louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00332774: Nevanac 3-Month Safety Study With QID Dosing
Official title: A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 149
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.


Eligibility criteria: Inclusion Criteria:

* Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 10
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Macular thickness
Secondary outcomes:
measure: contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon for Trial Locations
state: Texas
Study officials:
affiliation: Medical Monitor
name: Stephen Lane
role: STUDY_DIRECTOR
References:
Clinical trial NCT00763074: Exercise and Diet in Type 2 Diabetic Women
Official title: Clinical Trial of Exercise and Diet in Type 2 Diabetic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Type 2 Diabetes
Keywords: Intra-Abdominal Fat
Adipokines
Exercise
Diet therapy
Lead sponsor: Eulji University Hospital
Sponsor class: OTHER
First posted: 2008-09-30
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effects of 12 weeks' increased daily physical activity versus diet restriction on regional fat distribution, insulin sensitivity and adipokines including retinol binding protein-4 (RBP-4), leptin, adiponectin, and a new marker, adiponectin to leptin ratio (AL ratio), in type 2 diabetic women.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patient
* BMI\>23kg/m2
* Female

Exclusion Criteria:

* The patients with co-morbidity such as heart failure, chronic kidney disease or liver cirrhosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Eulji University
name: Kyung Wan Min, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06646874: Active Video Game Influence Cognitive Ability
Official title: Active Video Game Using Virtual Reality Influence Cognitive Ability in Sedentary Female University Students: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Keywords: Virtual Reality
Cognitive performance
Physical activity
Sedentary female student
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The experiment was conducted at the Human Biomechanics Laboratory of the College of Applied Medical Sciences of Prince Sattam bin Abdulaziz University between February 2024 and May 2024. During the briefing, all questions were answered to ensure that participants understood the experiment and its objectives. On the day of the experiment, demographic information was collected, including age, height, weight, body mass index (BMI), and preferred leg. An Eye-Level Weight Beam scale (Detecto, Webb City, MO, USA) was used to determine the weight and height of the subjects. To identify the preferred leg, participants were observed ascending stairs or kicking a ball.

Participants were recruited and assigned to one of two groups, either the control group or the VR group. Participants were required to attend one experimental session in a random order using Microsoft Excel's (Microsoft Corp., Redmond, WA, USA) random list function. The VR group was required to play a 20-minute game of Beat Saber VR, while the control group was asked to sit quietly for 20 minutes without any activities assigned. This study used an accelerometer from ActivPal (PAL Technologies Ltd, Glasgow, UK) to capture the PA levels of the VR group throughout the VR game. Following previously published validation studies and manufacturer recommendations, a strip of Tegaderm (3M, St. Paul, MN) was attached to the preferred leg's front thigh.


Eligibility criteria: Inclusion Criteria:

* Female college students
* Low physical activity (inactive)
* Age (18 to 23 years)
* No previous medical condition affecting PA level
* No visual impairments
* Have never experienced the VR game used in the trial

Exclusion Criteria:

* Male students
* Physically active

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 20 minutes
measure: ActivPal
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Human Biomechanics Laboratory of the College of Applied Medical Sciences of Prince Sattam bin Abdulaziz University
state: Central
Study officials:
References:
Clinical trial NCT00357474: Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs
Official title: A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: HCC, TACE, PEIT
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2006-07-27
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.

Detailed description: To compare the below things between PEIT group and TACE group

1. Survival

   1. 5 year overall survival rate
   2. Disease free survival rate
2. Recurrence a. recurrence rate

Eligibility criteria: Inclusion Criteria:

* The evidences of HBV(+) \&/or HCV(+) infection or liver cirrhosis
* Two to three tumor nodules with Child-Pugh classification A or single to three tumor nodules with Child-Pugh classification B
* The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm.
* 1) Only for newly detected HCCs which were not treated before or 2) If treated before, it should be noted that there is no evidence of recurrence within the latest 6 months and, and also it should be remotely recurred more than 2cm apart from primary lesion.
* It should be compatible with the typical findings of HCCs radiologically(MD CT or dynamic MRI)

Exclusion Criteria:

* In case of hepatic vein or portal vein invasion radiologically(CT or MRI)

Primary outcomes:
measure: overall survival rate
timeFrame: 5 year
Secondary outcomes:
measure: Disease free survival rate and recurrence rate
timeFrame: 5 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul NUH
state: Chongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: J H Yoon, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03754374: Health Care Access for Asylum Seekers in Brittany : Description, Associated Factors and Levers of Improvement
Official title: Health Care Access for Asylum Seekers in Brittany : Description, Associated Factors and Levers of Improvement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adult Asylum Seekers Who Have Applied for Asylum at the Regional Prefecture in Rennes
Keywords: Primary health
migrants
health care utilization
access to healthcare
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult asylum seekers who have applied for asylum in the prefecture of Brittany

Brief summary: The main objective of this research is to study the logics and the associated factors with asylum seekers use of dedicated health structures.

This objective aims to address major concerns related to the entry and continued participation in the health care system of asylum seekers, including the medical and social dimensions.

It aims to produce, then analyze and disseminate data on the factors associated with seeking asylum seekers to optimize the care of migrants in the French health system


Eligibility criteria: Inclusion Criteria:

- Adult asylum seekers who have applied for asylum in the prefecture of Brittany from May 22, 2018 to May 21, 2019 (or one year after obtaining authorization from the CCTIRS and the CNIL).

Exclusion Criteria:

* Migrants not asylum seekers (with tourist visa, migrants of the European Union (foreign nationality and not membership in the Schengen area), migrants arriving in a family reunification, migrant in irregular situation).
* Minor : unaccompanied foreign minor or with their family
* Incapacity of a person to consent

Primary outcomes:
measure: Use of health care structure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: COALLIA - Plateforme d'accueil des demandeurs d'asile
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Pascal Jarno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01002274: Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
Official title: Open-Label, 40-weeks Extension of Protocol MCS-2-TWN-a to Further Evaluate the Efficacy and Safety of MCS-2 for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
BPH
MCS-2
Multi-Carotenoids
Lower Urinary Tract Symptoms
International prostate symptom score
Lead sponsor: Health Ever Bio-Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 180
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label extension study of another study protocol, MCS-2-TWN-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for this study.

Detailed description: This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 40 weeks of MCS-2 treatment at the same daily dosage as the active treatment given under the protocol MCS-2-TWN-a. Subjects are limited to those who are currently not being treated medically for BPH or LUTS.

Eligibility criteria: Inclusion Criteria:

* Subject has completed 12 weeks of treatment under the protocol MCS-2-TWN-a.
* Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study.

Exclusion Criteria:

* Subject has severe LUTS at the last visit under the protocol MCS-2-TWN-a.
* Subject is considered ineligible for the study by the investigator(s).

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 40 weeks
Secondary outcomes:
measure: Changes from baseline in International Prostate Symptom Scores (I-PSS)
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yeong-Shiau Pu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00168974: Neuropathic Pain and Fabry Disease
Official title: Somatosensoric and Autonomic Disturbances in Female Patients With Fabry Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fabry Disease
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Fabry disease is a rare X-linked lysosomal storage disorder. The mutations result in a deficiency of the lysosomal enzyme α-galactosidase causing accumulation of glycosphingolipids in the vascular endothelial cells and many other tissues. An early sign of the disease is painful small fibre neuropathy presenting in two forms: 1. a constant burning sensation in the hand and feet and 2. Fabry crises consisting of attacks of excruciating pain. Given the X-linked inheritance, male patients are severely affected. Recently attention has been drawn to female patients whether they also show signs of nerve involvement.

The purpose of this study is to evaluate the small fibre neuropathy in female Fabry patients. Correlation with X-chromosome inactivation will be attempted. Recombinant human α-galactosidase A is now available for patients. A part of this study is evaluation the long term efficacy of enzyme replacement therapy in female patients with Fabry disease and neuropathy.

Male family members with Fabry disease will be examined.


Eligibility criteria: Inclusion Criteria:

* All adult patients with confirmed Fabry disease

Exclusion Criteria:

* Patients who cannot cooperate
* Patients who are unable to understand the purpose

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
Study officials:
affiliation: Danish Pain Research Center
name: Anette T Moller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish Pain Research Center
name: Troels S Jensen, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04703374: A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects
Official title: A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Compare Pharmaciokinetics, Pharmacodynamics and Safetry After Single/ Multiple Administration of CKD-382 and D026 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: GERD
Keywords: CKD-382
D026
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382 and D026 in healthy subjects

Detailed description: A randomized, open-label, crossover phase 1 clinical trial to compare pharmacokinetics, pharmacodynamics and safety after single / multiple administration of CKD-382 and D026 in healthy subjects

Eligibility criteria: Inclusion Criteria:

1. Between 19 aged and 50 aged in healthy adult
2. Body weight more than 50kg
3. Body Mass Index more than 18.0 and under 27.0
4. Who has negative result on Helicobacter Pylori antibody test

Exclusion Criteria:

1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
2. Have a gastrointestinal disease history(including surgery) that can effect drug absorption
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.

Primary outcomes:
measure: AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) Evaluation PK after multiple dose
timeFrame: 0~24h
measure: Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose Evaluation PD for ambulatory 24hr pH monitor
timeFrame: Baseline versus Multiple dose during 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
Study officials:
References:
Clinical trial NCT03413774: Unexplained Early Miscarriage : Role and Prevalence of Lower Genital Tract Infections
Official title: Unexplained Early Miscarriage : Role and Prevalence of Lower Genital Tract Infections in Rural Area in Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: First Trimester Abortion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 1850
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * The Study group included Women with recent unexplained early miscarriage (pregnancy duration 12 weeks or less and miscarriage within 4 weeks)
* The control group included Women with any other gynecological complaint or in need of family planning

Brief summary: The study group included 910 women who attended Fayoum university hospital gynecology outpatient clinic for postabortive evaluation. The control group included 940 women attended outpatient clinic for any other procedure or complaint

Detailed description: The study group included 910 women who attended Fayoum university hospital gynecology outpatient clinic for postabortive evaluation. The control group included 940 women attended outpatient clinic for any other procedure or complaint all patients were screened by serum samples to detect IgM / IgG to Chlamydia trachomatis (DRG Chlamydia Trachomatis IgM / IgG Enzyme immunoassay) and by high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR- (from +ve samples to chlamydial IgM / IgG).

Eligibility criteria: Inclusion Criteria:

* The Study group included Women with recent unexplained early miscarriage (pregnancy duration 12 weeks or less and miscarriage within 4 weeks)
* The control group included Women with any other gynecological complaint or in need of family planning

Exclusion Criteria:

* Miscarriage of Pregnancy duration more than 12 ws Documented causes of miscarriage as fetal or uterine anomalies, antiphospholipid syndrome, endocrine factors....etc
* Recent antibiotic, antifungal or antiprotozoal treatment

Primary outcomes:
measure: prevalence of lower genital tract infection
timeFrame: At time of examination
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: professor
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06876974: Assessment of Prognosis and Myocardial Reperfusion in Patients with ST-segment-elevation Myocardial Infarction (STEMI) According to Coronary Atherosclerotic Burden.
Official title: Assessment of Prognosis and Myocardial Reperfusion in Patients with ST-segment-elevation Myocardial Infarction (STEMI) According to Coronary Atherosclerotic Burden.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: STEMI - ST Elevation Myocardial Infarction (MI)
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with STEMI and treated with primary PCI (pPCI) at the University Hospital of Nancy between 2003 and 2023.

STEMI was defined as follows:

1. continuous chest pain lasting at least 20 min
2. ST-segment elevation ≥1 mm in ≥2 contiguous leads on a 12-lead electrocardiogram or left bundle branch block and (3) treatment within 24 h of pain onset.

Brief summary: In the current literature, it has been widely demonstrated that the extend of coronary atherosclerotic burden is associated with adverse long-term outcomes. Little is known about the impact of atheroma burden and either myocardial reperfusion and short-term outcomes after ST-segment elevation myocardial infarction (STEMI). Several angiographic scores have been used to measure the extend and severity of coronary atheroma. The SYNTAX score and the Gensini score have been shown to be independent predictors of cardiovascular events and mortality in stable coronary artery disease as well as in myocardial infarction.

This research therefore aims to assess the impact of overall coronary atherosclerotic burden, measured by two angiographic scores (SYNTAX score and Gensini score), both before and after primary percutaneous angioplasty, in patients with STEMI according to different clinical subgroups.


Eligibility criteria: Inclusion criteria:

- patients presenting with STEMI and treated with primary PCI (pPCI) at the University Hospital of Nancy between 2003 and 2023.

Exclusion criteria:

- patients with missing or incomplete coronary angiogram.

Primary outcomes:
measure: All-cause mortality
timeFrame: 2 years
measure: Recurrent acute coronary syndrome
timeFrame: 1 year
Secondary outcomes:
measure: All-cause mortality in patients with STEMI related to out-of-hospital cardiac arrest or cardiogenic shock
timeFrame: 2 years
measure: Recurrent acute coronary syndrome in patients with STEMI related to out-of-hospital cardiac arrest or cardiogenic shock
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01218074: Platelets Antiaggregation Control Enhancement (PACE) Study
Official title: Platelets Antiaggregation Control Enhancement Study: an Independent Randomized Blind Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bleeding
Blood Transfusion
Keywords: bleeding
blood sparing procedure
desmopressin
aggregometry
thromboelastography
Lead sponsor: Cardiochirurgia E.H.
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs. This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. The investigators test the hypothesis that routine use of aggregometry could show antiaggregated patient and lead to normalization of platelet function via administration of Desmopressin thus limiting bleeding and transfusions.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing surgical myocardial revascularization.

Exclusion Criteria:

* none.

Primary outcomes:
measure: Bleeding Volume
timeFrame: 12 hours after end of operation
Secondary outcomes:
measure: Use of allogenic blood transfusions.
timeFrame: In hospital stay (usually 5 to 8 days after operation)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: European Hospital
Study officials:
References: