bioihbjkbjnl/mcl2 huggingface dataset:
Stepping Training Using Feedback in Stroke
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      -  Are there differences in immediate effects of stepping training with and without the use
           of visually weight-taking machine (VWTM) on variables relating to well-controlled
           walking and walking symmetry in ambulatory patients with stroke?

        -  Are there differences of 4-week stepping training with and without the use of VWTM on
           variables relating to well-controlled walking and walking symmetry in ambulatory
           patients with stroke?
    

Detailed description: 
      -  To compare immediate effects of stepping training with or without the use of VWTM on
           variables relating to well-controlled walking and walking symmetry in ambulatory
           patients with stroke.

        -  To compare effects of 4-week stepping training with or without the use of VWTM on
           variables relating to well-controlled walking and walking symmetry in patients with
           stroke.
    

Intervention name(s): Stepping training with feedback
Intervention type(s): Other
Intervention description(s): Stepping training with the use of external feedback. The subjects will be instructed to shift/take their body-weight onto the affected leg until the green zone of the displayed section is lighting and a beep sound to alarm the subjects to step the non-affected leg forward and backward as much as they can.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Feedback; Physical Therapy
Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block in Pediatric.
Condition: Anesthesia, Local; Analgesia
Study type: Interventional

Summary: 
      This randomized, double-blinded, study aims to compare the efficacy of analgesia and any side
      effects of U/S guided bilateral Erector SpinaePlane block versus non-block t paediatric
      patients undergoing corrective cardiac surgeries.
    

Detailed description: 
      Our study will be designed to estimate and compare the analgesic effect of single
      shotbilatral erector spinae plane block in pediatric patients undergoing corrective cardiac
      surgeries versus non-block as the control group. Our primary outcome will be the total dose
      of intraoperative fentanyl boluses.

      Randomization will be achieved by using an online random number generator. Patient codes will
      be placed into sequentially numbered sealed opaque envelopes by a research assistant who is
      not involved in the study. A medical personnel not involved in patient management will be
      responsible for opening the envelope and give the instructions contained within each envelope
      to the anesthesiologist who is expert in doing the ESP block in patients included within the
      block group. The anesthesia team who managed the patients intraoperatively did not share in
      recording data for the research. However, another physcian will be responsible for recording
      the intraoperative data.
    

Intervention name(s): bilateral erector spinae block
Intervention type(s): Procedure
Intervention description(s): An ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process.
Three muscles; trapezius , rhomboids major , and erector spinae will be identified superior to the hyperechoic transverse process.
Using in-plane approach a 25 G needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle.
Correct needle tip location will be confirmed by injecting 3 mL of saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..
0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread in the fascial plane between the erector spinae muscle andthe transverse process12.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erector spinae plane block; Pediatric; sternotomy
The Effect of Linagliptin on Mitochondrial and Endothelial Function
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigators propose to examine the effect of 12 weeks of Linagliptin, a diabetes drug,
      treatment on inflammation as well as vascular and mitochondrial function in diabetic
      patients. Investigators hypothesize that Linagliptin will reduce the proinflammatory state,
      improve endothelial function, increase the blood flow at the muscle microcirculation level
      and improve mitochondrial function. In this study, investigators will perform tests that
      evaluate the function of small and large blood vessels by employing ultrasound and laser
      doppler techniques. In addition MRI scans that evaluate the mitochondrial function of the
      lower extremity muscles at rest and during exercise will also be employed. Forty subjects
      with Type 2 diabetes will be studied for twelve weeks and half of them will be randomly
      assigned to receive linagliptin while the other half will receive placebo. All tests will be
      performed at the beginning and the end of the study.
    


Intervention name(s): Linagliptin; Placebo; Microcirculation testing; Macrocirculation testing; MRI Scans
Intervention type(s): Drug; Drug; Other; Other; Other
Intervention description(s): The endothelial function of the micro-circulation will be assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.; Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodilation).; Phosphorus-31 MRI data will be obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia.
Other intervention name(s): Tradjenta
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type II Diabetes Mellitus; Diabetes; Metabolism; Linagliptin; Tradjenta; Glucose
Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia
Condition: Hypertension,; Hyperlipidemia
MeSH terms: Hypertension; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the efficacy and safety of the coadministration of valsartan
      (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component administered
      alone in patients with hypertension and hyperlipidemia.
    


Intervention name(s): Valsartan 160mg; Rosuvastatin 20mg; Valsartan 160mg placebo; Rosuvastatin 20mg placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Diovan; Crestor
Intervention MeSH terms: Valsartan; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands
Condition: Skin Laxity; Skin Roughness
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      People lose collagen all over the body, not just in the face; skin roughness and laxity of
      the dorsum of the hands can result from chrono and photo-aging. This skin roughness and
      laxity can range from very mild to severe; injection procedures can provide new tone and
      firmness to the skin of the hand dorsum. Dermal fillers are the most used non-permanent
      injectable materials available today to correct skin flaccidity and roughness on the dorsum
      of the hands. They give immediate aesthetic effect due to elastic gel matrix injected and
      impart longer term effects due to bio stimulation, promoting new collagen formation. The
      objective of this study is to investigate the aesthetic performance of the Hyaluronic acid
      (HA)- based dermal filler Profhilo® Body injected by a blunt tip microcannula (25G or 22G,
      preferably 22G), with fanning technique through a single entry point performing 5 passages
      and injecting 0,3 ml per passage, 1,5 ml for each hand. Volunteers of both sexes, aged 18-65
      years with mild-moderate skin roughness and laxity at the level of hand dorsum are to be
      treated.
    

Detailed description: 
      Open, monocentric. 3 visits, 55 subjects.

      Primary endpoint of the study is the evaluation of performance and tolerance of Profhilo Body
      (3ml) treatment in the back of the hands ( or dorsum of the hands). Secondary endpoint is
      self-assessment questionnaire by both doctors and volunteers.

      Profhilo® Body (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 3.25 ml
      non-pyrogenic pre-filled syringe, containing 3 ml of 3.2% hyaluronic acid for intradermal use
      (48 mg H-HA + 48 mg L-HA) dissolved in 3 ml of saline buffered sodium chloride. - IBSA
      Farmaceutici Italia S.r.l. - ITALY. The principle component is cross-linked Hyaluronic Acid
      of non-animal origin, produced by bacterial fermentation.
    

Intervention name(s): Profhilo® Body
Intervention type(s): Device
Intervention description(s): Dosage form: Profhilo® Body (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 3.25 ml non-pyrogenic pre-filled syringe, containing 3 ml of 3.2% hyaluronic acid for intradermal use (48 mg H-HA + 48 mg L-HA) dissolved in 3 ml of saline buffered sodium chloride.
Intervention model: Single Group Assignment
Intervention model description: 55 subjects undergoing Profhilo Body treatment in the back of the hands, 3 visits: Day 0 (treatment) Day 30 (1 month after Day 0 treatment) Day 120 (4 months after Day 0 - follow-up).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin laxity; Skin roughness; Profhilo Body; Hyaluronic Acid; Hybrid Cooperative Complexes
Using the Objective Physiological Parameters to Test TCM Syndrome in Sub-health Subjects
Condition: Health Status
MeSH terms: Syndrome
Study type: Observational

Summary: 
      Background: Suboptimal health status (SHS) is a dynamic state potential clinical stage or
      prior psychosomatic disease stage during which people have not been diagnosed with a disease,
      but they have risk factors for illness and have tendency to develop diseases. The term refers
      to an existing condition of ill health that could lead to a pathologic condition but could
      also be eliminated, enabling the individual in question to return to a state of good health.
      Traditional Chinese medicine (TCM) emphasizes the importance of health care and the idea that
      preventive treatment for diseases is superior to curative treatment. Therefore, early
      TCM-based intervention can improve the health status of people with SHS. People with SHS
      often experience such nonspecific symptoms as fatigue; such symptoms are typical of SHS from
      the perspective of TCM. The present study investigated people with SHS and fatigue as their
      primary symptom. All enrolled participants completed a physical questionnaire, after which
      their physiological parameters were monitored using a cloud physiological signal monitoring
      system to investigate correlations with TCM patterns. Methods: The participants first
      completed a body constitution questionnaire, the WHO Quality of Life questionnaire, the
      SHSQ-25 questionnaire, the Epworth Sleepiness Scale, and the Pittsburgh Sleep Quality Index,
      and subsequently underwent sphygmography to determine their pulse patterns. Analyses of pulse
      waves were presented in relation to the spectral energy ratio (SER), and SER10 scores
      represented subtle changes in internal organ blood flow; 13-50-Hz spectrum analysis for pulse
      delineated any flow energy deviation in organs.
    


Intervention name(s): heart rate variability, pulse diagnosis device
Intervention type(s): Diagnostic Test
Intervention description(s): check heart rate and pulse rate
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study enrolled individuals aged between 20 and 39 years based on previous studies,
        which showed that SHS is most prevalent in people aged 20 to 39 years. Individuals who
        conformed to A+B+D or A+C+D (described below) and who had not been diagnosed as having a
        disease by personnel practicing Western medicine were defined as having SHS. Individuals
        who did not meet the criteria for SHS and who had not been diagnosed as having a disease by
        Western medicine were defined as healthy.
      
Keywords: subhealth; obese; hypertension; sleep apnea syndrome; fatigue; TCM syndrome; physiological signal monitor system
Encouraging Calcium Absorption and Bone Formation During Early Puberty
Condition: Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Increasing bone mass during puberty can ultimately decrease the risk of developing
      osteoporosis, which causes bones to weaken and break more easily later in life. The purpose
      of this study is to compare calcium absorption and bone growth in boys and girls on diets
      including either a nondigestible oligosaccharide (NDO) or simple sugar.
    

Detailed description: 
      Rapid increases in bone mass occur during calcium absorption and bone calcium deposition
      during puberty, and these increases can enhance peak bone mass and ultimately decrease the
      lifetime risk of osteoporosis. However, dietary, hormonal, and genetic factors likely affect
      increased bone mass. This study will examine if adding NDO to a pubertal diet allows more
      absorption of calcium by the body, producing stronger bones. The study will also assess how
      the hormones produced by the body during puberty affect bone growth and whether genetic
      factors affect calcium absorption or bone growth.

      This study will last 2 years. At study entry, baseline pubertal hormone levels and bone mass
      will be assessed. Both a dual-energy X-ray absorptiometry (DEXA) scan and a calcium stable
      kinetic study measuring calcium absorption will be performed. Participants will then be
      randomly assigned to receive calcium fortified food with or without added NDO for 1 year.
      Calcium absorption will be measured again at 2 months. After the first year, calcium kinetic,
      hormonal, and DEXA studies will be performed and compared to baseline results. A final DEXA
      scan will be performed at the end of 2 years.
    

Intervention name(s): Nondigestible oligosaccharide (NDO)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Bone growth; Calcium; Children; Diet; Puberty
Effect of Cold Air Cooling on the Incidence of Post Inflammatory Hyperpigmentation Following Laser Treatment
Condition: Nevus; Hyperpigmentation
MeSH terms: Hyperpigmentation
Study type: Interventional

Summary: 
      - To investigate the benefit of epidermal cooling on the incidence of post inflammatory
      hyperpigmentation after laser irradiation
    

Detailed description: 
      -  70% incidence of post inflammatory hyperpigmentation has been reported following a
           Q-switched nd:YAG laser treatment of acquired bilateral nevus of Ota-like macules.

        -  We assumed that epidermal cooling may minimize the non-specific injury to the epidermis
           caused during laser irradiation, leading to the decreased incidence of post inflammatory
           hyperpigmentation.
    

Intervention name(s): Cold air cooling
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Acquired bilateral nevus of Ota-like macules; Postinflammatory hyperpigmentation; Cold air cooling
A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
Condition: NASH - Nonalcoholic Steatohepatitis; Fibrosis, Liver; NAFLD - Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431
      in presumed NASH F2/F3 subjects.
    

Detailed description: 
      This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431
      in presumed NASH F2/F3 subjects. Study will evaluate the safety and tolerability of a once
      daily 75mg dose and 225mg of CRV431 compared to placebo over 28 days of dosing.
      Pharmacokinetic parameters of CRV431 and its major metabolites and fraction unbound will also
      be evaluated. Non-invasive antifibrotic bio-markers will be collected and quantified from
      presumed NASH F2/F3 subjects dosed with 75mg CRV431 or placebo.
    

Intervention name(s): CRV431 75mg; Placebo (1 softgel); CRV431 225mg; Placebo (3 softgels)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 x 75mg softgel capsule; 1 x placebo softgel capsule; 3 x 75mg softgel capsule; 3 x placebo softgel capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, multi-center, single-blind
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anti-fibrotic
Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™
Condition: Incisional Hernia; Hernia; Abdominal Hernia
MeSH terms: Hernia; Incisional Hernia; Hernia, Abdominal; Internal Hernia
Study type: Interventional

Summary: 
      This study is designed to examine the effects on post operative pain after the use of a
      fixation device to secure a mesh in the abdomen to repair a hernia of the abdominal wall. The
      fixation devices to be used differ with one being made from titanium and is permanent and the
      other being made from an absorbable material. Both fixation devices are commonly used but two
      questions remain unanswered, does one cause more chronic pain and also what if any will be
      the effect on recurrence rates of the hernia. No trial has been undertaken to date which will
      not only examine the fixation device but in the setting where the hernia is closed first. The
      closure of the hernial defect by the keyhole technique is a relatively new and growing
      concept in the hernia world.
    

Detailed description: 
      TACKoMESH study (Comparison of using absorbable tacks (ReliaTack™) against a non-absorbable
      tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional
      hernia) is a prospective, single-centre, double blinded randomised trial which aims to
      establish whether the use of absorbable (ABS) compared to non-absorbable (Non-ABS) tacks in
      adult patients undergoing elective incisional hernia repair produces a lower rate of pain
      both immediately and long-term. Secondary outcomes to be explored include seroma formation,
      hernia recurrence, length of postoperative hospital stay, wound infection, reoperation rate,
      operation time, health related quality of life and time to return to normal daily activity.

      Patients entering TACKoMesh will be randomised immediately prior to their operation with a
      1:1 ratio of ABS versus Non-ABS tack arm allocation. The same composite mesh will be used for
      all operations. Follow-up is according to a predetermined schedule, using specifically
      designed Case Report Forms to collect the blinded data.
    

Intervention name(s): ReliaTack™; Protack™
Intervention type(s): Device; Device
Intervention description(s): Absorbable tack (ReliaTack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.; Non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Surgery; Laparotomy; Tack; Non-absorbable Tack; Absorbable Tack; Pain
Contingency Management for Meth in South Africa Methamphetamine Abuse in South Africa
Condition: Methamphetamine Abuse
Study type: Interventional

Summary: 
      This study will link findings from neuroscience with clinical outcomes using contingency
      management (CM) to identify changes in brain structure and function that emerge during purely
      behavioral therapy for methamphetamine (MA) use.
    

Detailed description: 
      This study will correlate MA-abstinence outcomes from an 8-week program of voucher-based
      incentives using an escalating schedule for 30 treatment-seeking, MA-dependent individuals
      with scores on tasks of working memory and assessments of neuropsychological and demographic
      status. At the beginning and end of the CM program, participants will participate in MRI
      scans while performing a working memory task and will complete a battery of select
      neurocognitive and psychological assays to address two specific aims: (1) to determine
      whether changes in neural function within frontostriatal circuitry from baseline to end of
      the 8-week CM program are associated with parallel changes in measures of cognitive control
      and impulsivity and with MA abstinence outcomes and (2) to determine whether structural
      changes in frontostriatal circuitry over the 8-week CM intervention correspond with
      neurocognitive, psychological and MA abstinence measures.
    

Intervention name(s): Contingency Management
Intervention type(s): Behavioral
Intervention description(s): as described above
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment