessment
timeFrame: baseline
Secondary outcomes:
measure: Postural evaluation
timeFrame: baseline
measure: Psychomotor assessment
timeFrame: baseline
measure: Balance
timeFrame: baseline
Other outcomes:
measure: Quality of sleep
timeFrame: baseline
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
affiliation: Universidad de Granada
name: Irene Cabrera Martos, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cabrera-Martos I, Valenza MC, Valenza-Demet G, Benitez-Feliponi A, Robles-Vizcaino C, Ruiz-Extremera A. Repercussions of plagiocephaly on posture, muscle flexibility and balance in children aged 3-5 years old. J Paediatr Child Health. 2016 May;52(5):541-6. doi: 10.1111/jpc.13155.