louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00899587: Evaluation of the Effects of Oxygen Therapy and Enalapril for Diabetic Macular Ischemia
Official title: Evaluation of the Effects of Oxygen Therapy and Enalapril for Diabetic Macular Ischemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetic Macular Ischemia
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-05-12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: In this study, patients were divided into 3 group with 35 cases including: 1.oxygen 2.enalapril 3.control.

In the beginning of the study, best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), and optical coherence tomography (OCT) were measured. Patients in the oxygen group were given oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month. In the enalapril group, patients were given enalapril 5 mg every night and placebo was given for the patients in third group. At the end of first month the patients' vision was checked again and at the the end of the third month the first physical examinations were performed. In the first group, arterial blood gas (ABG) was taken before and after oxygen therapy as well.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with diabetic macular ischemia

Exclusion Criteria:

* HTN \> 1140/90 or HTN controlled by ACE inhibitors
* FBS \> 200
* Severe anemia, COPD, cataract, HRPDR and diffuse macular edema

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT03500887: Monitoring Stomach Function With an Intragastric Balloon - a Pilot
Official title: A Pilot Study to Investigate Whether Intragastric Pressure During Food Intake Can be Measured Using an Intragastric Bag in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Disorders of Stomach
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.


Eligibility criteria: Inclusion Criteria:

* They are between 18-60 years old.
* Male and female.
* Patients must provide witnessed written informed consent prior to any study procedures being performed.

Exclusion Criteria:

* They are older than 60 years old.
* Have severely decreased kidney function.
* Have severely decreased liver function.
* Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
* Have severe lung disease.
* Have severe psychiatric illness or neurological illness.
* Have any gastrointestinal disease.
* Have any dyspeptic symptoms.
* Women that are pregnant or breastfeeding.

Primary outcomes:
measure: Intragastric pressure during food intake
timeFrame: max 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: KU Leuven
name: Jan Tack, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01858987: Stapler vs. LigaSure in Elective Hepatic Resection
Official title: Stapler vs. LigaSure for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH II - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Resection
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 138
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 optimal technique of parenchymal transection in liver surgery has remained a matter of controversial debate among hepatobiliary surgeons. The optimal technique should enable secure sealing of the vascular and biliary structures that results in low intraoperative blood loss as well as low postoperative complication rates. Although numerous devices have been introduced and are used widely, high-level evidence, randomized controlled trials, that evaluate efficacy and safety of these devices are scarce. In the present randomized controlled trial two techniques of hepatic resection using vascular staplers and the LigaSure vessel sealing device are compared. While the primary endpoint is intraoperative blood loss a set of general and surgical variables will be analyzed to evaluate efficacy and safety of both methods.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective hepatic resection
* Parenchymal transection by vascular stapler and LigaSure feasible
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Extrahepatic resection required based on preoperative imaging
* Participation in concurrent surgical intervention trials
* Expected lack of compliance
* Impaired mental state or language problems

Primary outcomes:
measure: Intraoperative Blood loss
timeFrame: Beginning to end of surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: UniversityHospital Dresden
Study officials:
References:
citation: Fritzmann J, Kirchberg J, Sturm D, Ulrich AB, Knebel P, Mehrabi A, Buchler MW, Weitz J, Reissfelder C, Rahbari NN. Randomized clinical trial of stapler hepatectomy versus LigaSure transection in elective hepatic resection. Br J Surg. 2018 Aug;105(9):1119-1127. doi: 10.1002/bjs.10902.
Clinical trial NCT06858787: Validating CGM for GDM
Official title: The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective pilot study to assess the validity of using a continuous glucose monitor (CGM) in diagnosing gestational diabetes mellitus (GDM). Pregnant individuals between the ages of 18-50 years old receiving prenatal care at Mount Sinai Hospital (e..g, E-Level clinic and Faculty Practice Associates) will be enrolled. Potential participants will be approached during their prenatal care appointments. Participants will complete an informed consent form for the study during their standard-of-care prenatal appointments at our institution.


Eligibility criteria: Inclusion Criteria:

* Ages 18-50
* Singleton pregnancy between 24-32 weeks gestational age
* Prenatal care and delivery at Mount Sinai Hospital

Exclusion Criteria:

* Multiple fetal gestation
* Preexisting diabetes
* Concurrent use of steroids
* Anomalous fetus
* Insufficient prenatal care (identified as missing half the recommended visits or establishing care after 20 weeks gestation)
* Unable to tolerate oral glucose test

Primary outcomes:
measure: Blood glucose from CGM
timeFrame: 10 days from sensor application to completion of testing
measure: Glucose Tolerance Test (GTT) values
timeFrame: 1 hour and 3 hours
measure: Postpartum blood glucose
timeFrame: 4 hours after childbirth
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Angela Bianco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01160887: Diabetes Peripheral Neuropathy and Small-fibre Nerve Damage: A Comparative Study
Official title: Is Diabetic Peripheral Neuropathy Accompanied by Internal Nerve Damage? A Comparative, Clinical Experimental Study of Peripheral and Visceral Nerve Damage in Diabetic Patients and Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Peripheral Neuropathy
Small Fibre Neuropathy
Autonomic Neuropathy
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2010-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with verified diabetic neuropathy.

Brief summary: The purpose of this study is to investigate whether patients with diabetes-related peripheral neuropathic pain also have non-recognized damage to the intestine caused by autonomic neuropathy. The model will shed light on aspects of peripheral nerve injuries on both somatic and as well as visceral sensory nerves. Classical autonomic parameters from electrocardiography (ECG) and Holter (24-h ECG and blood pressure) are compared with peripheral nerve injuries. The damage of autonomic nerves often recognized late in the course when patients develop gastroparesis, however an earlier recognition of this nerve damage may help clarifying the fundamental pathomechanisms and thereby optimize treatment for this patient group in the future.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients between 18 and 75 years with diagnosed diabetes mellitus, according to WHO criteria (World Health Organization).
2. Proven peripheral neuropathy.
3. Oral and written consent, with documentation that all relevant information about the program is given to the patient.
4. The patient must be willing and able to, to meet the planned visit and meet the planned curriculum, including the participation in the experimental investigations.

Exclusion Criteria:

1. Pregnancy or breastfeeding
2. Medical or surgical disease for the study doctor's assessment makes the patient unsuitable for participation in the study
3. Previous or ongoing major depression
4. Patients who can or will not comply with the recommended instructions given by the study doctor
5. Use of analgesic opioid medication less than 24 hours before screening
6. Competitive conditions that can cause peripheral neuropathy (eg, herpes zooster)
7. Clinically significant disease less than 2 weeks from the planned entry in the study
8. People involved in the planning or execution of the study

Primary outcomes:
measure: glucose
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital, Bergen, Norway
name: Georg Dimcevski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05849987: In Depth Observational Clinical Trial Of Retinitis Pigmentosa Patients
Official title: Retinitis Pigmentosa Clinical Study: Examining the Clinical Trial Journey of Retinitis Pigmentosa Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Retinitis Pigmentosa
Keywords: retinitis pigmentosa
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retinitis Pigmentosa patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and registration.

Brief summary: Typically, clinical research participation favors a specific demographic group, and little research exists on how trial attributes affect participation. As such, this study seeks to analyze data from different demographic groups and check for recurring trends that could provide valuable insights for future retinitis pigmentosa patients.


Eligibility criteria: Inclusion Criteria:

* Is 18+ years old
* Confirmed diagnosis of retinitis pigmentosa
* Signed Written Informed Consent

Exclusion Criteria:

* Inability to perform regular electronic reporting
* Participant is actively receiving study therapy in another trial
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.

Primary outcomes:
measure: Number of patient decides to enroll in clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Miura G, Sugawara T, Kawasaki Y, Tatsumi T, Nizawa T, Baba T, Hanaoka H, Yamamoto S. Clinical Trial to Evaluate Safety and Efficacy of Transdermal Electrical Stimulation on Visual Functions of Patients with Retinitis Pigmentosa. Sci Rep. 2019 Aug 12;9(1):11668. doi: 10.1038/s41598-019-48158-5.
citation: Arslan U, Ozmert E, Demirel S, Ornek F, Sermet F. Effects of subtenon-injected autologous platelet-rich plasma on visual functions in eyes with retinitis pigmentosa: preliminary clinical results. Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):893-908. doi: 10.1007/s00417-018-3953-5. Epub 2018 Mar 15.
citation: Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment. Arch Ophthalmol. 2004 Sep;122(9):1297-305. doi: 10.1001/archopht.122.9.1297.
Clinical trial NCT01249287: FMRI in Monitoring Intracerebral Stem Cell Implantation for Chronic Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: stroke
stem cell
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University hospital

Brief summary: A growing number of studies highlight the potential of stem cell transplantation as a novel therapeutic approach for stroke in animal model. But the stem cell therapy for chronic stroke patients has not been well investigated yet. In this study, the investigators will test the hypothesis that intracerebral peripheral blood hematopoietic stem cell (CD34+) (PBSC) transplantation induces neuroplasticity in chronic stroke patients. The remyelination of corticospinal tract in the lesion side, focal increased perfusion and increased cortical activity in the peri-infarcted area will be monitored by the functional MRI after stem cell therapy. The investigators study is aimed to find the potential mechanisms of the functional recovery after stem cell implantation. The investigators also hope to find image surrogate markers for prediction of patient outcome. The possible surrogate markers will be helpful in improving the treatment procedure and patient selection.


Eligibility criteria: Inclusion Criteria:

* Old stroke half an year \~3 year
* One-sided MCA infarction
* NIHSS stroke scale: 9-20

Exclusion Criteria:

* Pacemaker
* Cerebral aneurysm clips
* Neurostimulator
* Metallic heart valves
* IUD
* Joint replacement
* Metal plates
* Bone or joint pins
* Vena cava filters
* Embolization coils
* Cochlear implants
* Greenfieid filer
* Seizures
* Claustrophobia
* Bullet/gunshot
* Prosthesis (non-removeable)
* Artificial limbs (non-removeable)
* Surgical slips
* Metal screws or pins\>
* Shrapnel/metallic fragments
* Harrington rod
* Insulin pump
* Ever had metal removed from in or around the eye
* Ever been metal worker (i.e., welder, machinist)
* Non-removeable hearing aids
* Birdnest or Gianturco filter
* Pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01130987: Implementing a Comprehensive Handoff Program to Improve Patient Safety
Official title: Implementing a Comprehensive Handoff Program to Improve Patient Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Errors
Keywords: resident
intern
patient safety
medical error
time motion
handoff
sign-out
Resident Workflow
Resident Communications
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Walter Reed Army Medical Center
name: Madigan Army Medical Center
First posted: 2010-05-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for internal medicine residents on inpatient units at Walter Reed and Madigan Army Medical Centers - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.

Detailed description: Following collection of baseline data on inpatient wards at both hospitals, teamwork training will be provided, accompanied by the introduction of a new computerized handoff tool that facilitates accurate transmission of data. The effects of this combined intervention on safety and workflow will be assessed on the intervention wards at both hospitals as compared with the historical control period.

Eligibility criteria: Inclusion Criteria:

* all internal medicine residents completing rotations through intervention units during data collection periods

Exclusion Criteria:

* none

Primary outcomes:
measure: Rates of resident communication and total medical errors
timeFrame: July 2010
Secondary outcomes:
measure: Rates of all medical errors
timeFrame: July 2010
measure: Rates of verbal miscommunications
timeFrame: July 2010
measure: Rates of written miscommunications
timeFrame: July 2010
measure: Resident workflow, especially time spent updating the signout; time spent at bedside; time spent at computer
timeFrame: July 2010
measure: Resident care experience
timeFrame: July 2010
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed Army Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Brigham and Women's Hospital
name: Christopher P Landrigan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04611087: Self-monitoring Focus Groups With Vibrant Lives Pasadena Participants
Official title: Self-Monitoring Focus Groups With Vibrant Lives Pasadena Participants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity-Related Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have completed a weight loss program

Brief summary: This study investigates how individuals feel about a dietary mobile application. Information collected from focus groups and interviews may help doctors and mobile application developers to determine preferences and participant feedback about the appeal and usefulness of a mobile application.

Detailed description: PRIMARY OBJECTIVE:

I. To gather qualitative data to assess appeal, preference, and usefulness of a food and beverage self-monitoring mobile application.

OUTLINE:

PHASE I: Participants attend 4 sessions of focus groups.

PHASE II: Participants attend virtual Zoom interviews or one-on-one interviews.

Eligibility criteria: Inclusion Criteria:

* Pasadena Independent School District (ISD) employees who have completed the 6-month Vibrant Lives weight loss program or adults who have completed a weight loss program within the last 12 months

Primary outcomes:
measure: Preferences of food and beverage self-monitoring methodology and respective feedback messages
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen M Basen-Engquist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01175187: Intrapartum Fever and Histopathological Placental Findings
Official title: Intrapartum Fever and Histopathological Placental Findings
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Histological Placental Inflamation With or Without Fever
Keywords: evron
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 normal deliveries

Brief summary: Intrapartum fever associated with epidural anesthesia is caused by non infectious causes therefore without histological findings


Eligibility criteria: Inclusion Criteria:epidural with and without fever

-

Exclusion Criteria:

* Patients with infectious backgroud or prilinged PROM

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv University
name: shmuel evron, md
role: PRINCIPAL_INVESTIGATOR
References: