louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01061710: Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)
Official title: Champix Tablets Special Investigation -Retrospective Survey For Subjects Who Have Been Retreated With Champix.-(Regulatory Post Marketing Commitment Plan).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Keywords: Smoking
smoking cessation
Japanese
varenicline
retreatment
Regulatory Post Marketing Commitment Plan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects who have been retreated with varenicline in A3051109 (NCT# NCT00772941) within 52 weeks of initial treatment.

Brief summary: The purpose of this study is to collect the efficacy and safety information in subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941).

Detailed description: The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.

Eligibility criteria: Inclusion Criteria:

* Male or Female subjects intend to quit tobacco use who are prescribed varenicline (Champix®) by their Physicians
* Subjects who are prescribed varenicline (Champix®) for the second time within 52 weeks of initial treatment.

Exclusion Criteria:

Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events (AEs)
timeFrame: 24 weeks
measure: Number of Responders to Varenicline Treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert
timeFrame: 24 weeks
measure: Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)
timeFrame: 24 weeks
measure: Number of Participants With Risk Factors Likely to Affect the Proportion of Responders
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02303210: Evaluation of Frequency Lowering Technique
Official title: Evaluation of Frequency Lowering Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Phonak AG, Switzerland
Sponsor class: INDUSTRY
First posted: 2014-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine two frequency lowering techniques in case of audibility, recognition, distinction, discriminability and sound quality.

Detailed description: This is a controlled, single blinded and randomised comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test two frequency lowering techniques with an amount of 30 moderate to severe, symmetrically sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during 6 months including seven appointments of 2 hours.

Eligibility criteria: Inclusion Criteria:

* female and male adults (\>18 years old)
* mild to severe Hearing Loss
* symmetric Hearing Loss
* german native speakers

Exclusion Criteria:

* persons who are not able to attend multiple appointments
* persons who are not able to handle a hearing aid
* persons with a mental handicap
* persons with limited access to multiple hearing situations
* persons with psychological disease
* no acclimatization to hearing aids

Primary outcomes:
measure: Audibility improvement (Delta of dB SPL thresholds) of high frequency sounds measured with a Phoneme Perception Test.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Hoerzentrum Oldenburg
state: Niedersachsen
Study officials:
affiliation: Phonak AG
name: Julia Rehmann, B.Sc.
role: STUDY_CHAIR
References:
Clinical trial NCT03759210: Outcome After Out of Hospital Cardiac Arrest in Bern, Switzerland
Official title: Outcome After Out of Hospital Cardiac Arrest in Bern, Switzerland
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Resuscitation
Outcome, Fatal
Out-Of-Hospital Cardiac Arrest
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 1000
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 OHCA cases in the region of Bern, Switzerland in the year 2015-2017

Brief summary: Sudden cardiac arrests is one of the most frequent causes of death. In Switzerland every year 8000-10.000 people suffer from a cardiac arrest. The EuReCa ONE Study showed regional differences in incidence and chances of survival after cardiac arrests in Europe. The current European Resuscitation Council (ERC) resuscitation guidelines 2015 recommend extracorporeal membrane oxygenation (ECMO) as treatment option for therapy refractory out-of-hospital cardiac arrests (OHCA). ECMO used under cardiopulmonary resuscitation (CPR) is called eCPR (extracorporeal CPR). In the year 2018 eCPR is started to be used in Bern, Switzerland. This study investigates retrospectively the survival and neurologic outcome of patients after OHCA in the region of Bern, Switzerland from 2015-2018. The data will be used as baseline for a prospective evaluation of eCPR cases.

The prospective Evaluation of e CPR will last from 2018 - 2022.


Eligibility criteria: Inclusion Criteria:

* All OHCA in the region of Bern, Switzerland in the year 2015-2017

Exclusion Criteria:

* if patient has previously declined to be included in a study (advance directive)

Primary outcomes:
measure: Neurologic Outcome after 30 days
timeFrame: 30 days after OHCA
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Anaesthesiology and Pain Medicine
Study officials:
affiliation: University Hospital Bern, Bern, Switzerland
name: Robert Greif, Prof., M.D.
role: STUDY_CHAIR
affiliation: University Hospital Bern, Bern, Switzerland
name: Sabine Nabecker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01150110: Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)
Official title: Evaluation of Resilient Occlusal Splints in the Control of Patients With Temporomandibular Disorder (TMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Temporomandibular Disorders
Keywords: Temporomandibular disorders
occlusal splints
electromyography
TMD (muscle and joint dysfunction)
masseteres e anterior temporalis muscles.
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2010-06-24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the effectiveness of soft occlusal splint therapy on the electromyographic activity of masticatory muscles (ateriors temporalis and masseter) before and after the application of a muscle relaxation splint. Electromyography recordings from the masseter and anterior temporalis muscles were analyzed quantitatively during maximal clench, rest and mastication usual, before and after the treatment without a splint. Ten patients whose chief complaint was Temporomandibular Disorders (TMD) were selected for the study. After the initial evaluations soft occlusal splints (muscle relaxation splints) were applied, and the patients were instructed to use the splints for four weeks. Surface electromyographic recordings were taken from each patient, as clinical evaluations of TMD (Index of Helkimo), both evaluations before the beginning of clinical therapy and after four weeks of wearing splints. The data obtained were analyzed by Wilcoxon´s and Friedman´s tests.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical and/or diagnosis of TMD
* With complaints of muscle disorders and / or joint pain, pain symptoms
* Presence of occlusal interferences
* Minimum of 20 functional teeth in the oral cavity with subsequent bilateral occlusion

Exclusion Criteria:

* Individuals with extensive dental flaws
* Orthodontic treatment in progress
* History of systemic diseases as advanced arthritis, diabetes and conservative and reversible treatments such as occlusal splints are recommended

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Uberlandia
country: Brazil
facility: Germana De Villa camargos
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Germana Camargos, academic
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03968510: Swalqol in Primary Hyperparathyroidism
Official title: The Effect of Parathyroidectomy on Swallowing Related Quality of Life in Primary Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperparathyroidism
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with primary hyperparathyroidism

Brief summary: Swallow related quality of life before and after parathyroidectomy will be evaluated in patients with primary hyperparathyridism.

Detailed description: Patients who will undergone parathyroidectomy for primary hyperparathyroidism will be included in the study. Swal-Qol and Sf-36 forms will be used for evaluation of quality of life before and 1 month after the surgery. The change in the quality of life and swallowing related quality of life will be evaluated.

Eligibility criteria: Inclusion Criteria:

* no diagnosis of Alzheimers disease
* must be able to swallow tablets Planned operation for primary hyperparathyroidism

Exclusion Criteria:

* secondary or tertiary hyperparathyroidism
* insulin dependent diabetes
* thyroid disease

Primary outcomes:
measure: Change in quality of life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: Uşak University
Study officials:
affiliation: Uşak University
name: Barış Sevinç
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03035110: A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings
Official title: A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Injurious Behavior
Lead sponsor: University of Essex
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The current research is being undertaken as part of a professional doctorate in clinical psychology, which aims to evaluate the feasibility of a group programme to address self-harm within 23 days, to provide evidence for a controlled trial. The intervention will include four group sessions conducted over 2 weeks, based on Dialectical Behavioural Therapy. Specifically the aims are to determine 1) means and a standard deviation for two pre and post treatment outcome measures in order to estimate sample size for the main study, 2) the need for an inpatient intervention for self-harm measured by number of participants eligible and accepting of the treatment, 3) retention of participants for 4 groups given the predicted short stays of patients on wards, and 4) the acceptability of the research process for this client group through feedback.


Eligibility criteria: Inclusion Criteria:

* Participants will be screened by their allocated clinician and included if they are aged between 18-65
* admitted to hospital
* have a history of or engaged in at least one episode of self-harm, iv) have capacity to understand the information sheet.

Exclusion Criteria:

* Participants will be screened by clinicians and they will exclude people if i) they are Non-English speakers (due to translation costs)
* they lack the capacity to give informed consent (assessed by their key clinician)
* their symptoms prevent them from concentrating for an hour at a time (i.e. severe thought disorder), and therefore not benefiting from the group (assessed by their key clinician)

Primary outcomes:
measure: The Inventory of Statements About Self-Injury (ISAS)
timeFrame: 23 days
measure: The Distress Tolerance Scale (DTS)
timeFrame: 23 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ilford
country: United Kingdom
facility: Goodmayes Hospital
state: Essex
Study officials:
References:
Clinical trial NCT03440710: The Therapeutic Effect of BET in COM With ETD
Official title: The Therapeutic Effect of Balloon Eustachian Tuboplasty (BET) in Chronic Otitis Media (COM) With Eustachian Tube Dysfunction (ETD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Balloon Eustachian Tuboplasty
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently, surgical treatment of patients with chronic otitis media is one of the most important treatment methods. However, the current results show that some patients with eustachian tube dysfunction can't reconstruct the gas-containing structure of the middle ear after operation.

This is a randomized controlled trial that aims to evaluate the therapeutic effect of balloon eustachian tuboplasty (BET) for the treatment in chronic otitis media (COM) with eustachian tube dysfunction (ETD). This future study will aim to address the question: Does BET gain better recovery of auditory function and lower recurrence rate in chronic otitis media with eustachian tube dysfunction?


Eligibility criteria: Inclusion Criteria:

1. Patients who need tympanoplasty, with clear diagnosis of chronic otitis media, middle ear cholesteatoma;
2. Patients with eustachian tube dysfunction using TMM;
3. Subjects or their legal representatives can understand the purpose of the study, show sufficient compliance with the research protocol, and sign the informed consent form.

Exclusion Criteria:

1. Secondary chronic otitis media (after head and neck cancer radiotherapy);
2. Ipsilateral ear recurrence after surgical treatment, requiring secondary surgery;
3. Two tympanoplasty surgery;
4. Typical allergic rhinitis, nasal endoscopy or imaging studies suggest chronic rhinosinusitis, nasal polyps and other short-term eustachian tube function of a greater impact on the disease;
5. poor general health, with severe liver and kidney dysfunction, coagulation disorders, cardiovascular disease, neurological diseases can not tolerate surgery.

Primary outcomes:
measure: Recurrence rate in chronic otitis media with eustachian tube dysfunction
timeFrame: 6months after the surgery
Secondary outcomes:
measure: Hearing change in chronic otitis media with eustachian tube dysfunction
timeFrame: before the surgery, and 6months after the surgery
measure: The change of Eustachian tube function using TUBOMANOMETRY (TMM)
timeFrame: before the surgery, and 6months after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
state: Shanghai
Study officials:
References:
Clinical trial NCT00437710: Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction
Official title: Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Myocardial Infarction
Keywords: bone marrow, cell transplantation, stem cells, PTCA
Lead sponsor: Azienda Unita Sanitaria Locale di Piacenza
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 50
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: We will study in a prospective randomised fashion 50 patients who will be treated by intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition to standard therapy after MI or standard therapy.

After standard therapy for acute MI, 10 patients were transplanted with autologous mononuclear BMCs via a balloon catheter placed into the infarct-related artery during balloon dilatation (percutaneous transluminal coronary angioplasty). Another 10 patients with acute MI were treated by standard therapy alone. After

Detailed description: Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).

Eligibility criteria: Inclusion Criteria:

* Recent acute transmural anterior myocardial infarction, (in agreement with WHO)
* single left anterior descending coronary artery disease
* \<72 hour from the origin of symptoms
* successful primary angioplasty of the culprit lesion

Exclusion Criteria:

* screening \>72 hours after infarction,
* cardiac shock, severe comorbidity, alcohol or drug dependency
* severe comorbidity (DM,renal or liver insufficiency)
* potential child bearing woman
* inability to provide informed consent

Primary outcomes:
measure: Mortality
measure: Mortality and Morbidity
measure: Left ventricular function
Secondary outcomes:
measure: Left ventricular remodeling
measure: Heart rate variability
measure: Baroreflex sensitivity
measure: Stress induced myocardial ischemia
measure: Cell dose response
Other outcomes:
Locations:
city: Piacenza
country: Italy
facility: G da Saliceto Hospital
Study officials:
affiliation: G. da Saliceto Hospital, Regional Health Authority
name: Massimo Piepoli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000510: Platelet-Inhibitor Drug Trial in Coronary Angioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Angina Pectoris
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To determine the effectiveness of dipyridamole and aspirin in prevention of restenosis of the dilated lesion in patients who had undergone percutaneous transluminal coronary angioplasty (PTCA). Secondary aims were to determine the effectiveness of platelet inhibitor therapy in reducing the incidence of coronary events and the severity and incidence of angina.

Detailed description: BACKGROUND:

By dilating coronary stenoses, PTCA can relieve angina pectoris and improve exercise tolerance and left ventricular function. However, restenosis occurs in 20-30 percent of dilated stenoses within three to six months following PTCA making it necessary to restrict patient activities, resume antianginal medications, repeat PTCA, or perform coronary artery bypass surgery.

Balloon dilatation of the atherosclerotic lesion damages the endothelium, intima, and media of the artery. This may lead to restenosis via platelet deposition, mural thrombus formation, and intimal proliferation by mechanisms that appear similar to those causing aortocoronary vein graft (ACVG) occlusions. It had been demonstrated that dipyridamole plus aspirin therapy suppressed these mechanisms of ACVG occlusion in the animal model, prolonged a shortened platelet survival in patients with coronary artery disease, and reduced ACVG occlusions in patients both early and late after the operation. Thus, a trial of these drugs in patients undergoing PTCA was a logical and necessary step to reduce the major shortcoming of the initially successful PTCA therapy, namely the high rate of restenosis.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. Patients were randomized to treatment with dipyridamole plus aspirin or placebo.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Eligibility criteria: Patients to age 80 with angina pectoris.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Foundation
name: James Chesebro
References:
Clinical trial NCT00302510: Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy
Official title: Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment
Keywords: lipoprotein glomerulopathy
treatment
immunoadsorption
apolipoprotein E
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2006-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.

Detailed description: Lipoprotein glomerulopathy is characterized by nephritic syndrome glomerular protein thrombi and lipid abnormalities, particularly with an elevated level of plasma apoprotein E (apoE).There are no efficiency way to treat lipoprotein glomerulopathy. We firstly successfully treat 2 patients by protein A immunoadsorption with remarkable decreased urine protein and reduction of lipoprotein thrombi on repeated renal biopsy.

Eligibility criteria: Inclusion Criteria:

1. A new diagnosis of lipoprotein glomerulopathy proved by histology and serology
2. Age 15\~60 years, sex free

Exclusion Criteria:

1. Serum creatinine \> 500 umol/l
2. Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
3. Congenital or acquired immunodeficiency
4. Patients with severe infection or central nervous system symptoms
5. Immediately life-threatening organ manifestations (e.g. lung haemorrhage or massive gastro-intestinal bleeding, heart failure due to pericarditis or myocarditis, liver dysfunction measured on at least 2 separate occasion)

Primary outcomes:
measure: To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy.
timeFrame: 3 months
Secondary outcomes:
measure: To assess the safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.
timeFrame: 3 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
state: Jiangsu
Study officials:
affiliation: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
name: Zhi-hong Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: