louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02128867: Safety Study of Airway Clearance Techniques in Infants.
Official title: Influence of Bouncing, Assisted Autogenic Drainage (AAD) and Bouncing and AAD (BAAD) on Gastro-oesophageal Reflux ( GOR ), Oxygen Saturation (SaO2) and Heart Rate in Infants From 0 to 12 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-esophageal Reflux
Keywords: gastro-esophageal reflux
GOR
GER
airway clearance techniques
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 159
Sex: ALL
Minimum age (years): 1
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year.


Eligibility criteria: Inclusion Criteria:

* infants \< 1 year
* acid reflux monitoring

Exclusion Criteria:

* gestational age \<24 w
* anti-reflux medication
* Nissen fundoplication
* no parental consent

Primary outcomes:
measure: Number of Refluxes
timeFrame: 15 minutes
Secondary outcomes:
measure: Duration of Reflux Episodes
timeFrame: 15 minutes
Other outcomes:
measure: Heartrate
timeFrame: 15 minutes
measure: Sa02
timeFrame: 15 minutes
Locations:
city: Jette
country: Belgium
facility: UZBrussel
state: Brussels
Study officials:
References:
Clinical trial NCT03281967: Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
Official title: Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Conduction Deafness
Unilateral Deafness
Middle Ear Deafness
Mixed Hearing Loss
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2017-09-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.


Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Patient indicated for an ear level bone anchored sound processor.
* Healthy bone quality to allow for 4mm implant insertion.

Exclusion Criteria:

* Intraoperative switch to an alternative surgical technique
* Patients undergoing re-implantation (on the side being included in the study)
* Previous participation in the C47 study.
* Inability to participate in follow-up.
* Psychiatric disease in the medical history.
* Mental disability.
* Presumed doubt, for any reason, that the patient will be able to show up on all follow-ups.
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
* Patients with natural skin height of \>12mm (as there will be additional skin reduction needed)

Primary outcomes:
measure: Numbness (sensibility) around surgery area
timeFrame: 6 months post surgery
Secondary outcomes:
measure: Time needed for surgery
timeFrame: At surgery
measure: Unplanned visit
timeFrame: 36 months
measure: Adverse Events
timeFrame: 36 months
measure: Pain perception by patient
timeFrame: 36 months
measure: Implant survivability
timeFrame: 36 months
measure: Implant stability as measures by Implant stability quotient.
timeFrame: 36 months
measure: Surgical wound healing time
timeFrame: 36 months
measure: Quality of Life Assessment
timeFrame: 36 months
measure: Aesthetic Assessment
timeFrame: 36 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: University Medical Center St Radboud
Study officials:
affiliation: Radboud UMC, Department of Otorhinolaryngology. The Netherlands
name: Myrthe Hol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03057067: Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
Official title: Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Pain
Varicose Veins
Keywords: Embolization, Therapeutic
Pelvis
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All female patients referred for assessment of chronic pelvic pain at the gynecological outpatient clinic or the Multidisciplinary Pain Clinic at St. Olavs Hospital are eligible for initial assessment
Primary purpose: TREATMENT

Brief summary: Results of recent systematic reviews suggest favorable results of embolization for the treatment of Pelvic Congestion Syndrome (PCS) compared with pre-procedure symptoms for several outcomes, including pain reduction, overall patient satisfaction, and technical feasibility. Reported complication rates appears relatively low.

Pelvic vein embolization is a relatively new technology and the results may provide background for an evidence based decision to offer embolization of pelvic varicosities for women with PCS in Norway.


Eligibility criteria: Inclusion Criteria:

* Pelvic pain (lasting for more than 6 months)
* Symptoms of PCS - deterioration of pain when standing and improvement in supine position (with or without dyspareunia or dysmenorrhea).
* Confirmed pelvic varicosities by magnetic resonance examination.
* Signed, written and informed consent

Exclusion Criteria:

* Inability to communicate in Norwegian
* Known endometriosis
* Uterine myoma, uterine anomalies, or cancer
* Postmenopausal
* not having been pregnant

Primary outcomes:
measure: chronic pelvic pain
timeFrame: 3 months
measure: chronic pelvic pain
timeFrame: 6 months
measure: chronic pelvic pain
timeFrame: 1 year
Secondary outcomes:
measure: Health related quality of life (HRQOL)
timeFrame: 3 months
measure: Health related quality of life (HRQOL)
timeFrame: 6 months
measure: Health related quality of life (HRQOL)
timeFrame: 1 year
measure: Sexual function
timeFrame: 3 months
measure: Sexual function
timeFrame: 6 months
measure: Sexual function
timeFrame: 1 year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Risa AM Lonnee-Hoffmann, md phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01230567: Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds
Official title: Comparison Between the Histological and Clinical Diagnosis of Non Healing Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds and Injuries
Keywords: Problem wounds
Non healing wounds
BCC
SCC
Vasculitis
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2010-10-29
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from non healing wounds, which do not respond well to six weeks of adequate treatment.

Brief summary: 50 patients with non healing wounds will undergo biopsy to conclude wether there is an occult etiology for the wound.

Detailed description: 25 patients suffering from non healing wounds which have non typical features for the clinical diagnosis (such as pale granulation, raised lesions and more) will undergo biopsy of the wound.

Another 25 patients suffering from non healing wounds with typical features for the clinical diagnosis will undergo biopsy of the wound.

The hypothesis is that non healing wounds harbor undiagnosed etiologic factors such as BCC, SCC, vasculitis etc. and that some clinical features should raise our suspicion for these occult etiologies.

Eligibility criteria: Inclusion Criteria:

* patients with non-healing wounds (for \> 6 weeks)
* consent to be included in the study
* age 18-85

Exclusion Criteria:

* patients taking anti coagulant therapy
* patients taking steroids or immunosuppressive therapy
* pregnancy
* pace maker

Primary outcomes:
measure: HISTOLOGY RESULTS
timeFrame: 04/2013
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Yaron Har-Shai, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02771067: The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.


Eligibility criteria: Inclusion Criteria:

* adult patients aged over 19 years who are scheduled for robotic or laparoscopic gastrectomy

Exclusion Criteria:

* cardiac arrhythmia
* valvular heart disease
* ischemic heart disease
* left ventricular ejection fraction less than 40%
* Pulmonary disease
* esophageal disease
* upper gastrointestinal bleeding
* Body mass index more than 40 kg/m2.

Primary outcomes:
measure: Pulse pressure variation
timeFrame: During the surgery. At Day 0.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University
Study officials:
References:
Clinical trial NCT02173067: Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective
Official title: Local Anesthesia With Epinephrine for Oral Surgery in Type 2 Diabetes Mellitus With Corornary Disease is Safe and Effective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Coronary Disease
Keywords: Diabetes mellitus
Epinephrine
Anesthesia, Dental
lidocaine
Ambulatory Surgical Procedures
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-06-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We enrolled pharmacologically controlled type 2 diabetes mellitus (in use of insulin and/or hypoglycemic agents) and with coronary disease adult patient who needed to have at least one posterior maxillary tooth to be extracted.

Brief summary: The purpose of this study is to investigate the variation in blood glucose levels, hemodynamic effects and patient anxiety score during tooth extraction in type 2 diabetes mellitus with coronary disease patient under local anesthesia with lidocaine 2% with and without epinephrine.

Detailed description: This is a prospective randomized study including 70 diabetes with coronary disease patients that needed to be submitted to oral surgery. The study was double blind in relation to glycaemia measurements. Continuous monitoring of blood glucose levels for 24 hours was performed using the Minimed Continuous Monitoring System (CGMS, Medtronic). Patientes were randomized into two groups: 35 received 5.4 mL of 2% lidocaine and 35 received 5.4 mL of 2% lidocaine with 1:100,000 epinephrine. In addittion, hemodynamic effects (blood pressure and heart rate) and degree of anxiety were also evaluated.

Eligibility criteria: Inclusion Criteria:

Type 2 diabetes mellitus pharmacologically controlled (in use of insulin and/or hypoglycemic agents) Coronary disease -

Exclusion Criteria:

* Pregnant sepsis acute renal failure

Primary outcomes:
measure: varition in blood glucose levels during oral surgery with local anaesthesia (lidocaina and lidocaine with epinephrine)
timeFrame: 24 hours
Secondary outcomes:
measure: Hemodynamic effects during the surgery with local anesthetia (lidocaine and lidocaine with epinephrine)
timeFrame: almost 3 hours
Other outcomes:
measure: Anxiety levels during the oral surgery with local anesthesia (lidocaine and lidocaine and epinephrine)
timeFrame: almost 3 hours
Locations:
city: São Paulo
country: Brazil
facility: Unit of Dentistry, Heart Institute
Study officials:
affiliation: University of Sao Paulo
name: Marcela A Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05081167: A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 Monotherapy for Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: REL-1017
Lead sponsor: Relmada Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-18
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as a monotherapy for Major Depressive Disorder.


Eligibility criteria: Inclusion Criteria:

* Adults 18 to 65 years, inclusive.
* Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.
* Current major depressive episode.

Exclusion Criteria:

* Any current and primary psychiatric disorder other than Major Depressive Disorder.
* Severe alcohol or substance use disorder.
* History of bipolar I and II disorder, psychosis, and/or mania.
* Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
* Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.

Primary outcomes:
measure: Change in the MADRS10 Total Score From Baseline to Day 28
timeFrame: Day 28
Secondary outcomes:
measure: MADRS10 Remission Rate (Total Score ≤10) at Day 28
timeFrame: Day 28
measure: MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28
timeFrame: Day 28
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Relmada Site
state: Florida
city: Miami Springs
country: United States
facility: Relmada Site
state: Florida
city: Miami
country: United States
facility: Relmada Site
state: Florida
city: Miami
country: United States
facility: Relmada Site
state: Florida
city: Orlando
country: United States
facility: Relmada Site
state: Florida
city: Palm Bay
country: United States
facility: Relmada Site
state: Florida
city: Chicago
country: United States
facility: Relmada Site
state: Illinois
city: Boston
country: United States
facility: Relmada Site
state: Massachusetts
city: Watertown
country: United States
facility: Relmada Site
state: Massachusetts
city: Austin
country: United States
facility: Relmada Site
state: Texas
Study officials:
affiliation: Relmada Therapeutics
name: Marco Pappagallo, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04111367: Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients
Official title: A Phase IIa, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 2,3,6 Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatitis C Virus Infection
Lead sponsor: Ginkgopharma CO., LTD
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir in patients with Hepatitis C (HCV) genotype2,3,6. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).


Eligibility criteria: Inclusion Criteria:

Hepatitis C virus (HCV) genotype 2,3,6 infection (confirmed at screening). HCV RNA greater than 10,000 IU/mL at screening. Participant must be willing and able to comply with the protocol requirements. weight was more than 40 kg. age is between 18-75,either sex.

Exclusion Criteria:

Co-infection with hepatitis B virus or human immunodeficiency virus (HIV). Infection with HCV non-genotype 2,3,6,or Infection with mixed genotype,or Genotype cannot be confirmed.

Medical history of major functional organ transplantation. Suffering from serious blood system disease(such us Thalassemia/Sickle Cell Anemia).

Participation in a clinical study within 3 months prior to first dose

Primary outcomes:
measure: Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12）
timeFrame: Posttreatment Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
timeFrame: Posttreatment Week 4
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital,Capital Medical University
state: Beijing
city: Liuzhou
country: China
facility: Liuzhou General Hospital
state: Guangxi Zhuang Autonomous Region
city: Changchun
country: China
facility: The first hospital of JILIN University.
state: Jilin
city: Guangxi
country: China
facility: The First Affiliated Hospital Of Guangxi Medical University
state: Nanning
Study officials:
affiliation: Ginkgo Pharma Co., Ltd.
name: Xuegang Wu
role: STUDY_DIRECTOR
References:
Clinical trial NCT04337567: Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation
Official title: A Prospective Randomized Trial for the Comparison of Procedural Characteristics and Long-term Effects of Radiofrequency Ablation and Balloon Cryoablation in Elderly Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: ablative treatment of atrial fibrillation
ballon cryoablation
radiofrequency ablation
elderly patients
Lead sponsor: Vivantes Netzwerk für Gesundheit GmbH
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 80
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the procedural characteristics and effectivity of radiofrequency ablation and cryoablation in patients with atrial fibrillation that are 75 years or older.

Detailed description: Radiofrequency and cryoballon ablation have been shown to be comparable to each other in terms of safety and effectivity in patients with atrial fibrillation. However, elderly patients have been underrepresented in the previous studies. The number of older patients with atrial fibrillation is high and the number of who undergo an ablation procedure for atrial fibrillation increases steadily. This prospective randomized trial compares the effectivity (recurrency of atrial arrhythmias) and periprocedural characteristics of the two established ablation methods in patients who are 75 years or older.

Eligibility criteria: Inclusion Criteria:

* Patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation
* At the day of their inclusion in the study the patients have to have completed the 75th year of life

Exclusion Criteria:

* Dementia
* Presence of left atrial thrombus
* Left atrial volume\> 50 ml/m²
* Renal failure (GFR≤ 30 ml/min)
* Comorbidity with an expected survival of 12 months or less.

Primary outcomes:
measure: atrial arrhythmia recurrence
timeFrame: 1 year
Secondary outcomes:
measure: procedural duration
timeFrame: periprocedural
measure: time to wake-up after propofol withdrawal
timeFrame: periprocedural
measure: contrast medium dosis
timeFrame: periprocedural
measure: Propofoldosis
timeFrame: periprocedural
measure: groin complications
timeFrame: up to 3 months after dismission from the hospital
measure: Neurological complications
timeFrame: 1 year
measure: vascular complications
timeFrame: 1 year
measure: duration of hospital staying [days]
timeFrame: 1 year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
Study officials:
affiliation: Vivantes Clinic Neukölln
name: Charalampos Kriatselis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00568867: Evaluation of Preexisting Immunity Markers in Human Tumor Tissue Sample
Official title: Evaluation of Preexisting Immunity Markers in Human Tumor Tissue Sample
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult patient with a tumor who is scheduled to undergo surgery to either remove or biopsy the tumor.

Brief summary: The purpose of this study is to evaluate markers of immune response in human tumor samples.

Detailed description: Cancer immunotherapy has been shown to be effective in isolated instances, but ineffective in most patients. The reason for this inconsistency, and the conditions necessary for successful immunotherapy, are not well understood. Our studies in animal tumor models indicate that the effectiveness of IL-12-based immunotherapy depends upon the presence of a preexisting immune response to the tumor. The presence of T cell infiltrates and IFN-gamma expression in tumor indicate such an immune response. We therefore plan to evaluate the existing immune response in human tumor samples in an effort to identify those patients most likely to respond to therapy with IL-12.

Eligibility criteria: Inclusion Criteria:Any adult patient with a tumor who is scheduled to undergo surgery to either remove or biopsy the tumor. Exclusion Criteria:Patients without tumor and pediatric patients (children) will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Jeffrey A. Norton
role: PRINCIPAL_INVESTIGATOR
References: