louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01038453: Effects of Vitamin D Supplement Before and During Pregnancy on Birth Weight
Official title: Effects of Vitamin D Supplement Before and During Pregnancy on Complications, Birth Weight and Bone Mineral Density During Lactation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Birth Weight
Vitamin D Deficiency
Pregnancy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a daily supplement of vitamin D, taking before and during pregnancy, effects child birth weight, pre- and postpartum complication and bone mineral density during lactation.


Eligibility criteria: Inclusion Criteria:

* P-OH25-vitamin D \< 50 nmol/l
* Woman age 30-35 years
* In good general health

Exclusion Criteria:

* Infertility
* Intake of 400 IU or more Vitamin D/day
* Cancer
* Alcohol or drug abuse
* Calciummetabolic disturbances
* Spontaneous abortion within last 6 month

Primary outcomes:
measure: Birth Weight
timeFrame: 0-24 hours after delivery of the child
Secondary outcomes:
measure: Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD).
timeFrame: Day 1 to 4 months after delivery.
measure: Infections of the newborn
timeFrame: Day 1 of the child to 16 weeks after birth.
measure: Growth of the newborn measured by weight, crown-heel length and head circumference
timeFrame: Day 1 of the child to 16 weeks after birth
measure: Time to accomplish pregnancy
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: University of Aarhus, Aarhus Universityhospital
Study officials:
affiliation: Aarhus University Hospital
name: Gitte Bloch Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Lars Rejnmark, MD, PhD, Drmed.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05856253: Enhanced Recovery in Esophageal Surgery
Official title: Implementation and Early Results on an Enhanced Recovery Program in Esophageal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ERAS Protocol, Esophagectomy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated on esophagectomy for malignant and non malignant esophageal pathologies.

Brief summary: Esophageal surgery remains the main treatment for esophageal cancer. Despite constant improvements, morbidity of esophagectomy remains high. For several years, enhanced rehabilitation programs have been used to reduce the impact of surgery on the patients to support a faster recovery. This study analyses the first results of newly implemented enhanced program after esophagectomy within the framework of an academic center.


Eligibility criteria: Inclusion Criteria:

* All consecutive esophagectomy

Exclusion Criteria:

* Contraindication for surgery according to the WHO physical status of IV, emergency surgery, mental illness and patient's refusal.

Primary outcomes:
measure: Number of participants who reach the the 23 measurements of the enhanced recovery program
timeFrame: an average of 15 days (During the surgical period (hospital stay)
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT00075153: Quality of Life in Children With HIV Infection
Official title: Quality of Life in Children With HIV Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: ADOLESCENCE
HIV INFECTION
PEDIATRIC AIDS
QUALITY OF LIFE
HIV
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2004-01-08
Enrollment: 1993
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and youth, from birth to 25 years, with perinatally acquired HIV infection enrolled in PACTG 219/219C

Brief summary: The purpose of this study is to characterize the quality of life (QOL) and longitudinal patterns of change in QOL outcomes in children and youth with HIV infection; to identify demographic, social, disease status, treatment, and health care utilization factors that predict longitudinal changes in outcomes; to develop a conceptual model that characterizes the effects of specific factors that predict longitudinal changes in QOL; and to characterize the influence of HIV symptoms on QOL outcomes in the domains of health perceptions, physical, psychological, and social role functioning.

Detailed description: This is a Phase III study. This study will use national data available through a prospective, observational, longitudinal study of children and youth (n=1,993) from birth to 25 with HIV infection (Pediatric AIDS Clinical Trials Group Protocol 219/219C) to develop knowledge about the quality of life (QOL) and the factors that affect it in order to be able to implement effective nursing interventions and clinical programs to support and improve QOL in this vulnerable population of children.

Eligibility criteria: Inclusion criteria

* Children and youth with perinatally acquired HIV infection
* Enrolled in PACTG 219/219C
* Completed quality of life assessment

Exclusion criteria

--HIV exposed, not infected

Primary outcomes:
measure: Quality of Life assessment
timeFrame: 1999
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Medicine and Dentistry of NJ
state: New Jersey
Study officials:
affiliation: School of Nursing, Rutgers, The State University of New Jersey
name: Deborah S. Storm, MSN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00617253: Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients
Official title: An Open Label, Dose Escalation Safety and Tolerability Trial of the Combination of s.c. Recombinant Human IL-21 (rIL-21) and Sunitinib (Phase 1) Followed by an Open Label Stratified Randomized 2-arm Trial of rIL-21 Plus Sunitinib Versus Sunitinib Alone (Phase 2a) in Subjects With Stage IV Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Renal Cell Carcinoma
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase 1/2a trial is conducted in Europe. The first part of the trial is a dose escalation safety trial determining the maximum tolerated dose of rIL-21 when administered in combination with sunitinib.

The second part, scheduled to start in September 2008, is a randomised 2-arm trial comparing the anti-tumour effect of rIL-21 plus sunitinib with sunitinib alone.


Eligibility criteria: Inclusion Criteria:

* Histologically verified and surgically incurable stage IV Renal Cell Carcinoma
* ECOG performance status of 0 or 1 (i.e. good performance status)
* Life expectancy of at least 3 months

Exclusion Criteria:

* Prior systemic therapy for metastatic disease
* Radiotherapy within the last 4 weeks prior to start of treatment
* Receipt of any investigational drug within 3 months of starting treatment
* History of any other active malignancy within five years prior to enrolment

Primary outcomes:
measure: Toxicity according to CTCAE version 3.0
timeFrame: For the duration of the trial
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: For the duration of the trial
measure: rIL-21 antibodies
timeFrame: For the duration of the trial
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
city: Amsterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Nijmegen
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03316053: Cell Marker Predictors in Barrett's Esophagus
Official title: Cell Marker Predictors in Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Barrett's Esophagus Without Dysplasia
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a history of Barrett's esophagus

Brief summary: The purpose of this study is to analyze biopsied tissue samples for changes in cells and genes involved in Barrett's Esophagus.

Detailed description: Patients with a history of Barrett's esophagus who are scheduled for a routine endoscopy will have an additional biopsy taken for genetic testing.

Eligibility criteria: Inclusion Criteria:

* History of Barrett's esophagus; scheduled for routine upper endoscopy

Exclusion Criteria:

* Under 18 years of age
* Unable to consent on own behalf

Primary outcomes:
measure: Cell Markers
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sayre
country: United States
facility: The Guthrie Clinic
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: John Ford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06441253: Development and Evaluation of a Portable Wedge Device for Calf Stretching to Alleviate Strain and Spasms
Official title: Development and Evaluation of a Portable Wedge Device for Calf Stretching to Alleviate Strain and Spasms: A RCT Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spasm
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research aimed to contribute valuable insights into the potential benefits of incorporating the portable wedge device into preventive or therapeutic interventions for calf-related musculoskeletal issues.

Detailed description: By combining economical, ergonomic principles and user-friendly features, the proposed device offered individuals a convenient and efficient means to enhance their calf flexibility, ultimately mitigating strain and reducing spasms. Developing and successfully integrating a portable wedge device could mark a significant breakthrough in preventive and rehabilitative care for musculoskeletal problems associated with the calf region. This innovative device can enhance the overall well-being and musculoskeletal health of individuals suffering from such issues, providing a more effective and convenient treatment solution.

Eligibility criteria: Inclusion Criteria:

* Male and female patients diagnosed with Calf Strain and Spasm
* Age above 18
* Participants who are volunteer for the study
* Patients who suffer from leg pain or functional disability

Exclusion Criteria:

* Unconscious patients
* Patients with difficulty in seeing and hearing
* Patients having a history of mental illnesses (Stroke, Multiple sclerosis, Parkinsonism, Alzheimer's Disease)
* Patient history of severe mobility disorder
* Systemic illness (Liver Failure, Active cancer, Cardiopulmonary distress)
* Decline to participate in this study
* Active fracture and dislocations
* Arthritic disorders (such as osteoarthritis, Rheumatoid Arthritis, Psoriatic Arthritis, and Fibromyalgia)

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 12 Months
measure: Functional Disability Scale for Ankle (FADI)
timeFrame: 12 months
measure: Range of motion (ROM)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Ramay Clinic (Physiotherapy and Orthopedic Department)
state: Punjab
Study officials:
References:
Clinical trial NCT06892353: AI-Powered DIY Screening System for Diabetic Retinopathy
Official title: AI-powered Low-cost Portable Fundus Camera to Deliver Diabetic Retinopathy Screening At Primary Health Care Setting: a Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: diabetic retinopathy
AI
screening system
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: A pragmatic trial will be conducted in two representative clinics in each of the three types of targeted settings. It will be run for 3 months in each clinic to complete data collection of up to 100 patients in SPGC and Optometry Clinics, 200 at GPGC and 200 in GOPC in total. All the subjects will conduct a DIY screening, physician consultation, survey with questionnaires and a phone interview three months after their baseline assessment. This study will assess automated screening in terms of success rate of the DIY system without active assistant help, accuracy, screening rate and detection rate, adherence to referral and experience of participants, as well as cost-effectiveness in real-world settings.


Eligibility criteria: Inclusion Criteria:

1. subjects who are 50 years of age or older, or subjects who are 18 years of age or older and have diabetes, and
2. have not undertaken an eye examination in the previous 12 months (elevated risk of undiagnosed disease).
3. Provide written informed consent.

Exclusion Criteria:

1. individuals with physical disabilities that prevent the use of a fundus camera, or
2. individuals with speech impairments who are unable to complete telephone follow-ups.

Primary outcomes:
measure: Success Rate without Active Assistant Help
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of Consumer Acceptability
timeFrame: 3 months
measure: Diagnostic Accuracy
timeFrame: 3 months
measure: Disease Detection Rates
timeFrame: 3 months
measure: Adherence to Referral
timeFrame: 3 months
measure: Technical Feasibility: Quality of Image Acquisition
timeFrame: 3 months
measure: Cost-effectiveness of DIY Screening
timeFrame: 3 months
measure: Assessment of Consumer Satisfaction
timeFrame: 3 months
measure: Diagnostic Accuracy
timeFrame: 3 months
measure: Diagnostic Accuracy
timeFrame: 3 months
measure: Diagnostic Accuracy
timeFrame: 3 months
measure: Diagnostic Accuracy
timeFrame: 3 months
measure: Technical Feasibility:The duration of Clinic Flow
timeFrame: 3 months
measure: Technical Feasibility:Reporting and Impact on Clinic Flow
timeFrame: 3 months
measure: Technical Feasibility: The type of technical error
timeFrame: 3 months
measure: Technical Feasibility: Number of Recorded Technical Errors
timeFrame: 3 months
measure: Technical Feasibility: Remedies for technical errors
timeFrame: 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: SPGC and Optometry Clinics
Study officials:
References:
Clinical trial NCT06400953: The Effect of Kinetic Brain Exercises on Balance and Dual Task Activities in the Elderly
Official title: The Effect of Kinetic Brain Exercises on Balance and Dual Task Activities in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Exercise
Keywords: Kinetic Brain Exercises
Balance
Dual Task Performance
Elderly
Core Stabilization
Lead sponsor: Fenerbahce University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the balance and dual-task activities of Kinetic Brain Exercises in healthy elderly individuals living in nursing homes.

Detailed description: A total of 33 people, 4 women and 29 men between the ages of 65-80 (73.88±3.69 years) completed in the research. Demographic and clinic information of the individuals were recorded and Dual Task Performance Tests for dual task activities, Timed Up and Go Test (TUGT) , Functional Reach Test for balance, 10 Meter Walk Test for walking speed, Fall Efficacy Scale (FES) for the fear of falling, Dual Task Questionnaire for to determine individuals difficulties during dual tasks and World Health Organization Quality of Life Instrument- Older Adults Module (WHOQOL-OLD) was used for quality of life. Individuals were applied an exercise program of 40 minutes, 2 days a week for 8 weeks. Individuals were divided into 2 groups. Kinetic Brain Exercises and Core Stabilization Exercises were applied to Group 1 (n=17), and only Core Stabilization Exercises were applied to Group 2 (n=16).

Eligibility criteria: Inclusion Criteria:

* Individuals living in nursing homes between the ages of 65-80,
* Having signed the Informed Volunteer Consent Form,
* Sufficient cognitive functions (Mini Mental State Test score being 24 and above)
* Those who can stand independently on their own

Exclusion Criteria:

* Those with neurological, musculoskeletal, inner ear or eye diseases that will cause impairment in vision or standing balance,
* Those with moderate and severe congenital heart disease, coronary heart disease and cerebrovascular disease

Primary outcomes:
measure: Demographic and Clinical Evaluation Form
timeFrame: At baseline and after 8 weeks
measure: Mini Mental State Test
timeFrame: At baseline and after 8 weeks
measure: Dual Task Performance Tests
timeFrame: At baseline and after 8 weeks
measure: 10 Meter Walking Test
timeFrame: At baseline and after 8 weeks
measure: Functional Reaching Test
timeFrame: At baseline and after 8 weeks
measure: Dual Task Survey
timeFrame: At baseline and after 8 weeks
measure: Tinetti Fall Activity Scale
timeFrame: At baseline and after 8 weeks
measure: World Health Organization Quality of Life Scale Elderly Module
timeFrame: At baseline and after 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
References:
Clinical trial NCT01280253: Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture
Official title: Can Biochemical Tests Predict Outcome in Patients With Hip Fracture?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fracture
Keywords: Predictor
outcome
biochemical
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Anna and Edwin Berger Foundation
First posted: 2011-01-20
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presenting with hip fracture at University Hospital Lund Sweden

Brief summary: The objective of the study is to identify biochemical predictors of morbidity and mortality in patients suffering from hip fracture. For this purpose blood samples are collected prehospitally or in the emergency department in patients with a suspected hip fracture. During the hospital stay medical history, anesthesiological management recorded. In addition, american society of anesthesiology physiological score (ASA), revised cardiac risk index (RCRI), and POSSUM score is calculated. Morbidity and mortality is recorded " in house", after 30 days, after 4 months and after 1 year. Biochemical predictors of outcome will be evaluated with logistic regression analysis. Biochemical predictors include pro-brain natriuretic peptide, lactate, pro-calcitonin, adrenomedullin, copeptin, cystatin c. The predictive value of the potential markers will be compared to that of ASA, RCRI and POSSUM.


Eligibility criteria: Inclusion Criteria:

* Patients presenting with out of hospital hip fracture at University Hospital Lund Sweden
* Informed consent
* Blood sampling within 3 hrs of first contact with healthcare

Exclusion Criteria:

* No consent can be obtained
* Non-operative management
* Followup through the Swedish National Quality for Hip fracture patients not possible
* High energy trauma

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Morbidity
timeFrame: 30 day
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital, Lund
state: Skane
Study officials:
affiliation: Skane University Hospital
name: Peter Bentzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01073553: Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules
Official title: Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef (Cephalexin 500 mg Capsules) From Bayer and Keflex (Cephalexin 250 mg Capsules) From Eli Lilly po in Healthy Subjects Using Equivalent Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anti-Infective Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Corporación Bonima S.A. de C.V.
First posted: 2010-02-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

Exclusion Criteria:

* History of illnesses or any organic abnormalities that could affect the results of the study
* History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup

Primary outcomes:
measure: Least square estimator of average maximum plasmatic concentration (log transformed)
timeFrame: After two months
measure: Least square estimator of area under the pharmacokinetic curve (log transformed)
timeFrame: After two months
Secondary outcomes:
measure: Time at which maximum concentration is reached
timeFrame: After two months
measure: Area under the pharmacokinetic curve from time=0 to last blood sample
timeFrame: After two months
measure: Clearance constant of plasmatic concentration of study drug
timeFrame: After two months
measure: Half life of plasmatic concentration of study drug
timeFrame: After two months
measure: Adverse events collection
timeFrame: Up to six weeks
Other outcomes:
Locations:
city: Morelia
country: Mexico
state: Michoacán
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: