louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04683523: Anaerobic Exercises on Cardiac Workload, Peripheral Resistance and Lipid Index Among Grade 1 Hypertensive Young Adults
Official title: Anaerobic Exercise Impact on Cardiac Workload, Peripheral Resistance and Lipid Index Among Grade 1 HTN Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Impact of resistance exercises on grade I hypertensive patients were monitored on three outcome measures that were blood pressure, peripheral resistance and lipid index after 12 weeks of intervention


Eligibility criteria: Inclusion Criteria:

* grade I HTN Age 20-40years Both male and female

Exclusion Criteria:

* unable to perform exercises Comorbidities like Diabetes

Primary outcomes:
measure: Systolic blood pressure
timeFrame: From baseline to 12 weeks of training
measure: Peripheral Resistance
timeFrame: From baseline to 12 weeks of training
measure: Lipid index
timeFrame: From baseline to 12 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ali Farhad
state: Sindh
Study officials:
References:
Clinical trial NCT05541523: Improve Mental Health and Emotional Labor Among Nurses Who Care the End-of-life Patients
Official title: Does Cognitive Behavioural Therapy or Mindfulness-based Therapy Improve Mental Health and Emotional Labor Among Nurses Who Care the End-of-life Patients? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End-of-life
Depression, Anxiety
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CBT: cognitive behavioural therapy MBT: mindfulness-based therapy

Detailed description: Nurses caring for terminally ill patients suffer from negative emotions and emotional labor, which may lead to a decline in the quality of end-of-life care. CBT and MBT are currently two commonly used psychological methods. They can be effective in improving bad mood. However, to the best of our knowledge, no investigators have used CBT and MBT among nurses caring for terminally ill patients. Could CBT and MBT be effective in alleviating the psychological distress of these nurses? Which psychological method is more effective?

Eligibility criteria: Inclusion Criteria:

* (1) Eligible participants were the nurses who nursing patients with stage IV cancer or other incurable diseases;
* (2) agree to participate in this research;
* (3) no history of mental illness.

Exclusion Criteria:

* None

Primary outcomes:
measure: Anxiety
timeFrame: up to 8 weeks
measure: Emotional labor
timeFrame: up to 8 weeks
measure: Self-Efficacy
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Wu Ye
state: Jiangsu
Study officials:
References:
Clinical trial NCT00409123: Effect of Systemic Cooling in Vasospasms
Official title: Effect of Systemic Cooling in Vasospasms (Kühleffekte Beim Vasospastischen Syndrom)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vasospastic Syndrome
Keywords: vasospastic women
controls
core cooling
core warming
external cooling
external warming
LDF
choroidal blood flow
temperature
vasospastic subjects
normal subjects
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2006-12-08
Enrollment: 28
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: vasospastic women

Brief summary: This study tests whether women with Vasospastic Syndrome (VS) react more intensive than controls with distal vasomotions and choroidal blood flow changes to internal cooling/warming and external cooling/warming.

Detailed description: Distal vasomotions and choroidal blood flow changes to internal cooling/warming and external cooling/warming was studied in VS and controls.Core cooling was induced by drinking of 250g ice/water mixture (4°C). Core warming was induced by drinking of 250g warm water (55°C). The study was controlled with respect to posture and room temperature.

Eligibility criteria: Inclusion Criteria:

* women
* luteal phase or contraceptives
* 19-35 years

Exclusion Criteria:

* somatic diseases
* psychiatric diseases
* BMI \> 25
* BMI \< 18

Primary outcomes:
measure: LDF blood flow
timeFrame: repeated after each challenge
measure: LDF velocity
timeFrame: repeated after each challenge
measure: finger skin temperature
timeFrame: repeated after each challenge
measure: core body temperature
timeFrame: repeated after each challenge
measure: corneal temperature
timeFrame: repeated after each challenge
Secondary outcomes:
measure: subjective sleepiness
timeFrame: repeated after each challenge
measure: subjective ratings of thermal comfort
timeFrame: repeated after each challenge
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Eye Clinic
Study officials:
affiliation: Unversity Eye Clinic Basel
name: Selim Orguel, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00582023: Role of Positive Affect in Adjustment to HIV
Official title: CHAI Study: Coping, HIV, and Affect Interview Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
coping
emotion
affect
HIV infection
Complimentary therapies
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-12-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults newly diagnosed with HIV in the San Franicsco Bay Area.

Brief summary: The purpose of this study is to examine the role of emotion and mood in the context of HIV.

Detailed description: A growing body of literature indicates that positive affect may have a unique adaptive role in the process of adjustment to chronic stress, independent of the effects of negative affects like depression. The overarching goal of this research is to provide evidence and direction for the development of interventions for people with HIV that include a focus on positive affect. To this end, this study will document the occurrence, predictors, and consequences of positive affect during the 18 months post-notification of HIV+ serostatus.

Eligibility criteria: Inclusion Criteria:

* Have been informed they were HIV positive within the past two months
* Speak English
* Be 18 years or older
* Have the ability to provide informed consent to be a research participant

Exclusion Criteria:

* Severe cognitive impairment
* Active psychosis

Primary outcomes:
measure: Well being
timeFrame: 18 month follow-up
measure: Physical & Mental Health
timeFrame: 18 months
measure: Coping Response
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine, UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Judith Moskowitz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04196023: Ca:Mg Ratio and Cognitive Function
Official title: Ca:Mg Ratio and Cognitive Function in the Personalized Prevention of Colorectal Cancer Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-12-12
Enrollment: 129
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Between 2000 and 2015, mortality due to Alzheimer's disease (AD) increased by 123%. No drugs have yet been approved to stop or slow the progression of AD. A delay of five years in the expression of AD would reduce the incidence rate by half. Thus, it is critical to develop novel prevention strategies to delay the onset of this common disease.

As an ancillary study conducted within a precision-based randomized trial (R01CA149633; PI, Dai \& Yu\]"), the investigators reduced Ca:Mg ratios to 2.3 through 3-month personalized Mg supplementation among those who consumed high Ca:Mg ratio diet, but otherwise in good general health. The investigators test the hypothesis that actively reducing the Ca:Mg ratio among those aged \>65 years who consume high Ca:Mg ratio diets improves cognitive function compared to the placebo arm. The investigators further conduct molecular epidemiologic studies to understand the molecular mechanisms.


Eligibility criteria: Inclusion Criteria:

1. Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106);
2. Participants who completed the MoCA

Exclusion Criteria:

1. Participants did not provide their blood samples in the parent study.

Primary outcomes:
measure: Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo
timeFrame: 12 weeks
measure: Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged ≤65 Years Old)
timeFrame: 12 weeks
measure: Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged >65 Years Old)
timeFrame: 12 weeks
measure: Changes From Baseline of 5-mC Methylation (CpG Sites) in Apolipoprotein E (APOE) by Magnesium Treatment vs. Placebo
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zhu X, Borenstein AR, Zheng Y, Zhang W, Seidner DL, Ness R, Murff HJ, Li B, Shrubsole MJ, Yu C, Hou L, Dai Q. Ca:Mg Ratio, APOE Cytosine Modifications, and Cognitive Function: Results from a Randomized Trial. J Alzheimers Dis. 2020;75(1):85-98. doi: 10.3233/JAD-191223.
Clinical trial NCT00795223: Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA
Official title: Comparative Effect of 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for Femoral Nerve Block After Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Total Knee Replacement
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital
First posted: 2008-11-21
Enrollment: 160
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparative efficacy of 24 and 48 hours post operative pain control in single total knee replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or 0.5 % bupivacaine for single femoral nerve block


Eligibility criteria: Inclusion Criteria:

* Single elective total knee replacement in ASA 1-3 without significant cardiovascular limitation

Exclusion Criteria:

* patient at risk in usage COX-2 for post operative pain control

Primary outcomes:
measure: Global assessment in post operative pain control
timeFrame: Begining of first enrollment in december 2008
Secondary outcomes:
measure: Global assessment of post operative pain in 48 HOURS AND SIDE EFFECTS
timeFrame: first enrollment in December 2008
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
state: Bangkoknoi
Study officials:
affiliation: Siriraj Hospital
name: Thitima Chinachoti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05165823: The Significance of Sodium Balance and the Value of Salt-blood Test in Identifying Salt Sensitive Patients
Official title: The Significance of Sodium Balance for Blood Pressure in Patients With Essential Hypertension and the Value of Salt-blood Test in Identifying Salt Sensitive Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension,Essential
Keywords: Salt sensitivity
Sodium sensitivity
Salt restriction
Salt-blood test
Dietary intervention
Hypertension
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 72
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 is a randomized controlled trial with 72 patients with hypertension examining the effects on blood pressure of sodium restriction and whether the blood analysis Salt-blood test is associated to a decrease in blood pressure. Patients will be randomized 2:1 to either sodium restriction or usual diet for 4 weeks. Baseline measures will be done before intervention and outcome measures after the 4 weeks.


Eligibility criteria: Inclusion Criteria:

* BMI ≤ 35 kg/m2
* Essential hypertension
* eGFR \> 15 ml/min/1,73m2
* Albumine-to-creatinine-ratio \< 500 mg/g
* Safe anticonception if women in childbearing age.
* Able to adhere to dietary regimen

Exclusion Criteria:

* Secondary hypertension
* Clinically significant heart failure (NYHA 3-4)
* Clinically significant liver disease
* Diabetes mellitus (type 1 and 2)
* Active cancer (except skin cancer)
* Renal transplant
* Recent stroke, transcient ischemic attack or myocardial infarction (within 6 months)
* Proliferative glomerulonephritis or ANCA-related disease
* Continuous immunosuppressant treatment
* Pregnancy or lactation
* Alcohol abuse
* If the investigator finds the participant unfit to complete the project

Primary outcomes:
measure: Change in systolic 24-hour blood pressure
timeFrame: Measured before and after 4 weeks' intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: University Clinic in Nephrology and Hypertension
Study officials:
affiliation: University Clinic in Nephrology and Hypertension
name: Camilla Lundgreen Duus
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00712023: Effect of Forced-air Warming and Circulating-water Mattress in Preventing Heat Loss During Vascular Surgery
Official title: Effect of Forced-air Warming and Circulating-water Mattress in Preventing Heat Loss During Vascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypothermia
Vascular Surgery
Forced-air Warming Mattress
Circulating-water Mattress
Keywords: Hypothermia
Vascular surgery
Forced-air warming mattress
Circulating-water mattress
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a custom-made forced-air warming mattress can prevent heat loss in patients undergoing vascular surgery better than a circulating-water mattress

Detailed description: A reusable, custom-made forced-air warming mattress was made of a light to medium weight water resistant canvas, sewn like mattress with 2 arms placed underneath the patient. An open hole at proximal part of one arm was designed to attach with a hose of warm air delivery device. Small holes (2-3 mm2), 5 inches apart were punched on the upper surface of this mattress around the patient except for the area underneath the patient that the holes were 9 inches apart. The weight of the patient will obstruct the air flow and prevent direct blowing of warm air onto the underside of patients. There is a special appendage connected to the upper part of mattress which can connect warm air to cover the patient's chest. There is a special appendage connected to the upper part of mattress which can convect warm air to cover the patient's chest. The mattress is 97 inches x 97 inches, with 2 arms of 25 inches x 16 inches and a special appendage of 45 inches x 12 inches for covering the chest with warm air delivery. This size is proper for patient of 170 cm. height. In order to reuse it, the mattress can be washed, dried and sterilized by gas or autoclaved for more than 50 times. A sterile sheet well enhance the sterile environment of the operating field.

Eligibility criteria: Inclusion Criteria:

Patients undergoing vascular surgery

Exclusion Criteria:

Preoperative fever

Primary outcomes:
measure: skin and nasopharyngeal temperature
timeFrame: 180 min
Secondary outcomes:
measure: burn wound
timeFrame: 3 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Departnment of Anesthesiology,Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Suwannee Suraseraniwongse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01486823: Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects
Official title: An Open-label, Single-dose Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: BioInvent International AB
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2011-12-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a study in healthy volunteers designed to investigate the PK following intravenous and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of MLDL1278A after subcutaneous administration will be determined.


Eligibility criteria: Inclusion Criteria:

* Adult males/females aged 18 to 55 years inclusive at screening;
* Subjects who are between 18.0 and 30.0 kg/m2 body mass index (BMI) inclusive and weigh between 55.0 and 100.0 kg inclusive;

Exclusion Criteria:

* Any clinically relevant disease or disorder (past or present), which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study;
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, coagulation, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study;

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of MLDL1278A.
timeFrame: Up to 70 days post administration.
Secondary outcomes:
measure: Peak plasma concentration (Cmax) of MLDL1278A.
timeFrame: Up to 70 days post administration.
measure: Plasma clearance (CL) of MLDL1278A.
timeFrame: Up to 70 days post administration.
measure: Number of participants with an anti therapeutic antibody (ATA) response.
timeFrame: Up to 140 days post administration.
measure: Number of participants with adverse events.
timeFrame: Up to 140 days post administration.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Quintiles Drug Research Unit at Guy's Hospital
Study officials:
affiliation: Quintiles, Inc.
name: Darren Wilbraham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04757623: COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"
Official title: COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Site Infection
Difference in Surgical Site Infection According to Gender and Age Groups
Lead sponsor: Combined Military Hospital, Pakistan
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised control trial of two arms
Primary purpose: PREVENTION

Brief summary: The study will be carried out in Surgical Unit-III, Lahore General Hospital, Lahore for one year . . Patients undergoing surgery for Ileostomy will be randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay.

Detailed description: The study will be carried out in Surgical Unit-III, Lahore General Hospital. It will be a randomized control trial. Patients undergoing surgery for Ileostomy were randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow-up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay. The data will be statistically analyzed by using SPSS v23.0.t test (independent sample) used for the comparison of hospital stay mean. Chi-square will also used for the comparison of the frequencies of SSI. Data were stratified for gender and age. A p-value ≤0.05 will be considered as significant.

Eligibility criteria: Inclusion Criteria:

* included in the study 1. Patients of both gender 2. Patients ages between 25-70 3. Patients undergoing surgery for having ileostomy for benign disease of intestine (as per operational definitions).

Exclusion Criteria:

* Following patients were excluded 1. Patients with pre-existing stomal site wound infection 2. Reversal of stoma through laparatomy 3. Post-operative anastomotic leak 4. Ureamic patients 5. Patients on chemotherapy and radiations

Primary outcomes:
measure: Surgical Site infection
timeFrame: 14th post operative day
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Anum Arif
state: Select A State Or Province
city: Karachi
country: Pakistan
facility: Ammad Asim
Study officials:
References: