bioihbjkbjnl/mcl2 huggingface dataset:
Sildenafil in Single Ventricle Patients
Condition: Heart Disease
MeSH terms: Heart Diseases; Univentricular Heart
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with single ventricle anatomy undergo staged surgical palliation. The result is an
      "in series" circulation with pulmonary blood flow and cardiac output directly related to
      pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the
      single ventricle palliation results in continued long term attrition. Elevated pulmonary
      vascular resistance and impaired systemic ventricular function are important risk factors for
      failure of single ventricle palliation.

      Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in
      the pressure overloaded right ventricle.

      The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of
      sildenafil in single ventricle patients following stage II and III surgical palliation.
    


Intervention name(s): Sildenafil by injection; Sildenafil by injection; Sildenafil by injection; Sildenafil by injection
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sildenafil 0.125mg/kg injection over 20min; Sildenafil 0.25mg/kg injection over 20min; Sildenafil 0.35mg/kg by injection over 20min; Sildenafil 0.45mg/kg by injection over 20min
Other intervention name(s): Revatio; Revatio; Revatio; Revatio
Intervention MeSH terms: Sildenafil Citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoplastic left heart syndrome; Hypoplastic right heart syndrome; Superior cavopulmonary anastomosis; Total cavopulmonary anastomosis; Children with single ventricle anatomy
Neurobehavioral Moderators of Post-traumatic Disease Trajectories
Condition: PTSD; Trauma
MeSH terms: Wounds and Injuries
Study type: Observational [Patient Registry]

Summary: 
      The research goal is to uncover the neurocognitive moderators of PTSD trajectories, by
      documenting clinical symptoms, cognitive functioning, and brain structure and function, one-,
      six- and fourteen months following a traumatic event, in a large population of survivors at
      initial high risk for PTSD.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult civilians admitted to Tel-Aviv Sourasky Medical Center's Emergency Room (ER),
        following a potentially traumatic incident. The initial screening will be done via
        telephone-based structured interviews within 10 days of ER admission, in order to confirm
        the occurrence of psychologically traumatic event, identify & assess those expressing
        initial Acute Stress Disorder (ASD) symptoms.
Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot
      medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic
      cystectomy.
    


Intervention name(s): depot medroxyprogesterone acetate
Intervention type(s): Drug
Intervention description(s): DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate that atomoxetine is superior to other early
      standard therapy (any treatment that investigator considers is appropriate to initiate for
      the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term
      functioning in approximately 400 children and adolescents with ADHD. Patients will be
      pharmacological naïve prior to entry into the study.
    


Intervention name(s): Atomoxetine; Other standard therapy for ADHD
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension; Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Plavix on NO (Nitrogen Monoxide) Production of the Endothelial Function
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine whether in the laser Doppler flowmetric parameters characteristic of endothelial
      dysfunction at patients with clinically manifest atherosclerosis any change can be detected
      at plavix (clopidogrel) treatment. Laser Doppler /LD/ measurement combined with iontophoresis
      evaluates the effect of acetylcholine /ACh/ /endothelium dependent/ and sodium nitroprusside
      /NSP/ /endothelium independent/ on the microcirculation of the skin
    


Intervention name(s): Clopidogrel (Plavix)
Intervention type(s): Drug
Intervention MeSH terms: Clopidogrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fontain II-III stage
Proof of Principle Study of Pulse Dosing of IL-15 to Deplete the Reservoir in HIV Infected People
Condition: HIV; Stable ART
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of
      ALT-803 in HIV
    

Detailed description: 
      This is an open-label, single-arm intra-patient dose escalating pilot study of ALT-803, a
      recombinant human super agonist interleukin-15 (IL-15) complex with an expansion cohort at
      the maximum tolerated dose (MTD). The primary aim is to investigate the safety and
      tolerability of ALT-803 in HIV-infected people receiving potent and optimized antiretroviral
      therapy. All infusions will occur on a Monday. Subjects will be monitored for 24 hours after
      the first infusion and then for 6 hours after each subsequent infusion, provided no
      unacceptable toxicity.
    

Intervention name(s): ALT-803
Intervention type(s): Drug
Intervention description(s): Interleukin 15 (IL-15) is a common γ-chain cytokine that is related to interleukin-2 (IL-2) and is a critical factor for the development, proliferation, and activation of effector natural killer (NK) and CD8+ memory T cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; ART
High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional

Summary: 
      Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a
      progressive course that can lead to liver cirrhosis. There are few studies on dietary
      management in primary biliary cirrhosis and most of them have focused on micronutrients
      specifically vitamin D intake to prevent osteoporosis, and lipid control to prevent
      hyperlipidemia, but few recommendations have been made regarding a complete dietary approach.
      Fiber has been proven to increase the excretion of nitrogen products and consequently reduce
      its blood levels, and an adequate protein intake (1- 1.5 g per kg) has shown to decrease
      endogenous catabolism in cirrhotic patients.

      The purpose of this study is to evaluate the impact of a high-protein, high-fiber diet in the
      nutritional status of patients with primary biliary cirrhosis.
    


Intervention name(s): High protein high fiber diet
Intervention type(s): Dietary Supplement
Intervention description(s): A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effect of Dose on the Pharmacokinetics of OROS Hydromorphone Under Fasted Conditions in Healthy Taiwanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of OROS Hydromorphone in
      healthy adult Taiwanese participants after oral administration of 4 different dose strengths
      of 8, 16, 32 and 64 mg under fasted conditions.
    

Detailed description: 
      This is a single-center, randomized (study drug assigned by chance like flipping a coin),
      open-label (all people involved know the identity of the intervention), 4-way crossover
      (participants receive different interventions sequentially during the trial) study in healthy
      adult Taiwanese participants. All participants will be randomly assigned to 1 of the 4
      different possible treatment sequences and will receive all treatments in the order specified
      by the randomization schedule. The study consists of a screening phase, an open-label
      treatment phase consisting of 4 single-dose treatment periods, and end-of-study or withdrawal
      assessments. During the open-label treatment periods, the participants will stay in the
      center until completion of the 72-hour pharmacokinetics [PK] (how the drug is absorbed in the
      body, distributed within the body, and how it is removed from the body over time) blood
      sample on Day 4. A 7- to 14-day washout period (period when receiving no treatment) will
      separate the open-label treatment periods. The safety and tolerability will be evaluated over
      the investigated dose range. The duration of participation in the study for an individual
      participant will be approximately 12 weeks.
    

Intervention name(s): Treatment A: Hydromorphone 8 mg; Treatment B: Hydromorphone 16 mg; Treatment C: Hydromorphone 32 mg; Treatment D: Hydromorphone 64 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): type= exact number, unit= mg, number= 8, form= tablet, route= oral use. One tablet of Hydromorphone 8 mg in each of 4 treatment sequences.; type= exact number, unit= mg, number= 16, form= tablet, route= oral use. One tablet of Hydromorphone 16 mg in each of 4 treatment sequences.; type= exact number, unit= mg, number= 32, form= tablet, route= oral use. One tablet of Hydromorphone 32 mg in each of 4 treatment sequences.; type= exact number, unit= mg, number= 64, form= tablet, route= oral use. One tablet of Hydromorphone 64 mg in each of 4 treatment sequences.
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Dose Proportionality; Pharmacokinetics; OROS Hydromorphone; Hydromorphone; Taiwan
Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Quadriceps-sparing minimally invasive total knee arthroplasty (TKA) with side-cutting
      instruments has been proposed to limit surgical dissection without compromising the surgical
      outcome. We conducted a prospective, randomized study to compare the outcomes of
      quadriceps-sparing TKA with conventional medial parapatellar TKA, with two-year follow-up.

      We hypothesize that the quadriceps-sparing arthrotomy would not outperform the conventional
      medial parapatellar arthrotomy in TKA, in terms of postoperative recovery of quadriceps
      muscle strength, alignment of the prosthetic knee, and clinical outcome.
    

Detailed description: 
      Eighty primary TKAs in sixty patients of osteoarthritis constituted this study. Patients were
      randomly assigned to either quadriceps-sparing (QS, 40 knees) or medial parapatellar (MP, 40
      knees) group. All surgeries were designed to set the prosthesis with thefemoral component
      alignment of 7º valgus and the tibial component alignment perpendicular to tibial shaft.
      Outcome variables included knee function defined by Hospital for Special Surgery knee score,
      quadriceps muscle strength measured by isokinetic dynamometer, pain indicated on visual
      analogue scale, range of motion, and post-operative alignment measured on plain radiograph.
    

Intervention name(s): total knee arthroplastyinstruments
Intervention type(s): Procedure
Intervention description(s): Quadriceps-sparing arthrotomy with side-cutting instruments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: total knee arthroplasty; minimally invasive; quadriceps-sparing; Quadriceps-sparing total knee arthroplasty
Dysesthesia Study After Sternotomy
Condition: Ischemic Cardiopathy; Other Forms of Cardiopathy
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      Chronic pain associated to sternotomy occurs in 40 to 50% of patients after cardiac surgery.

      33 to 66% of these patients suffer during 3 month and 25 to 33% have postoperative pain for
      at least 1 year.

      This pain has often negative effects on daily activity. Despite its frequency and importance,
      the etiology of this chronic pain is not completely understood.

      The goal of this study is to understand the mechanism of this chronic pain, to prevent and/or
      to treat better in the future.

      The sensitivity of the thorax after cardiac surgery seems to follow a dynamic evolution which
      can be observed within several weeks. Therefore we decided to study this evolution.

      This study is different from previous ones observing the sensitivity of the thorax at a well
      defined moment immediately after the surgery.
    


Intervention name(s): cardiac surgery with sternotomy
Intervention type(s): Procedure
Time perspective: Prospective
Fasted Bioequivalence Study of Clopidogrel Film-coated Tablets, 75 mg in 48 Healthy, Adult Male and Female Subjects.
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to compare bioequivalence of the Test Product Clopidogrel bisulfate,
      film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg
      film-coated tablets (Sanofi Winthrop Industrie, France) in healthy male and female volunteers
      under fasting conditions.
    

Detailed description: 
      An open, comparative, randomized, four-period, two- sequence, two-way crossover clinical
      trial to evaluate the Bioequivalence of Single Doses of Test Product Clopidogrel bisulfate,
      film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg
      film-coated tablets (Sanofi Winthrop Industrie, France) in healthy adult male and female
      volunteers under fasting conditions.
    

Intervention name(s): Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine); Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)
Intervention type(s): Drug; Drug
Intervention description(s): One film-coated tablet was administrated orally with 240 ml of water after an overnight fast; One film-coated tablet was administrated orally with 240 ml of water after an overnight fast
Other intervention name(s): Trombonet
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; pharmacokinetics; generic drugs; Clopidogrel; Film-coated Tablets
Diabetes and Hypertension Self Management Program
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this R15 project is to test the feasibility and effectiveness of a 12-week
      diabetes and hypertension self-management program using trained health coaches.
    

Detailed description: 
      West Virginia has high prevalence of comorbid diabetes and hypertension. Most diabetes
      self-management programs are hospital or clinic based and none are tailored to address the
      unique needs of rural WV adults with comorbid diabetes (T2DM) and hypertension (HTN). There
      is a critical need for new and creative community-based, culturally appropriate
      self-management programs in this medically underserved state. This study will use a
      wait-listed randomized control trial (RCT) design, using evidence-based interventions, to
      improve patient self-management behaviors and health outcomes (HbA1c and BP). Eligible adults
      with comorbid T2DM and HTN will be randomized with a 1:1 ratio to the immediate diabetes and
      hypertension self-management program (DHSMP; n=35) or to 6-month wait-listed control group
      (N=35), based on an allocation sequence generated by the biostatistician using a randomly
      varying block randomization method to ensure equal distribution among treatment groups.
    

Intervention name(s): diabetes and hypertension self-management
Intervention type(s): Behavioral
Intervention description(s): 12-weeks of 75 minutes of educational sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT with wait-listed control
Masking: None (Open Label)
Primary purpose: Other
Study of Motilitone to Treat Functional Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate efficacy of the investigational drug Motilitone at 90 mg in
      patients with Functional Dyspepsia as measured by change in maximum tolerated volume and
      aggregate symptom score on the nutrient drink test.
    


Intervention name(s): Motilitone 30mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30mg of Motilitone in tablet form, to be taken 3 times daily for 4 weeks; Placebo, in tablet form, to be taken 3 times daily for 4 weeks. The placebo is the same formulation as Motilitone except that it does not contain the active pharmaceutical ingredient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional Dyspepsia
Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy and structural change of intraarticular single platelet-rich
      plasma(PRP) versus novel crosslinked Hyaluronic Acid(HA)(HyajointPlus) for the treatment of
      early stage knee osteoarthritis(OA). This was a prospective, double-blind, RCT with an
      allocation ratio of 1:1.
    

Detailed description: 
      In the PRP group, an Aeon Acti-PRP set was used and an approximately 4-mL PRP volume was
      yielded and was used in a single-dose treatment. In the HA group, HYAJOINT Plus containing 60
      mg of purified sodium hyaluronate was used in a single-dose treatment. All PRP and HA
      injection syringes were covered with opaque envelop, and the intra-articular injection
      procedure was performed by the same physician without ultrasound or other imaging guidance.
    

Intervention name(s): Platelet Rich Plasma; Hyaluronic Acid
Intervention type(s): Combination Product; Combination Product
Intervention description(s): In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given.; In the Hyaluronic group, 3mLHYAJOINT Plus was given.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
Condition: Acute Myeloid Leukemia; Lymphoblastic Leukemia; Acute Leukemia; Non Hodgkins Lymphoma; Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Hematologic Neoplasms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional

Summary: 
      This is a phase I study using Intensity Modulated Total Marrow Irradiation (IM-TMI) in
      addition to a chemotherapy regimen in preparation for an allogeneic stem cell transplant for
      advanced hematologic malignancies such as acute myeloid or lymphoblastic leukemia, high grade
      non Hodgkin's or Hodgkin's lymphoma, chronic myelogenous leukemia, and plasma cell leukemia.
      Because the subjects participating in this study have a disease that is severe and has a high
      risk of relapse even after transplant, the investigators propose to use a chemotherapy
      regimen (fludarabine/busulfan), the name for the combination of chemotherapy drugs that is
      given to patients prior to transplantation of the donor stem cells, along with intensity
      modulated radiation (IM-TMI) to the bone marrow. Total body irradiation (TBI) in conjunction
      with chemotherapy is a standard of care as a pre-conditioning regimen prior to bone marrow
      transplant (BMT) in patients with hematologic malignancies. However, TBI can cause severe
      side effects due to irradiation of organs such as the lenses of the eye, whole brain, lungs,
      liver, kidneys, heart, small bowel and oral cavity. IM-TMI allows for the delivery of
      adequate doses of radiation to the bone marrow while sparing other organs and therefore
      limiting radiation side effects. The irradiation, along with receiving the chemotherapy drugs
      will suppress the subject's immune system and kill off tumor cells, but will also intensify
      the effect of the conditioning regimen thus allowing the bone marrow transplantation to have
      a greater chance of being successful.

      No investigational drugs are used in this study. The investigational part of this study is
      the use of intensity modulated total marrow irradiation instead of conventional radiation.
      IMTMI can deliver 99% of the prescribed treatment to the targeted bones and reduce the doses
      of radiation to surrounding organs, as received in conventional TBI, by 29% to 65%.
    


Intervention name(s): IM-TMI (3Gy); IM-TMI (6Gy); IM-TMI (9Gy); IM-TMI (12Gy)
Intervention type(s): Radiation; Radiation; Radiation; Radiation
Intervention description(s): Patients will receive 3Gy per day for 1 day.; Patients will receive 3Gy per day for 2 days.; Patients will receive 3Gy per day for 3 days.; Patients will receive 3Gy per day for 4 days.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Dose escalation of total marrow irradiation prior to stem cell transplantation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: total marrow irradiation; intensity modulated radiation; leukemia; hematologic diseases