bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Endometrial Receptivity of FET Patient by Ultrasounicelastography
Condition: Assisted Reproductive Technology; Ultrasonography
Study type: Interventional

Summary: 
      Prospective clinical study ：observing the correlation between endometrial elasticity score,
      endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical
      pregnancy rate. In order to find a non-invasive, convenient and comprehensive evaluation
      method of evaluating the endometrial receptivity, and to provide effective means for the
      frozen embryo transplantation patients to improving pregnancy outcome.
    

Detailed description: 
      Randomly selecting 20-40 years patients were prepared to accept frozen embryo transplant ;
      HRT cycle preparation of endometrium；choosing HRT plan to prepare the transplantation
      endometrium.Establishing a strict standard of exclusion and exclude standard to exclude
      endometrial lesions and underlying disease.The patients were given elastography for 5-7 days
      afterEndometrium transformation.Observing the correlation between endometrial elasticity
      score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and
      clinical pregnancy rate. In order to find a non-invasive, convenient and comprehensive
      evaluation method of evaluating the endometrial receptivity, and to provide effective means
      for the frozen embryo transplantation patients to improving pregnancy outcome.
    

Intervention name(s): Ultrasounicelastography
Intervention type(s): Other
Intervention description(s): Observing the correlation between endometrial elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate.
Intervention model: Single Group Assignment
Intervention model description: Prospective study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ultrasounicelastography; Frozen embryo transplantation; Endometrial Receptivity; pregnancy outcome
A Study To Estimate The Amount Of CP-690,550 (Study Drug) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of CP-690,550 In Tablet Form
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate
      occasions by two different routes of administration: One time by mouth in tablet form and one
      time by vein (intravenous form). The amount of CP-690,550 available in the blood following
      administration by vein will be measured and is expected to reflect the maximum amount
      possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the
      blood following oral tablet administration will also be measured and compared to that
      achieved following administration by vein in order to estimate how much of the maximum amount
      possible is actually absorbed into the blood following administration by mouth as a tablet.
    

Detailed description: 
      To estimate the absolute bioavailability of a 10 mg oral dose of tasocitinib (CP-690,550)
      compared to a 10 mg intravenous dose of tasocitinib (CP-690,550) in healthy subjects.
    

Intervention name(s): Tasocitinib 10 mg oral tablet; Tasocitinib 10 mg IV Infusion
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet; Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Absolute Bioavailability; Rheumatoid Arthritis
HIV and HCV Intervention In Drug Treatment Settings - 1
Condition: Behavior Therapy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test two strategies to reduce the risk of contracting Human
      Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) by reducing risk behaviors in
      patients undergoing drug detoxification.
    


Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Primary purpose: Prevention
Keywords: behavioral intervention
A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant
Condition: Allografts; Rejection; Transplant, Kidney; Transplant Rejection; Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of dual
      costimulation blockade with VIB4920 in combination of belatacept in adult male or female
      recipients of a renal allograft from a deceased, living unrelated or human leukocyte antigen
      (HLA) non-identical living related donor.
    


Intervention name(s): Belatacept; VIB4920; Thymoglobulin; Methylprednisolone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Protocol versions 1 through 4: Belatacept 10 mg/kg by intravenous (IV) infusion on post-op Day 1, repeated on post-op Day 3 or 4 (timing is at investigator's discretion), and at the end of Weeks 2, 4, 8 and 12; then 5 mg/kg IV every 4 weeks from Week 16 to Week 48.; Protocol versions 1 and 2: VIB4920 1500 mg by IV infusion on post-op Days 1 and 14, and at the end of Weeks 4, 6, 8 and 10; then 1500 mg every 4 weeks from Week 12 to Week 48.
Protocol versions 3 and 4: VIB4920 1500 mg by IV infusion on post-op Days 1, repeated on post-op Day 3 or 4 (timing is at investigator's discretion), Week 2, and at the end of Weeks 4, 6, 8, and 10; then 1500 mg every 4 weeks from Week 12 to Week 48.; Protocol versions 1 and 2: Thymoglobulin 3.0 mg/kg by intravenous (IV) infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0) (1 dose).
Protocol versions 3 and 4: Thymoglobulin 1.5 mg/kg by intravenous infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0), prior to VIB4920+belatacept infusion on post-op Day 1, on post-op Day 2, and prior to VIB4920+belatacept infusion on post-op Day 3 or 4.; Protocol versions 1 and 2: Methylprednisolone by IV infusion (500, 250, 125 and 60 mg on Days 0, 1, 2 and 3, respectively) followed by oral administration of prednisone 30 mg per day on Days 4, 5, and 6.
Protocol versions 3 and 4: Methylprednisolone by IV infusion (500, 250, 125 and 60 mg on Days 0, 1, 2 and 3, respectively) followed by oral administration of prednisone 30 mg per day on Days 4, 5, 6 and 7. Participants may be tapered to at least 20 mg per day on Day 8, to at least 10 mg per day on Day 15, and to at least 5 mg per day on Day 22. Discontinuation of prednisone following the post-op Day 28 visit.
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Abatacept; Prednisolone hemisuccinate; Prednisolone phosphate; Thymoglobulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Renal allograft dysfunction; Cell-mediated rejection; Antibody mediated rejection; Immunosuppression; Acute rejection; VIB4920; MEDI4920; Belatacept; Thymoglobulin; Methylprednisolone; Corticosteroids
Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)
Condition: Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate immunogenicity and safety of Measles
      Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two
      vaccinations.
    


Intervention name(s): MV-CHIK lyophilised formulation, low dose; MV-CHIK liquid frozen formulation, low dose; MV-CHIK SPS® formulation, low dose; MV-CHIK liquid frozen formulation, high dose; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Other
Intervention description(s): MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular [IM] injection): 5x10^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.; MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.; MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10^5 ±0.5 log TCID50/dose.; MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10^6 ±0.5 log TCID50/dose.; Sterile physiological saline solution (0.9% sodium chloride [NaCl]), administered by IM injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Chikungunya fever
Face Photoaging: Efficacy and Tolerance Evaluation of an Intradermal Injective Treatment
Condition: Face Skin Photoaging
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      Efficacy and tolerance evaluation of an intradermal injective treatment
    

Detailed description: 
      Primary end point of the study was to evaluate clinically and by non-invasive instrumental
      evaluations tolerance and efficacy of SUNEKOS ® 200 injectable treatment on main sign of face
      skin photoaging; the micro-injections of the study product were performed by a specialized
      dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior
      margin of tragus, lip marionette lines, mandibular angle) of female volunteers aged 45-65
      years, with photoaging of mild/moderate grade.
    

Intervention name(s): SUNEKOS ® 200
Intervention type(s): Device
Intervention description(s): micro-injections of the study product were performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of female volunteers aged 45-65 years, with photoaging of mild/moderate grade
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ACUpuncture in Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      Multicentric,randomized, two-armed confirmatory trial on the effectiveness of acupuncture in
      patients with symptomatic peripheral diabetic neuropathy compared to routine care.
    

Detailed description: 
      The study will investigate the effect of a series of acupuncture treatments on subdimensions
      of neuropathic symptoms, such as pain, tingling and numbness. Neurophysiological testing of
      the affected nerves are incorporated into the study as a possible morphological correlate of
      functional and clinical findings.
    

Intervention name(s): acupuncture; routine care
Intervention type(s): Procedure; Drug
Intervention description(s): semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks; pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: multicenter, open label, randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acupuncture; peripheral neuropathy; diabetes mellitus type II; neurophysiology; nerve conduction velocity
Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue for the Treatment of Type-1 Diabetic Patients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study seeks to use microdialysis and microperfusion techniques to assess the feasibility
      of combining insulin delivery and glucose sensing at a single subcutaneous tissue site.
    

Detailed description: 
      Current treatment of in type 1 diabetes comprises the measurement of glucose in capillary
      blood obtained by fingersticking and administration of exogenous insulin in the form of a
      subcutaneous bolus injection or subcutaneous infusion. This treatment could be simplified if
      there were a stable ratio between blood glucose concentration and tissue glucose level at the
      site of insulin delivery so that tissue glucose levels could be used to estimate blood
      glucose levels, thereby circumventing the need for fingerstick blood glucose monitoring.

      The aim of this study is to ascertain whether a stable ratio between the blood glucose
      concentration and the glucose levels at the tissue site of insulin infusion exists when this
      tissue site is exposed to variable insulin infusion rates. To achieve this, microdialysis and
      microperfusion probes are applied in healthy and type 1 diabetic subjects to perform insulin
      delivery and glucose sampling at the same adipose tissue site during euglycemic clamps and
      oral glucose tolerance tests.
    

Intervention name(s): OGTT and CLAMP
Intervention type(s): Procedure
Intervention description(s): Oral Glucose Tolerance Test (OGTT):
Oral glucose tolerance test combined with subcutaneous insulin delivery and glucose sampling using a single microdialysis or microperfusion probe.
Hyperinsulinemic euglycemic clamp (CLAMP):
Hyperinsulinemic euglycemic clamp with simultaneous subcutaneous insulin delivery and glucose sampling using microdialysis and microperfusion probe.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B
      virus treatment drug Freethiadine in Healthy subjects and in patients with chronic hepatitis
      B
    


Intervention name(s): Freethiadine tablets(part I); Freethiadine tablets (part II); Freethiadine placebo tablets; entecavir tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV); once or twice daily for consecutive 28 days; Subjects will receive either a single dose of Freethiadine on Day 1 only (SAD HV), twice daily dosing of Freethiadine starting on Day 1 through Day 10 (MAD HV); once daily for consecutive 28 days
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Phase I Study of GW856553 (Losmapimod)
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first study of losmapimod in Japanese subjects. This study will be a
      single-center, single blind, phase I and two part study to characterize the safety,
      tolerability, pharmacokinetic and pharmacodynamic profiles in healthy Japanese volunteers
      (male and female of non-childbearing potential). Part1 will be a single dose, randomized,
      three-period, placebo-controlled and dose escalation part. Each subject will participate in 3
      dosing sessions, and receive, on separate days, three of four treatments of losmapimod 2.5,
      7.5 and 20 mg, and the matching placebo in the fasted state after overnight fast (at least 10
      hours). The design incorporates sufficient washout between treatments (at least 7 days after
      the previous administration), and is an efficient design for the study objectives. Part 2
      will be a fixed dose and placebo-controlled part. Each subject will participate in one dosing
      session, and receive losmapimod 7.5 mg or the matching placebo twice daily in the fasted
      state for 14 days. Only subjects will be blind to the sequence and dose studied. The study
      will include the placebo treatment to allow a valid evaluation of adverse events attributable
      to treatment versus those independent of treatment. Approximately 18 subjects in each part
      will receive treatments of losmapimod and/or placebo in the design. The primary objective of
      the study is to characterize the safety and tolerability of single doses and repeat doses of
      losmapimod in healthy Japanese subjects. Serial pharmacokinetic samples will be collected and
      safety assessments will be performed following each dose.
    


Intervention name(s): Losmapimod for single dose; Losmapimod for repeat dose
Intervention type(s): Drug; Drug
Intervention description(s): Film coated white tablet; Film coated white tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis
Condition: Hyperhidrosis Primary Focal Axilla
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is intented to evaluate the efficacy and safety of MEDITOXIN compared to placebo
      in treatment of primary axillary hyperhidrosis.
    


Intervention name(s): Meditoxin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 50U of MEDITOXIN is injected intradermally to each axilla; normal saline is injected intradermally to each axilla
Intervention MeSH terms: Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
I-STAND R21: Reducing Sedentary Time in Older Adults
Condition: Obesity; Sedentary Lifestyle
Study type: Interventional

Summary: 
      The investigators are doing a study to learn how to support patients aged 60+ in taking more
      breaks from sitting and reducing total sitting time. The goal of the study is to find out if
      a sitting time reduction intervention reduces sitting time compared with a control group.
    

Detailed description: 
      More than one-third of American adults over 60 have a body mass index > 30 kg/m2. These older
      adults have more sedentary time than any other group -- an average of 10-11 hours per day.
      Reducing the sedentary behavior of older adults with obesity, rather than only promoting more
      intensive physical activity, could provide a more feasible approach to health promotion.

      This randomized control pilot trial will evaluate a 12-week intervention to decrease sitting
      time and increase standing time and light physical activity among sedentary older adults a
      body mass index > 30 kg/m2 as compared to control group. Baseline and 12-week measurements
      include anthropometric measures, blood draw by finger stick, cardiovascular health
      assessments, physical function tasks, and a survey. The intervention will consist of two
      in-person visits with a health coach followed by phone-based coaching.
    

Intervention name(s): I-STAND; Healthy Living
Intervention type(s): Behavioral; Other
Intervention description(s): Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.; Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Sedentary time; Sit-to-stand transitions
Imaging Biomarkers for TMS Treatment of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this research is to learn more about how rTMS works to reduce the symptoms of
      depression. This information can be used to improve the effectiveness of the treatment. The
      study will use functional magnetic resonance imaging (fMRI) to examine changes in brain
      function after treatment with rTMS. fMRI is a safe and painless technique that allows
      investigators to observe the brain "at work." The investigators will use fMRI to see what
      regions of the brain become active when you perform a concentration task and how that
      activation is changed after rTMS.
    


Intervention name(s): repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention type(s): Device
Intervention description(s): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.
Other intervention name(s): TMS; NeuroStar; Sham treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Major Depression; Major Depressive Disorder; TMS; rTMS
Pharmacokinetics - Pharmacodynamic Study of HT-2157 in Healthy Subjects and in Patients With Major Depressive Disorder
Condition: Healthy Volunteers (Part 1); Major Depressive Disorder (Part 2)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability,
      and pharmacokinetics of HT-2157 in healthy normal volunteers

      Part 2 is a randomized, double-blind, placebo-controlled, multiple (21-day) ascending-dose
      evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-2157 in
      patients with major depressive disorder
    

Detailed description: 
      This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability,
      and pharmacokinetics of HT-2157 administered for 7-days in healthy normal volunteers

      Part 2 is a randomized, double-blind, placebo-controlled, multiple ascending-dose evaluation
      of the safety, tolerability, pharmacokinetics of HT-2157 administered for 21-days in patients
      with major depressive disorder. The primary objective of Part 2 is to assess the CNS
      penetration of HT-2157 in cerebrospinal fluid. In addition, the potential activity of HT-2157
      in this patient population may be assessed using exploratory biologic and pharmacodynamic
      markers of potential efficacy
    

Intervention name(s): HT-2157; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): QD oral dosing; QD oral dosing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science