louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04903457: The Effect of tDCS on Motor Learning and Neural Network in Stroke Patients
Official title: Investigation of Compensational Mechanism and Effect of Transcranial Direct Stimulation on Motor Learning Through Neural Network Analysis in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation on motor learning to stroke patients compared to sham stimulation


Eligibility criteria: Inclusion Criteria:

* Unilateral stroke including basal ganglia lesion patients
* Chronic patients over 6 months after onset
* Patients with the movement of fingers

Exclusion Criteria:

* History of psychiatric disease
* Significant other neurological diseases except for stroke
* Difficult to perform this experiment
* Patients who are deemed difficult to participate in this research by the investigator
* Patients with metal implants and medical devices
* History of epilepsy
* Pregnancy
* Skin defect at the site of electrode attachment

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: Baseline, immediately after five brain stimulation sessions
Secondary outcomes:
measure: Changes in cortical activity using fNIRS signals during brain stimulation
timeFrame: Baseline, during, immediately after five brain stimulation sessions
measure: Changes in motor evoked potential
timeFrame: Baseline, immediately after five brain stimulation sessions
measure: 9-hole pegboard test
timeFrame: Baseline, immediately after five brain stimulation sessions
measure: Grip & Tip pinch strength test
timeFrame: Baseline, immediately after five brain stimulation sessions
measure: Box & Block test
timeFrame: Baseline, immediately after five brain stimulation sessions
measure: Sequential Finger tapping test
timeFrame: Baseline, immediately after five brain stimulation sessions
measure: Jebsen-Taylor hand function test
timeFrame: Baseline, immediately after five brain stimulation sessions
Other outcomes:
measure: Resting-state functional MRI
timeFrame: Baseline (Before stimulation sessions)
measure: Changes in cortical activity using fNIRS signals.
timeFrame: Baseline (Before stimulation sessions)
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT06233357: Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
Official title: Course of Inflammation and Infection Markers in Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Outcome, Fatal
Tocilizumab
Interleukin 6
Critically Ill
Keywords: COVID-19
critically ill
ICU
casirivimab imdevimab
tocilizumab
interleukin 6
C-reactive protein
ferritin
procalcitonin
mortality
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In a retrospective observational study, critically ill COVID-19 patients admitted to the ICU with the CoV-2 delta-variant between august 2021 and february 2022 were evaluated. IgG seronegative SARSCoV2-Spike antibody (\< 0,80 U/ml) COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP \> 75 mg/l or IL-6 \> 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight.

Brief summary: In a retrospective observational study, critically ill COVID-19 patients admitted to the ICU with the CoV-2 delta-variant between august 2021 and february 2022 were evaluated (ethics application nr. 129/22 of the ethics commssion of the university Ulm.

Detailed description: According to the recommendations, IgG seronegative SARSCoV2-Spike antibody (\< 0,80 U/ml) COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP \> 75 mg/l or IL-6 \> 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight. 28-day mortality and 30-day time course of leukocyte counts and serum concentrations of C-reactive protein (CRP), procalcitonin (PCT), interleukin 6 (IL-6) and ferritin in 4 patient groups, i. e., treated without (N) or with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T), were evaluated.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COVID-19
* CoV-2 delta-variant
* critically ill patients
* ICU

Exclusion Criteria:

* tuberculosis
* active hepatitis
* HIV

Primary outcomes:
measure: Mortality rates in the 4 groups
timeFrame: 28-day mortality
Secondary outcomes:
measure: Leukocyte count in 4 groups
timeFrame: 30-days
measure: C-reactive protein in 4 groups
timeFrame: 30-days
measure: Interleukin 6 serum concentrations in 4 groups
timeFrame: 30-days
measure: Ferritin serum concentrations in 4 groups
timeFrame: 30-days
measure: Procalcitonin serum concentrations in 4 groups
timeFrame: 30-days
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Clinic of Anesthesiology
Study officials:
affiliation: University of Ulm
name: Manfred Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01749748: The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy
Official title: The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Diseases
Keywords: Breast diseases
magnetic resonance spectroscopy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 270
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To delineate if the chemical composition (lipid and water) in the presumably normal breast of the high risk women is different from those of the low risk group.

Detailed description: The researchers would like to investigate and compare the chemical composition in the normal breast between high risk women and general population.

Eligibility criteria: Inclusion Criteria:

* Women without breast symptoms (without family history of breast cancer; or with at least first-degree relative of breast cancer) with negative mammography and ultrasound result in recent 3 months or contralateral normal breasts from women with newly diagnosed unilateral breast cancer
* 25-75 years old.

Exclusion Criteria:

* renal function impairment
* past history of anaphylactoid reaction to MRI contrast media (Gd-DTPA)
* pregnant or lactating women
* medication of HRT or oral pills in recent 6 months
* past history of surgery of the breast (either side)
* past history of breast cancer
* with breast implant or silicone injection
* past history of cardiac surgery, mechanical valve replacement, aneurismal clip, endotracheal tube or tracheostomy tube, any metallic implants.

Primary outcomes:
measure: comparison of lipid water composition and ratio of the normal breasts in women of high risk group and low risk group.
timeFrame: up to 5 years ( July 2008 to June 2013)
Secondary outcomes:
measure: to investigate the association between breast density and lipid water ratio of normal breasts
timeFrame: up to 5 years (July 2008 to June 2013)
measure: to investigate the association between menopausal status and lipid water ratio of normal breasts
timeFrame: up to 5 years ( July 2008 to June 2013)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jane Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06732648: The Efficacy and Safety of HRS8179 in Severe Cerebral Edema Following Large Hemispheric Infarction
Official title: The Efficacy and Safety of Intravenous HRS8179 for the Prevention and Treatment of Severe Cerebral Edema Following Large Hemispheric Infarction: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II/III Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Severe Cerebral Edema Following Large Hemispheric Infarction
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-12-13
Enrollment: 725
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy, and safety of HRS8179 injection in preventing and treating severe cerebral edema after large area cerebral infarction in the cerebral hemisphere


Eligibility criteria: Inclusion Criteria:

1. Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative);
2. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
3. National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening;
4. A large hemispheric infarction defined as: lesion volume of 80 to 160 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP).
5. The time from onset to treatment must be ≤ 10 hours; if the onset time is unknown, treatment must be initiated within 10 hours after the time last known normal.

Exclusion Criteria:

1. Theparticipant is likely to withdraw the supportive treatment on the first day;
2. There is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.
3. There are clinical signs of brain herniation; CT/MRI indicates a midline shift of \>2 mm; CT/MRI indicates cerebral hemorrhage;

Primary outcomes:
measure: Mortality rate at Day 90
timeFrame: at Day 90
Secondary outcomes:
measure: The modified Rankin Scale (mRS) score at Day 90
timeFrame: at Day 90
measure: The proportion of participants who achieved mRS score 0-4 at Day 90
timeFrame: at Day 90
measure: Changes in midline shift from baseline to 72 hours
timeFrame: from baseline to 72 hours
measure: The proportion of participants who meet the indications for decompressive craniectomy by Day 14
timeFrame: Day 14
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT04599348: Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng
Official title: Treatment of CFS and Fibromyalgia With HRG 80 Red Ginseng
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Fibromyalgia
CFS
Keywords: Ginseng
Lead sponsor: Practitioners Alliance Network
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label study
Primary purpose: TREATMENT

Brief summary: Will a unique form of ginseng be clinically helpful in those with chronic fatigue syndrome and fibromyalgia?

Detailed description: Ginseng has been shown in earlier studies to help fatigue in a number of conditions. But because of overharvesting, most ginseng is no longer have optimal levels of the active ginsenosides. A new technique has been developed to restore the level of active ginseng components those found in the wild ginseng used in earlier studies. This is available in a form called HRG 80 Red Ginseng.

The study is an open pilot study to explore whether this treatment would be helpful for improving clinical function and symptomatology in chronic fatigue syndrome and fibromyalgia. Current clinical experience is suggesting that it may be.

Eligibility criteria: Inclusion Criteria:

1. be diagnosed with CFS and/or fibromyalgia
2. live in the United States 3 - be over 18 years of age

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Composite Visual analog scale of symptoms
timeFrame: 6 weeks
Secondary outcomes:
measure: VAS of pain and sleep
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kailua
country: United States
facility: Kona Research Center
state: Hawaii
Study officials:
affiliation: FFTF LLC
name: Jacob Teitelbaum
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03884348: Tailored H. Pylori Eradication Based on Clarithromycin Resistance
Official title: Helicobacter Pylori Eradication According to Sequencing-based 23S Ribosomal RNA Point Mutation Associated With Clarithromycin Resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Antibiotic Resistant Strain
Lead sponsor: Kangdong Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 431
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Helicobacter-pylori positive patients with gastritis, ulcer, adenoma

Brief summary: The investigators investigated the point mutations in the 23S rRNA genes of patients infected with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the identified clinically significant point mutations.

Detailed description: Sequencing-based detection of point mutations identified four mutations that were considered clinically significant (A2142G, A2142C, A2143G, A2143C), while all the other mutations were considered clinically insignificant.

Participants who did not have point mutations related to clarithromycin resistance and/or had clinically insignificant point mutations were treated with PAC (proton pump inhibitor, amoxicillin, clarithromycin) for 7 days, while participants with clinically significant point mutations were treated with PAM (proton pump inhibitor, amoxicillin, metronidazole) for 7 days. H. pylori eradication rates were compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Helicobacter pylori infection

Exclusion Criteria:

* H. pylori eradication therapy within 1 year,
* antibiotics within 4 weeks,
* surgery for gastric cancer
* malignant tumors other than gastric cancer
* end-stage renal disease
* liver cirrhosis,
* pregnancy

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kangdong Sacred Heart Hospital
name: Woon Geon Shin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02116348: Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy
Official title: Effect of Nerve Growth Factor (Cerebrolysin) Therapy on Neurodevelopment, Sleep Pattern and Quality of Life in Children With Traumatic Brain Injury and Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cerebral Palsy Children
Children With Traumatic Brain Injury
Mental Handicap
Delayed Speech Development
Keywords: Cerebral palsy children
Cerebrolysin
Sleep questionnaire
Quality of life
Bayley III scale
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is the most frequent cause of motor handicap among children. The economic burden of CP in USA includes $1.18 billion in direct medical costs, $1.05 billion in direct non-medical costs, and an additional $9.24 billion in indirect costs, for a total cost of $11.5 billion or $921,000 average cost per person. Associated disabilities as mental retardation, delayed speech development add psychological burden of the disease on the family as well as economic burden.

Mental retardation is the major problem in children with cerebral palsy. Improving mental development will have a positive effect on quality of life for the child and his family. Treating associated impairments (mental retardation) with Cerebrolysin will improve mental development and quality of life, and will decrease the economic burden in children with cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Cerebral palsy with mental retardation
* Severe perinatal brain insult

Exclusion Criteria:

1. Severe growth retardation
2. Gastrostomy tube feeding
3. Intractable seizures.
4. Severe motor handicap and deformities from long standing spasticity.
5. Congenital malformations.
6. Suspected inborn error of metabolism.
7. Suspected inherited neurologic disease.
8. Children with auditory and visual impairments.
9. Care giver's refusal to participate in the study.

Primary outcomes:
measure: neurodevelopment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
state: Abassia
Study officials:
affiliation: Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
name: Sahar M.A. Hassanein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01259648: Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects
Official title: Randomized Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tachycardia
Keywords: remifentanil
anesthesia induction
reactional tachycardia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine whether, during a rapid sequence intubation by etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2 different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous reactional tachycardia.


Eligibility criteria: Inclusion Criteria:

* Patients requiring rapid sequence intubation for whatever reason. This includes the following: a full stomach, obesity, diabetic gastroparesis, gastroesophageal reflux
* Patient able to give informed consent, and sign the consent.

Exclusion Criteria:

* Contraindication for the use of any drugs used (regardless of the patient group): a history of serious side effects, allergic reaction
* Morbid obesity (Body Mass Index \> 40)
* Emergency situation with unstable hemodynamics, and stabilization is impossible before induction
* Inclusion in another research project within the past 3 months
* The patient is not insured or beneficiary of a health insurance plan (for the French centers)
* Patient under guardianship of any kind
* Patient unable to give informed consent
* Refusal to sign the consent form

Primary outcomes:
measure: Cardiac frequency (beats per minute)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
city: Nîmes
country: France
facility: Polyclinique Grand Sud
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Arnaud Chaumeron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05021848: Partnered Multicomponent Exercise for Elderly in Long-term Care Facilities
Official title: Effects of a Partnered Multicomponent Exercise Program on Improving the Physical Function and Well-being of Elderly People in Long-term Care Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Long Term Care Facilities
Physical Function
Happiness
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 22
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to explore the effects of a partnered multicomponent exercise program on improving the physical function and sense of well-being of elderly people in Long-term Care Facilities (LTCFs).

Detailed description: This study is a single-blinded randomized controlled trial. Elderly residents were recruited from two LTCFs in Yilan county. The experimental group (N=14) received a 90-minute partnered multicomponent exercises intervention once weekly for 12 weeks. The control group (N=14) carried out the usual activities without intervention. The Barthel Index (BI), Short Physical Performance Battery (SPPB), De Morton Mobility Index(DEMMI), handgrip strength, and Chinese Happiness Inventory (CHI) were measured before and after the interventions.

Eligibility criteria: Inclusion Criteria:

* Over 60years old,living in the long term care facilities,after Physician agrees.No infectious diseases.

Exclusion Criteria:

1. Acute disease or unstable state (such as heart failure).
2. Severe musculoskeletal diseases (such as fractures, lower limb joint pain and deformation).
3. Cognitive impairment (MMSE\<20) .
4. At the end of life.

Primary outcomes:
measure: Change of activities of daily living function
timeFrame: before , after 12-weeks interventions
measure: Change of physical function
timeFrame: before , after 12-weeks interventions
measure: Change of mobility
timeFrame: before , after 12-weeks interventions
measure: Change of grip strength
timeFrame: before , after 12-weeks interventions
measure: Change of sense of well-being
timeFrame: before , after 12-weeks interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Chen-Yi Song
role: PRINCIPAL_INVESTIGATOR
References: