louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05966454: Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure - UCSF
Official title: Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) Using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR) -A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Appendicitis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 145
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 purpose of this study is to demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

Detailed description: This is a single center, randomized controlled trial to determine if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.

Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years

* Age ≥ 18 years
* Planned appendectomy (laparoscopic or open)
* Working telephone number or reliable method to contact patient after hospital discharge

Exclusion Criteria:

* Unable to consent
* Pregnant Women
* Prisoners
* Immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage AIDS
* Heart failure
* Allergy to bupivacaine
* Unlikely to comply with treatment or follow-up
* Inpatient consultation for appendicitis
* Clinically suspected of sepsis based on Sepsis-3 definition
* Current use of antibiotics for other indications
* Type 1 Diabetes or uncontrolled hyperglycemia
* Surgeon preference
* Patient preference
* Research team unavailable

Primary outcomes:
measure: Incidence of Infectious/Antibiotic Complications
timeFrame: Up to 30 days after appendicitis surgery
measure: Number of participant deaths
timeFrame: Up to 30 days after appendicitis surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Lucy Kornblith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01376154: Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)
Official title: Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B, Chronic
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 342
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese subjects with hepatitis B virus-induced liver cirrhosis, in whom lamivudine tablet was administered alone for 6 months or longer, or those in whom lamivudine tablet was expected to be administered alone for 6 months or longer.

Brief summary: The purpose of this study is to confirm efficacy and safety when administering lamivudine tablet alone in subjects with hepatitis B virus-induced liver cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Subjects with hepatitis B virus-induced liver cirrhosis, in whom lamivudine tablet was administered alone for 6 months or longer, or those in whom lamivudine tablet was expected to be administered alone for 6 months or longer

Exclusion Criteria:

* Subjects previously enrolled in Drug Use Investigation or Special Drug Use Investigation of lamivudine tablet
* Subjects with a history of hypersensitivity of the ingredients of lamivudine tablet

Primary outcomes:
measure: Number of adverse events in Japanese subjects with hepatitis B virus-induced liver cirrhosis treated with lamivudine tablet
timeFrame: 6 months or more
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03402854: tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
Official title: tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Hemiplegic Cerebral Palsy
Spastic Hemiplegic Cerebral Palsy
Spastic Hemiparesis
Spastic Hemiplegia
Keywords: pediatric
children
non-invasive brain stimulation
transcranial direct current stimulation
bimanual training
hand training
Lead sponsor: Burke Medical Research Institute
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Teachers College, Columbia University
First posted: 2018-01-18
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children will be randomly allocated to one of two parallel arms of the study.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test the efficacy of transcranial direct current stimulation combined with bimanual training on hand function in children with unilateral spastic cerebral palsy (USCP). Children who enroll in the protocol will be randomized to receive either sham (not stimulating) tDCS plus bimanual training, or active (stimulating) tDCS plus bimanual training.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of congenital hemiplegic cerebral palsy
* Ability to lift and grasp light objects with affected hand
* Ability to extend wrist of affected hand 15 degrees
* Ability to follow instructions and provide informed assent
* Parent(s) able to provide informed consent

Exclusion Criteria:

* Seizures after age 2 years
* Spasticity medication within 6 months before study
* Selective dorsal rhizotomy
* Surgery in affected upper extremity within year before study

Primary outcomes:
measure: Change in Assisting Hand Assessment
timeFrame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Secondary outcomes:
measure: Jebsen-Taylor Test of Hand Function
timeFrame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
measure: Box and Blocks test
timeFrame: Day before intervention begins, compared to day after intervention ends (six days after intervention begins)
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Medical Research Institute
state: New York
Study officials:
affiliation: Burke Medical Research Institute
name: Kathleen M Friel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gordon AM, Ferre CL, Robert MT, Chin K, Brandao M, Friel KM. HABIT+tDCS: a study protocol of a randomised controlled trial (RCT) investigating the synergistic efficacy of hand-arm bimanual intensive therapy (HABIT) plus targeted non-invasive brain stimulation to improve upper extremity function in school-age children with unilateral cerebral palsy. BMJ Open. 2022 Feb 21;12(2):e052409. doi: 10.1136/bmjopen-2021-052409.
Clinical trial NCT00102154: An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2005-01-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).


Eligibility criteria: Inclusion Criteria:

* Healthy adults who are between the ages of 18 and 64

Exclusion Criteria:

* Adults who are diagnosed with insomnia

Primary outcomes:
measure: 4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability
Secondary outcomes:
measure: Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00571454: Culturally Sensitive Depression Care Management for Latino Primary Care Patients
Official title: Culturally Sensitive Depression Care Management for Latino Primary Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: depression
primary care
Latino
telephone
care management
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: Neighborhood health Plan of RI
name: Beacon Health Strategies
name: Robert Wood Johnson Foundation
First posted: 2007-12-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether telephonic depression care management can improve depression outcomes for Latino primary care patients who are enrolled in Medicaid and are receiving an antidepressant from their primary care doctor.


Eligibility criteria: Inclusion Criteria:

* Latino
* Adult
* Received an antidepressant prescription from primary care provider
* Not current receiving care from behavioral health provider
* Diagnosis of major depression, minor depression, dysthymia, or significant depression symptoms
* English or Spanish speaking
* Member, Neighborhood Health Plan of RI

Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Clinician Administered (QIDS-C)
timeFrame: 3 months
Secondary outcomes:
measure: Center for Epidemiological Studies-- Depression
timeFrame: 3 months
measure: WHO Disability Assessment Schedule (WHO-DAS)
timeFrame: 3 months
measure: Treatment Utilization
timeFrame: 3 months
measure: Treatment Satisfaction
timeFrame: 3 months
measure: costs: health care utilization
timeFrame: 3 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Neighborhood Health Plan of RI
state: Rhode Island
Study officials:
affiliation: Neighborhood health Plan of RI
name: Beth Ann Marootian, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital
name: Ivan W Miller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital
name: Lisa A Uebelacker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uebelacker LA, Marootian BA, Tigue P, Haggarty R, Primack JM, Miller IW. Telephone depression care management for Latino Medicaid health plan members: a pilot randomized controlled trial. J Nerv Ment Dis. 2011 Sep;199(9):678-83. doi: 10.1097/NMD.0b013e318229d100.
Clinical trial NCT02265354: Developing Smokers for Smoker (S4S): A Collective Intelligence Tailoring System
Official title: Developing Smokers for Smoker (S4S): A Collective Intelligence Tailoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Keywords: Tobacco Smoking Cessation
Computer tailored health communication
messaging
collective intelligence
recommender systems
machine learning
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Amherst
name: National Cancer Institute (NCI)
First posted: 2014-10-15
Enrollment: 260
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will advance computer tailoring by adapting machine learning collective intelligence algorithms that have been used outside healthcare by companies like Amazon and Google to enhance the personal relevance of the health communication.

Detailed description: Smoking is still the number one preventable cause of cancer death. New approaches are needed to engage smokers in the 21st century in smoking cessation. I propose to develop S4S (Smokers for Smoker), a next-generation patient-centered computer tailored health communication (CTHC) system. Unlike current rule-based CTHCs, S4S will replace rules with complex machine learning algorithms, and use the collective experiences of thousands of smokers engaged in a web-assisted tobacco intervention to enhance personally-relevant tailoring for new smokers entering the system. The investigators will adapt collective intelligence algorithms that have been used outside healthcare by companies like Amazon and Google to enhance CTHC. Using knowledge from scientific experts, current CTHC collect baseline patient "profiles" and then use expert-written, rule-based systems to tailor messages to patient subsets. Such theory-based "market segmentation has been effective in helping patients reach lifestyle goals. However, there is a natural limit in the ability of a rule-based system to truly personalize content, and adapt personalization over time. Current CTHC have reached this limit, and the investigators propose to go beyond. The investigators first aim is to develop the Web 2.0 "S4S" recommender system. The investigators second aim is to evaluate S4S within the context of a NCI funded web-assisted tobacco intervention (Decide2Quit.org).

Eligibility criteria: Inclusion Criteria:

* Current Smokers

Exclusion Criteria:

-

Primary outcomes:
measure: Repeated Use of website measure
timeFrame: Every Login for 6 months
Secondary outcomes:
measure: 30-day point prevalent smoking cessation at six months
timeFrame: At 6 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Rajani S Sadasivam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06316154: Presentation of Protoscolexes and Acephalocysts in the Fibrous Capsule Area of the Liver with Echinococcosis
Official title: Presentation of Protoscolexes and Acephalocysts in the Fibrous Capsule Area of the Liver with Echinococcosis During Organ-preserving Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Echinococcosis, Hepatic
Lead sponsor: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary or recurrent liver echinococcosis

Brief summary: The objective of the study is to determine the presence of germinal elements of echinococcosis in the liver parenchyma next to and in the thickness of the fibrous capsule of hydatid cysts.


Eligibility criteria: Inclusion Criteria:

* Presence of primary or recurrent liver echinococcosis disease requiring surgical treatment
* Cyst diametr \>5 cm;
* Performing one of the surgical treatment of liver echinococcosis with intraoperative sampling of part of the fibrous capsule with or without adjacent liver tissue for research;
* Signed informed consent of patients for inclusion in the study;

Exclusion Criteria:

* Liver echinococcosis with cysts less than 5 cm in diametr;
* Presence of severe concomitant disorders

Primary outcomes:
measure: Presence of viable germinal elements of echinococcosis
timeFrame: 1 day
Secondary outcomes:
measure: Recurrence of liver echinococcosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov
Study officials:
References:
Clinical trial NCT03948854: Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients
Official title: Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients: Which Educational Method Works Best
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are trying to determine the best course of action regarding the dietary management with a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP diet) for irritable bowel syndrome.

Detailed description: An analysis of different educational programs providing information on the low FODMAP diet will be performed.

Eligibility criteria: Inclusion Criteria:

* Adult subjects (18-75 years) seen in the primary care clinic or in the Gastroenterology clinic at Mayo Clinic Florida, who are diagnosed with IBS by Rome IV criteria

Exclusion Criteria:

* Subjects who have previously tried the low FODMAP diet (whether successful or not)
* Current or recent (less than 4 weeks) opioid use
* Current or recent (less than 10 weeks) rifaximin use
* Inability to speak or read English
* Pregnancy and/or breast-feeding
* Medical or psychological issues that would prevent modifying their diet for 8 weeks.

Primary outcomes:
measure: Improvement in IBS symptoms
timeFrame: Baseline, end of study approximately 8 to 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Brian Lacy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04756154: Efficacy Study of Patient Preoperative Preps In-vivo
Official title: Assessment of the Antimicrobial Efficacy of 3M™ SoluPrep™ Preoperative Skin Preparation Against Resident Human Skin Flora on the Inguinal Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Skin Preparation
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2021-02-16
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.

Detailed description: Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2.

Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used.

Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.

Eligibility criteria: Inclusion Criteria:

* Subjects of any race
* Subjects in good health
* Minimum skin flora baseline requirements on inguinal region

Exclusion Criteria:

* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days

Primary outcomes:
measure: Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes
timeFrame: 10 minutes
measure: Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sterling
country: United States
facility: Microbac Laboratories, Inc
state: Virginia
Study officials:
affiliation: Microbac
name: Muhammad H Bashir, MD, CCRP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03046654: Cervical Cerclage Position Throughout the Pregnancy.
Official title: Cervical Cerclage Position Throughout Pregnancy, it's Distance From the Inner and Outer Cervical os', and Implications of the Position on Pregnancy Outcomes.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervix Uteri-Diseases
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cervical cerclage is an obstetric intervention used in women with poor obstetric histories. After recruiting the participant, Trans vaginal sonography will be used to examine cervical length and funneling. In addition vaginal examination will be performed to evaluate the cervix. After placing the cerclage, the participant will be invited every 4 weeks for a follow up evaluation session in order to examine the cervix and cerclage position. .

Detailed description: Cervical cerclage is an obstetric intervention used in women with poor obstetric histories due to late abortions, premature deliveries and painless dilatation. These 3 situations are usually due to cervical incompetence though can be caused by infection and other factors.

The cerclage is usually placed from 12-24 weeks of gestation depending on the indication and medical follow up during pregnancy. There are 2 methods for cerclage performance-McDonald and Shirodkar that have the same efficacy.

After recruiting the participant, Trans vaginal sonography will be used to examine cervical length and funneling. In addition vaginal examination will be performed to evaluate the cervix. After placing the cerclage, the participant will be invited every 4 weeks for a follow up evaluation session in order to examine the cervix and cerclage position. Each follow up will include a vaginal examination and trans vaginal sonography. The trans vaginal sonography will examine total cervical length, funneling, and the cerclage's distance from the inner and outer os' of the cervix.

Eligibility criteria: Inclusion Criteria:

* Women that have a cervical cerclage placed during pregnancy at the investigator's medical center.

Exclusion Criteria:

* Women that do not require cervical cerclage.
* Women that had a cervical cerclage placed at a different medical center.

Primary outcomes:
measure: Gestational age at the time of delivery
timeFrame: Up to 9 months
Secondary outcomes:
measure: Gestational age at the time of the removal of the cervical cerclage
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References: