louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00264524: DNA Typing of HLA-DR/DQ Alleles in Taiwan Chinese With Rheumatic Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Heart Disease
Keywords: Rheumatic heart disease, HLA, Genetics, Taiwan
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2005-12-13
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: The current study was designed to determine whether the HLA-DRB1, DQA1, DQB1 alleles are associated with the risk and the pattern of valve damage of RHD.


Eligibility criteria: Inclusion Criteria:

* 1.Patients with Rheumatic mitral stenosis 2.Chinese Han ethnicity

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Division of cardiology, China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Hsiang-Tai Chou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00625924: Sensory Morbidity Following Breast Surgery
Official title: Sensory Morbidity Following Breast Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Plastic surgery
reconstruction
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 290
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinics

Brief summary: The goal of the study is measure breast sensations after breast surgery. The results of this study will help surgeons better understand breast sensations and may improve the way surgery is done.


Eligibility criteria: Inclusion Criteria:

* The Samples used will be derived from three cohorts below and will only include patients who have completed mastectomy or reconstruction within 1-5 years of enrollment.
* Patients who have undergone immediate, two-stage expander/implant postmastectomy reconstruction
* Patients who have undergone immediate, autogenous tissue flap reconstruction following mastectomy
* Patients who have undergone mastectomy alone
* Patients at least 21 years of age
* Patients who completed mastectomy ± immediate post-mastectomy reconstruction at least one year but no longer than five years prior to study entry

Exclusion Criteria:

* Patients who have had any of the following:
* delayed reconstruction (no reconstruction at time of surgery) combined autogenous tissue/implant breast reconstruction, and/or
* Patients who have a pre-surgical history of complex regional pain syndrome
* Patients who have had radiation therapy
* Patients who have had a local recurrence
* Patients who do not speak the English language (validated translations of key questionnaires are not available).

Primary outcomes:
measure: To evaluate the prevalence, severity and level of distress of subjective breast sensations following mastectomy and postmastectomy reconstruction.
timeFrame: conclusion of the study
Secondary outcomes:
measure: To compare sensory morbidity following three types of breast surgery: tissue expander/implant breast reconstruction, autogenous tissue reconstruction, and no reconstruction.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrea Pusic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03593824: The Visual Plasticity During Adversity and Prosperity in Infants With Congenital Cataracts
Official title: The Susceptibility of Phenotypic Plasticity During Adversity and Prosperity in Infants With Visual Deprivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Phenotypic plasticity
Adversity
Prosperity
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Phenotypic plasticity is the ability of individuals to change their phenotypic status when exposed to environmental variations. However, whether the plastic changes show differential susceptibility in adversity and prosperity is debated and the specific pattern of plasticity remains elusive.

Here the investigators address this question by tracking the phenotypes (functional, structural, physical, and attachment traits) in two groups of infants before and after visual deprivation: one group experienced a short duration of complete deprivation (extreme adversity) and the other group experienced a long durations of partial deprivation (watered-down adversity).


Eligibility criteria: Inclusion Criteria:

* Diagnosis with dense or non-dense nuclear congenital cataract

Exclusion Criteria:

* no metabolic diseases, mental retardation or central nervous diseases
* had no history of inherited diseases

Primary outcomes:
measure: Change from baseline in visual acuity measured by Teller visual acuity cards
timeFrame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Secondary outcomes:
measure: Change from baseline in refractive status measured by autorefractor and objective retinoscopy
timeFrame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellis BJ, Boyce WT, Belsky J, Bakermans-Kranenburg MJ, van Ijzendoorn MH. Differential susceptibility to the environment: an evolutionary--neurodevelopmental theory. Dev Psychopathol. 2011 Feb;23(1):7-28. doi: 10.1017/S0954579410000611.
citation: Pluess M, Belsky J. Vantage sensitivity: individual differences in response to positive experiences. Psychol Bull. 2013 Jul;139(4):901-16. doi: 10.1037/a0030196. Epub 2012 Oct 1.
Clinical trial NCT03528824: Fenugreek Wraps in Osteoarthritis of the Knee
Official title: Randomised Controlled Trial on the Efficacy of Fenugreek Wraps in Symptomatic Primary Gonarthrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomised controlled trial aims to investigate the efficacy of fenugreek wraps in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply fenugreek wraps or diclofenac gel daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire on pain, disability,function, quality of life and pressure pain sensitivity.


Eligibility criteria: Inclusion Criteria:

* osteoarthritis of the knee, Kellgren Lawrence stadium 2-3
* at least 50% of days with complaints in past 3 months
* initial pain intensity \>45mm on a 100mm visual analoge scale

Exclusion Criteria:

* systemic medication with corticoids or immunosuppressive drugs
* systemic medication with chondroitinsulfate or glucosamine
* secondary arthrosis
* operation on the knee within the past 12 months
* injection within 4 weeks (cortisone) or 6 months prior (hyaluronic acid)
* severe comorbidities (tumor, psychiatric disorders etc.)
* participation in other studies, regarding gonarthrosis
* asthma
* pregnancy, breastfeeding

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
Secondary outcomes:
measure: knee function (WOMAC)
timeFrame: 4 weeks
measure: measure yourself medical outcome profile (MYMOP)
timeFrame: 4 weeks
measure: Quality of Life (SF-36)
timeFrame: 4 weeks
measure: self-efficacy (ASES-D)
timeFrame: 4 weeks
measure: physical function (30second chair test)
timeFrame: 4 weeks
measure: Course of Pain
timeFrame: 4 weeks
measure: Pressure pain sensitivity
timeFrame: 4 weeks
measure: Adverse events Safety measure
timeFrame: 4 weeks
measure: knee function (WOMAC)
timeFrame: 12 weeks
measure: measure yourself medical outcome profile (MYMOP)
timeFrame: 12 weeks
measure: Quality of Life (SF-36)
timeFrame: 12 weeks
measure: self-efficacy (ASES-D)
timeFrame: 12 weeks
measure: Course of Pain
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Pain intensity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Study officials:
References:
Clinical trial NCT00219024: Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.
Official title: An 8 Week Double-blind, Multicenter, Randomized, Multifactorial, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, blood pressure, hydrochlorothiazide (HCTZ).
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 2775
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (HCTZ)


Eligibility criteria: Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of hypertensive encephalopathy or cerebrovascular accident

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in diastolic blood pressure after 8 weeks
Secondary outcomes:
measure: Change from baseline in systolic blood pressure after 8 weeks
measure: Diastolic blood pressure is < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks
measure: Blood pressure < 140/90 mmHg
measure: Change from baseline in standing diastolic blood pressure after 8 weeks
measure: Change from baseline in standing systolic blood pressure after 8 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Yan JH, Jarugula V, Sabo R, Papst CC, Zhang J, Dole WP. Pharmacokinetics and pharmacodynamics of aliskiren/hydrochlorothiazide single-pill combination tablets and free combination of aliskiren and hydrochlorothiazide. J Clin Pharmacol. 2012 May;52(5):645-55. doi: 10.1177/0091270011405499. Epub 2011 Jun 9.
Clinical trial NCT06934824: Clinical Study of Double-Endoscopic Combined With Minimally Invasive Treatment for Early Gastric Cancer at Clinical Stage T1b
Official title: Clinical Study of Double-Endoscopic Combined With Minimally Invasive Treatment for Early Gastric Cancer at Clinical Stage T1b
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For patients diagnosed with early gastric cancer involving submucosal invasion, super-ESD indications, or lymph node metastasis, a combination of preoperative endoscopic ultrasound and abdominal contrast-enhanced CT was utilized to ascertain the depth of tumor invasion and to identify any suspicious metastatic lymph nodes in the vicinity of the stomach. Subsequently, a local full-thickness resection, coupled with or followed by individualized precise lymph node dissection, was conducted to fulfill the following objectives: ① To investigate the safety, feasibility, and efficacy of local resection for patients meeting super-ESD criteria; ② To offer a clinical foundation for the individualized and precise lymph node dissection treatment of early gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years old;
2. Endoscopic pathological diagnosis: adenocarcinoma;
3. Enhanced abdominal CT combined with endoscopic ultrasound clinical staging: T1bN0-1M0.
4. Has not received other treatment;
5. No other serious comorbidities;
6. Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. History of previous abdominal surgery
3. History of other previous malignancies
4. Can patients with severe heart, lung, brain diseases tolerate surgical treatment

Primary outcomes:
measure: Rate of recurrence
timeFrame: Within 2 years
Secondary outcomes:
measure: The operation time, complications and hospital stay were recorded
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03125824: Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial Protocol
Official title: Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tattooing
Lead sponsor: Soliton
Sponsor class: INDUSTRY
Collaborators: name: MedSource LLC
First posted: 2017-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group
Primary purpose: TREATMENT

Brief summary: To further evaluate accelerated fading resulting from additional treatment sessions of Soliton AWD as accessory to laser in tattoo reduction treatment.

Detailed description: To further evaluate accelerated fading resulting from additional treatment sessions of multi-pass Q-Switched laser with the Soliton Planar Acoustic Wave Device System (AWD) as an accessory to Q-Switched laser in tattoo reduction treatment.

Eligibility criteria: Inclusion Criteria:

* Range of Fitzpatrick skin color scores I to III
* The identical tattoo located on the arms, legs, and torso treated by Q-Switched laser and Laser + AWD during Soliton's previous 2016-001 clinical trial
* Black ink only. Other ink colors may be present, but areas of black only tattoo should meet inclusion criteria
* Approximately 1" x 3" tattoo with at least 30-50% of the treatment area containing black tattoo ink

Exclusion Criteria:

* Subject is pregnant or planning to become pregnant during the duration of the study
* Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)
* Skin disorders (skin infections or rashes, scarring, moles,birthmarks, psoriasis, etc.)
* Any surgical procedure in the prior 3 months, or planned during the duration of the study
* Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, etc.
* Moderate to heavy tanning on and around the tattoo to be treated as determined by the Principle Investigator.

Primary outcomes:
measure: Tattoo clearance
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of Treatment Emergent Adverse Events for Safety Reporting
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
Study officials:
affiliation: Soliton
name: Christopher Cappelli, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05265624: The Moran AMD Genetic Testing Assessment Study
Official title: A Phase 2 Study of the Value of Pre-symptomatic Genetic Risk Assessment for Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Genetic Testing
Nutritional Biomarkers
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goals of this study are:

To assess the impact of genetic testing for Age-related Macular Degeneration (AMD) on lifestyle behaviors as measured by systemic and ocular carotenoid status.


Eligibility criteria: Inclusion Criteria:

* Participants must be between 18 and 64 years of age.
* They must also be Caucasian as this genetic test is only validated in Caucasians.
* They can have a positive family history of AMD but this is not necessary.

Exclusion Criteria:

* Personal history of AMD
* Non Caucasian
* Employee of the Moran or other eye care practice (likely to have more knowledge about AMD than a layperson)
* Personal history of prior genetic testing for AMD risk
* Anticipated cataract surgery in the upcoming year (can affect Macular Pigment measurement)
* Major psychiatric disorder

Primary outcomes:
measure: Change in skin carotenoid status in response to genetic risk disclosure as measured by Reflectance Spectroscopy
timeFrame: Baseline and Month 12
measure: Change in skin carotenoid status in response to genetic risk disclosure as measured by Resonance Raman Spectroscopy
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Volume
timeFrame: Baseline and Month 12
measure: Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Density
timeFrame: Baseline and Month 12
measure: Chang in serum carotenoid status in response to genetic risk disclosure
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah John A. Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah Moran Eye Center
name: Paul Bernstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05784324: COMPRESSED - A Longitudinal Study of Compressed Work Schedules Within the Health, Care and Welfare Services
Official title: COMPRESSED - A Longitudinal Study of Compressed Work Schedules Within the Health, Care and Welfare Services
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: The Focus of the Study is Shift Work
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: University of Oslo
name: Maastricht University
First posted: 2023-03-24
Enrollment: 700000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employes within the municipal health, care and welfare service

Brief summary: The aim of COMPRESSED is to investigate the potential consequences of a compressed work schedule within the municipal health, care and welfare services.

Detailed description: The aim of COMPRESSED is to investigate the potential consequences of a compressed work schedule within the municipal health, care and welfare services.

A compressed work schedule is defined by an increase in numbers of hours per day, and a reduction of number of days per week. Compressed work schedules are advocated as a tool to reduce involuntary part-time contracts, and improve employee recruitment and retention, as well as improve employee health and quality of care.

However, the empirical support of such claims is limited, mixed, and suffers from several methodological shortcomings. There is a clear lack in studies investigating the potential moderating and mediating mechanisms, despite moderating variables such as shift intensity being likely to have an impact. In collaboration with unions and employers, COMPRESSED uses a longitudinal mixed method design, to investigate the short- and long-term consequences of compressed work schedules, as well as potential moderating and mediating variables. Each of the research questions will be addressed with complimentary methods in each of the work packages.

The project COMPRESSED will examine:

In-depth narrative interviews eliciting employees', employers', and patients'/users' own perceptions of consequences, moderators and mechanisms.

A retrospective intervention study using registry data, examining compressed work schedules implemented over the past 5 years.

A two year longitudinal survey looking at long-term effects and 4) a diary study across two weeks, looking at short-term effects.

Eligibility criteria: Inclusion Criteria:

* Employed within the municipal health, care and welfare services.

Exclusion Criteria:

-

Primary outcomes:
measure: Featigue
timeFrame: 2027
measure: Mental health
timeFrame: 2027
measure: Generell helse
timeFrame: 2027
measure: Sickness absence
timeFrame: 2027
measure: Quality of care
timeFrame: 2027
measure: Care left undone
timeFrame: 2027
measure: Intention to quit
timeFrame: 2027
measure: Occupational commitment
timeFrame: 2027
measure: Regestry-data
timeFrame: 2027
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: