louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03173378: Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
Official title: Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narcolepsy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 and Type 2 narcoleptic patients and adult age-matched family members of the patients (1 or 2 control per patient)

Brief summary: Narcolepsy is a chronic, disabling condition characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults. Symptoms of narcolepsy are responsible for an important handicap in everyday life, and are often misunderstood by the family and professional environment. In addition, many comorbidities are associated with narcolepsy, such as depression, anxiety, or obesity.

Few studies have examined the impact of narcolepsy on patients' educational background, socio-professional integration, and quality of life. In particular, the factors of professional handicap related to the characteristics of the disease and the determinants of the insertion of the patients remain poorly known.

As a better understanding of these determinants could help to inform patients and guide them in their choices, NARCOWORK study aims at evaluating the academic and professional trajectories of a wide population of narcoleptic patients.


Eligibility criteria: Inclusion Criteria:

Group "Narcoleptic Patients":

* Type 1 or Type 2 narcolepsy
* \> 18 years
* Usually followed at the Lyon Sleep Medicine Center

Group "Control":

* At least one member of each family of cases (siblings, cousins ...)
* \> 18 years and of the same age as the case if possible (+/- 5 years)
* No narcolepsy

Exclusion Criteria:

* uncertain diagnosis (for the "Narcoleptic Patients" Group)
* poor knowledge of the French language
* Refusal to participate

Primary outcomes:
measure: Occupational situations
timeFrame: 30 to 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon
Study officials:
References:
citation: White M, Charbotel B, Fort E, Bastuji H, Franco P, Putois B, Mazza S, Peter-Derex L. Academic and professional paths of narcoleptic patients: the Narcowork study. Sleep Med. 2020 Jan;65:96-104. doi: 10.1016/j.sleep.2019.07.020. Epub 2019 Aug 2.
Clinical trial NCT05311878: Non-invasive BCI for Cognitive Enhancement
Official title: Non-invasive Brain Computer Interface for Cognitive Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Neuropsychiatric Disorders
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People's perceptual skills can significantly affect their abilities to make optimal decisions, judgments, and actions in real-world dynamic environments. Perceptual learning refers to training and experiences to induce improvements in the ability to make sense of what people see, hear, feel, taste or smell based on ambiguous sensory information. In this study, investigators hypothesise that there exist neural signatures that robustly encode the conscious visual perception of rotations of a cursor and the magnitudes of these rotations in a novel, rotation-based perceptual learning task. Investigators also hypothesise that online, instantaneous EEG-based feedback on subjects' visual perceptions of rotations with an EEG-based Brain Computer Interface (BCI) can foster perceptual learning much more effectively than behaviour perceptual training, especially in very small rotation magnitudes that represent extremely difficult perceptual tasks.


Eligibility criteria: Inclusion Criteria:

Able-bodied volunteers:

* good general health
* normal or corrected vision
* no history of neurological/psychiatric disease
* ability to read and understand English
* ability to understand information and ability to give a free and informed consent

Subjects with neuropsychiatric diseases

* Subjects with neuropsychiatric diseases such as bipolar disorder and schizophrenia.
* normal or corrected vision
* ability to read and understand English
* ability to understand information and ability to give a free and informed consent

Exclusion Criteria:

* short attentional spans or cognitive deficits that prevent to remain concentrated during the experimental sessions
* concomitant serious illnesses (e.g., metabolic disorders, cardiac arrest)
* factors hindering proper EEG acquisition (e.g., scalp wound, uncontrolled muscle activity)

Primary outcomes:
measure: Change in correct answer rate of different rotation magnitudes across 5 intervention sessions
timeFrame: Difference is measured every 24 hours, before versus after each intervention session
Secondary outcomes:
measure: Change in neural correlates of conscious perception across 5 intervention sessions
timeFrame: Difference is measured every 24 hours, before versus after each intervention session
Other outcomes:
Locations:
city: Austin
country: United States
facility: Engineering Education and Research Center
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Jose del R. Millan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05535478: Deprescribing of Diabetes Regimens in Long Term Care Residents With Alzheimer's
Official title: Deprescribing of Diabetes Treatment Regimens in Long Term Care (LTC) Residents With Alzheimer's Disease or Related Dementias (ADRD)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes
Dementia
Hypoglycemia; Drug
Keywords: older adults
long term care facility
high risk medications
hypoglycemia
deprescribing
diabetes
dementia
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Brown University
name: Theoria Medical
First posted: 2022-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Objectives To 1) examine the ability of the STRIDE (Simplification of Treatment Regimens and Individualized Diabetes Education) educational program to increase deprescribing of high hypoglycemia risk glucose-lowering medications (HRMs) among long term care facility (LTCF) residents with ADRD, 2) assess key implementation constructs (secondary outcomes) of the STRIDE program, including acceptability, appropriateness, and feasibility, and 3) validate the primary HRM use outcome measure.


Eligibility criteria: Inclusion Criteria:

* Clinical staff at the LTCF (MDs, PAs, NPs, clinical pharmacists) - (Targeted providers for STRIDE program)
* Clinical staff that participated in the STRIDE program (Providers doing stakeholder exit interviews)

Exclusion Criteria:

* Consistent with the pragmatic nature of the trial, there are no exclusion criteria.

Primary outcomes:
measure: Change in proportion of long term care facility (LTCF) residents with Alzheimer's disease adn related dementias (ADRD) and diabetes with high risk medications (HRM) use
timeFrame: Baseline vs 6 months
Secondary outcomes:
measure: Acceptability of the STRIDE Educational Program
timeFrame: 6 months
measure: Appropriateness of the STRIDE Educational Program
timeFrame: 6 months
measure: Feasibility of the STRIDE Educational Program
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Medha Munshi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00338078: Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration
Official title: Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration. A Randomized Double-Blind Placebo Controlled Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2006-06-20
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether oxygen therapy during sleep improves quality of life, exercise capacity and heart function among patients with chronic heart failure and central sleep apnea.

Detailed description: Oxygen therapy reduces the number of central apneas among patients with congestive heart failure but it is unknown whether quality of life and heart function also improve. We aim to test whether the quality of life, exercise capacity and heart function are improved with nocturnal oxygen therapy during 6 weeks with nocturnal oxygen from oxygen concentrator or nocturnal air from placebo concentrator.

Eligibility criteria: Inclusion Criteria:

* Stable heart failure with left ventricular dysfunction
* Cheyne-Stokes respiration with central AHI\>15 and obstructive AHI\<5

Exclusion Criteria:

* Heart infarction within 3 months.
* Dementia
* Chronic obstructive pulmonary disease and daytime hypoxemia.

Primary outcomes:
measure: Exercise capacity
measure: Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)
measure: Brain natriuretic peptide (BNP)
Secondary outcomes:
measure: Echocardiography
measure: Radionuclide determination of ejection fraction
measure: Mortality and hospitalization for cardiovascular causes (combined and individually)
measure: Hospitality anxiety and depression scale
measure: Epworth sleepiness scale
measure: Karolinska sleepiness scale
measure: Routine lab (haemoglobins, thyroid status, creatinin)
measure: Urinary catecholamines
measure: Urinary cortisol
measure: Polysomnography
measure: Arrhythmias from 24 hour Holter-ECG registration
measure: Heart rate variability
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept of respiratory medicine
Study officials:
affiliation: Dept Respiratory Medicine, University Hospital, Umeå
name: Karl A Franklin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05452278: A Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products
Official title: A Randomised, Cross-over, Single-blind, Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Imperial Brands PLC
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This will be a randomised, cross-over, single-blind, confinement study conducted in 27 male or female snus or nicotine pouch users. The study will investigate 4 different nicotine containing products in a cross-over design, incorporating pharmacokinetic (PK) evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety and tolerability evaluation.

During the study participation, subjects will come for 2 visits to the clinic, including a screening visit and a 4-day confinement period. A final follow up end-of-study telephone call will be performed within a week of last product use.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 18.0 and ≤ 30.0 kg/m2
* Clinically normal medical history
* User of snus or nicotine pouches for ≥1 year, with a minimum weekly use of 2 or more snus or nicotine pouch cans and who is willing and considered able to use brands with nicotine content in the range of 14 to 20 mg nicotine/pouch

Exclusion Criteria:

* History of any clinically significant disease or disorder
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of IP.
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and HIV
* Female subjects who are pregnant or breastfeeding
* Presence or history of drug or alcohol abuse
* Excessive caffeine consumption defined by a daily intake of \>5 cups of caffeine containing beverages
* Intend to change nicotine-use habit or make a quit attempt within the next 3 months from the screening visit.

Primary outcomes:
measure: Nicotine Cmax
timeFrame: 5 minutes prior to product use and 5, 10, 15, 20, 25, 30, 45, 60, 90 minutes, 2, 4, 6 and 8 hours post start of product use
measure: Nicotine AUCt
timeFrame: 5 minutes prior to product use and at 5, 10, 15, 20, 25, 30, 45, 60, 90 minutes, 2, 4, 6 and 8 hours post start of product use
Secondary outcomes:
measure: Extracted dose of nicotine
timeFrame: 20 minutes
measure: Urge to use Emax
timeFrame: 5 minutes prior to product use and at 5, 10, 15, 20, 25, 30, 45, 60, 90 minutes, 2, 4, 6 and 8 hours post start of product use
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: CTC Clinical Trial Consultants AB
Study officials:
References:
Clinical trial NCT01879878: Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
Official title: Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: pancreatic adenocarcinoma
broccoli sprouts
sulforaphane
palliative chemotherapy
cancer stem cells
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
First posted: 2013-06-18
Enrollment: 40
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 goal of the POUDER trial is to determine the feasibility of a randomized controlled trial regarding the application of freeze-dried broccoli sprouts rich in sulforaphane and quercetin in patients with advanced pancreatic ductal adenocarcinoma that receive palliative chemotherapy.

Detailed description: Patients will be randomly classified into two groups - verum and placebo. The patients in the experimental arm will receive capsules with broccoli sprout grain containing a total of 90mg sulforaphane active substance per day over one year as nutrition supplement whereas patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution.

Eligibility criteria: Inclusion Criteria:

* Advanced, surgically non-treatable pancreatic ductal adenocarcinoma (surgical exploration, intraoperative biopsy but also palliative bypass interventions (bileodigestive anastomosis and/or gastroenterostomy because of preoperative cholestasis or impaired gastric emptying due to tumor-mass effect)
* Intact gastric emptying
* Written informed consent
* Patients ≥18 years of age
* Palliative chemotherapy

Exclusion Criteria:

* Intolerance to broccoli or its ingredients
* Impaired mental status or language problems / barriers

Primary outcomes:
measure: Feasibility of a randomized controlled trial
timeFrame: One year
Secondary outcomes:
measure: Disease status (imaging and tumor markers)
timeFrame: One year
Other outcomes:
measure: Substance bioavailability
timeFrame: One year
Locations:
city: Heidelberg
country: Germany
facility: Dept. of General and Transplant Surgery, University Hospital of Heidelberg, Germany
Study officials:
affiliation: Heidelberg University
name: Peter Schemmer, Prof. Dr. med.
role: STUDY_DIRECTOR
affiliation: Heidelberg University
name: Ingrid Herr, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lozanovski VJ, Houben P, Hinz U, Hackert T, Herr I, Schemmer P. Pilot study evaluating broccoli sprouts in advanced pancreatic cancer (POUDER trial) - study protocol for a randomized controlled trial. Trials. 2014 Jun 3;15:204. doi: 10.1186/1745-6215-15-204.
Clinical trial NCT02278978: BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma
Official title: A Phase II Trial of BIBF1120 in Patients With Advanced FGFR3 Mutated, FGFR3 Overexpressed, or FGFR3 Wild Type Urothelial Carcinoma of Urinary Bladder, Urethra, Ureter, and Renal Pelvis and Who Have Failed Platinum-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Urothelial Carcinoma
Keywords: urothelial carcinoma
BIBF1120
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 129
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BIBF1120 in patients with advanced FGFR3 mutated, FGFR3 overexpressed, or FGFR3 wild type urothelial carcinoma of urinary bladder, urethra, ureter, and renal pelvis and who have failed platinum-based chemotherapy.


Eligibility criteria: Inclusion Criteria:

* KPS 60%
* Histological confirmation of urothelial carcinoma , with metastatic disease
* Measurable disease
* Previously treated with platinum-based chemotherapy administered

Exclusion Criteria:

* Radiographic evidence of cavitary or necrotic tumours
* Active brain metastasis.Leptomeningeal metastasis
* Chemotherapy, radiotherapy, targeted therapy with monoclonal antibodies or small tyrosine kinase inhibitors
* Grade 1 treatment-related toxicity from previous chemotherapy, radiotherapy, or targeted therapy
* Prior treatment with BIBF 1120 or other VEGFR inhibitors
* Significant cardiovascular diseases:
* Pericardial effusion
* Significant bleeding or thrombosis
* Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
* Major injuries within the past 10 days with incomplete wound healing and/or planned surgery during the on-treatment study period

Primary outcomes:
measure: Response rate assessed by RECEST version 1.1
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chia-Chi Lin
Study officials:
affiliation: National Taiwan University Hospital
name: Chia-Chi Lin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152178: The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)
Official title: The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 680
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after surgery. To evaluate the safety, data on adverse events will be collected during treatment. Patients'quality of life will be assessed by means of a questionnaire.


Eligibility criteria: Inclusion Criteria:

* Age 20 to 65
* Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3 Hemoglobin ≥ 11.0 g/dL
* Hepatic AST and ALT ≤ 40 U/L Total bilirubin ≤ 1.5 mg/dL
* Renal BUN ≤ 25 mg/dL Creatinine ≤ 1.5 mg/dL

Primary outcomes:
measure: Relapse-free survival
timeFrame: recurrence and survival will be collected for 5 years after surgery
Secondary outcomes:
measure: Overall survival, adverse events, and the quality of life
timeFrame: adverse events will be collected during treatment
Other outcomes:
Locations:
city: 1-1-3, Nakamichi, Higashinari-ku, Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka
Study officials:
affiliation: Osaka Medical Center for Cancer and Cardiovascular Diseases
name: Hiroki Koyama, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park Y, Okamura K, Mitsuyama S, Saito T, Koh J, Kyono S, Higaki K, Ogita M, Asaga T, Inaji H, Komichi H, Kohno N, Yamazaki K, Tanaka F, Ito T, Nishikawa H, Osaki A, Koyama H, Suzuki T. Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluorouracil, and tamoxifen in post-operative adjuvant therapy for stage I, II, or IIIA lymph node-positive breast cancer: a comparative study. Br J Cancer. 2009 Aug 18;101(4):598-604. doi: 10.1038/sj.bjc.6605218. Epub 2009 Jul 28.
Clinical trial NCT05575778: Peri-operative Foot CT Perfusion in CLI Patients
Official title: The Clinical Value of Quantitative Analysis of Peri-operative Foot Supply Through CT Perfusion in Patients With Critical Limb Ischemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Critical Limb Ischemia
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with critical limb ischemia, who completed both pre- and post-operative CTP workups

Brief summary: To investigate the clinical value of quantitative analysis of peri-operative foot supply through CT perfusion in patients with critical limb ischemia


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old;
* CLI patients with Fontaine grade III-IV or Rutherford grade 4-6 and underwent a successful revascularization;
* Patients completed both pre- and post-operative CTP workups;
* Patients signed the informed consent form and be able to complete the clinical follow-up for 12 months.

Exclusion Criteria:

* Patients has participated in other clinical studies;
* Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate\<60 ml/min)
* Any allergic constitution;
* Pregnancy and childbirth;
* Life expectancy\<12 months.

Primary outcomes:
measure: Pre-operative computed tomographic perfusion parameters
timeFrame: 18months
measure: Post-operative computed tomographic perfusion parameters
timeFrame: 18months
measure: Alteration of computed tomographic perfusion parameters
timeFrame: 18months
Secondary outcomes:
measure: Major adverse limb events
timeFrame: 12months
measure: Major adverse cardiovascular events
timeFrame: 12months
Other outcomes:
measure: All-cause deah
timeFrame: 12months
Locations:
city: Shanghai
country: China
facility: Hua Dong Hospital Affiliated to Fu Dan University
Study officials:
affiliation: Huadong Hospital affiliated to Fudan University, Shanghai, China, 200040
name: Wan Zhang, PH.D.
role: PRINCIPAL_INVESTIGATOR
References: