louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03272815: Percussion Device (PD) for Detection of Pneumothorax
Official title: Evaluation of a Novel Point-of-care Percussion Device (PD) for Detection of Pneumothorax in Patients Following Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pneumothorax
Keywords: pneumothorax
chest tube removal
percussion
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A prospective clinical feasibility cohort study.
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to examine the safety and efficacy of the Percussion Device in detecting a pneumothorax in patients that have undergone thoracic surgery.

Detailed description: A prospective, non-randomized clinical feasibility cohort study. The purpose of this feasibility study is to collect preliminary performance and safety information for the Percussion Device (PD). Patients satisfying the inclusion criteria will be approached for study enrolment before their surgery in clinic. Following surgery and after the patient's chest tube has been removed, evaluation of the chest using the PD and ultrasound will be performed by two independent assessors (a nurse practitioner or resident on the Thoracic Surgery Team) prior to the post-removal CXR. Details of study procedure are details in section 2.8. The PD's performance metric will be compared against CXR results, which is considered the gold standard in diagnosing a pneumothorax.

Eligibility criteria: Inclusion Criteria:

* All patients that have undergone an open or thoracoscopic thoracic procedure requiring a chest tube at London Health Sciences Centre (LHSC), London, Ontario.

Exclusion Criteria:

* Patients less than 18 years old Patients unable to consent Patients with known persistent pneumothorax prior to chest tube removal Patients who are pregnant Patients with severe chest wall deformity.

Primary outcomes:
measure: Performance metrics
timeFrame: 2 years
Secondary outcomes:
measure: Inter-rater reliability
timeFrame: 2 years
measure: Adverse Events
timeFrame: 2 years
measure: Marginal Costs
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Richard Malthaner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00624715: Cannabinoid Receptor Function & Alcoholism
Official title: Cannabinoid Receptor Function & Alcoholism: Effects of Δ-9-THC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcoholism
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2008-02-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study attempts to characterize the effects of tetrahydrocannabinol (THC). Tetrahydrocannabinol is the active ingredient of marijuana, cannabis, "ganja", or "pot". This study will involve healthy volunteers who 1) have no history of alcoholism in their family or 2) have a family history of alcoholism. This study looks at individuals with or without a family history of alcoholism to determine if there is a difference between the two groups in the response to THC.


Eligibility criteria: Inclusion Criteria:

* Exposure to cannabis at least once

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale ("High" rating), Rey Auditory Verbal Learning Test
timeFrame: Baseline, +15, +25 (RAVLT only), +70, +240
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepak D'Souza, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02695615: Stress During Elective or Emergency Cesarean Operations
Official title: The Evaluation of the Effects of Stress During Elective or Emergency Cesarean Operations; Prospective, Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Keywords: cesarean operation
Spielberger State Trait Anxiety Inventory
pain
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-03-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included pregnant women aged ≥18 years (gestational age: 37-40 weeks) in whom emergent or elective C/S was indicated

Brief summary: We investigated a correlation between maternal anxiety and age, body mass index (BMI), parity-gravidity, patient satisfaction, antenatal care, postoperative pain according to emergent or elective C/S under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* pregnant women aged ≥18 years (gestational age: 37-40 weeks) underwent emergent or elective C/S.

Exclusion Criteria:

* patients with cardiopulmonary,
* renal,
* hepatic or
* psychiatric disease,
* obstetric-fetal anomaly and
* weighing ≥ 100 kg were excluded.

Primary outcomes:
measure: correlation between maternal anxiety and age according to emergent or elective C/S under general anesthesia.
timeFrame: during operation
measure: correlation between maternal anxiety and body mass index according to emergent or elective C/S under general anesthesia.
timeFrame: during operation
Secondary outcomes:
measure: correlation between maternal anxiety and parity-gravidity according to emergent or elective C/S under general anesthesia.
timeFrame: during the operation
measure: correlation between maternal anxiety and patient satisfaction according to emergent or elective C/S under general anesthesia.
timeFrame: during the operation
measure: correlation between maternal anxiety and postoperative pain according to emergent or elective C/S under general anesthesia.
timeFrame: during the operation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: gulsah Karaoren
Study officials:
affiliation: Umraniye Education and Research Hospital
name: Muhammed A Erkmen, MD
role: STUDY_CHAIR
References:
citation: Duggan M, Dowd N, O'Mara D, Harmon D, Tormey W, Cunningham AJ. Benzodiazepine premedication may attenuate the stress response in daycase anesthesia: a pilot study. Can J Anaesth. 2002 Nov;49(9):932-5. doi: 10.1007/BF03016877.
Clinical trial NCT03569215: Psychiatric Disorders With Prolonged Infertility
Official title: Psychiatric Disorders Among Egyptian Women With Prolonged Infertility With or Without Invitro Fertilization /Intracytoplasmic Spem Injection Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Disorder
Invitro Fertilization /Intracytoplasmic Spem Injection Failure
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 324
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All infertile women with prolonged infertility with or without history of IVF/ICSI failure

Brief summary: Psychiatric disorders in women with prolonged infertility with or without IVF/ICSI failure will be included then a questionnaire will be applied plus psychiatric examinatins

Detailed description: All patients will be recruited from both psychiatry and obstetrics and gynecology departments. Referred cases from gynecologists and Assisted reproductive technologies centers were also included.

Inclusion criteria:

Infertile couples Infertility \>= 5 years invitro fertilization /intracytoplasmic spem injection failure for group 1 and not included for group 2

Eligibility criteria: Inclusion Criteria:

* Infertile women
* prolonged infertility ≥ 5 years
* Failed invitro fertilization /intracytoplasmic spem injection for group 1
* not bearing any children
* accepting to share in the study.

Exclusion Criteria:

* patients with diagnosed psychiatric or neurologic disorders
* patients with diabetes mellitus or any anatomical defects in genital tract
* patients who didn't complete their questionnaires.

Primary outcomes:
measure: Prevalence and types of psychiatric disorders among prolonged infertility couples
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Reham Amer
Study officials:
affiliation: Lecturer at Tanta University
name: Ayman Dawood, MD
role: STUDY_DIRECTOR
affiliation: Lecturer at Tanta University
name: Reham Amer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213915: L-Arginine Supplementation and Exercise; L-Arginine Supplementation and Renal Function
Official title: Effects of Oral Chronic L-Arginine Supplementation on Exercise and Renal Function of Heart Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Transplantation
Keywords: L-arginine
exercise capacity
renal function
nitric oxide
exercise capacity using a maximal exercise test
urinary elimination of a saline load using blood and urinary samples
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 30
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: * exercise capacities are still altered after heart transplantation partly due to peripheral endothelial dysfunction
* cyclosporin-induced renal dysfunction may be due to renal endothelial dysfunction and can be reversed in an animal model by L-arginine supplementation
* to determine the potential beneficial effect of L-arginine supplementation on exercise capacity and renal function of heart transplant recipients


Eligibility criteria: Inclusion Criteria:

* Male (\> 18 years old) stable heart transplant recipient for at least 6 weeks
* Stable treatment for at least 3 months
* Sedentary people

Exclusion Criteria:

* Unstable cardiac pathology
* Obesity (IMC \> 40)
* Participation in another study in the last month
* Chronic renal failure (creatinine clearance \< 20 ml/min)
* Renal transplantation
* Diabetes
* Impossibility to practice exercise test
* Nitrate therapy

Primary outcomes:
measure: Maximal and sub maximal exercise capacity at the end of the 6 weeks L-arginine supplementation. Renal function at the end of the 6 weeks
Secondary outcomes:
measure: No secondary effects
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de Physiologie
city: Strasbourg
country: France
facility: Service de Chirurgie Vasculaire
city: Strasbourg
country: France
facility: Service des Explorations Fonctionnelles Respiratoires et de l'Exercice
Study officials:
affiliation: Service de Physiologie et d'Explorations Fonctionnelles
name: Stephane DOUTRELEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03534115: NAC Prevents Toxicity of Teeth Bleaching
Official title: NAC Prevents Side-Effects of Teeth Bleaching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Removal of Toxicity From Dental Bleaching
Keywords: bleaching, toxicity, NAC
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dental bleaching is a simple procedure for aesthetic restoration of vital and non-vital discolored teeth. Nevertheless, a number of studies conducted previously demonstrated the risk of tissue damage from contact of these agents with the oral mucosa along with their possible genotoxic potential after exposure to oral mucosa. Hence the aim of this study is to conduct a human clinical trial to incorporate the chemoprotectant N-acetyl cysteine (NAC) in the procedure of bleaching which could safely be used to eliminate the toxicity of bleaching materials leaving their esthetic benefits intact. 30-40 human subjects will be recruited and bleaching will be done at the UCLA School of Dentistry dental clinic.


Eligibility criteria: Inclusion Criteria:

* Subjects will be self reported as healthy individuals with no significant medical issues.

Exclusion Criteria:

* Self-report of present medical history (determined by the primary care doctors) of donors for:
* Pregnancy
* HIV-seropositivity and AIDS because the study is designed to evaluate the effect of NAC in general population with no underlying immunological deficiencies or general pathologies which may result in confounding effect in the outcome. Since this is a small study we are limiting the procedure to healthy individuals with no known underlying pathologies.

Primary outcomes:
measure: inhibition of pain
timeFrame: 3 weeks
Secondary outcomes:
measure: white lesion in gingiva
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00080015: Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)
Official title: A Phase II Open Label Study Investigating the Activity of Diflomotecan (BN80915) Administered at the Fixed Dose of 7mg as a 20 Minute Intravenous Infusion Once Every 3 Weeks in Patients With Sensitive Small Cell Lung Cancer (SCLC) Who Have Failed First-line Treatment With a Platinum Based Regimen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2004-03-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II, open-label, multicenter, single-arm, exploratory "proof of concept" study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive disease after first-line treatment with a platinum-based regimen.


Eligibility criteria: Main Inclusion Criteria:

* Documented small cell lung cancer (SCLC)
* Measurable disease
* One line of previous chemotherapy, including any platinum analogue, and excluding any camptothecin analogues, with objective response and relapsed no less than 3 months

Main Exclusion Criteria:

* Uncontrollable brain metastasis
* Treated with an investigational drug within 30 days

Primary outcomes:
measure: Overall objective response rate (tumour assessments should be performed every 6 weeks)
Secondary outcomes:
measure: Time to tumour progression
measure: Time to treatment failure
measure: Duration of overall response
measure: Overall complete response, partial response and stable disease
measure: Time to response
measure: Six month and one year survival rates
measure: Median survival
measure: Best overall response
measure: Overall objective response rate
Other outcomes:
Locations:
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00795015: Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With IV Insulin
Official title: Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With an Intravenous Insulin Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: postoperative blood glucose control
IV insulin infusion
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 93
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 investigators are testing whether a written protocol or a computerized program can more effectively control blood glucose after surgery.

Detailed description: In 2002 we adapted the protocol described by Van den Berghe et al. for use in our own surgical intensive care unit (SICU) with a target blood glucose range from 80 to 120mg/dL. After five years of implementation, we were able to achieve a mean BG of 117 mg/dL in the SICU. 2% of glucose values were \<60 mg/dL in the SICU. Given the concern of safety while optimizing glycemic control, we investigated the etiologies for these hypoglycemic episodes and have found two frequent risk factors; the failure to consistently measure blood glucose every hour and in patients with end stage renal failure.

We will investigate whether a computer-based algorithm for the titration of IV insulin will translate to better clinical outcomes and less hypoglycemia. Therefore, we will conduct a prospective randomized trial comparing the Glucommander, a computer-based algorithm with our Van den Berghe protocol for titration of IV insulin in patients after cardiovascular or transplant surgery. This computer based algorithm was invented in 1984 in Atlanta by Dr. Davidson and Dr. Steed who have used it in a variety of applications of IV insulin.

Eligibility criteria: Inclusion Criteria:

* s/p open heart or kidney or liver transplant surgery

Exclusion Criteria:

* admission blood glucose less than 120 mg/dl

Primary outcomes:
measure: Percent of blood glucose values in the target range 80-120 mg/dl
timeFrame: first 200 hours post-op in the ICU
Secondary outcomes:
measure: Percent of patient days with a low blood glucose, defines as less than 60 mg/dl
timeFrame: 200 hours while in ICU
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: David Baldwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00610415: Biopsy of Human Tumors for Cancer Stem Cell Characterization: a Feasibility Study
Official title: Biopsy of Human Tumors for Cancer Stem Cell Characterization: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Head and Neck Cancers
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will have a diagnosis of squamous cell carcinoma

Brief summary: To see if a limited sampling of tumor tissue from human subjects is a feasible way to gather adequate tissue for cancer stem cell quantification.


Eligibility criteria: Inclusion Criteria:1. Patients with malignant tumors seen at the Stanford University Cancer Center. Eligible patients will have a diagnosis of squamous cell carcinoma (HNSCC) and will have been seen in the Stanford Head and Neck Oncology Program. A decision to undergo surgery at Stanford will have been made, prior to recruiting patients for the study, and prior to obtaining the samples during surgery. (Histological confirmation of the diagnosis need not be made prior to obtaining consent.) 2. A definitive resection of a malignant tumor is planned. 3. Surgeon judgment that the definitive procedure will not be compromised by including

* FNA
* Core needle biopsy
* Cup forceps or punch biopsy of\<4mm. 4. Informed consent documented prior to procedure

Primary outcomes:
measure: Quantification of the cancer stem cell population by flow cytometry
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. A. Dimitrios Colevas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06132815: The Efficacy of Different Gingival Displacement Methods Before Definitive Digital Impression
Official title: The Efficacy of Different Gingival Displacement Methods Before Definitive Digital Impression: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Displacement
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to evaluate and compare the efficacy of four methods in achieving vertical and horizontal gingival tissue displacement to be captured by optical digital impression. Moreover, the effect of the gingival displacement methods on the periodontal tissues around the final restoration will be assessed.


Eligibility criteria: Inclusion Criteria:

* Patients having normal occlusion.
* Good oral hygiene with no signs of periapical pathology or periodontal disease (plaque index score ≤10).
* Clinically and radiographically healthy gingiva and periodontium around the abutments with no evidence of attachment loss.
* Thick gingival biotype (determination using color coded probe).
* Patient having natural teeth as opposing dentition.
* Gingival sulcus of the abutment teeth (≤ 3mm).
* Adequate abutment tooth length for retention without deep subgingival extension (not more than 0.5mm)

Exclusion Criteria:

* Pregnancy, which prevents the use of diagnostic x-rays.
* Parafunctional habits.
* Mobility of abutment teeth.
* Gingival Recession
* Patient presenting allergy to materials being used.
* Smoking.
* Medical history that could affect their periodontal condition.

Primary outcomes:
measure: Horizontal displacement measurement
timeFrame: up to one month
measure: Vertical Displacement measurement
timeFrame: up to one month
Secondary outcomes:
measure: Dental plaque measurement
timeFrame: up to one month
measure: Gingival inflammation measurement
timeFrame: up to one month
measure: Gingival Height loss measurement
timeFrame: up to one month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Mohamed F Elashry, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Sanaa Hussein, PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Ihab Hammad, PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Rania Fahmy, PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Islam M Abdel Raheem, PhD
role: STUDY_DIRECTOR
References: