louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03324529: Autonomic Modulation in Takotsubo Syndrome
Official title: Autonomic Modulation in Takotsubo Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Takotsubo Syndrome
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a minimal risk case-controlled single arm intervention study, including 10 patients with a prior history of takotsubo and 10-age and sex matched healthy controls. Subjects will undergo in laboratory testing to measure autonomic function. They will then undergo a 15-week program of device-guided breathing with remote measures of autonomic function obtained at home. Analysis will determine the reproducibility of home autonomic measures and the provide preliminary data to determine the efficacy of device-guided breathing on autonomic measures and quality of life in patients with takotsubo.


Eligibility criteria: Inclusion Criteria:

* Confirmed history of takotsubo syndrome
* Healthy person with no significant past history of cardiovascular or neurological disease such as heart failure or heart attack; people with cardiovascular risk factors such as hypertension will be permitted to participate

Exclusion Criteria:

* Pacemaker or defibrillator implanted
* Evidence of autonomic neuropathy, alcohol or drug abuse or exposure to neurotoxins (chemotherapy).
* Diabetes

Primary outcomes:
measure: heart rate variability
timeFrame: 10 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Harmony Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06601829: Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University Hospital
Official title: Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University Hospital
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: cross sectional study prospective and retrospective

Brief summary: polycystic kidney disease is aherditary disorder characterized by the formation of numerous fluid filled cysts in the kidneys which can lead to progressive renal impairment PKDencompasses aspectrum of disorders with autosomal dominant polycystic kidneydisease and autosomal recessive polycystic kidney disease being the two main types


Eligibility criteria: Inclusion Criteria:

* pediatric patients aged 0-18 years both male and female patients

Exclusion Criteria:

* patients whose guardians dont provide informed consent patients who are not complient with follow up vists and data collection protocols

Primary outcomes:
measure: incidence of congenital hepatic fibrosis in patient with autosomal recessive polycyctic kidney disease
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Paul BM, Vanden Heuvel GB. Kidney: polycystic kidney disease. Wiley Interdiscip Rev Dev Biol. 2014 Nov-Dec;3(6):465-87. doi: 10.1002/wdev.152. Epub 2014 Sep 3.
citation: Salman MA, Elgebaly A, Soliman NA. Epidemiology and outcomes of pediatric autosomal recessive polycystic kidney disease in the Middle East and North Africa. Pediatr Nephrol. 2024 Sep;39(9):2569-2578. doi: 10.1007/s00467-024-06281-0. Epub 2024 Jan 23.
citation: Khare A, Krishnappa V, Kumar D, Raina R. Neonatal renal cystic diseases. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2923-2929. doi: 10.1080/14767058.2017.1358263. Epub 2017 Aug 2.
citation: Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.
citation: Lucchetti L, Chinali M, Emma F, Massella L. Autosomal dominant and autosomal recessive polycystic kidney disease: hypertension and secondary cardiovascular effect in children. Front Mol Biosci. 2023 Mar 10;10:1112727. doi: 10.3389/fmolb.2023.1112727. eCollection 2023.
Clinical trial NCT02801929: 18670 - Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay ,UVA Protection Factor Assay (UVAPF), Minimal Persistent Pigment-Darkening Dose (MPPD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF(Self History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05395429: Clinical Evaluation of Genetron TERT/BRAF PCR Kit in Thyroid Cancer Patients
Official title: Clinical Evaluation of Genetron TERT/BRAF PCR Kit in Thyroid Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Cancer
Lead sponsor: Genetron Health
Sponsor class: INDUSTRY
Collaborators: name: Tianjin Medical University Cancer Institute and Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Yunnan Cancer Hospital
name: First Affiliated Hospital of Kunming Medical University
First posted: 2022-05-27
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital sample

Brief summary: The purpose of this trail is to evaluate the performance of Genetron TERT/BRAF PCR Kit in Thyriod Cancer patients using real-time PCR method.

Detailed description: This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron TERT/BRAF PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.

Eligibility criteria: Inclusion Criteria:

1. Patients with clinical diagnosis of suspected thyroid cancer who underwent fine-needle aspiration (FNA)
2. The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc.
3. Subjects who can provide a complete FNA sample
4. Subjects who agree to provide follow-up diagnosis and treatment information

Exclusion Criteria:

1. The investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps.
2. Samples with incomplete information required.
3. The amount of DNA extracted is not enough to complete the samples tested by the assessment reagent or comparative method.

Primary outcomes:
measure: The main purpose of this study is: by evaluating the Genetron TERT/BRAF PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Yunnan
country: China
facility: Yunnan Cancer Hospital
Study officials:
References:
Clinical trial NCT05482529: Integrative Omics Analysis for Colorectal Cancer and Metastasis
Official title: A Prospective Study of Integrative Omics Analysis for Colorectal Cancer and Metastasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Keywords: Integrative omics
colorectal cancer
distant metastasis
prognostic analysis
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with colorectal cancer and metastasis will be enrolled.

Brief summary: The pathogenesis of Colorectal cancer (CRC) metastasis remains unclear.We collect clinical data from our center and use Integrative omics to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis.

Detailed description: Colorectal cancer (CRC), one of the most common malignant cancer around the world, CRC patients with distant metastasis. However, the pathogenesis of metastasis remains unclear. Integrative omics have begun to enable personalized medicine at an extraordinarily detailed molecular level. All patients with colorectal cancer and metastasis in our center who meet the inclusion criteria and exclusion criteria will be enrolled. The specimen collected by surgery and clinical data will be collected . We use Integrative omics such as RNA-sequencing,ATAC-seq(Assay for Transposase-Accessible Chromatin using sequencing), CUT\&Tag（ Cleavage Under Targets and Tagmentation）to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis. This study will contribute to understanding the molecular mechanism of CRC metastasis in depth and contribute to the discovery of new appropriate molecular diagnostic and therapeutic targets, and more accurately prognose long term outcome in patients with CRC.

Eligibility criteria: Inclusion Criteria:

* colorectal adenocarcinoma by biopsy。
* at least 1 metastasis lesion comfirmed by at least 1 kind of imaging examination (CT, MRI and PET-CT )

Exclusion Criteria:

* recent diagnosis with other malignancies
* can not tolerate the surgery
* history of serious mental illness
* pregnancy or lactating women
* the researchers believe the patients should not enrolled in

Primary outcomes:
measure: overall survival rate
timeFrame: 3 years after surgery
measure: disease free survival rate
timeFrame: 3 years after surgery
Secondary outcomes:
measure: Quality of life outcomes evaluation(QLQ-CR38)
timeFrame: 0- 2 years after surgery
measure: Quality of life outcomes evaluation(QLQ-C30)
timeFrame: 0- 2 years after surgery
measure: R0 resection rate
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping hospital
Study officials:
References:
Clinical trial NCT02729129: Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation
Official title: Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Diesel exhaust
Air pollution
Intervention
Plethysmography
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University of Edinburgh
First posted: 2016-04-06
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Air pollution exposure is a major environmental and public health concern. The findings from controlled exposure studies have given biological plausibility to the epidemiological associations, and have defined important pathways that may be amenable to intervention. Ultimately, there is a need to address how one may protect the public from these detrimental effects. Two studies have been performed assessing the cardiovascular effects of wearing a face mask in a highly polluted urban area in China in healthy volunteers and patients with coronary heart disease. These demonstrated lower blood pressure and increased heart rate variability when wearing a face mask as compared to not. The investigators aim to test if wearing a highly efficient face mask during exposure to dilute diesel exhaust abrogates the well-known adverse cardiovascular effects.


Eligibility criteria: Inclusion Criteria:

* Healthy males
* Non-smoking
* All subjects undergo a general health examination and are required to have normal clinical examination, ECG, blood tests and lung function

Exclusion Criteria:

* Metabolic or cardiovascular disease
* Asthma or other respiratory disease
* Respiratory infection within 2 weeks of the study
* Antioxidant- and/or vitamin supplementation within 1 week prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
* Smokers or regular snus usage

Primary outcomes:
measure: Vascular vasomotor function
timeFrame: 2 hours
Secondary outcomes:
measure: Fibrinolytic function
timeFrame: 2 hours
measure: Blood pressure
timeFrame: 24 hours
measure: Heart rate variability
timeFrame: 24 hours
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Umeå University
name: Jenny A Bosson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04558229: RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users
Official title: Randomized Control Trial Evaluating Impact of Standardized Counseling on Early Discontinuation for Irregular Bleeding in Users of the Contraceptive Implant
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Birth Control
Contraception
Contraceptive Usage
Family Planning
Keywords: Contraceptive implant
Birth control
Nexplanon
Lead sponsor: Planned Parenthood of the St. Louis Region and Southwest Missouri
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2020-09-22
Enrollment: 348
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 fashion with block sizes of 8 using a computer-generated random allocation
Primary purpose: SUPPORTIVE_CARE

Brief summary: Clinician counseling for implant users should involve an explanation of the likelihood of irregular bleeding and the possibility of continued or frequent bleeding throughout three years of use. If that counseling does not provide specifics of the actual distribution of bleeding patterns described in published literature, there remains the real possibility of biased or directed counseling, leading to an inaccurate and exaggerated expectation of potential bleeding changes. This study aims to evaluate if a standardized script accompanied by a visual aid regarding expected bleeding profiles, with intention to remove any possibility of negative or positive framing, could change users' expectations and satisfaction with their method, leading to lower discontinuation rates.


Eligibility criteria: Inclusion Criteria:

* Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits
* Ability to consent in English

Exclusion Criteria:

* Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment

Primary outcomes:
measure: Nexplanon Discontinuation Rates
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Planned Parenthood of the St. Louis Region and Southwest Missouri
state: Missouri
Study officials:
affiliation: Planned Parenthood of the St. Louis Region and Southwest Missouri
name: Colleen P McNicholas, DO, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02001129: Improving Follow-Up Adherence in a Primary Eye Care Setting
Official title: Improving Follow-Up Adherence in a Primary Eye Care Setting: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Diseases
Keywords: Eye care adherence
health care utilization
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to examine the effectiveness of three different ways of helping patients attend their recommended eye care appointments.

Detailed description: The three ways are 1) usual care, which involves a standard reminder letter; 2) automated telephone calls, which utilizes a machine to automatically call patients one month prior to their recommended follow-up date; 3)personalized telephone calls, which utilizes a staff member to personally call patients and offer them the opportunity to schedule at the time of the telephone call.

Eligibility criteria: Inclusion Criteria:

* Age: Over 18 years
* Primary Eye Care Patients who were recommended for a 6-month, 12-month, or 24-month follow-up appointment during September 2013 through November 2013.
* Access to a telephone

Exclusion Criteria:

* Does not speak English

Primary outcomes:
measure: Appointment Adherence
timeFrame: 3 months
Secondary outcomes:
measure: Scheduling Appointment
timeFrame: 1 month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Wills Eye
name: Lisa Hark, PhD
role: STUDY_DIRECTOR
References:
citation: Callinan CE, Kenney B, Hark LA, Murchison AP, Dai Y, Leiby BE, Mayro EL, Bilson J, Haller JA. Improving Follow-Up Adherence in a Primary Eye Care Setting. Am J Med Qual. 2017 Jan/Feb;32(1):73-79. doi: 10.1177/1062860615616860. Epub 2016 Jul 10.
Clinical trial NCT01607229: Multi-frequency Bioelectrical Impedance for Estimating Total Body Water by Deuterium Dilution
Official title: Utility of Multi-frequency Bioelectrical Impedance Compared to Deuterium Dilution for Assessment of Total Body Water
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Body Water Assessment
Keywords: multi-frequency
bioelectrical impedance
body composition
hydration
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: SPECIFIC AIM:

Determine the validity of the Biospace bioelectrical impedance devices compared to deuterium water (D2O) measurements.

HYPOTHESIS:

The Biospace Body Composition Analyzers are valid tools for measuring total body water and body composition.


Eligibility criteria: Inclusion Criteria:

* men and women between 18-59 years of age

Exclusion Criteria:

* Acute illness (infection, recent surgery, trauma).
* pregnancy
* pacemaker or defibrillator
* We would like to standardize the procedures and measurements in the adult population first. Older adults are excluded because by including older adults at this time, we would need to increase the sample size because we believe older adults have greater fluctuations in hydration due to medications, diet, and co-morbidities.

Primary outcomes:
measure: Total Body Water differences between criterion and test devices
timeFrame: Baseline only
Secondary outcomes:
measure: Total lean body mass differences between criterion and test devices
timeFrame: Baseline only
measure: Appendicular lean mass differences between criterion and test devices
timeFrame: Baseline only
measure: Trunk lean mass differences between criterion and test devices
timeFrame: Baseline only
measure: Total fat mass differences between criterion and test devices
timeFrame: Baseline only
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References: