bioihbjkbjnl/mcl2 huggingface dataset:
A Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug interaction of SH229 tablets and
      Daclatasvir dihydrochloride tablets. The study also evaluates the pharmacokinetics and
      tolerability of co-administration of SH229 tablets and Daclatasvir dihydrochloride tablets in
      healthy subjects. This study provides evidence for the designing of following clinical trial
      protocols.
    

Detailed description: 
      A total of 28 evaluable healthy subjects will be enrolled in this study. The dose of SH229 is
      600 mg. The dose of Daclatasvir dihydrochloride is 60 mg.
    

Intervention name(s): SH229; SH229; Daclatasvir dihydrochloride; Daclatasvir dihydrochloride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablet, oral, 600 mg once daily for day 1 to day 14; tablet, oral, 600 mg once daily for day 8 to day 14; tablet, oral, 60 mg once daily for day 8 to day 14; tablet, oral, 60 mg once daily for day 1 to day 14
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV; SH229
Mental Imagery Enhances Proprioception in Patients With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Mental imagery has been used in a variety of pathological instances in support to classical
      therapeutic treatments. The aim of the present study was to observe the effect of internal
      Kinesthetic and external Visual Imagery to improve proprioceptive feedback in low back pain.
      Fifty-five subjects with a history of low back pain were included in two experimental groups
      who used mental imagery and one control group who did not. The results showed the
      effectiveness of the Internal Kinesthetic Imagery to improve the accuracy of repositioning of
      lumbo-sacral spine that may subsequently improve the quality of the proprioceptive input. The
      possibility to use effectively mental imagery, as a part of proprioceptive rehabilitation
      process, is the principal outcome of this study.
    


Intervention name(s): Watching or imagining movement
Intervention type(s): Other
Intervention description(s): Mental imagery are administered in two forms : kinesthetic when subjects imagine the movement of flexion and extension of the lumbar spine and Visual when subjects watch a video of a third person doing the flexion and extension movement
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fifty-five patients, with a history of common low back pain, have participated to the
        study. The subjects have been randomly distributed in two experimental groups and one
        control group. The gender, age, weight and height characteristics of the three groups
        (Visual Imagery Group, VIG; Kinesthetic Imagery Group, KIG; and Control Group, CG) are
        presented in Table 1. The patients presented no history of neurological or psychiatric
        disease, and gave their informed written consent.
      
Keywords: Improvement of the accuracy of Lumbar repositioning
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
Condition: Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with
      Systemic Lupus Erythematosus.
    

Detailed description: 
      This is a phase 1, randomized, double-blind, placebo-controlled, single-and multiple
      ascending dose study. Up to eighty-eight subjects with Systemic Lupus Erythematosus will be
      selected to participate. Subjects will be randomized to receive either ABT-199 or placebo.
      Subjects will be administered ABT-199/placebo as a single dose or up to 14 days as multiple
      doses.
    

Intervention name(s): ABT-199; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Tablet; Tablet
Intervention MeSH terms: Venetoclax
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety
Condition: Maternal Distress (During Labor); Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The incidence of cesarean deliveries (CD) worldwide is increasing, around 30% in United
      States. Although very common surgery women undergoing non emergent CD still experience fear
      and anxiety. It is known that increased levels of stress can negatively affect pain
      perception and the usage of analgesics postoperatively as well as lactation.

      this present study investigate the effect of exposure to informative video before cesarean
      delivery on maternal anxiety.
    

Detailed description: 
      A multi-center randomized control trial the will examine the effect of exposure to
      informative video before cesarean delivery on maternal anxiety and satisfaction
    

Intervention name(s): Informative video
Intervention type(s): Behavioral
Intervention description(s): Exposure to informative video before cesarean delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cesarean delivery; Anxiety; Informative-video
Assessment of Temperature by Infrared Thermography and Blood Conduction Velocity by Doppler After Applying Shortwave Diathermy and Microwave - Correlations With Cardiovascular and Hemodynamic Parameters
Condition: Healthy Individuals
MeSH terms: Hyperthermia
Study type: Interventional

Summary: 
      The deep heat therapies are increasingly frequent in daily physical therapist for the
      treatment of musculoskeletal diseases. The use of such procedures is justified by their
      analgesic, anti-inflammatory, antiespasmolíticos and hiperemiantes. However, studies on the
      cardiovascular effects of these therapies are still incipient. Therefore, this study has as
      objectives: map the skin temperature changes in the lower limbs in different areas and
      positions after applying shortwave diathermy and microwave; assess hemodynamic and autonomic
      cardiovascular parameters, and investigate the occurrence of changes in conduction velocity
      superficial blood resulting from the application of these thermal features. The study will be
      conducted on 40 female volunteers between 18 and 30 years, university, healthy, that fit the
      inclusion and exclusion criteria of the study. The analysis by infrared thermography will be
      held in a room with temperature maintained at 23 ± 1°C and humidity average 50%. The
      volunteers will stay in prone position, with the legs bare, resting for 20 min to stabilize
      skin temperature with temperature of the room. After this period will be held applying
      diathermy of shortwave or microwave for 20 minutes at moderate heat on the lower limb regions
      of the hamstrings and triceps surae in extension and flexion to 180° to 90°. The records beat
      to beat blood pressure and heart rate to autonomic and cardiovascular hemodynamic evaluation
      will be performed by means of equipment Finometer (Finapress Medical Systems, Inc.) and
      electrocardiogram (ADInstruments, Inc.), respectively, before and after application of
      diathermy. On the other hand, the images will be processed using FLIR ThermoScan and blood
      flow data will be collected through the Doppler ultrasound. The results will be processed and
      analyzed using descriptive statistics, submitted to a linear regression model with mixed
      effects (random effects and fixed), with p≤0.05.
    


Intervention name(s): Shortwave therapy; Microwave therapy
Intervention type(s): Other; Other
Intervention description(s): Will be conducted in four stages, on different days: i) lower limb in extension and application of 180° for 20 min, ii) Lower limb knee flexion of 90° and application for 20 min; iii) lower limb extension in 180° without application iv) lower limb knee flexion of 90° without application.; Will be held in two stages, on different days: i) lower limb in extension with angle of 180° and application for 20 min, ii) lower limb in extension of 180° without application.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate improvement and efficacy of paliperidone
      extended-release for subjective well-being and drug attitudes of participants, when switching
      from oral antipsychotics in participants with schizophrenia (psychiatric disorder with
      symptoms of emotional instability, detachment from reality, often with delusions and
      hallucinations, and withdrawal into the self).
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multi-centric
      (conducted in more than one center), prospective (study following participants forward in
      time), and non-comparative study, in participants with schizophrenia. The study consists of
      following parts: Screening (that is, 14 days before study commences on Day 1); Acute
      Treatment phase (24 weeks); Extension phase 1 (24 weeks), which will be followed by
      additional Extension phase 2 (48 weeks). Total study duration per participant will be 96
      weeks. Efficacy will primarily be evaluated by change from Baseline in Subjective Well-being
      Under Neuroleptic (SWN-20) Scale score and change from Baseline in Drug Attitude Inventory
      scores. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Paliperidone
Intervention type(s): Drug
Intervention description(s): Paliperidone ER oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.
Other intervention name(s): R076477; Invega Extended-release tablet
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone Extended-release; Paliperidone; R076477
Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Studies reveal special function of fucoidan so far include anti-virus, anti-tumor,
      immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney
      dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on
      the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.
    

Detailed description: 
      Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy
      surface of brown seaweed has unique ingredients and different kind of brown seaweed has
      slightly different effectiveness. The strongest fucoidan among all seaweed for inhibiting
      cancer cells is in Okinawa Japanese waters. For chemically speaking, the major components for
      fucoidan consisted of mainly fucose which is a kind of polysaccharide with strong biological
      activity. However, patients need to take actual fucoidan in order to reach the best
      effectiveness for inhibiting cancer cell.

      Studies reveal special function of fucoidan so far include anti-virus, anti-tumor,
      immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney
      dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on
      the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.
    

Intervention name(s): 275mg Oligo Fucoidan + 275mg HS Fucoxanthin; placebo pills
Intervention type(s): Other; Other
Intervention description(s): Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.; taking placebo pills as if patients are under treatment.
Intervention MeSH terms: Fucoidan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Comprehensive Investigation of Heart Rate Variability as a Measure of the Autonomic Nervous System in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      The purpose of this research is to study heart rate patterns in people with moderate to
      severe atopic dermatitis and how itching affects those patterns.
    

Detailed description: 
      To comprehensively evaluate the autonomic nervous system through heart rate variability (HRV)
      measurements in patients with moderate to severe atopic dermatitis suffering from pruritus.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Wake Forest University Health Sciences Dermatology Clinic population and from appropriate
        IRB-approved advertising in the community.
Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the
      symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side
      effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney
      abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the
      knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is
      to determine the safety and effectiveness of a topical NSAID when used alone or when combined
      with an oral NSAID in the treatment of osteoarthritis of the knee.
    

Detailed description: 
      During this 12-week study, patients will visit the study clinic 5 times. At the screening
      visit, the patient's demographic information, medical and medication history will be recorded
      and a physical examination performed. After washout of all NSAIDs/other analgesic medication,
      the patient will return for the baseline visit. During the treatment phase of the study, the
      patient will apply a topical solution to his/her osteoarthritic knee and take an oral study
      tablet. The patient may randomly receive active treatment with topical diclofenac, oral
      diclofenac, both, or neither (placebo). Follow-up clinic visits are conducted at 4, 8 and 12
      weeks. Routine laboratory analyses are done at baseline, 4 and 12 weeks.
    

Intervention name(s): Diclofenac, topical
Intervention type(s): Drug
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: topical NSAID; topical diclofenac
High-intensity Exercise Training or Multidisciplinary Treatment in Extremely Obese Adolescents
Condition: Obesity; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The aim of the present study was to determine the effects of a multidisciplinary approach and
      intensity-controlled interval training on cardiovascular risk factors in overweight
      adolescents
    


Intervention name(s): intensity controlled interval training (AIT); Multidisciplinary approach (MTG)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 4 x 4 min intervals at 90% of maximal heart rate, each interval separated by 3 min at 70%, twice a week for 3 months; exercise, dietary and psychological advice, twice a month for 12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent; Overweight; Exercise; multidisciplinary approach; Oxygen uptake; Flow mediated dilatation; Cardiovascular Risk Factors
Establishing Malnutrition Diagnosis System by Using Artificial-intelligence Technology
Condition: Disease-related Malnutrition
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      The prevalence of malnutrition is estimated at 30-50% of hospitalized patients in China.
      Disease-related malnutrition increases the risk of infection, mortality, length of
      hospitalization as well as the economic burden. National Nutrition Plan proposed to reduce
      malnutrition, but a clear, effective roadmap and protocol has not existed yet. Several
      factors impede to resolve the above challenges. They include :1) the low efficiency of
      current malnutrition diagnosis methods; 2) the lack of dynamic, standard method that can
      evaluate nutritional status in quantitative way. To this end, the investigators aim to
      establish an artificial-intelligence malnutrition diagnosis system to improve the application
      of malnutrition Clinical Pathway. Firstly, the investigators will establish a
      multidimensional malnutrition large data set, based on our previously built national hospital
      nutrition screening data set.

      It will contain deep 3D facial images, semi-structured and structured electronic medical
      record. Then, the investigators will use ensemble learning algorithm to establish a fully
      automatic, artificial-intelligence malnutrition diagnosis model that includes both
      etiological and phenotypic diagnosis.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Hospitalized patients in Peking Union Medical College
Patient Anxiety Associated With Lymphedema Surveillance Method
Condition: Anxiety
MeSH terms: Lymphedema; Anxiety Disorders
Study type: Interventional

Summary: 
      We propose to study the impact of BIA screening on anxiety and primary prevention strategies
      for lymphedema development among patients with recent surgery for breast cancer. Currently,
      professional societies recommend scheduled follow-up visits to screen for lymphedema after
      recovery from breast cancer (e.g., 6-week, 3-month, 6-month visits with a certified
      lymphedema therapist). Screening involves a discussion of lymphedema symptoms and risk
      reduction strategies, measurement of the affected limb with a tape measure, and physical
      inspection for physical changes consistent with lymphedema. In the proposed study, patients
      will be randomly assigned to the addition of BIA screening vs. usual care. At each screening
      visit, all patients will be assessed for their current lymphedema risk behaviors, as outlined
      by the National Lymphedema Network (7). To evaluate anxiety levels, all patients will be
      asked to fill out the Beck Anxiety Inventory, a validated screening tool used in prior
      studies of patients with breast cancer (8,9). This questionnaire will be administered at each
      follow-up lymphedema screening visit, and the baseline will be administered at the
      preoperative visit. For patients randomly assigned to BIA screening, this involves the
      placement of adhesive electrodes on the each wrist and an ankle, followed by connection of
      the electrodes to the BIA machine, which then uses a painless electrical impulse to measure
      impedance of flow and thus asymmetry in the extracellular lymphedema volume between the 2
      upper limbs (6,10). Statistical analysis will involve comparison of lymphedema risk behaviors
      and anxiety levels between those patients with vs. without BIA screening.
    


Intervention name(s): Bio-Impedance Testing; Anxiety Questionnaire; Traditional Circumferential Measurements
Intervention type(s): Device; Other; Other
Intervention description(s): Participants in the BIA Arm will also undergo bio-impedance testing with this device.; 21 item questionnaire
Other intervention name(s): LTU-400 by Impedimed; Beck Anxiety Inventory will be administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Lymphedema
Plug Arterial Closure System (PACS, 7F)
Condition: Angioplasty, Transluminal, Percutaneous Coronary; Coronary Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and feasibility of the 7F Ensure Medical
      Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or
      interventional coronary procedures using a standard 7F introducer sheath.
    

Detailed description: 
      Achieving hemostasis at the arterial puncture site after percutaneous cardiac catheterization
      is a potential cause of bleeding, hematomas, pseudoaneurysms, and various other vascular
      complications. Hemostasis at the femoral artery access site after diagnostic or
      interventional procedures is typically achieved using either manual compression or the
      deployment of a vascular closure device. Manual compression is time consuming for the
      health-care provider, and painful for the patient. In addition, prolonged periods of
      immobilization and bed rest may be required. Vascular closure devices have been developed to
      avoid manual compression, shorten bed rest, and allow earlier ambulation.

      The Ensure Medical Vascular Closure device (VCD) is intended for femoral artery puncture site
      closure in patients who have undergone coronary catheterizations using a standard 7F
      introducer sheath. The device is comprised of a bio-absorbable plug and a plug delivery
      system. The plug delivery system is designed to position the bio-absorbable plug to the
      extravascular surface of the femoral artery access site, facilitating a hemostasis response.
      The Ensure Medical VCD has been studied in a prior feasibility trial of 149 patients
      utilizing a 6F introducer sheath, which demonstrated that: (1) the device could be used to
      successfully obtain rapid hemostasis and early ambulation in patients undergoing
      catheterization procedures; and (2) the low incidence and relatively minor nature of the
      observed closure related complications suggests that the device is safe for its intended
      purpose.
    

Intervention name(s): Vascular access site closure (7F Ensure)
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Closure Device; Angiography; Angioplasty; Hemostasis; Heart Catheterization; Vascular Closure; Peripheral Closure; Coronary Angiography