louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00023101: Lead, Endocrine Disruption and Reproductive Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lead Poisoning
Infertility
Keywords: lead
endocrine dysfunction
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-08-24
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This prospective cohort study of 400 lead exposed and 400 non-lead exposed women and their husbands assesses endocrine dysfunction and adverse reproductive outcomes. Residing in two study areas in Shenyang, China, the women are married, 20 and 34 years of age, never smokers, have obtained permission to have a child, and have attempted to become pregnant over the course of the study. Lead exposure is defined by lead levels in blood samples collected at the baseline survey (both women and their husbands), first and second trimesters, and at delivery (both maternal and cord blood). Endocrine dysfunction is monitored by urinary hormone metabolites including follicle-stimulating hormone (FSH), luteinizing hormone (LH), estrone conjugates (E1C), and pregnanediol-3-glucuronide (PdG). Reproductive endpoints include menstrual disturbance, time to conception, spontaneous abortion, preterm delivery, and low birth weight.


Eligibility criteria: married women who:

* currently reside in two study areas in Shenyang, China
* between 20 and 34 years of age
* never smokers
* have obtained permission to have a child
* are attempting to become pregnant over the course of the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06116201: Influences of Long Term Hormone Therapy on Physical Fitness and Vascular Function in Transgender Women
Official title: Influences of Long Term Hormone Therapy on Physical Fitness and Vascular Function in Transgender Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transgender Women
Keywords: Transgender women
Physical fitness
Vascular function
Hormone therapy
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Transgender women who transitioned from male to female by hormone therapy demonstrate similar physical fitness and vascular function to males or females.

Detailed description: This cross-sectional study was to compare physical fitness and vascular function between cisgender men, cisgender women, and transgender women.

Eligibility criteria: Inclusion Criteria:

1. Cisgender men group (Body mass index between 18.5-24.9 and NO NCDs).
2. Cisgender women group (Body mass index between 18.5-24.9, No pregnant, NO NCDs).
3. Transgender women with orchiectomy (Body mass index between 18.5-24.9, taking estradiol, testosterone level below 10 nmol/L, NO NCDs).
4. Transgender women without orchiectomy (Body mass index between 18.5-24.9, taking estradiol and anti-androgen, testosterone level below 10 nmol/L, NO NCDs).

Exclusion Criteria:

* Participants had an injury during testing.

Primary outcomes:
measure: Heart rate
timeFrame: Baseline
measure: Blood pressure
timeFrame: Baseline
measure: Body weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Resting metabolic rate
timeFrame: Baseline
measure: Vascular structure
timeFrame: Baseline
measure: Macro vascular function
timeFrame: Baseline
measure: Arterial stiffness
timeFrame: Baseline
measure: Micro vascular function
timeFrame: Baseline
measure: Muscle mass
timeFrame: Baseline
measure: Fat mass
timeFrame: Baseline
measure: Bone mineral content
timeFrame: Baseline
measure: Bone mineral density
timeFrame: Baseline
measure: T-score of bone density
timeFrame: Baseline
measure: Cardiorespiratory fitness
timeFrame: Baseline
measure: Muscle strength and muscle endurance
timeFrame: Baseline
measure: Flexibility
timeFrame: Baseline
measure: Agility
timeFrame: Baseline
measure: Balance
timeFrame: Baseline
measure: Coordination and reaction time
timeFrame: Baseline
measure: Muscular power
timeFrame: Baseline
measure: Speed
timeFrame: Baseline
measure: Anaerobic fitness
timeFrame: Baseline
Secondary outcomes:
measure: Quality of life level
timeFrame: Baseline
measure: Stress level
timeFrame: Baseline
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Faculty of Sports Science, Chulalongkorn University
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Daroonwan Suksom, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01880801: Immunoglobulins Anti Platelets In Breast Milk Of Maternal ITP
Official title: IMMUNOGLOBULINS ANTI PLATELETS IN BREAST MILK OF MATERNAL ITP
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mothers With ITP Condition
Keywords: ITP
Lead sponsor: Laniado Hospital
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lactating women diagnosed with ITP

Brief summary: The purpose of this study is to determine whether mothers with Idiopathic thrombocytopenic purpura (ITP) has antibodies against platelets in breastfeeding milk aside control group of healthy mothers.

In order to prevent severe thrombocytopenia in infants born to mothers with ITP.

Detailed description: Samples of breastfeeding milk and sera will be collected from 10 lactating women diagnosed with ITP and from 10 healthy women in the same stage after giving birth. Antibodies against platelets in the samples will be examined by using anti human IgM/G/A antibody following incubation of the serum/milk samples with platelets. The platelets will be from leftovers of samples send to platelets functionality test and found to be normal (the platelets samples will be taken without any identification and be marked only with lab number). The measurement will be done by flow cytometer. Sample will be consider as positive when the signal will be greater than 2 fold of control samples standard deviation. In addition, the presence of antibodies in different times from the birth will be checked in breastfeeding milk and sera of ITP patients. If the milk proteins and lipids will disturb the exam, the immunoglobulins from the milk will be isolated using Ig isolation kit from plasma.

Eligibility criteria: Inclusion Criteria:

* Maternal ITP
* Newborns above 35W and above 2.5 kg

Exclusion Criteria:

* mothers who do not breast feeding
* Thrombocytopenia from other reasons

Primary outcomes:
measure: IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP
timeFrame: 4 times in the first month after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Sharon Nechama, Laniado Hospital
Study officials:
References:
Clinical trial NCT02066701: Gene Methylation in the Diagnosis of Barrett's Esophagus: Identification of Candidate Diagnostic Markers
Official title: Utility of Aberrant Gene Methylation in the Diagnosis of Barrett's Esophagus: Identification of Candidate Diagnostic Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Keywords: Barrett's esophagus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for clinically indicated upper endoscopy will be approached to participate in this study

Brief summary: This study is to identify potential markers from esophageal biopsies and brush cytology for feasibility of use in stool specimens for detection of Barretts Esophagus.


Eligibility criteria: Inclusion Criteria:

Controls: No endoscopic evidence of Barrett's Esophagus, able to give informed consent, 18 years of age or older.

Cases: At least 1 cm of visible columnar epithelium with intestinal metaplasia on histology confirmed by an expert GI pathologist (on biopsy), able to give informed consent, 18 years of age or older.

Exclusion criteria:

Controls: Patients with history of esophagectomy or mucosal ablation, gastrectomy, or known non-Barrett's esophageal pathology (e.g. eosinophilic esophagitis or achalasia), varices, esophagitis LA Grade B, C, D will be excluded. Patients with prior history of colon polyps or colon/esophageal/gastric/pancreatic carcinoma (unless had negative colonoscopy within 2 years to clear polyps).

Cases: Patients with history of esophagectomy or mucosal ablation, gastrectomy, or known non-Barrett's esophageal pathology (e.g. eosinophilic esophagitis or achalasia), will be excluded. Patients with prior history of colon polyps or colon/gastric/pancreatic carcinoma (unless had negative colonoscopy within 2 years to clear polyps).

Primary outcomes:
measure: to determine if assay of aberrantly methylated gene markers can discriminate Barrett's Esophagus tissue (and presence of dysplasia) from esophageal squamous and gastric cardia tissue.
timeFrame: 1 day
Secondary outcomes:
measure: Assess the accuracy of candidate markers in stool for detection of Barrett's Esophagus
timeFrame: One day
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Prasad G Iyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03069001: Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV
Official title: Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Egyptian Patients With HCV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HCV
Keywords: HCV treatment
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 90
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: This prospective study was conducted at Ain Shams University Hospital, Internal Medicine, Hepatology and Gastroenterology Department, and Tropical Medicine Department.

To compare the efficacy of the combination of sofosbuvir and simeprevir for 12 weeks with the combination of sofosbuvir and ribavirin for 24 weeks in Egyptian patients with HCV-related Child A cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic HCV infection with a positive HCV RNA level by PCR.

Exclusion Criteria:

* Total bilirubin \> 2 mg/dl.
* serum albumin \< 2.8 g/dl.
* INR \> 1.7.
* platelet count \< 50000/mm3.
* serum creatinine \> 2.5 mg/dl.
* patients presented by ascites or hepatic encephalopathy.
* patients with evidence of other causes of liver diseases, including hepatitis A, hepatitis B, autoimmune hepatitis, alcoholic liver disease, drug-induced hepatitis, haemochromatosis, Wilson disease or alpha-1 antitrypsin deficiency.
* patients with any advanced systemic disease.
* pregnancy or inability to use effective contraception in females.

Primary outcomes:
measure: Evaluation at end-of-treatment response
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06842901: Feasibility Study on PoRi Device
Official title: Feasibility Study on Portable Rehabilitation (PoRi) Device in Hand Spasticity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Spasticity
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study population only includes participants who present for follow up management of hand spasticity at the Yale New Haven Hospital's Physical Medicine and Rehabilitation (PM\&R) outpatient clinic or who are admitted to the Yale New Haven Hospital's Inpatient Rehabilitation Unit (IRU).
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study is a feasibility study of a new device that moves the hand of patients with spasticity to reduce hand muscle tone. The device's ability to improve spasticity before and after a 20-minute session with the device at Yale New Haven Hospital's outpatient clinic of Physical Medicine \& Rehabilitation, or the Inpatient Rehabilitation Unit.

Detailed description: Each patient will participate in a single 20 minute session, during which the device will extend and flex finger muscles. Each participant's duration will be approximately 1 hour during clinic, including time to address any further questions, to calibrate the device, and to measure the Modified Ashworth Score (MAS) before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Modified Ashworth Scale (MAS) score of at least 1
* Participants with paralysis or motor function problems of the fingers of one or both hands.

Exclusion Criteria:

* Minors (below age 18)
* Vulnerable populations
* Inability of fingers and wrist to stretch to neutral during passive range of motion

Primary outcomes:
measure: Feasibility assessed using the change in Modified Ashworth Scale (MAS) score
timeFrame: immediately prior to intervention session and immediately following 20 minute intervention session
Secondary outcomes:
measure: Device usability and accessibility survey
timeFrame: immediately following 20 minute intervention session
Other outcomes:
Locations:
city: New Haven
country: United States
facility: , Yale New Haven Hospital's Physical Medicine & Rehabilitation (PM&R) outpatient clinic
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital's Inpatient Rehabilitation Unit
state: Connecticut
Study officials:
affiliation: Yale University
name: Necolle Morgado-Vega
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05927701: Self-perceived Health Status and Healthcare Consumption of Idiopathic Scoliosis Patients Treated More Than 20 Years Ago: How Much do Operated and Non-operated Patients Differ?
Official title: Self-perceived Health Status and Healthcare Consumption of Idiopathic Scoliosis Patients Treated More Than 20 Years Ago: How Much do Operated and Non-operated Patients Differ?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 100
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: Patients with a Diagnosis of Adolescent Idiopathic Scoliosis aged 10 to 18 years at the time of treatment (surgical or nonsurgical)

Brief summary: Adolescent idiopathic scoliosis (AIS) is a common condition that affects millions of patients worldwide. This is characterized by a spinal deformity that leads to a deformation of the trunk, an imbalance of the shoulders and waist folds as well as the appearance of gibbosity.

Posterior arthrodesis correction is a common practice surgery for the treatment of AIS after failure of medical treatment with a corset or functional rehabilitation. Surgery allows functional improvement and is indicated for curves greater than medically treated scoliosis.

The objective of this international study is to have a better understanding of the long-term outcomes (\> 20 years of follow-up) after treatment (surgical and non-surgical) of AIS and to compare the long-term status of the patient with AIS to the general population of the same age, sex and comorbidities.

All of this information will help justify or modify the strategy, techniques and goals of early treatment in adolescence to achieve a better long-term outcome.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Adolescent Idiopathic Scoliosis
* Main baseline curve magnitude over 40º
* Aged 10 to 18 years at the time of treatment (surgical or nonsurgical)
* More than 20 years of follow up
* Current contact information available

Exclusion Criteria:

* Non-idiopathic scoliosis
* Younger than 10 or older than 18 at the time of initial treatment
* Less than 20 years of follow up
* Patients unable to understand and answer the questionnaires because of language difficulties or because of cognitive impairments

Primary outcomes:
measure: Long-term quality of life
timeFrame: 1 day
Secondary outcomes:
measure: The long-term quality of life
timeFrame: 1 day
Other outcomes:
Locations:
city: Bruges
country: France
facility: Clinique du dos
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT05873101: Comparison Of Effectiveness of Mobilization With Movement (MWM) and Kelternborn Treatment Technique to Increase ROM, Reducing Pain in Patient of ACL Reconstruction
Official title: Comparison Of Effectiveness of Mobilization With Movement (MWM) and Kelternborn Treatment Technique to Increase ROM, Reducing Pain in Patient of ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine the Comparison Of Effectiveness of Mobilization With Movement (MWM) and Kelternborn Treatment Technique to Increase ROM, Reducing Pain in Patient of ACL Reconstruction


Eligibility criteria: Inclusion Criteria:

* • Subjects with age group between 20 to 60 years with sedentary lifestyle were included.

  * Both males and females were included.
  * Patients with diagnosed Tight hamstrings having knee extension less than 160º with the hip at 90º flexion.
  * Patients with decreased ROM at the knee joint.
  * Patients with reduced straight leg raise.
  * Patients with pain in posterior compartment of thigh.
  * Asymptomatic patients will be included.

Exclusion Criteria:

* • Patients with prolapsed disc were excluded.

  * Patients with lower extremity injuries (strain, sprain, ligament injuries, etc.) in last 6 months were excluded.
  * Patients with severe hamstring injury either acute or chronic were excluded.
  * Patients with visual acute swelling in the region of hamstring muscle
  * Patients with fracture of any type and area.
  * Patients with dislocations or subluxations present were excluded.
  * Patient recommended for TKR of knee joint.
  * Patients with any neurological disease like lumbar/cervical herniation, polyneuropathy, scoliosis etc.)

Primary outcomes:
measure: Goniometer (Range of Motion)
timeFrame: 6 Months
measure: Visual Analog Scale ( VAS)
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Superior University
state: Punjab
Study officials:
References:
Clinical trial NCT01936701: Comparison of the Effect of Hydrophobic Acrylic and Silicone 3-piece IOLs on Posterior Capsule Opacification
Official title: Comparison of the Effect of Hydrophobic Acrylic and Silicone 3-piece IOLs on Posterior Capsule Opacification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Capsule Opacification
Cataract
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Age-related cataract is the main cause of impaired vision in the elderly population worldwide.

The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.

The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.

Modifications in IOL design and material lead to a decrease in the incidence of PCO.

During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.

The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 2 years.


Eligibility criteria: Inclusion Criteria:

* bilateral age-related cataract
* good overall physical constitution

Exclusion Criteria:

* previous intraocular surgery or ocular trauma
* intraocular complication like posterior capsular tear
* glaucoma
* uveitis
* corneal diseases, diabetic retinopathy and any other severe retinal -pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely

Primary outcomes:
measure: posterior capsular opacification (PCO)
timeFrame: 2 xears
Secondary outcomes:
measure: best corrected visual acuity (BCVA)
timeFrame: 2 years
measure: Nd:YAG rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology and Optometry of the Medical University Vienna
Study officials:
References: