louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03353935: Functional Outcomes After Nerve Sparing Surgery for Deep Endometriosis
Official title: Functional Outcomes of Nerve-sparing Laparoscopic Eradication of Deep Infiltrating Endometriosis: a Prospective Analysis Using Validated Questionnaires
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: surgery
pelvic function
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoimg nerve-sparing surgery for deep endometriosis were enrolled if they were operated by a single surgeon with extensive background in minimally-invasive pelvic surgery.

Brief summary: Patients who underwent surgery for deep endometriosis were submitted to procedures aiming at sparing the pelvic autonomic nervous system. They were observed prospectively followed and interviewed in order to evaluate functional outcomes after surgery.

Detailed description: Surgical tretament for deep endometriosis can produce lesions at the level of the pelvic autonomic system.

Before surgery and 3-12 months after the nerve-sparing surgical procedures, patients were assessed for urinary, sexual and fecal function, in order to evaluate whether sparing of the nerves during the intervention had a beneficial impact on post-operative pelvic function.

Eligibility criteria: Inclusion Criteria:

* Deep endometriosis
* Surgical treatment
* Single surgeon

Exclusion Criteria:

* Lost to follow-up
* unwillingness to answer the interview

Primary outcomes:
measure: Pelvic function
timeFrame: 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Department of Obstetrics and Gynecology Universita' Dell'Insubria
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Stefano Uccella
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03028935: Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas
Official title: Fuerte y Sanas: Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-01-23
Enrollment: 15
Sex: FEMALE
Minimum age (years): 40
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 pilot clinical trial studies how well an evidence-based exercise and nutrition program adapted for Latinas works in improving physical activity and dietary behavior in non-active, overweight, or obese rural Latinas. An exercise and nutrition program may reduce the risk for developing certain cancers, obesity, and chronic health conditions in Latinas who are non-active, overweight, or obese.

Detailed description: PRIMARY OBJECTIVES:

I. Adapt an effective evidence-based exercise and nutrition program to meet the needs of rural Latinas.

II. Implement the adapted program in a rural Latina population. III. Evaluate feasibility and potential to improve physical activity and dietary behavior of the adapted program in a rural Latina population.

OUTLINE:

Phase I: Create a community advisory board to adapt Strong Women Healthy Hearts Program (SWHHP) using feedback on the existing SWHHP from Latinas residing in the community.

Phase II: Conduct a small pilot study to assess effectiveness of the adapted program (one group pre-post design, with data collected at three time points).

INTERVENTION GROUP: Participants undergo instructor-led exercise and nutrition education classes for 60 minutes each twice a week for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Phase I:
* Bilingual Latina
* Live in the community
* Phase II:
* Latina
* Currently non-active (exercise two days or less per week)
* Overweight or obese (body mass index \[BMI\] of 24 or greater)

Exclusion Criteria:

* A medical condition that precludes moderate-vigorous physical activity as determined by health care provider
* Pregnancy

Primary outcomes:
measure: Change in weight
timeFrame: Baseline up to post intervention, up to 7 months
Secondary outcomes:
measure: Change in fitness level as assessed by the 6 minute walk test
timeFrame: Baseline up to post intervention, up to 7 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Cynthia Perry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00284635: Fast-Track vs Conventional for UKA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unicompartmental Knee Replacement
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2006-02-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to see if it is possible to discharge patient undergoing a UKA 1 day postoperatively


Eligibility criteria: Inclusion Criteria:

* UKA, ASA I-II

Exclusion Criteria:

* medical history of abdominal bleeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Frederiksberg University Hospital
state: Frederiksberg C
Study officials:
affiliation: Frederiksberg University Hospital
name: arne borgwardt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01562535: A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
Official title: A Randomized Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nursemaid Elbow
Pulled Elbow
Keywords: pulled elbow
nursemaid elbow
Lead sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
Sponsor class: OTHER
First posted: 2012-03-26
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nursemaid elbow or pulled elbow is a condition commonly seen in the emergency department. It is the sudden pull of the radial head (a bone in the elbow) in toddlers. Usually occur when a parent tries to pull the child by the arm and a "clic" or "clunk" is felt with immediate pain and unwilling to move the arm. It is not a dangerous condition although it is distressing for kids and their parents/caretakers.

Detailed description: The usual therapy consists of one of two maneuvers: supination maneuver or pronation maneuver. They both are safe to perform but none of them have been statistically superior over the other. More studies are needed to confirm or discard the tendency of the studies to favor the pronation maneuver.

The investigators intend to perform a randomized trial evaluating which of these techniques is better than the other in terms of returning the mobility of the affected arm and decreasing pain.

Eligibility criteria: Inclusion Criteria:

* Pulled elbow suspected in any child presenting one of the following:

  1. History of an adult or bigger person that had pulled the child's elbow non-intentionally
  2. Presence of intense pain at the arrival at the emergency department and unwilling to move the arm.

Exclusion Criteria:

* Any suspect of injury that could be intentional (child abuse)
* Any suspicion child of suffering a possible fracture (the mechanism of the injury was not from pulling the child's arm, the arm presents obvious deformity, ecchymoses, edema, etc.)
* The mechanism was from multiple trauma
* Any chronic disease affecting the adequate bone mineralization (vitamin D deficiency, osteogenesis, etc.)

Primary outcomes:
measure: Successful reduction
timeFrame: 10 to 20 minutes
Secondary outcomes:
measure: Pain of the procedure
timeFrame: 1 to 5 min
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: School of Medicine and Health Sciences
state: Nuevo Leon
Study officials:
affiliation: Instituto Tecnologico y de Estudios Superiores de Monterey
name: Carlos A Cuello-Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04880135: Supervised Versus Home Based Exercises Neck and Low Back Pain Among Students Due to Quarantine During COVID-19
Official title: Effects of Supervised Versus Home Based Stretching and Strengthening Exercise Program on Neck Pain and Back Pain Among University Students Due to Quarantine During COVID-19: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: Musculoskeletal Pain
COVID-19
strengthening exercises
stretching exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates whether or not the stretching and strengthening exercises are effective both at home and under supervision for people suffering from neck pain from using equipment for online courses due to quarantine during COVID-19.

Detailed description: The aim of this study is to investigate which regime is best to follow a recommendation, be it under the supervision of the therapist or at home with stretching and strengthening exercises. There was no study that could explain the effect of stretching and strengthening exercises as a comparison between a supervised and a home treatment plan for neck pain in students during quarantine due to Covid-19.This study examines whether or not the recommendations given are effective both at home and under supervision.

Eligibility criteria: Inclusion Criteria

* Participants using gadget like computer, mobile or laptop for online education during quarantine
* Participants having musculoskeletal pain during COVID-19 quarantine
* Prolonged sitting and low physical activity during quarantine
* Prolonged exposure of screen more than 6 hours per day due online classes during the quarantine

Exclusion Criteria:

* Participants having musculoskeletal pain before the quarantine
* Participants doing any type of physical activity during quarantine
* Participants taking online classes or any online educational program before quarantine
* Participants with known congenital, inflammatory and infectious conditions of spine
* Participants following any ergonomic recommendations or any postural awareness during and after quarantine

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 2 month
measure: International Physical Activity Questionnaire
timeFrame: 2 months
measure: Neck Disability Index
timeFrame: 2 months
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 2 months
measure: Nordic Musculoskeletal Questionnaire
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Riphah International University
state: Punjab, Pakistan
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT02199535: The Analysis of the Risks of the Personnel Working in Anesthesiology Departments in Turkey
Official title: The Analysis of the Risks of the Personnel Working in Anesthesiology Departments in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposure
Keywords: operating room,
risk factors
anesthesiologists
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The anesthesia staff doctors nurses and anesthesia personal

Brief summary: The aim of the study was to investigate the analysis of the risks faced by the personnel working in the field of Anesthesiology and Reanimation in Turkey

Detailed description: There are many potential risks in operating room such as anesthetic gas exposure, chronic noise, fair, intensive working conditions, frequent guardians of the doctors and anesthesia staff. Those are effects the staff of anesthesia such as doctors, anesthesia assistants, anesthesia nurses. They usually suffer from hard working, fatigue and exposing anesthetic gases effects them as well. These reasons cause some undesirable adverse effects. The scientific dates are really limited in uour country. We aimed to ask questions the anesthesia staff and determine the environment conditions and the other risk in operating room that effects the staff. For t his purpose we prepared a questionaire and send to their e-mail address.

Eligibility criteria: Inclusion Criteria:

* anesthesia doctors anesthesia nurses anesthesia technic personal

Exclusion Criteria:

-

Primary outcomes:
measure: The analysis of the risks in the operating room
timeFrame: during 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
References:
Clinical trial NCT00031135: Total Parenteral Nutrition-Associated Liver Disease
Official title: Prevention of TPN-Associated Hepatic Steatosis: A Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Liver Diseases
Keywords: Parenteral Nutrition, Total
Lipotropic Agents
Choline
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2002-02-27
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: This is a study to determine whether choline, when added to total parenteral nutrition (TPN), can help prevent the development of hepatic steatosis, a liver disease, in patients on TPN.

Detailed description: Choline deficiency-induced hepatic steatosis occurs in patients that require long-term TPN and may progress to significant hepatic disease and death. Initial studies indicate choline-supplemented TPN may reverse TPN-associated hepatic steatosis.

Choline chloride or placebo will be added to each patient's TPN for 16 weeks by the hospital or pharmacy providing their usual TPN. Patients will receive their TPN in the hospital until they are medically stable for discharge. If patients are discharged before study completion, the pharmacy will deliver the TPN supply to them. Evaluation of hepatic steatosis is done by CT scans and blood analyses. Blood will be drawn on a biweekly basis during the first 4 weeks and at Week 8, 12, 16 or withdrawal. CT scans will be done at Week 4, 8, 16, or withdrawal.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: Inclusion criteria:

* Underlying pathology may include, but is not limited to: short bowel syndrome, chronic pancreatitis, pancreatic pseudocysts, pseudo-obstruction, enterocutaneous fistula, entero-enteric fistula, or malabsorption syndrome.
* Requirement for TPN to supply greater than 85 percent of nutritional needs for at least 16 weeks.

Exclusion criteria:

* Not receiving lipid emulsion with TPN regimen
* Albumin less than 2.5 g/L
* Renal failure requiring hemo- or peritoneal dialysis
* Hepatic failure (PT greater than 2 times control)
* Diabetes
* Hepatitis C
* AIDS
* Concurrent hospitalization for organ transplantation or rejection treatment
* Concurrent cholinergic medication
* Positive pregnancy test
* Refusal to use an acceptable method of birth control
* Ethanol abuse
* More than 40 kcal/kg/day ideal body weight
* Obesity with ensuing weight loss
* Use of IV tetracycline, valproic acid, corticosteroids, methotrexate, or amiodarone

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT00544635: The Effect Of Light On Scar Appearance
Official title: The Effect Of Light On Scar Appearance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cutaneous Scars
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2007-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this project is to examine the ability of light exposure to improve the appearance of cutaneous scars.

Detailed description: Light would be efficacious in improving scar appearance due to its known effects on wound healing, acne, and its use for skin rejuvenation. Light interacts with cells and stimulates the production of new collagen and elastin. This same energy can be used to inhibit collagen formation and help improve scars.

Eligibility criteria: Inclusion Criteria:

* Have two lesions that have been selected for excision
* Have two cutaneous scars from previous excisions as part of a standard of care
* Subjects are in good health
* Subject has a willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Exclusion Criteria:

* Pregnancy or lactation
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness

Primary outcomes:
measure: Scar vascularity
timeFrame: 24 weeks
measure: Scar pigmentation
timeFrame: 24 weeks
measure: Scar thickness
timeFrame: 24 weeks
measure: Scar length
timeFrame: 24 weeks
measure: Scar width
timeFrame: 24 weeks
measure: Scar surface area
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06050135: Roadmap to Parenthood: Testing the Efficacy of a Decision Aid and Planning Tool for Family Building After Cancer
Official title: Roadmap to Parenthood: Testing the Efficacy of a Decision Aid and Planning Tool for Family Building After Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quality of Life
Parenthood Status
Keywords: Roadmap to Parenthood
Decision aid
Planning tool
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2023-09-22
Enrollment: 256
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will test a decision support intervention that consists of a web-based 'decision aid and planning tool' for family building after cancer in a randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Assigned female at birth
* Aged 18 to 45 years old
* Understands verbal and written English
* History of a cancer diagnosis.
* Completed cancer treatment(s) with known or uncertain gonadotoxic effects (e.g., systemic chemotherapy, surgery or radiation affecting reproductive organs or hormone regulation, stem cell or bone marrow transplant, and/or immunotherapy)
* Interested in having a future child (or more children) or uncertain about family building plans
* Access to the Internet and use of a computer, tablet, or smartphone
* Ability to understand and the willingness to personally sign the written IRB-approved informed consent document

Exclusion Criteria:

* Currently undergoing cancer treatment excluding long term adjuvant or maintenance therapies, such as tamoxifen
* Significant physical or mental disability that prevents completion of study activities

Primary outcomes:
measure: Decision Conflict Scale
timeFrame: 12 months
Secondary outcomes:
measure: Planning Behaviors for Future Family Building
timeFrame: 12 months
measure: Patient-Reported Outcomes Measure-29 (PROMIS-29) Quality of Life
timeFrame: 12 months
Other outcomes:
measure: Unmet Fertility Information Needs
timeFrame: 12 months
measure: Patient-Reported Outcomes Measure (PROMIS) General Self Efficacy
timeFrame: 12 months
measure: Reproductive Concerns After Cancer (RCAC) Scale
timeFrame: 12 months
measure: COMRADE subscale
timeFrame: 12 months
measure: Patient-Reported Outcomes Measure (PROMIS) General Self-Efficacy and Self-Efficacy for Managing Emotions
timeFrame: 12 months
Locations:
city: Palo Alto
country: United States
facility: Stanford Universtiy
state: California
Study officials:
affiliation: Stanford University
name: Catherine Benedict, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05346835: Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
Official title: Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Multiple Myeloma
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2022-04-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.


Eligibility criteria: Inclusion Criteria:

* Eligible for treatment with cilta-cel per United States Prescribing Information (USPI)
* Has serious or life-threatening multiple myeloma per USPI, and where re-apheresis, re-manufacturing, or other anti-myeloma directed therapy is not considered feasible or adequate per treating physician discretion
* Favorable participant benefit/risk assessment determined by Janssen medical review
* Treating physician confirms the favorable risk benefit profile, and that proceeding with this treatment is in the best interest of the participant
* Able to provide informed consent indicating they understand the purpose of this expanded access program (EAP)
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: