louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04177459: Rehabilitation of Adolescents Living With Chronic Fatigue
Official title: Rehabilitation of Adolescents Living With Chronic Fatigue. Health and Quality of Life During the Disease, and How to Remain in School and Spare-time Activities. Testing of a Structured Home-based Rehabilitation Program.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fatigue Syndrome, Chronic
Keywords: Adolescent
Fatigue
Rehabilitation
Health Promotion
Health-related Quality of Life
Sense of Coherence
Emotions
Mood
Leisure Activities
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Trondheim Kommune
First posted: 2019-11-26
Enrollment: 3
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous studies have shown that health-related quality of life (HRQoL) in adolescents living with chronic fatigue syndrome (CFS/ME) is low if compared with healthy adolescents and adolescents living with other chronic diseases. Effective strategies to improve HRQoL in this group are still lacking. Recently we have observed HRQoL in a group of Norwegian adolescents with CFS/ME (not yet published), which is the background for a new study where we have planned an intervention with health promoting dialogues between patient and nurse, as a strategy to improve HRQoL. In this study we have also opened to include adolescents with other chronic fatigue diagnosis with similar challenges in follow-up as in CFS/ME.


Eligibility criteria: Inclusion Criteria:

* chronic fatigue as main symptom (including but not limited to diagnostic codes ICD-10 G93.3 CFS/ME, F48.0 Neurasthenia, R53 Fatigue)
* having undergone an interdisciplinary diagnostic evaluation at The Children's Clinic or at The Fatigue and CFS/ME Outpatient Clinic, St. Olavs hospital during the period 1.8.2019 - 1.4.2020.
* being a pupil or wishing to be a pupil.

Exclusion Criteria:

* not Norwegian speaking
* for any reason unable to read and answer a questionnaire
* for any reason unable to take part in the health promoting dialogues

Primary outcomes:
measure: Health-related quality of life (HRQoL)
timeFrame: 1 year
Secondary outcomes:
measure: Fatigue Questionnaire
timeFrame: 1 year
measure: Mood and Feelings Questionnaire
timeFrame: 1 year
measure: Self-reported follow-up, School functioning and participation in Leisure activities
timeFrame: 1 year
measure: EQ-5D-5L
timeFrame: 1 year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Barne og ungdomsklinikken (Children's Clinic)
Study officials:
affiliation: St. Olavs Hospital
name: Elisabeth Selvaag, md phd
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology
name: Torstein Baade Rø, md phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03278600: Tissue-of-origin Directing Therapy in Patients With Cancer of Unknown Primary
Official title: The Value of Tissue-of-origin (ORIGIN-PanCA○R) Profiling in Predicting Primary Site and Directing Therapy in Patients With Cancer of Unknown Primary: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer of Unknown Primary Site
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tissue-of-origin test
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the value of tissue-of-origin (ORIGIN-PanCA○R) profiling in predicting primary site and directing therapy in patients with cancer of unknown primary.


Eligibility criteria: Inclusion Criteria:

* had a diagnosis of cancer of unknown primary (CUP) after a standard evaluation (medical history, physical examination, blood counts, chemistry profile, chest/abdomen computed tomography scans, positron emission tomography scan, and directed evaluation of all symptomatic areas). Patients were required to have one of the following histologies: adenocarcinoma, poorly differentiated neoplasms, poorly differentiated carcinoma, squamous carcinoma. Sufficient archived biopsy tissue from a surgical or core needle biopsy was required to perform the molecular profiling assay. Eastern Cooperative Oncology Group performance status of 0 to 2; no previous systemic therapy; measurable or evaluable disease (RECIST); and adequate organ function.

Exclusion Criteria:

* carcinoma limited to single site which can be potentially cured by surgery of radiotherapy.patients with symptomatic brain metastases, active clinical severe infection

Primary outcomes:
measure: progression free survival
timeFrame: 6 months
Secondary outcomes:
measure: overall response rate
timeFrame: 2 months
measure: overall survival
timeFrame: 12 months
measure: Adverse Events
timeFrame: 2 months
measure: biomarker analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
References:
Clinical trial NCT05665400: A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring
Official title: A Cross-sectional, Interventional, Exploratory Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Monitoring
Lead sponsor: Bloom Technologies
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Bloomlife Lovelace FT is a non-invasive, wireless, external measurement system used to measure accelerometer and electrophysiological signals on pregnant women with a singleton pregnancy, by acquiring biopotential signals from abdominal surface electrodes.

In this study, Bloomlife Lovelace FT is used to collect the dataset needed for the development of a future product (Bloomlife Lovelace) for the monitoring of fetal heart rate, maternal heart rate and uterine activity.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman ≥ 18 years old
* Gestational age greater or equal to 24 weeks and 0 days
* Singleton pregnancy
* Ability to read and understand Dutch
* Willingness to participate in the study

Exclusion Criteria:

* Implanted pacemaker or any other implanted electrical device
* History of allergies to skin adhesives
* Irritated or lesioned skin at the Bloomlife Lovelace FT electrodes locations
* Contraindication to the use of CTG based on physician's decision (e.g. due to preterm contractions)

Primary outcomes:
measure: Extent of agreement between Bloomlife Lovelace FT and CTG in fetal heart rate
timeFrame: 1 hour
measure: Extent of agreement between Bloomlife Lovelace FT and CTG in maternal heart rate
timeFrame: 1 hour
measure: Performance metrics of Contraction Detection with Bloomlife Lovelace FT
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Caroline Van Holsbeke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03079700: Immune Modulation From Trichuris Suis
Official title: Mucosal and Systemic Immune Modulation From Trichuris Suis in a Self-infected Individual
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Ulcerative Colitis
Intestinal Helminthiasis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A single healthy volunteer

Brief summary: Mucosal immunology during helminth infection

Detailed description: The present study investigates the effects of Trichuris suis on human mucosal and systemic immunity in a single self-infected individual.

Eligibility criteria: Inclusion Criteria:

* The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his inclusion in the study was that he was healthy.

Exclusion Criteria:

-

Primary outcomes:
measure: Faecal egg excretion
timeFrame: 15 weeks
Secondary outcomes:
measure: Mucosal T cell associated cytokines
timeFrame: 15 weeks
measure: Systemic immune parameters (eosinophilia, Subtypes of circulating T cells)
timeFrame: 15 weeks
measure: Adverse events
timeFrame: 15 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05332600: Pre and Post Muscular Fatigue - DROP-JUMP TEST
Official title: Assessment Protocol on Lower Limbs Aligment Pre and Post Muscular Fatigue During DROP-JUMP TEST
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Control
Keywords: rehabilitation
lower limb-muscle
alignment, sequence
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Many studies have related the presence of dynamic valgus with several musculoskeletal injuries of the hip, knee and ankle. The weakness of the hip abductors is cited as one of the factors linked to this poor dynamic alignment of the lower limb, however, motor control can also be one of the factors responsible for the poor alignment of the lower limbs.


Eligibility criteria: Inclusion Criteria:

Women aged between 18 and 29 years body mass index between 18.5 and 24.99 sedentary irregularly active no pain no injuries (hip, knee, foot, ankle or lumbar spine) no neurological sequelae

Exclusion Criteria:

pain during the test

Primary outcomes:
measure: lower limb motor control
timeFrame: assessment pre fatigue
measure: lower limb motor control
timeFrame: assessment pos fatigue up to 01 week
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: ISCMSP
Study officials:
References:
Clinical trial NCT00267800: Database of Interstitial Lung Diseases
Official title: Registration of Clinical Data and DNA/Serum of Patients With Interstitial Lung Diseases (ILD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Diseases
Keywords: Lung disease, Interstitial
Sarcoidosis
Pulmonary fibrosis
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2005-12-21
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The cause of most interstitial lung diseases (ILDs) is still unknown. Further research, for example to determine predisposing genetic factors, is therefore needed. A database with relevant clinical data and DNA/serum samples of ILD patients could facilitate future research on the cause of ILDs.

Detailed description: Protocol title: 'Registration of clinical data and DNA of patients with Interstitial Lung Disease (ILD)' Rationale: The etiopathogenesis of most Interstitial Lung Diseases (ILDs) is still unknown. Further research, e.g. to determine predisposing genetic factors, is therefore needed. A database with relevant clinical data and DNA/serum samples of ILD patients could facilitate future research on the etiopathogenesis of ILDs.

Objective: Availability of relevant clinical data and DNA/serum samples of ILD patients in a database. Those data can be used for future research.

Study design: A prospective observational study

Study population: Patients diagnosed with ILD attending the pulmonology department in participating hospitals.

Intervention: a blood sample is taken from each patient. Furthermore, additional information is collected from the medical file.

Main study parameters/endpoints: DNA and serum sample, demographic variables, medical information, occupational history and hobbies.

Nature and extent of the burden and risks associated with participation, group relatedness: two tubes of blood will be drawn from the patients. The risks of drawing blood from a vein are minimal.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of an ILD, as stated by the American Thoracic Society (ATS)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: Mesos Medisch Centrum
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: J.M.M. van den Bosch, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: J.C. Grutters, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jessurun NT, Drent M, Wijnen PA, Harmsze AM, van Puijenbroek EP, Bekers O, Bast A. Role of Drug-Gene Interactions and Pharmacogenetics in Simvastatin-Associated Pulmonary Toxicity. Drug Saf. 2021 Nov;44(11):1179-1191. doi: 10.1007/s40264-021-01105-8. Epub 2021 Oct 4.
Clinical trial NCT01272700: The Effect of Pressure Controlled Ventilation on the Pulmonary Mechanics in Prone Position Using the Wilson Frame: A Comparison With Volume Controlled Ventilation
Official title: The Effect of Pressure Controlled Ventilation on the Pulmonary Mechanics in Prone Position Using the Wilson Frame: A Comparison With Volume Controlled Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herniation of Lumbar Vertebral Disc
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prone position in spinal surgery can increase airway pressure and decrease dynamic lung compliance by a frame used for postural stabilization. Also, it can increase hemodynamic instability such as reduced blood pressure by aggravating cardiac index.

Former study shows pressure controlled ventilation on the pulmonary mechanics can improve alveolar use and oxygenation than volume controlled ventilation. The latter one means controlling a patient's breathing completely through tidal volume and set breathing rate. This could be useful for the patients not possible to breath by themselves because it guarantees the perfect breathing.

The pressure controlled ventilation is used when there is a possibility to change a patient's environment. The pressure will be maintained steadily, but volume and flux will be changed. That means through the pressure already set, the whole breathing will be maintained from the beginning to end. If a patient's resistance is increased, the volume will be decreased even though the way of blood pressure control is same. However, the tidal volume per minute can be controlled somewhat and barotrauma can be decreased by controlling respiratory rate. Through this study, we are expecting the pressure controlled ventilation in prone position can improve lung mechanics and oxygenation.


Eligibility criteria: Inclusion Criteria:

* scheduled for lumbar spine surgery under general anaesthesia

Exclusion Criteria:

* Patients with coronary artery occlusive disease
* morbid obesity (body mass index ≥ 30 kg/m2)
* cerebrovascular disease and major obstructive or restrictive pulmonary disease

Primary outcomes:
measure: peak airway pressure
timeFrame: 30 minutes after prone position
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT03459300: Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia (Actisom dépistage)
Official title: Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia in Reference Centers Rare Hypersomnia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypersomnia
Keywords: actimetry
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with a sleepiness evoking a primary hypersomnia

Brief summary: 7 to 14 days actimetry recording in order to exclude sleep deprivation just before hospitalisation for differential diagnosis of hypersomnia

Detailed description: This is an observational study

Urine drug screening will also be performe

The suty includes four centers in France

The study duration is of one year

Eligibility criteria: Inclusion Criteria:

* Men or women aged \> 18 years
* Patient with a sleepiness evoking a primary hypersomnia
* Epworth sleepiness scale \> 10
* Information note signed

Exclusion Criteria:

* Patient with type 1 or 2 narcolepsy and/or known hypersomnia
* Frank cataplexy
* Not stable metabolic, neurological or psychiatric disease
* Patient treated by a medicine acting on the central nervous system
* Patient having a shift work or having made a transmeridian flight of more than 3 hours lag in the previous month the research
* Non affiliation to social security
* Pregnancy
* Patient under guardianship or curatorship

Primary outcomes:
measure: mean total sleep time
timeFrame: 7-14 days before hospitalisation
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital raymond Poincaré
state: Ile De France
Study officials:
affiliation: APHP
name: Maria Antonia QUERA SALVA, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01606800: Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)
Official title: Randomized Open Label Study to Assess the Efficacy and Safety of Short Course Therapy (24 Weeks) With Peginterferon Alpha-2b and Ribavirin for Chronic Hepatitis C (Genotype 4) Patients Who Achieve a Rapid Virological Response (HCV -RNA Undetectable at Week 4 of Treatment)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-05-28
Enrollment: 45
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 assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.

Detailed description: Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.

Eligibility criteria: Inclusion Criteria:

* Participant is ≥40 kg and ≤120 kg weight
* Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
* Previously documented CHC genotype 4 infection
* Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).

Exclusion Criteria:

* Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
* Treatment for hepatitis C with any investigational medication
* Treatment with any investigational drug within 30 days of the screening visit
* Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
* Autoimmune hepatitis or a history of autoimmune disease
* Hepatic fibrosis score F4
* Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
* Autoimmune hepatitis or a history of autoimmune disease
* Thyroid disease uncontrolled with conventional treatment
* Epilepsy and/or compromised central nervous system (CNS) function

Primary outcomes:
measure: Number of Participants Achieving Sustained Virologic Response (SVR)
timeFrame: At 24 weeks after the completion of therapy (up to 72 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04802200: Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery
Official title: Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Artery Injury
Aortic Valve Insufficiency
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject adult voluntarily agreeing to participate in the study operated between December 16, 2019 and june 30, 2021 from minimally invasive cardiac surgery with femoral cannulation for cardiopulmonary bypass in Dijon University Hospital, in whom the MANTA device has been used for femoral artery closure

Brief summary: The percutaneous MANTA Vascular Closure Device is dedicated to the closure of large bore arteriotomies. It appears to be a safe and doable option for vascular access closure in patients undergoing transfemoral Transcatheter Aortic Valve Implantation. Data concerning safety and efficacy of MANTA Vascular Closure Device in Minimally Invasive Cardiac Surgery are scarce. This study aim to assess this novel collagen-based technology in minimal invasive aortic valve replacement surgery.


Eligibility criteria: Inclusion Criteria:

* Subject voluntarily agreeing to participate in the study
* Subject \>= 18 years of age
* Patients operated between december 16, 2019 and june 30, 2021 from minimally invasive cardiac surgery with femoral cannulation for cardiopulmonary bypass in Dijon University Hospital
* Patients in whom the MANTA device has been used for femoral artery closure

Exclusion Criteria:

Not applicable

Primary outcomes:
measure: Occurence of major access site vascular complications
timeFrame: 30 days
measure: Hemostasis success
timeFrame: 10 min
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: