bioihbjkbjnl/mcl2 huggingface dataset:
Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV
      infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging,
      placebo-controlled 'proof of concept' study is to be conducted to compare antiviral effect,
      safety, tolerability, and pharmacokinetics of GSK1349572 monotherapy versus placebo over 10
      days in ART-naïve and experienced, but integrase inhibitor naïve (meaning never having had an
      integrase inhibitor) HIV-1 infected adults who are not currently receiving antiretroviral
      therapy. This study consists of a screening visit, a treatment period and a follow-up
      evaluation. Thirty subjects will be randomized to receive one of three doses of GSK1349572 or
      placebo q24h over 10 days. Antiviral effect measures include viral load and CD4 cell count.
    


Intervention name(s): GSK1349572; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK1349572 is an experimental drug being developed for the treatment of HIV. It is in the class of integrase inhibitors.; Placebo is a tablet with no drug in it.
Intervention MeSH terms: Dolutegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dose-ranging study; phase IIa; integrase inhibitor; HIV-1 infection
Letrozole in Preventing Breast Cancer in Postmenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. Letrozole may be effective in preventing the development
      or recurrence of breast cancer in postmenopausal women who are at increased risk of
      developing breast cancer because of elevated estradiol levels.

      PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing
      breast cancer in postmenopausal women with elevated estradiol levels.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  The primary outcome of the study is the change in bone mineral density following a year
           on letrozole vs. a year on placebo.

      Secondary

        -  Compare the safety, acceptability, and adherence to letrozole vs placebo in
           postmenopausal women at increased risk for the development or recurrence of breast
           cancer based on elevated plasma estradiol levels through evaluation of menopausal
           symptoms (including hot flushes, weight changes, sexual functioning, and genitourinary
           effects), blood lipid levels, markers of bone turnover, and multidimensional quality of
           life.

        -  Determine the effect of letrozole-induced reduction of plasma estradiol levels on
           mammographic percent breast density.

        -  Obtain background information for a future large chemoprevention trial to address the
           question of whether a reduction in plasma estradiol levels can reduce the risk of breast
           cancer in postmenopausal women.

      OUTLINE: This is a pilot, randomized, double-blind, placebo-controlled, multicenter study.
      Patients are randomized to 2:1 (experimental treatment: placebo arms).

      PROJECTED ACCRUAL: A total of 110 patients (73 for arm I and 37 for arm II) will be accrued
      for this study.
    

Intervention name(s): Letrozole; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Femara
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; breast cancer in situ; ductal breast carcinoma in situ
PEERS® for Italy, a Study on Social Skills Intervention for Adolescents With Autism Spectrum Disorder (ASD).
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      TThe research aims to verify the Italian adaptation of a parent-mediated group training
      focused on social skills for adolescents with autism spectrum disorder (ASD). The Program for
      the Education and Enrichment of Relational Skills PEERS® is an evidence-based program with
      substantial literature (over 40 studies) applied in several countries. For the present study,
      about 40 adolescents, both boys, and girls with ASD, are enrolled and randomized into two
      groups. Groups (experimental group and waiting list) took part in the Italian telehealth
      adaptation of PEERS® at different times and were evaluated at several time points (baseline,
      pre-treatment, post-treatment, and follow-up). The objective of the comparison was to explore
      the primary outcomes, such as the impact of training on social knowledge and performance, and
      secondary outcomes, like psychiatric comorbidities and neuropsychological profile. The
      hypothesis is that social skills (knowledge and performance) improve after training in the
      experimental group and affect the secondary outcomes, and the achievements are maintained at
      3-months follow-up.
    


Intervention name(s): Program for the Education and Enrichment of Relational Skills
Intervention type(s): Behavioral
Intervention description(s): Social training targeting adolescents with ASD and focused on making and keeping friends
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; social skills training
First Trimester Prediction of Preeclampsia and Fetal Growth Restriction
Condition: Preeclampsia; Fetal Growth Restriction
MeSH terms: Pre-Eclampsia; Fetal Growth Retardation
Study type: Observational

Summary: 
      To evaluate the feasibility of screening for preeclampsia and fetal growth restriction
      between 11-13+6 weeks' gestation utilizing the combination of uterine artery doppler,
      maternal blood pressure, maternal characteristics, placental volume, and maternal serum
      factors, including PAPPA-A, PLGF, AFP and free Beta HCG. This is a non interventional study.
    

Detailed description: 
      Preeclampsia (PE) is a condition which affects approximately 2% of all pregnancies and can be
      a major cause of maternal and perinatal morbidity/mortality (2). The suspected underlying
      mechanism of PE is thought to be impaired trophoblastic invasion of the maternal spiral
      arteries leading to impaired placental perfusion, placental ischemia and subsequent
      development of endothelial dysfunction (3). There is evidence that PE, which is commonly
      associated with fetal growth restriction, can be predicted effectively at 11-13 weeks
      gestational age by combined screening algorithms combining uterine artery pulsatility index
      (PI), maternal mean arterial pressure (MAP) and maternal serum concentrations of placental
      products including but not limited to plasma protein A (PAPP-A), and placental growth factor
      (PLGF) (4-6).

      Aim of Study/Hypothesis:

      The aim of this study is to develop an algorithm based on the combination of maternal
      factors, uterine artery pulsatility index, mean arterial pressure, placental volume and serum
      biomarkers to estimate patient specific risks for the development of Preeclampsia in a US
      population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All pregnant patients during their first trimester
      
Biospecimen description: 
      A 5cc maternal blood sample will be obtained through standard blood draw. The blood will
      first be transferred onto a dry blood requisition form card. The blood sample will be
      refrigerated and the serum and dried blood spot samples will be sent to Perkin Elmer
      Laboratories (see attachment C for collection protocols). The maternal serum levels of
      PAPP-A, PLGF, AFP, and free β hCG will be measured according to a protocol established by
      Perkin Elmer Laboratories.
Intensive Care Nurses' Training Package on the Safety Culture of Geriatric Patients
Condition: Safety
Study type: Interventional

Summary: 
      This study aims to determine the effect of intensive care nurses' training package on the
      safety culture of critically ill geriatric patients.

      Study hypothesis:

      Intensive care nurses who receive the proposed training package exhibit higher scores on
      critically ill geriatric patients' safety culture awareness than those who do not receive it.
    

Detailed description: 
      The researchers will prepare the proposed nurses' training package program. The program will
      be planned to be carried out in 10 sessions that will be classified into; sessions regarding
      knowledge about the age-related changes affecting elderly patients that should be considered
      while caring for them and how to care for and maintain the safety of the critically ill
      geriatric patients. The researchers will prepare an illustrative PowerPoint presentation of
      each study program's session.
    

Intervention name(s): Intensive Care Nurses' Training Package
Intervention type(s): Behavioral
Intervention description(s): For the study group, the researcher will explain the method of the training package program application to critical care nurses as follows; firstly, the researchers will assess the nurses' roster, then the researchers will classify the subjects into groups in order to conduct the training package for a group of them while the other subjects taking care of the patients in the intensive care units and repeat the same session to the others in the same manner.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Geriatric Patients; Critically ill
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of
      velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched
      healthy participants as a control group.
    


Intervention name(s): Velpatasvir
Intervention type(s): Drug
Intervention description(s): Velpatasvir 100 mg (2 x 50 mg tablets) administered orally
Other intervention name(s): GS-5816
Intervention MeSH terms: Velpatasvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A 2-year Study of Patients With Schizophrenia Who Are Treated With Long-acting Injectable Risperidone.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine treatment practices of adult schizophrenia patients
      by their own doctors, and to assess patient outcomes when treated with long-acting
      risperidone injection over a two-year period of observation.
    

Detailed description: 
      Controlled clinical trials for treating schizophrenia often involve selected patients with
      common characteristics. It is recognized that schizophrenia are much more diverse than those
      in the clinical setting, and that physician's prescribing practices may vary. The objective
      of the study is to examine treatment practices for adult schizophrenic patients by their own
      physicians, and to assess patient outcomes when treated with long-acting risperidone
      injection. This is a 2-year, prospective, multi-center, longitudinal, observational study in
      adults with schizophrenia. Physicians will determine the appropriate treatment for their
      patients, according to their usual practice. Patients starting treatment with long-acting
      risperidone injections and meeting all the study criteria may enroll in the study. Patients
      will continue their treatment according to usual care by their physicians. Patients will be
      asked questions at baseline and every three months for a period of two years to assess:
      efficacy of the medication, how well the patient is functioning, use of healthcare resources
      (e.g., emergency room visits, hospitalizations) patient work status, quality of life and
      patient satisfaction with the medicine. Safety will be monitored throughout the study. A dose
      of 25, 37.5 or 50 mg of risperidone, administered every 2 weeks by intramuscular injection.
    

Intervention name(s): GAIN Acceptance Approach
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; acceptance; motivational enhancement therapy; long-acting risperidone; intramuscular injection; Treatment Guidebook; GAIN Acceptance Approach
Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty
Condition: Pain, Postoperative; Ropivacaine; Therapeutic Use; Arthroplasty, Replacement, Hip
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The patients will be included the 1. or 2. day after surgery. All THA patients will be
      screened. Those reporting VAS > 40 during active 30 degrees hip flexion will be asked to
      participate.

      Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then
      ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be
      45 minutes between the two blockades. The blockades will be ultrasound guided.
    


Intervention name(s): Ropivacaine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).
Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.; Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).
Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.
Other intervention name(s): Naropin; NaCl; Placebo
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: US guided nerve block; Total hip Arthroplasty; NCFL; nervus cutaneous femoralis lateralis
Comparison of Colloid (20% Albumin) Versus Crystalloid (Plasmalyte) for Fluid Resuscitation in Cirrhotics With Sepsis Induced Hypotension.
Condition: Cirrhosis With Sepsis
MeSH terms: Sepsis; Toxemia; Hypotension
Study type: Interventional

Summary: 
      Consecutive cirrhotics who present to emergency department of Institute of Liver & Biliary
      Sciences with documented or suspected sepsis induced hypotension will be randomized to
      receive either human albumin infusion over 3 hours or plasmalyte as per requirement. At
      admission, all patients will undergo physical examination and baseline investigations to
      identify site of sepsis. The aim of study is to compare the efficacy of using 20% human
      albumin versus plasmalyte in resuscitation of the patient that is attainment of mean arterial
      pressure above 65 mm of Hg at three hour after intervention and sustenance of mean arterial
      pressure above 65 mm of Hg at 6th hour. The randomized patient will be administered 20%
      albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. After the
      intervention changes in MAP (Mean Arterial Pressure), lactate level, urine output, incidence
      of complications, duration of ventilator, ICU (Intensive Care Unit) stay and mortality after
      one week will be studied.
    


Intervention name(s): 20% Albumin; Plasmalyte
Intervention type(s): Biological; Other
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions
Condition: Conscious Sedation Failure During Procedure
Study type: Interventional
Phase: Phase 4

Summary: 
      Ketamine provides a safety zone for sedated but spontaneously ventilated children especially
      in remote conditions such as radiotherapy units where sedation is an essential practice for
      children to keep calm and motionless In this study, investigators planned to analyse ketamine
      doses needed and the recovery times in pediatric oncology patients undergoing repeated
      radiotherapy sessions.
    

Detailed description: 
      Ketamine provides a safety zone for sedated but spontaneously ventilated children especially
      in remote conditions such as radiotherapy units where sedation is an essential practice for
      children to keep calm and motionless.However, there had been a disagreement about the
      ketamine doses needed for a continuous and steady level of sedation during repeated
      radiotherapy sessions in children. In this study, investigators planned to analyse ketamine
      doses needed and the recovery times in pediatric oncology patients undergoing repeated
      radiotherapy sessions.After approval from the Baskent University, School of Medicine, Ethics
      and Research Committee (KA09/247) and informed consents of the patients' guardians, 33
      pediatric patients undergoing radiotherapy due to oncologic disorders were enrolled to
      receive ketamine 2 mg/kg and atropine 10 μg/kg.Patients' demographic data such as age,
      gender, weight, ASA physical status and duration and total number of radiotherapy sessions
      were noted. Total ketamine consumption to maintain the targeted sedation level during each
      session, additional dose administration and the recovery time were recorded. The adverse
      events such as apnea, laryngospasm, bronchospasm, desaturation, respiratory depression,
      bradycardia, sedation levels deeper or superficial than intended to, excessive salivation,
      allergy, nausea and vomiting and need for emergency medication were also noted after each
      session. The study drugs were prepared, labelled and administered by an anesthetist according
      to the study protocol and data were recorded by an anesthetist blind to the amount of the
      study drug used.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): Repeated ketamine 2 mg/kg administration intravenously for sedation during each radiotherapy sessions
Other intervention name(s): Atropine
Intervention MeSH terms: Atropine; Ketamine
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Peginterferon and TIL Therapy for Metastatic Melanoma
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Adoptive T cell therapy with tumor infiltrating lymphocytes (TIL) has achieved impressive
      clinical results with durable complete responses in patients with metastatic melanoma. The
      TILs are isolated from the patients own tumor tissue followed by in vitro expansion and
      activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of
      preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion
      Interleukin-2 are administered to support T cell activation and proliferation in vivo.

      In this trial the therapy is combined with peginterferon (the pegylated form of interferon
      alpha 2b). Interferon alpha has immunomodulatory effects and is known to upregulate HLA
      expression on melanoma cells and are hypothesized to synergize with TIL therapy.
    


Intervention name(s): Cyclophosphamide; Fludarabine; TIL infusion; Interleukin-2; Peginterferon alfa-2b
Intervention type(s): Drug; Drug; Biological; Drug; Drug
Intervention description(s): Cyclophosphamide 60 mg/kg are administered i.v on day -7 and -6; Fludarabine 25 mg/m2 are administered i.v on day -5 to -1; The maximum number of expanded TILs are infused over 30-45 min on day 0; Interleukin-2 are administered as a continuous i.v. infusion in a decrescendo regimen (18 MIU/m2 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU IL-2 over 24 hours followed by 4.5 MIU/m2 IL-2 over another 24 hours for three days); Peginterferon alpha-2b, 3 microgram/kg are administered as subcutaneous injection on day -2, day 7 and day 14.
Other intervention name(s): Fludarabinephosphate; Fludara; T cell infusion; IL-2; Proleukin; PegIntron
Intervention MeSH terms: Peginterferon alfa-2b; Cyclophosphamide; Fludarabine; Interleukin-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Turkish Version of the Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)
Condition: Musculoskeletal Diseases; Genetic Disease; Metabolic Disease; Delays Developmental
MeSH terms: Musculoskeletal Diseases; Genetic Diseases, Inborn; Metabolic Diseases
Study type: Observational

Summary: 
      This study aimed to translate the Affordance in the Home Environment for Motor Development
      -Toddler (AHEMD-T) into Turkish and examine its psychometric properties.
    

Detailed description: 
      Child motor development is a complex process which results from the interaction between
      genetics and the environment. The role of the home as the first environment for child
      experiences is very important for motor development, especially during infancy. Thus, a more
      supportive and stimulating environment is associated with more affordances and challenges for
      infant motor development that may lead to improvement in social and cognitive development.

      There is no Turkish questionnaire to evaluate home environment so we aimed to translate the
      AHEMD-T for using with Turkish children and to investigate psychometric properties.
    

Intervention name(s): investigating the psychometric properties of Turkish Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)
Intervention type(s): Other
Intervention description(s): AHEMD-T will apply to parents who have 18-42 months child/children
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  Parent who have 18-42 months child

          -  Volunteers