louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01044589: Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone
Official title: Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fecal Incontinence
Anal Incontinence
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Cook Group Incorporated
First posted: 2010-01-08
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.


Eligibility criteria: Inclusion Criteria:

* Female
* Age 18 years or older
* fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles
* Fecal incontinence severity score of 10 or more
* Fecal incontinence episodes of 4 or more over a 2 week period

Exclusion Criteria:

* History of diabetes
* History of allergy to porcine derivatives
* History of infection in the anal area (abscess, fistula)
* History of inflammatory bowel disease
* History of hidradenitis suppurativa
* History of immunosuppression
* History of HIV positivity
* History of radiation to the study site within the last 12 months
* Patients who cannot travel to keep follow up appointments
* Patients who are prisoners
* Patients who are mentally handicapped
* Patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding
* Patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment.
* Patients with a FIQL baseline score of ≤ 4
* Patients participating in another clinical trial for the same indication
* Patients unwilling to give informed consent

Primary outcomes:
measure: Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
timeFrame: 24 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Massarat Zutshi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01048489: Evaluation of a Program to Reduce Smoking in High School Students
Official title: Effectiveness of a Community Integrated Program to Reduce Smoking Incidence in High School Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking in Adolescents
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Institut Catala de Salut
First posted: 2010-01-13
Enrollment: 2256
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Effectiveness of health education regarding the smoking habit is under discussion . Nevertheless, according to the literature, some personal, familiar, cultural, and social factors are considered risk factors for students to become smokers. Probably, a health education intervention integrated in the school program will show a higher rate of effectiveness regarding incidence and prevalence of smoking habit in this age-group .

OBJECTIVE: To evaluate the effectiveness of a health education program to reduce the smoking habit in students.

METHODOLOGY: Quasi-experimental design including all the junior high school students in an educational district in Tarragona (Spain). The sampled schools will be randomised into two groups (experimental and control). All the included students will be monitored for three years.

The health education program will be divided in three interventions: role games and debates (1st year), workshops regarding the family and the social role of smoking (2nd year) , and the analysis of smoking advertising (3rd year). The incidence and prevalence rates will be compared on the experimental and control group, before de beginning of the intervention and at the beginning of each year.


Eligibility criteria: Inclusion Criteria:

* Students in high school
* Male and female
* Ages 12 to 16 years old

Exclusion Criteria:

* No Spanish speakers

Primary outcomes:
measure: Prevalence and incidence of smoking is measured annually at the beginning and end of each school year by the use of a validated questionnaire and by the monitoring of carbon monoxide in expired air
timeFrame: January 2007 at June 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: Institut Català de la Salut
Study officials:
affiliation: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
name: Empar Valdivieso, RN, MSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valdivieso López A, Ledo Garcia J, Barrera Uriarte M, Rivera Bosch G, Fuentes Bellido CM. Muniain Diaz de Cerio MP. Efectividad de un programa comunitario integrado en la escuela para reducir la incidencia de tabaquismo entre los escolares de ESO. Nure Investigación 2005;14. available at: http://www.fuden.es/proyectos_detalle.cfm?ID_INV_NURE=37&FilaInicio=21
Clinical trial NCT02148289: Dietary Nitrate in COPD
Official title: Dietary Nitrate in COPD: A Double-blind, Randomized, Placebo-controlled, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, beetroot, dietary nitrate, nitric oxide
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: University College Dublin
First posted: 2014-05-28
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption, in the form of beetroot juice, might increase incremental shuttle walk test (ISWT) distance in COPD subjects.

Detailed description: Acute consumption of dietary nitrate (as beetroot juice) has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity, The investigators hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in COPD subjects compared to a matched, low-nitrate drink.

This study is a randomized, double-blind placebo-controlled, crossover trial.

Resting blood pressure, phlebotomy and ISWT are performed. Following completion, each subject is randomized to consume beetroot juice or placebo. 3 hours later, the same assessments are repeated by the same people. After a 7d washout, the entire protocol is repeated with the crossover beverage.

Eligibility criteria: Inclusion Criteria:

* Information consenting out-patients with a previous physician diagnosis of COPD
* Clinically stable
* Ambulatory

Exclusion Criteria:

* Subjects who required supplemental oxygen for exercise
* Subjects with pulmonary hypertension and angina
* Intolerant to beetroot
* Insulin dependent diabetes
* Thyroid disease

Primary outcomes:
measure: Change in Incremental Shuttle Walk Test Distance
timeFrame: day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h
Secondary outcomes:
Other outcomes:
measure: Resting blood pressure
timeFrame: day 1, time 0, day 1, time 3h, day 8, time 0, day 8, time 3h
Locations:
Study officials:
affiliation: University College Dublin
name: Conor P Kerley, BSc
role: STUDY_DIRECTOR
affiliation: Royal College of Surgeons in Ireland
name: Liam J Cormican, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01292889: Study of Genes in Relation to Seasonal Affective Disorder and Major Depressive Disorder
Official title: Gene Polymorphisms in Mood Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seasonal Affective Disorder
Keywords: Seasonal Affective Disorder
Major Depressive Disorder
Depression
Winter Blues
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The investigators are looking for volunteers who have a history of Major Depressive Disorder, the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not have a history of these disorders for a research study on genetics.

Detailed description: The investigators are looking for volunteers who have a history of Major Depressive Disorder, the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not have a history of these disorders for a research study on genetics. Participation involves one 2-3 hour visit involving two diagnostic interviews, DNA collection, and questionnaires.

Eligibility criteria: Inclusion Criteria:

* SAD or MDD
* healthy control

Exclusion Criteria:

* drug or alcohol dependence
* Bipolar Disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Department of Psychology 605 Old Engineering Hall
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kathryn A Roecklein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00160589: LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)
Official title: A Multicentre, Double-blind, Parallel, Randomized, Placebo-controlled Study : Evaluation of the Efficacy and Safety of Levocetirizine 5 mg and Desloratadine 5 mg Administered Orally as Capsules Once Daily, in the Morning, Over 2 Weeks in Patients Suffering From Allergic Rhinitis (AR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis, Allergic, Perennial
Keywords: Allergic Rhinits, Symptoms (sneezing, rhinorrhea, nasal/ocular pruritus, nasal congestion), LEADER, Xyzal, Levocetirizine
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 729
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Two weeks study to evaluate the efficacy and safety of Levocetirizine and Desloratadine in patients suffering from Allergic Rhinitis (AR)


Eligibility criteria: Inclusion Criteria:

* At least 2-year history of Allergic Rhinitis that became symptomatic during the annual grass pollen season.
* A skin test for grass pollens positive:
* Have rhinitis symptoms of such severity that the mean T4SS over the baseline period must be 6.

Exclusion Criteria:

* Have an associated asthma requiring corticosteroid treatment,
* Have an atopic dermatitis or an urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids,

Primary outcomes:
measure: Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment
Secondary outcomes:
measure: Clinical efficacy over the first and over two weeks of treatment measured by symptoms (scored and individuals); Onset of action; Safety
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02412189: Pressure-dependent Changes in Hematocrit and Plasma Volume During Anesthesia
Official title: Pressure-dependent Changes in Hematocrit and Plasma Volume During Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Hematocrit Change
Anesthesia
Keywords: Anesthesia
Blood pressure
Plasma volume
Vasopressor agents
Continuous noninvasive hemoglobin measurement
Coronary artery bypass
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The arterial blood pressure affects the ratio between filtration and reabsorption of fluids in the circulating blood volume and thereby the hematocrit. During induction of anesthesia blood pressure, hemoglobin level and hematocrit decreases. The aim of the study is to evaluate weather a maintained blood pressure with norepinephrine during anesthesia induction reduces the decrease in hematocrit.

Detailed description: 24 patients scheduled for coronary artery bypass surgery will be included and randomized to receive either norepinephrine in the dose needed to maintain pre-anesthesia blood pressure or to a control group and receive norepinephrine only if mean arterial pressure decreases below 60 mmHg. Arterial blood gas will be analysed every ten minutes. Equal anesthesia in both groups will be monitored. No fluids will be infused. Noninvasive continuous hemoglobin measurement (SpHb) will be measured.

Eligibility criteria: Inclusion Criteria:

* Elective coronary artery surgery patients

Exclusion Criteria:

* Age under 18 years
* untreated hypertension
* a reduced left ventricular systolic ejection fraction of 45 % or less
* diabetes mellitus
* former stroke and/or a known carotid artery stenosis.

Primary outcomes:
measure: The magnitude and dynamics of the decrease in hematocrit during anesthesia induction
timeFrame: 70 minutes from anesthesia induction
Secondary outcomes:
measure: Reduced hematocrit decrease by vasopressor infusion maintained blood pressure
timeFrame: 70 minutes from anesthesia induction
Other outcomes:
measure: Accuracy of continuous non-invasive hemoglobin monitoring (SpHb) to invasive Hb levels
timeFrame: 70 minutes from anesthesia induction
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sweden: Sahlgrenska University hospital
name: Andreas Nygren, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02471989: FODMAPs and Refractory GERD
Official title: Randomized Controlled Study of Low-FODMAP Diet in Patients With GERD Refractory to Protons Pump Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-esophageal Reflux Disease (GERD)
Keywords: FODMAP
Diet
pH-impedance monitoring
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 31
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: The aim of this study is to determine the effects of a low Fermentescible Oligosaccharides Disaccharides Monosaccharides and Polyols (FODMAP) diet in patients with documented refractory GERD on proton pump inhibitor (PPI) therapy.

Detailed description: Colonic fermentation has been shown to influence oeso-gastric motility : increased gastric relaxation, increased rate of lower esophageal sphincter relaxation. Experimental increased colonic fermentation (FOS in diet) increase the occurrence of reflux events in patients with GERD. The aim of this study is to compare the low-FODMAP diet and classical GERD dietary recommendations (avoid fatty meals, head of bed elevation etc..) in patients with refractory GERD symptoms.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Affiliation to French Social Security
* Informed written consent
* RDQ score \> 3
* Abnormal pH-impedance monitoring on PPI twice daily (since 3 months) according to normal values published by Zerbib et al (CGH 2013)

Exclusion Criteria:

* Pregnancy or breast feeding
* Women of childbearing potential without an effective method of contraception
* Person under guardianship
* History of thoracic of abdominal surgery (excepted appendectomy and cholecystectomy)

Primary outcomes:
measure: Percentage of patients with clinical remission as defined by a RDQ score ≤ 3
timeFrame: at Week 4 of diet
Secondary outcomes:
measure: Between-group comparison of efficacy
timeFrame: at Week 4 of diet
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hépato-Gastroentérologie et oncologie digestive,
city: Colombes
country: France
facility: Gastroentérologie
city: Lyon
country: France
facility: Explorations fonctionnelles
city: Nantes
country: France
facility: Gastroentérologie
city: Rennes
country: France
facility: Explorations fonctionnelles Digestives
city: Rouen
country: France
facility: Gastroentérologie
Study officials:
affiliation: University Hospital, Bordeaux
name: Frank ZERBIB, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03791489: Multi-Treatment PNN Modulation for Chronic Rhinitis
Official title: Feasibility Study of Multi-Treatment Posterior Nasal Nerve (PNN) Modulation for Treatment of Chronic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinitis
Lead sponsor: Arrinex, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, feasibility study of multi-treatment locations
Primary purpose: TREATMENT

Brief summary: Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis


Eligibility criteria: Inclusion Criteria:

* Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion symptoms for \>3 months.
* Documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens, or is willing to have one performed prior to study exit.
* Able to provide informed consent and willing to complete study activities and visits per protocol.

Exclusion Criteria:

* Clinically significant anatomic obstructions that limit access to the posterior nose.
* Prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
* Moderate to severe ocular symptoms as determined.
* History of epistaxis in the past 3 months.
* History of rhinitis medicamentosa.
* Prior head or neck irradiation.
* Active or chronic nasal or sinus infection.
* Pregnant.
* Allergy or intolerance to anesthetic agent.
* Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
* Currently participating in another clinical research study.
* Any physical condition that, in the investigator's opinion, would prevent adequate study participation or pose increased risk.

Primary outcomes:
measure: Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE)
timeFrame: Study duration (90-days)
Secondary outcomes:
measure: Pain Scores
timeFrame: Day of treatment during procedure and for up to 1 hour post procedure
measure: Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)
timeFrame: 30 and 90 days after treatment
measure: Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score
timeFrame: 30 and 90 days after treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Otolaryngology Medical Group
state: California
city: Bethlehem
country: United States
facility: Bethlehem ENT
state: Pennsylvania
city: Fredericksburg
country: United States
facility: Tracy Byerly, MD
state: Texas
Study officials:
affiliation: Specialty Physician Associates
name: David Yen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01781689: The Relationship Between Motor Cortex Oxygenation and Motor Function Recovery in Stroke Patients
Official title: The Relationship Between Motor Cortex Oxygenation and Motor Function Recovery in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: cortical activation
motor function
activity of daily living
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Stroke is the most common cause of motor function impairment. However, the functional impairment is not totally irreversible. Several mechanisms may involved in both the cortical and motor function recovery after onset of stroke, and most of them are related to changes of cortical perfusion and metabolism.

Motor function recovery after stroke (especially middle cerebral artery territory lesion) frequently follow stereotypic pattern (brunnström stage).

This study is designed to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke. To seek if there is similar stereotypic pattern of motor cortex oxygenation/metabolism change during the recover stage after stroke.

Detailed description: Participants receive evaluations (1/week for 3 months period) of

* motor function (Include: MMSE, brunnström stage, Fugl-Meyer Assessment of Physical Performance, Box and Block Test of Manual Dexterity, Functional Independence Measure)
* cortical perfusion detection during performing limb movements (using NIRS)

Then use path analysis to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke.

Eligibility criteria: Inclusion Criteria:

* Ischemic stroke(unilateral, onset within 7 days, without previous stroke history)
* Vital sign stable
* Upper extremity motor function impairment(brunnström stage I\~III)

Exclusion Criteria:

* with pacemakers
* Seizure history
* Serious dysrhythmias
* Poor cognition function(MMSE\<13)

Primary outcomes:
measure: Cortical activation
timeFrame: weekly changes within 3 months
Secondary outcomes:
measure: motor function
timeFrame: weekly changes within 3 months
Other outcomes:
measure: Activity of daily living function
timeFrame: weekly changes within 3 months
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Zheng-Yu Hoe
role: PRINCIPAL_INVESTIGATOR
References: