louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02361983: Airway Management in Thoracic Anesthesia in Italy
Official title: Airway Management in Thoracic Surgery and Incidence Rate of Dislocation and Related Intraoperative Hypoxemia: State of the Art in Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Lead sponsor: Azienda Ospedaliera S. Maria della Misericordia
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 2129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing thoracic surgery

Brief summary: The aim of this study is to compare the success rate of lung isolation and time to accomplish a correct placement of the device between anesthetists with experience in thoracic anesthesia (defined as at least 4 years clinical practice experience as attending anesthetists in thoracic) and residents in training in thoracic anesthesia.

Detailed description: The aim of this study is to compare the success rate of lung isolation and time to accomplish a correct placement of the device between anesthetists with experience in thoracic anesthesia (defined as at least 4 years clinical practice experience as attending anesthetists in thoracic) and residents in training in thoracic anesthesia.

A prospective randomized trial was designed. To check the optimal DLT (Broncho-Cath Covidien, Ireland, Dublin, Teleflex Medical, Athlone, Irelanad) and/or BB (Uniblocker, Phycon, Fuji, Japan Arndt Cohen Cook, Australia), placement a fiberoptic bronchoscope (FOB) was used. The lung collapse was assessed by surgeons.

Time from laringoscopy to the correct placement of the device, confirmed with FOB, was checked.

Data were analyzed with Student't Test and Chi-square test; p value \< 0.05 was considered to be significant.

Eligibility criteria: Inclusion Criteria:

* patients who need one lung ventilation undergoing thoracic surgery

Exclusion Criteria:

* age \< 18 years old

Primary outcomes:
measure: DOUBLE LUMEN TUBE AND BRONCHIAL BLOCKER POSITIONING SUCCESS RATE: RESIDENTS vs. ATTENDING ANESTHETISTS.
timeFrame: 11/19/2012
Secondary outcomes:
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Department of Anesthesia and Intensive Care
state: Udine/Italy
Study officials:
affiliation: AOU Santa maria della Misericordia
name: Giorgio Della Rocca, prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Narayanaswamy M, McRae K, Slinger P, Dugas G, Kanellakos GW, Roscoe A, Lacroix M. Choosing a lung isolation device for thoracic surgery: a randomized trial of three bronchial blockers versus double-lumen tubes. Anesth Analg. 2009 Apr;108(4):1097-101. doi: 10.1213/ane.0b013e3181999339.
citation: Campos JH, Hallam EA, Ueda K. Training in placement of the left-sided double-lumen tube among non-thoracic anaesthesiologists: intubation model simulator versus computer-based digital video disc, a randomised controlled trial. Eur J Anaesthesiol. 2011 Mar;28(3):169-74. doi: 10.1097/EJA.0b013e328340c332.
Clinical trial NCT00150683: Effectiveness of Vibration and Standing Versus Standing Alone for the Treatment of Osteoporosis for People With Spinal Cord Injury.
Official title: Evaluation of Conventional and Innovative Standing Frame for the Treatment of Osteoporosis After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury.
Osteoporosis.
Keywords: Spinal Cord Injury.
Osteoporosis.
Standing.
Vibration.
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Ontario Neurotrauma Foundation
First posted: 2005-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if standing and/or standing with vibration works for the treatment of osteoporosis for people with a spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* Traumatic spinal cord injury of greater than 12 months.
* Osteopenia or osteoporosis of the hip.

Exclusion Criteria:

* Pregnant or lactating females.
* Nonunion lower extremity fracture within the last 6 months.
* Bilateral hip or knee flexion contractures.
* Bilateral lower extremity total hip or knee replacement.
* Heterotopic ossification of the hip or knee.
* Concurrent treatment with a bisphosphonate.

Primary outcomes:
measure: Change in bone mineral density from baseline of the hip, distal femur and proximal tibia at 6-months and 12-months.
Secondary outcomes:
measure: Spasticity (modified Ashworth).
measure: Quality of life.
measure: Frequency and severity of adverse events.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehab, Lyndhurst Centre
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: B. Cathy Craven, BPHE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02655783: Use of Normal Saline With or Without Dextrose During Induction of Labor in Nulliparous
Official title: Utilisation parentérale de Normal Salin Avec ou Sans Dextrose Durant l'Induction du Travail Chez Les Nullipares
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delivery Uterine
Keywords: induction of labor
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to compare the effects of use of normal saline (250 cc / h), with or without dextrose supplement, on the evolution of labor in nulliparous.

Detailed description: There is some controversy regarding intravenous hydration of patients during labor. While the use of a fast flow of hydration appears to be recognized beneficial, the addition of glucose is less well accepted. However studies on exercise physiology clearly demonstrates improved performance of skeletal muscle by increased hydration and carbohydrate replacement during prolonged exercise. This situation is similar to the condition of the uterus in labor especially since it is now established that glucose represents its principal source of energy.

However, the effect of an additional carbohydrate intake on the evolution of labor has not been extensively studied until now, and there are several schools of thought on this subject. While some studies show that such glucose addition could reduce the total duration of labor as well as its second stage, others claim that this glucose supplement offers no benefit and may even be harmful to the fetus.

It therefore seems imperative to conduct a study to compare the use of hydration with normal saline with or without dextrose during labor, as recommended in current flow (250 cc / h). To our knowledge, this has never been done.

Eligibility criteria: Inclusion Criteria:

* nulliparous woman
* monofetal pregnancy
* delivery at term
* elective induction
* favorable cervix (Bishop score of at least 6)
* cephalic presentation

Exclusion Criteria:

* diabetes
* preeclampsia
* maternal heart disease

Primary outcomes:
measure: 2nd stage of labor
timeFrame: during delivery of a first baby, for an average of 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Yves-André Bureau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06879483: Thoraco-laparoscopic Partial Esophagogastrectomy for Management of Esophageal Cancer
Official title: Early and Intermediate Term Outcomes of Thoraco-laparoscopic Partial Esophagogastrectomy for Management of Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Sohag University
Sponsor class: OTHER
Collaborators: name: Mansoura University
First posted: 2025-03-17
Enrollment: 30
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: Thoraco-laparoscopic partial esophagogastrectomy has emerged as a promising minimally invasive alternative, combining thoracoscopy and laparoscopy to reduce the trauma associated with open surgery.Early and intermediate-term outcomes provide critical information on both the oncological efficacy and functional benefits of the procedure. By examining recurrence rates within the first 12-24 months, this study will provide valuable insights into the oncological robustness of this approach compared to more invasive approaches.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with resectable esophageal cancer (stages I-III).
* Suitable for thoraco-laparoscopic partial esophagogastrectomy.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:

* Presence of distant metastasis at diagnosis.
* History of previous esophageal or gastric surgery.
* Contraindications to laparoscopy or thoracoscopy.

Primary outcomes:
measure: Immediate Postoperative complications
timeFrame: first month post operative
measure: Dysphagia
timeFrame: Collected at base line preoperative,one month, and 12 months post-surgery.
measure: resection margin status
timeFrame: 2 weeks postoperative
measure: lymph node yield.
timeFrame: first month post operative
measure: regurgitation
timeFrame: Collected at one month, and 12 months post-surgery.
Secondary outcomes:
measure: recurrence rate
timeFrame: first year post operative
measure: body mass index
timeFrame: Collected at base line preoperative,one month, and 12 months post-surgery.
measure: serum albumin
timeFrame: Collected at base line preoperative,one month, and 12 months post-surgery.
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
References:
Clinical trial NCT04716283: Sleep Quality Among Students in Sohag University.
Official title: Sleep Quality and Its Determinants Among Students in Sohag University.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted in Sohag University where there are ten practical faculties and six theoretical faculties .

Two medical faculties and two non medical faculties were chosen randomly to be the setting of the study.

Brief summary: The study will be done among undergraduate students in Sohag University for assessment of quality of sleep and its determinants .It will be done in practical faculties and theoretical faculties .

Detailed description: Sleep is very necessary to our physical and mental health. Sleep is classified into satisfactory and unsatisfactory sleep. Good sleep is sleep which is sufficient in duration and has a good quality while bad sleep is the sleep which makes individual feels unsatisfactory .

University students are exposed to poor sleep, due to high work and study loads. Poor quality sleep has negative consequences on the daily life activities , associated with memory reduction , reduced learning abilities which ultimately can lead to reduce their academic achievements, and can also trigger negative health outcomes, such as mood disturbance, fatigue, impaired concentration .

Eligibility criteria: Inclusion Criteria:

* students who are in the first four years in the selected faculties .

Exclusion Criteria:

* students who will refuse to participate in this study.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index [PSQI]
timeFrame: It will be measured after completion of the study ,approximately in october 2022.
measure: Epworth Sleepiness Scale [ESS]
timeFrame: It will be measured after completion of the study ,approximately in octuber 2022.
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Faculty of Medicine -Sohag University
name: Dalia S Louis, Demonstrator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02137083: A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer
Official title: A Prospective Single-center Randomized Phase 2 Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Chemotherapy
Endocrine therapy
Docetaxel
Fulvestrant
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer

Detailed description: Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer

Eligibility criteria: Inclusion Criteria:

* Postmenopausal female between 18 and 70 years old
* ECOG performance status of ≤ 1
* Life expectancy more than 3 months
* Histologically confirmed metastatic breast cancer
* ER and\&or PR pqositive, HER2-negative
* Disease progression during adjuvant or first-line endocrine therapy, or endocrine naive but unsuitable for endocrine therapy alone
* No pretreated chemotherapy for metastatic disease
* Have at least one target lesion according to RECIST 1.1
* No therapy (chemotherapy, endocrine therapy, target therapy and operation) within 4 weeks before enrollment
* Hemoglobin ≥ 90 g/L, Absolute Neutrophil Count ≥ 1.5×10\^9/L, Platelet Count ≥ 75×10\^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 1.5×ULN, Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance\>50ml/min

Exclusion Criteria:

* Pregnant or lactating women
* Evidence of CNS metastasis
* Seriously uncontrolled infection
* History of another malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pretreated with Fulvestrant
* Pretreated with two or more lines of endocrine therapy

Primary outcomes:
measure: Progression Free Survival
timeFrame: 6 weeks
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 6 Weeks
measure: Overall Survival
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
affiliation: Fudan University
name: Xichun Hu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01069783: Study of A3309 in Patients With Dyslipidemia
Official title: A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Keywords: dyslipidemia
cholesterol
LDL
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with dyslipidemia (high cholesterol levels).


Eligibility criteria: Inclusion Criteria:

* Patients meet protocol specified criteria for dyslipidemia and has successfully completed study requirements with no clinically relevant findings

Exclusion Criteria:

* Medical history or medical condition that would not make the patient a good candidate for the study or would limit the patient´s capability to complete the study

Primary outcomes:
measure: Change from baseline in low-density lipoprotein (LDL) cholesterol
timeFrame: eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: BCRC
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Rudling M, Camilleri M, Graffner H, Holst JJ, Rikner L. Specific inhibition of bile acid transport alters plasma lipids and GLP-1. BMC Cardiovasc Disord. 2015 Jul 22;15:75. doi: 10.1186/s12872-015-0070-9.
Clinical trial NCT01474083: A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes
Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Multiple-Dose Study Assessing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GK1-399 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
pharmacokinetics
pharmacodynamics
Lead sponsor: vTv Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 248
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: BASIC_SCIENCE

Brief summary: The purpose of this trial is to study the drug levels and biomarkers in the body and the safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4 treatments will be placebo, which does not contain an active ingredient. The study participation includes in-patient and out-patient days.


Eligibility criteria: Inclusion Criteria:

* Be male or female, aged 18 through 75 years at screening.
* Have a diagnosis of Type 2 Diabetes Mellitus (T2DM)
* On a stable dose of background medication for the treatment of diabetes
* Body Mass Index (BMI) between 20-40 kg/m2 (inclusive)

Exclusion Criteria:

* Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease

Primary outcomes:
measure: Pharmacokinetic parameters of GK1-399 from plasma concentrations
timeFrame: 52 time points over a 6 week period
Secondary outcomes:
measure: Pharmacodynamic parameters of plasma glucose
timeFrame: 52 time points over a 6 week period
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Forest Investigative Site 009
state: Arkansas
city: Chula Vista
country: United States
facility: Forest Investigative Site 006
state: California
city: Deland
country: United States
facility: Forest Investigative Site 002
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 001
state: Florida
city: Overland Park
country: United States
facility: Forest Investigative Site 010
state: Kansas
city: St. Paul
country: United States
facility: Forest Investigative site 011
state: Minnesota
city: Springfield
country: United States
facility: Forest Investigative Site 005
state: Missouri
city: Neptune
country: United States
facility: Forest Investigative Site 003
state: New Jersey
city: Willingboro
country: United States
facility: Forest Investigative Site 008
state: New Jersey
city: New York
country: United States
facility: Forest Investigative Site 007
state: New York
city: San Antonio,
country: United States
facility: Forest Investigative Site 004
state: Texas
Study officials:
affiliation: TransTech Pharma, Inc.
name: Aaron Burstein, Pharm.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00032383: Complementary/Alternative Medicine for Abnormality in the Vestibular (Balance) System
Official title: Complementary/Alternative Medicine for Vestibulopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Vestibular Neuronitis
Vestibulopathy
Keywords: Rehabilitation
Tai Chi
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the relative merits of vestibular rehabilitation and Tai Chi for patients with inner ear (vestibular) disorders.

Detailed description: It is proposed a randomized, blinded, controlled trial comparing vestibular rehabilitation (VR) to Tai Chi (TC). Our overall goal is to explore whether, and if so, how TC can improve functional, dynamic stability in persons with vestibulopathy (VSP). It is hypothesized that the TC group will demonstrate significantly greater improvement in performing functional activities than the VR group.

Sixty subjects will be randomly assigned into either TC instruction or VR. Both treatment groups will receive identical duration treatment once a week for 10 weeks, with supplemental home exercises. It is hypothesized that 1) TC improves whole-body dynamic locomotor stability more than does VR; 2) TC improves gait coordination during planned and unplanned obstacle encounters more than does VR; 3) TC improves whole-body speed related movement control more than does VR.

Eligibility criteria: Main inclusion criteria:

* vestibulopathy and locomotor unsteadiness

Main exclusion criteria:

* diseases/impairments that prevent rehab participation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Biomotion Laboratory
state: Massachusetts
Study officials:
References: