louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02342080: Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury
Official title: Effects of System Suspended Robotic Lokomat Gait in Patients With Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Rehabilitation
Walking
Robotics
Neuronal Plasticity
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with incomplete spinal cord injury

Detailed description: The objective of this project is to verify the effects of suspended robotic gait training (Lokomat) in recovery of functional capacity of the lower limbs patients with incomplete spinal cord injury.

Eligibility criteria: Inclusion Criteria:

* Clinical and radiological diagnosis of incomplete spinal cord injury of traumatic origin
* Injury time from 1 to 36 months
* Stability verified in clinical medical evaluation
* ASIA C or D
* Absence of severe psychiatric amendment requiring psychiatric evaluations
* Present functional recovery of the upper limb compatible with stages III and IV of Brunnstrom
* Patients cannot use a cardiac pacemaker ; have unstable angina or other decompensated heart disease; have chronic obstructive pulmonary disease; dysreflexia without having autonomic control; have some fracture of the bones of the lower limbs; tracheostomy; presenting deformity and stiffness of the hip joint, knee (20 ° or more of flexion ) and ankle ( 10 or more plantar flexion ) and pressure ulcers.
* Absence of illicit drug use
* Grant writing the informed consent to participate in the study

Exclusion Criteria:

* Lack of resistance
* Disabling fatigue
* Worsening of spasticity which prevents the movement
* Body weight in excess of 150Kg
* Risk of osteoporosis with pathological fracture
* Asymmetry in the lower limbs greater than 2 cm
* Skin lesions and / or pressure ulcers in areas where the orthosis Lokomat pressuring

Primary outcomes:
measure: Walking Index for Spinal Cord Injury II
timeFrame: 6 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
Study officials:
affiliation: University of Sao Paulo
name: Linamara Rizzo Battistella, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00917280: Connecting the Lab to Everyday Life: The Relevance of Executive Dysfunction to Participation and Quality of Life in Parkinson's Disease (PD) Without Dementia
Official title: Connecting the Lab to Everyday Life: The Relevance of Executive Dysfunction to Participation and Quality of Life in PD Without Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 174
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Controls:

Recruited from community, VFH.

Brief summary: The overall purpose of this research is to learn how Parkinson's disease affects thinking and memory in everyday life. Participation will involve thinking tests, questionnaires and interviews about thinking and activities in everyday life.

Detailed description: The overall purpose of this research is to learn how Parkinson's disease affects thinking and memory in everyday life. Participation will involve thinking tests, questionnaires and interviews about thinking and activities in everyday life.

Eligibility criteria: Inclusion Criteria PD participants:

* WUSM Movement Disorders Clinic patients
* males or females between 40 and 70
* meet criteria for idiopathic typical PD
* classified at Hoehn \& Yahr12 stage I, II, or III
* are currently treated with levodopa/carbidopa

Inclusion Criteria Control:

* The groups will be matched for age, education and gender
* No Parkinson Disease

Exclusion Criteria PD participants and Control:

* suspected dementia
* treatment with certain dopaminergic, anticholinergic or benzodiazepine medications
* other neurological problems
* brain surgery
* history or current psychotic disorder
* any condition which would interfere with testing
* control only: a biological family history of PD and being a caregiver or spouse of someone who has PD

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Erin Foster
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01521780: Characterization of Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma (MK-0000-215)
Official title: A Clinical Study to Characterize Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma for Utilization of Target Engagement and Pharmacodynamic Biomarkers in Future Phase I Trials
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
MRI
pharmacogenomics
beta-catenin
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to characterize the baseline variability of a panel of tissue (tumor and adjacent) and blood-based biomarkers obtained from participants with hepatocellular carcinoma (HCC). The primary hypothesis is that the upper bound of the 80% Confidence Interval of log beta-catenin protein or messenger RNA (mRNA) expression from one core needle biopsy (CNB) equivalent is =\< 0.65.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with HCC.
* Candidate for surgical resection or has no contraindications to MRI procedures.

Exclusion Criteria:

* Prior loco-regional treatment of tumor, unless there is untreated tumor present representing a distinct untreated nodule.
* Confirmed or suspected diagnosis of fibrolamellar HCC, mixed HCC/cholangiocarcinoma or metastatic tumor.
* Had a liver transplant.

Primary outcomes:
measure: Expression Levels of Beta-catenin mRNA From Core Needle Biopsy (CNB) Equivalents of Resected HCC.
timeFrame: Visit 3, approximately 7 days after screening Visit 1.
measure: Expression Levels of Beta-catenin Protein From Core Needle Biopsy (CNB) Equivalents of Resected HCC.
timeFrame: Visit 3, approximately 7 days after screening Visit 1.
Secondary outcomes:
measure: Tumor Volumes From Repeated MRI Measurements of HCC.
timeFrame: Visit 2, approximately 7 days after screening Visit 1.
measure: Median Apparent Diffusion Coefficient (Median ADC) of Tumors From Repeated MRI Measurements of HCC.
timeFrame: Visit 2, approximately 7 days after screening Visit 1.
measure: Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC.
timeFrame: Visit 3, approximately 7 days after screening Visit 1.
measure: Expression Levels of Beta-catenin Protein From CNB Equivalents of Liver Adjacent to HCC.
timeFrame: Visit 3, approximately 7 days after screening Visit 1.
measure: Expression Levels of Low Density Lipoprotein Receptor (LDL-R) in Resected HCC and Adjacent Liver From Whole Tissue Sections.
timeFrame: Visit 3, approximately 7 days after screening Visit 1.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01355380: Efficacy of Ventavis Used in Real-life Setting.
Official title: The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension
Inhaled iloprost
Quality of life
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-05-18
Enrollment: 55
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: Adult patients prescribed Ventavis within the Pulmonary Arterial Hypertension Therapeutic Programme.

Brief summary: This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.

Typical clinical measures and quality of life will be prospectively followed in 12 months period.


Eligibility criteria: Inclusion Criteria:

* Pulmonary arterial hypertension in WHO functional class III or IV
* Age 18+
* Patients newly treated with Ventavis or switched from sildenafil

Exclusion Criteria:

* Retrospective documentation is not allowed

Primary outcomes:
measure: Changes of the exercise capacity as measured by 6-minutes walking distance
timeFrame: 3, 6, 9 and 12 months vs. baseline
Secondary outcomes:
measure: Changes of depression score over time
timeFrame: 3, 6, 9 and 12 months vs. baseline
measure: Changes of functional capacity as measured by WHO classification system
timeFrame: 3, 6, 9 and 12 months vs. baseline
measure: Changes of pulmonary haemodynamics
timeFrame: 3, 6, 9 and 12 months vs. baseline
measure: Changes of serum level of natriuretic peptide B
timeFrame: 3, 6, 9 and 12 months vs. baseline
measure: Changes of Quality of Life score
timeFrame: 3, 6, 9 and 12 months vs. baseline
measure: Changes in cardiac echo parameters
timeFrame: 3, 6, 9 and 12 months vs. baseline
measure: Number of patients with treatment-emergent adverse events
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Many Locations
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05117580: Telemedicine With Metabolic Syndrome
Official title: Risk Reduction in Patients With Metabolic Syndrome Through Telemedicine-led Lifestyle Interventions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Life Style
Keywords: Telemedicine
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on cardiovascular risk factors, functional indicators, in patients with metabolic syndrome.

Detailed description: The patients are using mobile phone-based nutrition diary with heart rate monitoring watch (including activity meter) connected to a mobile phone with bluetooth technology worn on a wrist. These devices, and the weight scale, blood pressure monitor are connected with bluetooth to an IT system, that transmits and displays data from these devices. the patients are using the devices during 3 months, and get instructions about lifestyle.

Eligibility criteria: Inclusion Criteria:

* Age between 18 years and 75 years
* Presence of at least three of the following five risk factors (Metabolic Syndrome ATP III Criteria):

  1. waist width above 102 cm in men and 88 cm in women
  2. treated diabetes or blood sugar above 5.6 mmol / l
  3. treated hypertension or spontaneous blood pressure ≥ 130/85 mmHg
  4. fibrate treatment or triglyceride levels above 1.7 mmol / l
  5. blood HDL cholesterol levels below 1.03 mmol / l in men and 1.3 mmol / l in women

Exclusion Criteria:

* Low level of physical activity (less than 30 minutes a day)
* IT proficiency at least for basic use of mobile phones (answering / making voice calls).
* For women with childbearing potential, by definition, all women who are able to conceive physiologically use dual contraception
* Signing an informed consent.
* The subject communicates well with the investigator and is able to help understand and adhere to the requirements of the study plan.

Primary outcomes:
measure: Change of abdominal circumference
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.
timeFrame: 3 months
measure: Impact of the system to the cardiovascular risk
timeFrame: 3 months
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged
Study officials:
References:
Clinical trial NCT04688580: Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers
Official title: An Open-label, Crossover Study to Assess the Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Immediate- and Modified-release Formulations in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: XWPharma
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of various formulations of XW10172 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male of female participants who are 18 to 55 years of age, inclusive.
* Participant is willing and able to provide signed and dated written informed consent to participate prior to admission to the study.

Exclusion Criteria:

* Evidence or history of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, psychiatric, neurological, immunological, or endocrine disorders, poor vision, or allergic disease including drug allergies, including immediate type hypersensitivity. A history of childhood asthma that has resolved is acceptable.
* Participant who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, pharmacokinetics or pharmacodynamics of the investigational drug; or is unable to comply with the study protocol.

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: 12 hours
measure: Trough concentration (Cmin)
timeFrame: 12 hours
measure: Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-tlast)
timeFrame: 12 hours
measure: AUC from time 0 extrapolated to infinity (AUC0-inf)
timeFrame: 12 hours
measure: AUC over the dosing interval (AUCtau)
timeFrame: 12 hours
measure: Apparent terminal half-life (t1/2)
timeFrame: 12 hours
measure: Cmax and AUC ratios of metabolite to XW10172
timeFrame: 12 hours
measure: Apparent oral clearance (CL/F)
timeFrame: 12 hours
measure: Time to reach Cmax (Tmax)
timeFrame: 12 hours
Secondary outcomes:
measure: Incidence, severity, and causality of AEs
timeFrame: Up to 14 Days
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
Study officials:
affiliation: XWPharma
name: Daniel M. Canafax, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02119780: Clinical Study to Evaluate the Efficacy and Safety of YVOIRE® Contour Compared With Restylane SubQ™ Injected Into the Anteromedial Malar Region
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2014-04-22
Enrollment: 83
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with Restylane SubQ™ injected into the anteromedial malar region.


Eligibility criteria: Inclusion Criteria:

* Be male or female, 20-65 years of age
* Have anteromedial malar region volume loss as grade 2, 3, or 4 on the Mid Face Aesthetic Scale (MFAS) symmetrically on both sides
* Desire filler treatment to correct volume loss in the anteromedial malar region
* Accept the obligation not to receive any other mid facial procedures or treatments during the study
* Signed informed consent
* Those who fall under one of the following 3 cases

  1. Males or females who are surgically sterile
  2. Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
  3. Fertile premenopausal females or males without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the last treatment of the investigational device to avoid pregnancy

Exclusion Criteria:

* Have a history of hypertrophic scars or keloids
* Other criteria as identified in the protocol

Primary outcomes:
measure: Mid Face Aesthetic Scale (MFAS) score
timeFrame: 26 weeks after treatment
Secondary outcomes:
measure: Mid Face Aesthetic Scale (MFAS) score
timeFrame: 2, 14, and 52 weeks after treatment
measure: Mid Face Aesthetic Scale (MFAS) score
timeFrame: 2, 14, 26, and 52 weeks after treatment
measure: Mid Face Aesthetic Scale (MFAS) Responder rate
timeFrame: 2, 14, 26, and 52 weeks after treatment
measure: Global Aesthetic Improvement Scale (GAIS) score
timeFrame: 2, 14, 26, and 52 weeks after treatment
measure: Global Aesthetic Improvement Scale (GAIS) Responder rate
timeFrame: 2, 14, 26, and 52 weeks after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06719180: Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
Official title: A Prospective Randomized Controlled Trial of Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hysterectomy
Post Operative Analgesia
Lead sponsor: MediSys Health Network
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 100
Sex: FEMALE
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 determine whether an injection of a local anesthetic (Bupivacaine with epinephrine) in the vaginal cuff prior to closure would result in less immediate postoperative pain medication and increase patient comfort/satisfaction.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions
* Presence of malignancy

Exclusion Criteria:

* Conversion to laparotomy

  * Previous multiple abdominal and/or pelvic surgeries
  * Significant medical comorbidities or cardiac history
  * Poor initial Aldrete score4 (\<10)
  * Significant pre-op pain medication use
  * Contraindication to any medication that would be used in the study (Bupivacaine, epinephrine, tramadol or oxycodone)

Primary outcomes:
measure: Milligrams of Morphine Equivalent Used
timeFrame: From enrollment to end of treatment at 4 hours.
Secondary outcomes:
measure: Counts of Non-Opioid Analgesics Used
timeFrame: From enrollment to end of treatment at 4 hours.
measure: Patient Change in Pain Score (0-10)
timeFrame: From Baseline to end of treatment at 4 hours
Other outcomes:
Locations:
city: Flushing
country: United States
facility: Flushing Hospital Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02366780: Breast Milk Content Expressed Manually Compared to Electric Pump
Official title: Breast Milk Content Expressed Manually Compared to Electric Pump
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant
Keywords: Lactation
Breastmilk
Macronutrients
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-02-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive factors for the health and development of infants.Colostrum, which is produced in low quantities for the first 3 to 4 days after birth, is rich in immunologic components and developmental factors.

Breastfeeding difficulties during the first days of life of an infant are common. Moreover, not all infants can be directly fed at the breast.

Therefore, breast milk feeding at this early stage is initiated and promoted by the expression of breast milk either manually or by use of a pump. Whether the method of milk expression at this stage has a qualitative impact on colostrum is currently unknown.

The purpose of this randomized controlled study is to compare the effect of manual expression with electric pump expression upon the macronutrient composition of breast milk.


Eligibility criteria: Inclusion Criteria:

* Healthy lactating mothers of term infants

Exclusion Criteria:

* HIV infected mothers

Primary outcomes:
measure: Macronutrient content of expressed breast milk
timeFrame: 3 to 5 min
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Neonatology, Lis Maternity Hospital, Tel Aviv medical Center
Study officials:
affiliation: Department of Pediatrics, Sakler Faculty of Medicine
name: Shaul Dolberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mangel L, Ovental A, Batscha N, Arnon M, Yarkoni I, Dollberg S. Higher Fat Content in Breastmilk Expressed Manually: A Randomized Trial. Breastfeed Med. 2015 Sep;10(7):352-4. doi: 10.1089/bfm.2015.0058. Epub 2015 Jul 14.