louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01099319: Renalof in the Treatment of Elderly Patients With Gallstones
Official title: Efficacy and Safety of Renalof Administration in the Treatment of Elderly Patients With Gallstones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholelithiasis
Keywords: Dietary supplement
Renalof
gallstones
elderly
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2010-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: 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 efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged \>65 years). The duration of this double-blind placebo controlled phase 3 clinical trial will be 6 months. The estimated number of patients to be recruited and randomized for the study is 40.


Eligibility criteria: Inclusion Criteria:

* Confirmation of cholelithiasis by ultrasonography with or without clinical symptoms.
* Signed informed consent

Exclusion Criteria:

* Previous surgical intervention for the treatment of cholelithiasis
* Cholelithiasis with acute symptoms requiring emergency surgery
* Cholelithiasis associated with neoplastic condition of any localization or origin
* Usage of other antioxidants within the duration of the clinical trial
* Handicap and/or psychiatric condition preventing treatment accomplishment

Primary outcomes:
measure: Size of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment)
timeFrame: 6 month
measure: Number of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment)
timeFrame: 6 month
Secondary outcomes:
measure: Presence of digestive symptoms associated with cholelithiasis
timeFrame: 6 month
measure: Occurrence of adverse effects during treatment
timeFrame: 6 month
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: "Dr. Salvador Allende" Clinical-Surgical-Docent Hospital
state: Havana
Study officials:
affiliation: "Dr. Salvador Allende" Clinical-Surgical-Docent Hospital
name: Guillermo Hernández Mojena, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02594319: Understanding Mechanisms of Health Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fruit and Vegetable Consumption
Incentive Interventions
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically fruit and vegetable consumption. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with a control condition in which no rewards are offered. Study participants will provide reports of their fruit and vegetable consumption each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their fruit and vegetable consumption. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards.


Eligibility criteria: Inclusion Criteria:

* Consume fewer than 5 servings/day of fruits and vegetables
* Daily access to internet for 3 weeks following baseline session
* Have or are willing to create an account on PayPal

Exclusion Criteria:

-

Primary outcomes:
measure: Fruit and Vegetable Consumption, servings per week
timeFrame: 3 weeks
measure: Perceived Behavioral Control scale score
timeFrame: 3 weeks
measure: Attitudes scale score
timeFrame: 3 weeks
measure: Intrinsic Motivation scale score
timeFrame: 3 weeks
measure: Fruit and vegetable consumption, servings per week
timeFrame: 5 weeks
measure: Perceived Behavioral Control scale score
timeFrame: 5 weeks
measure: Attitudes scale score
timeFrame: 5 weeks
measure: Intrinsic Motivation scale score
timeFrame: 5 weeks
Secondary outcomes:
measure: Perceived Stress Scale score
timeFrame: 3 weeks
measure: Perceived Stress Scale score
timeFrame: 5 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Gardiner CK, Bryan AD. Monetary Incentive Interventions Can Enhance Psychological Factors Related to Fruit and Vegetable Consumption. Ann Behav Med. 2017 Aug;51(4):599-609. doi: 10.1007/s12160-017-9882-4.
Clinical trial NCT05515419: Allogeneic Cord Blood for Neurological Diseases in Adults
Official title: Allogeneic Cord Blood in the Treatment of Neurological Diseases in Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Neurological Diseases
Stroke
Spinal Cord Injuries
Keywords: Adults
Lead sponsor: The Medical Pavilion Bahamas
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: allogeneic cord blood for adult patients with neurological diseases
Primary purpose: TREATMENT

Brief summary: This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood therapy for adult patients with neurological diseases.

Detailed description: Neurological diseases such as stroke or spinal cord injuries are very common etiologies causing disability in developed countries. Cord blood possess various stem and progenitor cells, as well as their secreted regenerative factors, and is known to repair injured brain. The investigators clinical research aims to determine the safety and efficacy of allogeneic Umbilical Cord Blood for adult patients with neurological diseases such as stroke and spinal cord injury.

Eligibility criteria: Inclusion Criteria:

* Ischemic or hemorrhagic stroke (onset \< 24 months), or
* Spinal cord injury (onset \< 24 months)

Exclusion Criteria:

* Raised intracranial pressure
* Malignant cancer
* Renal failure
* Severe pulmonary dysfunction

Primary outcomes:
measure: Changes in modified Rankin Scale (mRS)
timeFrame: 1 month - 3 months - 6 months - 12 months
Secondary outcomes:
measure: Monitoring Adverse Events
timeFrame: 1 month - 3 months - 6 months - 12 months
Other outcomes:
Locations:
Study officials:
affiliation: The Medical Pavilion Bahamas
name: Conville S Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01178619: Sonographic Differences in Brain Measurements Between Normal and Intrauterine Growth Restriction (IUGR) Fetuses
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intra-uterine Growth Restriction
Keywords: IUGR fetuses
symmetrical IUGR
asymmetrical IUGR
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women 28-37 GA, singleton, otherwise normal fetuses

Brief summary: Intrauterine growth restriction is being suspected in cases where the fetal estimated weight is less then the 10 th percentile for its gestational age. Abdominal circumference is the most influenced measurement in this cases. Head circumference on the other hand can be or not be influenced. Previous studies have shown that transverse cerebellar diameter (TCD) is constant to gestational age and is not influenced by IUGR.Other showed lower TCD in IUGR fetuses. We would like to study the differences in cerebellar, vermian and corpus callosum growth between normal to IUGR fetuses and between symmetrical and asymmetrical IUGR. In this observational study we will include pregnant women between 28-37 gestational week with a singleton otherwise normal pregnancies. We will measure the fetal TCD, vermian distances and the CC, abdominal circumference, head circumference and femur length. we will compeer these measurements according to the following groups:normal fetuses, symmetrical and asymmetrical IUGR.


Eligibility criteria: Inclusion Criteria:

* singleton,
* 28-37 GA,
* well dated pregnancy.

Exclusion Criteria:

* multifetal pregnancies,
* no first trimester dating,
* fetuses with known chromosomal or structural anomalies.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03351218: Agency in Dystonia
Official title: Neuronal Correlates of Agency in Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dystonia, Primary
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2017-11-22
Enrollment: 76
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups study : patients versus healthy controls
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, using computerized cognitive assessments combined with multi-modal neuroimaging approach investigators aim to address three specific questions on patients with cervical and myoclonus dystonia:

(i) investigate various aspects of the sense of agency and relationship to the severity of dystonia symptoms, (ii) characterize the possible link between abnormalities of movement perception and alteration of sense of agency in dystonia, (iii) (identify the neuronal underpinnings of the defective sense of agency in dystonia.

Detailed description: This is a single-centre, two-group ( dystonia and control), case-control study using behavioural and novel multimodal neuroimaging techniques to address the study aims.

The battery of the tasks will include explicit-agency tasks, a visual discrimination task on objects movement perception. The magnetic resonance acquisition protocol will include MP2RAGE structural (10 min duration), multi echo (3 echo times) multiband (MB factor 4) resting state functional neuroimaging (15 minutes duration) and multi shell diffusion imaging sequence (15 minutes duration)

Eligibility criteria: Inclusion Criteria:

* diagnosis of isolated adult-onset cervical dystonia (CD) or myoclonus dystonia (MD);
* duration of disease of more than one year
* no botulinum toxin injection for at least three months before the study
* normal or corrected-to-normal vision.

Exclusion Criteria

* any neurological history except for dystonia,
* history of dopamine antagonist treatment,
* secondary dystonia,
* dystonia in the upper limbs,
* inability to maintain gaze straight.

Primary outcomes:
measure: agency tasks behavioral outcome measures
timeFrame: throughout study completion, an average 2 years
measure: agency tasks behavioral outcome measures
timeFrame: throughout study completion, an average 2 years
Secondary outcomes:
measure: MRI measures
timeFrame: throughout study completion, an average 2 years
measure: MRI measures
timeFrame: throughout study completion, an average 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'investigation Clinique
state: Ile de France
Study officials:
References:
Clinical trial NCT02835118: A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose, Safety and Pharmacokinetic Study of Ascending Doses of Oral CB-183,315 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clostridium Difficile Associated Diarrhea (CDAD)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2016-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of oral doses of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and females.


Eligibility criteria: Inclusion Criteria:

* Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease
* Electrocardiogram (ECG) shows no clinically significant abnormalities
* Is in good health

Exclusion Criteria:

* Pregnant or lactating females
* Has prior exposure to surotomycin
* Has received an investigational drug or participated in any experimental procedure within1 month prior to study entry and at least 6 half lives from last intake of study drug
* Participants 18 to 49 years of age that has taken any regular, prescribed, or over-the-counter medication
* Has any significant concurrent therapies
* Has a positive drug screen
* Has a positive human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C screen
* Has donated blood or blood products in the 60 days preceding screening
* Is an active intravenous drug user or abuses alcohol
* Has had a malignancy within the last 5 years
* Has inadequate protection against pregnancy during the conduct of the study and until 1 month after last dose of study drug
* Has received any antibiotics within 30 days prior to first dose of study drug
* Has known hypersensitivity to daptomycin

Primary outcomes:
measure: Number of participants with an Adverse Event (AE)
timeFrame: Up to Day 21
measure: Number of participants who discontinued study treatment due to an AE
timeFrame: Up to Day 14
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Chandorkar G, Zhan Q, Donovan J, Rege S, Patino H. Pharmacokinetics of surotomycin from phase 1 single and multiple ascending dose studies in healthy volunteers. BMC Pharmacol Toxicol. 2017 Mar 28;18(1):24. doi: 10.1186/s40360-017-0123-z.
Clinical trial NCT05045118: The Impact of Structured Patient Education Material (SPEM) in Improving Clinical and Behavioural Outcomes in Home-based Cardiac Rehabilitation Program Participants: A Pilot Study
Official title: The Impact of Structured Patient Education Material (SPEM) in Improving Clinical and Behavioural Outcomes in Home-based Cardiac Rehabilitation Program Participants: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischaemic Heart Disease
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to examine the impact of providing a digital education material to participants of home based cardiac rehabilitation in improving clinical and behavioural outcomes

Detailed description: This is a pilot study aiming to assess the impact of providing a structured patient education material in a digital form to participants of home based cardiac rehabilitation program in University Malaya Medical Centre.

Eligibility criteria: Inclusion Criteria:

* Age 20-70 years
* Fulfills the low to moderate exercise participation risk criteria for Cardiac rehabilitation program phase 2 as per the American Association of Cardiovascular and Pulmonary Rehabilitation standards
* Able to participate in a treadmill exercise program
* Cognitively able to give consent, and able to read and utilize the digital education material

Exclusion Criteria:

* Stratified as high risk to participate in an aerobic exercise program as per the American Association of cardiovascular and Pulmonary Rehabilitation standards

Primary outcomes:
measure: Retention rate
timeFrame: 3 months
measure: Cardiorespiratory fitness
timeFrame: 3 months
Secondary outcomes:
measure: Smoking status
timeFrame: 3 months
measure: Compliance to medication
timeFrame: 3 months
measure: Compliance to exercise
timeFrame: 3 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya
Study officials:
References:
Clinical trial NCT00410618: Neurological Effects of Chemotherapy and Radiation Therapy in Patients With Colon Cancer
Official title: Neurological Effects of Chemotherapy and Radiation Treatment: Colon Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive/Functional Effects
Colorectal Cancer
Long-term Effects Secondary to Cancer Therapy in Adults
Keywords: cognitive/functional effects
long-term effects secondary to cancer therapy in adults
recurrent colon cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-12-13
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Colon cancer

Brief summary: RATIONALE: Learning about the long-term effects of chemotherapy and radiation therapy on brain function may help doctors plan cancer treatments.

PURPOSE: This clinical trial is looking at the neurological effects of chemotherapy and radiation therapy in patients with colon cancer.

Detailed description: OBJECTIVES:

Primary

* Identify the nature and long-term ramifications of CNS injury as a result of cancer treatment in patients with colon cancer.

Secondary

* Analyze differences in cognitive measures and MRI data in these patients.
* Correlate MRI measures with cognitive performance in these patients.

OUTLINE: Patients undergo cognitive performance assessment and MRI.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer
* Received chemotherapy and radiotherapy for colon cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Nature and long-term ramifications of CNS injury as a result of cancer treatment
Secondary outcomes:
measure: Differences in cognitive measures and MRI data
measure: Relationship between MRI measures and cognitive performance
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center at University of Arizona Health Sciences Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Sheryl Reminger, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06824818: Study to Assess the Feasibility of Stopping Prostate Cancer Treatment Early in Elderly Patients
Official title: A Feasibility Trial of LHRH Agonist Discontinuation in Elderly Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elderly
Prostate Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 155
Sex: MALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study follows a \*\*single-group assignment\*\* model, where all participants discontinue LHRH agonist therapy and are monitored for testosterone and PSA levels over 3 years to assess the feasibility of this approach.
Primary purpose: TREATMENT

Brief summary: This study seeks to identify if it is feasible to stop Luteinizing Hormone-Releasing Hormone (LHRH) Agonist Therapy in elderly men with prostate cancer. We hypothesize that elderly prostate cancer patients on long term androgen ablation with LHRH agonists will be permanently castrated and do not require ongoing LHRH agonist therapy. Participants will be monitored by testosterone testing throughout study.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer with \>3 years of LHRH agonist therapy.
* Age ≥70 years.
* ECOG performance status ≤2
* Baseline testosterone of \< 20 ng/ml
* No prior chemotherapy or Lu-PSMA (unless survival predictions are favorable).
* Ability to understand and sign informed consent.

Exclusion Criteria:

* none

Primary outcomes:
measure: feasibility of stopping LHRH agonist therapy
timeFrame: 12 months after discontinuing LHRH agonist therapy
Secondary outcomes:
measure: Patient interest in stopping treatment
timeFrame: End of enrollment (approximately 3 years after study start)
measure: Medication Impact
timeFrame: End of study (approximately 3 years after last participant is enrolled)
measure: Impact on Testosterone Levels (12 months)
timeFrame: 12 months after last participant starts study
measure: Impact on Testosterone Levels (36 months)
timeFrame: 36 months after last participant starts study
measure: Health Care Savings
timeFrame: End of study (approximately 3 years after last participant is enrolled)
measure: Visit Compliance
timeFrame: End of study (approximately 3 years after last participant is enrolled)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Illinois at Chicago (UIC)
state: Illinois
city: Chicago
country: United States
facility: UChicago Medicine Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Nabiel Mir, MD
role: STUDY_CHAIR
References: