louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03337425: Psychoeducational Groups for Adults With ADHD
Official title: Psychoeducational Groups for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder (ADHD): a Randomized Waitlist-controlled Multicenter Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Psychotherapy, group
Adults
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Helse Nord-Trøndelag HF
First posted: 2017-11-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: a Norwegian multicenter study
Primary purpose: TREATMENT

Brief summary: This pilot study aims to assess patient satisfaction and preliminary efficacy of a psychoeducational group treatment, using a randomized waitlist-controlled trial, at two different outpatient clinics in mid-Norway. All participants will receive standard treatment during the intervention period. Assessment of client satisfaction (CSQ 8), general self-efficacy (GSE-6), ADHD-related quality of life (AAQoL) symptoms of ADHD (SCL-9; ASRS), and work participation will be conducted at time of recruitment prior to randomization (T0), pre- (T1), post-treatment (T2), with a 10 week follow-up.


Eligibility criteria: Inclusion Criteria:

* confirmed ADHD diagnosis
* speaking a Scandinavian language

Exclusion Criteria:

* not able or willing to give informed consent
* psychosis
* severe learning difficulties

Primary outcomes:
measure: Change in patient satisfaction
timeFrame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
measure: Change in general self-efficacy
timeFrame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Secondary outcomes:
measure: Change in ADHD-related symptoms (ASRS)
timeFrame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
measure: Change in ADHD-related symptoms (SCL-9)
timeFrame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
measure: Change in ADHD-related quality of life
timeFrame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks)
Other outcomes:
Locations:
city: Levanger
country: Norway
facility: Levanger Hospital, Nord-Trøndelag Hospital Trust
state: N-T
city: Trondheim
country: Norway
facility: Tiller DPS - St. Olavs University Hospital
state: S-T
Study officials:
affiliation: St. Olavs Hospital
name: Terje Torgersen, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaag JR, Lara-Cabrera ML, Hjemdal O, Gjervan B, Torgersen T. Psychoeducational groups versus waitlist in treatment of attention-deficit hyperactivity/impulsivity disorder (ADHD) in adults: a protocol for a pilot randomized waitlist-controlled multicenter trial. Pilot Feasibility Stud. 2019 Jan 23;5:17. doi: 10.1186/s40814-019-0401-1. eCollection 2019.
Clinical trial NCT03805425: PiXL for Correction of Hyperopia
Official title: Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperopia
Keywords: Hypeorpia
Crosslinking
PiXL
Lead sponsor: Gemini Eye Clinic
Sponsor class: INDUSTRY
First posted: 2019-01-15
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: This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.

Detailed description: This clinical study aims to investigate the efficacy and safety of PiXL in the refractive correction of low hyperopia.Slightly modified settings from previously published study is applied to eyes with low hyperopia with an expected refractive change of 0.75 D. Aim is to evaluate the refractive outcome of this procedure.

Eligibility criteria: Inclusion Criteria:

* low hyperopia of spherical equivalent from +0.5 up to +1.75 D sp. eq.
* astigmatism up to 0.75 Dcyl
* corneal thickness above 400 µm
* endothelial cell density above 1500 cell/mm2

Exclusion Criteria:

* any prior corneal surgery or any eye surgery within the last 3 months,
* any corneal pathology e.g. corneal scar or dystrophy
* unstable refraction
* patient not able to understand and sign informed consent
* patients with connective tissue disorder or uncontrolled diabetes
* pregnant or lactating women
* aphakic eyes or pseudophakic eyes without UV blocking IOL

Primary outcomes:
measure: Change in Uncorrected Distance Visual Acuity
timeFrame: Month 12
measure: Change in Subjective Refraction
timeFrame: Month 12
Secondary outcomes:
measure: Change in keratometry
timeFrame: Month 12
measure: Change in Higher Order Aberrations
timeFrame: Month 12
measure: Change in pachymetry
timeFrame: Month 12
measure: Subjective questionnaire score
timeFrame: Month 12
measure: Change in Corrected Distance Visual Acuity
timeFrame: Month 12
measure: Change in Spherical aberration
timeFrame: Month 12
Other outcomes:
Locations:
city: Zlín
country: Czechia
facility: Gemini Eye Clinic
Study officials:
affiliation: Gemini Eye Clinic
name: Pavel Stodulka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanellopoulos AJ, Asimellis G. Hyperopic correction: clinical validation with epithelium-on and epithelium-off protocols, using variable fluence and topographically customized collagen corneal crosslinking. Clin Ophthalmol. 2014 Dec 2;8:2425-33. doi: 10.2147/OPTH.S68222. eCollection 2014.
Clinical trial NCT03535025: Postoperative Quality of Recovery in Patients Receiving Anaesthesia
Official title: Postoperative Quality of Recovery in Patients Receiving Anaesthesia: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elective Surgeries
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 195
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: all patients above the age of 18yrs under going elective surgery under anaesthesia

Brief summary: The investigator's study is designed to evaluate the recovery of patients receiving anaesthesia for surgeries; in different domains like the physiological, nociceptive, cognitive and emotional to the participants' preoperative state.


Eligibility criteria: Inclusion Criteria:

* All patients aged 18 years or over who are undergoing surgery with anesthesia

Exclusion Criteria:

* Inability to complete the baseline questionnaire for any reason as assessed by the examiner
* Patient with any current psychiatric disturbance
* Patient undergoing a neuropsychological procedure that may impair their ability to participate in the assessment
* Patients undergoing emergency surgery

Primary outcomes:
measure: quality of recovery from anaesthesia
timeFrame: 24 hours post operatively
Secondary outcomes:
measure: factors delaying recovery
timeFrame: 24 hrs post operatively
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: BPKIHS
state: Sunsari
Study officials:
References:
Clinical trial NCT00883025: Correlation Between Friedman Classification and the Apnea Hypopnea Index (AIH) in a Population With Obstructive Sleep Apnea Syndrome (OSAS)
Official title: Correlation Between Friedman Classification Ande ApneaHypopnea Index in a Population With OSAS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Friedman Classification
Apnea-Hypopnea Index
Obstructive Sleep Apnea Syndrome
Lead sponsor: Irmandade da Santa Casa de Misericoridia de Limeira
Sponsor class: OTHER
Collaborators: name: Hospital Dia
First posted: 2009-04-17
Enrollment: 147
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Study population: Patients of Ambulatory of Sleep Respiratory Disorders of Santa Casa de Limeira

Brief summary: Introduction:

OSAS is an important disease in the actual medic scene. It is important for correlation with chronic cardiovascular disease that leaves an increase in morbimortality and socioeconomic disability to patients with apnea.

Objectives:

Determinate the correlation between Friedman Classification and the obstructive sleep apnea syndrome (OSAS) gravity through AHI (Apnea Hypopnea Index) in patients with OSAS for surgical indication and evaluation.

Materials and Methods:

The investigators evaluated and classified 84 patients, in the scale of Epworth, Friedman and how much the gravity of the SAHOS for the AHI.


Eligibility criteria: Inclusion Criteria:

* Not exhibiting any exclusion criteria
* Age \> 21 years

Exclusion Criteria:

* Nasal tumor
* BMI \> 40
* No acceptance of study
* Nasal poliposis

Primary outcomes:
measure: Friedman Classification
timeFrame: one year
Secondary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: one year
Other outcomes:
Locations:
city: Limeira
country: Brazil
facility: Hospital Dia
state: São Paulo
Study officials:
References:
citation: Rodrigues MM, Dibbern RS, Santos VJ, Passeri LA. Influence of obesity on the correlation between laryngopharyngeal reflux and obstructive sleep apnea. Braz J Otorhinolaryngol. 2014 Jan-Feb;80(1):5-10. doi: 10.5935/1808-8694.20140004. English, Portuguese.
Clinical trial NCT00882622: Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery
Official title: Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Atrial Fibrillation
Ventricular Arrythmias
Myocardial Injury
Cardiac Function
Keywords: Ischemic Preconditioning
Cardiac Surgery
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Goethe University
First posted: 2009-04-16
Enrollment: 0
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: The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention.

Detailed description: In detail, we will focus on new onset of atrial fibrillation, ventricular arrhythmias, myocardial injury, and cardiac function. Furthermore, we aim to investigate underlying pathways of RIPC in modifying the perioperative stress response.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing heart surgery on cardiopulmonary bypass

Exclusion Criteria:

* Emergency cases
* Myocardial infarction up to 7 days prior to enrollment
* Ejection fraction less than 30%
* Inability to give informed consent

Primary outcomes:
measure: New onset of atrial fibrillation
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Ventricular arrhythmias, myocardial injury, cardiac function. Underlying pathways of Remote Ischemic Preconditioning in modifying the perioperative stress response.
timeFrame: Within 24 hours after surgery
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: University Hospital
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
Study officials:
References:
Clinical trial NCT00773422: The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Official title: The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Keywords: smoking lapse behavior
smoking cessation
varenicline
naltrexone
medication effect on smoking lapse behavior
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2008-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine how medications thought to attenuate the effects of alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming drink, in non-treatment seeking alcohol-drinking daily smokers.


Eligibility criteria: Inclusion Criteria:

* ages 21-55
* ability to read and write in English
* alcohol-drinking smokers

Exclusion Criteria:

* any significant current medical conditions that would contraindicate smoking
* current DSM-IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse.
* positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
* women who are pregnant or nursing
* suicidal, homicidal or evidence of current severe mental illness
* participants prescribed any psychotropic drug in the 30 days prior to study enrollment
* blood donation within the past 6 weeks
* individuals seeking treatment for smoking cessation or drinking or have attempted to quit smoking or drinking within the past 3 months
* specific exclusion for administration of naltrexone not specified above including chronic pain conditions necessitating opioid treatment, and evidence of significant hepatocellular injury as evidenced by SGOT or SGPT \> 3x normal or elevated bilirubin
* known allergy to varenicline or taking H2blockers (e.g., Cimetidine)
* participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current protocol

Primary outcomes:
measure: Latency to Initiate Ad-lib Smoking Session
timeFrame: day 8
Secondary outcomes:
measure: Number of Cigarettes Smoked During the Ad-lib Period
timeFrame: day 8
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation, Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Sherry A McKee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05205122: Evaluation of Primary Congenital Glaucoma at Asyut University Hospital
Official title: Evaluation of Primary Congenital Glaucoma Management at Asyut University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Congenital Glaucoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Evaluation of the management of primary congenital glaucoma regarding the results of surgical intervention at Asyut University Hospital


Eligibility criteria: Inclusion Criteria:

Typical symptoms of epiphora , photophobia and blepharospasm Corneal diameter \> 13 mm Increased ocular tension \> 25 mmHg UGA using schiotz tonometer

Exclusion Criteria:

Infants with history of previous surgery Secondary glaucoma Glaucoma associated with other congenital anomalies

Primary outcomes:
measure: IOP follow up
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01853722: A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to Unisol® Following Topical Periocular Administration in Healthy Volunteers
Official title: A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to Unisol® Following Topical Periocular Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Infection
Keywords: DCN01
Ocular Surgical Preparation
Prophylaxis against infection
Pre-operative prep
Lead sponsor: Deacon Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2013-05-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.


Eligibility criteria: Inclusion Criteria:

* Have given a written, informed consent
* Be willing and able to follow all instructions
* A negative urine pregnancy test if female of childbearing potential

Exclusion Criteria:

* Known sensitivities to study medication or its components
* Any signs of an active infection
* Use of disallowed products during the period indicated prior to the enrollment or during the study
* Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
* Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation

Primary outcomes:
measure: Change from baseline in periocular region bacterial load
timeFrame: Baseline to 10 min post dose
Secondary outcomes:
measure: Proportion of periocular regions with a reduction from baseline in bacterial load.
timeFrame: Baseline to 10 min post dose
Other outcomes:
measure: Adverse Events (reported, elicited, observed)
timeFrame: Post dose and up to 2 weeks after (Day 1-14)
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT02846922: Catheter Ablation and Rate Control of Atrial Fibrillation in Patients With Heart Failure
Official title: Catheter Ablation Versus Rate Control in Patients With Atrial Fibrillation and Heart Failure: A Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheter Ablation
Rate Control
Heart Failure
Atrial Fibrillation
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients coexisted with heart failure and atrial fibrillation

Brief summary: To evaluate the efficacy of catheter ablation and rate control in heart failure patients with atrial fibrillation.

Detailed description: All patients received either catheter ablation for rhythm control or rate control before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.

Eligibility criteria: Inclusion Criteria:

* age\>18 years
* documented atrial fibrillation
* New York Heart Association Ⅱ-Ⅳ or left ventricular ejection fraction \<50%

Exclusion Criteria:

* heart failure that had a suspected reversible cause
* previous ablation
* any contraindication to catheter ablation

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: up to 3 years
Secondary outcomes:
measure: all-cause mortality
timeFrame: up to 3 years
measure: stroke
timeFrame: up to 3 years
measure: unplanned hospitalization due to cardiovascular reasons
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Jin Geng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huai'an First People's Hospital
name: Bingjian Wang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02133222: Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy
Official title: Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic (Stage IV) Melanoma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Therapies that target specific molecules markedly inhibit cancer growth in several malignancies, and provide valuable strategies for the treatment of advanced melanoma. In recent years, BRAF and KIT have become established therapeutic targets in melanoma patients showing activating mutations in these oncogenes. However, it is crucial that genetic mutations present in the melanoma lesions are identified if the investigators are to design tailormade therapies for individual patients. The tumour genotypes that determine the selection of molecular-targeted therapies are usually identified in primary tumours; however, primary tumours are not always representative of metastases. Circulating free DNA may be a source of valuable information because it can be obtained via routine blood sampling, it provides real-time information about a patient's current disease state, and it allows monitoring and molecular characterization before and after chemotherapy. The aim of the study is to determine the mutational status in circulating DNA in melanoma metastatic patients, with the Sequenom Mass Array, a next generation sequencing technology. Results obtained before and after treatment will be compared with the primary tumor genotype.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Surgical biopsy for histologic diagnostic
* All melanoma subtypes
* Known genotype BRAF V600
* Affiliation social security
* Consent form signed

Exclusion Criteria:

* Patient with histories of cancer or the other synchronous cancer
* Pregnant women
* Breast-feeding women
* Vulnerable patients: major under guardianship; patient deprived of its rights

Primary outcomes:
measure: Response to treatment (MRI, Scanner)
timeFrame: at three months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Elodie LONG-MIRA, PH
role: PRINCIPAL_INVESTIGATOR
References: