louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01569282: Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer
Official title: Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pancreatic Cancer
Periampullary Tumor
Keywords: Surgical bypass
Hepaticojejunostomy
Gastrojejunostomy
Biliary stent
Enteral stent
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible.


Eligibility criteria: Inclusion Criteria:

1. Preoperatively

   * Patients with stent treated tumor in the pancreatic head or periampullary planned for pancreaticoduodenectomy
   * The patient jaundice should have worn off and there should be no signs of duodenal obstruction
   * The patient has given informed consent after verbal and written information in accordance with approved ethics application
   * The patient has no anatomical conditions making endoscopic therapy impossible such as previous Billroth II or Gastric Bypass.
2. Intraoperatively

   * Peroperative findings of of carcinomatosis, metastases or local irresectability who oppose radical surgery
   * Surgical double bypass should be technically feasible
   * The patient has given informed consent after verbal and written information in accordance with approved ethics application

Exclusion Criteria:

* Peroperative signs of dysfunction on biliary stent
* Peroperative findings of gastric outlet obstruction
* Surgical double bypass not technically feasible

Primary outcomes:
measure: Morbidity
timeFrame: Day 1-30 after randomization
Secondary outcomes:
measure: Quality of life
timeFrame: Preop, 1 month postop and every third month
measure: Numbers of readmissions to hospital
timeFrame: Up to two years after the laparotomy
measure: The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions
timeFrame: Up to 24 months after the randomization
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Surgery, Sahlgrenska University Hospital
city: Linköping
country: Sweden
facility: Department of surgery, University Hospital
city: Lund
country: Sweden
facility: Department of Surgery, Skane University Hospital
city: Stockholm
country: Sweden
facility: Gastro Center Surgery, Karolinska University Hospital
city: Umeå
country: Sweden
facility: Department of Surgery, University Hospital
city: Örebro
country: Sweden
facility: Department of Surgery, University Hospital
Study officials:
affiliation: Göteborg University
name: Lars Fändriks, Professor
role: STUDY_CHAIR
affiliation: Gothenburg Universitity
name: Claes Jönsson, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05548582: Reduced Opioid Prescription After Laparoscopic Hysterectomy
Official title: A Randomized Controlled Trial to Study Reduced Opioid Prescription After Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Opioid Misuse
Opioid Use
Pain
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Given the nationwide epidemic of opioid use and abuse (in part due to over prescription), this study aims at addressing the need for opioid prescription after laparoscopic hysterectomy.

Detailed description: Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. Given the increasing opioid abuse and over-prescription post-operatively, an effort must be made to determine whether non-opioid multimodal medications are adequate in treating postoperative pain after laparoscopic hysterectomy and would not increase the need for additional prescriptions or unscheduled patient contacts. This study aims to find the optimal prescriptions for pain after laparoscopic hysterectomy in an attempt to eliminate opioid use.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 undergoing outpatient laparoscopic (conventional or robotic) hysterectomy for benign indications

Exclusion Criteria:

* Allergy or other contraindication to the prescribed medications such as acetaminophen, ibuprofen, or oxycodone
* Known opioid use or abuse (defined as reported use or treatment for abuse within the last 3 months)
* Chronic pain patients
* Conversion to laparotomy
* Malignancy as the indication for surgery

Primary outcomes:
measure: Pain score on post-operative day one
timeFrame: 1 day
measure: Pain score on post-operative day seven
timeFrame: 7 days
Secondary outcomes:
measure: Satisfaction of pain control on postoperative day one
timeFrame: 1 day
measure: Satisfaction of pain control on postoperative day seven
timeFrame: 7 days
measure: Mobility on postoperative day one
timeFrame: 1 day
measure: Mobility on postoperative day seven
timeFrame: 7 days
measure: Total opioid consumption on postoperative day one
timeFrame: 1 day
measure: Total opioid consumption on postoperative day seven
timeFrame: 7 days
measure: Opioid related side effects on postoperative day one
timeFrame: 1 day
measure: Opioid related side effects on postoperative day seven
timeFrame: 7 days
measure: Unplanned calls/visits
timeFrame: 7 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mostafa Borahay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04160182: Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors
Official title: Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Fatigue
Keywords: Breast cancer
fatigue
Intervention
Lead sponsor: University of Toledo
Sponsor class: OTHER
Collaborators: name: University of Toledo
First posted: 2019-11-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to determine the feasibility and effectiveness of a 6-week, internet-based, Energy Conservation and Activity Management intervention among women who report cancer-related fatigue following breast cancer treatment.


Eligibility criteria: Inclusion Criteria:

* breast cancer diagnoses
* not currently receiving active treatment in the form of chemotherapy or radiation therapy
* at least 18 years of age
* fatigue severe enough to limit daily activities (score ≥ 4 on 7-point Fatigue Severity Scale)(Krupp, LaRocca, Muir-Nash, \& Steinberg, 1989);
* functional English fluency and literacy;
* Participant has a smart device that operates on the Android or Apple platform
* Participant is able to use the Ecological Momentary Assessment application before going to bed every night

Exclusion Criteria:

* self-reported history of diagnosis of co-morbidities that have been associated with poor sleep and fatigue: chronic insomnia, chronic fatigue syndrome, unstable heart, lung, or neuromuscular disease, insulin-dependent diabetes, sleep apnea, chronic oral steroid therapy, and night-shift employment,
* Disability due to a diagnosis other then breast cancer
* Currently taking medication for depression, sleep issues, or fatigue.

Primary outcomes:
measure: Change in Fatigue Scores (Revised Piper Fatigue Scale)
timeFrame: Baseline to 14 weeks
Secondary outcomes:
measure: Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale)
timeFrame: Baseline to 14 weeks
measure: Change in Fatigue Impact (Modified Fatigue Impact Scale)
timeFrame: Baseline at 14 weeks
measure: Change in Severity of Fatigue Measured Via Ecological Momentary Assessments
timeFrame: Baseline to 14 weeks
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
Study officials:
affiliation: University of Toledo
name: Ketki Raina, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03494582: Abdominal Versus Vaginal Hysteropexy
Official title: Trans Vaginal Sacrospinous Hysteropexy Versus Abdominal Sacral Hysteropexy for the Management of Uterine Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Prolapse
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 53
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the vaginal versus the abdominal approach for the management of uterine prolapse

Detailed description: this study compares The unilateral sacrospinous hysteropexy with prolene sutures versus the abdominal sacral hysteropexy using Mersilene suture for the management of uterine prolapse

Eligibility criteria: Inclusion Criteria:

* Uterine Prolapse

Exclusion Criteria:

* Previous prolapse surgery Hereditary Connective tissue disorders

Primary outcomes:
measure: Pelvic organ prolapse quantification system
timeFrame: 3 month
Secondary outcomes:
measure: Perioperative data
timeFrame: 1 day
measure: operative details
timeFrame: 1 day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Urogynecology Unit
Study officials:
affiliation: Ain Shams University
name: Hamdy HA Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01339182: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers
Official title: A Randomized, Open-label, Single-dose, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated-Somatropin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: somatropin
PK
PD
male
pharmacokinetics
pharmacodynamics
safety
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking Union Medical College Hospital
First posted: 2011-04-20
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data for the design and conduct of subsequent studies.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* Age(yr)between 18 and 45
* Body mass index(BMI)between 20 and 28
* sign informed consent

Exclusion Criteria:

* Known hypersensitivity to somatropin or any other components of the study drug
* Organic lesion in heart, liver, kidney or any other major organs
* History of diabetes mellitus, cancer, autoimmune disease, genetic disease, mental disease
* Alcoholic, smokers or drug abusers
* Blood donation, or massive blood loss due to injury or surgery within 3 months
* Other conditions which in the opinion of the investigator preclude enrollment into the study.

Primary outcomes:
measure: Measurement of the IGF-1 levels for pharmacodynamics study
timeFrame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug
Secondary outcomes:
measure: Measuring the drug levels in blood samples
timeFrame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug
measure: Measurement of IGFBP-3 levels for pharmacodynamic study
timeFrame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Hu Pei, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05724082: The Effect of Household Air Pollution on Lung Function Growth in Infants With Pneumonia in Sub-Saharan Africa
Official title: The Effect of Household Air Pollution on Lung Function Growth in Infants With Pneumonia in Sub-Saharan Africa
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pneumonia
Pollution; Exposure
Lung Function Decreased
Chronic Respiratory Disease
Pediatric Respiratory Diseases
Lungs; Developmental Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
First posted: 2023-02-13
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off.
Primary purpose: PREVENTION

Brief summary: This study will evaluate the feasibility and acceptability of a household-based clean air intervention

Detailed description: A clean air intervention will be implemented in each household, including HEPA- based air filtration, solar lighting, and education. The air filtration system will be cycled monthly, with active filtration alternating with no filtration for one month on/one month off. To determine the effect of the clean air intervention within the household, PM2.5 concentration during each cycle and lung function will be measured among household members.

Eligibility criteria: Inclusion Criteria:

* Age \< 12 months

  • First episode of WHO-defined severe pneumonia22: cough or difficulty breathing with
* Oxygen saturation \< 90% or central cyanosis,
* Severe respiratory distress, or
* Signs of pneumonia with a general danger sign
* Be willing to commit to entire 2 years of follow up visits.
* (Controls) Matched to each case on age (+/-1 month), sex, and community

Exclusion Criteria:

* Craniofacial, cardiac or other major malformation
* Neuromuscular condition that affects respiration
* Outside Smart Discharges Project catchment area
* Prior hospitalizations or known episodes of respiratory illness or episodes of pneumonia before index admission,

Primary outcomes:
measure: Feasibility and acceptability of the clean intervention
timeFrame: 2 years
Secondary outcomes:
measure: Air quality
timeFrame: Up to 2 years
measure: Pulmonary function testing
timeFrame: Up to 2 years
measure: Acceptability of using air filter device
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
affiliation: Massachusetts General Hospital
name: Peter Moschovis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mbarara University of Science and Technology
name: Jerome Kabakyenga, MBChB, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018382: Insulin, Neurogenetics and Memory in Alzheimer's Disease
Official title: Insulin, Neurogenetics and Memory in Alzheimer's Disease: A Novel Therapeutic Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study examines the use of insulin-sensitizing compounds, as therapeutic agents for cognitive impairment in Alzheimer's disease.


Eligibility criteria: Men and women with mild Alzheimer's Disease without serious medical or psychiatric comorbid conditions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
name: Steven Kahn, M.D.
name: Sanjay Asthana, M.D.
name: Alfred Fujimoto, M.D.
References:
Clinical trial NCT01549782: Mixture of Prebiotics on Intestinal Microbiota of Patients Receiving Abdominal Radiotherapy.
Official title: Effect of a Mixture of Inulin and Fructo-oligosaccharide on Lactobacillus and Bifidobacterium Intestinal Microbiota of Patients Receiving Radiotherapy: a Randomised, Double-blind, Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prebiotics
Microbiota
Radiation Therapy Complication
Endometrial Neoplasms
Keywords: Prebiotics
Microbiota
Radiotherapy
Gynaecological Cancer
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Abdominal and pelvic radiotherapy (RT) reduces the renewal capacity of the epithelium. Rectal biopsies obtained from patients receiving pelvic RT have revealed atrophy of surface epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal inflammation. Modifications in intestinal microbiota, such as an increase in the number of pathogens, may contribute to intestinal injury. The prebiotic effect of a carbohydrate is assessed by its capacity to stimulate the proliferation of healthy bacteria (Bifidobacterium, Lactobacillus) rather than pathogenic bacteria (Clostridium, E. coli).

The hypothesis of the study is that a mixture of inulin and fructooligosaccharide could modulate Lactobacillus and Bifidobacterium and reduce the intestinal injury in patients affected of gynaecological cancer and treated with abdominal radiotherapy.


Eligibility criteria: Inclusion Criteria:

* female gender, age ≥ 18 years, and a diagnosis of gynaecologic cancer requiring postoperative pelvic RT.

Exclusion Criteria:

* previous RT, previous or adjuvant chemotherapy, other types of pelvic tumours or other gynaecologic malignancies, antibiotic or immunosuppressive treatment one week before inclusion or during treatment, and the presence of acute or chronic gastrointestinal disease contraindicating ingestion of the fibre

Primary outcomes:
measure: Changes in Lactobacillus and Bifidobacterium populations
timeFrame: 2 months
Secondary outcomes:
measure: Changes in calprotectin and DNA levels.
timeFrame: 2 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Nutrition Unit. HGU Gregorio Marañón
Study officials:
affiliation: Nutrition Unit. HGU Gregorio Maranon
name: Pilar Garcia-Peris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Peris P, Velasco C, Lozano MA, Moreno Y, Paron L, de la Cuerda C, Breton I, Camblor M, Garcia-Hernandez J, Guarner F, Hernandez M. Effect of a mixture of inulin and fructo-oligosaccharide on Lactobacillus and Bifidobacterium intestinal microbiota of patients receiving radiotherapy: a randomised, double-blind, placebo-controlled trial. Nutr Hosp. 2012 Nov-Dec;27(6):1908-15. doi: 10.3305/nh.2012.27.6.5992.
Clinical trial NCT04482920: Effect of Hormone Therapy on Renal Function
Official title: The Effects of Hormone Therapy on Renal Hemodynamic Function in Transgender Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transgenderism
Kidney Diseases
Kidney Injury
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 22
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 transgender youth and young adults (10 transgender females, 10 transgender males) before and 3 months after initiation of gender affirming hormone therapy to determine the impact of gender affirming hormone therapy on intrarenal hemodynamic function and tubular function.

Brief summary: The purpose of this study is to understand the effects of testosterone or estradiol on kidney function in transgender adolescents and young adults.


Eligibility criteria: Inclusion Criteria:

* Identify as transgender
* Age 17-30 years (inclusive)
* Plan to start gender affirming hormone therapy (testosterone or estradiol) clinically in ≤ 1 months and remain on for at least 3 months

Exclusion Criteria:

* Cognitive, psychiatric or physical impairment resulting in inability to tolerate the study procedures (e.g. intellectual disability, schizophrenia, hallucinations)
* Type 1 or Type 2 diabetes
* Chronic kidney disease, or eGFR \<60ml/min/1.73m2 by CKD-EPI formulation
* Uncontrolled hypertension (resting BP ≥ 140/90 mm/Hg)
* Allergy to shellfish, iodine or iohexol
* Currently taking: sulfonamides, procaine, thiazolesulfone and probenecid (renal clearance measurements of PAH cannot be made accurately if individuals are on these medications)
* Prior gender affirming hormone therapy use
* Prior gonadectomy
* Pregnancy

Primary outcomes:
measure: Change in measured glomerular filtration rate (GFR)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in effective renal plasma flow
timeFrame: Baseline, 3 months
measure: Change in biomarkers of tubular injury and repair (Neutrophil gelatinase-associated lipocalin [NGAL], Kidney injury molecule-1 [KIM-1], Chitinase-3-like protein 1 [YKL-40])
timeFrame: Baseline, 3 months
measure: Change in fat mass
timeFrame: Baseline, 3 months
measure: Change in fat-free mass
timeFrame: Baseline, 3 months
measure: Change in intracellular fluid
timeFrame: Baseline, 3 months
measure: Change in extracellular fluid
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Natalie J Nokoff, MD, MSCS
role: PRINCIPAL_INVESTIGATOR
References: