louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01037933: Comedy in Chemotherapy (COMIC) Study
Official title: Comedy in Chemotherapy (COMIC) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Chemotherapy
Keywords: Cancer
Humor
Distraction
Comedy
Chemotherapy
Lead sponsor: Queen's Medical Center
Sponsor class: OTHER
Collaborators: name: Queen Emma Nursing Research Institute
name: University of Hawaii
First posted: 2009-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary aims: To compare changes in (a) symptoms related to cancer and chemotherapy, (b) a marker of immune function (salivary immunoglobulin A), and (c) a hormonal marker of emotional stress (salivary cortisol) between two groups of patients who view a humorous or non-humorous DVD.

Secondary aim: To describe the perception of patients, caregivers, and nurses regarding the overall intervention experience.

Detailed description: Patients were recruited from the Outpatient Oncology (OPO) clinic at QMC. After signing an informed consent, patients receiving intravenous chemotherapy were randomly assigned to view a 45-minute humorous DVD or non-humorous DVD. The following measurements were obtained before and after patients viewed the DVD: Edmonton Symptom Assessment Scale (ESAS) and the state portion of the Spielberger State-Trait Anxiety Index (STAI-S) to assess symptoms related to cancer and chemotherapy, salivary immunoglobulin A (IgA) to assess immune function and salivary cortisol to assess emotional stress. In addition, patients, caregivers, and nurses were asked open-ended questions after the intervention to ascertain their impression of the overall intervention experience. Multiple analysis of covariance (MANCOVA) were be used to analyze changes in ESAS, STAI-S, IgA and cortisol within and between the two groups.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of cancer
2. Receiving intravenous chemotherapy in the OPO clinic at QMC
3. Has a minimum appointment time in OPO of two hours
4. Age 21 or older
5. Speaks English

Exclusion Criteria:

1. Blind
2. Deaf
3. Diagnosis of head/neck cancer
4. Severe oral mucositis
5. Cognitively impaired

   -

Primary outcomes:
measure: To compare changes in symptoms related to cancer and chemotherapy after a humor vs. non-humor intervention
timeFrame: One day
Secondary outcomes:
measure: To compare changes in a marker of immune function (salivary immunoglobulin A), and a hormonal marker of emotional stress (salivary cortisol) between two groups of patients who view a humorous or non-humorous DVD.
timeFrame: One day
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
Study officials:
affiliation: The Queen's Medical Center
name: Hob Osterlund, RN, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Queen's Medical Center
name: Brad Willcox, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06858033: Evaluation of the Effect of Labio-Lingual Spring Hawley and Clear Aligners on Periodontal Health and Salivary Parameters
Official title: Assessment of the Effect of Labio-Lingual Spring Hawley and Clear Aligners on Children's Oral Microflora and Salivary Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Crossbite
Keywords: Clear aligner
Labiolingual spring hawley
Oral health
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: Akdeniz University
First posted: 2025-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Objective: The aim of our study was to determine the effect of two different types of removable appliances on periodontal health, dental plaque colonization, as well as saliva, pH, flow rate, and buffering capacity of the patients.

Method: A total of 30 pediatric patients aged 7-12 years were treated with a total of 30 appliances including 15 clear aligners (Group A) and 15 labiolingual spring hawleys (Group B). In the clinical examination of the patients, dental caries status was evaluated by DMFT and dft index, periodontal health status was evaluated by probing pocket depth measurements and plaque, gingival and probing bleeding indices. In addition, saliva and dental plaque samples were taken and salivary parameters and microbiologic structure of plaque were analyzed. All these procedures were performed in 2 different time periods for each patient; before and after the treatment. The results were statistically evaluated using SPSS (SPSS Statistics v23.0 for Windows, Chicago, IL, USA).

Detailed description: In the clinical examination of the participants, dental caries status was evaluated by DMFT and dft index, and periodontal health status was evaluated by probing pocket depth measurements; PI, GI, SDI. In addition, saliva and dental plaque samples were taken and salivary parameters (flow rate, pH and buffering capacity) and microbiological structure of plaque were analyzed.

Eligibility criteria: Inclusion Criteria:

• Dental anterior crossbite

Exclusion Criteria:

* Skeletal anterior crossbite
* Systemic disease
* Regular medication use

Primary outcomes:
measure: PIaque index (PI)
timeFrame: 3 months
measure: DMFT index
timeFrame: 3 months
measure: Oral microorganisms count
timeFrame: 3 months
measure: Gingival index (GI)
timeFrame: 3 months
measure: Bleeding on probing index (BOP)
timeFrame: 3 months
measure: dft index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry
state: Konyaaltı
Study officials:
affiliation: Akdeniz University
name: Özge GÜNGÖR, DDS, Assoc. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00286533: Evaluation of Implants Placed in the Regular Dentist's Practice
Official title: Retrospective Evaluation of Implants Placed in the Regular Dentist's Practice. A Study to Evaluate Implant Success, Prosthetic Complications, Opinion of the Patient, and Quality of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Keywords: Implant
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an evaluation of the implants placed in a regular dentist's practice regarding:

* gingiva condition
* stability of implant
* prothetic quality
* questionnaires for the patients


Eligibility criteria: Inclusion Criteria:

* Patients with implants placed in a regular dentist's practice

Primary outcomes:
measure: gingiva condition
timeFrame: t0
Secondary outcomes:
Other outcomes:
measure: stability of implant
timeFrame: t0
measure: prothetic quality
timeFrame: t0
measure: questionnaires for the patients
timeFrame: t0
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hugo De Bruyn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01944033: β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation
Official title: β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Exacerbation of Chronic Obstructive Airways Disease
Keywords: β2-agonist
Ipratropium Bromide
Chronic Obstructive Pulmonary Disease Exacerbation
Emergency departement
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effectiveness of β2-agonists in the treatment of exacerbations of COPD is already established. The purpose of this study is to compare the effectiveness of the β2-agonists alone in nebulization with the association β2-agonists + Ipratropium bromide in the treatment of an acute exacerbation of COPD consulting the emergency departement based on the clinical and arterial blood gas.

Detailed description: It is a prospective study and randomized performed in patients admitted to the emergency departement for acute exacerbation of COPD. The patients were divided in two groups: Group Terbutaline/Ipratropium Bromide; received Terbutaline + Ipratropium bromide in nebulization and Group Terbutaline received Terbutaline alone in nebulization)

Eligibility criteria: Inclusion Criteria:

* have known or suspected COPD based on pulmonary function test, arterial blood gas, clinical history, physical examination, and chest radiograph
* Age over 18 years old.
* COPD Exacerbation: sustained worsening of patient's condition from stable state necessitating change in regular medication within the last two weeks and need for non invasive ventilation with regard to arterialo blood gas abnormalities: PaCO2 \> 45 mmHg, PH\<7,35 SaO2\<90%

Exclusion Criteria:

* GCS ≤ 14
* hypersensitivity to anticholinergic
* severe acidosis
* immediate need for intubation
* lack of patient cooperation
* serious hemodynamic unstability or systolic blood pressure \< 90 mmHg, heart arrhythmia

Primary outcomes:
measure: hospital admission rate and ICU admission rate
timeFrame: within 24 hours after ED admission
Secondary outcomes:
measure: dyspnea score
timeFrame: 24 hours after ED admission
measure: endotracheal intubation rate
timeFrame: within 24 hours after ED admission
Other outcomes:
Locations:
city: Monastir,
country: Tunisia
facility: University Hospital of Monastir
state: Monastir
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University Hospital
Study officials:
affiliation: University of Monastir
name: semir nouira, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00572533: Intelligent Control Approach to Anemia Management
Official title: Intelligent Control Approach to Anemia Management (AIM 4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Keywords: End-Stage Renal Disease
Chronic Hemodialysis
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-12-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: First clinical evaluation of "Smart Anemia Manager" algorithm.

Detailed description: The purpose of this single-center study is to test whether "Smart Anemia Manager" algorithm improves Hemoglobin stability compared to standard Anemia Management Protocol. Study site: Kidney Disease Program dialysis facility, University of Louisville, Louisville, KY.

Eligibility criteria: Inclusion criteria:

1. ages 18 to 80,
2. receiving dialysis treatment,
3. receiving or expected to receive ESA treatment,
4. adequacy of dialysis Kt/V \>= 1.2,
5. adequate iron stores (Ferritin \> 200 ng/mL, TSat \> 20%).

Exclusion criteria:

1. life expectancy less than 12 months,
2. frequent uncontrolled blood loss,
3. frequent dialyzer clotting,
4. frequent access related problems,
5. active infections,
6. severe cardiac disability,
7. coronary bypass within three months prior to the study
8. documented resistance to ESA
9. bone marrow suppression due to HIV, leukemia, or pharmacologic agents.

Primary outcomes:
measure: Percent Hb 10-12 g/dL
timeFrame: 12 months
Secondary outcomes:
measure: Percent Hb < 10 g/dL
timeFrame: 12 months
measure: Percent Hb > 12 g/dL
timeFrame: 12 months
measure: Mean Hb
timeFrame: 12 months
measure: ESA Dose
timeFrame: 12 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Kidney Disease Program
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Adam E Gaweda, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01976533: Eisenmenger Syndrome in the Nordic Countries
Official title: Eisenmenger Syndrome in the Nordic Countries: Advanced Treatment and Mortality 1977-2012
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eisenmenger Syndrome
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Lund University Hospital
name: Rikshospitalet University Hospital
name: Hospital for Children and Adolescents, Finland
name: Actelion
First posted: 2013-11-06
Enrollment: 714
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nordic patients with Eisnemnger syndrome

Brief summary: This is a historical cohort study with retrospective collection of data comprising all Nordic patient's diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The goal is to determine prognostic factors for mortality and morbidity.

Detailed description: The following variables are obtained from national registries for each individual fulfilling the inclusion criteria:

* Personal data: Gender, day of birth, vital status (dead/alive), date of death, cause of death, all cause hospitalization days
* Specific cardiac malformation diagnosis
* Heart-lung transplantation.
* Social data: Highest educational level, marital status, employment status (Denmark only)

Primary endpoints

* Incidence and prevalence of Eisenmenger Syndrome
* All-cause mortality
* All-cause morbidity (hospitalization for any cause)
* Heart-lung transplantation
* Advanced treatment
* Mortality with AT
* Highest educational level
* Personal income
* Marital status
* Job status

Eligibility criteria: Inclusion Criteria:

* Eisenmenger syndrome

Exclusion Criteria:

-

Primary outcomes:
measure: All cause mortality
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. Cardiology B, Rigshospitalet
city: Various
country: Finland
facility: Centers for Adult Congenital Heart Disease
city: Various
country: Norway
facility: Centers for Adult Congenital Heart Disease
city: Various
country: Sweden
facility: Centers for adult congenital heart disease
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lars Soendergaard, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04034433: Exercise Program for Arteriovenous Fistula Maturation
Official title: Benefits of a Perioperative Exercise Program on Maturation of Dialysis Arteriovenous Fistulas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arteriovenous Fistula
Keywords: Arteriovenous Fistula Diameter
Handgrip
Program exercise
Maturation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Arteriovenous fistula (AVF) is the recommended vascular access for chronic hemodialysis, as it is associated with less mortality and better patency than arteriovenous graft (AVG) or central venous catheter (CVC).

Unfortunately, AVF suffers from a high failure rate, due, in part, to poor venous diameter.

The aim of this study is to investigate whether a perioperative handgrip training can improve the diameter of AVF in patients with chronic kidney disease (CKD) (stage IV-V).


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* with chronic kidney disease (Estimated Glomerular Filtration Rate (eGFR) \<30 milliLiter/minute (mL/min))
* with follow-up at the University Hospital of Lyon Sud
* who choose hemodialysis as renal replacement therapy

Exclusion Criteria:

* contraindication for arteriovenous fistula (AVF) surgery
* refusing AVF creation
* prior vascular access
* antecedent of IV substance abuse
* active cancer
* inability to perform handgrip exercise
* physical or mental disability limiting follow-up possibility
* inclusion in an other interventional study
* no social welfare

Primary outcomes:
measure: Arteriovenous Fistula (AVF diameter)
timeFrame: at 6 weeks (after surgery)
Secondary outcomes:
measure: Echographic maturation rate
timeFrame: at 6 weeks (after surgery)
measure: Clinical maturation rate
timeFrame: at 6 weeks (after surgery)
measure: Arteriovenous Fistula (AVF) localization (arm or forearm)
timeFrame: at 6 weeks (after surgery)
measure: Arteriovenous Fistula (AVF) interventions
timeFrame: up to 6 weeks
measure: Emergency hemodialysis on Central Venous Catheter (CVC)
timeFrame: up to 6 weeks
measure: Emergency hemodialysis on Arteriovenous Graft (AVG)
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de néphrologie, dialyse et nutrition rénale - Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Abbas DEEB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02583633: Transdermal Nitroglycerin and Nifedipine in Preterm Labor
Official title: Transdermal Nitroglycerin and Nifedipine for Managing Preterm Labor: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Managing Preterm Labor
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: One of the important complications of pregnancy is preterm labor (PTL) and delivery. There are different tocolytic agents to enhance the time of delivery. The aim of this study was to compare the effect of transdermal nitroglycerin (glyceryl trinitrate, GTN) and oral nifedipine for managing preterm labor. This was a randomized clinical trial in women admitted with diagnosis of PTL. Group one have received transdermal GTN whereas group two have received oral nifedipine, vital signs, FHR, contractions, dilation and effacement as well as gestation age at the time of delivery have been monitored and evaluated in both groups of patient. Our main goal has been delay of delivery to have the most beneficial effect of primary corticosteroid administration for fetus.


Eligibility criteria: Inclusion Criteria:

* GA between 24 to 34 weeks
* early-onset signs of delivery (≥4 uterine contractions during 20 minutes, ≥1 centimeters (cm) of dilation and effacement over 80%).

Exclusion Criteria:

* maternal or fetal life-threatening conditions which require emergency termination
* multiple pregnancy
* premature rupture of membrane
* fatal anomaly or intra-uterine fetal death
* cervical dilation ≥4 cm
* any tocolytic treatment in previous days and positive allergy to GTN

Primary outcomes:
measure: Time of Delivery
timeFrame: Delivery
Secondary outcomes:
measure: APGAR scores
timeFrame: Delivery
Other outcomes:
Locations:
Study officials:
References:
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Clinical trial NCT00121433: Leptin and Endothelial Function
Official title: The Role of Leptin in Modulating Vascular Tone and Endothelial Function in Obese and Normal Weight Adults: A Vascular-Protective Effect of Leptin?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2005-07-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to determine if injections of leptin would improve vascular function in normal-weight, healthy volunteers.

Detailed description: The researchers plan to enroll a total of 15 non-obese (BMI \< 27 kg/m2) otherwise healthy adults into a randomized, double-blinded, cross-over study of the impact of recombinant methionyl human leptin 0.2 mg/kg SC, hereafter called rL, (Amgen Inc, Thousand Oaks, Calif) versus placebo SC (sorbitol and sodium acetate, pH 4.0 of same volume) in 15 non-obese adults. Subjects will have baseline vascular studies performed by brachial artery ultrasonography-flow-mediated dilatation and nitroglycerin mediated dilatation and blood drawn for measures of leptin levels. They will then receive rL SC or placebo SC (randomized order). They will then have vascular studies performed and blood levels drawn every 2 hours for 6 hours total. After completion of day 1, patients will return 1-4 weeks later and repeat the protocol crossed-over to the alternate intervention (rL or placebo).

Eligibility criteria: Inclusion Criteria:

* Healthy male or female ages 18-50.
* BMI \< 27 kg/m2 for lean group

Exclusion Criteria:

* Any CVD risk factor (diabetes or fasting glucose \> 126 mg/dL
* Hypertension or measured BP \> 140/90 mmHg
* Current tobacco smoking within last month
* LDL\>160 mg/dL, HDL\<35 mg/dL)
* Renal insufficiency (creatinine \> 1.4 mg/dL)
* Thyroid abnormalities (abnormal TSH)
* Established CVD (any atherosclerosis, or history of peripheral arterial disease, previous stroke, myocardial infarction, angina, heart failure, aortic aneurysms)
* Usage of medications which impact endothelial function within last month (folate, fish oil, Vitamin C or E, L-arginine, blood pressure or lipid-lowering medications, diabetes medications)

Primary outcomes:
measure: flow-mediated dilatation (FMD) of the brachial artery (conduit artery shear stress-mediated endothelial-dependent vasodilatation)
Secondary outcomes:
measure: basal brachial arterial diameter (BAD) (resting conduit artery tone)
measure: basal brachial arterial blood flow (BABF) (resting resistance artery tone)
Other outcomes:
Locations:
Study officials:
References: