louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03577951: Comparing the Establishment of Operation Space Between High Position and Low Position in Endoscopic Thyroid Surgery
Official title: Comparing the Two Ways of Creating a High Position and Low Position Operating Space in Endoscopic Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Endoscopy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 48
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: Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group. The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.

Detailed description: Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group.The sternum angle level is used as the dividing line between the two groups。The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* Patients with endoscopic thyroid surgery
* No previous neck surgery

Exclusion Criteria:

* Patients undergoing lateral neck lymph node dissection during the same period

Primary outcomes:
measure: Intercostal arterial bleeding
timeFrame: During surgery
measure: Thyroidectomy time
timeFrame: During surgery
Secondary outcomes:
measure: Thyroid volume
timeFrame: Before surgery
measure: Patient's BMI
timeFrame: Before surgery
measure: Assessment of skin sensory abnormalities
timeFrame: two months after surgery
Other outcomes:
Locations:
city: FuZhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT04127851: Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients
Official title: A Phase IV, Multicenter, Randomized, Single-blinded(Evaluator), Active-controlled, Parallel Study for Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Moderate to Severe Dry Eye Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Dry Eye Syndromes
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-16
Enrollment: 438
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Multicenter, Randomized, Single-blind Study for Evaluating the Efficacy of HA 0.15% Compared with Cyclosporine 0.05% in Moderate to Severe Dry Eye Syndrome
Primary purpose: TREATMENT

Brief summary: In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug.

Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 20 or over
* Moderate to Severe Dry Eye Disease Patients
* Written informed consent to participate in the trial

Exclusion Criteria:

* Any laser or ocular surgery within 2 months prior screening
* Use of contact lenses
* Any condition limiting patient's ability to participate in the trial

Primary outcomes:
measure: Change From Baseline in Corneal Staining Score at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Corneal Staining Score at Week 4 and Week 8
timeFrame: Baseline, Week 4 and Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Taejoon Pharmaceutical Co., Ltd.
Study officials:
References:
Clinical trial NCT03363451: A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)
Official title: A Retrospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Liver Disease
Infection
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic liver disease

Brief summary: The term of End Stage of Liver Disease (ESLD) was raised in 80's of 20 Century, but without a restrict definition. Infections are the cause and effect in occurrence and development of ESLD, which not only induce or exacerbate ESLD, but also are the most combined complication. Multi-resistant bacteria, multi-organ injury, selection of anti-microbes, supporting treatment, disorder of intestine microbiota, et al are dilemma in clinical practice. Appropriate and formal diagnosis and treatment of ESLD combined infection are imperious nowadays.


Eligibility criteria: Inclusion Criteria:

Decompensation of liver cirrhosis:

1. ALB \<35 g / L; A / G \<1.0
2. TBIL\> 35μmol / L;
3. ALT\> 1 × ULN and / or AST\> 1 × ULN
4. PTA \<60%
5. Ascites or hepatic encephalopathy or esophageal variceal bleeding

Acute-on-chronic liver failure:

1. Chronic liver disease based on: chronic hepatitis or decompensated cirrhosis
2. onset time: \<4 weeks
3. Hepatic encephalopathy: with or without
4. Coagulation: PTA ≤ 40% or INR ≥ 1.5
5. Jaundice: TBIL ≥ 171μmol / L or daily increase ≥ 17.1μmol / L

Chronic liver failure:

1. The basis of chronic liver disease: decompensated cirrhosis
2. onset time: -
3. Hepatic encephalopathy: with or without
4. Coagulation: PTA ≤ 40% or INR ≥ 1.5 Jaundice: significantly higher

Exclusion Criteria:

-

Primary outcomes:
measure: Complete response rate to empirical antibiotic treatment
timeFrame: 6 months
Secondary outcomes:
measure: Non-liver transplant survival
timeFrame: 6 months
measure: Hospitalization time
timeFrame: 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT01196351: Activity at Ventilation Threshold on Appetite and Food Intake in Boys
Official title: Effect of Activity at the Ventilation Threshold on Appetite and Food Intake After a Glucose Drink in Normal Weight, Overweight and Obese Boys
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Prevention
Keywords: boys
obesity
physical activity
exercise
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2010-09-08
Enrollment: 35
Sex: MALE
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize exercise increases short term appetite and food intake, and interferes with satiety and satiations to a preload in normal weight, overweight and obese boys.

Detailed description: The effect of exercise (EXR) on short-term food intake (FI) and subjective appetite was investigated in normal weight (NW), overweight (OW) and obese (OB) boys were randomized into 4 treatments. Each boy consumed either a non-caloric sweetened control (CON) or GLU drink after either exercise (EXR) or sedentary activity. Subjects exercised at their ventilation threshold (VeT).

Eligibility criteria: Inclusion Criteria:

* Healthy boys with no emotional, behavioral or learning problems

Exclusion Criteria:

* Girls

Primary outcomes:
measure: food intake (kcal)
timeFrame: at 30-35 min after the treatment
Secondary outcomes:
measure: Subjective appetite
timeFrame: 0-80 min
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences
state: Ontario
Study officials:
affiliation: University of Toronto
name: Harvey G. Anderson, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellissimo N, Desantadina MV, Pencharz PB, Berall GB, Thomas SG, Anderson GH. A comparison of short-term appetite and energy intakes in normal weight and obese boys following glucose and whey-protein drinks. Int J Obes (Lond). 2008 Feb;32(2):362-71. doi: 10.1038/sj.ijo.0803709. Epub 2007 Aug 14.
citation: Bellissimo N, Thomas SG, Goode RC, Anderson GH. Effect of short-duration physical activity and ventilation threshold on subjective appetite and short-term energy intake in boys. Appetite. 2007 Nov;49(3):644-51. doi: 10.1016/j.appet.2007.04.004. Epub 2007 Apr 22.
citation: Bozinovski NC, Bellissimo N, Thomas SG, Pencharz PB, Goode RC, Anderson GH. The effect of duration of exercise at the ventilation threshold on subjective appetite and short-term food intake in 9 to 14 year old boys and girls. Int J Behav Nutr Phys Act. 2009 Oct 9;6:66. doi: 10.1186/1479-5868-6-66.
Clinical trial NCT05412251: Smart Integrated Health Promotion Program
Official title: Smart Integrated Health Promotion Program and Health Behavior for Older Adult
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Keywords: leisure activity
nutrition status
quality of life
subjective well-being
older adults
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group and experimental group
Primary purpose: PREVENTION

Brief summary: health promotion behavior is important in older adults.The purpose of this study is to examine the efficacy of smart integrated health promotion intervention among middle age adults and older adults in community.

Detailed description: There very limited research focused on leisure activity, nutrition status, quality of life and subjective well-being. In addition, there is lack of research develop smart integrated health promotion intervention to enhance well-being for middle age adults older adults in community and examine the efficacy of the intervention. The purpose of this study is to examine the efficacy of smart integrated health promotion intervention among middle age adults and older adults in community .

Eligibility criteria: Inclusion Criteria:

(1) age over 50 years

Exclusion Criteria:

1. those who could not understanding protocol or communication with search nurses;
2. or with cognitive impairment or mental disorders;
3. or advance cancer;
4. or have been myocardial infarction;
5. or congestive heart failure was excluded.

Primary outcomes:
measure: Changes from baseline life quality at 3, 6, 9 month
timeFrame: baseline, 3, 6, 9 month
measure: Changes from baseline life quality at 3, 6, 9 month
timeFrame: baseline, 3, 6, 9 month
Secondary outcomes:
Other outcomes:
measure: Changes from baseline one touch blood sugar in mg/dl at 3, 6, 9 month
timeFrame: baseline, 3, 6, 9 month
measure: Changes from baseline one touch urine acid in mg/dl at 3, 6, 9 month
timeFrame: baseline, 3, 6, 9 month
measure: Changes from baseline one touch total cholesterol in mg/dl at 3, 6, 9 month
timeFrame: baseline, 3, 6, 9 month
Locations:
city: Taichung
country: Taiwan
facility: WISON Pharmacy
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Heng-Hsin Tung, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03553251: Protocol of Reintroduction of Beta-lactams in Children at Low Risk of Anaphylaxis.
Official title: Oral Beta-lactam Drug Reintroduction Protocol, Without Previous Skin Tests, in Children Under 16 Years of Age With a Clinical History That is Not Suggestive of Immunoglobulin E (IgE)-Mediated Anaphylaxis or Toxidermia to Beta-lactams.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypersensitivity
Beta Lactam Adverse Reaction
Keywords: Hypersensitivity
Beta Lactam Adverse Reaction
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 200
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children under 16 years of age with a clinical history that is not suggestive of IgE-mediated anaphylaxis or toxiderma to beta-lactams.

Brief summary: The purpose of this study is to establish the rationale for the practice of performing an oral reintroduction test without previous skin tests in children at low risk of IgE-mediated reaction or drug-induced toxidermia, and to confirm the criteria for a drug reintroduction test could be performed without previous skin tests, without subsequent risk of reaction for the child. The primary endpoint will be the risk of a severe IgE-mediated or delayed hypersensitivity reaction in children who received beta-lactam drug reintroduction protocol prior to skin testing.


Eligibility criteria: Inclusion Criteria:

* Children under 16 years of age coming for a consultation for a beta-lactam oral reintroduction test.

Exclusion Criteria:

* Refusal of the legal representatives of the subject for their child to participate in the study,
* If his age permits, refusal of the subject to participate in the study,
* Subject aged over 16,
* Pregnancy,
* Absence of affiliation of the subject to a social security scheme,
* Skin tests with incriminated beta-lactam already made before the consultation,
* Existence of contraindications to the realization of oral reintroduction drug test with the suspected antibiotic,
* Existence of criteria in the initial reaction suggestive of a non-low risk of IgE-mediated or delayed hypersensitivity to the incriminated beta-lactam, Taking antihistamine, corticosteroids or beta-blockers within 5 days prior to the oral reintroduction drug test,
* Travel abroad of the child scheduled within 7 days of the oral reintroduction drug test.

Primary outcomes:
measure: low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction
timeFrame: At the end of the study, after 2 years.
Secondary outcomes:
measure: Risk evaluation
timeFrame: At the end of the study, after 2 years.
measure: explain the occurrence of a reaction of IgE-mediated or delayed hypersensitivity
timeFrame: At the end of the study, after 2 years.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00463151: An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
Official title: An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Keywords: Rebamipide
Enema
Ulcerative Colitis
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 124
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).


Eligibility criteria: Inclusion Criteria:

1. Patients with active ulcerative colitis
2. Patients having an insufficient response to ASA oral formulation: (1) Patients whose ongoing use of ASA oral formulation from ≥2 weeks prior to the day before registration is fixed at mesalazine ≥2 g/day or salazosulfapyridine 3-6 g/day, (2) Patients with continuous bloody stools from ≥2 weeks prior to the day before registration, (3) Patients whose DAI subscores are ≥2 points for "bloody stools" and ≥2 points for "endoscopic findings"
3. Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum (with lesions not extending beyond the splenic flexure)
4. Outpatients

Exclusion Criteria:

1. Patients who have a history of intestinal resection (other than appendiceal resection)
2. Patients who have a complication of malignant tumor
3. Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period
4. Patients who have complications of serious cardiac, hepatic or renal impairment

Primary outcomes:
measure: Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100)
timeFrame: Week 6
Secondary outcomes:
measure: Clinical Remission (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100)
timeFrame: Week 6
measure: Mean Change From Baseline in Total DAI Score
timeFrame: Baseline and Week 6
measure: Percentage of Subjects Showing Improvement in Each DAI Subscore
timeFrame: Baseline and week 6
measure: Mean Change From Baseline in Total Endoscopic Index (EI) Score
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku Region
country: Japan
city: Hokkaido region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
Study officials:
affiliation: Division of New Product Evaluation and Development
name: Katsuhisa Saito
role: STUDY_DIRECTOR
References:
Clinical trial NCT05145751: SARS CoV-2 Infection and Inflammatory Biomarkers
Official title: SARS CoV-2 Infection and Simple Inflammatory Biomarkers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Inflammation
Keywords: COVID-19
Biomarkers
Inflammation
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with SARS CoV-2 infection who were treated by the Department of Respiratory Medicine in the UHL will be done. The subjects will be followed from admission to the hospital and up until discharge, transfer to the ICU or death

Brief summary: Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. This study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients.

Detailed description: Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. Moreover, previous studies have demonstrated that a sustained release of anti-inflammatory cytokines may lead to high levels of circulating neutrophils and lymphocytes' apoptosis with subsequent lymphopenia and immune response imbalance. Therefore, circulating biomarkers that represent inflammation and immune status could serve as potential predictors for the prognosis of SARS CoV-2 patients. The neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are cheap and simply calculated biomarkers which have been identified as markers of systemic inflammation, severity of the disease and prognosis in several patient populations.

This study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection

Exclusion Criteria:

* Patients aged\<18 years

Primary outcomes:
measure: Outcome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Univeristy of Thessaly
state: Thessaly
Study officials:
affiliation: Study Chair
name: Eleni Arnaoutoglou, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00858351: Thermal Biofeedback for the Treatment of Diabetic Neuropathy
Official title: A Placebo-Controlled Trial of Thermal Biofeedback Assisted Relaxation for the Treatment of Diabetic Neuropathy: An Evaluation of Outcomes and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy, Painful
Keywords: Diabetes
Neuropathy
Peripheral
Painful
Thermal
Temperature
Biofeedback
Relaxation
Diabetic
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Insulin Dependent Diabetes Trust
name: American Pain Society
name: Rosalind Franklin University of Medicine and Science
First posted: 2009-03-09
Enrollment: 32
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: The purpose of this study is to examine potential treatment options for a condition in diabetics that causes tingling, pain, and numbness in the hands and /or feet, also known as diabetic peripheral neuropathy.

Detailed description: Participants attend 6 sessions lasting from 35 minutes to 2 hours (depending on the session). Sessions can be scheduled once or twice per week. Sessions involve a walking task, filling out questionnaires, and having temperature of hands and feet monitored. This study involves no drugs, blood draws, or any other invasive procedures. Participants are urged to continue the treatment of diabetes and diabetic neuropathy as directed by their physician for the duration of their involvement with the study. After 3 months, a packet of questionnaires will be mailed with a stamped addressed envelope to be returned.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Diabetic Neuropathy in Hands and/or Feet
* Must have some sensation left in hands and feet

Exclusion Criteria:

* Any partial or total amputation of an limb or digit
* Any previous experience with biofeedback
* Prior treatment for alcohol abuse
* Severe Psychopathology

Primary outcomes:
measure: Subjective Pain
timeFrame: Change in subjective pain rating from baseline to end of intervention
Secondary outcomes:
measure: Perceived Control
timeFrame: Change from mid-intervention (visit 4) to end of intervention
measure: Temperature
timeFrame: Change within each session and across sessions from baseline to end of intervention
Other outcomes:
Locations:
Study officials:
References: