louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01850173: Whole Body Vibration in Chronic Obstructive Pulmonary Disease
Official title: Effects of Whole Body Vibration Training in Severe Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 60
Sex: MALE
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators designed the current study with the main objective of determining whether Whole Body Vibration Training (WBVT) alone improves muscular force and/or modifies the functional capacity parameters in severe Chronic Obstructive Pulmonary Disease (COPD) patients referred to a rehabilitation programme.


Eligibility criteria: Inclusion Criteria:

* severe COPD defined as a post-bronchodilator forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) \< 0.7 and FEV1 \< 50% predicted,
* stable disease defined as no exacerbation,
* hospital admission or change in treatment in the previous 3 months.

Exclusion Criteria:

* other significant respiratory disease (bronchiectasis,
* lung fibrosis, asthma, etc),
* active smoking,
* severe cardiovascular,
* neurological, and/or metabolic pathology that could interfere with the results,
* total hip, knee or ankle arthroplasty,
* previous vitreous haemorrhage,
* severe alcoholism (\> 80 g/day) and
* severe malnutrition (BMI \< 19 Kg/m2) to reduce the risk of falling and dropouts.

Primary outcomes:
measure: isokinetic knee flexor and extensor testing muscular force
timeFrame: basal, 3 months follow up
measure: distance performed in the six minutes walking test (6MWT)
timeFrame: Basal, 3 months follow up
Secondary outcomes:
measure: respiratory muscular strength was assessed with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
timeFrame: Basal, 3 month follow up
Other outcomes:
measure: Complications
timeFrame: 3 months follow up
Locations:
city: Mataró
country: Spain
facility: Eulogio Pleguezuelos
state: Barcelona
Study officials:
affiliation: Hospital de Mataró
name: Eulogio Pleguezuelos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05256173: Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy
Official title: Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy，Cognition
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epilepsy is one of the common chronic diseases of the central nervous system. 30% to 40% of patients with epilepsy have varying degrees of cognitive impairment, which affects their quality of life. At present, the treatment of cognitive impairment in patients with epilepsy is relatively scarce, and the therapeutic effect is still not ideal. Recent studies have shown that sleep disorder is also an important factor causing cognitive dysfunction, and improving sleep quality has a prospect to become a new way to treat cognitive impairment in patients with epilepsy. The purpose of this study is to observe the relationship between sleep and cognitive function in patients with epilepsy, and to improve the sleep quality of patients with epilepsy, so as to provide new ideas for improving cognitive impairment in patients with epilepsy.


Eligibility criteria: Inclusion Criteria:

* 1. In accordance with the diagnostic criteria of epilepsy; 2. History of epilepsy ≥ 1 year; 3. Epilepsy with cognitive impairment; 4. Age 7-65 years old; 5. There was no change in the type and dose of antiepileptic drugs during the experiment; 6. Patients and their families were aware of this study and signed an informed consent form.

Exclusion Criteria:

* 1. Status epilepticus; 2. Complicated with severe infection, cerebrovascular diseases, malignant tumors, other nervous system diseases, and systemic diseases that can involve the nervous system (such as immune diseases, etc.), serious dysfunction of heart, liver, kidney and other organs; 3. Non-epileptic seizures such as syncope and hysteria; 4. Women during lactation or pregnancy; 5. Combined use of sleeping and sedative drugs; 6. There are contraindications of melatonin and percutaneous vagal nerve stimulation (tVNS).

Primary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: Week 4
Secondary outcomes:
measure: Rey complex figure test
timeFrame: Week 4
measure: Rey auditory verbal learning test
timeFrame: Week 4
measure: Boston naming test
timeFrame: Week 4
measure: Quality of life questionnaire in epilepsy inventory
timeFrame: Week 4
measure: Wechsler Memory Scale
timeFrame: Week 4
measure: Pittsburgh sleep quality index
timeFrame: Week 4
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital,the Air Force Medical University
state: Shaanxi
Study officials:
References:
Clinical trial NCT03778073: Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma
Official title: A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: B-cell Non Hodgkin Lymphoma
Richter's Transformation
Keywords: relapsed or refractory
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 18
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: Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory B-cell Non Hodgkin's Lymphoma.

Detailed description: This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.

Eligibility criteria: Key Inclusion Criteria:

* Histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
* Measurable disease and adequate organ function as specified in the protocol

Key Exclusion Criteria:

* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or prior therapy with bendamustine.
* Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1 Day 1.
* Prior autologous stem cell transplant within 3 months
* Active Hepatitis B or Hepatitis C

Primary outcomes:
measure: Adverse Events That Are Related to Treatment
timeFrame: 6 months of therapy
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Alabama
city: Tucson
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arizona
city: Fayetteville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arkansas
city: Peoria
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Fort Wayne
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Indiana
city: Fairway
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kansas
city: Louisville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kentucky
city: Charlotte
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Seattle
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
Study officials:
References:
Clinical trial NCT01285973: Evaluation of Integra® Artificial Dermis for the Treatment of Leg Ulcers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Limb Ulcer
Lead sponsor: Integra LifeSciences Services
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be patients with "difficult" lower limb ulcers, whose wounds have not responded to directed healing for more than 6 months or who have a wound \> 10 cm².

Brief summary: The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound.

This is a multi-centre study on 60 patients who have a lower limb ulcer.


Eligibility criteria: Inclusion Criteria:

* patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (\> 10 cm²)
* patients in whom the surgeon has recommended that an Integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis.
* not eligible for skin flap surgery,
* the patient or patient's representative has agreed to sign the information letter before any investigation required by the research.

Exclusion Criteria:

* circumferential wound,
* wound infection
* immunosuppressed patient,
* known allergy to bovine collagen, bovine glycosaminoglycans or silicone,
* patients under legal guardianship,
* pregnant women
* patients whose health would compromise follow-up for at least 18 months,
* patients whose mental health would compromise completion of the self-evaluation questionnaires.
* wound located in an area not visible by the patient (as no self-assessment would be possible).

Primary outcomes:
measure: Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting.
timeFrame: 18 months
Secondary outcomes:
measure: Functional complications of healing at 3, 6, 12 and 18 months
timeFrame: 3, 6, 12 and 18 months
measure: Complete wound healing (reduction in wound surface area >90%)
timeFrame: 3, 6, 12, 18 months
measure: Pain
timeFrame: 3, 6, 12, 18 months
measure: Quality of life
timeFrame: 3, 6, 12, 18 months
measure: Transcutnaeous oxygen pressure (TcPO2)
timeFrame: 6, 12 and 18 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital,
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki - Papageorgiou General Hospital
city: Messina
country: Italy
facility: Policlinico Universitario "G. Martino"
Study officials:
References:
Clinical trial NCT02361073: The Role of Emotional Stress in Patients With Stress-induced Cardiomyopathy
Official title: Event-related Potentials in Patients With Takotsubo Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Takotsubo Cardiomyopathy
Keywords: Stress-induced cardiomyopathy
ERP
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Takotsubo Cardiomyopathy compared with healthy subjects and patients with ACS.

Brief summary: The event-related potentials may be different in patients with Takotsubo cardiomyopathy than in patients without Takotsubo.

Detailed description: In patients with Takotsubo diagnosed by coronary angiography, the event-related potentials are investigated and compared with a control group, which consists of subjects without Takotsubo.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Written informed consent
* Takotsubo cardiomyopathy for group 1. ACS for group 3.

Exclusion Criteria:

* Psychiatric diseases
* Impaired versus, non compliant patients, heart disease for group 2.
* Takotsubo-like syndrome.

Primary outcomes:
measure: Event-related potentials
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: University Hospital Magdeburg
Study officials:
References:
Clinical trial NCT04378673: The Effect of Parental Presence on Pain and Anxiety Levels During Peripheral Intravenous Catheterization in Infants
Official title: Pediatric Nursing in Bagcilar Training and Research Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Family Centered Care
Keywords: family centered care
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants and their parents were randomly sampled from the universe using a simple random sampling method, peripheral intravenous catheterization, volunteering to participate in the study, infants and parents between 1 and 24 months.

Brief summary: Children's changing emotional and physical needs, continuous, comprehensive, accessible, coordinated and family requires a centered care.Parental presence during invasive procedures is important in family-centered-care. Family-centered-care is a basic principle of pediatric nursing. It is extremely important that parents are with their children during painful procedures. Research; parents during peripheral intravenous catheterization in infancy It was planned to determine the effect of inclusion on pain and anxiety.

Detailed description: This randomized controlled trial included data from 120 cases in the Pediatric Health and Diseases Department of Istanbul, during March 2020-August 2020 (parental involvement group, n = 46; parental presence group, n = 42; parental absence group, n = 32). Information form, State-Trait Anxiety Inventory and FLACC scale were used to collect data.

Eligibility criteria: Inclusion Criteria:

* Children within the age group of 1-24 months Parents know Turkish language

Exclusion Criteria:

-

Primary outcomes:
measure: hypothesis 0
timeFrame: March 2020-August 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Training And Research Hospital
Study officials:
affiliation: Bagcilar Training and Research Hospital
name: Nilüfer Demir, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05734573: The Effectiveness of Eating Disorder Treatment
Official title: Effects of Family-based Treatment on Adolescent Outpatients Treated for Anorexia Nervosa in the Eating Disorder Unit of Helsinki University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 52
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Family-based treatment (FBT), a form of family therapy for eating disorders (ED) in young patients, has proven to be effective in numerous large-scale studies. This study aims to evaluate outcomes of the treatment for anorexia nervosa (AN) in a 'real-world' setting in a specialized outpatient clinic in Helsinki, Finland. Fifty-two young female patients seen for treatment between June 2013 and December 2017 were included in the study. Demographic and treatment characteristics, weight, and ED symptoms before and after treatment are reported

Detailed description: Aim: The naturalistic outcome of outpatient FBT for adolescent AN was investigated.

Methods: Fifty-two female patients and their families who received FBT at a tertiary eating disorders unit participated in the study. Data on their pre-treatment parameters, treatment details, and condition at the end of treatment (EOT) was collected from their medical records

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Anorexia nervosa
* Admitted to FBT at the Eating Disorder Unit from June 1, 2013, through December 31, 2017

Exclusion Criteria:

* No exclusions

Primary outcomes:
measure: % of patients with body weight normalization in treatment
timeFrame: Treatment period, aprox. 1 year
measure: % of patients with eating disorder symptoms at the end of treatment
timeFrame: Treatment period, aprox. 1 year
measure: % of patients in need for a further treatment after the intervention
timeFrame: Treatment period, aprox. 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Jaana Suokas, Dos
role: STUDY_DIRECTOR
References:
citation: Jones M, Volker U, Lock J, Taylor CB, Jacobi C. Family-based early intervention for anorexia nervosa. Eur Eat Disord Rev. 2012 May;20(3):e137-43. doi: 10.1002/erv.2167. Epub 2012 Mar 22.
citation: Lock J. Family therapy for eating disorders in youth: current confusions, advances, and new directions. Curr Opin Psychiatry. 2018 Nov;31(6):431-435. doi: 10.1097/YCO.0000000000000451.
citation: Lock J, Le Grange D. Family-based treatment: Where are we and where should we be going to improve recovery in child and adolescent eating disorders. Int J Eat Disord. 2019 Apr;52(4):481-487. doi: 10.1002/eat.22980. Epub 2018 Dec 6.
Clinical trial NCT02795273: Efficacy and Safety of Grass-SPIRE Registration Study
Official title: A Combined Phase 2b/3, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study to Assess the Efficacy and Safety of Grass-SPIRE in Subjects With Grass Pollen-Induced Allergic Rhinitis, With or Without Conjunctivitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Rhinitis
Conjunctivitis
Keywords: Rhinitis
Conjunctivitis
Grass
Allergy
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
First posted: 2016-06-10
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
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 safety of Grass-SPIRE compared with placebo and to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication during the grass pollen season


Eligibility criteria: Inclusion Criteria:

* Clinical history of grass pollen-induced allergic rhinitis with or without conjunctivitis for at least 2 years
* Score of ≤ 21 on RCAT questionnaire
* Rye grass specific IgE of ≥ 0.7 kU/L
* Positive skin prick test to Rye grass whole allergen extract

Exclusion Criteria:

* History or findings of significant disease
* Asthma requiring GINA Step 3 or higher treatment
* History of severe drug allergy, severe angioedema or systemic allergic reaction
* Course of short-duration allergy-specific immunotherapy or more than 3 months treatment with long-duration allergen immunotherapy within 5 years
* Contraindications for administration of epinephrine

Primary outcomes:
measure: Combined Score of symptoms and allergy medication
timeFrame: Approximately 66 weeks
measure: Safety of Grass-SPIRE
timeFrame: Approximately 66 weeks
Secondary outcomes:
measure: Symptom Scores
timeFrame: Approximately 66 weeks
measure: Rescue Medication Use
timeFrame: Approximately 66 weeks
measure: Quality of Life
timeFrame: Approximately 66 weeks
Other outcomes:
Locations:
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: David Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02843373: Brain-Based Biomarkers in Response to TMS in MDD
Official title: Longitudinal, Prospective Study to Examine the Brain-based Biomarkers of Response to Transcranial Magnetic Stimulation Treatment in Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Depression
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community care clinic

Brief summary: The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. By using concurrent TMS and EEG, the investigators can overcome a major limitation of EEG - the inability to demonstrate causality. Here, we plan to recruit patients with medication-resistant depression undergoing rTMS treatment. At multiple time points, we will perform TMS-EEG to investigate the excitability and connectivity profiles of brain networks and how they are modulated during treatment. This study aims to provide objective brain network measures that can predict and track clinical response to TMS treatment. Findings from this study will be utilized to develop a novel, personalized treatment protocol based on individual brain networks.

Detailed description: Goals of the study are as follows:

* To evaluate the ability to predict and track brain network changes during TMS treatment for medication-resistant depression.
* To develop quantitative tools that measure the connectivity and excitability of the brain using resting and single pulse TMS-EEG.
* To determine the feasibility of recording EEG biomarkers in the clinic without disrupting clinical care.

Eligibility criteria: Inclusion Criteria:

* Men and women, ages 18 to 60
* Medication-resistant depression as assessed by psychiatrist
* Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
* Has failed \>1 previous adequate antidepressant medication trials
* Right-handed
* No current or history of neurological disorders
* No seizure disorder or risk of seizures
* No use of PRN medication within 48 hours of the scheduled study appointment

Exclusion Criteria:

* Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc
* Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
* Currently pregnant or breastfeeding

Primary outcomes:
measure: TMS-EEG
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Corey Keller, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: