louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06396000: Factors Analysis Related to Prolonged Stay in the Pediatric Post-Anesthesia Care Unit(PACU)
Official title: Prolonged Stay in the Pediatric PACU
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anesthesia; Adverse Effect
Keywords: Post-anesthesia care unit
Risk factors
Pediatrics
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 10000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patient entering the Pediatric Post-Anesthesia Care.

Brief summary: The purpose of this study is to determine which factors contribute to prolonged stay of children in the PACU.

Detailed description: Studying the factors associated with prolonged stay of children in the PACU is of great significance to the medical team, as it can improve the quality and speed of anesthesia recovery, not only in line with the concept of accelerated rehabilitation surgery, but also through intervention and optimization of specific factors to improve the efficiency of children's postoperative discharge from the PACU, reduce the incidence of complications, lower medical costs, and increase patient and family satisfaction. Therefore, this study aims to explore the factors associated with prolonged stay of children in the PACU through retrospective analysis.

Eligibility criteria: Inclusion Criteria:

* Children aged 0-18 years old; Child entering the Pediatric Post-Anesthesia Care.
* Emergency surgery; Pediatric patients with incomplete medical history; Pediatric patients requiring postoperative ICU care; Pediatric patients with preoperative altered consciousness; Neurological disorders; Severe liver, kidney, lung, and heart diseases.

Primary outcomes:
measure: Anesthesia Plan Selection
timeFrame: Day 1
measure: Pain Score
timeFrame: Day 1
measure: Complications in PACU
timeFrame: Day 1
measure: American Society of Anesthesiologists（ASA）
timeFrame: Day 1
measure: The medication usage in PACU
timeFrame: Day 1
Secondary outcomes:
measure: The use of PCA（Patient-Controlled Analgesia）in PACU
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00548600: Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy With Temporary Iridium Implant Plus External Beam Radiation in Carcinoma of the Prostate
Official title: A Randomized Clinical Trial Comparing Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy Using a Combination of a Temporaory Iridium Implant Plus External Beam Radiation in Surgically Staged B2 and C Carcinoma of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Iridium
Implant
Radiotherapy
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
First posted: 2007-10-24
Enrollment: 112
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be assessed in terms of local recurrence, survival, and toxicity.


Eligibility criteria: Inclusion Criteria:

* All patients must have histologically proven adenocarcinoma of the prostate
* The primary tumour should be staged clinically B2 or C as classified by A.J.C. Staging System

Exclusion Criteria:

* Patients requiring transurethral prostatectomy (TURP) prior to diagnosis
* Presence of metastases identified by bone scan, chest x-ray or CT scan of the abdomen and pelvis, or staging lymphadenectomy
* Karnofsky performance status less than 80
* Inadequate laboratory results: i.e. Hb \< 12 gm/litre, WBC \< 3.5 x 10 per litre, platelets \< 100 x 10/litre, urea \> 13 mmol/litre, creatinine \> 220 mmol/litre
* Unfit for surgery for other medical reasons
* Age above 75 years
* Failure to provide written informed consent

Primary outcomes:
measure: Rate of local control as determined by biopsy at 18 months
timeFrame: 18-months
Secondary outcomes:
measure: Distant metastasis
timeFrame: survival
measure: Overall mortality
timeFrame: survival
measure: Mortality due to prostate cancer
timeFrame: survival
measure: Local complications of radiation
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
Study officials:
affiliation: Juravinski Cancer Centre
name: Jinka Sathya, MD
role: STUDY_CHAIR
References:
citation: Sathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. doi: 10.1200/JCO.2005.06.154.
Clinical trial NCT02980900: The Effect of Protein Ingestion on the Recovery of Skeletal Muscle Function Following Eccentric Exercise.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study will assess the effect of the type and timing of protein ingestion 6 days prior to, and 7 days following eccentric exercise on the time course of 1) the recovery of muscle function, 2) the recovery of perceived muscle soreness, 3) muscle metabolism.


Eligibility criteria: Inclusion Criteria:

* Men and women who are generally healthy and recreationally active

Exclusion Criteria:

* Active cardiovascular disease or hypertension
* Diagnosed metabolic impairment
* Use of nutritional supplements
* Use of anti-inflammatory medications
* Habitual dietary protein intake of \<0.8g/kg/day
* Musculoskeletal disorders

Primary outcomes:
measure: Isokinetic force production of the knee extensor muscles
timeFrame: 14 days
Secondary outcomes:
measure: Muscle protein synthesis
timeFrame: 14 days
measure: Thigh volume
timeFrame: 14 days
measure: Perceived muscle soreness
timeFrame: 14 days
measure: Isometric force production of the knee extensor muscles
timeFrame: 14 days
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport and Health Sciences
state: Devon
Study officials:
References:
citation: Jameson TSO, Pavis GF, Dirks ML, Lee BP, Abdelrahman DR, Murton AJ, Porter C, Alamdari N, Mikus CR, Wall BT, Stephens FB. Reducing NF-kappaB Signaling Nutritionally is Associated with Expedited Recovery of Skeletal Muscle Function After Damage. J Clin Endocrinol Metab. 2021 Jun 16;106(7):2057-2076. doi: 10.1210/clinem/dgab106.
Clinical trial NCT01149200: Proof-of-Principle Study of TC-6499 in the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof-of-Principle Study to Evaluate the Safety, Tolerability, and Efficacy of TC-6499-12 in the Treatment of Constipation Predominant IBS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
IBS-C
Lead sponsor: Targacept Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant IBS patients over a 28-day period.

Detailed description: This is a randomized, double blind, placebo controlled study of a maximum of 24 subjects with constipation predominant irritable bowel syndrome (IBS-C). Sixteen subjects will receive active treatment and 8 subjects will receive matching placebo. There will be a 21-day screening phase before 1st study drug administration on Day 1.

Eligibility criteria: Inclusion Criteria:

* Men with IBS-C (ROME III) between 18 and 65 years of age, inclusive.
* Women with IBS-C (ROME III) between 55 and 65 years of age, or 18 to 55 years of age with documentation of non-childbearing potential status (surgical sterilization or one year post last menses with elevated FSH/LV).
* All subjects should have a body mass index (BMI) between 18 and 34 kg/m2, inclusive and a body weight of not less than 45 kg.

Primary outcomes:
measure: Change from baseline in global IBS symptom relief score
timeFrame: 28 days
Secondary outcomes:
measure: Weekly number of spontaneous bowel movements (SBM)
timeFrame: 28 days
measure: Severity of pain, bloating, degree of straining, and stool consistency
timeFrame: 28 days
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Quotient Clinical Ltd
city: Ruddington
country: United Kingdom
facility: Quotient Clinical Ltd
Study officials:
affiliation: Quotient Bioresearch
name: Stuart Mair, MB, ChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00889200: Eszopiclone Treatment & Cortisol Responsivity
Official title: Eszopiclone Treatment & Cortisol Response to HPA Axis Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma America, Inc.
First posted: 2009-04-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study was designed to use a sensitive neuroendocrine probe, the Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults with insomnia. The primary aim was to assess cortisol reactivity before and after long-term (6 weeks) administration of eszopiclone. It was hypothesized that treatment with eszopiclone would result in a significant reduction in plasma cortisol response to the DEX/CRH test following treatment of insomnia with standard dose of eszopiclone.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* Mild to Moderate Insomnia

Exclusion Criteria:

* Any acute or chronic medical condition involving function of HPA axis (e.g., Cushing's or Addison's Disease, adrenal or pituitary gland disorders)
* Currently taking, or unable to be free of, antidepressant, neuroleptic, anxiolytic, or thymoleptic drugs for at least 2 weeks preceding the DEX/CRH test (free of fluoxetine for at least 6 weeks)
* Current use of psychotropic medication or medication (prescribed or over the counter) thought to affect HPA axis function or glucocorticoid synthesis/release (e.g., prednisone, anabolic steroids, DHEA, ketoconazole, metyrapone)
* History of a significant adverse reaction to eszopiclone
* Meets DSM-IV criteria for any Axis I psychiatric disorder, including substance abuse presently, or substance dependence within the past 6 months
* Pregnancy, lactation, or unable/unwilling to use reliable methods of contraception during the study procedures
* Limited mental competency and the inability to give informed, voluntary, written consent to participate.

Primary outcomes:
measure: Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug)
timeFrame: post drug (6 weeks oral eszopiclone)
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Linda Carpenter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04223700: Ultrasound-guided Thoracic Spinal Level Identification
Official title: Ultrasound-guided Thoracic Spinal Level Identification Using Rhomboid Muscle as a Reference Landmark
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Diseases
Myofascial Pain
Keywords: Ultrasound guided intervention
Rhomboid muscle
Thoracic spine
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Typically, the rhomboid minor muscles rise from the C7-T1 spinous process and run downward to touch the upper inner corner of the scapula, and the rhomboid major muscles rise from the T2-T5 spinous process and run downward to reach the lower middle inner corner of the scapula. In anatomical research articles, it has been reported that the rhomboid muscle's anatomical variations are rare. Considering the characteristics of these rhomboid muscles, the investigators planned a study on the utility of rhomboid muscles as a landmark for identifying thoracic spine levels.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing thoracic nerve root block due to herpes zoster, postherpetic neuralgia, complex regional pain syndrome, post traumatic pain syndrome, or compression fracture of vertebra.

Exclusion Criteria:

1. Previous T-spine surgery
2. Patient refusal
3. Coagulopathy
4. Generalized infection or localized infection at injection site
5. Anatomical abnormality of T-spine
6. Allergic reaction to local anesthetics

Primary outcomes:
measure: Ultrasound-guided Thoracic Spinal Level
timeFrame: during the procedure
Secondary outcomes:
measure: 1. Changes in marker position when raised the arm above the head and in a relaxed position
timeFrame: during the procedure
measure: 2. Rhomboid muscle variation
timeFrame: during the procedure
measure: 3. Visibility grade of muscle fascia using Ultrasound (I - IV)
timeFrame: during the procedure
measure: 4. Depth: The distance from the skin where the marker is attached to the transverse process of thoracic spine
timeFrame: during the procedure
measure: 5. Difference between left and right sides
timeFrame: during the procedure
Other outcomes:
Locations:
Study officials:
References:
citation: Jung H, Bae J, Kim J, Yoo Y, Lee HJ, Rho H, Han AH, Moon JY. Can the Rhomboid Major Muscle Be Used to Identify the Thoracic Spinal Segment on Ultrasonography? A Prospective Observational Study. Pain Med. 2022 Sep 30;23(10):1670-1678. doi: 10.1093/pm/pnac043.
Clinical trial NCT00007800: NEW DAY: Nutrition, Exercise, Weight Loss, Diabetes And You
Official title: Obesity Treatment and NIDDM in Black and White Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Obesity
Keywords: obesity treatment
non insulin dependent diabetes
type 2 diabetes
behavioral weight control
motivational interviewing
motivational enhancement
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2001-01-05
Enrollment: 218
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial examines whether the addition of individual sessions of a motivational intervention to a state-of-the art behavioral group weight loss intervention for overweight women with Type 2 diabetes improves the weight losses and glycemic control outcomes.

Detailed description: The multi-disciplinary behavioral, group-based intervention focuses on dietary and exercise changes, with group meetings over an 18-month period. Participants are assessed at 6-month intervals (for a total of 18 months) to examine the impact of the interventions on body weight and blood sugar control (primary outcomes), as well as on blood pressure, cholesterol, quality of life and attitudes (secondary outcomes). All enrolled participants receive group-based weight loss intervention. Half the women enrolled also receive several individual sessions of motivational interviewing and the other half of enrolled women receive the same number of individual sessions of health education, which focus on issues relevant to women (e.g., mammography, sleep hygiene, menopause, etc).

Eligibility criteria: Inclusion Criteria:

* Body Mass Index of 27 - 50
* Type 2 diabetes currently treated with oral medications
* Ability to walk for exercise

Exclusion Criteria:

* Use of insulin
* Current pregnancy
* Presence of debilitating disease, psychotic condition or any other condition that might interfere with participation
* Failure to complete self monitoring diary for 1 week
* Plans to move out of the area in the upcoming 18 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT00492700: A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
Official title: A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Alcoholic Steatohepatitis
Keywords: steatosis,
fibrosis,
diabetes,
obesity
Lead sponsor: Association pour la Recherche sur les Maladies Hépatiques Virales
Sponsor class: OTHER
First posted: 2007-06-27
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).

Detailed description: Phase one : A double blind randomized placebo controlled trial of rosiglitazone

* 64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8 mg/day or placebo for one year.
* after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment

Primary endpoint: improvement of at least 30% of the histological score of steatosis Secondary endpoints: improvement in ALT values, in necrosis and inflammation and fibrosis

Phase II extension open label trial

All participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years. A liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in NASH patients.

Eligibility criteria: Inclusion Criteria:

* Histologically proven NASH with steatosis \>= 20%
* Increased serum ALT

Exclusion Criteria:

* bland steatosis
* daily alcohol \> 20/30 g (women/men)
* any other cause of liver disease
* secondary NASH including drug-induced steatohepatitis
* treatment with insulin or glitazones
* cardiac insufficiency
* Hb \< 10 g/dl

Primary outcomes:
measure: improvement in steatosis
Secondary outcomes:
measure: improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'hépatogastroenérologie, Hôpital Pitié Salpêtrière
Study officials:
affiliation: Hôpital Pitié Salpêtrière, APHP
name: Vlad Ratziu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ratziu V, Charlotte F, Bernhardt C, Giral P, Halbron M, Lenaour G, Hartmann-Heurtier A, Bruckert E, Poynard T; LIDO Study Group. Long-term efficacy of rosiglitazone in nonalcoholic steatohepatitis: results of the fatty liver improvement by rosiglitazone therapy (FLIRT 2) extension trial. Hepatology. 2010 Feb;51(2):445-53. doi: 10.1002/hep.23270.
Clinical trial NCT03092700: Pulmonary Rehabilitation, Dyspnoea and Emotional Cognition in COPD
Official title: Effects of Pulmonary Rehabilitation on Dyspnoea Affective Dimension and Emotional Cognition in Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Dyspnea
Rehabilitation; Tobacco Use
Emotional Disturbances
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients admitted for a pulmonary rehabilitation

Brief summary: To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (COPD).To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (COPD).

Detailed description: The aim of the study will be to evaluate the effect of pulmonary rehabilitation on dyspnoea emotional component and on emotional cognition. It will add a better understanding of the mechanisms of pulmonary rehabilitation on dyspnoea.

Patients with COPD will be included before starting a pulmonary rehabilitation and be evaluated with questionnaires (including the Multidimensional Dyspnea Profile, and quality of life questionnaires), emotional cognition (at rest and right after an endurance test, using some short movies sequences and pictures of faces expressing some well defined emotions) and smile production analysis.

After having followed a pulmonary rehabilitation, the same evaluation will be realised and results will be compared before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* COPD patients with pulmonary rehabilitation indication, hospitalized in Department of Pulmonary Diseases in La Pitié-Salpêtrière, Paris, France.
* Age of 40 at least.

Exclusion Criteria:

* Facial paralysis
* Neuromuscular disease
* Contraindication for pulmonary rehabilitation
* Severe depression syndrom or psychiatric disease
* Drug use
* Impaired vision
* Higher functions disorders (Mini Mental Score Examination \< 26)
* Severe obesity (BMI\>40kg/m²)

Primary outcomes:
measure: emotional cognition
timeFrame: 6 weeks
Secondary outcomes:
measure: Correlation between physical improvement, quality of life improvement and time to recognize facial emotions.
timeFrame: 6 weeks
measure: Correlations between physical improvement and production of the smile.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique Paris Est, Groupe Hospitalier Pitié-Salpêtrière
Study officials:
References: