louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05373459: Effect of a Third COVID-19 Booster Among Health Care Workers
Official title: Effect of a Third COVID-19 Booster on COVID-19 Infection Rate and Return to Works During Fifth Wave COVID-19 Among Health Care Workers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Vaccines
Lead sponsor: Hong Kong Sanatorium & Hospital
Sponsor class: INDUSTRY
First posted: 2022-05-13
Enrollment: 3167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All full time staff members of the private hospital

Brief summary: A new wave of COVID-19 infections, mainly caused by the Omicron/ Delta variant, has been sweeping the globe since the start of 2022. In response, the administration of a third dose of COVID-19 vaccine was considered to address potential waning immunity over time and reduced effectiveness against the Omicron/ Delta variant. The pandemic also resulted in many infections among health care workers (HCWs) and their households. In this study, a retrospective analysis would perform on risk of COVID-19 infection and their outcome in relation to their COVID-19 vaccination history by using the data repository from one of the Hong Kong private hospitals.

HCWs were required to submit a standardized online self-declaration form for report of 1) demographic of the HCWs, 2) symptoms related history and 3) COVID-19 exposure history once they were COVID-19 confirmed by rapid antigen test against COVID-19 and/or polymerase chain reaction (PCR) test for COVID-19. Subsequent follow up such as contact tracing, COVID-19 PCR testing results of these HCWs and status of return to work were captured by the infection control team in a systematic manner.


Eligibility criteria: Inclusion Criteria:

* All full time staff members of the private hospital

Exclusion Criteria:

* History of COVID-19 before 2022

Primary outcomes:
measure: COVID-19 Infection
timeFrame: During 1 February - 31 March 2022
measure: Number of days return to work after COVID-19 infection
timeFrame: During 1 February - 31 March 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Sanatorium & Hospital
Study officials:
affiliation: Hong Kong Sanatorium & Hospital
name: Jonpaul Sze Tsing Zee, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543959: Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)
Official title: An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels
* Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened

Exclusion Criteria:

* Patients taking any medicines that affect body fluid level such as a diuretic or water pill
* Patients taking niacin or other certain medications
* Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders
* Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study

Primary outcomes:
measure: Body fluid gain from baseline after 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting plasma glucose after 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00564759: Gene Therapy for Chronic Granulomatous Disease
Official title: Phase I/II Gene Therapy Study for X-Linked Chronic Granulomatous Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Granulomatous Disease, Chronic
Keywords: CGD
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2007-11-28
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The aim of the study is to evaluate the side effects and risks after infusion of retroviral gene corrected autologous CD34+ cells of the peripheral blood of chemotherapy conditioned (busulphan)patients with chronic granulomatous disease (CGD). Also gene corrected and functional active granulocytes in the peripheral blood and the engraftment in the bone marrow of the patients will be monitored an documented.


Eligibility criteria: Inclusion Criteria:

* x-linked Chronic Granulomatous Disease
* history of life-threatening severe infections
* no HLA-matched related or non-related donor
* therapy resistent life threatening infections/organ dysfunction
* no other treatment options e.g. BMT

Exclusion Criteria:

* \< 18 years of age
* HIV infection
* life expectancy \> 2 years
* infections treatable by conventional therapy (antibiotics, allogeneic granulocytes)

Primary outcomes:
measure: safety, toxicity and feasibility
timeFrame: 2 years
Secondary outcomes:
measure: Engraftment of gene corrected stem cells, functional reconstitution of respiratory burst, clinical benefit
timeFrame: 2 years
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital, Hematology
Study officials:
affiliation: Goethe University
name: Dieter Hoelzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ott MG, Schmidt M, Schwarzwaelder K, Stein S, Siler U, Koehl U, Glimm H, Kuhlcke K, Schilz A, Kunkel H, Naundorf S, Brinkmann A, Deichmann A, Fischer M, Ball C, Pilz I, Dunbar C, Du Y, Jenkins NA, Copeland NG, Luthi U, Hassan M, Thrasher AJ, Hoelzer D, von Kalle C, Seger R, Grez M. Correction of X-linked chronic granulomatous disease by gene therapy, augmented by insertional activation of MDS1-EVI1, PRDM16 or SETBP1. Nat Med. 2006 Apr;12(4):401-9. doi: 10.1038/nm1393. Epub 2006 Apr 2.
Clinical trial NCT00624559: The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure
Official title: COX-2 Regulation of Renal Sodium Handling in Blood Pressure Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Salt sensitivity of Blood Pressure
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: Christiana Care Health Services
First posted: 2008-02-27
Enrollment: 12
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if the drug Celebrex changes the way the kidney gets rid of salt and maintains blood pressure.

Detailed description: There have been many studies done with analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs; however it is not understood how blood pressure changes while using Celebrex. The study hypothesis is that Celebrex will increase salt sensitivity of blood pressure.

Eligibility criteria: Inclusion Criteria:

* healthy men and women

Exclusion Criteria:

* history of heart disease
* have had heart surgery
* high blood pressure
* diabetes
* cancer
* any other disease such as kidney or neurological diseases
* taking medications such as aspirin or medicines for your heart or blood pressure
* have asthma or are allergic to sulfa drugs
* body mass index greater than 30
* use tobacco
* pregnant
* women using oral contraceptives or hormone replacement therapy

Primary outcomes:
measure: Mean Arterial Pressure
timeFrame: 24 hours
Secondary outcomes:
measure: Urinary Sodium Excretion
timeFrame: 24 hour
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: William B Farquhar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Care Health Services
name: Michael Stillabower, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04382859: TOTEM: Trial of TAP Block Effective Medications
Official title: TOTEM: Trial of TAP Block Effective Medications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Western Michigan University School of Medicine
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our goal is to determine if liposomal bupivacaine compared to standard bupivacaine results in increased pain control and decreased narcotic pain medication use when used in TAP blocks prior to laparoscopic hysterectomies for benign indications.


Eligibility criteria: Inclusion Criteria:

* Women undergoing non robotic assisted laparoscopic surgery for benign gynecologic conditions
* English speaking

Exclusion Criteria:

* Known current malignancy
* Contraindication to medications

Primary outcomes:
measure: Pain rating 1 hour post operation
timeFrame: 1 hour post operation
measure: Pain rating 2 hours post operation
timeFrame: 2 hours post operation
measure: Pain rating 4 hours post operation
timeFrame: 4 hours post operation
measure: Pain rating 72 hours post operation
timeFrame: 72 hours post operation
Secondary outcomes:
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
Study officials:
affiliation: Western Michigan University Homer Stryker M.D. School of Medicine
name: Melinda Abernethy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04850859: Study on Human Glenoid Cavity and Acetabulum
Official title: Morphological and Morphometric Study on Human Glenoid Cavity and Acetabulum With Correlation to Their Functions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glenoid Cavity
Acetabulum
Keywords: glenoid cavity
acetabulum
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: scapulae bones and hip bones will be collected at anatomy department of Sohag faculty of medicine

Brief summary: 1 - study morphological and morphometric features of the glenoid cavity in human scapulae bone and its function.

2- study morphological and morphometric features of the acetabulum in human hip bone and its function.

Detailed description: study morphological features of the glenoid cavity and to measure various dimensions of the glenoid in dry human scapulae bone and correlation to its function.

The knowledge of normal anatomical features and variations of the shape and size of glenoid cavity are prerequisites for complete understanding of the mechanics of shoulder joint, this information has clinical application in shoulder arthroplasty, gleno-humeral instability and rotator cuff tear management.

study morphological features of the acetabulum and to measure various dimensions of the acetabulum in dry human hip bone and correlation to its function.

Knowledge of the dimensions of acetabulum are vital to understand the mechanics of hip joint, and will assist the prosthetists to construct the suitable prostheses

Eligibility criteria: Inclusion Criteria:

* The scapulae with clear and intact glenoid cavity will be used for the study. The hip bones with clear and intact acetabulum will be used for the study

Exclusion Criteria:

* Bones with gross damage or anomalies will be excluded from the study.

Primary outcomes:
measure: study morphological features of the glenoid cavity and measure various dimensions of the glenoid in dry human scapulae bone.
timeFrame: 2months following the start point of the study
measure: study morphological features of the acetabulum and measure various dimensions of the acetabulum in dry human hip bone.
timeFrame: 2months following the start point of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
affiliation: Sohag University
name: Mary Milad Alkesan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05482659: The Effect of Online Transtheoretic Model Based Health Education on Overweight University Students
Official title: The Effect of Online Transtheoretic Model Based Health Education on Overweight University Students on Nutrition and Physical Activity Change Processes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Public Health Nursing
Keywords: transtheoretical model
Public Health Nursing
University Student
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Aim: In this study, it was aimed to determine the effect of health education given to overweight university students based on the Transtheoretic Model (TTM) on nutrition and physical activity behaviors.

Materials and Methods: The research was conducted in a randomized controlled experimental design. The sample of the study consisted of 54 students, 27 of which were in the experimental group and 27 in the control group, who met the inclusion criteria between October 2021 and November 2021. Students were divided into nutrition and exercise change stages groups according to TTM. The students in the experimental group were given one-on-one health education in accordance with the TTM change stages, using the online method. In the study, data were collected using the Sociodemographic Form, Nutrition and Exercise Stage Determination Form according to TTM, Nutrition Change Processes Scale (NCPS) and Exercise Change Processes Scale (ECPS). Chi-square test and t test for dependent and independent groups were used in the analysis of the data obtained. Statistical significance level was accepted as p\<0.05.


Eligibility criteria: Inclusion Criteria:

* Agreeing to participate in the research,
* University students without chronic diseases
* BMI level between 24.9 and 30,
* Open to communication and cooperation,
* Internet and smartphone/tablet/computer etc. owner.

Exclusion Criteria:

* BMI level of 24.9 and below,
* Using any drug,
* Who left the research voluntarily.
* Under the age of 18

Primary outcomes:
measure: Stages of change according to the transtheoretic model - pre-intervention and post-intervention
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Nuh Naci Yazgan University
state: Küme Evler Mahallesi
Study officials:
affiliation: cyasar@nny.edu.tr
name: Cansu Yaşar, 1
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05847959: The Relationship Between XinKang-I and Chronic Heart Failure
Official title: The Relationship Between XinKang-I and Chronic Heart Failure: Protocol for a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Traditional Chinese Medicine
Lead sponsor: Dongguan Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Heart failure is the severe and terminal stage of various heart diseases, which is characterized by high morbidity, mortality and readmission. There are few studies on the relationship between XinKang-I(XK-I) and chronic heart failure.

Objective: To explore the relationship between XK-I and chronic heart failure. Methods/design: The trial is a single-center, single-blind, randomized study (1:1). It will recruit 110 patients with chronic heart failure who syndrome of qi deficiency yang deficiency and blood stasis. The intervention group will receive not only Western medicine, but also XK-I. The primary end points will be the changes in oxygen consumption volume of anaerobic threshold (VO2AT), maximum oxygen volume uptake (VO2max), and 6-minute walking distance after 8 weeks of treatment. Both groups will receive 8 weeks of treatment.

Ethics and dissemination: Ethical approval was granted by Ethics Committee of Dongguan TCM Hospital. Results will be disseminated via peer-reviewed publications and presentations at international conferences.


Eligibility criteria: Inclusion Criteria:

1. History of CHF or clinical findings of CHF for more than 3 months. CHF was diagnosed in accordance with the European Society of Cardiology's 2021 Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure.
2. Patients ranged in age from 18 to 85.
3. Cardiac function was graded at grade II-IV (New York Heart Association functional class).
4. Patients who had not used traditional Chinese medicine for treating heart failure within 1 week before enrollment;
5. Written informed consent will be obtained.

Exclusion Criteria:

1. acute cardiac insufficiency, acute myocarditis, severe valvular heart disease, malignant arrhythmia, obstructive cardiomyopathy, pericardial tamponade, constrictive pericarditis or acute coronary syndrome
2. severe lung, liver or kidney dysfunction
3. nervous and hematopoietic system
4. malignant tumors
5. hemodynamic nstability
6. pulmonary embolism
7. severe infection
8. pregnant or lactating
9. refusal to provide written informed consent for this study

Primary outcomes:
measure: The changes in 6-minute walking distance(distance, meter).
timeFrame: 8 weeks
measure: oxygen consumption volume of anaerobic threshold (VO2AT, ml)
timeFrame: 8 weeks
measure: maximum oxygen volume uptake (VO2max, ml/min) in cardiopulmonary function test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05756959: Myopia Control Combined PBM With Myopic Defocus Lens in Children
Official title: Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Lead sponsor: Beijing Airdoc Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The First People's Hospital of Xuzhou
First posted: 2023-03-07
Enrollment: 304
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.

Detailed description: myopic children with age from 6 \~13 years old. And refraction from -0.50D\~-5.50D.

The red light is low lever laser therapy at wavelength of 650nm.

Eligibility criteria: Inclusion Criteria:

* Informed consent by the supervision of the children
* 6\~13 years old (including both the 6 and 13)
* SE range: -0.50\~-5.50D
* Astigmatism \<=2.00D
* BCVA \>=0.8
* Anisometropia \<=1.50D
* Confirmed to no use of other myopia control intervention

Exclusion Criteria:

* Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.)
* Halo, glare, toutic, ADHD, psoriasis
* Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction.
* Squint, ocular lesion or acute imflammation.
* Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.

Primary outcomes:
measure: axial length (mm)
timeFrame: 6 month
measure: SE (Diopter, D)
timeFrame: 6 month
Secondary outcomes:
measure: UCVA (logMar visual acuity record)
timeFrame: 6 month
measure: BCVA (logMar visual acuity record)
timeFrame: 6 month
measure: OCT
timeFrame: 6-month
measure: SFCT （um)
timeFrame: 6-month
Other outcomes:
measure: Adverse Event
timeFrame: 6 month
Locations:
city: Xuzhou
country: China
facility: the first people's hospital of Xuzhou
state: Jiangsu
Study officials:
affiliation: The First People's Hospital of Xuzhou
name: Yan Wang, BA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00728559: Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy
Official title: Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: laparoscopy
preemptive
postoperative
pain
trocar
site
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Israel
First posted: 2008-08-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the literature there is conflicting data on administration of local analgesia in addition to the general anesthesia to the trocar sites during laparoscopy, We believe that adding local analgesia to the general anesthesia during laparoscopy is beneficial . the current study will evaluate prospectivly the impact of local analgesia on postoperative pain and recovery in patients undergoing operative laparoscopy

Detailed description: Methods: this is a blinded prospective randomized study. After approval of IRB and informed consent 120 patients undergoing for laparoscopy will be randomized after the induction of general anesthesia into three groups: Group A will receive preemptive analgesia using 3-5 cc of 0,5 % marcaine at the beginning of the procedure. Group 2 will receive a local analgesia using 3-5 cc marcaine at the end of the procedure. Group 3 will be operated under general anesthesia only. The post operative pain and patient recovery will be assessed by the nurses during the hospitalization using a VAS (Visual Analog Scale) the total analgetic drugs will be noted and after the patients discharge the patient status and satisfaction will be evaluated by phone up to 2 wks

Eligibility criteria: Inclusion Criteria:

* Female older then 18 y/o

Exclusion Criteria:

* Allergy to marcaine

Primary outcomes:
measure: postoperative pain measured by VAS
timeFrame: 2 years
Secondary outcomes:
measure: total analgesics required, patient recovery, patient satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: Poria Gov Hospital
state: Lower Galilee
Study officials:
affiliation: Ministry of Health, Israel
name: Ilan Atlas, MD
role: STUDY_CHAIR
References: