louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03050892: Impact of Donor and Recipient ST2 / IL-33 Pathway After Heart Transplantation
Official title: Impact of Donor and Recipient ST2 / IL-33 Pathway on Recipient Survival and Acute Rejection After Heart Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Transplant Failure and Rejection
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart donors and heart recipients

Brief summary: Evaluate the association between donor soluble protein ST2 (sST2) serum levels and 30-day recipient mortality in order to improve graft screening.

Detailed description: Soluble protein sST2 has recently become a prognostic biomarker in the context of acute myocardial infarction and chronic heart failure, and recent studies also show that sST2 is involved in acute rejection of the cardiac graft in recipients. Experimental studies confirm that the ST2 / IL-33 pathway is involved in the process leading to cardiac transplant rejection in animals. In particular, administration of IL-33 would have a positive effect on pre-clinical cardiac graft survival. No study have looked at the level of ST2 / IL-33 of the donor, with the purpose that it might reflect the condition of the transplanted heart and its initial level of Immune tolerance and maybe predict the risk of subsequent dysfunction.

In this non-interventional study, several blood samples will be taken on donors before organ procurement and on recipients prior to grafting, on day 7 and at the time of each myocardial biopsy (approximately 16 myocardial biopsies the first year). Serum level of sST2 and IL-33 will then be determined according to the ELISA method on each blood sample.

Fifty consecutive couple donors/ recipients will be included in the study. This number of subjects is calculated to detect a doubling of the donor sST2 level between the two recipient groups with 30-day mortality and without mortality (potency: 90%, alpha risk: 0.05, bilateral).

Eligibility criteria: Inclusion Criteria:

* Consenting recipients
* Consenting donors to organ/tissue donation for the purpose of scientific research

Exclusion Criteria:

* Non consenting recipients
* Non consenting donors to organ/tissue donation for the purpose of scientific research
* Multi-organ transplantation

Primary outcomes:
measure: Survival
timeFrame: 30 days
Secondary outcomes:
measure: Survival and Rejection and IL-33
timeFrame: 1 year
measure: Survival and Rejection and sST2
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Thoracic and Cardiovascular Surgery, Cardiac Institute, Groupe Hospitalier La Pitié Salpêtrière
Study officials:
References:
Clinical trial NCT05675189: Exploring Clinical Trial Experiences of Patients With Migraine
Official title: An In Depth Study Examining Patterns in the Clinical Trial Experiences of Migraine Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Migraine
Migraine Disorders
Keywords: Migraine
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with migraine who are actively considering enrolling in an interventional clinical trial for said condition, but have not yet completed enrollment and randomization phases in said clinical trial.

Brief summary: Clinical study participation has historically been heavily biased toward specific demographics.

This study will invite several participants to gather a wide range of information on clinical trial experiences for migraine patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of migraine.

People with migraine who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility criteria: Inclusion Criteria:

* Patient is a minimum of 18 years of age
* Patient has been diagnosed with a type of migraine
* Patient plans to participate in an interventional clinical trial for the condition of migraine
* Patient has access to a home internet connection in order to provide regular updates through the course of the study

Exclusion Criteria:

* Patient has an ECOG score of 4 or higher
* Patient is not able to provide consistent digital updates as per study requirements
* Patient does not complete or agree to terms outlined in the Informed Consent Form

Primary outcomes:
measure: Number of patients who decide to enroll in a migraine clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in migraine clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Peters GL. Migraine overview and summary of current and emerging treatment options. Am J Manag Care. 2019 Jan;25(2 Suppl):S23-S34.
citation: Tfelt-Hansen P. Understanding clinical trials in migraine. J Headache Pain. 2006 Apr;7(2):101-8. doi: 10.1007/s10194-006-0278-2. Epub 2006 Mar 31.
citation: Solomon S. Selection of patients for clinical drug trials in migraine. Neuroepidemiology. 1987;6(4):164-71. doi: 10.1159/000110115.
Clinical trial NCT04236089: Compare Effects of the Mirror Therapy and Robotic Mirror Therapy in Electroencephalography of Healthy Adults and Stroke Patients.
Official title: Compare Effects of the Mirror Therapy and Robotic Mirror Therapy in Electroencephalography of Healthy Adults and Stroke Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Stroke Patients
Keywords: mirror therapy
robotic mirror therapy
Electroencephalography
stroke
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mirror therapy has recently attracted increasing attention; however, most patients have the difficulties to perform mirror therapy due to limited imaginary ability. A mirror robotic hand system was developed, which consisted with a wearable exoskeletal hand, sensor glove, and a control box. The patient's unaffected hand wears the sensor glove, the affected hand wears the wearable exoskeleton hand, and the unaffected hand does the certain transitive and intransitive tasks as the mirror group, and then makes the affected hand do the same movements driven by the exoskeleton robotic hand. The investigators hypothesize that combining both approaches might facilitate the sensorimotor cortex that controls movement and might augment somatosensory input and further treatment efficacy. This study is aimed at investigating the effects of Mirror therapy and robotic mirror therapy on motor cortical activations in healthy adults and stroke patients using electroencephalography. All participants will perform the conditions of resting, moving right hand with or without robotic hand as the baseline data, then they will do mirror therapy using the right hand as active hand, or wearing robotic hand doing mirror therapy in random sequence. Electroencephalography (EEG) assessment will be done to assess the neurophysiologic effects of the different interventions. The investigators will use a questionnaire to assess the subjective opinion about the different interventions.

combined with execution (video AOE). The investigators will use the pair-t test to assess the within subjects differences in EEG and the questionnaire results.

This study will be done during 2020/02/01 - 2021/03/31.


Eligibility criteria: Inclusion Criteria:

* healthy adults: right handed, with normal upper extremity and cognition functions
* stroke patients:one side upper limb spasticity

Exclusion Criteria:

* 1. wrist weakness or deformity 2. skin problem 3. musculoskeletal injury of upper extremities

Primary outcomes:
measure: Electroencephalography assessment
timeFrame: 1.5hours
Secondary outcomes:
measure: Questionnaire
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Study officials:
References:
Clinical trial NCT00885989: Safety and Tolerability of the First IV Dosing of SLV338 in Healthy Volunteers
Official title: A Placebo-Controlled, Combined Single and Multiple Rising Dose Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV338 After Intravenous Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: SLV338
phase I
healthy volunteers
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-04-22
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and tolerability of the first IV dosing of SLV338 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* not healthy

Primary outcomes:
measure: Safety and tolerability parameters, including administration site tolerability, adverse events, clinical laboratory tests, vital signs and ECG
timeFrame: 7 days
Secondary outcomes:
measure: Pharmacokinetic parameters: AUC, Cmax, tmax, t½, λz, CL, CLR, Vz, Vss, MRT, Ae, and fe.
timeFrame: 48 hours
measure: Pharmacodynamic parameters: Plasma levels of ANP, cGMP, BNP, VIP, Big ET, ET-1, angiotensin II and aldosteron. Urinary volume and urine levels of cGMP, sodium, potassium, chloride, uric acid and creatinine, and creatinine clearance.
timeFrame: 48 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Site 1
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT05281289: Effect of Kinesio Tape Application and Stretching Exercises on Calf Cramps During Pregnancy
Official title: Effect of Kinesio Tape Application and Stretching Exercises on Calf Cramps During Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Calf Cramps During Pregnancy
Keywords: kinesio-tape,stretching exercises, calf cramps, pregnants, cramp questionnaire
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 52
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of kinesio-tape application and stretching exercise on calf muscle cramp during pregnancy

Detailed description: Up to 30% to 50% of pregnant women suffered from leg cramps, especially in the third trimester. Almost two-thirds of these women experience leg cramps twice per week and they can occur at any time, particularly at night.In mild and moderate cases, calf cramps may last for seconds, but in severe cases, leg cramps in pregnancy may last for minutes .In many cases calf cramps are very painful , which can affect daily activities, restrict exercise and performance, motive sleep disturbance and reduce the quality of life.Non-drug treatments are found to being effective for the treatment of muscle cramps. Non-drug treatments such as muscle stretching, physical exercise, avoidance of physical fatigue, massage, relaxation, heat therapy, weight loss, sensory nerve stimulation, ankle splints worn while sleeping, and changes to sleeping and sitting positions.This study has two groups; one recieved kinesio-tape application and stretching exercises and the second one recieved instructions about dealing with cramps with self low sustained stretch

Eligibility criteria: Inclusion Criteria:

* pregnant women who are suffering from calf cramps.
* Their age range from 25 to 35 years.
* Their body mass index range from 25 to 29.9 kg/m2 .

Exclusion Criteria:

* Skin abnormalities (skin malignancy in the treated area or burned).
* History of previous back surgery.
* Neuromuscular diseases like multiple sclerosis.
* Sensory disturbances.
* Evidence of previous vertebral fractures or major spinal structural abnormality, spondylolisthesis or spinal stenosis.
* Systemic disease of musculoskeletal system.
* Viscerogenic cause of back pain.
* Also, women who have eclampsia or pre-eclampsia.

Primary outcomes:
measure: calf pain intensity
timeFrame: 2days
Secondary outcomes:
measure: weight bearing ankle dorsiflexion ROM
timeFrame: 2days
measure: straight leg raising ROM
timeFrame: 2days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00642889: Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)
Official title: A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Lead sponsor: Newron Pharmaceuticals SPA
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 227
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the long-term safety and efficacy of a dose range of safinamide of 50-200 mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic Parkinson's disease who are currently receiving a stable dose of a single dopamine (DA) agonist.

Detailed description: The study will consist of 12 months of double-blind treatment. Patients will continue to take the original treatment administered in Study 015 (safinamide 100 mg/day, safinamide 200 mg/day, or placebo).

Eligibility criteria: Inclusion Criteria:

1. The patient completed 24 weeks of treatment in Study 015, or if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) as part of the Retrieved Dropout (RDO) population.
2. The patient was compliant with taking study medication in Study 015.
3. The patient is willing to participate in the study and signed an approved Informed Consent form.

Exclusion Criteria:

1. The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
2. The patient has shown clinically significant deterioration during participation in Study 015.
3. The patient discontinued Study 015 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) in Study 015.

Primary outcomes:
measure: Time from baseline to intervention (e.g., increase in dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacy); or time from baseline to the last follow up, if the event did not occur
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04012489: Breath and Air Stacking on Respiratory Mechanics in Tracheostomized Patients
Official title: Comparison Between Breath Stacking and Air Stacking on Respiratory Mechanics and Ventilatory Pattern in Tracheostomized Patients: Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Lung Infection
Keywords: Physical Therapy Modalities
Respiratory Care Units
Respiratory Mechanics
Lead sponsor: Brazilian Institute of Higher Education of Censa
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The researchers hypothesized that the aid of the resuscitator by the technique Air Stacking increase lung volume, promoting increased lung compliance and improvement of the ventilatory pattern. In addition, Air Stacking does not depend on patient collaboration. The objective of this study was to compare the effects of breath stacking and air stacking techniques on respiratory mechanics and ventilatory pattern in patients admitted to the ICU


Eligibility criteria: Inclusion Criteria:

* Patients without mechanical ventilation for more than 72 hours
* Mucus hypersecretion (defined as the need for suctioning \< 2-h intervals)

Exclusion Criteria:

* bronchospasm.
* Pleural effusion or pneumothorax undrained.
* Bronchopleural or tracheoesophageal fistula.
* Neuromuscular disease.

Primary outcomes:
measure: Static compliance of respiratory system
timeFrame: Baseline (before) and immediately after Breath Stacking or Air Stacking
measure: Total Resistance of respiratory system
timeFrame: Baseline (before) and immediately after Breath Stacking or Air Stacking
Secondary outcomes:
Other outcomes:
Locations:
city: Campos Dos Goytacazes
country: Brazil
facility: Luciano M Chicayban
state: RJ
Study officials:
References:
Clinical trial NCT03307889: SOMNOmedics Clinical Validation Trial
Official title: SOMNOmedics Clinical Validation Trial of Pulse Transit Time (PTT) Compared With Arterial Line in Patients Undergoing Nonvascular Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Perioperative/Postoperative Complications
Keywords: perioperative monitoring
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and adult patients in anesthesia or intensive care.

Brief summary: Observational study in which pulse transit time (PTT) as a method and the device to register this data is compared with arterial blood pressure.

The population is composed of pediatric and adult patients in anesthesia or intensive care in need of arterial blood pressure monitoring.

Detailed description: Plan to enroll patients who accept the terms of the study consecutively. The population is composed by pediatric and adult patients in anesthesia and intensive care in need of close blood pressure monitoring.

After informed consent from the patients themselves, patient and parents and sometimes only parents.

The device measuring PTT is the prepared and calibrated with existing arterial blood pressure. Data is then recorded via the storage capacity of the device and via videocamera. The videocamera is used to identify large disturbances in data registration. This is to identify confounding data and in the end calibrate the device to be more accurate.

Data from the PTT device and the camera is then downloaded to the study computer and to an external hard drive in order to create redundancy in data storage.

Data is then analysed to compare the difference between data recorded from the PTT device and arterial pressure respectively. Aim is to be able to collect sufficient data to be able to decide wether to recommend or advice against clinical use.

Patient data is registered and then handled by our departmental clerk. Data is stored for ten years.

Eligibility criteria: Inclusion Criteria:

* Arterial line planned or existing

Exclusion Criteria:

* suspected major perioperative hemodynamic variation.
* non existing consent.

Primary outcomes:
measure: Accuracy of pulse transit time (PTT) estimation of blood pressure against intra arterial measurement.
timeFrame: 45 minutes- 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
state: Upp
Study officials:
affiliation: Uppsala University
name: Michael Hultström, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01664689: Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including IOL implantation. Equally important is the ease of use, good visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2% hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these in clinical scenarios, there is no randomized trial comparing intraoperative performance and postoperative outcomes. The aim of this study was to compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification when using one of the three OVDs


Eligibility criteria: Inclusion Criteria:

* Age related, uncomplicated senile cataracts

Exclusion Criteria:

* presence of glaucoma,
* shallow anterior chamber (ACD \< 2.1mm),
* pupillary dilatation \< 6mm,
* extremely dense cataracts,
* posterior polar cataract,
* subluxated cataract,
* white mature cataract,
* diabetic retinopathy,
* high myopia (defined as AL \> 25mm),
* uveitis, or
* previous ocular trauma/surgery.

Primary outcomes:
measure: Corneal clarity on postoperative day 1
timeFrame: postoperative day 1
Secondary outcomes:
measure: Central corneal thickness on postoperative day 1 and week 1
timeFrame: day 1 and week 1
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Iladevi Cataract & IOL Research Centre
state: Gujarat
Study officials:
References: