louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00742430: Resistance on Antithrombotic Drugs in Ischemic Heart Disease
Official title: Assessment of Aspirin and Clopidogrel Resistance in Ischemic Heart Disease Using Multiplate Function Analyser and it's Correlation With Major Adverse Cardiac Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: aspirin resistance
coronary artery disease
clopidogrel resistance
major adverse cardiac events
multiplate platelet function analyser
percutaneous coronary intervention
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2008-08-27
Enrollment: 141
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with coronary artery disease

Brief summary: The purpose of this study is to determine whether aspirin and clopidogrel resistance measured with Multiplate function analyser has a good correlation with incidence of major adverse cardiac events in patients with coronary artery disease (CAD).

Detailed description: Our plan is to enroll 180 patients with diagnosed CAD who electively undergo percutaneous coronary intervention (PCI). Blood samples will be taken just before the procedure and one day after the procedure and analysed on Multiplate function analyser. Assessing aspirin and clopidogrel resistance incidence using Multiplate platelet function analyzer we will also try to find resistance correlation with the incidence of major adverse cardiac events in a one year follow up.

Eligibility criteria: Inclusion Criteria:

* Elective PCI
* \> 7 days on aspirin 100mg therapy before the intervention
* \> 7 days on clopidogrel 75mg therapy before the intervention

Exclusion Criteria:

* Loading dose of clopidogrel
* \< 7 days on aspirin therapy before the intervention
* Myocardial infarction less than 30 days before the intervention
* Cerebrovascular incident less that three months before the intervention
* Haemorrhagic diathesis
* Trc \< 100
* Htc \< 30%
* Creatinine \> 140

Primary outcomes:
measure: Major adverse coronary event
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro
Study officials:
affiliation: Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro, Zagreb, Croatia
name: Davor Milicic, prof.dr.sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic of Cardiovascular Diseases, Clinical Medical Centre Rebro, Zagreb, Croatia
name: Bosko Skoric, dr.
role: STUDY_CHAIR
References:
Clinical trial NCT03933930: Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.
Official title: Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Organ Failure, Multiple
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hyperthermic intraperitoneal chemotherapy is a major surgery for tumor peritoneal metastasis. For anesthesiologist, the intra-operative fluid control is always a big challenge. We try to compare the prognosis of lactate-directed and goal-directed therapy. We expect to confirm the better prognosis of lactate-directed therapy.


Eligibility criteria: Inclusion Criteria:

* Patients receiving hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

* Unable to set arterial line Severe liver or renal disease Severe heart disease Unconscious patients

Primary outcomes:
measure: pulmonary complication
timeFrame: 1 week
Secondary outcomes:
measure: Renal complication
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01200030: Effects of Home-based Program in Improving Sitting Balance and Upper Limb Functions in Patients With Stroke
Official title: A Home-Based Program of Transcutaneous Electrical Nerve Stimulation and Task-Related Trunk Training Improves Trunk Control in Patients With Stroke: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Sitting balance
Stroke
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 37
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: The investigators hypothesize that application of electrical stimulation would augment the effects of exercises in patients with stroke. Combined electrical stimulation with exercises for 6 weeks would lead to earlier and greater improvement in motor functions when compared with placebo-stimulation with exercises.

Detailed description: Previous studies have shown that repeated sensory inputs from transcutaneous electrical stimulation (TES) could enhance brain plasticity and conical motor output. Home-based rehabilitation is shown to be effective in motor recovery and improvement of functional ability in stroke rehabilitation.

The aim of this study was to develop a home-based rehabilitation program to investigate whether combined electrically induced sensory inputs through TES with task-related trunk training (TRTT) in a home-based program would induce earlier and/or greater improvement in, seated reaching distance and trunk control when compared with placebo TES and TRTT, or control with no active treatment in subjects with chronic stroke.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis with first stroke for more than 6 months
2. Discharge from all rehabilitation services
3. Ability to understand and follow commands
4. A carer able for helping the home program
5. No contraindication to assessment protocol and training

Exclusion Criteria:

1. Cognitive disorder with Abbreviated Mental Test less than 7
2. Unilateral neglect with Star cancellation Test less than 47
3. Sensory deficit
4. Unable to give informed consent
5. Unable to speak either Cantonese or English or Mandarin
6. Commodity that preclude them from undergoing training and assessment
7. Neurological disease other than stroke

Primary outcomes:
measure: Trunk Impairment Scale
timeFrame: baseline, 6 weeks
Secondary outcomes:
measure: Forward Sitting Functional Reach Test
timeFrame: baseline, 6 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Shamay Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01155830: Inflammatory Cytokine Quantification in Infants
Official title: Inflammatory Cytokine Quantification in Infants With Documented Sepsis, Congenital Diaphragmatic Hernia and/or ECMO Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Congenital Diaphragmatic Hernia
Neonatal Cardiopulmonary Failure
Keywords: inflammatory cytokines
extracorporeal membrane oxygenation
ECMO
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 21
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants admitted into the NICU at the University of Utah Health Sciences Centers and Primary Children's Medical Center.

Brief summary: This study proposes to quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).

Detailed description: Very small blood samples (500 microliters) will be collected serially in these patients and analyzed with current cytokine array technology. A convenience sample of 60 patients, 20 with each of these diagnoses, will be collected over a 2 year period. These data will provide baseline information for possible therapeutic intervention with agents that enhance or suppress specific mediators, or adjust mediator balance to promote patient healing.

Eligibility criteria: Inclusion Criteria:

* Gestational age ≥ 34 weeks,
* Indwelling vascular catheter available for blood draws,
* Documented culture positive sepsis on vasopressors , and/or
* Congenital diaphragmatic hernia (CDH), and/or
* ECMO therapy

Exclusion Criteria:

* Other major congenital anomalies
* Lack of parental consent

Primary outcomes:
measure: TNF-alpha, Baseline
timeFrame: Baseline
Secondary outcomes:
measure: TNF-alpha, Maximum
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
Study officials:
affiliation: University of Utah
name: Donald Null, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04561830: Open or Laparoscopic Mesolectal Excision in Low Rectum Cancer
Official title: Total Mesorectal Resection With Dissection of the Lateral Pelvic Lymph Nodes in Low Advanced Cancer Rectum Patients; Laparoscopic Versus Open Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the open approach and the laparoscopic-assisted approach of dissection of lateral lymph nodes in low advanced rectal cancer patients with clinically suspected nodal metastases in terms of safety, technical feasibility, and patient's oncological outcomes.

Detailed description: the investigators collected data of sixty low advanced cancer rectum patients who underwent either laparoscopic (30 cases) or open total mesorectal excision (30 cases) in addition to lateral pelvic dissection. The duration of operation in the laparoscopically assisted procedure was longer than the open procedure (p=0.003). The postoperative hospital stay time was longer in the open group than in the laparoscopic group (P=0.043). No significant differences between both groups regarding the number of excised lymph nodes, disease recurrence, RFS, or OS rate.

Eligibility criteria: Inclusion Criteria:

* Patients aged from 20-70 years with
* Sure diagnosis of locally advanced (T3 and T4) adenocarcinoma located in the middle or lower part of the rectum
* Clinical or radiological evidence of lateral pelvic lymph nodes metastases

Exclusion Criteria:

* Patients refused to be included in the study,
* Patients with concurrent primary cancer in other locations
* Patients with recurrent cancer after treatment
* Patients with distant metastasis
* Previously managed for pelvic cancer

Primary outcomes:
measure: operative time
timeFrame: during operative time
measure: operative complication
timeFrame: durning operative time
measure: feasibility of procedure
timeFrame: operative time
Secondary outcomes:
measure: post operative morbidity
timeFrame: 5 years
measure: mortality
timeFrame: 5 years
measure: recurrence
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03906630: Comparison of the Accuracy of Telehealth Examination Versus Clinical Examination in the Detection of Rotator Cuff Tears
Official title: Comparison of the Accuracy of Telehealth Examination Versus Clinical Examination in the Detection of Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 40 with shoulder pain that can be MRIed

Brief summary: The purpose of this study is to compare how accurately a pseudo-telehealth shoulder examination diagnoses rotator cuff tears compared to a regular clinical examination. MRI is used as the gold standard.


Eligibility criteria: Inclusion Criteria:

* 40 years of age or older, presenting with shoulder pain, and seen in the Duke Sports Medicine clinic by Dr. Wittstein or Dr. Lassiter

Exclusion Criteria:

* Patient cannot have had prior shoulder arthroplasty, instability or history of fracture/dislocation. Pregnant women will be excluded from the study because there will be an MRI. Anyone unable or unwilling to have an MRI will be excluded from the study.

Primary outcomes:
measure: Agreement with MRI findings as they pertain to presence or absence of a rotator cuff tear
timeFrame: Within 1 month of exam
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Southeastern Orthopedics Shoulder Center
state: North Carolina
city: Wake Forest
country: United States
facility: Duke Health Heritage
state: North Carolina
Study officials:
affiliation: Duke Health
name: Jocelyn Wittstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bradley KE, Cook C, Reinke EK, Vinson EN, Mather RC 3rd, Riboh J, Lassiter T, Wittstein JR. Comparison of the accuracy of telehealth examination versus clinical examination in the detection of shoulder pathology. J Shoulder Elbow Surg. 2021 May;30(5):1042-1052. doi: 10.1016/j.jse.2020.08.016. Epub 2020 Aug 29.
Clinical trial NCT05894330: Perception About Upper Limb Functional Recovery, Barriers & Use of Training Devices Among Indian Stroke Survivors.
Official title: Perception About Upper Limb Functional Recovery, Barriers & Use of Training Devices Among Stroke Survivors- A Cross-Sectional Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Middle Cerebral Artery With Infarction, Rehabilitation, Upper Limb Recovery, Economic Burdon
Lead sponsor: Mahatma Gandhi Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke Survivors

Brief summary: The goal of this observational study is to evaluate perceptions regarding affected arm and hand function and their willingness to use devices to enhance upper limb functions among stroke survivors. The main question\[s\] it aims to answer are:

* what will the stroke survivor's perception of interventions and device development in his/her arm recovery?
* Wheather he is willing to use it for his arm recovery?

Detailed description: Individuals with stroke will be recruited from MGM Hospital and other hospitals from Aurangabad. Participants will be adults (age \>30) with stroke and with the capacity to provide written or verbal informed consent, and the ability to communicate verbally/online/phone. Participants will be contacted via phone or email by a member of the research team. If needed personal interviews of the patients will be taken. The research team will consist of the author and one helper Physical Therapy student and the guide. All team members participating in the training will ensure consistency in communications with participants. All the participants will be provided with information about the study objectives and procedures and will be asked if they are willing to participate. If they consent, they will be given one of three options:

1. Complete the survey via phone immediately
2. Complete the survey online. In this case, they will be sent a link to their email to complete an online survey.
3. Complete the survey via personal interview

Eligibility criteria: * Inclusion Criteria:
* First-ever stroke
* All stages of stroke
* Onset of a stroke at least 1 year ago
* Age group: 30 to 75
* Both genders included
* Patients diagnosed with MCA (Middle Cerebral Artery) stroke
* Exclusion Criteria:
* Aphasia
* Patients who are unable to follow commands
* Patients with other neurological disorders such as Multiple sclerosis and Parkinson's disease

Primary outcomes:
measure: Self Structured Marathi language translated Version Questionnaire
timeFrame: One Month
Secondary outcomes:
Other outcomes:
Locations:
city: Aurangabad
country: India
facility: MGM's Institute of Physiotherapy
state: Maharashtra
Study officials:
References:
Clinical trial NCT03281330: Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)
Official title: Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Revalidatie & MS Centrum Overpelt
name: National MS Center Melsbroek
First posted: 2017-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: persons with Multiple Sclerosis and healthy volonteers

Brief summary: The study investigates the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls. The study extends over a four session period, each session lasting maximally 1h30 minutes The experimental conditions include participants walking to music and metronome (at different tempi) for 3minutes and 15 seconds per condition, with a rest period of 3 minutes in between each condition. Non-invasive equipment will be used. participants are equipped with sensors (watch-like straps at the wrists, ankles and across the chest) and are given wireless headphones.


Eligibility criteria: Inclusion Criteria:

* diagnosis of MS of \>1 year,
* no relapse in the last 1 month,
* ability to walk for 12 minutes without interruption,
* an average usual walking speed between the range of 0.4 and 1.2 m/s.

Exclusion Criteria:

* cognitive impairment hindering the understanding and execution of the experimental procedures
* pregnancy
* hearing impairment
* amusia
* beat deafness

Primary outcomes:
measure: Spatio-temporal parameters of gait
timeFrame: day 1
measure: Spatio-temporal parameters of gait
timeFrame: week 1
measure: Spatio-temporal parameters of gait
timeFrame: week 2
measure: Spatio-temporal parameters of gait
timeFrame: week 3
measure: Parameter's of sychronisation
timeFrame: day 1
measure: Parameter's of sychronisation
timeFrame: week 1
measure: Parameter's of sychronisation
timeFrame: week 2
measure: Parameter's of sychronisation
timeFrame: week 3
Secondary outcomes:
measure: subjective physical /mental fatigue
timeFrame: day 1
measure: subjective physical /mental fatigue
timeFrame: week 1
measure: subjective physical /mental fatigue
timeFrame: week 2
measure: physical /mental fatigue
timeFrame: week 3
measure: motivation
timeFrame: day 1
measure: motivation
timeFrame: week 1
measure: motivation
timeFrame: week 2
measure: motivation
timeFrame: week 3
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University of Ghent
city: Melsbroek
country: Belgium
facility: Nationaal Multiple Sclerose Center
city: Overpelt
country: Belgium
facility: Revalidatie & MS Centrum Overpelt
Study officials:
References:
Clinical trial NCT00920530: Real-Time PCR for the Detection of Vaginal Group B Streptococcus Carriage: a Medico-Economic Study
Official title: Real-Time PCR for the Detection of Vaginal Group B Streptococcus Carriage at Delivery : a Medico-Economic and Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Infections
Streptococcus Agalactiae
Keywords: Screening
real time PCR
Streptococcus agalactiae
Pregnant women
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2009-06-15
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women having a pregnancy follow up with Streptococcus agalactiae monitoring according with french recommandations.

Brief summary: Group B streptococcus infections may be serious for the neonates. The infection can occur during the birth, by contact with the genital area. That is why the detection of this bacteria is systematically realised in pregnant women between 34 and 37 weeks of amenorrhea in order to give prophylactic antibiotic treatment in case or positive carriage. This strategy presents 2 disadvantages : (1) detection of the group B streptococcus at 34 and 37 weeks of amenorrhea in not predictive of a carriage at delivery, (2) many pregnant women escape from systematic screening, leading to a systematic antibiotic treatment, which means useless costs, and useless antibiotic exposure with resistant bacteria selection. Real time polymerase chain reaction (PCR) allows a rapid detection anytime with no specific microbiological qualification. The aim of the study is to assess the economic outcomes of this strategy and the epidemiological values for St Etienne hospital.


Eligibility criteria: Inclusion Criteria:

* women giving birth

Exclusion Criteria:

* planned caesarian
* minor
* cervical diameter \> 5 cm
* women giving birth at less than 35 weeks of amenorrhea
* recent antibiotherapy

Primary outcomes:
measure: number of women receiving a useless antibiotic prevention
timeFrame: 1 day
Secondary outcomes:
measure: economic outcomes
timeFrame: 1 day
measure: epidemiological outcomes for group B streptococcus
timeFrame: 1 day
measure: diagnosis efficacy of the real time PCR
timeFrame: 1 day
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Bruno POZZETTO, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: