louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04392635: Device to Assist With Abdominal Access During Laparoscopic Surgery
Official title: Pilot Study to Establish Safety and Ease of Use of a TauTona Pneumoperitoneum Assist Device (TPAD) for Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgery
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: TauTona Group
First posted: 2020-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and ease of use of a TauTona Pneumoperitoneum Assist Device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Age \>/= 18
* Scheduled for laparoscopic surgery
* Able to understand and willing to sign a written informed consent form

Exclusion Criteria:

* Age \< 18
* Any situation where blind, peri-umbilical passage of a Veress needle is contraindicated.
* Any situation where patients have suspected or confirmed intra-abdominal adhesions involving the peri-umbilical abdominal wall.
* Any situation where patients have a suspected or confirmed umbilical hernia or peri-umbilical ventral hernia.
* Any situation where there is not intact, uncompromised skin of the peri-umbilical region where the device is to be placed.

Primary outcomes:
measure: Surgeon satisfaction survey
timeFrame: up to 1 minute on day of surgery
Secondary outcomes:
measure: Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery
timeFrame: Up to 10 minutes
measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Continuous from start of surgery through postoperative day 7
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Shannon Meyer
state: California
Study officials:
affiliation: Stanford University
name: James R Korndorffer Jr, MD MHPE FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02277535: An Email Intervention to Prevent Iatrogenic Malnutrition in the ICU
Official title: An Email Intervention to Prevent Iatrogenic Malnutrition in the ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Malnutrition in the ICU (caloric deficit >4000 kcal or 150 g protein deficit) or >48hrs of admission without receiving nutrition
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a quality improvement research project evaluating if a targeted feedback email to clinicians impacts their nutrition delivery in the ICU.

Detailed description: This prospective study looks to determine if a targeted email to clinicians taking care of critically ill patients will allow reduce malnutrition in the Intensive Care Units (ICU). Four ICUs will be included: medical ICU (MICU), coronary care unit (CCU) and two surgical ICUs. The investigators will rotate a 2 month period intervention amongst the aforementioned participating ICUs and follow simultaneous cohorts to evaluate the effect of our intervention (email feedback to treating clinicians) on nutrition delivery in the ICU. After the completion of the intervention, there will be a six-month follow-up of nutritional adequacy to assess the durability of changes in behavior.

Eligibility criteria: Inclusion Criteria:

* Clinicians taking care of patients admitted to the ICU within the past 48hrs
* Clinicians taking care of patients in whom enteral nutrition is prescribed

Exclusion Criteria:

* Clinicians taking care of patients in whom enteral nutrition is not prescribed.

Primary outcomes:
measure: Patients started on nutrition within 72 h of ICU admission
timeFrame: After completing the intervention for each ICU (2 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03746158: Interindividual Variation in Excretion of Curcumin
Official title: University of Massachusetts Amherst
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolites
Gut Microbiota
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this project is to elucidate the interindividual variations in excretion of curcumin and its metabolites.


Eligibility criteria: Inclusion Criteria:

* 18-30 year old healthy adults

Exclusion Criteria:

* Exclusion criteria included those who are \<18 or \>30 years old, have a BMI of \<20 or \>29 kg/m2, have a weight change \>4.5 kg in the past 3 months, exceed exercise activities of a curcumin level over the past 3 months, have any diseases, especially intestinal disorders, had abnormal liver or kidney function tests. Those who smoke, consume more than two alcoholic drinks per day, use medication affecting gut microbiota profile (e.g., antibiotics and probiotics) in past three months will also be excluded.
* Additionally, this study excludes menopausal women, those using hormone-based contraceptives, those with abnormal menstrual cycles, and those who are pregnant, lactating or planning to become pregnant.

Primary outcomes:
measure: Determine the concentration of curcumin and its metabolites in the human fecal samples.
timeFrame: 3-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amherst
country: United States
facility: Institute for Applied Life Sciences
state: Massachusetts
Study officials:
References:
Clinical trial NCT04988958: Radical Versus Conservative Surgical Treatment of Liver Hydatid Cysts
Official title: Radical Versus Conservative Surgical Treatment of Liver Hydatid Cysts: A Propensity Score Matching Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydatid Cyst
Lead sponsor: Université de Sousse
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 914
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 914 Patients , who underwent surgical treatment at the Department of General and Digestive Surgery, Sahloul University Hospital Center, Sousse, Tunisia from 1st January 2000 to 31st December 2019 was performed. The diagnosis of LHC was established by clinical history, physical examination and abdominal ultrasonography (USG) in all patients

Brief summary: The management of liver hydatid cysts (LHC) is controversial. Surgery remains the basic treatment, and can be divided into radical and conservative approaches. The purpose of this study was to compare the outcome of radical and conservative surgery (CS) in the treatment of LHC and to evaluate the efficiency and safety of radical surgery (RS).

Detailed description: The management of liver hydatid cysts (LHC) is controversial. Surgery remains the basic treatment, and can be divided into radical and conservative approaches. The purpose of this study was to compare the outcome of radical and conservative surgery (CS) in the treatment of LHC and to evaluate the efficiency and safety of radical surgery (RS).

Data from all patients with LHC treated in Sahloul Hospital, between January 2000 and December 2019, were retrieved from a retrospective database. To minimize selection bias, propensity score matching (PSM) was performed, based on variables representing patient characteristics and operative risk factors.

RS especially total pericystectomy had fewer postoperative complications and lower recurrence rate compared to CS. RS may be the preferred procedure for LHC if the expertise is available.

Eligibility criteria: Inclusion Criteria:

* age over 14 years old.
* Patients presenting liver hydatid cyst .

Exclusion Criteria:

* age less than 14 years old.
* Patients presenting other localization of hydtic cyst , than the liver.
* calcified cysts.
* patients with incomplete medical records.
* patients who were lost to follow up.

Primary outcomes:
measure: recurrence of hydatic cyst
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02626858: Optimizing the Delineation of the Tumour Bed in Breast Irradiation
Official title: Optimizing the Delineation of the Tumour Bed in Breast Irradiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 25
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the present study is:

1. to verify whether the delineation of the tumour bed, based on the combination of the visible postoperative changes and the position of the surgical clips on a CT scan in treatment position acquired 1 week before the start of the radiotherapy (RT), provides an accurate localisation of the boost volume compared to the localisation of the tumour on a pre-operative CT-scan.
2. to document the changes that occur in the tumour bed as seen on a CT scan as a function of the delay between surgery and radiotherapy.
3. to determine the ideal number and the positioning of the clips needed to reproduce the best treatment volume for the boost.
4. to propose new guidelines for tumour bed definition and delineation based on the study findings.

Detailed description: Start of the study: february 2012

Eligibility criteria: Inclusion Criteria:

* Breast Cancer patients, without metastases, who will undergo breast conserving surgery and probably will receive adjuvant chemotherapy and thereafter radiotherapy.

Exclusion Criteria:

* Metastases at time of diagnosis

Primary outcomes:
measure: the interobserver variability (IOV) (%) of the delineated Clinical Target Volume (CTV) boost (cm3) with and without the fusion of the pre-operative CT-scan.
timeFrame: 2 years
measure: the volume of the delineated CTVboost (cm3) with and without the fusion of the pre-operative CT-scan.
timeFrame: 2 years
Secondary outcomes:
measure: the correlation of the Cavity Visibility Scale (CVS) to volume changes and IOV
timeFrame: 2 Years
measure: the volume changes over time (in case of adjuvant chemotherapy)
timeFrame: 2 years
measure: the usefulness of the surgical clips assessed by the 6 observers.
timeFrame: 2 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Caroline Weltens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02732158: Novel Laboratory Methods in Nutrition Studies
Official title: Feasibility of Novel Laboratory Methods for Use in Nutrition Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Novel laboratory methods
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2016-04-08
Enrollment: 55
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This prospective, nonrandomized, feasibility study will compare laboratory measures at the beginning and end of the study period in adults consuming a nutritional study product.


Eligibility criteria: Inclusion Criteria:

* Participant must agree to refrain from taking supplements other than study product.
* Participant states willingness to follow protocol as described, including consumption of study product per protocol, performing finger stick/DBS on Day 60 and completing any forms needed throughout the study.

Exclusion Criteria:

* Body Mass Index (BMI) \> or equal to 35 kg/m2
* Has planned elective surgery requiring 2 or more days of hospitalization during the entire study
* Has stated active malignant disease
* Has a known history of chronic renal parenchymal disease
* Has a known history of severe liver disease/liver failure
* Has any psychiatric disorders that would interfere with study product consumption or compliance with the study procedures
* Known allergy or intolerance to any study product ingredient
* Participation in another study that has not been approved as a concomitant study

Primary outcomes:
measure: Comparison of lab values from venipuncture and DBS methods
timeFrame: Baseline
Secondary outcomes:
measure: Change in AN777
timeFrame: Baseline to Day 60
measure: Change in carotenoids
timeFrame: Baseline to Day 60
measure: Compliance of study product consumption
timeFrame: Baseline to Day 60
Other outcomes:
Locations:
city: College Station
country: United States
facility: Texas A&M University, Center for Translation Research in Aging and Longevity
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Carolyn Alish, PhD, RD
role: STUDY_CHAIR
References:
Clinical trial NCT04805658: Natural History Study of Retinitis Pigmentosa Type 11
Official title: Natural History Study of Retinitis Pigmentosa Type 11
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Retinitis Pigmentosa 11
Retinitis Pigmentosa
Keywords: Retinitis
RP
PRPF31
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients over the age of 18 with the clinical diagnosis of retinitis pigmentosa type 11 or asymptomatic carriers of the disease.

Brief summary: Observational study of patients with retinitis pigmentosa type 11

Detailed description: Natural history study with clinical examination every 6 months.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of retinitis pigmentosa caused by a disease-causing mutation involving the PRPF31 gene
* Or disease-causing mutation involving the PRPF31 gene without the clinical diagnosis of retinitis pigmentosa

Exclusion Criteria:

* Under 18 years
* Other types of retinitis pigmentosa

Primary outcomes:
measure: Progression of disease
timeFrame: 24 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Ophthalmology, Oslo University Hospital
Study officials:
affiliation: Department of Ophthalmology, Oslo University Hospital
name: Josephine P Holtan, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01008358: Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Official title: Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Hepatitis C Virus Chronic Infection
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2009-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the immune response against tumoral or viral antigens. In this clinical trial, the ability of tremelimumab to produce tumor responses among hepatitis C virus-infected patients with hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the effect on the replication of the virus will be analysed.


Eligibility criteria: Inclusion Criteria:

* Unequivocal diagnosis of HCC
* unresectable disease not amenable to locoregional treatment.
* a 4-week washout period after sorafenib or any other systemic agent
* a 2-month washout period after internal or external radiation
* HCV chronic infection
* Child-Pugh stage A or B
* Measurable disease according to RECIST criteria
* ECOG \< 2
* expected survival \> 3 months
* Adequate liver, renal and blood functions
* ability to sign informed consent

Exclusion Criteria:

* previous treatment with an anti-CTL-4 agent
* serious infections or disease compromising general health status
* autoimmune disease that requires therapy
* treatment with immunosuppressors
* treatment with investigational agents
* other neoplasms except skin and bladder superficial tumors
* pregnancy or lactation
* SNC metastasis
* HIV infection
* relevant heart disease (NYHA class III or IV)

Primary outcomes:
measure: Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)
Secondary outcomes:
measure: Changes in Hepatitis C Virus (HCV) viral load
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
Study officials:
affiliation: Clinica Universidad de Navarra
name: Jesús Prieto-Valtuena, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Sangro B, Gomez-Martin C, de la Mata M, Inarrairaegui M, Garralda E, Barrera P, Riezu-Boj JI, Larrea E, Alfaro C, Sarobe P, Lasarte JJ, Perez-Gracia JL, Melero I, Prieto J. A clinical trial of CTLA-4 blockade with tremelimumab in patients with hepatocellular carcinoma and chronic hepatitis C. J Hepatol. 2013 Jul;59(1):81-8. doi: 10.1016/j.jhep.2013.02.022. Epub 2013 Mar 4.
Clinical trial NCT00763958: Relapse Prevention to Reduce HIV Among Women Prisoners
Official title: Relapse Prevention to Reduce HIV Among Women Prisoners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Dependence
HIV
Keywords: opiates
HIV
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-10-01
Enrollment: 44
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a feasibility and acceptability study assessing whether providing buprenorphine for women under criminal justice supervision leaving a controlled environment and returning to the community would prevent opioid relapse and reduce HIV risk behaviors.

Detailed description: This study sought to enroll opioid dependent women under supervision in the criminal justice system and in a controlled environment (substance abuse treatment)but at at high risk for opioid relapse and engaging in HIV risk behaviors when returning to the community. Initially, 9 women were enrolled and received buprenorphine medication. After the first 9 participants, women were randomized to either buprenorphine or placebo. Women received the buprenorphine medication for 12 weeks in the community and at the end of the 12 weeks were transitioned either to another buprenorphine provider, methadone provider, or tapered off buprenorphine based on the participant's preferences. One additional follow-up at 3 months after treatment was conducted. The primary outcome was opioid positive urines at all time points.

Eligibility criteria: Inclusion Criteria:

* female,
* history of opioid dependence,
* released back to the community from a controlled environment,
* criminal justice involvement.

Exclusion Criteria:

* under age 19,
* medical contraindications,
* major psychiatric problems.

Primary outcomes:
measure: Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.
timeFrame: 12 weeks
measure: Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of Participants Who Enroll in the Study.
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06516458: Development of Camera Based Gait Quality Measure for Persons With Multiple Sclerosis
Official title: Development of Camera Based Gait Deviation Index for Persons With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Multiple Sclerosis, Secondary Progressive
Multiple Sclerosis Relapse
Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with multiple sclerosis who can ambulate overground

Brief summary: The purpose of this study is to develop a measurement of walking quality, called Gait Deviation Index (GDI) for people with Multiple Sclerosis (MS).

Detailed description: In rehabilitation in general, in order to track patients' progress and provide next steps, there is a need for easily obtainable, understandable, and objective measures of ability. Currently, there is no measure that clinicians can utilize to determine walking quality. While Gait Deviation Index has been validated and can reliably be used in adults who experienced a Spinal Cord Injury, it has not yet been validated in people with MS. After the MS-specific GDI is developed from this study, therapists and clinicians will be able use it as a reliable progress measure. Which may lead to the delivery of more effective therapy for patients with MS.

Here we plan to measure body position with camera based tracking during your gait cycle.

Eligibility criteria: Inclusion criteria:

* Diagnosis of relapsing form of MS (including relapsing-remitting MS and secondary progressive MS)
* Able to ambulate overground
* Relapse free for at least 1 month
* Age ≥18 and ≤ 75 years
* Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening

Exclusion criteria:

- Orthopedic injuries, fractures, surgeries or other conditions affecting locomotor function or weight bearing

Primary outcomes:
measure: Kinematics of the gait cycle
timeFrame: at the time of session
Secondary outcomes:
measure: 6 minute walk test
timeFrame: at the time of session
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Milap Sandhu, PhD
role: PRINCIPAL_INVESTIGATOR
References: