louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004268: Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Orthostatic Hypotension
Keywords: cardiovascular and respiratory diseases
disease-related problem/condition
orthostatic hypotension
quality of life
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Roberts Pharmaceutical
First posted: 1999-10-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Study further the safety and efficacy of the alpha-receptor agonist midodrine in patients with neurogenic orthostatic hypotension.

II. Assess the quality of life in these patients with this treatment regimen.

Detailed description: PROTOCOL OUTLINE: This is a partially randomized, multicenter study. Patients receive oral midodrine three times a day during weeks 1 and 3-5, then either oral midodrine or placebo for weeks 6-8.

Quality of life is assessed at weeks 3, 6, and 8.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Orthostatic hypotension due to autonomic nervous system failure, i.e.: Fall in systolic blood pressure (supine to standing) of at least 15 mm Hg AND Symptoms of dizziness, lightheadedness, unsteadiness with a severity of 4.5 or less on a 10 point scale in 2 of 3 evaluations over a 3 day period --Prior/Concurrent Therapy-- No concurrent sympathomimetics or alpha-receptor agonists or antagonists No concurrent drug with significant smooth muscle relaxant or constrictive properties e.g., calcium channel blockers At least 30 days since other prior investigational agents --Patient Characteristics-- Hepatic: No coagulopathy Renal: No acute nephritis or chronic renal failure Cardiovascular: No sustained supine hypertension greater than 180/110 mm Hg No congestive heart failure No myocardial infarction within the last 6 months No uncontrolled arrhythmia (ventricular tachycardia or second or third degree heart block not treated with pacemaker) No unstable angina pectoris No history of cerebral vascular accident Other: No pheochromocytoma No thyrotoxicosis No seizure disorder Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Roberts Pharmaceutical
name: Horacio Kaufmann
role: STUDY_CHAIR
References:
Clinical trial NCT02418468: Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations
Official title: Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, FEV1, indacaterol
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-04-16
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compared the efficacy of indacaterol versus placebo in COPD patients classified as GOLD 2014 Patient Group B.

This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1 to receive prn salbutamol plus:

1. Indacaterol 150ug or
2. Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough FEV1) was assessed after 12 weeks.


Eligibility criteria: Inclusion criteria

1. Male or female adults aged ≥40 years, who have provided their consent and signed an Informed Consent Form. Written informed consent must be obtained before any assessment is performed.
2. Patients diagnosed with COPD at 40 years of age or older.
3. Patients with smoking history of at least 10 pack years, both current and ex-smokers are eligible. (Ten pack years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc)
4. Patients with stable COPD in Patient Group B according to GOLD 2014.

Exclusion criteria

1. Use of other investigational drugs within 5 half-lives of enrollment, or \[within 30 days /until the expected PD effect has returned to baseline\], whichever is longer.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
4. Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or 1 or more exacerbation resulting in hospitalization in the 12 months prior to Visit 1.
5. Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1.
6. Patients who develop a moderate or severe COPD exacerbation during the period between Visit 1 and Visit 2.
7. Patients with a history of asthma.

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
timeFrame: at week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
Study officials:
References:
Clinical trial NCT00333346: Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery
Official title: Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ambulatory Surgery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the administration of 1 unit dose of 100 mg tramadol intravenously versus multiple smaller dosages of tramadol during the first 6 hours post-operatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side-effects.


Eligibility criteria: Inclusion Criteria:

* ASA I and II female or male patients
* Aged 18-70 years
* Scheduled for ambulatory surgery requiring postoperative pain medication.

Exclusion Criteria:

* Weight less than 70% or more than 130% of ideal body weight
* Neurological disorder
* Recent use of psycho-active medication, including alcohol
* Patients suffering from chronic pain receiving pre-operative pain medication including NSAID's
* Use of chronic anti-emetic medication, use of chronic corticoid therapy

Primary outcomes:
measure: Time course of pain relief
measure: Accuracy of pain relief
measure: Onset of side-effects
measure: Duration of side-effects
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Michel Struys, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05599269: Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth
Official title: Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth SR Phonares II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Mouth
Dental Prosthesis Failure
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2022-10-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: retrospective study
Primary purpose: TREATMENT

Brief summary: This retrospective study investigates the longevity of dentures with SR Phonares II teeth after a wearing period of more than 10 years.

The primary objective is to assess the survival rate of dentures with SR Phonares II teeth after more than 10 years. The secondary objectives asses the quality of the dentures concerning aesthetic, functional and biological properties.


Eligibility criteria: Inclusion Criteria:

* informed consent signed and understood by the subject
* partial or full denture with SR Phonares II teeth
* dentures delivered in the internal clinic between August 2010 and August 2012
* to be able to visit the internal clinic (Exception: Patients with limited mobility are also included if another person can carry the dentures to the internal clinic of Ivoclar Vivadent AG for the examination.)

Exclusion Criteria:

* patient does not wear the dentures regularly
* health status (physical and mental) does not allow participation.

Primary outcomes:
measure: Survival Rate of Dentures With SR Phonares II Teeth
timeFrame: 10 years
Secondary outcomes:
measure: Quality of the Dentures Concerning Aesthetic, Functional and Biological Properties
timeFrame: 10 years
Other outcomes:
Locations:
city: Schaan
country: Liechtenstein
facility: Ivoclar Vivadent AG
Study officials:
References:
Clinical trial NCT01806246: A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome
Official title: An Integrative Approach Based Psychoeducation, Heart Rate Variability Coherence Biofeedback and Elements of, Pacing Cognitive Behavior Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Fatigue Syndrome
Keywords: rehabilitation
adolescent
heart rate variability biofeedback
psychoeducation
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 13
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the programme is to develop a treatment model for adolescents with Chronic Fatigue Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation reflecting the current knowledge about the disease, Heart Rate Variability Coherence Biofeedback, pacing and activity planning and some principles of cognitive behaviour therapy. The study is designed as a Single-Case study including 10- 15 participants.


Eligibility criteria: Inclusion Criteria:

* Participants who meet the diagnostic criteria of chronic fatigue syndrome
* Clinically evaluated, exclude any disease that can explain the chronic fatigue;
* Diagnosed and evaluated within the health region, Central Norway
* With written consent form signed by themselves and their parents.

Exclusion Criteria:

* serious comorbidity such as anorexia, psychosis
* serious depression

Primary outcomes:
measure: fatigue change
timeFrame: baseline and 52 weeks
measure: quality of life change
timeFrame: baseline and 52 weeks
Secondary outcomes:
measure: mood change
timeFrame: baseline and 52 weeks
measure: change in heart rate variability
timeFrame: baseline and 52 weeks
measure: school attendance change
timeFrame: baseline and 52 weeks
measure: general health change
timeFrame: baseline and 52 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Dept Child and Adolescent Psychiatry, St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Thomas Jozefiak, md phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT05178446: GERD After Sleeve Gastrectomy
Official title: The New Onset of GERD After Sleeve Gastrectomy: a Systematic Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
GERD
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 14362
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese patients underwent to sleeve gastrectomy with GERD symptoms

Brief summary: The main adverse effect is gastroesophageal reflux disease (GERD), with concern on the development of Barrett's esophagus and esophageal adenocarcinoma in the long term. However, the relationship between SG and GERD is complex. The aim of this study is to systematically evaluate all published data existing in the literature to evaluate the effect of sleeve gastrectomy on GERD, esophagitis, BE in order to clarify the long-term clinical sequelae of this procedure.

This systematic review was conducted in accordance with the guidelines for Preferred Reporting Items for Systematic Review and Meta-analyzes (PRISMA).

Published studies that contained outcome data for primary sleeve gastrectomy associated with the primary and secondary outcomes listed below were included.


Eligibility criteria: Inclusion Criteria:

* Patients underwent to sleeve gastrectomy with reflux symptoms

Exclusion Criteria:

* Patients underwent to other bariatric procedures

Primary outcomes:
measure: Gastroesophageal reflux disease after bariatric surgery
timeFrame: from 2014 to 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: University of Foggia
Study officials:
affiliation: University of Foggia
name: Nicola Tartaglia
role: STUDY_DIRECTOR
References:
citation: Pavone G, Tartaglia N, Porfido A, Panzera P, Pacilli M, Ambrosi A. The new onset of GERD after sleeve gastrectomy: A systematic review. Ann Med Surg (Lond). 2022 Apr 5;77:103584. doi: 10.1016/j.amsu.2022.103584. eCollection 2022 May.
Clinical trial NCT05416346: Digital Cognitive Behavioral Therapy for Insomnia in China
Official title: The Feasibility and Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in China: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Insomnia
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 217
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: Digital cognitive behavioral therapy for insomnia (dCBT-i) is found to be effective but is rarely used in China. Hence, the investigators developed an automated Chinese dCBT-i program and examined its feasibility, acceptability, and preliminary effectiveness in individuals with insomnia symptoms.


Eligibility criteria: Inclusion Criteria:

* were aged 18 or older;
* had a positive screening result for chronic insomnia, i.e., a score of 16 or lower on the Sleep Condition Indicator (SCI);
* had stable access to the internet via a smartphone.

Exclusion Criteria:

* additional sleeping conditions except for insomnia (such as restless legs syndrome and sleep apnea);
* psychosis or mania;
* serious physical health concerns necessitating surgery or with prognosis \<6 months;
* undergoing medical or psychological treatment for insomnia with a health professional;
* habitual night shift, evening, or rotating shift-workers.

Primary outcomes:
measure: sleep diary
timeFrame: week 4
measure: Sleep Condition Indicator-8
timeFrame: week 4
Secondary outcomes:
measure: the Insomnia Severity Index 7-item version
timeFrame: week 4
measure: the Dysfunctional Beliefs and Attitudes about Sleep Scale 16-item version
timeFrame: week 4
measure: the Epworth Sleepiness Scale
timeFrame: week 4
measure: the Patient Health Questionnaire 9-item version
timeFrame: week 4
measure: the Generalized Anxiety Disorder 7-item version
timeFrame: week 4
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
References:
Clinical trial NCT03901846: Duration of ColdZyme® II
Official title: Duration of ColdZyme® II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Lead sponsor: Enzymatica AB
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this investigation is to verify that ColdZyme® is deposited onto the throat and estimate the half-life of the ColdZyme® solution in the oropharynx of human volunteers using a log-linear mixed-effects model (LMM).

Detailed description: The study is an Open Label, Non-Comparative study intended to verify the method used to measure the duration of ColdZyme®. Each participant will be his own control as samples are taken before application of ColdZyme and used as an internal control. Samples will be taken from the oropharyngeal membrane using a cotton swab before application, and 1, 3, 5, 10, 20, and 60 minutes after application. Glycerol will then be extracted from the swabs using water and the concentration of glycerol will be measured.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects between 18-70 years. The investigator judges the definition of healthy by medical history.
* No reported symptoms of sore throat.
* Readiness to comply with trial procedures.
* Females of childbearing potential: should use reliable method of birth control.
* Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.

Exclusion Criteria:

* Known allergy or hypersensitivity to the components of the investigational product
* History and/or presence of clinically significant condition/disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject.
* Any current cold symptom such as sore throat, sneezing, rhinorrhea, malaise, nasal obstruction or cough.
* Use of products, drugs, or food containing glycerol that may influence the study outcome, or concomitant medication with pharmaceuticals that might cause dry mouth (xerostomia), e.g. but not restricted to, morphine or morphine derivates, diuretics, antidepressants or other drugs with anticholinergic effect.
* Females: Pregnant or breast-feeding
* History of (in the past 12 months prior to study start) or current abuse of drugs, alcohol or medication
* Inability to comply with study requirements according to investigator's judgement
* Participation in another clinical study in the 30 days prior to enrolment and during the study

Primary outcomes:
measure: Duration of the ColdZyme barrier
timeFrame: 0-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kopavogur
country: Iceland
facility: Cutis Clinical Research Center
Study officials:
affiliation: Cutis Clinical Research Center (CCRC)
name: Bardur Sigurgeirsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06632769: Continuous Monitoring of Body Temperature in Neonates During Skin-to-skin Care Immediately After Cesarean Section (MonT Neo)
Official title: Continuous Monitoring of Body Temperature in Neonates During Skin-to-skin Care Immediately After Cesarean Section (MonT Neo) - a Prospective Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Body Temperature Measurement
Keywords: monitoring
body temperature
term neonates
transition
skin-to-skin care
Cesarean section
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: term neonates born per caesarean section immediately after birth

Brief summary: The objective of this prospective observational pilot study is to apply the adhesive thermometer SteadyTemp® (SteadySense GmbH, Graz, Austria) in term neonates to monitor their body temperature non-invasively and continuously during skin-to-skin care with their mothers after Cesarean section and to compare these data with the one-time manual measurement of rectal body temperature as gold standard.

Detailed description: Primary aim: To apply the adhesive thermometer SteadyTemp® (SteadySense GmbH, Graz, Austria) in term neonates in the right axillary area immediately after birth and to monitor their body temperature continuously during skin-to-skin care with their mothers after Cesarean section for 15 minutes.

Secondary aim

* To compare the body temperature with manually measured rectal temperature (single measurement).
* To examine the skin condition under the adhesive patch after 15 minutes of application using the Neonatal Skin Condition Scale (NSCS)17.

Eligibility criteria: Inclusion Criteria:

* Term neonates after caesarean section receiving skin-to-skin care immediately after birth
* Parental written informed consent

Exclusion Criteria:

* Preterm birth
* Need for respiratory support after birth
* No decision to conduct full life support
* No written informed consent
* Congenital malformation

Primary outcomes:
measure: body temperature
timeFrame: up to 15 minutes after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
Study officials:
References: