bioihbjkbjnl/mcl2 huggingface dataset:
Detection of Human Immunodeficiency Virus Type 1 (HIV-1) in Vaginocervical Secretions: Correlation With Clinical Status, Virologic and Immunologic Parameters, and the Presence of Other Infections
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Observational

Summary: 
      To correlate HIV-1 viral load in vaginocervical secretions (VCS), as measured by culture and
      nucleic acid detection, with that found in peripheral blood and HIV clinical status. To
      determine whether systemic and local HIV specific antibody influences the quality and type of
      virus isolated from VCS. To ascertain whether the presence of specific infectious agents
      (e.g., HPV, HSV, CMV, etc.) influences the amount and type of virus isolated from VCS.

      Predictors for the development of the acquired immunodeficiency syndrome (AIDS) in HIV
      infected individuals have been studied primarily among adult males and in selected small
      populations. Although many of these predictors may be relevant to women, HIV infection does
      manifest itself differently between the sexes. Therefore, it is important to study the
      spectrum of HIV disease in women and to identify unique and common markers, cofactors, and
      predictors of disease progression.
    

Detailed description: 
      Predictors for the development of the acquired immunodeficiency syndrome (AIDS) in HIV
      infected individuals have been studied primarily among adult males and in selected small
      populations. Although many of these predictors may be relevant to women, HIV infection does
      manifest itself differently between the sexes. Therefore, it is important to study the
      spectrum of HIV disease in women and to identify unique and common markers, cofactors, and
      predictors of disease progression.

      Part 009: HIV-infected female adults, independent of CD4+ cell count, will provide blood and
      VCS specimens obtained at a single study visit, regardless of ovulatory phase.

      NOTE: Subjects in this study will be patients who are currently enrolled in a multisite
      longitudinal study, Women's Interagency HIV Study (WIHS), which is designed to elucidate the
      natural history of infection with HIV-1 in U.S. women. Participation in DATRI 009 will
      require additional blood at the patient's scheduled WIHS visit.

      Part 009a: Consent will be obtained from 65 women to allow additional evaluations to be
      completed on their reserve VCS specimen and on an additional peripheral blood specimen,
      specifically obtained for DATRI 009a during their 009 visit. An additional 8 ml CPT tube will
      be collected from these patients, bringing their total blood volume to 32 ml at their
      scheduled WIHS visit.
    

Observational model: Natural History
Keywords: HIV-1; Vagina
Serum and Peritoneal Fluid Bank for Endometriosis Markers
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The purpose of this study is to investigate differences in protein expression profiles of
      blood and peritoneal fluid samples obtained from patients who do, and those who do not, have
      endometriosis seen during laparoscopic surgery. These profiles may include both known and
      novel markers for diagnosing endometriosis.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing Laparoscopy at HUP
      
Biospecimen description: 
      Serum, Plasma, Peritoneal fluid
    
Keywords: Endometriosis
A Phase 1 Study of the Safety and Pharmacokinetics of GC4711 (Oral Capsule) Compared to GC4419 (IV Infusion) and GC4711 (IV Infusion) in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the phase 1, GTO-003 clinical study is to determine the safety and
      pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule.
      This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or
      GC4711 when either is given as an intravenous infusion.
    


Intervention name(s): GC4711 Oral Capsule G-101; IV GC4419; GC4711 Oral Capsule G-101; GC4711 Oral Capsule G-101; GC4711 Oral Capsule G-111; GC4711 Oral Capsule G-112; GC4711 Oral Capsule G-119; GC4711 Oral Capsule G-125; IV GC4711
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 82 mg (1 capsule); GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump.; 164 mg (2 capsules); 246 mg (3 capsules); 175 mg (1 capsule); 145 mg (1 capsule); 233 mg (1 capsule); 233 mg (1 capsule); GC4711 will be infused IV as a single dose of 30 mg in 250 mL normal saline, totaling 251 mL, over a 60-minute period using a programmable pump.
Intervention MeSH terms: Avasopasem manganese
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multicenter Study to Evaluate the Safety of Seasonique, an Oral Contraceptive.
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral
      contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for
      up to an additional three consecutive years.
    

Detailed description: 
      This study is being conducted to evaluate the safety of an extended-regimen oral
      contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for
      up to an additional three consecutive years. This is an extension of the Seasonique Phase 3
      clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are
      eligible for participation.
    

Intervention name(s): Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets
Intervention type(s): Drug
Intervention description(s): 1 tablet daily
Other intervention name(s): Seasonique
Intervention MeSH terms: Levonorgestrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: oral contraceptives; birth control; ethinyl estradiol; pregnancy prevention
Effect of Ursolic Acid of Loquat Extract on Function of Muscle
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This randomized, placebo-controlled, double-blind study was designed to investigate the
      efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function
      improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per
      day or a placebo for 12 weeks.
    

Detailed description: 
      This randomized, placebo-controlled, double-blind study was designed to investigate the
      efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function
      improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per
      day or a placebo for 12 weeks. Change over time in muscle fuction was evaluated by four
      outcomes: assessment of appendicular skeletal mass using DEXA (dual energy X-ray
      absorptiometry); quadriceps muscle power by Biodex; hand grib power; and Short Physical
      Performance Battery, SPPB.
    

Intervention name(s): UA group
Intervention type(s): Dietary Supplement
Intervention description(s): Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age
Condition: Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric
      subjects
    

Detailed description: 
      The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in
      pediatric subjects
    

Intervention name(s): ceftaroline
Intervention type(s): Drug
Intervention description(s): Single parenteral infusion at a dose of 8 mg/kg for subjects weighing less than 75 kg or at a dose of 600 mg for subjects weighing greater than or equal to 75 kg infused over 60 minutes.
Other intervention name(s): ceftaroline for injection; ceftaroline fosamil
Intervention MeSH terms: Ceftaroline fosamil; Cephalosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: PK; Pharmacokinetics
Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To
      evaluate the safety and tolerability of low concentration Ioforminol Injections. Study
      recruits healthy volunteers.
    


Intervention name(s): Ioforminol 160 mgI/mL; Ioforminol 200 mgI/mL; Iopamidol 300 mgI/mL
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Given as s single administration to the subject; Given as a single administration to the subject; Given as a single administration to the subject
Other intervention name(s): Ioforminol; Ioforminol; Iopamidol; Isovue 300; Isovue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Use in Abdominal; Contrast Enhanced; Computed Tomography; Optimize concentration; dosage of Ioforminol Injection
Teriparatide as a Chondroregenerative Therapy in OA
Condition: Knee Osteoarthritis; Cartilage Degeneration
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate teriparatide (TP) as a chondroregenerative therapy
      for human knee osteoarthritis (OA). The central hypothesis to be tested is that TP supports
      structural modification of the joint and improves biomarker, functional and patient-reported
      measures of knee OA.
    

Detailed description: 
      This is a prospective, randomized, placebo controlled, double blinded, crossover study. The
      investigators will identify, recruit and enroll 80 subjects with symptomatic, unilateral
      medial compartment knee OA. Enrolled subjects will be randomized into equal TP (in the FDA
      approved form, Forteo) or placebo arms of 40 subjects each (includes allowance for a 25%
      dropout rate with no replacements). All subjects will be treated for 24 weeks, then followed
      for an additional 24 weeks to assess the durability of any observed effects. The trial
      incorporates a crossover design, based on interim analysis of the 24 week outcome data after
      every subject has completed the 24 week treatment period. If positive effects on structural
      and/or biomarker measures are apparent from the interim analysis, placebo treated subjects
      will be offered TP (in the FDA approved form, Forteo) and followed for an additional 24
      weeks. If the placebo subjects who choose to participate in the crossover treatment have not
      yet completed the 48 week visit, it will not occur. These subjects will begin the crossover
      portion 24 week treatment and monitoring period when they receive the TP pens (in the FDA
      approved form, Forteo).
    

Intervention name(s): Teriparatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mcg of teriparatide injected in thigh or abdomen once a day for 24 weeks.; 20 mcg of saline injected in thigh or abdomen once a day for 24 weeks.
Other intervention name(s): Group 1; Forteo; Group 2
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, randomized, placebo controlled, double blinded study. Interim results will determine if there is a crossover.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the present study is to evaluate the effects of a blockade of the vasopressin
      system and central hemodynamic system in heart failure (HF) patients during physical
      exercise. The significance of the vasopressin system during physical exercise is unclear. If
      vasopressin is a significant regulator of exercise hemodynamics in HF, strategies to
      intervene against activation of the V1A-receptor might be expected to improve HF symptoms and
      possibly outcome.

      The potential effects of the central hemodynamic system will be evaluated with a Swan-Ganz
      catheter. Echocardiography will be performed at rest and during submaximal working capacity
      before and during the infusion of a vasopressin receptor antagonist (conivaptan) or placebo.
      Cardiac output will be measured by thermodilution. The exercise test will be performed at 50
      % of VO2 max and hemodynamic and echocardiographic measurements will be collected. The
      exercise test will be performed on a supine multistage bicycle.
    


Intervention name(s): Conivaptan; Placebo (Dextrose)
Intervention type(s): Drug; Drug
Intervention description(s): Conivaptan treatment: 20 mg bolus followed by infusion of 2 mg/hour; Placebo treatment: 20 mg bolus followed by infusion of 2 mg/hour
Other intervention name(s): Vaprisol; 5 % dextrose
Intervention MeSH terms: Conivaptan
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vasopressin; Exercise capacity; Conivaptan
Muscle Activity During Load Carriage in ROTC Cadets
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      Army ROTC Cadets who are currently enrolled in Military Science courses will be asked to
      participate in this experimental research design. A total of 30 healthy cadets consisting of
      approximately 24 males and six females will be recruited, as this will provide an accurate
      representation of the overall Army demographics with 17% being female.

      Paperwork: After providing consent, participants age and gender will be documented, and
      height and weight will be measured and documented. Participants will complete a modified
      version of the Modified Oswestry Low Back Pain Disability Questionnaire, which has been
      adjusted to be more specific to the military population. The questionnaire will be filled out
      indicating the cadet's current level of pain. They will then complete the same questionnaire
      indicating their pain within the last year.

      Protocol: First, the skin will be prepared and surface electromyography (EMG) electrodes will
      be placed. Dynamic, surface EMG data will be obtained of the gluteus medius, gluteus maximus,
      erector spinae, rectus femoris, and biceps femoris muscles in accordance with SENIAM (Surface
      Electromyography for the Non-Invasive Assessment of Muscles) guidelines. Skin preparatation
      will consist of trimming hair if the skin surface at which the electrodes have to be placed
      is covered with hair. Next, the skin will be cleaned with alcohol. The skin will be allowed
      to dry prior to electrode placement. Lastly, skin will be abraded to reduce impedance.
      Following electrode application, participants will complete five minutes of light activity on
      a bike or treadmill for warm-up. Next, in order to normalize the data, manual muscle tests
      will be performed for each of the six muscles being test. Then, participants will walk at a
      speed of four miles per hour for 10 seconds as a dynamic measurement for normalizing the
      data.

      After completion of the two normalization protocols, participants will complete a five
      kilometer (3.1 mile) walk on a treadmill at a speed of three miles per hour, with and without
      a 35 lb. load carried in a traditional rucksack. The load conditions will be randomized and
      counterbalanced in order to mitigate effects of fatigue, and the conditions will be performed
      in two separate sessions (separated by 24-48 hours).
    


Intervention name(s): load carriage
Intervention type(s): Other
Intervention description(s): 35 pound load carried on the back
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Screening
Study of the Bioequivalence and Food Effects of HRX0701 Tablets in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the bioequivalence of a single oral dose of HRX0701 tablets and the reference
      formulations retagliptin phosphate tablets and metformin hydrochloride tablets in healthy
      subjects in the postprandial state; To evaluate the pharmacokinetic effects of a high-fat
      diet on retagliptin and metformin after a single oral administration of HRX0701 tablets in
      healthy subjects.
    


Intervention name(s): hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets; hrx0701 tablets
Intervention type(s): Drug; Drug
Intervention description(s): High-specification group: subject preparation: HRX0701 (50 mg/1000 mg) 1 tablet (to be taken after a meal); Reference preparation: 1 tablet of retagliptin phosphate (50 mg), 2 tablets of metformin hydrochloride (Glucophage®) (500 mg), taken twice after meals.
Low Specification Group:
Preparation: HRX0701 (50 mg/850 mg) 1 tablet (taken after a meal); Reference: 1 tablet of retagliptin phosphate (50 mg), 1 tablet of metformin hydrochloride (Glucophage®) (850 mg), taken twice after meals.; High specification group HRX0701 (FDC) tablets (50 mg / 1000 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach).
Low-spec group HRX0701 (FDC) tablets (50 mg / 850 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach).
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: HRX0701 tablets are used alone, or Retagliptin phosphate tablets are used in combination with metformin hydrochloride tablets.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Tolerability of Topical LFX453 for External Genital Warts
Condition: External Genital Warts
MeSH terms: Warts; Condylomata Acuminata
Study type: Interventional
Phase: Phase 2

Summary: 
      The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety,
      tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an
      additional open label arm using imiquimod 5%.

      During the study the patients received either LFX453, placebo or active comparator and the
      tolerability and safety was assessed continuously through local tolerability assessments and
      adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study
      biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken
      for safety, pharmacokinetics (PK), and biomarkers.
    


Intervention name(s): Investigational Treatment; Aldara
Intervention type(s): Drug; Drug
Intervention description(s): Applied twice daily for up to 12 weeks; Applied 3 times a week for 16 weeks
Other intervention name(s): imiquimod
Intervention MeSH terms: Imiquimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: human papilloma virus (HPV), Genital Warts, Sexually transmitted disease (STD), viral disease
Mobile Monitoring of Fracture Healing
Condition: Tibial Fractures
MeSH terms: Fractures, Bone; Tibial Fractures
Study type: Observational

Summary: 
      The objective of this study is to develop methods for using forces measured on circular
      external fixators to predict the state of individual patient's healing of severe tibial
      fractures and defects.
    

Detailed description: 
      Patients receiving external fixators for tibial fractures and defects will be recruited.
      Normal struts on the device will be substituted with similar but instrumented struts which
      enable force measurement. During clinical visits, forces in the fixator, plus foot forces,
      will be measured during ambulation. Changes in force measurements across treatment and bone
      healing will be analyzed.

      Severe fractures in the lower limb are associated with high energy trauma in both civilian
      and military patients,and are sometimes treated with external fixation devices to stabilize
      the bone until healing has occurred. The devices are kept on the patient for up to a year or
      more at significant cost, intrusiveness, and risk of infection. The clinician must decide
      when to remove the device such that adequate healing has occurred and the bone will not
      re-fracture, but healing rates are variable and x-rays can be misleading. The clinician must
      also identify when a patient is starting to progress poorly and an early revision surgery is
      needed to prevent further complications.

      The investigators' goal is to develop novel approaches for instrumenting and collecting
      mechanical data from orthopaedic braces and devices, and identifying new methodologies for
      interpreting this large volume of functional data for optimizing personalized treatment. The
      present study is focused on external fixators. Strain gauges will be adhered to the fixators
      so that fixator forces can be measured during clinical visits. In this pilot study the
      investigators will develop methods to predict healing based on these measured forces.
    

Intervention name(s): Force monitoring of external fixator struts
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing treatment for severe tibia fracture and/or defect using a circular
        external fixator.
HBA1c and Diagnosis of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Following the 6th Tromso study subjects with HbA1c > 5.7 plus a subsample of subjects with
      lower hba1c values will be invited to an oral glucose tolerance test to see the predictive
      value of HBA1c in the diagnosis of type 2 diabetes.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        random sample of subjects living in Tromso and who participated in the 6 th Tromsø study
      
Biospecimen description: 
      serum
    
Keywords: type 2 diabetes; HbA1c; vitamin D; diagnosis