louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00812448: Catechin Containing Mask for the Prevention of Influenza Infection
Official title: The Effects of Tea Catechin Extracts Containing Mask on the Prevention of Influenza Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Infection
Keywords: prophylaxis
influenza infection
catechins
prophylaxis of influenza infection
Lead sponsor: University of Shizuoka
Sponsor class: OTHER
Collaborators: name: Seirei Hamamatsu General Hospital
name: Hamamatsu University
First posted: 2008-12-22
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of catechin extracts containing mask on prevention of influenza infection.

Detailed description: Catechins are the major components of tea flavonoids and are reported to possess physiological activities such as antiviral effects. Recent in-vitro experimental studies have revealed that tea catechin extracts possess the effects on the prevention of influenza infection. However, a limited number of studies have been conducted on the clinical effects. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of tea catechin extracts containing mask on the prevention of influenza infection.

Eligibility criteria: Inclusion Criteria:

* Possible to wearing mask for three months
* Possible to fill out a questionnaire personally
* Obtained written informed consent before participation

Exclusion Criteria:

* Possessing some infectious diseases in need of therapy
* Possessing tea or catechin allergy
* diagnosed as inadequate for other reasons to participate the study by principal investigator

Primary outcomes:
measure: the incidence rate of influenza infection during the study
timeFrame: assessed at each month
Secondary outcomes:
measure: the incidence rates of upper respiratory tract infections
timeFrame: assessed at each month
measure: the severity of the symptoms and the duration of the cold among incident cases
timeFrame: assessed at each month
measure: he incidence-free time for influenza or upper respiratory tract infections after the intervention
timeFrame: assessed at each month
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Shizuoka
country: Japan
facility: University of Shizuoka
Study officials:
affiliation: University of Shizuoka
name: Hiroshi Yamada, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03603548: Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial
Official title: Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplant Rejection
Immunosuppression
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)


Eligibility criteria: Inclusion Criteria:

adults 18- 70 after liver transplantation due to liver cirrhosis primary liver transplantation

Exclusion Criteria:

liver transplantation due to liver cirrhosis and hepatocellular carcinoma (HCC) retransplantation renal impairment Parkinson disease

Primary outcomes:
measure: acute rejection
timeFrame: 12 months
measure: chronic rejection
timeFrame: 5 years
measure: tremor
timeFrame: 12 months
measure: de novo diabetes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Warsaw Medical University
Study officials:
References:
Clinical trial NCT04256148: ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Warm Autoimmune Hemolytic Anemia
Keywords: Warm autoimmune hemolytic anemia
WAIHA
Immunoglobulin G (IgG)-mediated autoimmune disorder
Pathogenesis
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized in 1:1:1:1 ratio to 1 of 4 study arms.
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).

Detailed description: This study will consist of a 4-week Screening period, 13-week Primary Treatment period, and optional Extended Treatment period (up to 2 years).

Eligibility criteria: Key Inclusion Criteria:

* Primary or secondary WAIHA, diagnosed at least 6 weeks prior to Screening
* Failed or not tolerated at least 1 prior WAIHA treatment regimen, for example, corticosteroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, danazol, or vincristine
* Hemoglobin \< 10 g/dL and ≥ 6 g/dL
* Positive direct antiglobulin test (Coombs) (IgG positive, complement C3 \[C3\] positive or negative)
* Evidence of active hemolysis including any of the following: a) Lactate dehydrogenase (LDH) \> upper limit of normal (ULN), b) Haptoglobin \< lower limit of normal (LLN), c) Indirect bilirubin \> ULN
* Total IgG \> 500 mg/dL

Key Exclusion Criteria:

* Human immunodeficiency virus (HIV) infection (positive HIV-1 or HIV-2 antibody test)
* Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test

Primary outcomes:
measure: Percentage Of Participants With ≥ 2 Grams (g)/Deciliter (dL) Increase In Hemoglobin (Hgb) From Baseline
timeFrame: Baseline (Day 1) through Day 92
Secondary outcomes:
measure: Total Number Of Units Of Packed Red Blood Cells (pRBCs) Transfused
timeFrame: Day 15 through Day 92
measure: Mean Change From Baseline To Day 92 In Quality Of Life, Assessed Via EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
timeFrame: Baseline, Day 92
measure: Mean Change From Baseline To Day 92 In Quality Of Life, Assessed Via Functional Assessment Of Cancer Therapy Anemia (FACT-AN) Questionnaire
timeFrame: Baseline, Day 92
measure: Number Of Weekly Hgb Measurements With Change From Baseline ≥ 2 g/dL
timeFrame: Day 1 through Day 92
measure: Number Of Participants Needing New WAIHA Rescue Medication Or Increase In Dose Of WAIHA Medication
timeFrame: Day 15 through Day 92
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Alexion Study Site
state: California
Study officials:
References:
Clinical trial NCT03970148: YAG Laser Vitreolysis for Floaters
Official title: YAG Laser Vitreolysis of Symptomatic Vitreal Floaters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitreous Detachment
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
Collaborators: name: University of Split, School of Medicine
First posted: 2019-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vitreous fluid, containing 95% water, fills the space behind the lens. Its gelatinous consistency is due to the presence of hyaluronic acid, mucopolysaccharide and collagen fibers. With age, the collagen aggregates into parallel bundles, bound by cross links, leaving the pockets of liquid in the glass body. This redistribution is referred to as syneresis, which is found in 90% older than 40 years. After liquefaction, the vitreous enters the retroviral space and separates the posterior hyaloid membrane from the retina. When separating from the optical disk it forms an annular formation (Weiss ring) in front of the optical disc. These agglomerated collagen bundles (opacities) disperse the photons of light and are perceived by the patients as a "gray silhouette-like artifact". Two major interventions for these symptoms include Nd: YAG laser vitreolysis and vitrectomy. The less invasive method Nd: YAG laser increases the temperature of the opacity thus vaporizing them to smaller fragments that are easier to sediment onto the bottom of the vitreous cavity thereby relieving the symptoms.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Is able to give written informed consent to the procedure
* Patients with clinical symptoms of floaters and clinically confirmed diagnosis of opacity in the vitreous body.

Exclusion Criteria:

* Inability to tolerate the procedure
* Blurred anterior eye segment
* Cataract or Intraocular lens opacity
* Blurred posterior eye segment
* Active eye inflammation
* Iris synechiae
* Uncontrolled intraocular pressure elevation
* Peripheral retinal degeneration

Primary outcomes:
measure: Number of patients with resolution of symptoms
timeFrame: 1 month
Secondary outcomes:
measure: Macular Oedema Development rate
timeFrame: 1 month
measure: Rate of treatment side effects
timeFrame: 1 month
measure: Retreatment rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital of Split
state: Hrvatska
Study officials:
affiliation: University Hospital of Split
name: Ljubo Znaor, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06969248: Program to Increase Fathers' Involvement in Infant Care
Official title: The Effects of Interventions Targeted to Fathers on Fathers' Participation in Infant Care, Attachment Status, and Paternal Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Randomised Controlled Trial
Public Health Nursing
Child Health
Keywords: fathers&#39; involvement in infant care
Edinburgh Postpartum Depression Scale.
Father-Infant Attachment
Child Health
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: Health Institutes of Turkey
First posted: 2025-05-13
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

Brief summary: Fathers participating in the study will be given an 8-week formality intervention. Participants will be shown 4-week infant care training records and then 4-week videos prepared on educational topics. The effect of the intervention will be determined annually by the mean scores of the Fathers' Participation in Infant Care Questionnaire, Father Infant Attachment Scale, and Edinburgh Postpartum Depression Scale.

Detailed description: The study will be conducted in a Family Health Center in Turkey, selected by random lottery. Fathers who are registered in a family health center and have babies aged 4-12 months and fathers who have children for the first time will be included in the study. The type of the study is planned as randomized controlled pre-test post-test, parallel group experimental type. A total of 80 fathers will be included in the study, 40 in each group, according to the calculation made with Gpower analysis. Participants will be randomly assigned to groups. Nursing interventions will last for 8 weeks and participants will be given training and watched videos during this process.

Eligibility criteria: Inclusion Criteria

* Having a healthy baby between 4-12 months old,
* Being a first-time father,
* Volunteering to participate in the study,
* Having a smartphone

Exclusion Criteria:

* Being under 18 years old,
* Having a psychiatric diagnosis.

Primary outcomes:
measure: Fathers' Involvement in Infant Care Questionnaire
timeFrame: 8 week
measure: Father Infant Attachment Scale
timeFrame: 8 week
measure: Edinburgh Postpartum Depression Scale
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References:
citation: Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
Clinical trial NCT00370448: Evaluation of Interventions to Prevent Suicide of Medical Students Through the School-Based Social Support System
Official title: Evaluation of Interventions to Prevent Suicide of Medical Students Through the School-Based Social Support System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2006-08-31
Enrollment: 12000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether school-based social support systems are effective in preventing suicide in medical students.


Eligibility criteria: Inclusion Criteria:

* Medical university students Grades 1 through 2

Exclusion Criteria:

* Psychopath

Primary outcomes:
measure: Rate of suicide ideation
timeFrame: half of one year and one year after intervention
Secondary outcomes:
measure: Rate of suicide attempt
timeFrame: half of one year and one year after intervention
Other outcomes:
Locations:
city: Wuhu
country: China
facility: Wannan Medical College
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: Yehuan Sun, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00198848: Iron Supplementation Among Adolescent Girls in India
Official title: Iron Supplementation Among Adolescent Girls in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Keywords: Iron deficiency anemia
Adolescent girls
India
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2005-09-20
Enrollment: 2800
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will implement and evaluate a community-based intervention to distribute and promote consumption of weekly iron-folic acid supplements and to provide nutrition education to reduce the prevalence of iron deficiency anemia among adolescent girls in West Bengal, India.


Eligibility criteria: Inclusion Criteria:

* Girl 12-19 years of age
* Resides in study area

Exclusion Criteria:

* Does not reside in study area

Primary outcomes:
measure: Prevalence of anemia after 1 year of intervention
Secondary outcomes:
measure: Knowledge of anemia
measure: Practices regarding treatment and prevention of anemia
measure: Knowledge of iron supplements
measure: Practices regarding iron supplements
measure: Dietary iron intake
Other outcomes:
Locations:
city: Kolkata
country: India
facility: Child In Need Institute
state: West Bengal
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Michele L Dreyfuss, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03632148: Effect of Liver MSCs in Blood of Patients With Liver Disease.
Official title: In Vitro Evaluation of the Effect of HepaStem in the Coagulation Activity in Blood of Patients With Liver Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decompensated Cirrhosis
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalised cirrhotic patients in hepatology or intensive care unit

Brief summary: Liver MSCs or Adult Derived Human Liver Stem/progenitor Cells (ADHLSCs) infusions are currently being developed as a therapeutic medicinal product for the treatment of different liver defects. Nevertheless, a main concern for clinicians and health authorities is the risk of therapy-induced thrombosis, which has been reported in several patients after intravenous infusion. Previous studies showed in fact that most MSCs express a procoagulant activity. ADHLSCs could be used to treat acute de-compensated cirrhotic patients due to their immunomodulatory and anti-fibrotic effects. However in these patients, disturbances of coagulation and haemostasis are common and result in profound haemostatic alterations that can lead to thrombosis as well as to bleeding complications. The aim of this study is to evaluate the effect of ADHLSCs in cirrhotic blood compared to control blood.


Eligibility criteria: Inclusion Criteria:

* acute de-compensated cirrhotic patients

Exclusion Criteria:

* anticoagulant treatment except for prophylactic heparin treatment
* coagulopathy
* thrombosis
* cancer

Primary outcomes:
measure: Blood parameters in tubing loop model
timeFrame: 1 day
measure: Fibrin formation in thrombodynamics
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT06438848: Effects of Lymph Drainage on Patients With Axillary Web Syndrome
Official title: Effects of a Physical Therapy Program Combined With Manual Lymphatic Drainage on Shoulder Function, , and Pain in Breast Cancer Patients With Axillary Web Syndrome Following Axillary Dissection: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Movement Disorders
Lead sponsor: Taif University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled parallel groups
Primary purpose: TREATMENT

Brief summary: Effects of a physical therapy program combined with manual lymphatic drainage on shoulder pain and function, quality of life, lymphedema incidence in breast cancer patients with axillary web syndrome following axillary dissection: A randomized controlled trial.

Detailed description: This study's objective is to assess the effectiveness of physical therapy (PT) combined with manual lymphatic drainage (MLD) on shoulder pain and function, lymphedema, visible cords, and quality of life (QOL), compared to physical therapy alone, in subjects with breast cancer and suffering of axillary web syndrome (AWS).

Eligibility criteria: Inclusion Criteria:

* had a breast cancer dissection with lymphadenectomy and/or sentinel lymph node biopsy and a subsequent appearance of AWS (diagnosed by physical examination and also by using the Screening Test AWS (ST-AWS)) \[35\].

  * suffering of pain that exceeds 6-8 points (measured by the numeric rating scale (NRS)) in the region of the cording on the upper/lower arm, elbow, and dorsum site, and
  * have visible or palpable cords in the arm or breast.

Exclusion Criteria:

* suffering of both acute thrombosis and lymphedema,

  * suffering of skin issues like infections or musculoskeletal conditions like adhesive capsulitis, rheumatoid arthritis, pectoral muscle tightness, and diseases of the rotator cuff, and/or
  * having cording that doesn't involve an arm and only affects the chest or side of the thorax.

Primary outcomes:
measure: Pain intensity
timeFrame: 5 weeks
measure: Disability
timeFrame: 5 weeks
Secondary outcomes:
measure: Limb Girth
timeFrame: 4 weeks
measure: Cording
timeFrame: 5 weeks
measure: Muscular strength
timeFrame: 5 weeks
measure: Range of motion
timeFrame: 5 weeks
measure: Quality of life for participants
timeFrame: 5 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Taif University
name: Hassan Alzahrani, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT05185648: Analysis of Current Situation and Evaluation of Trauma Treatment Training in China
Official title: Analysis of Current Situation and Evaluation of Trauma Treatment Training in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Train Accident Involving Explosion, Passenger Injured
Train Collision With Streetcar, Pedestrian Injured
Trauma Injury
Train Accident Involving Burning, Passenger Injured
Keywords: trauma training
trauma care
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This study will rely on the training course of CTCT project to conduct standardized training for trauma practitioners in China. And the quality of training will be stratified research; Continuously improve the quality of trauma treatment and improve the prognosis of trauma patients.


Eligibility criteria: All CTCT participants from different administrative districts of China registered for standardized and procedural CTCT curriculum . All trainees have finished the general survey of personal background, trauma care status in local hospitals and pre-training tests of trauma knowledge. After CTCT curriculum and hifidelity trauma simulation training, they were also needed to finish post-training test about the initial evaluation of various kinds of traumas. The pre- and post-training examination were constantly about trauma evaluation of major trauma patients.

Inclusion criteria: Trainees who attended on CTCT curriculum. Exclusion criteria: Rejection for supplying training information, in-completed CTCT training information, lack of pre- and/or post-training scores.

Primary outcomes:
measure: training scores
timeFrame: Day 1.5
Secondary outcomes:
measure: score difference
timeFrame: Day 1.5
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: yongan xu, doctor
role: STUDY_CHAIR
References: