louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00562809: The Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Mild Hypertension
Official title: A Multicenter, Open-Label Study Assessing the Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Hypertension Not Controlled by Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-11-22
Enrollment: 1005
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: The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and 300/25 mg in patients with hypertension not controlled by monotherapy.

Detailed description: The primary and secondary endpoints applied to sub-groups defined by age, race, diabetes, metabolic syndrome and prior HTN therapy.

Eligibility criteria: Inclusion Criteria:

* The patient must have hypertension and uncontrolled SBP on monotherapy.
* Patients who have read, signed and received a copy of the informed consent prior to any study procedures

Note: Female patients must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception (intrauterine device, oral contraceptives, barrier method with spermicide) and must agree to use an effective method of contraception throughout the study.

Exclusion Criteria:

* Any history of secondary hypertension
* History of hypertensive encephalopathy, stroke, or transient ischemic attack (TIA) within the past 12 months
* History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months

Primary outcomes:
measure: Change in the mean SBP
timeFrame: from baseline to week 18
Secondary outcomes:
measure: Change in mean DBP
timeFrame: from baseline to week 18.
measure: Changes in mean SBP and DBP
timeFrame: from baseline to week 10
measure: SBP and DBP response and control rates
timeFrame: at weeks 10 and 18
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Linda Mooney
role: STUDY_DIRECTOR
References:
Clinical trial NCT01004809: AVODART® Alopecia Post-marketing Surveillance (PMS)
Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and Effectiveness of AVODART® Administered in Korean Androgenetic Alopecia Patients According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alopecia
Keywords: Dutasteride
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-10-30
Enrollment: 712
Sex: MALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients administrated dutasteride with male pattern hair loss (androgenetic alopecia)

Brief summary: Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients

Detailed description: An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and effectiveness of dutasteride administered in Korean androgenetic alopecia patients according to the prescribing information

Eligibility criteria: Inclusion Criteria:

* Men (18-41 years of age) with male pattern hair loss (androgenetic alopecia)
* Subjects with no experience of treatment using dutasteride
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol
* Subjects who prescribed with dutasteride according to the Prescribing Information

Exclusion Criteria:

* Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with dutasteride following the locally approved Prescribing Information. Subject who give informed consent is enrolled. However, if institution waives the requirement for informed consent, informed consent is not required. In this case, monitoring does not proceed.

Primary outcomes:
measure: Occurrence of adverse event after dutasteride administration
timeFrame: 2 years
Secondary outcomes:
measure: Occurrence of unexpected adverse drug reaction after dutasteride administration
timeFrame: 2 years
measure: Occurrence of serious adverse events after dutasteride administration
timeFrame: 2 years
measure: Effectiveness of dutasteride judged by a physician
timeFrame: 2 years
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06087809: Improving Short Course Treatment for Common Pediatric Infections
Official title: Improving Short Course Treatment for Common Pediatric Infections: A Randomized Quality Improvement Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-acquired Pneumonia
Skin Infection
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized quality improvement trial to improve the proportion of cases of community-acquired pneumonia (CAP) treated with no more than 5 days of antibiotics the proportion of cases of skin and soft tissue infections (SSTI) treated with no more than 7 days of antibiotics by primary care clinicians (PCC) within the Pediatric Physicians' Organization at Children's (PPOC), a state-wide pediatric primary care network. Interventions include education and feedback; clinical decision support (CDS) delivered at the point of care; and the combination of the two.


Eligibility criteria: INCLUSION CRITERIA

* Primary care clinician practicing within a PPOC primary care pediatric practice
* Treated at least one case of pneumonia or skin and soft tissue infection in calendar year 2022

EXCLUSION CRITERIA

-None

Primary outcomes:
measure: Proportion of cases of CAP and SSTI treated with short course antibiotic treatment
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of cases of CAP treated with short course antibiotic treatment
timeFrame: 3 months
measure: Proportion of cases of SSTI treated with short course antibiotic treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
References:
Clinical trial NCT01327209: Blood Glucose Monitoring System Clinical Study
Official title: Blood Glucose Monitoring System Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Intuity Medical, Inc
Sponsor class: INDUSTRY
First posted: 2011-04-01
Enrollment: 202
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who have been diagnosed with diabetes and are testing their blood glucose level at least once per day.

Brief summary: Verify the following with blood glucose monitoring system:

* precision and accuracy versus YSI reference
* user evaluation
* labeling comprehension


Eligibility criteria: Inclusion Criteria:

* Be diagnosed with Diabetes
* Be between 12 and 70 years of age
* Be able to read, write, and understand English
* Be able and willing to give Informed Consent
* Have used an SMBG meter system for at least one year
* Be currently testing blood glucose levels at least once per day

Exclusion Criteria:

* Inability to provide Informed Consent
* Subject does not meet Inclusion Criteria
* Subject does not agree to test for infectious diseases per clinical protocol
* Subject has minimally one positive test for any infectious disease listed under Exclusion Criteria per protocol
* Subject with any condition (in addition to those which are listed in the pre-screen Exclusion Criteria tests) which in the opinion of the Investigator may place the subject or site personnel at excessive risk
* Subject's physical condition/limitation prevents the person from using a BGMS on their own

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of San Diego
state: California
city: Miami
country: United States
facility: University of Miami - School of Medicine
state: Florida
city: Minneapolis
country: United States
facility: Park Nicollett Institute - International Diabetes Center
state: Minnesota
city: San Antonio
country: United States
facility: Cetero Research DGD
state: Texas
Study officials:
affiliation: Park Nicollett Institue - International Diabetes Center
name: Richard Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05797909: The PCOS Challenge Study
Official title: The PCOS Challenge Study: For the Collection of Information to Advance Research and Improve Care for PCOS Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Ovary Syndrome
Keywords: pcos
polycystic ovary syndrome
polycystic ovarian syndrome
stein leventhal syndrome
Lead sponsor: PCOS Challenge: The National Polycystic Ovary Syndrome Association
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population for The PCOS Challenge Study will include individuals with a clinical diagnosis of PCOS, individuals self-diagnosed with PCOS, individuals with symptoms of PCOS (e.g., hirsutism, irregular menstrual cycles), and demographic-matched controls without PCOS.

Brief summary: The primary purpose of The PCOS Challenge Study will be to conduct high-quality research where patients are included in the design, and answering the questions that patients identify as important to their lived experience with PCOS. In partnership with clinical investigators, patients will work on the development and management of data collection, the research agenda, and the sharing of research findings. The PCOSC Study will promote the advancement of research that provides reliable, useful, and meaningful information to patients with PCOS and their clinicians.

The population for The PCOS Challenge Study will include individuals with a clinical diagnosis of PCOS, individuals self-diagnosed with PCOS, individuals with symptoms of PCOS (e.g., hirsutism, irregular menstrual cycles), and demographic-matched controls without PCOS.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with PCOS by a health professional, self-diagnosed with PCOS or individuals with PCOS symptoms
* Willing to sign the consent form
* Able to understand the registry surveys or what is being asked

Exclusion Criteria:

* Unable to understand the surveys or what is being asked
* Unwilling to sign the consent form

Primary outcomes:
measure: Information
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: PCOS Challenge: The National Polycystic Ovary Syndrome Association
state: Maryland
Study officials:
affiliation: PCOS Challenge: The National Polycystic Ovary Syndrome Association
name: Sasha Ottey, MHA, MT (ASCP)
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Alabama at Birmingham
name: Ricardo Azziz, MD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05591209: Pattern of Admission and Outcome of Patients Admitted to the Intensive Care
Official title: Pattern of Admission and Outcome of Patients Admitted to the Intensive Care Unit of a Tertiary Hospital in Low Resource Setting. A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Treatment Outcome
Lead sponsor: Haramaya Unversity
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 419
Sex: ALL
Minimum age (years): 4
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients admitted to ICU of HrU- HFCSH

Brief summary: The study was a retrospective observational cohort where patient medical record review was done and data were gathered on 419 cases. The ICU admission pattern and patient outcome were the primary outcomes presented in the manuscript.

Detailed description: The study was conducted at a teaching University hospital in a low-resource setting retrospectively on admission to ICU over the last five years. samples were selected using a simple random sampling technique to come up with the desired number.

Eligibility criteria: Inclusion Criteria:

* complete medical record
* admission to ICU

Exclusion Criteria:

* patients who were transferred or self discharged

Primary outcomes:
measure: pattern of admission and outcome of patients admitted to the Intensive care Unit of a tertiary hospital in Low resource setting. A cohort study
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Harar
country: Ethiopia
facility: HFSUH
state: Harari NS
city: Harar
country: Ethiopia
facility: Haramaya university
Study officials:
References:
Clinical trial NCT06931509: Integration and Interactions Between Visual and Proprioceptive Feedbacks
Official title: Study of the Integration and Interactions Between Visual and Proprioceptive Feedbacks in Hemiplegic Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemiparetic Stroke
Keywords: Computerize mirror
Vibration
Upper limb rehabilitation
Stroke
hemiplegic
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Mental imagery is a rehabilitation technique for stroke patients, involving the mental representation of movement. Recent technical advancements have enabled the use of visual, proprioceptive, and mixed feedback to enhance motor stimulation. Currently, all post-stroke patients receive these techniques indiscriminately. This study aims to demonstrate differences in the integration of visual and proprioceptive feedback in stroke patients and understand the determinants based on the affected brain area.

Patients with motor disabilities will perform motor imagery tasks with various feedback types while their cortical activity is recorded using EEG. EEG data for each type of feedback will be correlated with the lesion area in order to better understand the ongoing mechanisms.


Eligibility criteria: Inclusion Criteria:

* Hemiplegic subjects : Male or female, aged 18 to 80 years, first ischemic or hemorrhagic stroke, having signed the written consent and affiliated or entitled to a social security scheme

Exclusion Criteria:

* Severe cognitive impairment, severe Aphasia or severe neglect that impair ability to understand instructions or to execute tasks

Primary outcomes:
measure: EEG beta desynchronization
timeFrame: Day 1
Secondary outcomes:
measure: Alpha Band
timeFrame: Day 1
measure: Occipital alpha band
timeFrame: Day 1
measure: Beta rebound
timeFrame: Day 1
measure: Parietal beta-band
timeFrame: Day 1
measure: Perception of movements
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Ahmed Adham, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00509509: High Risk Breast Cancer Screening Program
Official title: High Risk Breast Cancer Screening Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Hereditary Breast Cancer (BRCA1, BRCA2)
Lead sponsor: Organisation for Oncology and Translational Research
Sponsor class: OTHER
First posted: 2007-07-31
Sex: FEMALE
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women aged over 40 with high risk of breast cancer

Brief summary: Objectives:

* To screen population with high risk for breast cancer
* To promote the concept and importance of surveillance mammography
* To find out the incidence of breast cancer in population who are in high risk for breast cancer
* To collect blood samples for molecular analysis


Eligibility criteria: Inclusion Criteria:

* Female
* \> 40 years of age
* Women who have first-degree relative suffered from breast cancer
* Women who have first-degree relative suffered from ovarian cancer
* Family history of male breast cancer
* Family history of breast cancer (not necessarily first degree relatives) diagnosed before age of 40
* Family history of breast cancer (not necessarily first degree relatives) affecting 2 or more family members
* Personal history of ovarian cancer
* Personal history of premalignant conditions of breast and ovary

Exclusion Criteria:

* Women with mammogram within one year

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wanchai
country: Hong Kong
facility: UNIMED Medical Institute
Study officials:
affiliation: UNIMED Medical Institute
name: Louis WC Chow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00859209: Capnography in Infants Ventilated With High Frequency Ventilation
Official title: Capnography in Infants Ventilated With High Frequency Ventilation: Prospective, Observational, Multi-Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infants in NICU Ventilated With HFV
Keywords: HVF
Premature infants
ETCO2
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Carmel Medical Center
First posted: 2009-03-10
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants in NICU ventilated with HFV

Brief summary: The investigators hypothesize that dEtCO2 measured by the Microstream® technique via a double-lumen ETT in infants ventilated with HFV would be feasible and adequately represent the arterial CO2 (PaCO2).

Detailed description: All infants with double lumen ETT on HFV are eligible.

Eligibility criteria: Inclusion Criteria:

* All intubated infants with double lumen ETT ventilated with HFV

Exclusion Criteria:

* Infants ventilated with single lumen ETT

Primary outcomes:
measure: The investigators primary outcome measure will be to evaluate the accuracy and the correlation of Microstream® dEtCO2 with the gold standard of PaCO2.
timeFrame: A Year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Bnai Zion Medical Center
name: Kugelman Amir
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kugelman A, Riskin A, Shoris I, Ronen M, Stein IS, Bader D. Continuous integrated distal capnography in infants ventilated with high frequency ventilation. Pediatr Pulmonol. 2012 Sep;47(9):876-83. doi: 10.1002/ppul.22524. Epub 2012 Feb 10.
Clinical trial NCT04107909: Laparoscopic Cholecystectomy:
Official title: Three-port Versus Four-port Laparoscopic Cholecystectomy: A Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecystitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Various modifications have been tried in laparoscopic cholecystectomy since its introduction. One, two and three port LC have been performed on limited scale. we aim to compare three port LC with four port LC in patients with cholelithiasis. The main objective of this study is to evaluate the outcome of 3 ports LC for treatment of cholelithiasis by comparing the result with 4 ports LC with respect to safety and efficacy.

Detailed description: Various modifications have been tried in laparoscopic cholecystectomy since its introduction. One, two and three port LC have been performed on limited scale. we aim was to compare three port LC with four port LC in patients with cholelithiasis. The main objective of this study was to evaluate the outcome of 3 ports LC for treatment of cholelithiasis by comparing the result with 4 To study the efficacy and feasibility of 3 port and 4 port lap cholecystetctomy.

1. To compare the intraoperative and post-operative complications of 3 port and 4 port lap cholecystectomy

1. Operative time,
2. Days of hospital stay.
3. complication
4. post-operative pain ports LC with respect to safety and efficacy.

Eligibility criteria: Inclusion Criteria:

1. Age of patient between 25 and 65 years
2. Diagnosis of chronic cholecystitis, symptomatic cholelithiasis

Exclusion Criteria:

1. Choledocholithiasis
2. Severe Acute Calculus Pancreatitis
3. Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia) 4 . Previous operation or adhesion

Primary outcomes:
measure: compare between the prognosis of three port and four port laproscpic cholecyctectomy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Muhe E. [Laparoscopic cholecystectomy--late results]. Langenbecks Arch Chir Suppl Kongressbd. 1991:416-23. doi: 10.1007/978-3-642-95662-1_189. German.
citation: Traverso LW. Carl Langenbuch and the first cholecystectomy. Am J Surg. 1976 Jul;132(1):81-2. doi: 10.1016/0002-9610(76)90295-6.
citation: Trichak S. Three-port vs standard four-port laparoscopic cholecystectomy. Surg Endosc. 2003 Sep;17(9):1434-6. doi: 10.1007/s00464-002-8713-1. Epub 2003 Jun 13.