bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance
Condition: Excessive Sleepiness
MeSH terms: Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine whether treatment with armodafinil will
      provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive
      Sleep Apnea/Hypopnea Syndrome) who have residual sleepiness despite receiving nCPAP therapy.
    


Intervention name(s): Armodafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Armodafinil once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.; Matching Placebo dosed once-daily (50 mg/day (1 tablet) on Day 1; increased to 100 mg/day (2 tablets) starting on Day 2; increased to 150 mg/day (3 tablets) starting on Day 5; increased to 200 mg/day (4 tablets) starting on Day 8). Then continue 200 mg/day dosage through Day 14.
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the bioavailability, pharmacokinetic and safety
      profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy
      volunteers.
    


Intervention name(s): ABT-333 Tablet; Placebo; ABT-333 Capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): See Arm Description for more information.; See Arm Description for more information.; See arm description for more information
Other intervention name(s): ABT-333
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Bioavailability (BA); Single Ascending Dose (SAD)
Pharmacokinetics and Pharmacodynamics of BIWH 3 in Healthy Duffy Positive vs. Duffy Negative Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to compare the pharmacokinetic and pharmacodynamic effects of escalating dosages of
      recombinant human pyro-Glu MCP-1 (BIWH 3) in Duffy positive vs. Duffy negative healthy male
      volunteers: plasma levels of monocyte chemotactic protein-1 (MCP-1) and markers of leukocyte,
      coagulation, platelet and endothelial activation will be quantified; To examine the safety of
      BIWH 3 in this setting
    


Intervention name(s): BIWH 3; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Lipid Efficacy Study (0524B-022)(COMPLETED)
Condition: Primary Hypercholesterolemia; Mixed Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hyperlipoproteinemia Type V; Lipidoses; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed
      hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6
      scheduled clinic visits, and 7 treatment arms.
    


Intervention name(s): niacin (+) laropiprant (+) simvastatin; Comparator: niacin (+) laropiprant; Comparator: simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Duration of Treatment 12 Weeks; Duration of Treatment 12 Weeks; Duration of Treatment 12 Weeks
Other intervention name(s): MK0524B; MK0524A; MK0733
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess relative bioavailability of lesinurad/allopurinol fixed dose
      combination (FDC), its individual components and the effect of food.
    

Detailed description: 
      The study comprises 2 parts. Part 1 will assess the relative BA of lesinurad/allopurinol FDC
      and monocomponents in fasted subjects. Part 2 will assess the effect of food on the PK of FDC
      tablets.
    

Intervention name(s): lesinurad/allopurinol 200/300 FDC tablets; lesinurad 200 mg; allopurinol 300 mg; lesinurad/allopurinol 200/200 FDC tablets; allopurinol 200 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Allopurinol; Lesinurad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The recommended treatment for latent tuberculosis infection for adults is a daily dose of
      isoniazid 300mg during 6 months. In Brazil, isoniazid was formulated as 100 mg tables. The
      treatment duration and the high pill burden compromised patient adherence to the treatment.
      The Brazilian National Programme for Tuberculosis requested the development of a new 300mg
      isoniazid formulation. The aim of the study is to compare the bioavailability of the
      isoniazid 300mg new formulation and three 100mg tablets of the reference formulation.

      The study is a randomized, single dose, open label, fasting, two-phase crossover
      bioequivalence study with a wash out period of 7 days (>7 half-life) in 28 healthy human
      volunteers. For the determination of isoniazid in human plasma, the investigators developed
      and validated a sensitive, simple and rapid HPLC-MS/MS method.

      This will support the strategy adopted by the Brazilian National Program for Tuberculosis for
      the treatment of latent tuberculosis. The new formulation will increase patients' adherence
      to the treatment and quality of life. Medical doctors in Brazil should become aware of the
      new formulation and the new treatment strategy in order to prescribe the right medication and
      avoid errors that could result in a high frequency of adverse events. Future research studies
      should evaluate pharmacovigilance, acceptability of the new tablet formulation and its impact
      on the cure rate.
    


Intervention name(s): Isoniazida
Intervention type(s): Drug
Intervention MeSH terms: Isoniazid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Bathing and Moisturizers on Skin Hydration in Atopic Dermatitis: an in Vivo Study
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The purpose of this study is to determine the hydration effect of various regimens of skin
      bathing and moisturizer application on atopic dermatitis
    


Intervention name(s): bathing and moisturizer application
Intervention type(s): Procedure
Intervention description(s): regimen 1: soaking an arm for 10 minutes, no moisturizer application regimen 2: soaking an arm for 10 minutes,immediate moisturizer application regimen 3: soaking an arm for 10 minutes, delayed moisturizer application for 30 min.
regimen 4: wait for 10 minutes,no soaking, moisturizer application (moisturizer alone) (All regimens were completed in all patients with 2 visits (7 days interval))
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: atopic dermatitis, skin cleansing, cleanser, moisturizer, skin hydration
Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution
Condition: Bleeding Reduction
Study type: Observational

Summary: 
      This study will help enhance current understanding of the impact of Acute Normovolemic
      Hemodilution (ANH) administration on transfusion requirements post cardiac surgery, the
      effect of this procedure on coagulation, and platelet hemostasis, and the amount of chest
      tube drainage 24 hours post coronary artery bypass graft surgery (CABG) surgery.
    

Detailed description: 
      Acute Normovolemic Hemodilution (ANH) involves the removal of the patients own blood
      immediately at the induction of anesthesia and replacement of this blood intraoperatively
      with an equivalent volume of crystalloid or colloid solution in order to dissuade the loss of
      red blood cell mass, the mechanism of action is dilution of the blood, hematocrit reduction,
      and reduction of the anticoagulant components of the blood associated with bleeding during
      cardiopulmonary bypass graft surgery. The collected blood is isolated from the negative
      effects of the cardiopulmonary bypass machine.. The collected blood is then stored in
      anticoagulant treated blood bags in the cardiovascular operating room and re-infused into the
      patient in reverse order of collection at the commencement of surgery, leaving the most cell
      rich blood to be re-infused into the patient last. This study will evaluate the effect in
      patients with and without ANH utilization on; hemostatic markers, chest tube drainage 24
      hours post CABG, and need for allergenic blood transfusion. Positive effects on the
      hemostatic markers of anticoagulation and platelets, reduced chest tube drainage at 24 hours
      post CABG, and reduced number of transfused red blood cells will indicate a positive
      correlation with ANH utilization during isolated on pump CABG surgery.

      The benefits of ANH utilization in blood conservation will benefit patients by reducing their
      exposure to allogenic blood transfusion with its myriad side effects.
    

Intervention name(s): Acute Normovolemic Hemodilution
Intervention type(s): Procedure
Intervention description(s): Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population is inclusive of both genders and all racial and ethnic groups and
        subgroups. Subjects will be enrolled from age 18-85 years old.
      
Keywords: acute normovolemic hemodilution
Robotic Single Port Donor Nephrectomy
Condition: Renal Transplant Donor of Left Kidney; Donor Nephrectomy; Robotic Surgery; Single-port
Study type: Interventional

Summary: 
      Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci
      instrumentation and Single-Site platforms.
    

Detailed description: 
      Our center has performed over 200 single-port donor nephrectomies with standard laparoscopy
      and has reported patient benefits associated with a single port approach. The single port
      robotic platform offers the potential to ameliorate the significant technical and ergonomic
      challenges that currently limit more widespread application of single port donor surgery.
      After being informed of the potential risks and off-label use of the da Vinci Single-Site
      approach in our study, patients will undergo a robotic-assisted single-site donor nephrectomy
      performed by a two-surgeon team utilizing existing da Vinci instrumentation and Single-Site
      platforms. Renal mobilization and vascular dissection will be performed with manual
      laparoscopy performed for vascular division utilizing stapling devices.
    

Intervention name(s): da Vinci® Single-Site™
Intervention type(s): Device
Intervention description(s): Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Transplant; donor; nephrectomy; robotic; laparoscopy; single-port
Attentional Bias Retraining in Veterans
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The study has two goals. First to develop a computer-based intervention meant to alter
      cognitive biases that contribute to ongoing PTSD symptoms. Second, we sought to pilot test
      the intervention in a small sample of veterans for feasibility and acceptability.
    

Detailed description: 
      Aim 1: Develop Attentional Bias Retraining protocol (Phase 1)

        -  1.1 Computerized assessment & retraining programs

        -  1.2 Procedures and measures

      Aim 2: Implement in pilot sample (Phase 2)

        -  2.1: Assess feasibility and tolerability

        -  2.2: Collect pilot data to plan future studies

        -  2.3: Efficacy estimates based on changes in response time to dot probe task
    

Intervention name(s): Attentional bias retraining
Intervention type(s): Behavioral
Intervention description(s): Participants complete a computer-based intervention, which is designed to correct cognitive biases associated with PTSD by training to attend to neutral information rather than the trauma-related cue words.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Clinical Evaluation of Beta-D-Glucan Assay in Blood and BAL
Condition: Invasive Fungal Infection; Hematological Malignancy; Receipt of Solid Organ Transplant
MeSH terms: Infections; Mycoses; Invasive Fungal Infections; Hematologic Neoplasms
Study type: Interventional

Summary: 
      In patients with invasive fungal infection (IFI) rapid diagnosis is essential for early
      initiation of appropriate antifungal therapy and thereby survival. Conventional culture is
      still the Gold-Standard for diagnosis of IFI. Sensitivity of conventional culture, however,
      is low (50%) and time to results minimum 24 hours.

      Therefore usage of serological tests detecting fungal antigens has increased dramatically
      over recent years. Main advantages of this new methods are rapid results and higher
      sensitivity when compared to conventional culture. One of the most promising serological
      marker currently used is beta-D-Glucan, which is a component of the fungal cell wall.
      ß-D-Glucan has been detected in IFI caused by Aspergillus, Candida and Fusarium spp. The
      Fungitell Assay (Associates of Cape Code, Inc.) was developed and validated for detection of
      ß-D-Glucan in peripheral blood.

      Up to date information about clinical performance of the Fungitell Assays in bronchoalveolar
      lavage fluid (BAL) is limited. This study will therefore evaluate clinical and diagnostic
      performance of the Fungitell Assay in BAL from patients with solid organ transplant or
      hematologic malignancy.

      In addition Mn/A-Mn, the lateral flow device test for aspergillosis, and Galactomannan, as
      well as PCR will be determined and used as comparators for BDG performance.
    


Intervention name(s): Fungitell Assay in BAL
Intervention type(s): Other
Intervention description(s): Fungitell Assay will be performed in BAL from patients with clinical suspicion of IFI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: IFI
A Prospective and Randomized Controlled Evaluation of Sexual Health Education Program of Gynecological Cancer Women
Condition: Sexual Health
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the effectiveness of the Gender-Sensitive -Sexual
      Health Education Program (GS-SHEP) in enhancing the sexual health of patients with
      gynecologic cancer.
    

Detailed description: 
      This study recruited patients with cervical cancer from the gynecological wards of a
      large-scale medical center in northern Taiwan. A total of 63 participants were divided into
      two groups. The control group (n=30) received routine sexual health teaching (a 10-15-minute
      routine individual sexual health education and a sexual health pamphlet without a
      gender-sensitive and theoretically based design. The experimental group (n=33) received the
      GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet).
      GS-SHEP effectiveness was examined using a self-report instrument to measure background
      information and three dependent variables: "sexual knowledge," "sexual attitudes," "sexual
      self-efficacy", and "sexual activity". Data were collected at baseline, one week, six weeks,
      four months, and seven months after intervention and analyzed using the statistical software
      SPSS 20.0.
    

Intervention name(s): Received the GS-SHEP
Intervention type(s): Behavioral
Intervention description(s): The experimental group (n=33) received the GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet). GS-SHEP effectiveness was examined using a self-report instrument to measure background information and three dependent variables: "sexual knowledge," "sexual attitudes," and "sexual self-efficacy."
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For this two-group, controlled trial, 63 participants with cervical cancer were recruited from the gynecological wards of a large-scale medical center in northern Taiwan. The control group (n=30) received routine sexual health teaching (a 10-15-minute routine individual sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. The experimental group (n=33) received the GS-SHEP (a 10-15-minute individual sexual health education and a sexual health pamphlet).
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Sexual Self-efficacy; Sexuality; Health Education; Gender sensitivity; Transtheoretical Model
Evaluation the Effect of Muscle Functional Electrical Stimulation in the Upper Limb Tremor Invalidating
Condition: Upper Limb Tremor Invalidating
MeSH terms: Tremor
Study type: Interventional

Summary: 
      The main objective of this study is to identify the superficial muscle groups involved in
      gene-related tremor and assess the reduction in the intensity of the tremor after transient
      electrical stimulation.
    


Intervention name(s): tremor
Intervention type(s): Other
Intervention description(s): evaluation of the intensity of the tremor
Intervention model: Single Group Assignment
Masking: None (Open Label)
A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy
      volunteers.
    


Intervention name(s): CXL-1427 Ascending Dose; Placebo; CXL-1427 Descending Dose
Intervention type(s): Drug; Other; Drug
Other intervention name(s): BMS-986231; BMS-986231
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective of this study is to confirm the efficacy of HOE490 O
      (glimepiride/metformin) compared with placebo on top of glimepiride in HbA1c change.

      Secondary objectives of this study is to evaluate the safety of HOE490 O
      (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy
      parameters
    

Detailed description: 
      Patients treated with 2-6mg/day of glimepiride will be recruited. The study period consists
      of screening phase of 6 weeks and double-blinded phase of 24 weeks.
    

Intervention name(s): Metformin; placebo; Glimepiride (HOE490)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral administration; oral administration; oral administration
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Glimepiride; Metformin; Combination Drug Therapy
Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients
Condition: Secondary-progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a phase I, open, multicenter, international study performed by 3 participating
      centres across two countries (Italy and Switzerland). Fifteen to 24 patients affected by SPMS
      will be enrolled, according to a "standard" phase I design over 18 months. All patients will
      enter a 3 months run in phase. Thereafter they will receive one of four different doses of
      allogenic hNSCs (dose A=5 millions hNSCs; dose B=10 millions hNSCs; dose C=16 millions hNSCs;
      dose D=24 millions hNSCs). Following hNSCs injection, all SPMS patients will receive
      immunosuppression with tacrolimus for 6 months. Patients will be clinically followed monthly
      for 1 year and then every 6 months for the 5 years following the study completion (possibly
      all life long).

      MRI assessments will be performed monthly for the first 6 months and then every 3 months for
      5 years following the study completion.
    


Intervention name(s): Human Neural Stem Cells
Intervention type(s): Biological
Intervention description(s): Allogenic human Neural Stem Cells (hNSCs) in four different dosages (5, 10, 16 or 24 millions). hNSCs are produced by the Laboratorio Cellule Staminali of Terni according to GMP guidelines and are obtained from brain specimens of several fetal human donors from spontaneous miscarriages occurred after the 8th week after conception.
Intervention model: Sequential Assignment
Intervention model description: Fifteen to 24 patients affected by SPMS will be enrolled, according to a "standard" phase I design over 18 months. All patients will enter a 3 months run in phase. Thereafter they will receive one of four different doses of allogenic hNSCs (dose A=5 millions hNSCs; dose B=10 millionshNSCs; dose C=16 millions hNSCs; dose D=24 millions hNSCs).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cell Transplantation; Neural Stem Cells