louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01661374: The Effect of Humidification on Mucus Rheology
Official title: The Effect of Humidification on Mucus Rheology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease(COPD)
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2012-08-09
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic,ICU, Pulmonary Clinic

Brief summary: In this study the investigators will collect mucus from mechanical ventilated patients and patients with COPD to study the effect of temperature and humidity, on the biophysical properties of the airway mucus. It is hypothesised that changes in inspired gas temperature and humidity (over time) may affect the biophysical properties of the airway mucus and reduce the airway's ability to clear mucus, resulting in deleterious clinical affects.

Detailed description: Expectorated sputum samples are collected and used to measure the biophysical properties of mucus secretions. The samples are later exposed to different temperatures and humidity levels during bench experiments.

Eligibility criteria: Mechanically Ventilated Patients

Inclusion Criteria:

Any Subject Mechanically Ventilated and producing sputum.

Exclusion

* None

COPD Group

Inclusion Criteria:

* 40 to 90 years of age suffering from COPD
* History of mucus production

Exclusion Criteria:

* None

Primary outcomes:
measure: Sputum Collection
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University School of Medicine
name: Bruce K Rubin, MEngr, MD, MBA, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00568074: Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes
Official title: Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 131
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of repaglinide and Glurenorm® and Glucobay® given as the mono-therapy in Chinese subjects being treatment-naive type 2 diabetics.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* No previous treatment for diabetes
* HbA1c: 7.0-12.0%

Exclusion Criteria:

* Type 1 diabetes
* Uncontrolled treated/untreated hypertension
* Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results
* Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures (adequate contraceptive measures are: sterilisation, intra-uterine device (IUD), oral contraceptives or barrier methods)

Primary outcomes:
measure: HbA1c
timeFrame: after 3 months of treatment
Secondary outcomes:
measure: fasting blood glucose
measure: hypoglycaemia episodes
measure: adverse events
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Chengdu
country: China
facility: Novo Nordisk Investigational Site
state: Sichuan
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01206374: Questionnaire and Laboratory Data on Vitiligo Vulgaris
Official title: Demographic and Laboratory Data Collection for Patients With Vitiligo Vulgaris
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitiligo Vulgaris
Keywords: Vitiligo Vulgaris
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: Beth Israel Medical Center
First posted: 2010-09-21
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients willing to sign consent, complete questionnaire and/ or laboratory studies.

Brief summary: Vitiligo vulgaris is an autoimmune disorder that causes loss of pigmentation over the skin, hair and mucous membranes (e.g. lips, nose, genitals). While genes have been identified that are thought to be required for development of vitiligo, only 5-10% of relatives develop disease. The triggers for disease onset have not yet been identified. The intent of this study is to research trends in laboratory data, social and medical history that may be contributory to vitiligo onset, location of disease, course of illness and response to therapy.

Detailed description: Patients who participate in this study will be asked to complete a survey and have blood/ laboratory testing performed that relates or may relate to the diagnosis of vitiligo.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Vitiligo Vulgaris
* Ability to sign consent

Exclusion Criteria:

* Pregnant
* Inability to sign consent
* Inability to complete questionnaire

Primary outcomes:
measure: Quality of life disturbances in people with vitiligo
timeFrame: point prevalence
Secondary outcomes:
measure: self-reporting of vitiligo disease symptoms and history
timeFrame: single survey
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Dermatology, Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Department of Dermatology, St. Luke's-Roosevelt Hospital Center
state: New York
Study officials:
affiliation: StLukesNY
name: Nanette Silverberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silverberg NB. Update on childhood vitiligo. Curr Opin Pediatr. 2010 Aug;22(4):445-52. doi: 10.1097/MOP.0b013e32833b6ac3.
citation: Silverberg JI, Silverberg AI, Malka E, Silverberg NB. A pilot study assessing the role of 25 hydroxy vitamin D levels in patients with vitiligo vulgaris. J Am Acad Dermatol. 2010 Jun;62(6):937-41. doi: 10.1016/j.jaad.2009.11.024.
citation: Pagovich OE, Silverberg JI, Freilich E, Silverberg NB. Thyroid abnormalities in pediatric patients with vitiligo in New York City. Cutis. 2008 Jun;81(6):463-6.
Clinical trial NCT01050374: Safety and Efficacy of Drug Combinations Against Schistosomiasis
Official title: Gaps in Helminth Control: Safety and Efficacy of Drug Combinations. Praziquantel Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parasitic Diseases
Lead sponsor: DBL -Institute for Health Research and Development
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 650
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of MBD in combination with PZQ in the treatment of SCH and STH in children aged 1-15 years of age.


Eligibility criteria: Inclusion Criteria:

* Those with an age of 1-15 years of age
* Are infected with schistosomiasis and soil-transmitted helminthiasis
* Whose parent consent and who are willing to participate

Exclusion Criteria:

* Those with acute and chronic diseases other than schistosomiasis and soil-transmitted helminthiasis
* Those with a history of any serious adverse drug reactions

Primary outcomes:
measure: Efficacy of treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Record of adverse reactions
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Vector Control Division
Study officials:
References:
Clinical trial NCT00532974: A Phase 1 Safety and Immunogenicity Study of the Epitope Based DNA Vaccine (EP HIV-1090) in HIV-1 Infected Individuals Receiving Antiretroviral Therapy (ART)
Official title: A Phase 1 Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
Human Immunodeficiency Virus
Vaccines
HIV Vaccines
Peptide
Peptide Vaccines
HIV 1
Lead sponsor: Epimmune
Sponsor class: INDUSTRY
Collaborators: name: Pharmexa A/S
name: Pharmexa-Epimmune
First posted: 2007-09-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.


Eligibility criteria: Inclusion Criteria:

* HIV-1 Infection
* CD4 Tcell count \>350
* HIV-1 RNA levels to \<400 copies
* Negative HbsAg and anti-HCV antibody

Exclusion Criteria:

* Recent receipt of experimental HIV-1 vaccines
* Recent use of immunomodulatory agents
* Hypersensitivity or serious reactions to study vaccine components
* Active opportunistic infections

Primary outcomes:
measure: Safety and Immunogenicity: defined as the effect of the vaccine on peripheral blood CD8 CTL responses, CD4 T cell counts, plasma HIV-1 RNA levels and clinical signs and symptoms.
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: West Hollywood
country: United States
facility: AIDS Research Alliance
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
References:
Clinical trial NCT03113474: Profiling the Endocannabinoid Response to Hedonic Eating
Official title: Profiling the Endocannabinoid Response to Hedonic Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Food Preferences
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Study into the endocannabinoid response to consuming a palatable versus a neutral food.


Eligibility criteria: Inclusion Criteria:

* Healthy (self-report)
* Dutch
* Evaluating one of the used foods as palatable
* Evaluating one of the used foods as neutral
* Hb value between 8.1 and 11.0 mmol/L at screening

Exclusion Criteria:

* restraint eating
* lack of appetite
* difficulties eating/swallowing
* endocrine disorders
* energy restricted diet two months prior to study
* weight change \> 5 kg in two months prior to study
* stomach or bowel disease
* taste or smell disorders (self-report)
* not consuming foods used in the study
* smoking \> 1 cigarette per day
* drinking \> 21 units alcohol per week

Primary outcomes:
measure: Endocannainoid levels
timeFrame: prior to, during and two hours after eating
Secondary outcomes:
measure: Pancreatic polypeptide (pg/ml)
timeFrame: prior to, during and two hours after eating
measure: Ghrelin (pg/ml)
timeFrame: prior to, during and two hours after eating
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04392674: Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation
Official title: Safety and Efficacy of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Myomectomy Morcellation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Surgery
Keywords: morcellation
myomectomy
laparoscopic surgery
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the safety of performing the new tissue containment system during laparoscopic myomectomy morcellation. Pre- and perimenopausal women, aged 18-45 undergoing laparoscopic myomectomy morcellation


Eligibility criteria: Inclusion Criteria:

* Pre- and Peri-menopausal woman patient age 18-45 years

  * Women with fibroids and indication for laparoscopic myomectomy.
  * Normal Pap smear result within one year
  * MRI ( Magnatic Resonance Imaging ) or other imaging findings indicate the diameter of the largest uterine fibroids is between 4 to 10cm.
  * The body mass index of the patients is 18.5-27.9kg/m2
  * Signed informed consent form

Exclusion Criteria:

* • Women with Known or suspected malignancy

  * patients with severe pelvic adhesion found during the operation
  * The body mass index of the patient ≥ 28kg/m2
  * Diameter of a single uterine fibroid\>10cm
  * patients during pregnancy and lactation
  * Known blood diseases, bleeding coagulation disease, any part of the active bleeding or bleeding tendency of the constitution of the patient
  * Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2 times of normal upper limit, or renal function (Cr) ≥ normal upper limit
  * Patients who are known to have participated in any other clinical trial within 3 months
  * Patients who cannot sign informed consent
  * Patients with acute stage infection of the reproductive system or other sites

Primary outcomes:
measure: The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation
timeFrame: approximately two years
Secondary outcomes:
measure: The probability of failure during in-bag morcellation procedure
timeFrame: approximately two years
measure: Mean procedure time
timeFrame: approximately two years
measure: Estimated blood loss during operation
timeFrame: approximately two years
measure: Post-operative pain
timeFrame: approximately two years
measure: Intra- or post-operative complications
timeFrame: approximately two years
measure: The Surgeon Task Load Index
timeFrame: approximately two years
measure: The Patients' life quality postoperative
timeFrame: approximately two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
References:
Clinical trial NCT01202474: Apidra Children & Adolescents Study
Official title: A Study of Effectiveness and Safety of Apidra in Combination With Lantus Therapy in Basal-bolus Insulin Regimen in Inadequately Controlled Children and Adolescents With Type 1 Diabetes in the Russian Federation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level \< 8% (in patients of 6-12 years old) and HbA1c level \< 7.5% (in patients of 13-17 year old) at 6 and 12 months of treatment

Secondary Objectives:

Change in HbA1c level at 6 and 12 months of treatment Monthly rate of hypoglycaemia/per patient from the baseline to the end of the study Change in daily dose of glargine and glulisine at 6 and 12 months of treatment.


Eligibility criteria: Inclusion criteria:

* ChildrenAdolescents with Type 1 diabetes Mellitus l(T1DM) onger than 1 year duration
* Age 6 -17 y.o.
* With 8%\<HbA1c \<10%
* Treated with insulin glargine and any rapid insulin
* Ability to perform a self blood-glucose monitoring (SBGM)
* Signed Informed consent.

Exclusion criteria:

* Diabetes Mellitus type 2
* ChildrenAdolescents with Type 1 diabetes Mellitus previously treated with Apidra
* Hypersensitivity to Insulin glulisine
* Pregnant or lactation women
* Gestational diabetes mellitus
* Treatment with systemic corticosteroids in the 1 month prior to study entry
* T1DM complications: such as already existing active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of patients achieving HbA1c level < 8% (in patients 6-12 year-old) and HbA1c level < 7.5 % (in patients 13-17 year-old)
timeFrame: at 6 and 12 months of treatment
Secondary outcomes:
measure: Change in HbA1c plasma level
timeFrame: at 6 and 12 months of treatment
measure: Monthly rate of hypoglycaemia
timeFrame: from baseline to 12 months of treatment (study cut off)
measure: Change in daily dose of glargine and glulisine
timeFrame: at 6 and 12 months of treatment
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Administrative office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT05959174: Evaluation of 3D Michigan Appliance
Official title: Development of Algorithm for 3d Printed Michigan Appliances in Patients With Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Myofacial Pain Syndromes
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 20
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: * 20 patients will be divided into 2 groups
* Group 1 : in which conventional appliance will be constructed after alginate impression
* Group 2 : in which 3d printed appliance will be constructed after intra-oral scanning


Eligibility criteria: Inclusion Criteria:

* Patient with bruxism
* Trigger points
* Medically stable

Exclusion Criteria:

* • absence of other TMJ problem

Primary outcomes:
measure: visual analogue scale
timeFrame: Change from immediate postoperative to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Shaimaa Refahee
Study officials:
References:
Clinical trial NCT02942082: Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent During In-office Bleaching
Official title: Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent Before and /or After In-office Bleaching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Bleaching
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.

Detailed description: A randomized clinical trail will be done to evaluate the effect of a desensitizing agent ACP oral care gel in comparison to a control group on hypersensitivity after bleaching using a visual analogue scale.

Eligibility criteria: Inclusion Criteria:

* Patients must show no signs of spontaneous dental pain.
* Male or female patients between the ages of 18 to 40.
* Patients with good general and oral health.
* Patients having six caries-free maxillaryanterior teeth without restorations on the labial surfaces.
* Patients should have central incisors determined to be shade C2 or darker

Exclusion Criteria:

* Patient with spontaneous dental pain.
* Patient with anterior restorations or non carious cervical lesion.
* Patient having severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth), and bruxism habits.
* Tempro-mandibular joint problems involving symptomatic pain.
* Patients taking analgesics that could alter their normal pain perception level.
* Pregnant or breast feeding women.

Primary outcomes:
measure: Post-bleaching hypersensitivity assessed using visual analogue scale
timeFrame: one month
Secondary outcomes:
measure: Tooth color assessed using value-ordered VITA® Classical Shade Guide
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry Cairo university
Study officials:
References: