louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03440307: Intervention to Reduce Bisphenol A Exposure in Women
Official title: Intervention to Reduce Bisphenol A Exposure in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Exposure
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized to intervention or control.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a 3-week intervention reduces urinary Bisphenol A (BPA) in women with obesity

Detailed description: The purpose of this study is reduce BPA exposure in women. The intervention is rooted in social cognitive theory, and is applied to environmental health.

Eligibility criteria: Inclusion Criteria:

* BMI \>29.9
* Age 18-50 years
* Non-smoking
* English speaking

Exclusion Criteria:

* History of infertility
* Type 2 or Type 1 diabetes
* Cardiovascular disease, or any other metabolic disease/complication
* History of major psychiatric illness, drug abuse, or unsafe dieting practices
* History of bariatric surgery
* Pregnant women or women expecting or trying to become pregnant
* Participating in other studies

Primary outcomes:
measure: Change from Baseline Urine BPA at 3-weeks
timeFrame: Single urine overnight fasted sample at baseline (date of randomization) and 3-weeks
Secondary outcomes:
measure: Change from Baseline Urine BPS and BPF at 3-weeks
timeFrame: Single urine overnight fasted sample at baseline (date of randomization) and 3-weeks
measure: Change from Baseline Weight at 3-weeks
timeFrame: Overnight fasted weight at baseline (date of randomization) and 3-weeks
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
Study officials:
affiliation: Compliance/Information Officer
name: Debbie Hart
role: STUDY_CHAIR
References:
citation: Hagobian T, Delli-Bovi Z, Mercado A, Bird A, Guy M, Phelan S. Development and feasibility of randomized trial to reduce urinary bisphenols in women with obesity. Pilot Feasibility Stud. 2021 Jan 12;7(1):24. doi: 10.1186/s40814-020-00744-5.
Clinical trial NCT05545709: 5G-based Telerobot-assisted Spine Surgery
Official title: Clinical Application of 5G-based Telerobot-assisted Spine Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients accepted robot-assisted spine surgery

Brief summary: This study retrospectively analyzed cases of remote robot-assisted spine surgery performed jointly by the Beijing Jishuitan Hospital Spinal Surgery and partner hospitals, with cases of local orthopedic robot-assisted spine surgeries performed by Beijing Jishuitan Hospital between April 2021 and December 2021.

Detailed description: Local orthopedic robot-assisted spine surgeries were performed according to the guidelines for thoracolumbar pedicle screw placement assisted by orthopedic surgical robots.

Based on the 5G network, the orthopedic robotic remote surgery platform is built at Beijing Jishuitan Hospital, providing primary hospitals with a platform for preoperative consultation, intraoperative communication and surgical robot teleoperation, and postoperative follow-up. With the support of the 5G network, equipment and surgical robots are integrated into the remote surgery service platform, building a high-speed transmission channel between Beijing Jishuitan Hospital and other hospitals.

Eligibility criteria: Inclusion Criteria:

* patients received remote robot-assisted spinal surgery or local orthopedic robot-assisted spinal surgery;
* patients had complete medical records and imaging data;
* patients provided informed consent.

Exclusion Criteria:

* revision surgery;
* more than four surgical segments;
* patients with severe comorbidities.

Primary outcomes:
measure: The accuracy of guide-wire placement or positioning
timeFrame: 1 month
Secondary outcomes:
measure: operation time
timeFrame: 1 day
measure: complication
timeFrame: 1 month
measure: network interruptions
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan hospital
state: Beijing
Study officials:
affiliation: Beijing Jishuitan Hospital
name: Wei Tian
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01043809: Evaluation of a Handwashing Promotion Program in Three Countries
Official title: Evaluation of a School-based Handwashing Promotion Program in Three Countries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Disease
Respiratory Illness
Absenteeism
Keywords: schools
handwashing
prevention and control
communicable diseases
absenteeism
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Procter and Gamble
name: Zhejiang Provincial Center for Disease Control and Prevention
name: Centers for Disease Control and Prevention, China
name: Project HOPE
name: Field Epidemiology Training Program Alumni Foundation, Inc.
First posted: 2010-01-07
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess whether simple, school-based handwashing promotion impacts health and hygiene knowledge among students and their families.


Eligibility criteria: Inclusion Criteria:

* 19 students per first grade class

  * Piped water tap available to every 30 first grade students for handwashing

Exclusion Criteria:

* Compulsory handwashing or distribution of hand wipes before school lunch
* Commercial handwashing promotion at school during previous 5 years

Primary outcomes:
measure: student school absences / 100 student-weeks of observation
timeFrame: one semester
Secondary outcomes:
measure: Student absences due to respiratory illness / 100 student-weeks of observation
timeFrame: one semester
measure: student absences due to infectious syndromes / 100 student-weeks of observation
timeFrame: one semester
measure: longitudinal prevalence of infectious syndromes among students' family members
timeFrame: one semester
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Province CDC
state: Zhejiang
city: Karachi
country: Pakistan
facility: Project HOPE
state: Sindh
city: Manila
country: Philippines
facility: FETPAFI
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Anna Bowen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05523609: Vitamin D and Calcium Supplementation in Breast Cancer
Official title: Effect of Vitamin D and Calcium Supplementation on Letrozole-induced Musculoskeletal Side Effects in Breast Cancer Egyptian Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Forty breast cancer patients were included. They were divided into 2 equal groups: Control group received Letrozole only, and VitD/Ca group received Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks. Baseline serum 25-hydroxy vitamin D concentrations were assayed and standard health assessment questionnaire was completed to assess the disability caused by musculoskeletal symptoms.
Primary purpose: TREATMENT

Brief summary: This study aims at assessing the vitamin Dstatus in breast cancer patients who receive letrozole for more than two months and to evaluate effects of vitamin D3 and calcium supplementation on arthalgia caused by letrozole on these patients.

Detailed description: Background: Vitamin D deficiency (\< 10 ng/mL) and insufficiency (10-30 ng/mL) may contribute to musculoskeletal symptoms observed in patients taking letrozole. This study was undertaken to assess the vitamin D status in breast cancer patients who received letrozole for \> 6 months and to evaluate the effects of vitamin D3 and calcium supplementation on them.

Methods: Forty breast cancer patients were included. They were divided into 2 equal groups: Control group received Letrozole only, and VitD/Ca group received Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks. Baseline serum 25-hydroxy vitamin D concentrations were assayed and standard health assessment questionnaire was completed to assess the disability caused by musculoskeletal symptoms.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed breast cancer patients.
* Postmenopausal hormone receptor positive.
* Patients receiving letrozole for more than two months
* Gender: Female.
* Age: ≥ 50 years old.

Exclusion Criteria:

* Patients with bone metastasis.
* History of renal stones.
* Serum calcium \>11mg/L.
* Patients with renal insufficiency.
* Patients taking steroid hormone replacement therapy.
* Second Malignancy.

Primary outcomes:
measure: Osteocalcin level
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Cancer Center
state: El-Gharbia
Study officials:
affiliation: Head of clinical Pharmacy Department
name: Sahar K Hegazy, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00592709: Analysis of Brain Tumors Using Matrix Assisted Laser Desorption/Ionization Mass Spectrometry
Official title: Analysis of Brain Tumors Using Matrix Assisted Laser Desorption/Ionization Mass Spectrometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Diseases
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age 2 years through Age 85 years old

Brief summary: We are collecting brain tissue specimens and blood samples from patients at Vanderbilt University Medical Center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. These specimens will then be studied using a novel microscopic laser-directed protein mass spectrometric analysis, looking for unique protein signatures.

Detailed description: We are collecting brain tissue specimens and blood samples from patients at Vanderbilt University Medical Center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. These specimens will then be studied using a novel microscopic laser-directed protein mass spectrometric analysis. Data from different brain tissues including tumors of different histological sub-types will be analyzed for unique protein signatures. These protein signatures will then be statistically correlated with clinical data including time to tumor progression and response to therapy.

The goal of this study is to determine molecular patterns that will be more predictive of tumor behavior, thus leading to an improved understanding of the basic biology of these poorly understood cancers. This in turn, may lead to more refined therapies and improved outcomes.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of brain tumor or other non-cancerous tissue and are considered candidates fro a surgical procedure to biopsy or remove the brain tumor or other tissue type at Vanderbilt University Medical Center.
* Age 2 to 85

Exclusion Criteria:

* Patient or guardian that is unable to understand the informed consent process.

Primary outcomes:
measure: Measurement of proteomic signatures in brain tumor samples
timeFrame: immediately upon analysis of the sample
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Department of Neurological Surgery
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center, Department of Neurological Surgery
name: Reid C. Thompson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05080309: Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
Official title: Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delivery Complication
Labor Long
Pregnancy Related
Keywords: labor
intrumental vaginal delivery
oral intake
nulliparous
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled and monitored oral fruit juice intake in order to achieve an oral calory intake \> 44kCal/hour during labor
Primary purpose: OTHER

Brief summary: Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor which is a period of significant physical activity can decrease the instrumental vaginal delivery rate.

Following Siliso study we found a trend toward a decrease in instrumental vaginal delivery and the mount of carbohydrate intake durong labour. However due to some limitations no clear conclusion could be drawn.

The present study is designed to examine the relationship between a high calory oral intake (\>44 kCal/hour during labour) and the rate of instrumental delivery.


Eligibility criteria: Inclusion Criteria:

* nulliparous women
* singleton pregnancy
* social insurance
* uncomplicated pregnancy
* no contraindication to vaginal delivery

Exclusion Criteria:

* scheduled caesarean section
* labor \< 37 weeks of gestational age
* cervical dilation \> 8cm at inclusion
* scheduled induced delivery
* contraindication to pushing effort during labor and delivery
* BMI \> 40 kg/m2
* medical history of daibetes mellitus, hypertension, heart disease

Primary outcomes:
measure: instrumental vaginal delivery
timeFrame: 2 days
Secondary outcomes:
measure: oxytocin administration
timeFrame: 2 days
measure: caesarean section
timeFrame: 2 days
measure: nausea and vomiting
timeFrame: 2 days
measure: thirst sensation on verbal rating scale
timeFrame: 2 days
measure: hunger sensation on verbal rating scale
timeFrame: 2 days
measure: fatigue
timeFrame: 2 days
measure: umbilical blood pH
timeFrame: 1 min
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Caen
name: jean-luc hanouz, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01257009: Atorvastatin and Sympathetic Activity in Chronic Kidney Disease
Official title: Atorvastatin Reduces Sympathetic Activity in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stable Chronic Kidney Disease
Hypertension
Keywords: sympathetic activity
chronic kidney disease
atorvastatin
lipitor
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hypertensive chronic kidney disease (CKD) patients often have sympathetic hyperactivity which appears to contribute to the pathogenesis of hypertension and cardiovascular organ damage. Experimental studies and some clinical studies have shown that statin therapy can reduce central sympathetic activity. Blockade of the renin-angiotensin system (RAS), which is standard treatment for CKD, is known to lower sympathetic activity.

The investigators hypothesize that adding a statin for 6 weeks to RAS blockade would further lower sympathetic activity in hypertensive stage 2-4 CKD patients.

Methods: In ten stable CKD patients who are on chronic treatment with renin-angiotenis blockers, blood pressure and sympathetic activity (quantified by assessment of muscle sympathetic nerve activity, MSNA) will be assessed at baseline and 6 weeks after atorvastatin 20mg/day added.

Ten other CKD patients will serve as time control and will be studied twice with an interval of 6 weeks without any change in medication, to quantify within subject reproducibility.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* stable chronic kidney disease
* Hypertension

Exclusion Criteria:

* renal replacement therapy
* pregnancy
* diabetes mellitus

Primary outcomes:
measure: Sympathetic activity
timeFrame: 4-6 weeks treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center utrecht
Study officials:
References:
Clinical trial NCT04863209: Effect of Osteopathic Techiniques on Intraocular Pressure
Official title: Effect of Osteopathic Techiniques on Intraocular Pressure: a Randomized Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Osteopathic Manipulative Treatment
Keywords: intraocular pressure
sphenopalatine ganglion
superior cervical ganglion
aqueous humour
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects osteopathic techniques at the upper cervical vertebrae or at the sphenopalatine ganglia on the intraocular pressure.

Detailed description: The 7 volunteers will be randomized into 3 groups and there will be an experimental group 1 that will receive a technique of manipulation of the upper cervical, an experimental group 2 that will receive a technique of manipulation of the sphenopalatine ganglion and a control group that will not receive any intervention. Each volunteer will participate in the 3 groups. There will be 4 assessments, one before the procedure and one just after each procedure, including the control.

Eligibility criteria: Inclusion Criteria:

* Intraocular pressure below 21mmHg

Exclusion Criteria:

* Positive Klein test
* Use of medications that affect the circulatory system in up to one month before the procedures;
* Caffeine use 24 hours before procedures;
* Presence of ophthalmic diseases;
* History of hypertension or diabetes;
* Blindness;
* Tumor in the head;
* Skull or cervical fractures that occurred less than 6 months ago.

Primary outcomes:
measure: Change of the intraocular pressure after upper cervical manipulation
timeFrame: Immediately after the intervention and 30 minutes after the intervention
measure: Change of the intraocular pressure after sphenopalatine ganglion manipulation
timeFrame: Immediately after the intervention and 30 minutes after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Jundiaí
country: Brazil
facility: Escola Superior de Educação Física
state: São Paulo
Study officials:
References:
Clinical trial NCT01813409: Rheumatology Clinical Registry
Official title: American College of Rheumatology Clinical Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: American College of Rheumatology
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 820
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatology patients

Brief summary: The ACR Rheumatology Clinical Registry (RCR) is a tool developed to assist members in practice improvement, local population management, and efficient, successful participation in national quality programs. RCR integrates evidence-based quality measures aimed at improving care and drug safety for patients with rheumatoid arthritis, osteoarthritis, osteoporosis, gout and juvenile idiopathic arthritis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Rheumatoid Arthritis

Exclusion Criteria:

* None

Primary outcomes:
measure: Quality of the treatment of rheumatoid arthritis and other diseases
timeFrame: Up to a year
Secondary outcomes:
measure: Submission to federal reporting programs
timeFrame: Up to a year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Registry Site
state: Georgia
Study officials:
References:
Clinical trial NCT05131009: Postoperative Pulmonary Complications Between Patients Undergoing Abdominal Surgery in Plateau and Plain Areas
Official title: Differences in Incidence and Risk Factors of Postoperative Pulmonary Complications Between Patients Undergoing Abdominal Surgery in Plateau and Plain Areas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pulmonary Complications;Abdominal Surgery
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Qinghai People's Hospital
First posted: 2021-11-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older who planned elective abdominal surgery under general anesthesia

Brief summary: This study aims to collect perioperative diagnosis and treatment information of patients undergoing abdominal surgery at plateau and plain areas , collect blood and others samples for laboratory testing when necessary, analyzing the data to clarify the incidence and risk factors of pulmonary complications in patients undergoing abdominal surgery at different altitudes, so as to reduce the risk of pulmonary complications and even death in clinical practice.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years old；
2. scheduled for elective abdominal surgery under general anesthesia；
3. ASAⅠ-Ⅲ

Exclusion Criteria:

1. Patients and their family members refused to be enrolled；
2. patients were unable to communicate because of language disorders such as dementia and hearing impairment；
3. patients were admitted to ICU 48 hours before operation；
4. preoperative diagnosis of ARDS, aspiration pneumonia, pulmonary embolism or pulmonary edema or other acute respiratory diseases；
5. mechanical ventilation within one week before operation；
6. death or discharge within 24 hours after operation；
7. second operation due to postoperative complications

Primary outcomes:
measure: incidence and risk factors of pulmonary complications
timeFrame: 1 week after surgery
Secondary outcomes:
measure: ventilation duration,length of stay in ICU and Hospital Stay and death
timeFrame: within the 30 days after surgery
measure: incidence of Major Extrapulmonary Complications
timeFrame: within the 30 days after surgery
measure: Biomarkers
timeFrame: 1 week after surgery
measure: incidence and risk factors of various specific pulmonary complications
timeFrame: 1 week after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: