louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05288257: Mixed Method Study Protocol_Cognitive Non-technical Skills Learning Module for a Safe Laparoscopic Cholecystectomy
Official title: The Role Cognitive Non-technical Skills Learning Module in Promoting A Safe Laparoscopic Cholecystectomy: Critical Analysis on Situation Awareness and Intraoperative Decision Making in the Prevention of Complications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Learning Module
Cognitive Non-technical Skills
Keywords: Safe Laparoscopic Cholecystectomy
Situation Awareness
Decision Making
Lead sponsor: RSUP Fatmawati
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 217
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgeons and Surgical residents

Brief summary: A mixed-methods sequential explanatory design study. The first quantitative phase will be an online survey to surgeons that includes questions related to their experience learning and performing laparoscopic cholecystectomy. The second qualitative phase will use depth interview to elaborate surgeon's experience regarding a safe laparoscopic cholecystectomy

Detailed description: Bile duct injuries from laparoscopic cholecystectomy remain a significant source of morbidity and are often the result of intraoperative errors in perception, judgment, and decision-making. Cognitive non-technical skills namely situation awareness and decision-making skills are essential in doing a safe laparoscopic cholecystectomy, as in any kind of surgery. Studies regarding cognitive non-technical skills and how to teach them are still lacking, especially in the field of surgery.

With this study, the investigators aim to formulate a comprehensive learning module for a safe laparoscopic cholecystectomy accomodating cognitive non-technical skills based on the surgeon's experience while learning and doing laparoscopic cholecystectomy.

Eligibility criteria: Inclusion Criteria:

* Surgeons and / or surgical residents
* Complete all the required documents

Exclusion Criteria:

* Refuse to participate in one or more parts of the study

Primary outcomes:
measure: Quantitative: Community Survey
timeFrame: February - March 2022
measure: Qualitative: In Depth Interview
timeFrame: March - April 2022
measure: Qualitative: Delphi Study
timeFrame: May 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: RSUP Fatmawati
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT00833157: Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis
Official title: Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteoarthritis of the Knee
Keywords: Knee Osteoarthritis
exercise
strength training
Glucosamine
Dietary supplement
Ibuprofen
NSAID
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Lund University
name: The Danish Rheumatism Association
name: Ministry of the Interior and Health, Denmark
First posted: 2009-01-30
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will investigate the effect of glucosamine or ibuprofen combined with 12 weeks of muscle strength-training in patients with knee-osteoarthritis.

The investigators would like to elucidate whether treatment with glucosamine or NSAID interact with the effects of exercise in osteoarthritis patients.


Eligibility criteria: Inclusion Criteria:

* Age 50 to 70 years
* Bilateral tibiofemoral osteoarthritis of the knee on x-ray
* American College of Rheumatology (ACR) clinical classification criteria

Exclusion Criteria:

* Severe health problems such as cardiovascular disease, active cancer, diabetes, kidney or liver diseases
* Excess alcohol use (\> 21 alcoholic drinks per week)
* Severe overweight (BMI \> 35)
* History of injury or operation in the knee, planned knee-joint replacement, other rheumatologic diseases, previous gastric ulcer, allergy to the contents of ibuprofen or glucosamine, regular strength training prior to the inclusion

Primary outcomes:
measure: muscle strength and hypertrophy
timeFrame: We measure before and after 12-weeks strength training.
measure: cartilage biomarkers
timeFrame: We measure before and after 12 weeks strength training
Secondary outcomes:
measure: muscle regeneration and function
timeFrame: We measure before and after 12-weeks strength training.
Other outcomes:
Locations:
Study officials:
affiliation: Bispebjerg Hospital, Institute of Sports Medicine Copenhagen
name: Susanne G Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petersen SG, Beyer N, Hansen M, Holm L, Aagaard P, Mackey AL, Kjaer M. Nonsteroidal anti-inflammatory drug or glucosamine reduced pain and improved muscle strength with resistance training in a randomized controlled trial of knee osteoarthritis patients. Arch Phys Med Rehabil. 2011 Aug;92(8):1185-93. doi: 10.1016/j.apmr.2011.03.009.
citation: Petersen SG, Saxne T, Heinegard D, Hansen M, Holm L, Koskinen S, Stordal C, Christensen H, Aagaard P, Kjaer M. Glucosamine but not ibuprofen alters cartilage turnover in osteoarthritis patients in response to physical training. Osteoarthritis Cartilage. 2010 Jan;18(1):34-40. doi: 10.1016/j.joca.2009.07.004. Epub 2009 Jul 15.
Clinical trial NCT02108457: [18F] Flourothymidine (FLT) PET/CT Imaging for Gynecologic Cancers
Official title: [18F] Flourothymidine (FLT) PET/CT Imaging for Gynecologic Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Cancer
Keywords: concurrent chemotherapy
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects with diagnosed gynecologic cancer

Brief summary: The purpose of this study is to determine the effect of specific bone marrow maps developed with18F-FLT PET/CT imaging on the ability to spare proliferating bone marrow using proton beam radiotherapy compared to IMRT. Participants will be 18 years of age or old with a history of gynecologic cancer. Subjects will undergo 3 FLT-PET scans (one before treatment, one during the course of RT, and one 2-5 weeks after initiation of RT). Scans will take place in the Department of Radiation Oncology.


Eligibility criteria: Inclusion Criteria:

* Participants will be 18 years of age or older
* History of gynecologic cancer.
* Recommended to undergo IMRT or PBT of the pelvis with concurrent chemotherapy
* Female participants of child-bearing potential must have a negative urine or serum pregnancy test at the time of the screening visit.
* Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific procedures.
* Participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician.

Exclusion Criteria

* Females who are pregnant or breast feeding at the time of screening will not be eligible for this study.
* Inability to tolerate imaging procedures in the opinion of the investigator or treating physician
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subjects safety or successful participation in the study.
* Unwilling or unable to provide informed consent

Primary outcomes:
measure: Patients With Changes in Bone Marrow Assessed Through Images
timeFrame: up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Lilie Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01769157: Effects of L-carnitine on Hypothyroidism
Official title: Single-center, Randomized, Double-Blinded, Comparative Study of the Effectiveness of L-carnitine in Patients'Fatigue Degree Changing With Hypothyroidism Who Take Levothyroxine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothyroidism
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: IlDong Pharmaceutical Co Ltd
First posted: 2013-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: L-carnitine and thyroid hormone tended to antagonize reciprocally in human body. Urinary excretion of L-carnitine decreased in hypothyroid patients, and levothyroxine supplementation increased excretion of L-carnitine. The investigators hypothesized that supplying L-carnitine to hypothyroid patients with fatigue symptom could improve the quality of life, and fatigue score in them. Therefore, the investigators planned to compare the efficacy of L-carnitine and placebo in hypothyroid patients who had taken levothyroxine.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypothyroidism with fatigue symptom
* Currently use of the same amount of levothyroxine over at least six months
* Normal serum free T4 level

Exclusion Criteria:

* Current smoker
* Serum hemoglobin level of under 12mg/dL
* Clinical diagnosis of diabetes mellitus or fasting serum glucose level ≥ 126mg/dL or HbA1c level ≥ 6.5%
* History of significant heart failure
* History of large amount of alcohol consumption
* Uncontrolled hypertension (systolic blood pressure ≥ 160 millimeter of mercury (mmHg) or diastolic blood pressure ≥ 100 mmHg
* pregnant, or planning to be pregnant, or breast feeding women
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times of normal limit
* serum Cr level \> 2.0mg/dL

Primary outcomes:
measure: Fatigue Severity scale
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Wessely and Powell score
timeFrame: baseline and 12 weeks
Other outcomes:
measure: thyroid function test
timeFrame: baseline and 12 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
citation: An JH, Kim YJ, Kim KJ, Kim SH, Kim NH, Kim HY, Kim NH, Choi KM, Baik SH, Choi DS, Kim SG. L-carnitine supplementation for the management of fatigue in patients with hypothyroidism on levothyroxine treatment: a randomized, double-blind, placebo-controlled trial. Endocr J. 2016 Oct 29;63(10):885-895. doi: 10.1507/endocrj.EJ16-0109. Epub 2016 Jul 16.
Clinical trial NCT06731257: Virtual Ward-Assisted Very earLy dIschArge of Low-rIsk STEMI patieNTs: the VALIANT-STEMI Trial
Official title: Virtual Ward-Assisted Very earLy dIschArge of Low-rIsk STEMI patieNTs: the VALIANT-STEMI Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Observational studies have suggested that early discharge (24hrs with follow up virtually by telephone) of patients who are low risk and have had successful treatment following ST elevation myocardial infarction is safe. This has not been tested in a randomised controlled trial. In this trial the study team propose to identify low risk patients and randomise them to usual care or early discharge and follow up virtually by telephone. The primary endpoint would be readmission to hospital or all cause death up to 30 day following the event. If the outcome is positive, the study will assist early discharge of patients, reduce length of stay, potentially improve patient well being and have positive financial implications for the health service


Eligibility criteria: Inclusion Criteria:

* Successful revascularisation following STEMI
* Zwolle score \<=3
* No bystander disease awaiting inpatient intervention at the time of screening or consent (so if they have had intervention to a bystander vessel before this they would be eligible)

Exclusion Criteria:

* Haemodynamic instability (Killip class \>I)
* Left ventricular ejection fraction \<45%\<40%
* Sustained ventricular or atrial arrhythmias requiring intervention
* No support at home or social or physical circumstances preventing early discharge
* Unable to use home monitoring equipment
* Unwilling to consent or follow instructions
* Patients visiting from out of our catchment area
* Out-of hospital cardiac arrest
* Patients repatriated to their local hospital within 24 hours
* New or worsening renal failure (i.e. creatinine \>=1.5x baseline)

Primary outcomes:
measure: 30-day all-cause mortality or any rehospitalisation
timeFrame: 24-48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
Study officials:
References:
Clinical trial NCT06453057: Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients with Solid Tumours
Official title: A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients with Solid Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adult
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2024-06-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).


Eligibility criteria: Inclusion Criteria:

* 1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
* 2. Age 18 to 70 years old;
* 3. Ovarian cancer that progresses after recurrence or first-line chemotherapy；
* 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 5. Expected survival time of ≥ 12 weeks;
* 6. Good function of vital organs;
* 7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
* 8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
* 2.Known mental illness, alcoholism, drug use or substance abuse;
* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
* 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
* 5.The investigators determine that other conditions that make the patient not suitable for enrollment.

Primary outcomes:
measure: Incidence and severity of adcersed events per CTCAE 5.0
timeFrame: 3 years
measure: Objective response rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT04243057: Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study
Official title: Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholangiocarcinoma
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 21 hospitals limit:5000

Brief summary: This is a multicenter, two-way, non-intervention study. the main purpose: Understand the current status of diagnosis and treatment of cholangiocarcinoma patients in China and observe the effect of different treatment options on patient recurrence and long-term survival

Secondary purpose:

1. Exploring the actual clinical treatment situation and its compliance with the existing diagnosis and treatment of bile duct cancer
2. Exploring the establishment of clinical research standard fields and standards for diagnosis and treatment of bile duct cancer


Eligibility criteria: Inclusion Criteria:

1. above the age of 18 years old, male or female
2. clinical diagnosis of patients with cholangiocarcinoma
3. Child-Pugh classification of A, B
4. Eastern Cooperative Oncology Group scoring system (ECOG) score of 0-2 points

Exclusion Criteria:

* None

Primary outcomes:
measure: RFSR
timeFrame: 3 years
Secondary outcomes:
measure: OS
timeFrame: 3 years
measure: RFS
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00060957: Botulinum Toxin (BOTOX) for Cerebral Palsy
Official title: Botulinum Toxin for Spasticity in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Muscle Spasticity
Keywords: Cerebral Palsy
Spasticity
Botulinum toxin
BOTOX
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines botulinum toxin (BOTOX, or BTX) for the treatment of muscle twitches and spasticity associated with cerebral palsy in children. Botulinum toxin is a naturally occurring bacterial toxin (botulinum toxin) that inactivates certain parts of muscles.

Detailed description: This trial will test the effectiveness of BTX injections versus placebo to reduce plantar-flexor spasticity and improve function and mobility in children with spastic diplegia, a common form of cerebral palsy. The study will evaluate the effects of the treatment across five domains that relate to disability: pathophysiology, impairment, functional limitation, disability, and societal limitation.

Forty children, ages 4 to 12 years, will be recruited and randomized into one of two groups. Group A will receive BTX. Group B will receive a placebo injection. Participants will be assessed at the beginning of the trial and at Weeks 3, 8, 12, and 24. Assessments include quantitative electromyographic kinesiology measurements, electromechanical measurement of joint torque across the ankle joint using the Spasticity Measurement System, Gross Motor Function Measure, physical exam parameters, energy expenditure using the Energy Cost Index, kinematic gait analysis, and the Canadian Occupational Performance Measure.

Participants are followed for a total of 6 months. Participants initially randomized to Group B will have the opportunity for BTX treatment after 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Spastic diplegic cerebral palsy
* Community or independent ambulators
* Expressive communication skills at age 3 or above
* Stable social environment
* Reasonable proximity to the medical center
* Physical therapy at least once per week
* No other serious health problems that would interfere with the study

Exclusion Criteria:

* Other forms of cerebral palsy
* Previous treatment with botulinum toxin
* Musculoskeletal contractures greater than 15 degrees
* Unstable social environment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
Study officials:
affiliation: Children's Hospital and Regional Medical Center
name: Ross M. Hays, M.D.
role: PRINCIPAL_INVESTIGATOR
References: