louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06627543: Effect of Enzyme Replacement Therapy on Cardiac Function in Children With Gaucher Disease Type 3
Official title: Effect of Enzyme Replacement Therapy on Cardiac Function in Children With Gaucher Disease Type 3
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gaucher Disease Type 3
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: gaucher diseease type 3

Brief summary: all cases confirmed diagnosis of Gaucher disease type 3 recieving enzyme replacement therapy at Assiut university hospital

Detailed description: evaluate cardiac involvement in a group of GD type 3 patients, evaluate pulmonary hypertension and valvular involvement, compare the findings of basic echo before the start of replacement therapy as well as with healthy controls, to assess the effects of enzyme replacement therpay on the cardiac function.

Eligibility criteria: Inclusion Criteria:

* Any sex
* No age limit
* Gaucher disease type 3
* Receiving enzyme replacement therapy

Exclusion Criteria:

* Age18 years old
* Cases of gaucher type 1 and 2
* Other lipid storage disease

Primary outcomes:
measure: Evaluate Pulmonary Hypertension (PH) in Egyptian GD Type 3 Patients
timeFrame: 6 months
measure: Evaluate Valvular Involvement in Egyptian GD Type 3 Patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Mohammed Mohammed
Study officials:
References:
Clinical trial NCT04387643: Protecting Health Care Workers During the COVID-19 Outbreak
Official title: Protecting Health Care Workers During the COVID-19 Outbreak:Qualitative Study of AYUSH Initiative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: Samta Ayurveda Prakoshtha, India
First posted: 2020-05-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care workers at front line of Covid-19 screening, treatment and management

Brief summary: Preparing to deal with Covid-19 outbreak in Rajasthan, India, health care workers were given Ayurvedic Kadha (combination of ayurvedic herbal extracts) starting from the end of February 2020. Then, majority of these health care workers were put on front line managing screening, monitoring, quarantine and treating Covid 19 patients. This real-life study aimed to determine the experience of health care workers who had Ayurveda kadha before starting as front-line workers.


Eligibility criteria: Inclusion Criteria:

* Health care workers posted in Covid-19 duties at front line
* Health workers who had Ayurveda herbs combination over for at least 10-days

Exclusion Criteria:

* No willing to consent
* inability to participate

Primary outcomes:
measure: Physical Health
timeFrame: From baseline to 30-days
measure: Psychological Health
timeFrame: From baseline to 30-days
Secondary outcomes:
measure: Coping with distress
timeFrame: From baseline to 30-days
measure: Self-Help
timeFrame: From baseline to 30-days
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Samta Ayurveda Prakoshtha
state: Rajasthan
Study officials:
affiliation: British Ayurvedic Medical Council (UK)
name: Neha Sharma
role: STUDY_CHAIR
affiliation: Aarogyam UK
name: Jaydeep Joshi
role: STUDY_DIRECTOR
affiliation: Samta Ayurveda Prakoshtha, India
name: Parashar Sharma
role: STUDY_DIRECTOR
affiliation: Samta Ayurveda Prakoshtha, India
name: Sahil Singhal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06068543: Reducing Frailty for Older Cancer Survivors Using Supplements II
Official title: A Phase 2 Randomized Controlled Trial of Epigallocatechin-3-Gallate (EGCG) on Frailty and Inflammation in Older Survivors of Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Frailty
Inflammation
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 118
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients in the intervention Arm will receive 800 mg Epigallocatechin-3-Gallate (EGCG) + 250mg Ascorbic Acid
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a two-arm placebo controlled randomized clinical trial, to assess the effect of a 12-week EGCG intervention on physical frailty compared to placebo in pre-frail older cancer survivors.


Eligibility criteria: Inclusion Criteria:

1. Be age 65 or over.
2. Be diagnosed with stage I-III Cancer
3. Have completed curative intent treatment ≤10 years prior to screening Patients on the following endocrine therapies are allowed to enroll (Anastrozole,Leuprolide acetate, and Bicalutamide)
4. Have a Fried's Frailty Score (FFS) of ≥ 1
5. Able to provide informed consent

Exclusion Criteria:

1. Have chemotherapy or other systemic cancer treatment planned to occur during the study period.
2. Have abnormal liver function tests (ALT, AST, and bilirubin) per most recent available lab test (within 3 months of screening)

   * 3 times institutional upper limit of normal for ALT and AST
   * 1.5 times institutional upper limit of normal for bilirubin
3. Have uncontrolled or unmanaged liver disease.
4. Consume more than 6 cups of green tea per day.
5. Have known allergies to caffeine.
6. Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
7. Be diagnosed with dementia.
8. Cannot provide informed consent due to lack of decision-making capacity (as determined by the patient's oncologist).

Primary outcomes:
measure: Change of physical frailty measured using the Short Physical Performance Battery (SPPB) in patients in the EGCG arm compared to placebo; change in SPPB scores from baseline to 12 weeks.
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
Clinical trial NCT01544543: Validation of HealthCare Standards in Chronic Obstructive Pulmonary Disease
Official title: Validation of HealthCare Standards in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients hospitalized for an exacerbation of COPD

Brief summary: VESALIO is a pilot study aimed at evaluating the feasibility and reliability (time stability and interobserver reliability) of healthcare quality standards in chronic obstructive pulmonary disease (COPD) recently outlined by SEPAR (Spanish Pneumology and Thoracic Surgery Society), and at establishing the foundation for a future validation (construct and criterion validation) of the aforementioned standards.


Eligibility criteria: Inclusion Criteria:

* Men and women 40 years of age or older
* Diagnosis of COPD at hospital discharge
* Hospitalization for a COPD exacerbation

Exclusion Criteria:

* Patients hospitalized for the first time at the participating site without a documented history of COPD
* Patients currently participating of having ever participated in a COPD-related clinical trial
* Patients with a serious disease that might affect the measured outcomes (terminal oncologic disease, neoplastic disease for which the patient is receiving chemo/radiotherapy, terminal renal insufficiency, AIDS)

Primary outcomes:
measure: COPD exacerbation
timeFrame: Within 12 months after hospitalization
measure: Mortality
timeFrame: within 90 and 180 days after hospitalization
measure: Healthcare-associated cost
timeFrame: within 12 months after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Requena
country: Spain
facility: Hospital General de Requena
state: Valencia
Study officials:
affiliation: Hospital de Requena, Valencia
name: Juan J Soler Cataluna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04451343: The Life and Care of Patients With Colorectal Cancer Before Age 65 and Their Kindred
Official title: The Life and Care of Patients With Colorectal Cancer Before Age 65 and Their Kindred
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surviving patients over the age of 18 and diagnosed with invasive CRC, infiltrating adenocarcinoma of the colon or rectum irrespective of the stage before 65 years old will be selected in the Poitou-Charentes cancer registry 2 to 5 years after announcement of the diagnosis.

Brief summary: In a context the respect of the autonomy of the patients is important, it is necessary to pay a sustained attention to the experiences and the lived experience as well of the patients suffering or in remission of cancer as of their family. It is therefore, for the family, to deepen the synthesis carried out by the Societal Cancer Observatory which is a societal observatory of cancer


Eligibility criteria: Inclusion Criteria:

Patients will be

* over 18 years old
* with a diagnosis of CRC before 65 years.
* able to give their non-opposition and to nominate at least 2 family members who would be willing to participate in the study

The spouse and / or children and / or parents will be eligible:

if they are at least 18 years old, if they can be considered a caregiver or are first-degree relatives of the index patient for whom a diagnosis of CRC has been made. .

Exclusion Criteria:

* Patients under 18 years of age or with a diagnosis of CRC after 65 years.
* Near a deceased patient or under 18 years old.

Primary outcomes:
measure: Assess the interaction between the care path (surgery, chemotherapy, radiotherapy) and the life course in patients before 65 years old with colorectal cancer
timeFrame: 2 hours
measure: Assess how the patients, their relatives and their family members, face the disease.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Registre du Cancer
Study officials:
References:
Clinical trial NCT00092443: Dose Confirmation Efficacy Study (V260-007)
Official title: Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 1312
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

Detailed description: The duration of treatment is 10 months.

Eligibility criteria: Inclusion Criteria:

* Healthy infants

Exclusion Criteria:

* History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
* Known or suspected problems with immune system
* Fever at time of immunization
* Prior administration of a rotavirus vaccine
* History of known prior rotavirus disease
* Chronic diarrhea, or failure to thrive

Primary outcomes:
measure: Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.
timeFrame: At least 14 days following the 3rd vaccination
Secondary outcomes:
measure: Number of Subjects With ≥3 Fold Rise in Antibody Titer
timeFrame: 14 days following the 3rd vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Block SL, Vesikari T, Goveia MG, Rivers SB, Adeyi BA, Dallas MJ, Bauder J, Boslego JW, Heaton PM; Pentavalent Rotavirus Vaccine Dose Confirmation Efficacy Study Group. Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics. 2007 Jan;119(1):11-8. doi: 10.1542/peds.2006-2058.
Clinical trial NCT03010943: Brain Awake Surgery Using Virtual Reality Headset
Official title: Chirurgie Eveillee du Cerveau Sous Realite Virtuelle Integree Aux Outils Bloc Operatoire : Etude de Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Virtual Reality
Keywords: virtual reality
glioma surgery
awake craniotomy
brain tumor
glioma
neurosurgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-01-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Feasibility and tolerance study of virtual reality headset for brain mapping during brain awake surgery.


Eligibility criteria: Inclusion Criteria:

* Unilateral tumor or any type of brain lesion localized at the vicinity of eloquent area

Exclusion Criteria:

* Emergency
* Any contra-indication to awake brain surgery

Primary outcomes:
measure: percentage of patients in which assessment of language functions during awake craniotomy, is possible with virtual reality headset.
timeFrame: During awake surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University hospital of Angers
name: Philippe MENEI, MDPHD
role: STUDY_DIRECTOR
References:
citation: Mazerand E, Le Renard M, Hue S, Lemee JM, Klinger E, Menei P. Intraoperative Subcortical Electrical Mapping of the Optic Tract in Awake Surgery Using a Virtual Reality Headset. World Neurosurg. 2017 Jan;97:424-430. doi: 10.1016/j.wneu.2016.10.031. Epub 2016 Oct 15.
citation: Casanova M, Clavreul A, Soulard G, Delion M, Aubin G, Ter Minassian A, Seguier R, Menei P. Immersive Virtual Reality and Ocular Tracking for Brain Mapping During Awake Surgery: Prospective Evaluation Study. J Med Internet Res. 2021 Mar 24;23(3):e24373. doi: 10.2196/24373.
citation: Bernard F, Lemee JM, Aubin G, Ter Minassian A, Menei P. Using a Virtual Reality Social Network During Awake Craniotomy to Map Social Cognition: Prospective Trial. J Med Internet Res. 2018 Jun 26;20(6):e10332. doi: 10.2196/10332.
Clinical trial NCT03260543: Efficacy and Safety of Fermented Ginseng Powder on Liver Function
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Fermented Ginseng Powder on Liver Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver, Nonalcoholic
Keywords: ginseng powder
Fatty Liver
Clinical Trial
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the effects of daily supplementation of fermented ginseng powder on improvement of Liver function.

Detailed description: The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of fermented ginseng powder on improvement of Liver function. The investigators measured ALT(Alanine Transaminase) profiles, Liver function index, fatty liver grade, lipid metabolism index, total antioxidant capacity, imflammation index, and Multidimensional Fatigue Scale.

Eligibility criteria: Inclusion Criteria:

* Age 19-70 years with ALT 35-105 IU/L

Exclusion Criteria:

* Under antipsychotic drugs therapy within past 2 months
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test by show the following results

  * Serum Creatinine \> 2.0 mg/dl
* Pregnancy or breast feeding etc.

Primary outcomes:
measure: Changes of ALT(Alanine Transaminase)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Changes of Liver function index
timeFrame: Baseline and 12 weeks
measure: Changes of fatty liver grade
timeFrame: Baseline and 12 weeks
measure: Changes of lipid metabolism index
timeFrame: Baseline and 12 weeks
measure: Changes of total antioxidant capacity
timeFrame: Baseline and 12 weeks
measure: Changes of imflammation index
timeFrame: Baseline and 12 weeks
measure: Changes of Multidimensional Fatigue Scale
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
citation: Jung SJ, Hwang JH, Park SH, Choi EK, Ha KC, Baek HI, Shin DG, Seo JH, Chae SW. A 12-week, randomized, double-blind study to evaluate the efficacy and safety of liver function after using fermented ginseng powder (GBCK25). Food Nutr Res. 2020 Apr 6;64. doi: 10.29219/fnr.v64.3517. eCollection 2020.
Clinical trial NCT01541943: Efficacy and Safety of HL-040XC in Essential Hypertension and Hyperlipidemia
Official title: A Phase 3, Randomized, Double- Blind, Multi-center, Double Dummy, Clinical Trial Comparing HL-040XC With Single Component Therapies(Atorvastatin, Losartan) to Assess the Efficacy and Safety of HL-040XC in Patients With Essential Hypertension and Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Hyperlipidemia
Keywords: Atorvastatin
Losartan
Essential Hypertension
Hyperlipidemia
Lead sponsor: HanAll BioPharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 evaluate efficacy and safety of HL-040XC in patients with essential hypertension and hyperlipidemia


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 80 years
* History of essential hypertension and hyperlipidemia
* Able to sign informed consent

Exclusion Criteria:

* At screening, SBP ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C \> 250mg/dL or TG ≥ 400mg/dL
* Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug

Primary outcomes:
measure: Change from baseline to 8 week in SiDBP (Sitting Diastolic Blood Pressure)
timeFrame: Baseline and 8 week
measure: Percent change from baseline to 8 week in LDL-Cholesterol
timeFrame: Baseline and 8 week
Secondary outcomes:
measure: Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood Pressure Responder according to JNC VII Guideline.
timeFrame: Baseline and 4, 8 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Department of Cardiovascular, Korea University Guro Hospital
name: Chang-Gyu Park, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04885543: COVID-19 STAndard of Care in Sub-Saharan Africa
Official title: Observational Study of the Clinico-biological Evolution and the Standard of Care Offered to Symptomatic Covid-19 Patients in Sub-Saharan Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Alliance for International Medical Action
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 2495
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People hospitalized with symptomatic of COVID-19 and a positive RT-PCR SARS-CoV-2 test

Brief summary: This study was conducted in three African countries on four COVID-19 care centers (CCCs). The CCCs were set up in collaboration with a medical NGO with long experience in recording and monitoring data for cohorts and clinical trials in emergency contexts. The data were recorded using the WHO COVID-19 rapid core case report form.


Eligibility criteria: Inclusion Criteria:

* SARS-CoV-2 positive at RT-PCR

Exclusion Criteria:

* Asymptomatic patients

Primary outcomes:
measure: Mortality
timeFrame: During hospitalization, with an average of 11 days
Secondary outcomes:
measure: Clinical worsening
timeFrame: Hospitalization, with an average of 11 days
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Chu Tengandogo
city: Ouagadougou
country: Burkina Faso
facility: Clinique Princesse Sarah
city: Conakry
country: Guinea
facility: Chu Donka
Study officials:
affiliation: CHU Bordeaux, INSERM 1219
name: Denis Malvy, Pr
role: PRINCIPAL_INVESTIGATOR
References: