bioihbjkbjnl/mcl2 huggingface dataset:
Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT)
Condition: Maternal Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      To evaluate the effectiveness of a telephone based LTP Plus intervention for maternal
      depression.
    

Detailed description: 
      Despite the high prevalence of maternal depression in Pakistan, research on psychosocial
      interventions is limited. We will test the effectiveness of a telephone based intervention
      program called Learning through Play plus Interpersonal Psychotherapy (LTP Plus) that can be
      used by non-specialists, including trained graduates, mothers and lay health workers with
      minimal training. This telephone communication will be supplemented by the provision of LTP
      Plus pictorial calendars to the depressed mothers.

      Purpose of this RCT is to determine if telephone delivered intervention of the LTP plus
      programme reduces symptoms of maternal depression and improves infant development compared to
      Treatment as usual. A sample of 354 (177 in each group) will be required. The study will be
      conducted in big cities of Pakistan including Karachi, Lahore, Hyderabad, Nawabshah, Quetta
      and Peshawar.Participants will be screened using Patient Health Questionnaire (PHQ-9) and
      eligibility checklist. Those scoring 10 and above on PHQ-9 will be invited to participate in
      the study. Assessments will be done at baseline and after completion of intervention (3rd
      month and 6th month after randomization). All follow ups will be done by independent Research
      Assistants (RAs), blind to the treatment allocations.
    

Intervention name(s): LTP Plus; TAU
Intervention type(s): Behavioral; Other
Intervention description(s): LTP Plus is comprised of two components; Learning through play (LTP) and Interpersonal Psychotherapy (IPT). The LTP Plus is a low-literacy; sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Interpersonal Psychotherapy (IPT) intervention is comprised of a supportive element, an educational element, a parenting element and an interpersonal relationship element. Intervention goals include helping mothers feel supported, empowered and confident about their parenting abilities, which would directly influence reduction in depressive symptoms as well as resolution of interpersonal conflicts.; This group will be on their routine care and will not be given any intervention
Other intervention name(s): Psycho-social Intervention; Treatment as Usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a
      single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine (RSV
      6120/∆NS2/1030s) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative
      infants and children 6 to 24 months of age.
    

Detailed description: 
      This study will evaluate the infectivity, safety, and immunogenicity of a single dose of a
      recombinant, live-attenuated RSV vaccine (RSV 6120/∆NS2/1030s) in RSV-seropositive children
      12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.

      The vaccine will be evaluated in a stepwise fashion beginning in RSV-seropositive children
      (Group 1), and then in RSV-seronegative infants and children (Group 2). In each group,
      participants will be randomly assigned to receive a single dose of RSV 6120/∆NS2/1030s
      vaccine or placebo at study entry (Day 0).

      Participants will be enrolled in the study between April 1 and October 31, outside of the RSV
      season. Group 1 (RSV-seropositive children) will be followed for 28 days. Group 2
      (RSV-seronegative infants and children) will remain on study until they complete the post-RSV
      season visit.

      Group 2 participants may participate in an optional second season of RSV surveillance during
      November to March of the second year following enrollment.

      Study visits for all participants may include clinical assessments, blood collection, and
      nasal washes. Additionally, participants' parents or guardians will be contacted by study
      staff at various times during the study to monitor participants' health.
    

Intervention name(s): RSV 6120/∆NS2/1030s; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Delivered as nose drops; Delivered as nose drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease
Condition: COPD Patients
MeSH terms: Lung Diseases, Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations
      in patients with Chronic Obstructive Pulmonary Disease (COPD).
    

Detailed description: 
      A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter
      Exacerbation Study of Symbicort® pMDI 160/4.5 μg x 2 Actuations Twice-daily Compared to
      Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in COPD Patients.
    

Intervention name(s): Symbicort; Formoterol turbohaler; Placebo for Symbicort pMDI; Placebo for Formoterol Turbohaler
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses; Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses; pMDI, aerosol for oral inhalation, placebo, 120 doses; PLacebo powder for oral inhalation, 60 doses
Intervention MeSH terms: Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD, turbuhaler, pMDI
The Cytoadherence in Pediatric Malaria (CPM) Study
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Observational

Summary: 
      The purpose of this study is to determine the importance of key blood group molecules in the
      clinical outcome of Plasmodium falciparum malaria infection in children.
    

Detailed description: 
      Every year, nearly 2 million children die from infection with Plasmodium falciparum malaria.
      When red blood cells (RBC) become infected with malaria, a sticky parasite-derived knob
      protein, termed PfEMP-1, erupts on the RBC surfaces. PfEMP-1 attaches to several blood group
      molecules, including those found on other RBC, on blood vessels, and on the cells that
      normally help to stop bleeding (platelets). The cellular sticking results in a dangerous
      interruption in blood flow to vital organs, causing brain injury (cerebral malaria), systemic
      shock (lactic acidosis), and death. Depending on an individual's inherited blood groups of
      relevance, adhesion may be extensive or limited. In the laboratory, PfEMP-1 adheres to RBCs
      via the A or B (but not the O) antigens of the ABO blood group system, and to platelets and
      blood vessels via platelet glycoprotein IV (CD36) and ICAM-1. Consistent with the expected
      evolutionary advantage of being deficient in these binding targets, blood type O and
      low-expression of CD36 are found more frequently among Africans. The "Cytoadherence in
      Pediatric Malaria" (CPM) project is determining the distribution of adhesive blood group
      molecules in a cohort of 2000 Ugandan children according to the extent of malaria severity
      and death, and thus their ultimate clinical and evolutionary significance in malarial
      survival. This knowledge may serve as the grounds for developing targeted
      cytoadhesion-interruption therapies in our fight against malaria.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children, age 6 months to 12 years, with symptomatic malaria and (asexual) Plasmodium
        falciparum parasitemia.
      
Biospecimen description: 
      Freshly frozen citrated plasma aliquots, frozen spun red cell pellets, and whole blood blots
      onto nucleic acid storage cards (Whatman FTA).
    
Keywords: severe malarial anemia (SMA); cerebral malarial (CM); lactic acidosis; hyperparasitemia; respiratory distress; hypoxia; death; transfusion
The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients
Condition: HIV; Hepatitis C, Chronic; HCV Coinfection
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Coinfection; Hepatitis
Study type: Observational

Summary: 
      The purpose of this research study is to explore what role immune cells within the gut (the
      sigmoid colon) have locally and on the immune system of patients infected with HCV, HIV or
      HCV/ HIV co-infection.
    

Detailed description: 
      Objective 1: Characterization of the Gut Associated Lymphocytes (GALT) in HIV, HCV and
      coinfected patients regarding the role of Th17 and cytokine profiles.

      Hypothesis 1a: HIV and HCV/HIV coinfection is associated with changes in Th17 numbers and
      functions in GALT.

      Hypothesis 1b: HIV and HCV/HIV coinfection is associated with changes in cytokine profiles in
      intestinal mucosa.

      Objective 2: Identify the relationship between changes in Gut Associated Lymphocytes (GALT)
      in HIV, HCV and coinfected patients and markers of microbial translocation.

      Hypothesis 2a: Changes in GALT are associated with increase in microbial translocation in
      HIV, HCV and coinfected patients.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The investigators plan to enroll 40 human subjects including 10 HIV mono-infected, 10 HCV
        mono-infected, 10 HIV/HCV co-infected patients, and 10 control subjects from the outpatient
        clinic at the University of Cincinnati College of Medicine.
      
Biospecimen description: 
      Colon tissues
    
Keywords: HIV; HCV; Hepatitis C; HIV and Hepatitis C coinfection; HIV/HCV
The Effect of Kinesiology Taping on Lumbar Region Structures and Balance in Transfemoral Amputees
Condition: Transfemoral Amputees; Kinesiology Taping
Study type: Interventional

Summary: 
      With the initiation of prosthesis use following lower extremity amputations, the body shows
      biomechanical changes according to the amputation level, and as a result, it develops
      adaptation mechanisms on both the healthy and ampute sides. It has been reported that the
      most common secondary pathology caused by these mechanisms developed to compensate the
      amputated side is lower back pain and adaptation mechanisms vary according to the presence of
      pain. Adaptation strategies in transfemoral amputees cause permanent changes in the
      connective tissue structure properties of the toracolumbar region and reduce the contribution
      of these structures to dynamic stability. It has been reported that with the fascia
      correction technique, one of the kinesiological taping techniques, the connective tissue
      fiber alignment can be rearranged and the degree of stiffness can be reduced. Before the
      intervention, biomechanical properties of the toracolumbar region structures with MyotonPro
      and postural stability measurements with TekScan will be taken.
    


Intervention name(s): Kinesiology taping; Six minutes walking test; Shame Kinesiology Tape
Intervention type(s): Other; Other; Other
Intervention description(s): Y-type kinesiology tape will be applied to the thoracolumbar fascia in experimental gruoup.; Participants will be asked to walk as fast as they can for 6 minutes.; Sham kinesiology tape will be applied to the thoracolumbar fascia in sham gruoup.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: amputation, transfemoral, thoracolumbal fascia, kinesiotape
Effects of Consumption of Orange Juice on Vascular Protection and Immune Function: Clinical Study on the Specific Contribution of Citrus Flavanones
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Epidemiological studies have firmly established the health effects of high intakes of fruits
      and vegetables and in particular in regards to the prevention of cardiovascular diseases.
      Citrus fruits are the most widely consumed throughout the world, mainly as juice. Citrus
      fruits are rich in vitamin C but also in various plant micronutrients which are the most
      abundant polyphenols. Several in vitro studies and animal models suggest that the polyphenols
      of citrus are involved in the protective effects of citrus vis-à-vis the cardiovascular
      diseases. However, profits in health associated with taking these polyphenols are unknown and
      so far no clinical studies have been conducted to determine the contribution of polyphenols
      of citrus in this protection.

      The main objectives of this project are (1) to characterize the effects of single dose and
      made repeated consumption of orange juice on vascular protection and the immune response and
      (2) to assess the specific role of polyphenols present in citrus fruits in this protection.
      To do this the investigators will conduct a clinical study, randomized and crossover, among
      healthy men 50 to 65 years that are slightly overweight. These volunteers, who continue to
      follow their usual diet, should consume daily for 4 weeks (1) orange juice or (2) an
      isocaloric control beverage or (3) the same drink spiked with a dose of polyphenols similar
      to that given by orange juice.
    

Detailed description: 
      Clinical study, randomized, crossover, double-blind in healthy men 50 to 65 years who are
      slightly overweight.
    

Intervention name(s): Flavanones of orange juice
Intervention type(s): Drug
Intervention description(s): The main objective of this study is to evaluate, in healthy volunteers with young children (50 and 65) and slightly overweight according to their usual diet, the effects of single dose (in postprandial period) and made repeated orange juice or orange flavanones purified on vascular function. The selection criteria for age and weight should, within a healthy population to select individuals who exhibit cardiovascular risk factors, and thus for which it should be a priori easier to identify a beneficial effect of dietary factors on the parameters associated with cardiovascular risk.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Flavanones and vascular function
Effect of Prewarming on Microcirculatory Response
Condition: Coronary Artery Bypass Graft Triple Vessel
Study type: Interventional

Summary: 
      Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial
      injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery
      without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is
      important for clinical outcome. The investigators hypothesized that prewarming during
      induction of general anesthesia would reduce drop of body temperature and change of
      peripheral microcirculation.
    

Detailed description: 
      Microcirculatory parameters can be obtained from vascular occlusion test. Among those
      parameters, recovery slope during vascular occlusion test is known to reflect recruitment of
      microvasculature in response to hypoxic or ischemic insult. In this study, we will compare
      the recovery slope during vascular occlusion test between prewarming treatment group and
      control group.
    

Intervention name(s): prewarming
Intervention type(s): Device
Intervention description(s): recovery slope StO2
Other intervention name(s): prewarming by active air heater
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: microcirculation; off-pump coronary artery bypass surgery; tissue oxygen saturation; vascular occlusion test; recovery slope
Intensive Arterial Pressure Control in Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24
      hours can improve the prognosis in the short and long term.

      the study compare two treatment strategies (standard and intensive treatment) to assess their
      efficacy and safety in the treatment of acute coronary syndrome.
    

Detailed description: 
      Acute coronary syndrome is often associated with arterial pressure elevation which are
      deleterious for the heart and needs urgent intervention to lower the blood pressure to the
      required values, however there is no clear recommendations concerning the treatment intensity
      in this situation.

      The investigators know that high arterial pressure increases the oxygen myocardial
      consumption and it is deleterious in acute coronary syndrome, so , it is logical to reduce
      intensively this pressure.
    

Intervention name(s): Isosorbide Dinitrate
Intervention type(s): Drug
Intervention description(s): administration of continuous intravenous isosorbide dinitrate to obtain a SBP between 110 and 120 mmHg. After 2 hours from the start of treatment and if the blood pressure goal is not achieved, labetalol is used
Other intervention name(s): Risordan
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Acute Coronary Syndrome, arterial pressure
Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of conservative treatments of obesity
      with surgery (gastric bypass).
    

Detailed description: 
      The aim of this study is to evaluate 3 different treatments of obesity with gastric bypass.
      Two groups will be treated in different clinics and 1 group will be treated at our outpatient
      clinic. Sixty patients will participate in each group. Behavioural changes and weight loss
      over 4-5 years will be followed. We will also analyse changes in hormones, mental status,
      sexual behaviour, effect of training and quality of life.
    

Intervention name(s): lifestyle changes
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; lifestyle; treatment; Complications; endocrine changes; Lipids; C18.654.726.500.495
A Study of LY3015014 in Participants With High Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to define the amount and duration of cholesterol lowering and to
      assess the safety and tolerability of different dose regimens of LY3015014 in participants
      with high cholesterol. The study will also investigate how the body processes the drug and
      how the drug affects the body. Participants will remain on a stable diet and will continue
      taking cholesterol-lowering medications (statins with or without ezetimibe). After signing
      the informed consent document, the participant will complete a screening/run-in period that
      will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After
      the treatment period, the participants will complete a follow-up period lasting approximately
      8 weeks for a total study duration ranging from approximately 25 to 32 weeks.
    


Intervention name(s): LY3015014; Placebo; Statin; Ezetimibe
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered orally; Administered orally
Other intervention name(s): atorvastatin; simvastatin; rosuvastatin; pravastatin; lovastatin; fluvastatin; pitavastatin
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Simvastatin; Ezetimibe; Pravastatin; Pitavastatin; Lovastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: low density lipoprotein, heterozygous familial hypercholesterolemia, polygenic hypercholesterolemia
Management of RPOC After Induced Abortion
Condition: Abortion Induced Complicated
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized trial comparing expectant management and medical management in women diagnosed
      with retained products of conception after first trimester induced abortion
    

Detailed description: 
      An open label randomized controlled trial (RCT) of all women diagnosed with retained product
      of conception (RPOC) after first trimester medical TOP in a single university affiliated
      medical center. All consecutive women who underwent medical TOP by mifepristone and
      misoprostol at gestational age under 63 days from last menstrual period and were diagnosed
      with RPOC in a routine 3-week ultrasound follow-up are offered to participate. RPOC is
      defined as thick irregular endometrium (over 12 mm) with positive Doppler flow. Following
      recruitment, patients are randomized into either expectant arm or medical arm (800 mcg
      misoprostol). The primary outcome measure is RPOC rate in repeat ultrasound scan performed 5
      weeks after randomization.
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): sl 800 mcg misoprostol
Other intervention name(s): Cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RPOC, induced abortion, misoprostol