louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01141374: Application of Auriculotherapy on Nursing Professional Stress Levels
Official title: Analysis of the Application of Different Forms in Auriculotherapy on Nursing Professional Stress Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress
Keywords: Stress
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 75
Sex: ALL
Minimum age (years): 23
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and review the auriculotherapy effectiveness through semi-permanent needles and seeds.

Detailed description: Seventy five participants with average and high scores on the Stress Symptoms List (LSS) were divided in 3 groups (control, needles and seeds).

They were evaluated at the baseline, fourth and eighth sessions and 15-day follow-up and received 8 sessions through Shenmen, Kidney and Brainstem points.

Eligibility criteria: Inclusion Criteria:

* Average and high score by the List of Stress Symptoms
* Voluntary participation in the study
* Availability of time for submission to the sessions

Exclusion Criteria:

* Pregnancy
* Medical license or vacation during the period
* Low score of stress

Primary outcomes:
measure: Stress Levels After 4 Sessions (2nd Evaluation)
timeFrame: after 30 days
Secondary outcomes:
measure: Stress Levels(3rd and 4th Evaluation)
timeFrame: after 60 and 75 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Universitário da Universidade de São Paulo
Study officials:
affiliation: Escola de Enfermagem da Universidade de São Paulo
name: Maria Julia P Silva
role: STUDY_DIRECTOR
References:
Clinical trial NCT03031574: A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-D4010 in Healthy Subjects
Official title: A Phase 1, Single-Center, Single-Dose, 2-Way Crossover, Randomized Food-Effect and Non-Randomized Gender- and Age- Effect Pharmacokinetic Study of SUVN-D4010 Orally Administered in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognitive Disorder
Keywords: Serotonin 4 (5-HT4) receptor
Phase 1
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2017-01-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of food, gender, and age on the single-dose pharmacokinetics (PK) of SUVN-D4010.

Detailed description: The main objective of the study is to evaluate the safety and tolerability of orally administered SUVN-D4010 under single-dose conditions in healthy adult male and female subjects and healthy elderly male subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects, aged 18 to 45 years, inclusive; healthy female subjects, aged 18 to 45 years, inclusive; healthy elderly male subjects, aged ≥65 years.
* Have a body mass index (BMI) between 18.0 and 30.0kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg.

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the (first) administration of the study drug.
* Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
* Plasma or blood product donation within 1 month of the (first) administration of the study drug and any blood donation/blood loss more than 500 mL within the 2 months prior to the (first) administration of the study drug.
* As judged by the Investigator that the subject should not participate in the study if he/she is considered unlikely to comply with study procedures, restrictions, and requirements.

Primary outcomes:
measure: Area under concentration (AUC)
timeFrame: 72 hours
measure: Maximum observed concentration (Cmax)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences
state: Kansas
Study officials:
affiliation: PRA Health Sciences
name: Daniel Dickerson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nirogi R, Bhyrapuneni G, Muddana NR, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. First-in-Human Studies to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel 5-HT4 Partial Agonist, SUVN-D4010, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2021 May;41(5):469-482. doi: 10.1007/s40261-021-01027-4. Epub 2021 Mar 31.
Clinical trial NCT01299974: Project PARIS: Parents and Residents in Session
Official title: Project PARIS: Parents and Residents in Session
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family-centered Care
Keywords: Family-centered
teaching
residents
family faculty
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Picker Institute
name: The Arnold P. Gold Foundation
First posted: 2011-02-21
Enrollment: 83
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study seeks to implement and test a novel approach to teach pediatric residents about patient and family-centered care (PFCC). The approach calls for a supervised meeting between a family member of a previously hospitalized child and a resident in the context of a pediatric residency rotation.

Detailed description: A specific patient and family centered care module will be implemented in the context of an existing training rotation. This module includes a meeting between resident physicians (trainees) and parents of previously hospitalized children (members of the Family Faculty in our institution), monitored by a senior faculty member. Patient and family centered care will be discussed using predefined, manual-driven guidance. This meeting is followed by a discussion with the faculty member to identify core components of family-centered care as exemplified in the parent interview.

Eligibility criteria: Inclusion Criteria:

* Residents in good standing in a pediatric residency at Mount Sinai Medical
* Center who agree to participate in the study

Exclusion Criteria:

* Residents who did not agree to participate
* Residents who have less than 3 months to complete their residency

Primary outcomes:
measure: Resident's knowledge
timeFrame: The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview
Secondary outcomes:
measure: Residents' attitude towards family-centered care as measured by a questionnaire
timeFrame: The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview
measure: Parents' acceptance of family-centered care as measured by a questionnaire
timeFrame: The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Kravis Children's Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Joel Forman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05840874: Complications of Enterocystoplasty in Children
Official title: Surgical Complications of Enterocystoplasty in Children: A Retrospective Monocentric Study About 39 Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complications of Surgical Procedure
Neurogenic Bladder
Spina Bifida
Child, Only
Keywords: Augmentation Enterocystoplasty
Surgical Complications
Children
Retrospective Study
Lead sponsor: University of Lorraine
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 90
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with dysfunctional bladder

Brief summary: The goal of this observational study is to describe the complications in participants who underwent enterocystoplasty in childhood.

The main question\[s\] it aims to answer are:

* what kind of complications are there
* the kind of complications depending on the type of enterocystoplasty Participants data will be collected in the medical field. There is no comparison group.

Detailed description: From 1982 to 2020, all patients who had an enterocystoplasty in childhood were collected.

Complications were numbered depending on the type of enterocystoplasty and the investigators tried to find which risk factors exist.

Eligibility criteria: Inclusion Criteria:

* patients who underwent a enterocystoplasty before 18 years old

Exclusion Criteria:

* patients who underwent a enterocystoplasty after 18 years old

Primary outcomes:
measure: Surgical complications of bladder augmentation in children depending on the type of enterocystoplasty
timeFrame: 38 years
Secondary outcomes:
measure: Impact of the participants' age on the occurrence of complications depending on the type of enterocystoplasty
timeFrame: 38 years
measure: Impact of the participants' sex on the occurrence of complications depending on the type of enterocystoplasty
timeFrame: 38 years
measure: Impact of the participants' type of neurogenic bladder on the occurrence of complications depending on the type of enterocystoplasty
timeFrame: 38 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: ULorraine
Study officials:
References:
citation: Molina CA, Lima GJ, Cassini MF, Andrade MF, Facincani I, Tucci Junior S. Complications after bladder augmentation in children. Acta Cir Bras. 2016;31 Suppl 1:8-12. doi: 10.1590/S0102-86502016001300003.
Clinical trial NCT03080974: Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Official title: Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Adenocarcinoma
Keywords: irreversible electroporation
Nivolumab
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will undergo irreversible electroporation and treatment with Nivolumab
Primary purpose: TREATMENT

Brief summary: Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.

Detailed description: Immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. This is a Phase II study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years if age
* Diagnosed with stage III pancreatic cancer
* Tumor is measurable
* Glomerular Filtration Rate \> 60 m/L/min/1.73 m(2)
* Willing and able to comply with the protocol requirements
* Able to comprehend and have signed the informed consent to participate

Exclusion Criteria:

* Participating in another clinical trial for the treatment of cancer at time of screening
* Are pregnant or currently breast feeding
* Have a cardiac pacemaker or Implantable Cardioverter Defibrillator implanted that cannot be deactivated during the procedure
* Have non-removable implants with metal parts within 1 cm of the target lesion
* Had a myocardial infarction within 3 months prior to enrollment

Primary outcomes:
measure: Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment
timeFrame: Baseline thru 100 days after receiving last dose
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Every three months for 4 years.
measure: Overall Survival
timeFrame: Every three months for 4 years.
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Robert Martin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00457574: Safety and Efficacy of GMX1777 in the Treatment of Refractory Solid Tumors or Lymphomas
Official title: A Single-Center, Open-Label, Phase I Study of Single-Agent GMX1777 Administered as a 24-Hour Infusion Every 3 Weeks to Patients With Refractory Solid Tumors or Lymphomas
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Solid Tumors and Lymphomas
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2007-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: GMX1777 is a water-soluble, intravenously-administered prodrug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.

Detailed description: This is a single-center, open-label, Phase I study of single-agent GMX1777 administered every 3 weeks to patients with CLL, MM, refractory solid tumors or lymphomas. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Eligibility criteria: Inclusion Criteria:

* Patients must have a histologically or cytologically confirmed solid tumor or lymphoma
* No limitations on allowable type and amount of prior therapy.
* Patients must have a life expectancy of greater than 8 weeks
* Patients must have normal organ and marrow function
* Patients must be willing to submit blood sampling for planned PK analysis
* Patients must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

* No other agents or therapies administered with the intent to treat malignancy
* Patients with prior exposure to GMX1777 or GMX1778
* Uncontrolled, intercurrent illness
* Pregnant women and women who are breast feeding

Primary outcomes:
measure: Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters
timeFrame: 52 weeks
Secondary outcomes:
measure: Describe observed tumor responses
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Gemin X, Inc.
name: Mark Berger, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01874574: Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee
Official title: Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee: A Prospective, Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Corticosteroid
Hyaluronic acid
Intra-articular injection
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients.

Detailed description: Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients up to 6 months.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of knee OA
* Knee pain for most days of the prior month
* Radiographic evidence consistent with knee OA
* Aged between 40 and 80 years old

Exclusion Criteria:

* Lumbar spondylosis
* Gross deformity of the knee
* Co-existent inflammatory or crystal arthritis
* Prior knee surgery
* Injury to the knee in the preceding 6 months
* Any intra-articular injection in the preceding 3 months
* Pregnant or Lactating
* Current infection in the affected knee
* Inability to provide informed consent

Primary outcomes:
measure: WOMAC Score
timeFrame: 6 months
Secondary outcomes:
measure: Visual Analogue Scale(VAS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Prathumthani
country: Thailand
facility: Thammasat University Hospital, Thammasat University
Study officials:
affiliation: Department of Orthopaedics, Thammasat University
name: Nattapol Tammachote, MD, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT03512574: Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain
Official title: The Effect of the Combination of Pregabalin and Dexmedetomidine on the Management of Postoperative Pain in Patients Undergoing Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA) Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: pregabalin, dexmedetomidine, postoperative pain
Lead sponsor: Wonkwang University Hospital
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pregabalin and dexmedetomidine have been introduced to manage postoperative pain. The present study aimed to evaluate the effect of the combination of two drugs on pain relief in patients undergoing total knee or hip arthroplasty under spinal anesthesia

Detailed description: One hundred and twenty-four patients undergoing total knee or hip arthroplasty under spinal anesthesia were randomly assigned to either group C (n = 31, placebo), group P (n = 33, pregabalin), group PD (n = 29, pregabalin and dexmedetomidine) or group D (n = 31, dexmedetomidine). One hour before spinal anesthesia, patients received pregabalin 150 mg or placebo orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, followed by a continuous infusion of 0.5 μg/kg/hr or the same calculated volume of normal saline till completion of the surgery. Clinically relevant pain for 24 h after surgery including time to first analgesic request visual analog scale (VAS), ketorolac dose, and patient controlled analgesics (PCA) volume consumed were recorded.

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Aged 18-75 years

One hundred and twenty-four patients with intact cognitive function to understand this study undergoing elective total knee or hip arthroplasty under spinal anesthesia

Exclusion Criteria:

* Pregnant
* Allergic and/or contraindicated to the study drugs
* American Society of Anesthesiologists (ASA) score III and above
* Having drug
* Alcohol addiction
* Renal failure
* Diabetes mellitus
* Epilepsy
* currently using opioids for chronic pain and/or any of the drugs studied.

Primary outcomes:
measure: Patient controlled analgesics (PCA) volume
timeFrame: For 24 hours
Secondary outcomes:
measure: time to first analgesic request
timeFrame: for 24 hours
measure: visual analog scale (VAS)
timeFrame: for 24 hours
measure: ketorolac dose
timeFrame: for 24 hours
measure: adverse effects
timeFrame: within the first 24 hours postoperatively
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: WonwangUH
state: Jeonbuk
Study officials:
affiliation: Wonkwang University Hospital
name: Gilho Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04516174: Effect of Transversus Abdominis Plane Block Combined With Dexmedetomidine Infusion on the Prognosis in Elderly Patients Undergoing Abdominal Surgery
Official title: Effect of Transversus Abdominis Plane Block Combined With Dexmedetomidine Infusion on the Prognosis in Elderly Patients Undergoing Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Aged
Keywords: Delirium
Pain, Postoperative
Dexmedetomidine
Transversus abdominis plane block
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the prognosis of elderly patients undergoing radical resection of colorectal cancer treated with general anesthesia and general anesthesia combined with transversus abdominis plane block and continuous infusion of dexmedetomidine. The incidence of postoperative delirium, postoperative acute pain moderately to severely and poor postoperative recovery were composite endpoints to determine the prognosis of patients.


Eligibility criteria: Inclusion Criteria:

* Aged 65-80 years,regardless of gender
* American Society of Anesthesiologists physical status I-III
* Undergoing elective radical resection of colorectal cancer
* Sign informed consent

Exclusion Criteria:

* Could not cooperate to complete the pain VAS evaluation
* Could not cooperate to complete the cognitive function assessment

Primary outcomes:
measure: The prognosis of aged patients
timeFrame: Postoperative 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital
Study officials:
References: