louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04293666: Functional Evaluation of Kefir Drink on Antifatigue and Exercise Exercise Performance-2
Official title: Functional Evaluation of Kefir Drink on Antifatigue and Improving Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Performance
Fatigue
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
Collaborators: name: Synbio Tech Inc.
First posted: 2020-03-03
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Purpose: The aim of the present study was to evaluate potential beneficial effects of Kefir drink (Synbio Tech Inc., Kaohsiung City, Taiwan) on fatigue and ergogenic functions following physiological challenge. Methods: 16 male subjects, 8 in each group, were divided into two groups according to the principle of maximal oxygen uptake, which were (1) first-stage placebo and second-stage Kefir group (hereinafter referred to as group A). (2) The first phase of Kefeier, the second phase of the placebo group (hereinafter referred to as group B), after 4 weeks of supplementation, the performance and fatigue resistance tests were carried out in sequence, including: treadmill aerobic endurance exhaustion time, and fixation Exercise time and intensity challenge changes in blood lactate, blood urea nitrogen concentration and creatine kinase activity, as well as differences in body composition before and after supplementation. After the first phase of the test is completed, the four weeks of emptying are performed. And after adding the crossover sample, perform four weeks of supplementation and testing again.


Eligibility criteria: Inclusion Criteria:

* \>20 years old
* health

Exclusion Criteria:

* No smoking
* drinking habits
* no nutritional supplements or medications
* no food allergies
* normal liver and kidney function
* no diabetes and other chronic diseases

Primary outcomes:
measure: Exercise endurance exhaustion time
timeFrame: 28 days
measure: Clinical Biochemistry of lactate level
timeFrame: 28 days
measure: Clinical Biochemistry of ammonia level
timeFrame: 28 days
measure: Clinical Biochemistry of CK level
timeFrame: 28 days
measure: Clinical Biochemistry of glucose level
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: National Taiwan Sport University
Study officials:
References:
Clinical trial NCT06338566: Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle
Official title: Prospective Follow-up of Functional, Bone and Septic Results of Ankle Arthrodesis With Transplanted Nail
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ankle Fractures
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent ankle surgery and have an ankle arthrodesis.

Brief summary: The goal of this prospective, single-center observational study is to describe the functional outcome of the surgical procedure in patient who undergone transplanted centromedullary nailing in the septic setting.

Patients will be asked to complete a questionnaire during follow-up consultations.


Eligibility criteria: Inclusion Criteria:

* Patient \>18 years
* having undergone septic nailing in the operating theatre
* with social security coverage

Exclusion Criteria:

* Patient with 6-month follow-up not possible (medical wandering, transient patient),
* Patient who has benefited from another means of osteosynthesis
* Patients whose long-term return to weight-bearing will not be possible for reasons other than ankle arthrodesis surgery.
* Persons able to give consent but unable to read or write French
* Opposes participation in the study
* Patients whose cognitive capacity does not allow them to answer questionnaires

Primary outcomes:
measure: bony outcome of transcalcaneal nailing
timeFrame: up to 6 months
Secondary outcomes:
measure: functional result of the procedure
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01758666: A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteosarcoma
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: At present, the most effective drugs to osteosarcoma include ADM,DDP,,HD-MTX,IFO and so on.The effective rate of single drug was about 30%, and if the chemotherapy contains HD-MTX, the survival rate can reach about 60%, so the HD-MTX is the most important component in patients of osteosarcoma.

Studies have shown that, MTX efficacy and adverse reactions were associated with blood concentration level and duration, selecting the right time and dose to give CF is the critical point.


Eligibility criteria: Inclusion Criteria:

1. Proved by pathology in 60 cases of osteosarcoma patients
2. PS ≤ 2, survival period is more than 6 months
3. Normal function of liver and kidney
4. No chemotherapy contraindication, patients treat with high dose methotrexate
5. Get signed written informed consent form
6. Have a good compliance with take blood and follow-up

Exclusion Criteria:

Primary outcomes:
measure: blood concentration of MTX
timeFrame: up to 3 years
Secondary outcomes:
measure: other adverse reaction
timeFrame: up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Chen Wang
role: STUDY_CHAIR
References:
Clinical trial NCT04712266: A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
Official title: A Randomized, Double-blinded Trial to Investigate Glycemic Excursions Following an Oral Mixed Meal Challenge in Subjects With Type 1 Diabetes When Concomitantly Treated With Insulin Alone or Co-administered Insulin and Glucagon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 1 Diabetes Mellitus With Hypoglycemia
Lead sponsor: Abvance Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: T1D Exchange, United States
First posted: 2021-01-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.

Detailed description: Subjects were be studied on two occasions, in randomized sequence, whereby glycemic excursions are assessed following an oral mixed meal challenge while treated with either insulin alone or co-administered insulin and glucagon.

Eligibility criteria: Inclusion Criteria:

* Male or female patients aged between 18 and 64 years (both inclusive)
* Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
* Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit

Exclusion Criteria:

-

Primary outcomes:
measure: hypoglycemic excursions
timeFrame: 180-360 minutes post meal
measure: hyperglycemic excursions
timeFrame: 60-120 minutes post meal
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
Study officials:
affiliation: Atlanta Diabetes Associates
name: Bruce Bode, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00771966: Radical Prostatectomy and Perioperative Fluid Therapy
Official title: Radical Prostatectomy and Perioperative Fluid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: patients with cancer in the prostate
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The optimal amount of fluid a patient need under surgery is not clear. Both to much and to little fluid can damage the organ functions.

A strategy called "Goal directed therapy", where the fluid amount a patient need is guided by the stroke volume, has shown to minimize post-operative nausea and vomiting.

The investigators intend to investigate if patients treated after these standards, has a better outcome then patients treated after normal regimes, regarding post-operative orthostatic-intolerance.


Eligibility criteria: Inclusion Criteria:

* Patients with cancer in there prostate

Exclusion Criteria:

* Patients who don't understand the information
* ASA \> III
* Patients that are under treatment with the drug triazolam
* Patients with af known renal decease
* Patients with a psychiatric decease
* Alcohol abuse
* Severe haemorrhagic decease
* Cancer in the mouth,pharynx, larynx or oesophagus

Primary outcomes:
measure: To investigate orthostatic cardiovascular response and orthostatic intolerance in patients after removal of the prostate
timeFrame: 6 hours
Secondary outcomes:
measure: Investigate intraoperative haemodynamics
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept of anesthesiology, Rigshospitalet
Study officials:
References:
Clinical trial NCT01771666: Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer
Official title: A Pilot Study to Assess the Utility of Indocyanine Green™ (IC-GREEN™) SPY Imaging in the Mapping of Arm Draining Lymphatics and Nodes During Sentinel Node Resection With or Without Axillary Dissection in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.

Detailed description: It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the setting of sentinel node procedures with or without axillary node dissections in women with breast cancer. All participants will also have tumor samples evaluated with 99technetium-sulfur colloid, a radiolabel used to identify tumor markers.

Eligibility criteria: Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document.
* Signed written informed consent.
* Women undergoing sentinel lymph node biopsy.
* Women with breast cancer with known or suspected lymph node involvement.
* Women undergoing sentinel node identification and completion axillary lymph node dissection.
* Women of 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2.
* Complete Blood Count (CBC) and basic Metabolic Panel within 6 months

Exclusion Criteria:

* History of liver or kidney failure will not be eligible.
* Allergies to iodine containing products will not be eligible.
* Women who are pregnant will not be eligible.
* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Primary outcomes:
measure: Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)
timeFrame: 1 day
Secondary outcomes:
measure: Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes
timeFrame: 1 day
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Irene Wapnir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01229566: Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Study to Assess Efficacy and Safety of AKR-963 Therapy in Subjects With Severe Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Severe Hypertriglyceridemia
Lead sponsor: Trygg Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine the efficacy of AKR963 compared to placebo and active comparator in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 1500 mg/dL.

Detailed description: Increases in triglyceride concentrations have been correlated with increased risk for pancreatitis as well as for coronary heart disease (Ginsberg 2001, 2002). The incidence rates for major coronary events in the Munster Heart Study increased from 4.4% among Subjects with baseline TG concentrations under 200 mg/dL to 9.3% among Subjects with TG concentrations in the 200-399 mg/dL range, and up to 13.2% in Subjects with TG levels ranging from 400-799 mg/dL (Assmann 1996).

Eligibility criteria: Inclusion Criteria:

* Men and women, ages 18-79
* Fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL
* Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant
* Use of non-statin lipid-altering drugs which cannot be stopped or other supplements with potential lipid-altering effects
* History of pancreatitis
* History of bariatric surgery or currently on weight loss drugs or in weight loss programs
* Treatment with any agent that may affect lipid levels or hepatic function
* Consumption of more than 3 alcoholic beverages per day
* History of cancer within last 2 years
* Participation in another clinical trial involving an investigational agent in the last 30 days
* Other parameters will be assessed at the study center to ensure eligibility for this study

Primary outcomes:
measure: Difference between AKR963 and Control [placebo or active control] treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ]
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Illinois Recruiting
state: Illinois
Study officials:
affiliation: Addison, Illinois Recruiting
name: Kevin C Maki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03768466: Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment
Official title: An 8-week, Prospective, Interventional, Single-arm, Multi-centre, Phase IV Study to Evaluate the Efficacy and Safety of Controlled-release Oxycodone/Naloxone (Targin®) in Moderate to Severe Low Back Pain Patients Who Are Not Adequately Controlled by NSAIDs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Lead sponsor: Mundipharma Korea Ltd
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 123
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled\* by NSAIDs.


Eligibility criteria: Inclusion Criteria:

1. Korean patients age ≥ 19 years old
2. Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with NSAIDs
3. Patients showing average NRS pain score ≥4 over the last 1 week at screening point
4. In case of previous opioids medication history, opioids wash-out period \> 30 days before enrolment
5. Patients who is willing to voluntarily sign informed consent

Exclusion Criteria:

1. Patients with any history of hypersensitivity to oxycodone, naloxone or related products
2. Low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause
3. Pregnant or lactating women

Primary outcomes:
measure: Change of NRS average score from week 0 to week 8
timeFrame: week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: JaeHyup Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03968666: Compliance With Enhanced Recovery After Surgery Protocol (ERAS) in Surgical Patients
Official title: Evaluation of Compliance With Enhanced Recovery After Surgery (ERAS) Protocol in Benign Gynecological Surgical Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Anesthesia
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for benign gynecologic surgery who underwent ERAS protocol

Brief summary: The concept of "enhanced recovery" was introduced by European anesthesiologists and surgeons who challenged traditional clinical practices involved in peri-operative care in 1990s. The goal of enhanced recovery programs (ERP) is to maintain normal physiology thereby decreasing complications. It focuses on peri-operative optimization of patient care. It was originally created for open colorectal surgeries but now has shown benefit in various surgical specialities including thoracic surgery, vascular surgery, hepatobiliary as well as gynecological surgery.

The successful implementation of structured ERAS program requires an ERAS protocol, audit system and a multidisciplinary team. The investigators will evaluate the effect of compliance with the protocol and outcomes such as length of stay, readmissions, morbidity and mortality.

Detailed description: After approval by the Institutional Review Board, the investigators plan to retrospectively study gynecological patients who underwent ERAS protocol at Augusta University Medical Center between January 2017 and February 2019.

This is a retrospective observational study to evaluate the outcomes of patients who had ERAS protocol during their surgery.

Demographic and outcome variables will be obtained from the institutional health documentation system. The investigators will collect demographic variables (age, ASA status), morphometric measurements (body mass index), time from enrollment to ERAS protocol, hospitalization length of stay, and readmission rate. The investigators will also record the documentation of the ERAS protocol interventions against the ERAS protocol approved by the institution. The investigators will assess the effect of the degree of compliance on outcome variables.

Eligibility criteria: Inclusion Criteria:

* All elective benign gynecological surgical patients enrolled under ERAS protocol

Exclusion Criteria:

* History of oncologic pathologies

Primary outcomes:
measure: Length of stay
timeFrame: 2 weeks
Secondary outcomes:
measure: Readmission
timeFrame: 2 weeks
measure: Mortality
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
affiliation: Augusta University
name: Efrain Riveros Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05652166: What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?
Official title: What Information is Remembered by Parents Following the Ingestion of Foreign Body by Their Child?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Information Remembered by Parents Following the Ingestion of Foreign Body by Their Child
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children consulting at Robert Debre Hospital following the ingestion of foreign body

Brief summary: Foreign body (FB) ingestion is a very common domestic accident in children. The prevention of the recurrence by securing child's environment is mandatory. The study will study whether the advices of follow-up at home and recurrence prophylaxis were given to parents after a foreign ingestion by their child.

Detailed description: Foreign body ingestion (FB) is a very common domestic accident in children. When the FB is not dangerous or it is inaccessible after crossing the pylorus, the child should be monitored. In all cases, recurrence should be prevented by securing the environment of the swallowing child. The information on monitoring and securing the environment should be communicated during hospital care. This prospective study will analyze whether advices were correctly given to the families concerning the follow-up at home and the prophylaxis of FB ingestion.

Eligibility criteria: Inclusion Criteria:

* Children under 18 years
* Foreign body ingestion

Exclusion Criteria:

* Refusal to participate in the study
* Non-French speaking parents

Primary outcomes:
measure: Identify the instructions memorized by the parents after a visit to the hospital for a foreign body ingestion by their child.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jérôme VIALA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: