bioihbjkbjnl/mcl2 huggingface dataset:
Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to determine if the uptake of anti-HIV medication, called
      Genvoya®, at different time-frames, is different at several body sites, including mucosal
      tissues. This medication might be considered for on-demand PEP regimens in the future.
    

Detailed description: 
      Men who have sex with men (MSM) continue to be disproportionately affected by HIV. The
      majority of MSM acquire HIV after exposure to the rectal mucosa through unprotected receptive
      anal intercourse. Post-exposure-prophylaxis (PEP) is an intervention that is used to prevent
      HIV infection soon (72 hours) after a potential exposure. HIV-negative people with a possible
      exposure to HIV are instructed to take 28 days of a combination anti-HIV medication regimen,
      Truvada® + Raltegravir.

      This study is being conducted to determine if the uptake of another anti-HIV medication,
      called Genvoya®, at different time-frames, is different at several body sites, including
      mucosal tissues. This medication might be considered for on-demand PEP regimens in the
      future.
    

Intervention name(s): Genvoya
Intervention type(s): Drug
Intervention description(s): Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat.
At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic.
Other intervention name(s): Cobicistat/Elvitegravir/Emtricitabine/Tenofovir alafenamide
Intervention MeSH terms: Tenofovir; Emtricitabine; Cobicistat; Emtricitabine tenofovir alafenamide; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; MSM; Anti-retrovirals; Pharmacokinetics; Peri-exposure HIV prophylaxis
Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the pharmacokinetics (PK) of a single dose of pravastatin with and
      without concomitant GDC-0810 administration in healthy female subjects of non-childbearing
      potential. During Period 1 (Day -1 to Day 4) PK parameters of pravastatin will be determined
      in the absence of GDC-0810. During Period 2 (Days 5-28) PK parameters of pravastatin will be
      determined in the presence of GDC-0810.
    


Intervention name(s): GDC-0810; Pravastatin
Intervention type(s): Drug; Drug
Intervention description(s): During Period 2 subjects will be administered an oral 600 mg dose GDC-0810 daily beginning on Day 5 for 4 consecutive days (from Days 5 to 8, inclusive).; Subjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2.
Other intervention name(s): ARN-810; Pravachol
Intervention MeSH terms: Pravastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Arteriovenous Fistula; Fistula
Study type: Interventional
Phase: Phase 3

Summary: 
      This research study is designed to assess the safety and effectiveness of an experimental
      drug called PRT-201 in patients both receiving or expecting to receive dialysis who have
      chronic kidney disease and who are undergoing surgery to create a new access point to their
      bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research
      studies to help keep vessels patent when applied to the outside surface of the blood vessels
      (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula
      (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited
      segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves
      the patency of your AVF.
    


Intervention name(s): PRT-201; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): vonapanitase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: radiocephalic; arteriovenous fistula; AVF; hemodialysis; PRT-201; vascular access; kidney; renal; vonapanitase; PATENCY-1
Strength and Fundamental Movement Skill (FMS) Training in Children
Condition: Fundamental Movement Skill Competence
Study type: Interventional

Summary: 
      Competence in Fundamental movement skills (FMS) is essential to enable children to be
      physical active. The aim of this study was to investigate the effects of integrated FMS skill
      training (balancing and stabilisation skills, locomotor skills [e.g. run, hop, jump, crawl]
      and object control / manipulation [e.g. dribbling, rolling, striking, kicking and catching
      i.e. a ball] with strength training on FMS performance in children.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Intervention programmes were designed based on previous research (Duncan, et al., 2017; Faigenbaum, et al., 2011; Miller, et al., 2006) to ensure all exercises were developmentally appropriate for the age of the participants (an example session plan can be seen in the supplementary material). Each session consisted of five activities and lasted 50 - 60 minutes. Three out of the five activities were identical for the FMS and FMS+ groups, while two differed focusing on skill development for the FMS group and strength development for the FMS+ group. The FMS and FMS+ group received their sessions twice a week for 4 weeks. The sessions were delivered at least 48 hours apart to allow recovery and to reduce the risk of fatigue effecting performance (Faigenbaum, et al., 1996). All sessions were led by a researcher and a qualified sports coach.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Cluster randomised control trial.
Masking: None (Open Label)
Primary purpose: Treatment
Home Telemonitoring in Patients at High Risk for Readmission
Condition: Inpatients
Study type: Interventional

Summary: 
      This study will evaluate the efficacy of home telemonitoring as an intervention to decrease
      hospital readmissions in patients at high risk for readmission. The overall readmission rate
      for high-risk MCF hospital patients is approximately 20%. Currently a system is in place to
      identify and score all MCF patients for their risk of readmission. This score is based on
      multiple variables including but not limited to: co-morbid conditions, patient's health
      literacy, whether they are a Medicare/Medicaid patient, their in-home social support, and
      whether they have had prior hospital admissions within the previous year. The literature
      shows that home telemonitoring of patients has had mixed results for effectiveness at
      preventing hospitalizations and emergency department visits. Many of these reports have
      restricted studies to patients with specific diseases or general characteristics; some have
      shown improved results while others have not. No study has examined patients who are high
      risk for readmission to determine if home telemonitoring for 30 days post-discharge reduces
      the risk for 30-day readmission.
    

Detailed description: 
      We hope to enroll a total of 1900 participants, 950 in each arm, over the next 2 years. One
      arm will be the telemonitoring group and one arm will be the standard of care group.
      Participants will be in the study for 30 days. Participants in the telemonitoring group will
      receive a Telestation, blood pressure monitor, and pulse oximeter. If the participant also
      has congestive heart failure, they will receive a scale. All of these vital measurements are
      to be taken on a daily basis along with survey questions on how the patient feels. If set
      parameters are out of the normal range, a flag will trigger that requires follow
      up/intervention from a nurse by telephone. In some cases, the participant might need to come
      back in to see a physician through the outpatient clinic. The participant in the standard of
      care group will be contacted via phone 30 days after discharge to learn if they were
      readmitted to any hospitals or had any emergency room visits during the past 30 days. This
      data will be collected via Philips software and also entered into the RedCap database here at
      Mayo Clinic.
    

Intervention name(s): Philips Telehealth
Intervention type(s): Device
Intervention description(s): patients will be provided with a philips home telemonitoring system post hospital discharge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: home telemonitoring; readmission; high risk
Clinical Study of the TSP Crosser System for Transseptal Access and Left Atrial Catheter Navigation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The study is a prospective, multi-center, non-randomized single arm interventional
      investigation with the TSP Crosser Transseptal Access System, a new complete solution for
      transseptal puncture and left atrial access and catheter navigation, for patients with atrial
      fibrillation ablation referred for radiofrequency catheter ablation.
    

Detailed description: 
      Transseptal (TS) catheterization is a critical step for left atrial (LA) interventions
      (atrial fibrillation ablation, LA appendage closure, mitral valve interventions). The
      availability of suitable tools and techniques is essential to safely perform the TS puncture,
      effectively deliver radiofrequency lesions, deploy LA devices, and anticipate difficult
      procedural situations in which complications may arise. This study is intended to assess the
      safety, performance and usability of the TSP Crosser System in facilitating access to the
      left atrium and catheter navigation to the pulmonary veins (PV) during catheter based
      ablation procedures for the treatment of atrial fibrillation (AF). Moreover, the study will
      assess the impact of the TSP Crosser System on procedural times, including time to achieve
      left atrial accesses, total procedure times, total fluoroscopy time, left atrial mapping time
      and radiofrequency isolation times. The study is a prospective, multicenter, non-randomized
      single arm interventional investigation. Enrolled subjects who meet the study
      inclusion/exclusion criteria will be evaluated during the catheter mapping and ablation
      procedures and followed until release from hospital post procedure per institutional standard
      of care. After 30 days, patient will be contacted by telephone to obtain information on their
      clinical condition and any adverse events; if necessary, a clinic visit may be performed when
      required by the physician.
    

Intervention name(s): TSP Crosser Transseptal Access System
Intervention type(s): Device
Intervention description(s): for transseptal puncture, left atrial access and catheter navigation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Atrial fibrillation; Transseptal puncture; Atrial fibrillation ablation
A Survey About Trade-offs When Choosing Menopause Treatments
Condition: Moderate to Severe Vasomotor Symptoms
Study type: Observational

Summary: 
      This study is an online survey of women in menopause with moderate to severe hot flashes.
      Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often
      occur during menopause. They can disrupt a woman's daily life.

      This study is about collecting information only. There will be no treatment in this study.
      This study will provide information on the trade-offs women are willing to make when deciding
      which treatment or treatments work best for them.

      Women from Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden and the United
      Kingdom (UK) will take part in this study.

      Women will be recruited through a third-party recruitment company.

      Most women will be asked to complete an online survey. Before the survey is sent to the women
      in the study, it will be tested by a small group of women. This group will be asked to take
      part in a telephone interview while taking the survey. They will be asked to say their
      thoughts aloud while completing the survey. Researchers will record this and also take notes.
      The aim of the interview is to check that the survey is understood by the women before it is
      sent out to the rest of the women.

      The survey will have 3 sections: Firstly, the women will answer questions about their
      experience with menopause and their symptoms. Next, they will be shown pros and cons for
      specific treatments for their menopause symptoms. The women will be asked to choose which
      treatment they would prefer, based on this information. Finally, they will answer questions
      on how their menopause symptoms have impacted their lives.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): This is a non-product related survey.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        post-menopausal women with moderate to severe VMS associated with menopause
      
Keywords: menopause; vasomotor symptoms
Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?
Condition: Ovarian Failure
Study type: Observational [Patient Registry]

Summary: 
      The developement of a new, stable measurement of the Antimuellerian Hormon (AMH) together
      with Roche Diagnostics International (Rotkreuz, CH) shall enable an automized and timely
      measurement of AMH values in blood samples.
    

Detailed description: 
      An important requirement for the use of the new measurement to determine the AMH
      concentration is the stability of the AMH level over the menstrual cycle. So far the unbiased
      AMH concentration is the most important argument to manage this parameter.

      There are several studies, which give different professional opinions of the AMH
      concentration depending on the phase of the menstrual cycle. Some authors came to the
      conclusion that the AMH concentration over the menstrual cycle is constant, others described
      significant fluctuations. It is unclear, if the described fluctuation is relevant for the
      interpretation of the ovarian reserve. Recently it could be shown, that intraindividual
      fluctuations of joung women during the menstrual cycle is stronger, which means that the
      measurement of AMH in this age is less secure.

      The primary goal of the study is to evaluate, if the new AMH measurement with the ElecSys
      method delivers stable values over the menstrual cycle.

      The secondary goal of the study is to determine whether there are any fluctuations in the
      number of antral follicles as given by 3D ultrasound.

      For this reason we are recruiting a group of 50 women within two categories of age to measure
      eventually changes in AMH- concentration during their menstrual cycle.
    

Intervention name(s): blood sample and ultrasound
Intervention type(s): Procedure
Intervention description(s): When included in the study blood samples and ultrasound are taken every second day of the first and third menstrual cycle after inclusion.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        50 healthy female probands
      
Biospecimen description: 
      For screening titer of hepatitis B/C- and HIV is measured once

      On every second day of two non-consecutive menstrual cycles we take encoded blood samples and
      measure the AMH value with the "ElecSys" method as well as the hormons LH, FSH, Estradiol und
      Progesterone

      On every second day of two non-consecutive menstrual cycles we take an encoded vaginal 3D
      ultrasound.
    
Keywords: AMH measurement "ElecSys"
Early Airway Response to Allergen in Asthmatics (MK-0000-176)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the Early Airway Response (EAR) associated change in forced expiratory
      volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of
      nedocromil, montelukast, and mometasone.
    


Intervention name(s): Nedocromil; Comparator: Montelukast; Comparator: Mometasone; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge; Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge; Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge; Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet
Other intervention name(s): Singulair
Intervention MeSH terms: Mometasone Furoate; Nedocromil; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Absorption of Zinc (Zn) From Zn-biofortified and Zn-fortified Maize in Young Zambian Children Between 24-36 Months
Condition: Nutritional Deficiency
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study is to compare the quantity of Zn absorbed from an accurately
      weighed quantity (~100 g) of minimally milled control maize (~15 µg Zn/g maize), from
      biofortified maize (~30 µg Zn/g) and from the same control maize that has been fortified
      (total level of ~60 µg Zn/g) when fed to young children age 24-36 months whose major habitual
      food staple is maize.
    

Detailed description: 
      Participating children were randomized to receive an accurately weighed quantity of ~100g/day
      of either the control, fortified or biofortified study maize for 1 day.

      On day 1, mothers brought their child to the health center before breakfast. All meals were
      extrinsically labeled with a zinc stable isotope (70Zn). Meals on this day were consumed in
      the presence of the research staff. The quantities of nshima or porridge prepared and eaten
      were accurately weighed and duplicate meals were collected for subsequent mineral analyses.

      Between lunch and dinner on day 1 at the Health Center, a blood sample was collected for Hb
      and plasma Zn analyses and, immediately after and through the same needle, a stable isotope
      of zinc was intravenously administered into a forearm vein over 1-2 minutes. The family then
      returned home.

      Morning spot urine samples were collected twice daily starting on day 5 and continuing
      through day 8. Once these collections were finished, the study for this child was complete.

      Dietary Zn was measured from laboratory assays of the duplicate test meals. Fractional
      absorption of Zn (FAZ) was measured by dual isotope tracer ratio methods in urine. Absorbed
      Zn was calculated by multiplying dietary Zn by FAZ.
    

Intervention name(s): Biofortified Maize; Fortified Maize; Control Maize
Intervention type(s): Other; Other; Other
Intervention description(s): Participant in this arm were fed zinc biofortified maize (~30 µg Zn/g).; Participants in this arm were fed zinc-oxide fortified maize (total level of ~60 µg Zn/g).; Participants in this arm were fed maize that was not fortified or biofortified (~15 µg Zn/g maize).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Zinc Absorption; Biofortification; Maize; Zambia; Stable isotopes of Zn
Yoga as a Supportive Therapy for Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit
      of a supportive hatha yoga intervention for patients with hypertension using antihypertensive
      drugs. Patients will be randomized into 3 groups comparing hatha yoga with yoga postures,
      breathing and relaxation techniques to a hatha yoga intervention without yoga postures (only
      breathing and relaxation techniques) as well as to a wait list control group.
    


Intervention name(s): Yoga with Asana (yoga postures); Yoga without Asana (yoga postures)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Yoga intervention consisting of asana, breathing and relaxation, meditation; Yoga intervention without asanas, consisting only of breathing, relaxation and meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week
      study to evaluate the analgesic efficacy and safety of a single intra-articular (IA)
      CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic,
      moderate-to-severe osteoarthritis (OA) knee pain.
    


Intervention name(s): CNTX-4975-05; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Receiving CNTX-4975-05 injection; Receiving Placebo injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesic; non-opioid; capsaicin; intra-articular; osteoarthritis; pain; knee pain