louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04407572: Evaluation of the Relationship Between Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women
Official title: Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Zinc Deficiency
Vitamin D Deficiency
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Ayşegül Bestel
name: İbrahim Polat
name: Merve Aldıkaçtıoğlu Talmaç
First posted: 2020-05-29
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between 18-45 years old with positive covid-19 pcr test results

Brief summary: Zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms of patients' responses to computed tomography and treatment.

Detailed description: Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.

Eligibility criteria: Inclusion Criteria:

* covid-19 positive pregnant women
* under 18 or more than 45 years old

Exclusion Criteria:

* vitamin D , Vitamin B12 or Zinc supplement use
* Multivitamine use
* have taken vitamin supplements in the past 3 months
* use of medicines for vitamin deficiency
* having metabolic disease covid-19 negative pregnant women

Primary outcomes:
measure: Serum zinc, vitamin d vitamin b12 deficiency levels
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT06210672: Natural History Study in Patients With LGMDR5/2c
Official title: A Prospective Longitudinal Study of Natural History and Functional Status of Patients With Gamma-sarcoglycanopathy (LGMDR5)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gamma-sarcoglycanopathy
Lead sponsor: Atamyo Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll 30 ambulant pediatric patients less than 12 years of age (cohort 1) and 20 non-ambulant adolescent or young adults less than 35 years of age (cohort 2)

Brief summary: Prospective, longitudinal, interventional, multicenter natural history study to better understand the LGMDR5/2c disease physiopathology. The duration of participation for each patient will be up to 24 months.

Detailed description: Study duration Duration from First visit of first patient (FPFV) to Last visit of last patient (LPLV) : 3 years. Each patient will have a visit every 6 months over 2 years (5 visits in total).

Study primary objective is to characterize the disease course in gamma-sarcoglycanopathy (LGMDr5/2c) patients using standardized and disease appropriate evaluations.

Secondary objectives are to identify clinical, imaging and/or laboratory parameters that are indicators of the disease course in LGMD2c and to identify the best outcome measure for further therapeutics approaches

Eligibility criteria: Inclusion Criteria:

* Male and female patients 6 to less than 35 years of age
* Ambulant patients should be less than 12 years of age and able to walk/run 10 meters (item 29 of NSAD) in less than 15 sec
* Confirmed diagnosis of LGMDR5 (genotyping)
* FVC \> 40%

Exclusion Criteria:

* Subjects with co-morbidity which may interfere with LGMDR5 natural evolution and/or evaluation of outcome measures
* Need of non-invasive ventilation \> 16h per 24h or any invasive ventilation
* Left ventricular ejection fraction (LVEF) \< 30% or prior heart failure decompensation requiring hospitalization
* Past participation in a gene therapy or cell therapy trial

Primary outcomes:
measure: North Star Assessment for Neuromuscular Disorders (NSAD)
timeFrame: Baseline through 24 months
measure: Performance of Upper Limb (PUL)
timeFrame: Baseline through 24 months
measure: Timed Up and Go (TUG)
timeFrame: Baseline through 24 months
measure: 100-meter walk/run test (100MWT)
timeFrame: Baseline through 24 months
Secondary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Baseline through 24 months
measure: Muscle MRI
timeFrame: Baseline though 24 months
measure: Change from baseline in Activlim score
timeFrame: Baseline through 24 months
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Sfax
country: Tunisia
facility: Hedi Chaker Hospital Child Neurology Department
city: Tunis
country: Tunisia
facility: National Institute Mongi Ben Hmida of Neurology
Study officials:
References:
Clinical trial NCT01281072: Study To Evaluate Long Term Treatment Effect Of Diapep277® In Patients Who Have Completed Study 901 And Study 910** (Extension To 901)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Giving a Vaccination in Three Months
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: DIABETES UNIT
First posted: 2011-01-21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Open label study to evaluate long term treatment effect of diapep277.


Eligibility criteria: Inclusion Criteria:

1. patient that completed 901 and 910 study.

Exclusion Criteria:

1. cpeptide\<0.2

Primary outcomes:
measure: c peptide reserve
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01013272: Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load
Official title: Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B, Chronic
Keywords: entecavir
lamivudine
sequential therapy
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 50
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 with chronic hepatitis B and treated with entecavir for over 6 months (with no previous other antiviral treatment) will be invited to participate in this study. They will be eligible if their liver tests are normal and their viral load is undetectable. Patients will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate suppression of the hepatitis B virus after successful treatment with entecavir. Patients will be monitored closely after switching treatment at 1 months and then every 3 monthly. If there is any evidence of increase in viral load then patients will be given the option of changing back to entecavir.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic hepatitis B treated with entecavir for 6 months or more
* Normal ALT
* Undetectable HBV DNA by Roche Taqman PCR Assay
* No other previous therapy with nucleoside/nucleotide analogues

Exclusion Criteria:

* Presence of other liver diseases including hepatitis C co-infection, autoimmune hepatitis , primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease, and Wilson's disease
* History of hepatocellular carcinoma
* History of decompensated liver disease

Primary outcomes:
measure: Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load
timeFrame: 96 weeks
Secondary outcomes:
measure: Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: James Fung, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06945172: Comparison of Prostate Cancer-related Quality of Life in Sexually Active Men With Favourable Intermediate-risk Localised Prostate Cancer Treated With Total Prostatectomy or Focal HIFU
Official title: Comparison of Prostate Cancer-related Quality of Life in Sexually Active Men With Favourable Intermediate-risk Localised Prostate Cancer Treated With Total Prostatectomy or Focal HIFU
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 102
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this trial is to assess the impact of focal HIFU therapy on quality of life in patients with favourable intermediate-risk localised prostate cancer. The main question it aims to answer is:

What is the prostate cancer-related quality of life in patients with favourable intermediate-risk localised cancer treated by total prostatectomy or focal HIFU ?

Researchers will compare patients with favourable intermediate-risk localised cancer treated by total prostatectomy to patients with favourable intermediate-risk localised cancer treated by focal HIFU to see their quality of life.

Participants will answer EPIC-CP questionnaire 6 months, 12 months and 24 months after treatment


Eligibility criteria: Inclusion Criteria:

* Patient, male, aged between ≥ 40 and ≤ 75 years
* Patient with a life expectancy \> 10 years at the time of inclusion.
* Patient with a therapeutic strategy (prostatectomy or focal HIFU) defined during a PCR.
* Patient with a diagnosis of localised prostate cancer at favourable intermediate risk
* Patient able to tolerate general anaesthesia or type IV sedation
* Patient with normal urinary continence status
* Patient with satisfactory erectile function allowing penetration:
* Patient with targeted biopsies and systematic biopsies
* Patient affiliated to or benefiting from a social security scheme
* French-speaking patients who do not object to the use of their data.

Exclusion Criteria:

* Patients with a contraindication to MRI
* Stage T3a or b on MRI
* Patient on long-term anticoagulants and unable to stop them.
* Patient already included in another study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Quality of Life in relation to prostate cancer
timeFrame: Month 6, month 12 and month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Quint-Fonsegrives
country: France
facility: Clinique La Croix du Sud
Study officials:
References:
Clinical trial NCT00512772: Improved Use of Antibiotic Guidelines in Hospital Environment
Official title: Improved Use of Antibiotic Guidelines in in Hospital Environment: Research on an Implementation Model and the Role of the Hospital Pharmacist.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community-Acquired Pneumonia
Keywords: Time series
Implementation
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2007-08-08
Enrollment: 823
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the hospital with a diagnosis of community-acquired pneumonia or community-acquired pyelonephritis

Brief summary: The purpose of this study is to determine if the use of antibiotic guidelines and thus antibiotics can be improved through a description of possible barriers leading to tailored interventions.


Eligibility criteria: Inclusion Criteria:

* Diagnosed community-acquired pneumonia (CAP)
* Diagnosed community-acquired pyelonephritis

Exclusion Criteria:

* CAP: hospital-acquired pneumonia; patients transferred from other hospital; death within 24h, aspiration pneumonia, immunocompromised status, palliative status, admission due to social reasons
* Pyelonephritis: urinary tract with functional or physical abnormalities, urinary catheterisation, pregnancy, (immunocompromised status, palliative status, admission due to social reasons and history of renal transplant.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg
Study officials:
affiliation: KU Leuven
name: Pieter-Jan Cortoos, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Gert Laekeman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05425472: A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
Official title: An Open, Single-arm, Multicenter Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Esophageal Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: HR070803 for all enrolled subjects
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.


Eligibility criteria: Inclusion Criteria:

1. ECOG performance status 0 or 1
2. Histologically confirmed advanced esophageal carcinoma
3. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)
4. Able and willing to provide a written informed consent

Exclusion Criteria:

1. The tumor obviously invades adjacent organs of esophageal lesions
2. BMI≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening
3. Subjects with unresolved adverse effects of prior therapy at the time of enrolment
4. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently

Primary outcomes:
measure: Objective response rate
timeFrame: for 4 months following the date the last patient was randomized
Secondary outcomes:
measure: Progression Free Survival
timeFrame: for 4 months following the date the last patient was randomized
measure: Disease Control Rate
timeFrame: for 4 months following the date the last patient was randomized
measure: Duration of Response
timeFrame: for 4 months following the date the last patient was randomized
measure: Overall Survival
timeFrame: for 6 months following the date the last patient was randomized
measure: Number of Patients with Adverse Events as Assessed by NCI-CTCAE V5.0
timeFrame: for 6 months following the date the last patient was randomized
measure: ECOG Score for performance status
timeFrame: for 6 months following the date the last patient was randomized
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT00018772: Risk Factors for Venous Thromboembolism
Official title: 2779 Epidemiology of Genetic and Acquired Risk Factors for Venous Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Venous Thrombosis
Pulmonary Embolism
Keywords: coagulation
thrombosis genetic markers
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Deep venous thrombosis is the presence of blood clots, usually in the legs that lead to either local problems or breathing problems if the clot moves to the lungs. This study is designed to assess both clinical conditions as well as common genetic factors that lead to more risk of deep venous thrombosis. Clinical conditions of venous thrombosis include: stroke, malignancy, and situations such as surgery, pregnancy, trauma, or travel.


Eligibility criteria: Patients must be 18 years with the ability to understand and consent to questionnaire and blood draw, including understanding of genetic testing..

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: VAMC
state: Colorado
Study officials:
name: Richard Marlar, Ph.D.
References:
Clinical trial NCT00511472: An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)
Official title: A Multicenter, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 on Postprandial Plasma Glucose Concentrations After Daily Administration MK-0941 Before Each Meal (q.a.c) in Subjects With Type 2 Diabetes Being Treated With Basal Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-08-06
Enrollment: 70
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: A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.


Eligibility criteria: Inclusion Criteria:

* Male or female (of non-childbearing potential) between 18 to 70 years of age
* Diagnosed with Type 2 Diabetes and currently being treated with basal insulin
* Smokers may participate, but they are limited to 10 cigarettes per day while at the clinic and must follow clinic smoking rules

Exclusion Criteria:

* History of Type 1 diabetes
* Treated with peroxisome proliferator-activated receptor (PPAR) agonists within 12 weeks prior to study start
* History of severe hypoglycemia
* Allergic to insulin

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event During the Study
timeFrame: 39 days
Secondary outcomes:
measure: Number of Participants Who Experienced an Adverse Event - Titration Scheme 1
timeFrame: 25 days
measure: Number of Participants Who Experienced an Adverse Event - Titration Scheme 2
timeFrame: 25 days
measure: 24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7
timeFrame: 24 hours
measure: Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period
timeFrame: Outpatient Days 1 to 14
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03130972: Etiology of Motor Developmental Delay in Children
Official title: Etiology of Motor Developmental Delay in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delayed;Development;Physical
Delayed; Development, Intellectual
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 1355
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children visiting tertiary hospital for motor developmental delay

Brief summary: This study aims to identify the etiology of children with motor developmental delay, in association with the results of magnetic resonance imaging and genetic analysis.

Detailed description: Results of other available assessments including Gross Motor Function Measurements and Bayley Scale of Infant Development, second edition, modified Ashworth Scale, IQ score and developmental language assessments are to be collected.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of motor developmental delay
* available results of functional assessments at ages older than 18 months Functional measures include either GMFM or BSID_II

Exclusion Criteria:

* single domain delay other than motor (e.g., speech delay)

Primary outcomes:
measure: Change of Gross Motor Function Classification System from baseline at 6 months
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Brain MRI findings
timeFrame: From the date of the first documented developmental delay until the date of last documentation or date of death from any cause, whichever came first, assessed up to 100 months
measure: Mental quotient
timeFrame: From the date of the first documented developmental delay until the date of last documentation or date of death from any cause, whichever came first, assessed up to 100 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01966172: Multimodal Analgesic Treatment Versus Traditional Morphine Analgesia After Cardiac Surgery
Official title: Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Postoperative Pain
Keywords: NSAID, gabapentin, multimodal, morphine, dexamethasone, cardiac surgery, postoperative pain, analgesia.
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 180
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: To test if multimodal analgesia with different analgesic medication offer better pain relief, lesser side effects and is safe compared to conventionel opiod analgesia after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* age\>18
* any cardiac procedure with sternotomy
* able to give informed consent

Exclusion Criteria:

* cardiac surgery without sternotomy
* peripheral neuropathy
* neurological disease
* psychiatric illness
* history of GI bleeding
* chronic pain (i.e. back pain, cancer, arthritis)
* serum creatinine \>150 μmol/l
* hepatic disease with elevated liver enzymes (SGPT and SGOT elevated to 1.5 times maximum normal value)
* allergic to study medication
* alcohol abuse
* abuse of narcotics or medication
* pregnancy
* participation in other clinical trials
* insufficient language skills
* In addition intensive care unit (ICU) stay for more than 24 hours was used as a pre-defined post randomization exclusion criteria, because prolonged ICU stay and ventilator treatment would interfere with study analgesic protocol.

Primary outcomes:
measure: Evaluation of analgesic effect by 11-NRS scale
timeFrame: 4th postoperative day
Secondary outcomes:
measure: Additional analgesic consumption
timeFrame: 4th postoperative day
measure: Hospital stay in days.
timeFrame: days until discharge
measure: Evaluation of side-effects by daily questionnaire
timeFrame: 4th postoperative day
measure: Cardiac complications
timeFrame: 30th postoperative day
measure: Other complications
timeFrame: 30th postoperative day
measure: 30 day Mortality
timeFrame: 30th postoperative day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Peter Skov Olsen, MD,PhD,DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Sulman Rafiq, MD
role: STUDY_CHAIR
References:
citation: Rafiq S, Steinbruchel DA, Wanscher MJ, Andersen LW, Navne A, Lilleoer NB, Olsen PS. Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial. J Cardiothorac Surg. 2014 Mar 20;9:52. doi: 10.1186/1749-8090-9-52.