louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03604380: STATE Trial: SusTained Attention Training to Enhance Sleep - Remote
Official title: STATE Trial: SusTained Attention Training to Enhance Sleep (Phase I- Remote Trial Arm)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 134
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a validation study to document the acceptability of the Tonic and Phasic Alertness Training (TAPAT) program in older adults with chronic late-life insomnia. The goal of this study is to employ a computerized attention-training program, TAPAT, designed for chronic late-life insomnia in a remote, randomized, controlled trial to assess feasibility and initial efficacy in this population.


Eligibility criteria: Inclusion Criteria:

* Participant must be 55 years of age or older.
* Participant must meet criteria for clinical insomnia - moderate severity based on the Insomnia Severity Index.
* Participant must be a fluent English speaker.
* Participant must have adequate visual, auditory, and motor capacity to use computerized intervention.
* Participant must have a computer and access to the Internet.

Exclusion Criteria:

* Participants with untreated psychiatric conditions, including substance abuse/dependence disorders, untreated obstructive sleep apnea, diagnosis of other sleep disorders (e.g., restless legs syndrome), recent hospitalization, ongoing chemotherapy or other cancer treatment, and concurrent engagement in another insomnia treatment.
* Participants enrolled in another concurrent research study.
* Participants using computer-based cognitive training programs or has used them within a month of the consent date.

Primary outcomes:
measure: Sleep efficiency scores on the Pittsburg Sleep Quality Index
timeFrame: 6 months
measure: Sleep duration scores on the Pittsburg Sleep Quality Index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Posit Science Corporation
state: California
Study officials:
affiliation: Posit Science Corporation
name: Thomas Van Vleet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03023280: Radiofrequency Ablation in Patients With Large Cervical Heterotopic Gastric Mucosa and Globus Sensation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Heterotopic Gastric Mucosa
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 10
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: Patients with macroscopic and histologic evidence of large (≥ 20mm diameter) heterotopic gastric mucosa.

Brief summary: Symptomatic heterotopic gastric mucosa also known as cervical inlet patch (CIP) may be present in varying shapes and causes symptoms of laryngopharyngeal reflux like globus sensations, hoarseness and chronic cough. Unfortunately, argon plasma coagulation, standard treatment of small symptomatic CIP, is limited for large heterotopic gastric mucosa due to concerns of stricture formation. Therefore, the investigators aimed to investigate the effect of radiofrequency ablation (RFA), a novel minimal-invasive ablation method, in the treatment of large symptomatic CIP.


Eligibility criteria: Inclusion Criteria:

* negative PPI trial, ph-metry without correlation on globus sensation, prior high-resolution manometry

Exclusion Criteria:

* not willing to participate in follow up

Primary outcomes:
measure: Complete histologic eradication of heterotopic gastric mucosa
timeFrame: measured endoscopically throughout the study period. First time point of measurement is 3 months after first ablation. Further measurements are carried out 3 months after subsequent ablations up to a maximum number of three ablations.
Secondary outcomes:
measure: symptom assessment
timeFrame: measured at the beginning, 12 weeks after first ablation and 12 weeks after final endoscopic examination
measure: laryngopharyngeal reflux
timeFrame: at the beginning of the study period and 12 weeks after last endoscopic examination
measure: SF-12 quality of life
timeFrame: at the beginning of the study (before ablations) and 12 weeks after final endoscopic examination
measure: number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: adverse events are assessed within the first week after interventions
measure: laryngopharyngeal reflux II
timeFrame: 1 year after first ablation
Other outcomes:
Locations:
Study officials:
References:
citation: Kristo I, Rieder E, Paireder M, Schwameis K, Jomrich G, Dolak W, Parzefall T, Riegler M, Asari R, Schoppmann SF. Radiofrequency ablation in patients with large cervical heterotopic gastric mucosa and globus sensation: Closing the treatment gap. Dig Endosc. 2018 Mar;30(2):212-218. doi: 10.1111/den.12959. Epub 2017 Oct 3.
Clinical trial NCT04306380: Transoral Incisionless Fundoplication Database Repository (TIF)
Official title: Transoral Incisionless Fundoplication Database Repository (TIF)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 500
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Able to give written informed consent and having a TIF procedure for GERD at Indiana University, IU Health university Hospital. Those participants between the age of 13-18 will sign an assent while the parent or guardian will sign the informed consent.

Brief summary: Collect data on individuals who have a transoral incisionless fundoplication (TIF) performed by physicians at Indiana University for the treatment of gastroesophageal reflux disease.

Detailed description: Collect patient information related to transoral incisionless fundoplication (TIF) done for gastroesophageal reflux disease. The database information with be used for research to assess trends improve patient care.

Eligibility criteria: Inclusion Criteria:

* Having a TIF procedure completed at Indiana University Health, University Hospital

Exclusion Criteria:

* under 13 years of age

Primary outcomes:
measure: GERD-Health Related Quality of Life Questionnaire (GERD_HRQL)
timeFrame: baseline; 6,12,24 and 60 months
measure: RESQ-7 questionnaire
timeFrame: baseline; 6,12,24 & 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT02009280: A Comparison of Propofol Based Total Intravenous Anesthesia and Sevoflurane Based Balanced Anesthesia on Renal Protection During Lung Transplantation Under Extracorporeal Membrane Oxygenation - A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients Undergoing Lung Transplantation Under Extracorporeal Membrane Oxygenation
Keywords: Propofol
Lung transplantation
Extracorporeal membrane oxygenation
Acute kidney injury
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate whether propofol based total intravenous anesthesia reduces incidence of acute kidney injury following the lung transplantation under extracorporeal membrane oxygenation


Eligibility criteria: Inclusion Criteria:

* Sixty adults undergoing lung transplantation under extracorporeal membrane oxygenation

Exclusion Criteria:

* Patient having propofol allergy, BMI \> 30 kg/m2

Primary outcomes:
measure: Comparison of the incidence of acute kidney injury between the lung transplantation recipients under propofol based anesthesia and inhalation based anesthesia
timeFrame: Postoperative 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT04558580: Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Refractory Partial Seizures
Keywords: Seizure, Seizures, Epilepsy
Lead sponsor: University of South Alabama
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of Rufinamide in reducing seizure frequency in subjects with partial seizures not fully controlled despite treatment with 1 to 3 concomitant antiepileptic drugs.


Eligibility criteria: Inclusion Criteria:

* Male and Female patients between 12 and 80 years of age
* Dx of epilepsy with partial onset seizures woth or woth out secondarily generalized seizures
* Non controlled partial seizures despite treatment with 2 different AEDs for at least 2 years
* must have 6 seizures during baseline
* current treatment with maximum of 3 AEDs
* stable dose of AED(s)for at least 1 month
* if patient has VNS, must have been implanted 6 months prior to randomization

Exclusion Criteria:

* Participation in any investigational product for at least 1 month prior to visit 1
* Presence of non-motor simple partial seizures only
* presence of generalized epilepsies
* Evidence of clinically significant disease
* Clinically significant ECG
* Psychogenic seizure in previous year
* History of drug/alcohol abuse
* History of suicide attempt
* Multiple drug allergies
* Concomitant felbamate use
* Need for frequent rescue benzodiazepines
* Concomitant use of vigabatrin
* All patients diagnosed with congenital short QT syndrome

Primary outcomes:
measure: Percentage change in total partial seizure frequency from baseline.
timeFrame: 22 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
Study officials:
affiliation: University of South Alabama
name: Paul Maertens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02050880: OCT Agreement and Crossed Precision Study
Official title: Crossed Precision Design Study of the Nidek Optical Coherence Tomography RS-3000, RS-3000 Lite and RS-3000 Advance for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, and Pachymetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Retinal Disease
Corneal Disease
Keywords: Normal Eyes
Eye; Disorder with Glaucoma
Eye; Disorder with Retinal Disease
Eye; Disorder Corneal Disease incl kerato-refractive group
Lead sponsor: Nidek Co. LTD.
Sponsor class: INDUSTRY
First posted: 2014-01-31
Enrollment: 119
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic subjects, general population

Brief summary: The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.


Eligibility criteria: Inclusion Criteria: NORMAL EYES

* Subjects who do not have pathology in both eyes

Inclusion Criteria: GLAUCOMA

* Subjects who have a glaucoma diagnosis

Inclusion Criteria: RETINAL

* Subjects who have a retinal diagnosis including but not limited to:

  1. Diabetic macular edema
  2. Dry age related macular degeneration
  3. Wet age related macular degeneration
  4. Cystoid macular edema
  5. Epiretinal membrane
  6. Macular hole

Inclusion Criteria: CORNEAL

* Subjects who has one of these diagnosis:

  1. Post status LASIK surgery
  2. Keratoconus
  3. Other corneal dystrophies or degenerations.

Exclusion Criteria: ALL EYES

* Subjects who have any of the following conditions

  1. Diabetes mellitus (DM) and/or diabetic retinopathy
  2. Uncontrolled Hypertension (HT)
  3. Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
  4. Cardiac, hepatic, renal and hematologic diseases
  5. A current condition requiring systemic administration of steroid
  6. A history of, or currently receiving, anticancer therapy
  7. Epileptic seizures which are optically induced
  8. Dementia
* Subjects who have other life threatening and debilitating systemic diseases

Note: Additional criteria may apply

Primary outcomes:
measure: Retinal thickness
timeFrame: Approximately four hours
measure: Optic Disc Analysis
timeFrame: Approximately four hours
measure: Corneal Thickness
timeFrame: Approximately four hours
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: WCCT Global Opthalmology Research Center
state: California
Study officials:
References:
Clinical trial NCT02087280: Metabolic Phenotyping in Anorexia Nervosa
Official title: Metabolic Phenotyping to Predict Risk of Relapse in Patients With Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Anorexia Nervosa
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Deutsche Forschungegemeinschaft
First posted: 2014-03-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female adolescents with Anorexia Nervosa

Brief summary: After discharge from inpatient treatment, 30-50% of patients with Anorexia Nervosa require re-hospitalization within 4-12 months. So far, high relapse rates are mostly considered as lack of the patient's compliance and motivation to recover. However in studies, psychological relapse predictors explain only a minor part of the variance in relapse risk. Metabolic phenotyping has clinical value to predict weight course in obese patients and we assume that it could also be clinically relevant in patients with AN. We hypothesize that in patients with a dissipative but not with the thrifty phenotype, positive energy balance during refeeding causes an over proportional rise in energy expenditure, counteracts continuous weight gain during inpatient treatment, and increases relapse risk within one year after discharge. Thus we believe that metabolic phenotype as a biological parameter has prognostic value for the disease course in AN.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Anorexia Nervosa
* Between 12 and 18 years of age
* Written and informed consent of patient and parents
* Mental ability to understand the concept of the study
* Inpatient admission to Charité University Clinic with body weight below the 10th BMI-Percentile

Exclusion Criteria:

* Any further disease other than AN with significant influence on body composition and energy metabolism or its assessment

Primary outcomes:
measure: Relapse
timeFrame: 1 year after discharge
Secondary outcomes:
measure: Metabolic phenotype
timeFrame: Baseline (during inpatient stay)
measure: Biomarkers
timeFrame: Baseline (during inpatient stay)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Clinic
Study officials:
affiliation: Charité University Berlin
name: Verena K Haas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haas V, Stengel A, Mahler A, Gerlach G, Lehmann C, Boschmann M, de Zwaan M, Herpertz S. Metabolic Barriers to Weight Gain in Patients With Anorexia Nervosa: A Young Adult Case Report. Front Psychiatry. 2018 May 18;9:199. doi: 10.3389/fpsyt.2018.00199. eCollection 2018.
Clinical trial NCT03426280: Activity Therapy After Kidney Transplant
Official title: Activity Therapy After Kidney Transplant: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Transplant; Complications
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Apple Inc.
First posted: 2018-02-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To combat post-transplant weight gain, we seek to expand Stanford Kidney Transplant's multidisciplinary platform to include physical activity monitoring and coaching using the Apple Watch.


Eligibility criteria: Inclusion Criteria:

* All adults (18 years) who undergo kidney transplant at Stanford.

Exclusion Criteria:

* Poor vision with inability to use Apple Watch
* Permanently unable to ambulate

Primary outcomes:
measure: Activity Level (daily caloric consumption)
timeFrame: 1 year
measure: % Days using Apple Watch
timeFrame: 1st year of transplant
Secondary outcomes:
measure: Weight
timeFrame: 1st year of transplant
measure: Hemoglobin A1c
timeFrame: 1st year of transplant
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital and Clinic
state: California
Study officials:
References:
Clinical trial NCT00784680: ATAC - Quality of Life Sub-Protocol
Official title: A Randomised, Double-Blind, Parallel Group Trial to Assess Quality of Life With Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Quality of Life
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-04
Enrollment: 308
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To compare Quality of Life between the ARIMIDEX group, the NOLVADEX group and the ARIMIDEX plus NOLVADEX combination group during the first two years of treatment. (a) To compare the difference in Quality of Life between the ARIMIDEX group and the NOLVADEX group (b) To compare Quality of Life in the ARIMIDEX plus NOLVADEX combination group with the NOLVADEX group for non-inferiority; if non inferiority is concluded, the difference in QOL between these two groups will be assessed.


Eligibility criteria: Inclusion Criteria:

* Eligible for entry into the main ATAC trial 1033IL/0029
* Completion of a baseline questionnaire

Exclusion Criteria:

* Excluded from entry into the main ATAC trial (1033IL/0029)
* If, in the investigators opinion, the patient would be unable to comply with this sub-protocol due to psychiatric or literacy reasons

Primary outcomes:
measure: Time to withdrawal
measure: Time to recurrence
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02327780: The Effectivness of FODMAP Diet in Israel in Relieving Symptoms of Patients With Irritable Bowel Syndrome
Official title: The Effectivness of FODMAP Diet in Israel in Relieving Symptoms of Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-12-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Treatment of IBS is very problematic. Despite the wide range of pharmacological and non-pharmacological therapies, there is no universally accepted approach. In recent years, the low FODMAP diet has been developed, a dietary approach that aims to relieve the symptoms of IBS. FODMAPs (Fermentable Oligosaccharides, Di-saccharides, Mono-saccharides and Polyols) are a group of dietary sugars that may be poorly absorbed in the small intestine and fermented by bacteria to produce gas. Ingestion of FODMAPs may also result in alterations in fluid content in the colon and trigger functional gut symptoms in some individuals. This study aims to examine the effectiveness of the FODMAP diet in Israel in improving symptoms of IBS compared to the standard dietary advice.


Eligibility criteria: Inclusion Criteria:

1. Fulfillment of the Rome III criteria for IBS.
2. Aged 18-77 years at the time of screening.
3. Provision of written informed consent.
4. Commitment of availability throughout the 10 week study period.
5. Availability of at least one GI imaging study during the last 5 years (colonoscopy, sigmoidosopy, abdominal ultrasonography, barium enema) for subjects older than 50 years.

Exclusion Criteria:

1. Major abdominal surgery in the past.
2. The presence of any active (organic) GI disease.
3. Past or present major medical or psychiatric illness.
4. Any concomitant disease.
5. Alarming symptoms (rectal bleeding, weight loss, etc.)
6. Pregnancy.
7. Family history of colorectal carcinoma or IBD, under the age of 50.
8. Abnormal laboratory studies (blood biochemistry, liver enzymes, complete blood count), abnormal thyroid function.
9. Non-adjusted diet in the case of lactose or gluten intolerance.
10. Recent travel to regions with endemic parasitic diseases.

Primary outcomes:
measure: Irritable Bowel Syndrome (IBS) severity score
timeFrame: 9 weeks
measure: IBS quality of life score
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Clinical Nutrition Unit, Sourasky Medical Center
Study officials:
References: