louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03995940: Neurological Outcomes of Primary Intracerebral Haemorrhage
Official title: Neurological Outcomes of Primary Intracerebral Haemorrhage Admitted in Intensive Care Unit at the University Hospital of Grenoble Alpes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Hemorrhage, Hypertensive
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a primary and spontaneous supratentorial ICH

Brief summary: The main objective of this study is to determine the one-year neurological outcome of patients admitted to an intensive care unit (ICU) for a primary and spontaneous supratentorial intracerebral hemorrhages (ICH).

Detailed description: ICH represent a diagnostic and therapeutic emergency. ICH account for 20% of strokes with a one-year mortality of more than 45% and an uncertain neurological outcome.

For ICH patients, the main initial challenge is to determine the long term neurological outcomes and adapt the therapeutic strategy.

The majority of primary and spontaneous ICH studies involve patients in stroke units.

The study is an observational type 3 research with all the patients admitted in all the University Hospital of Grenoble Alpes ICUs between July 2012 and July 2017 for a primary and spontaneous supratentorial ICH

Eligibility criteria: Inclusion Criteria:

* Admission in one of the four University Hospital of Grenoble Alpes ICUs between July 2012 and July 2017 for primary and spontaneous supratentorial ICH.
* Not opposed to participate in a research protocol (asked by phone call)

Exclusion Criteria:

* Pediatric patient
* Infra-tentorials ICH
* No spontaneous ICH (after head trauma)
* Secondary ICH (anevrisum, arteriovenous malformation, tumor, hemorrhagic transformation, vascularitis)
* Persons referred to in Articles L1121-5 to L1121-8 of the french public health code

Primary outcomes:
measure: Neurological outcomes
timeFrame: One year after the stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
References:
Clinical trial NCT01988740: Markers of Oxidative Stress in a Early Week Miscarriage: Ischemia of Modified Albumin
Official title: Markers of Oxidative Stress in a Early Week Miscarriage: Ischemia of Modified Albumin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: First Trimester Pregnancy
Fetal Heart Activity Absent
Absence of Fetal Pole on Ultrasonographic Examination.
Keywords: Ischemia-modified albumin
Recurrent pregnancy loss
Abnormal placenta
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2013-11-20
Enrollment: 180
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: first trimester pregnancy with absence of fetal cardiac activity

Brief summary: The finding that ischemia-modified albumin (IMA) is increased in pre-eclamptic pregnancy suggests a role for IMA as a potential biomarker for abnormal placental development related to miscarriage.This study was undertaken to evaluate IMA levels in women with recurrent pregnancy loss (RPL).

Detailed description: Ischemia-modified albumin (IMA) measured by the albumin cobalt binding test is a relatively new biomarker in the identification of myocardial ischemia. Experimental studies have shown that pregnancies normally develop in a relatively hypoxic intrauterine environment, and the subsequent reperfusion and oxidative stress is important for physiological trophoblast development. The finding that maternal serum IMA levels are raised so early in pregnancy provides further support for IMA as a potential marker for abnormal placental development that may be related to early pregnancy loss. In this study, we aimed to evaluate maternal circulating IMA levels in women with RPL by comparing them with healthy controls.

Eligibility criteria: Inclusion Criteria:

* first trimester pregnancy
* absence of fetal cardiac activity
* absence of fetal pole
* history of two or more unexplained first trimester miscarriages
* no live births
* apparently healthy women attending for antenatal care in the first trimester with at least one previous uneventful natural pregnancy

Exclusion Criteria:

* pre-existing diabetes or vascular disease were excluded
* diagnosis of chromosomal, anatomic, endocrinologic and autoimmunologic etiology of recurrent pregnancy loss
* Women with multiple pregnancy
* any major or minor fetal anomaly
* current smokers

Primary outcomes:
measure: first trimester pregnant women
timeFrame: under 14 w gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Training and Research Hospital
Study officials:
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: hüseyin cengiz, md
role: STUDY_DIRECTOR
References:
citation: Cengiz H, Dagdeviren H, Kanawati A, Suzen Caypinar S, Yesil A, Ekin M, Yasar L. Ischemia-modified albumin as an oxidative stress biomarker in early pregnancy loss. J Matern Fetal Neonatal Med. 2016;29(11):1754-7. doi: 10.3109/14767058.2015.1061494. Epub 2015 Jul 2.
Clinical trial NCT06845540: Oral Metformin for Treating Melasma in Latin American Women
Official title: Oral Metformin in the Treatment of Melasma: a Prospective Trial in Latin American Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Melasma
Keywords: melasma
metformin
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if metformin can treat melasma in Latin American women. The main question it aims to answer is:

- Can metformin help reduce the dark patches of melasma?

Researchers will test two different doses of metformin (500 mg and 1000 mg) to see if either one helps improve melasma.

Participants will:

* Take a metformin pill every day for three months.
* Go to the clinic twice: once at the beginning and once at the end of the study.
* Get a phone call from the researchers to check how they're doing and ask about any changes or side effects.


Eligibility criteria: Inclusion Criteria: Latin American women aged 21 years or older, diagnosed epidermal or mixed melasma

Exclusion Criteria: pregnancy, breastfeeding, use of hydroquinone or tretinoin within 2 months before the study, or undergoing laser treatment, peels, microdermabrasion, or microneedling within 2 months of the study. Patients with a history of renal or liver disease, metformin allergy, diabetes, hypoglycemia, or those on medications that could interact with metformin will also be excluded.

Primary outcomes:
measure: Change in modified Melasma Area and Severity Index (mMASI) score from baseline to week 12
timeFrame: Baseline (Week 0) to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Administración de Servicios Médicos (ASEM) Clinicas Externas
Study officials:
affiliation: University of Puerto Rico
name: Cristina Brau
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00203840: Pediatric Sleep Questionnaire: Normalization and Validation Study
Official title: Pediatric Sleep Questionnaire: Normalization and Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders
Keywords: Sleep Disorders
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 325
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with sleep disorders

Brief summary: The information gathered from normal pediatric patients seen at the Pediatric Neurology Clinic in the DCAM and LaRabida Children's Hospital will be used to standardize and validate the information gathered from pediatric patients with sleep disorders. This will serve as the information source for a pediatric sleep database.

Detailed description: A sleep questionnaire will be administered to patients who present to the Pediatric Neurology Clinic and LaRabida Children's Hospital. The questions asked are those routinely obtained in the clinical practice of sleep medicine. Medical students, residents and faculty as part of their normal clinical responsibilities will administer the questionnaire. The database will be maintained in Filemaker Pro program for future research purposes. Collection of the data will require approximately 15 minutes. A database file number not related to the patient medical record number will be assigned to each patient. The investigator will keep a separate log linking patient database number and patient medical record number. The logbook will be kept under lock and key by the investigator.

Eligibility criteria: Inclusion Criteria:

* All patients seen in the Pediatric Neurology Clinic and at LaRabida Children's Hospital

Exclusion Criteria:

* Adults

Primary outcomes:
measure: Pediatric Sleep Questionnaire
timeFrame: When data from clinic patients becomes available
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Michael Kohrman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02291640: Pediatric Intubation Among Nursing
Official title: Coparison of Miller and CoPilot Laryngoscopes for Intubation by Nurses During Child Chest Compression. A Manikin Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Intubation, Endotracheal
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare time, success rates of video laryngoscope and direct laryngoscope for the emergency intubation with an immobilized cervical spine in a standardized pediatric manikin model.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in nursing

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Success of intubation
timeFrame: 1 day
Secondary outcomes:
measure: Time to intubation
timeFrame: 1 day
Other outcomes:
measure: Cormack-Lehan scale
timeFrame: 1 day
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04759040: Improvement of Migraine Severity and Frequency With Migraineguard ™
Official title: Migraineguard ™ Supplement Reduces the Severity and Frequency of Migraine , a Randomized, Placebo-controlled, Double-blind, Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Headache
Keywords: migraine
headache
Lead sponsor: Herbacure Natural
Sponsor class: INDUSTRY
First posted: 2021-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Numerous treatments have been recommended for the prevention of migraine. The purpose of this randomized double-blind placebo controlled trial was to assess the efficacy of MIGRAINEGUARD ™ supplement by Herbacure Natural containing a combination of COQ10 , magnesium, riboflavin ,feverfew , Skullcap and black pepper as prophylactic treatment for migraine.

Detailed description: Our team will assess MIGRAINEGUARD ™ , a migraine prevention supplement marketed Herbacure Natural for individual suffering from multiple migraine attacks in one month . The purpose of this 7-months , randomized, double-blind, placebo controlled study is to evaluate the efficacy and safety of MIGRAINEGUARD ™ produced by Herbacure Natural , A Canadian company based in Vancouver , BC , in reducing migraine headache severity and frequency of attacks compared to placebo when used every day, as a preventative solution for migraine and to assess and monitor the safety of its usage for adverse effects.

The primary end-point is the severity and the frequency reduction of migraine attacks. The secondary end-points will be the existence of adverse reaction.

Eligibility criteria: Inclusion Criteria:

* Adult aged 18 to 65 years Female and Male
* Based on IHS criteria ,are diagnosed with migraine (criteria of the International Classification of Headaches Disorders)
* Individuals with minimum of 3 severe to extreme migraine attacks during the last 3 months .
* Generally in good health

Exclusion Criteria:

* Individuals taking any preventive treatment for migraine
* Excessive usage of painkillers
* Cancer \& Head injury and trauma
* Any medical condition that may impact the validity of collected information
* Previous usage of Botox within 6 months of study
* Last week usage of triptans

Primary outcomes:
measure: Number of patient experiencing migraine attack reduction by at least 50 percent in one month .
timeFrame: 7 months
measure: Severity of migraine headache reduction after & Months
timeFrame: 7 Months
Secondary outcomes:
measure: Adverse Reactions
timeFrame: 7 months
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Herbacure Natural
state: British Columbia
Study officials:
affiliation: HERBACURE NATURAL INC
name: AMIR A DOWLATSHAHI, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01414140: Mirena Post-marketing Surveillance in Japan
Official title: Drug Use Investigation of Mirena
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Mirena, contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 567
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is women who patients who are inserted Mirena for intrauterine contraception. The study is expected to collect data of 550 women.

Brief summary: This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of women who are inserted Mirena for intrauterine contraception. The objective of this study is to assess safety and effectiveness of Mirena under real-life practice conditions. A total 550 patients will be recruited and followed for 5 years.


Eligibility criteria: Inclusion Criteria:

* Women who are inserted Mirena for intrauterine contraception Exclusion Criteria:
* Women who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena
timeFrame: After Mirera insertion, up to 5 years
measure: Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena
timeFrame: After Mirera insertion, up to 5 years
Secondary outcomes:
measure: Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of Mirena
timeFrame: After Mirera insertion, up to 5 years
measure: Pregnancy rate
timeFrame: After Mirera insertion, up to 5 years
measure: Released amount of Levonorgestrel [estimated from removed Mirena]
timeFrame: After Mirera insertion, up to 5 years
Other outcomes:
Locations:
city: Many locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03416140: Effectiveness Chronic Kidney Disease & Therapeutic Exercise
Official title: Effectiveness and Safety of the Therapeutic Exercise in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Diseases
Exercise
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 0
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 assess the effectiveness and safety of the therapeutic exercise effects in patients with chronic kidney disease. An randomized clinical trial is carried out. A total sample of 70 patients with chronic kidney disease is recruited and divided into a therapeutic exercise group and a control group. The kidney function (creatinine clearance as main outcome) is measured at baseline and 1 month after treatment start.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic kidney disease

Exclusion Criteria:

* Cognitive impairment and non signed consent inform form

Primary outcomes:
measure: Kidney function
timeFrame: Change from Baseline creatinine clearance at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Galdakao
country: Spain
facility: Pierre Neyra Bohórquez
state: Bizkaia
Study officials:
affiliation: Nephrology Unit, Galdakao Hospital, Spain
name: Pierre Neyra Bohórquez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02491840: Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study
Official title: Biomoleculars Markers of Sensitivity to Pre- and Post-operative Chemotherapy of Gastric and Cardia Adenocarcinomas: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric and Cardia Adenocarcinomas
Keywords: gastric cancer
cardia cancer
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Some subtypes of gastric and cardia tumors such as adenocarcinoma or gastric linitis with disseminated cells respond poorly to the pre-operative chemotherapy, and some of them do not respond to chemotherapy usually performed. Doing chemotherapy in these patients could delay their surgical management. The completion of chemotherapy for these patients would be a bad prognosis factor according to recent data from the literature. Therefore, the aim of this research is to find prognostic markers of sensitivity to chemotherapy usually performed. The investigators are going to use biopsies realized at diagnosis and select patients "good and bad" responders.

Primary purpose:

To study cardia and gastric tumors, molecular markers sensitivity to pre- and post- perative chemotherapy protocols (EOX protocol ... FOLFOX) or chemoradiation

Secondary purposes:

* To assess the impact of patients' lifestyle (via a questionnaire) on the response to chemotherapy
* To study markers of cancer stem cells
* To correlate clinical and molecular markers with patient survival and quality of life questionnaires
* To characterize the expression levels (Met, Her2, FGFR2) and mutations (p53 ras) in frequently deregulated genes in gastric cancers.
* To characterize the level of expression of predictive candidate markers (ΔNp73, TAp73, HDAC4, mir140, EZH2, CXCL12, CXCR4, CXCR7) found in the literature.
* To correlate the abnormalities found in the with tumor stages (before and after chemotherapy) and with 5 years overall survival and progression-free patients


Eligibility criteria: Inclusion Criteria:

Gastric adenocarcinoma (any location) or cardia adenocarcinoma

* Age\> 18 years
* WHO Index≤ 3
* Subject having signed an informed consent

Exclusion Criteria:

* Other cancers undergoing chemotherapy treatment
* Pregnant or breastfeeding
* Inability to understand information (understanding with difficulties ...)

Primary outcomes:
measure: Assessment of expression level of Met
timeFrame: at 15 days
measure: Assessment of expression level of Her2
timeFrame: at 15 days
measure: Assessment of expression level of FGFR2
timeFrame: at 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital, Strasbourg, france
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Benoît ROMAIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01398540: Cellular and Humoral Immunity in Elderly After Immunization With a Japanese Encephalitis Vaccine
Official title: Characterisation of Cellular and Humoral Immunity in Elderly People After Immunization With a Purified, Inactivated Japanese Encephalitis Vaccine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Humoral and Cellular Immune Responses
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this project is to investigate humoral and cellular immune responses before and after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 60 years of age and 18-40 years old subjects.


Eligibility criteria: Inclusion Criteria:

* adults (18-40 years old)
* adults (≥60 years),
* both sexes
* willingness to sign written informed consent form

Exclusion Criteria:

* age below 18 years or between 41-59 years old
* status post japanese encephalitis, tick born encephalitis (TBE), dengue, yellow fever or West Nile virus infection
* previous immunization against yellow fever, japanese encephalitis (dengue or WNV)
* current acute infection (body temperature above 37,9°C)

Primary outcomes:
measure: cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination
timeFrame: 7 days after the 2 JE vaccinations
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Specific Prophylaxis and Tropical medicine, Vienna
name: Ursula Wiedermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: