louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00405249: Safety Study of Elvucitabine in HIV-1 Subjects
Official title: 14-Day Randomized Double-Blind Comparative Viral Kinetic Study of Elvucitabine Versus Lamivudine Once Daily to HIv-1 Subjects With M184V
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV-1
Treatment Experienced
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2006-11-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.

Detailed description: This is a 14 day on treat/14 day off treatment randomized, double blind viral kinetic study of elvucitabine versus lamivudine administered once daily to HIV infected subjects with a documented M184V variant.

Eligibility criteria: Inclusion Criteria:

* HIV infected, clinically stable, adults
* HIVRNA 5000 -150,000, CD4 100
* Genotypically documented M184V variant
* Receiving stable ART.

Exclusion Criteria:

* Hep B
* HIV-1 genotype for 4 protease inhibitors
* HIV-1 genotype positive for 2 NNRTI mutations
* Previous therapy with system myelosuppressive potential within 3 months of study start
* Use of Epogen or Neupogen
* History of cirrhosis
* Alcohol or drug dependence
* Inability to tolerate oral medication
* Women who are pregnant or breast feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Kathleen Squires, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00557349: Ulcer Prevention Study in Post Gastric Bypass Patients
Official title: A Randomized, Double-blind Clinical Trial Comparing Zegerid Capsule to Famotidine in Preventing Anastomotic (Marginal) Ulcers in Post Gastric Bypass Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Marginal Ulcers
Keywords: gastric bypass surgery
anastomosis, Roux-en-Y
Complication, Postoperative
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2007-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery.

Detailed description: The purpose of this research is to evaluate information about the control of gastric acid in post gastric bypass surgery patients. Goal is to determine which medication best reduces the incidence of anastomotic ulcers post-operatively.

Eligibility criteria: Inclusion Criteria:

* Subject is age ≥ 18 years
* Patient meets the criteria for laparoscopic gastric bypass surgery
* Females only: Patient is willing to take a urine pregnancy test

Exclusion Criteria:

* Subject allergic to omeprazole or famotidine
* Patient receiving antifungal (i.e. ketoconazole or itraconazole)
* Hepatic insufficiency
* History of Crohns disease
* History of Zollinger-Ellison disease
* Patient received an investigational drug within 30 days of enrollment
* Patient currently enrolled in another research project
* Females Only: Pregnancy or plan on becoming pregnant during the next 14 weeks

Primary outcomes:
measure: Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.
timeFrame: during first 14 weeks after surgery
Secondary outcomes:
measure: Number of Participants With Upper Endoscopy Indicated Due to Complaints
timeFrame: during first 14 weeks after surgery
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Roger de la Torre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01797549: Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy
Official title: Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Traumatic brain injury
functional near infrared spectroscopy
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: Center for Neuroscience and Regenerative Medicine (CNRM)
First posted: 2013-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females (military health care beneficiaries and non military health care beneficiaries) age between 18 and 60 years who have a diagnosis of moderate or severe traumatic brain injury as well as age, gender, education matched non-TBI volunteers.

Brief summary: The goal of this project is to develop a test to assess frontal lobe function using a rapid, inexpensive, objective, and standardized method, without the need for expertise in cognitive test administration. Such methods would be particularly helpful in traumatic brain injury (TBI), where objective measures are needed, and would greatly expand the capacity to make such assessments in clinical practice and research.


Eligibility criteria: Inclusion Criteria:

* Able to read, write, speak and understand English
* history of having sustained a TBI prior to enrollment. Evidence will be any one of the following 3 criteria:

  1. GCS 3 - 12
  2. Post-traumatic amnesia \> 24 hours
  3. TBI-related abnormality on neuroimaging (either CT or MRI). (Some missing information about the initial injury (i.e. documentation of initial GCS) is not necessarily exclusionary if the bulk of the available history is indicative that the patient suffered a TBI and meets the inclusion criteria)

Exclusion Criteria:

* Multiple sclerosis, pre- or co-existing
* Stroke (other than stroke at the time of TBI)
* Pre-existing developmental disorder
* Pre-existing epilepsy
* Pre-existing major depressive disorder
* Pre-existing schizophrenia

Primary outcomes:
measure: Measure of hemodynamic response function
timeFrame: Two years
Secondary outcomes:
measure: Measure of the degree of impairment
timeFrame: Two years
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Center for Neuroscience and Regenerative Medicine (CNRM)
state: Maryland
Study officials:
References:
citation: Chernomordik V, Amyot F, Kenney K, Wassermann E, Diaz-Arrastia R, Gandjbakhche A. Abnormality of low frequency cerebral hemodynamics oscillations in TBI population. Brain Res. 2016 May 15;1639:194-9. doi: 10.1016/j.brainres.2016.02.018. Epub 2016 Mar 17.
Clinical trial NCT06975449: Validation the Effectiveness of Graded Training in the MultiComponent Physical Exercise Program (Vivifrail) Among Senile Care Center Residents: A Randomized Controlled Study
Official title: Validation the Effectiveness of Graded Training in the MultiComponent Physical Exercise Program (Vivifrail) Among Senile Care Center Residents: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty
Physical Inactivity
Aging
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effectiveness of the Vivifrail multicomponent physical exercise program among elderly residents with different levels of frailty in long-term care centers. A 12-week intervention will be conducted in randomly assigned experimental and control groups. Outcomes include physical performance, fall risk, grip strength, calf circumference, and ICOPE function.


Eligibility criteria: Inclusion Criteria:

* Age ≥70, resident in LTC center, ambulatory, physician-cleared for training

Exclusion Criteria:

* Conditions listed in Vivifrail exclusion criteria (e.g., acute MI, unstable angina, recent fractures, uncontrolled hypertension, etc.)

Primary outcomes:
measure: SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24
timeFrame: SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24
measure: Fall risk assessment (TUG, gait speed, number of falls) at Weeks 0, 4, 8, 12, 16, 20, 24
timeFrame: Fall risk assessment (TUG, gait speed, number of falls) at Weeks 0, 4, 8, 12, 16, 20, 24
Secondary outcomes:
measure: ICOPE function assessment at Weeks 0, 12, 24
timeFrame: ICOPE function assessment at Weeks 0, 12, 24
measure: Grip strength (hand dynamometer) at Weeks 0, 12, 24
timeFrame: Grip strength (hand dynamometer) at Weeks 0, 12, 24
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
References:
Clinical trial NCT06633549: The Effect of Home Accidents Prevention Training Given to Mothers of Mentally Disabled Children
Official title: Investigation of the Effect of Home Accidents Prevention Training Given to Mothers of Mentally Disabled Children Aged 0-6: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disability
Mothers
Home Injury
Keywords: home accidents
child
mother
risk factors
mental disability
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this research is to examine the effect of education for home accidents given to mothers with mentally disabled children in the age group of 0-6.

Detailed description: This study was conducted to examine the effects of education on home accidents given to mothers of mentally disabled children aged 0-6. The sample of the study consisted of 83 mothers of mentally disabled children aged 0-6 registered in four special education centers in Kocaeli province between May 2023 and June 2024 (education group: 40 mothers; control group: 43 mothers). Research data were collected using the Information Form and the Scale for Diagnosing Mothers' Safety Precautions for Home Accidents in 0-6 Year Old Children. The mothers in the education and control groups were informed about the study, their written consent was obtained, and they were asked to fill out information forms. The mothers in the education group were given a single, 45-minute face-to-face education on preventing home accidents. The Mothers' Safety Measures for Home Accidents in Children aged 0-6 were administered the Scale before and one month after the training. The mothers in the control group did not receive any training; the Scale for Identifying Mothers' Safety Precautions for Home Accidents in Children Aged 0-6 was administered during the first interview and again one month later.

Eligibility criteria: Inclusion Criteria:

* Mothers with mentally disabled children aged 0-6
* Mothers who agree to participate in the research
* Mothers who agree to be contacted after 1 month for the post-test
* Mothers who know and speak Turkish at the native level

Exclusion Criteria:

* Mothers with mentally disabled children over the age of 6
* Mothers who do not agree to participate in the study
* Mothers who do not agree to be contacted after 1 month for the post-test
* Mothers with mental disabilities
* Mothers who do not know or speak Turkish at the native level

Primary outcomes:
measure: The Scale for Diagnosing the Safety Measures of the Mother for Household Accidents in Children Aged 0-6
timeFrame: Before the training and one month after the training.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University
Study officials:
References:
Clinical trial NCT05135949: Strength After Elbow Fractures in the Elderly
Official title: Strength and Function After Non-operative Treatment of Displaced Olecranon Fractures in the Elderly: Implications of Standing UP From a Seat
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fracture;Elbow
Keywords: Operative
Non Operative
Lead sponsor: Fraser Orthopaedic Research Society
Sponsor class: NETWORK
First posted: 2021-11-26
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients for displaced olecranon fractures

Brief summary: Elderly patients strength and function, specifically the ability to rise from a seat after either operative or non operative treatment of an mayo type 2 olecranon fracture.

Detailed description: Elderly patients with an olecranon fracture will receive appropriate treatment as determined by the treating surgeon. Patients will then be assessed at 6 weeks, 6 months and 12 months post treatment. Assessments include, range of motion, patient reported outcomes and a strength test.

Eligibility criteria: Inclusion Criteria:

1. ≥65 years of age
2. Mayo type II olecranon fracture
3. Ambulatory (with or without the use of walking aides)

Exclusion Criteria:

1. Additional injuries to the affected arm or contralateral arm
2. Associated nerve injury
3. Dementia or cognitive impairment that inhibits the collection of outcome measures
4. Likely problems, in the judgement of the investigator, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged, patients without adequate support, etc.)
5. Injury or previous deficit to the contralateral arm
6. Currently enrolled in any other research study involving drugs or medical devices
7. Open fractures
8. Inability to provide informed consent

Primary outcomes:
measure: Extension Strength
timeFrame: 12 Months
Secondary outcomes:
measure: Arc of Motion
timeFrame: 12 months
measure: Mayo Elbow Performance Index
timeFrame: 12 Months
measure: Disabilities of the Arm, Shoulder, and Hand
timeFrame: 12 Months
measure: Satisfaction Score
timeFrame: 6 weeks, 6 months and 12 months
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
affiliation: Orthopaedic Surgeon
name: Farhad Moola, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02928549: Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study
Official title: Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Keywords: interviews
16-1378
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSK Gynecology clinic

Brief summary: The purpose of this study is to explore the experiences of Black women who receive care for ovarian cancer at Memorial Sloan Kettering Cancer Center, or "MSK" for short. The study consists of interviews with Black women who recently obtained some part of their ovarian cancer care at MSK.


Eligibility criteria: Inclusion Criteria:

* Participant must have been diagnosed with ovarian, fallopian tube or primary peritoneal cancer and treated by an MSK physician.
* Participants must be able to provide verbal informed consent.
* Participants must be 18 years of age or older.
* Participants must self-identify as Black/African American.
* Participant must be able to understand and speak in English

Exclusion Criteria:

* Inability or refusal to identify race/ethnicity.
* Presence or development of a physical, cognitive or psychiatric deficit resulting in an inability to provide meaningful informed consent or to understand the study or complete the interview.

Primary outcomes:
measure: accessing care
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kara Long-Roche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04466449: Identification of Entamoeba Spp. in Assuit Governorate Hospitals.
Official title: Different Methods for Detection and Identification of Entamoeba Species in Assuit Governorate Hospitals.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Entamoeba Spp. Identification
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients of different age groups with diarrhea/dysentery attending the outpatient clinics at Assiut University Hospitals

Brief summary: 1. Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery.
2. Evaluatation the role of different cultures in diagnosing Entamoeba .
3. Molecularly differentiation between Entamoeba species to monitor the true prevalence of E.histolytica .

Detailed description: Entamoeba histolytica is a common pathogenic protozoan widely distributed throughout the world (10% of the world's population), with 50,000-100,000 deaths reported annually(1) .It is a health problem both in Egypt and worldwide (2) The disease is more prevalent in densely populated areas with poor hygiene requirements and lacking sanitary water supply, especially in rural areas(3). It causes many digestive complications including diarrhea , and fever(2). it transmits through bloodstream forming abscesses in the brain, eye, liver and other vital organs and tissues or even lead to death in some cases . Some individuals have no symptom of the disease but transmit the infection to others(4) It is well- established that E. histolytica leads to invasive disease in humans. Although both E. dispar and E. moshkovskii are still considered to be non pathogenic and free-living amoebas, respectively, some reports suggest their potential role in provoking disease in humans (5) Cysts of E.dispar , E.moshkovskii and E.hartmanni can be confused with E.histolytica. cysts in the parasitological examination(6) The molecular assays, is preferable as it detects E. histolytica , differentiates it from other species and monitors its true prevalence for better treatment and effective control (2)

Eligibility criteria: Inclusion Criteria:

* : Male and female patients of different age groups with diarrhea/dysentery attending the outpatient clinics at Assiut University Hospitals .

Exclusion Criteria:

* No exclusion criteria .

Primary outcomes:
measure: Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery
timeFrame: 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Youstina Talaat
Study officials:
References:
Clinical trial NCT05429749: Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery
Official title: Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hip Fractures
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: JW Pharmaceutical
First posted: 2022-06-23
Enrollment: 264
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a clinical trial to evaluate the effect of intravenous iron supplement with Ferinject (Ferric Carboxymaltose) in preventing postoperative delirium after hip fracture surgery.

Detailed description: We hypothesized that IV iron supplement will (1) decrease postoperative delirium in hip fracture patients and (2) decrease the amount of transfusion and transfusion-related complications.

Eligibility criteria: Inclusion Criteria:

* femur neck fracture, intertrochanteric fractures
* Iron deficiency anemia (Hb\<12 in women, Hb\<13 in men)
* Iron deficiency (Serum ferritin \<100ug/L or transferrin saturation\<20%)
* Who understands this clinical trial and volunteers and agrees to this trial

Exclusion Criteria:

* Patient under the age of 65 years
* Hb\<7 or someone who has acute symptom of anemia(tachycardia, dyspnea, or dizziness)
* High energy trauma
* Preoperative delirium
* MMSE\<10
* Underlying disease which involves cognitive dysfunction (e.g. neurovascular diseases, acute myocardial infarction, pulmonary embolism)
* Those who are inappropriate to participate in the clinical trial assessed by the investigators

Primary outcomes:
measure: Postoperative delirium
timeFrame: since immediately after the surgery to the discharge date
Secondary outcomes:
measure: Postoperative transfusion
timeFrame: Postoperative admission datessince immediately after the surgery to the discharge date
measure: Transfusion-related complications
timeFrame: since immediately after the surgery to the discharge date
measure: Functional outcomes
timeFrame: since immediately after the surgery to the discharge date
measure: Hematologic outcomes
timeFrame: since immediately after the surgery to the discharge date
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References: