bioihbjkbjnl/mcl2 huggingface dataset:
Learning Through Play (LTP) Plus Intervention for Depressed Fathers (LTP Plus Dads)
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the clinical and cost effectiveness of culturally adapted
      group parenting intervention delivered by non-specialists and community health workers for
      depressed fathers.
    

Detailed description: 
      Most research on the association between parental depression and child outcomes has focused
      mainly on mothers. However, studies suggest that the relationship between parental depression
      and child outcome is not necessarily limited to mothers.

      The study has two phases quantitative and qualitative:

      Purpose of this quantitative phase is to determine if the LTP plus programme delivered by
      non-specialists and community health workers reduces symptoms of paternal depression and
      improves child development compared to treatment as usual.

      In the qualitative part of the study focus groups and in-depth digitally recorded interviews
      will be conducted with participants by trained research staff at two-time points both before
      and after the intervention. These focus groups and in-depth interviews will continue till the
      data saturation is achieved. In addition, Participants who refused to participate in the
      trial will be asked if they would be willing to be contacted by a researcher to discuss their
      reasons for not taking part. Moreover, in-depth digitally-recorded interviews with
      stakeholders (grandparents, therapists, health professionals, etc) will also be conducted by
      trained researchers.
    

Intervention name(s): LTP Plus
Intervention type(s): Behavioral
Intervention description(s): LTP+Dads is a 12 - session group integrated parenting intervention: i.e LTP (Learning through Play) which includes a pictorial calendar, consisting of stages of child development from birth to 3 years. It includes parent-child play and other activities that promote parental involvement, learning, and attachment. In each stage, there are five areas of child development: sense of self, physical, relationships, understanding, and communication. All areas are written in simple, low-literacy language.
Second component of intervention is CBT adapted from Jeanne Miranda manual (Group CBT for Depression, group leaders guide book-2006) focusing on the three areas: thoughts and your mood, activities and your mood, people interaction and your mood.
Third component of intervention is content taken from Ed Bader's manual (Focus on Fathers) includes importance of fathers in child development, stress management at work and home, budgeting, anger management, conflict resolution and time management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Learning Through Play Plus; Cognitive Behavior Therapy; Parenting Intervention; Low and middle-income country
Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the influence of Orlistat and Metformin on obesity
      treatment in obese PCOS women.
    

Detailed description: 
      In a randomized clinical trial study, 80 obese women with BMI≥30, oligomenorrhae, hirsutism
      and presence of > 12 ovarian follicles (2-10mm diameter), were evaluated. In metformin group
      , metformin was administered for patients 1500 mg daily for three months. In orlistate group,
      patients used orlistat tablets (120 mg, 3 times a day) for three months. BMI, serum LH and
      FSH levels, serum triglyceride and cholesterol levels and also patients' ovulation was
      compared before and after treatment.
    

Intervention name(s): orlistat
Intervention type(s): Drug
Intervention description(s): Tablet,120mg,three times a day,three months
Other intervention name(s): Xenical
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: metformin; orlistat; pcos; obese
Effects of Topical Clonidine vs. Brimonidine on Choroidal Blood Flow and Intraocular Pressure During Isometric Exercise
Condition: Ocular Physiology; Regional Blood Flow
Study type: Interventional
Phase: Phase 4

Summary: 
      Brimonidine tartrate is an alpha-2 agonist ocular hypotensive drug that exerts its effect by
      causing both a decrease in aqueous production and an increase in uveoscleral outflow. It has
      been proven to reduce increased intraocular pressure in glaucoma and ocular hypertension. As
      an alpha 2 agonist Brimonidine belongs to the same class of drugs as Clonidine; however, its
      molecular structure is sufficiently different to make it more selective for the alpha 2
      receptor than Clonidine. Unlike Clonidine, Brimonidine does not appear to have an effect on
      the central nervous system and therefore does not cause sedation or systemic hypotension.

      In addition to their known effect of lowering intraocular pressure, alpha 2 adrenoceptor
      agonists are neuroprotective. It has, however, been shown that Brimonidine is a very potent
      vasoconstrictor in the ciliary body thus reducing aqueous humor production. Little is,
      however, known about potential vasoconstrictor effects of Brimonidine in the posterior pole
      of the eye. This is of clinical importance, because optic nerve head ischemia appears to
      contribute to glaucoma pathophysiology.

      This study is performed to investigate the effects of topical Clonidine vs. topical
      Brimonidine on choroidal blood flow and intraocular pressure during isometric exercise.
    


Intervention name(s): Clonidin; Brimonidine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Brimonidine Tartrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Choroidal blood flow; Clonidin; Brimonidin
A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI)
      study in healthy female subjects on oral contraceptives (OC). There is no formal research
      hypothesis to be statistically tested. It is expected that coadministration of BMS-663068
      with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or
      norethindrone (NE).
    


Intervention name(s): BMS-663068; Oral Contraceptive; Loestrin 1.5/30
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Investigational product; Subject's existing combination OC tablet containing EE and progestin; OC containing EE and norethindrone acetate (NEA)
Other intervention name(s): Junel; Microgestin 1.5/30
Intervention MeSH terms: Fostemsavir; Contraceptive Agents; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Contraceptives, Oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Metabolic Syndrome
Study type: Interventional

Summary: 
      This is a randomized controlled Trial to evaluate effect of a culturally and linguistically
      tailored, telephone-delivered behavioral intervention on adherence to recommended assessment
      and treatment of sleep apnea in Blacks with Metabolic Syndrome. The investigators believe low
      awareness of Sleep Apnea and the risk it imposes to an individual health plays an important
      role in underdiagnosis and low adherence to treatment among Blacks. Hence, culturally and
      linguistically tailored health education will decrease the knowledge gap and improve
      adherence to recommended assessment and treatment of sleep Apnea. the investigators believe
      the effect of adherence to treatment of Sleep apnea is shown to improve the components of
      Metabolic syndrome and hence promote well control of Hypertension, Diabetes, weight,
      triglyceride and cholesterol.
    

Detailed description: 
      Primary aim: To evaluate effect of a culturally and linguistically tailored,
      telephone-delivered behavioral intervention, versus an attention-control condition, on
      adherence to recommended assessment and treatment of sleep apnea.

      Secondary aims: 1) To evaluate the maintenance of intervention effects on adherence 6 months
      post-intervention; and 2) To assess treatment effects on components of the metabolic syndrome
      (waist circumference, blood pressure, lipid level, and fasting plasma glucose/HbA1C).

      Exploratory aim: To identify the mediators of adherence to recommended sleep apnea assessment
      and treatment following exposure to the intervention.
    

Intervention name(s): Adherence to Sleep Apnea Treatment; Standard Care Group
Intervention type(s): Behavioral; Other
Intervention description(s): A health education material prepared after focus group discussion with community leaders and patients would be administered to the participants with an experienced health educator through phone. Upto 10 calls per each patient will be made to either group until 6 months or the patient has a sleep test done.; The standard care group gets a standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine
Other intervention name(s): Linguistically and culturally tailored intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Tailored Telephone Intervention
Influence of H1-antihistamines on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin.
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      In order to validate the accuracy and reliability of the histamine skin prick model for
      histaminergic itch and vasodilation, the dermal blood flow response induced by a histamine
      skin prick will be evaluated after the administration of certain H1-antihistamines. Besides,
      the influence of these H1-antihistamines on the dermal blood flow response induced by the
      topical application of cinnamaldehyde and capsaicin will be evaluated. Changes in dermal
      blood flow will be measured with laser speckle contrast imaging.
    


Intervention name(s): Desloratadine Single Dose; Levocetirizine Single Dose; Desloratadine Fourfold Dose; Levocetirizine Fourfold Dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Desloratadine (H1-antihistamine): oral tablet (1 x 5 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick; Levocetirizine (H1-antihistamine): oral tablet (1 x 5 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick; Desloratadine (H1-antihistamine): 2 oral tablets of 5 mg in the evening and 2 oral tablets of 5 mg in the morning, taken with 240 ml water, 14 and 4 hours prior to the histamine skin prick, respectively; Levocetirizine (H1-antihistamine): 2 oral tablets of 5 mg in the evening and 2 oral tablets of 5 mg in the morning, taken with 240 ml water, 14 and 4 hours prior to the histamine skin prick, respectively.
Intervention MeSH terms: Cetirizine; Loratadine; Levocetirizine; Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, cross-over study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
A Phase I of SS109 in Hemophilia A or and B With Inhibitors
Condition: Hemophilia A With Inhibitor; Hemophilia B With Inhibitor; Factor VII Deficiency
MeSH terms: Hemophilia A; Hemophilia B; Factor VII Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I study aims to evaluate the safety, PK/PD and immunogenicity of SS109 in
      hemophilia A or and B with inhibitors. Twenty -seven patients are enrolled in study, and
      divided into five dose cohorts, from 30μg/kg to 360μg/kg. Dose 1 cohort enrolls three
      patients, each other dose cohorts enroll six patients. All patients included in the study
      will continue to be followed up until 28 days after SS109 administration.
    

Detailed description: 
      This study is an open label, dose escalation, multicenter clinical trial. The study sets up a
      science review committee to assess the dose escalation. Serial blood samples for PK/PD
      analysis will be taken up to 72 hours after SS109 injection. Patients safety will be
      routinely monitored throughout the study.
    

Intervention name(s): SS109
Intervention type(s): Biological
Intervention description(s): 27 patients are enrolled in cohorts ,and will continue to be followed up until 28 days after SS109 administration for evaluating safety, PK/PD and immunogenicity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sensory Stimulation in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effectiveness of low-intensity and prolonged
      vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.
    

Detailed description: 
      The trial will last up to 8 weeks for each subject and includes:

      Three weeks treatment 1 (sham or actual) Two week washout Three weeks treatment 2 (sham or
      actual) Vibrotactile sensory stimulation will consist on whole-body stimulation with
      mechanical stimuli of pallesthetic type at high rate, low intensity and long daily duration.
    

Intervention name(s): Vibrotactile stimulation
Intervention type(s): Device
Intervention description(s): Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (20-90 Hz), low intensity and long daily duration (3h).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults
Condition: Pneumococcal Infections; Streptococcus Pneumoniae Infections; Pneumococcal Pneumonia
MeSH terms: Infections; Communicable Diseases; Pneumonia; Pneumonia, Pneumococcal; Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety, tolerability, and immunogenicity of an
      investigational pneumococcal vaccine in healthy adult volunteers.

      Primary Objective:

        -  To evaluate the safety and tolerability of an investigational pneumococcal vaccine.

      Observational Objective:

        -  To evaluate the immunogenicity of an investigational Pneumococcal vaccine.
    

Detailed description: 
      An initial cohort of 10 participants will receive a single dose of investigational
      pneumococcal vaccine. After safety assessment of this cohort during a 24-hour in-unit
      observation period, additional cohorts will receive two injections of the study vaccine 30
      days apart, at three dose levels, in ascending doses by cohort, pending safety review at each
      dose level. All participants will be monitored for safety for 30 days after each vaccination.
    

Intervention name(s): Pneumococcal vaccine Formulation 1; Pneumococcal vaccine Formulation 2; Pneumococcal vaccine Formulation 3; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular (Low dose); 0.5 mL, Intramuscular (Middle dose); 0.5 mL, Intramuscular (High dose); 0.5 mL, Intramuscular
Other intervention name(s): Tris Buffered Saline
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pneumococcal infections; Streptococcus pneumoniae Infections; Pneumococcal Vaccines
Symptom Adapted Therapy in GERD Patients
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether a maintenance treatment over 12 weeks with
      esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it
      compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy
      (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute
      treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.
    


Intervention name(s): esomeprazole; Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Esomeprazole; Aluminum Hydroxide; Magnesium trisilicate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nexium
Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction
Condition: Myocardial Infarction; Heart Failure; Myocardial Revascularization; Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The aim of the present study is to investigate the possible effects of supplementation with
      1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during
      a follow-up period of 2 years in an elderly population after having experienced an acute
      myocardial infarction.

      The hypothesis is that this supplementation on top of modern therapy will reduce the combined
      cardiovascular end-point of death, non-fatal myocardial infarction, stroke,
      revascularizations or hospitalization for new or worsened heart failure with at least 30%.
    


Intervention name(s): Pikasol; Corn oil
Intervention type(s): Drug; Other
Intervention description(s): Pikasol®, 3 capsules (1.8 g EPA+DHA)/day; Corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid), unchanged and according to the manufacturer
Other intervention name(s): omega-3; polyunsaturated fatty acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Fatty Acids, Omega-3; Aged; Myocardial Infarction
The Influence of Having Breakfast on Cognitive Performance and Mood
Condition: Fasting
Study type: Interventional

Summary: 
      Breakfast is often labelled the most important meal of the day.

      Parents and teachers quite often stress its importance for successful learning during the
      morning hours. With declining numbers of children and especially adolescents eating breakfast
      regularly, the study examines the influence of breakfast consumption on cognition and mood of
      high school students.
    


Intervention name(s): Breakfast/no breakfast
Intervention type(s): Other
Intervention description(s): A: Breakfast on the first day of intervention. Fasting (no breakfast) on the second day of intervention.
B: Breakfast on the second day of intervention. Fasting (no breakfast) on the first day of intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: High school students; Boarding school; Breakfast; Fasting; Memory; Attention; Mood
CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Sleep Apnea, Obstructive; Hypertension, Pulmonary; Hypertension
Study type: Interventional

Summary: 
      All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night
      polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary
      hypertension(PH). These patients seemed to have PH if mPAP ≥25 mmHg . All studied patients
      were received CPAP therapy with average cumulative adherence ⩾4 h/day of >70% nights [380]
      obtained from device download with AHI<5 /hr

      Echocardiography:

      It was performed initially to diagnose pulmonary hypertension and repeated after three months
      of CPAP therapy as a follow up . All enrolled patients were subjected to trans-thoracic
      echocardiography using Ultrasound system (Vivid I, GE Healthcare, Little Chalfont, UK), with
      a 2.5 MHz transducer. Certain measurements were then used to calculate mPAP.

      Patients were considered to have PH if mPAP ≥25 mmHg, and were classified into mild (20-40
      mmHg), moderate (41-55 mmHg), and severe (>55 mmHg) degrees.

      Evidence of PH is found by Doppler echocardiography showing an elevated right ventricular
      systolic pressure (RVSP).
    


Intervention name(s): CPAP therapy
Intervention type(s): Device
Intervention description(s): All studied patients were received CPAP therapy with average cumulative adherence ⩾4 h/day of >70% nights [380] obtained from device download with AHI<5 /hr
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment