bioihbjkbjnl/mcl2 huggingface dataset:
Mother and Late Preterm Lactation Study
Condition: Breastfeeding; Postnatal Depression; Stress, Psychological; Preterm Infant
MeSH terms: Premature Birth; Depression, Postpartum; Stress, Psychological
Study type: Interventional

Summary: 
      Breastfeeding has various benefits for the mother and infant. It has the capability of
      reducing the risk of short term and long term problems for the infant, such as
      gastroenteritis, respiratory infections, type II diabetes and obesity, and of providing
      benefits for neurodevelopment. Breast milk offers even greater benefits for preterm infants.
      Some of the advantages of breastfeeding are related to the constituents of breast milk such
      as the macronutrients and bioactive factors, the hormones associated with breastfeeding such
      as oxytocin, and the behavioural aspects of breastfeeding (maternal sensitivity to infant
      cues). Despite these advantages, breastfeeding rates are below target levels mainly due to
      the challenges that women face that hinder breastfeeding success. Interventions aimed at
      improving policies, practices, and maternal support have been developed. However, other
      interventions that target specific modifiable barriers to breastfeeding can be useful.

      The aim of this study is to investigate a simple support intervention for breastfeeding
      mothers of late preterm and early term infants on maternal stress reduction and infant weight
      gain. The investigators also aim to study the potential mechanisms by which this effect could
      be achieved (breast milk composition and volume, mother and infant behaviour).
    


Intervention name(s): Breastfeeding Support
Intervention type(s): Other
Intervention description(s): 12-minute simple technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: breastfeeding; postnatal mental health; breastfeeding support; stress; late preterm infant; breast milk
Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome
Condition: Eisenmenger Complex; Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Eisenmenger Complex
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the acute effects of oxygen supplementation during
      a submaximal exercise test in patients with Eisenmenger's Syndrome.
    

Detailed description: 
      Patients with Eisenmenger's syndrome were submitted to a submaximal exercise test (six-minute
      walking test) with and without supplemental oxygen. The distance walked during the two tests
      were compared to assess the impact of oxygen supplementation on the walking distance.
    

Intervention name(s): Oxygen Supplementation
Intervention type(s): Other
Intervention description(s): Oxygen delivery was continuous by mask at 40%
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Use of PRP and BMC in Patients With Internal Disc Disruption Multicenter Prospective Randomized Controlled Trial in Patients With Internal Disc Disruption
Condition: Internal Disc Disruption
Study type: Interventional

Summary: 
      The condition being studied is chronic low back or leg pain in patients with internal disc
      disruption (IDD). The intervention to be studied is the intradiscal delivery of autologous
      Platelet Rich Plasma (PRP) or bone marrow concentrate (BMC) into the nucleus pulposus of the
      disrupted disc(s).
    

Detailed description: 
      This multi-center randomized controlled pilot trial will be the first to evaluate the
      response of PRP and BMC for discogenic pain by direct comparison. The investigators propose
      to incorporate a crossover design that compares placebo to two treatment modalities (i.e.
      Neutrophil-Poor PRP [NP-PRP] and BMC).

      If the investigators can demonstrate statistically significant and clinically meaningful
      improvements in study's primary and secondary outcome measures, this study will have
      identified a natural, effective and sustainable treatment for discogenic back pain that
      currently accounts for the highest level of disability in US. This will help guide physicians
      in the choice of care between surgical and conservative treatment options when treating
      patients.
    

Intervention name(s): Intradiscal PRP & BMC Injections
Intervention type(s): Procedure
Intervention description(s): The intervention to be studied is the intradiscal delivery of autologous Platelet Rich Plasma (PRP) or bone marrow concentrate (BMC) into the nucleus pulposus of the disrupted disc(s).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be assigned to one of three arms of the study. The first group will receive a trigger point injection of saline into the deep tissue. The second group will receive an injection of approximately 1-2 mL of Platelet RP into the painful disc/discs. The third group will receive an injection of approximately 1-2 mL of Bone Marrow Concentrate into the painful disc/discs. No more than three discs will be injected.
Masking: Single (Participant)
Primary purpose: Treatment
Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children
Condition: HIV Infections; Cryptosporidiosis
MeSH terms: Cryptosporidiosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a
      significant problem for HIV infected children in developing countries. C. parvum infection
      can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV
      infected children. The purpose of this study is to test the safety of NTZ in HIV infected
      children who have chronic diarrhea caused by C. parvum.

      Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants,
      children, and adolescents with chronic diarrhea caused by C. parvum infection.
    

Detailed description: 
      C. parvum is a significant opportunistic infection in much of the developing world, where
      children may not have access to highly active antiretroviral therapy. There is currently no
      established therapy for chronic cryptosporidiosis in HIV infected children. The FDA has
      approved NTZ for the treatment of cryptosporidiosis diarrhea; however, there are no data on
      the safety and effectiveness of NTZ in HIV infected children. The purpose of this study is to
      evaluate the safety of different doses of NTZ in HIV infected children with chronic diarrhea
      caused by C. parvum.

      In Step 1, participants will receive one of four different doses of NTZ. Participants will
      take NTZ twice a day for 56 days in either a liquid or pill form. All participants will be
      closely monitored for drug toxicity. There will be seven study visits; they will occur at
      study entry, Weeks 1, 2, 4, 6, and 8, and Day 70. Study visits will include a physical exam
      and blood, urine, and stool collection. Pharmacokinetic (PK) sampling will be performed
      during four of the study visits. PK sampling requires the participants to take their morning
      NTZ doses while in the clinic; participants will undergo additional blood collection either
      before or after taking NTZ. At the end of the 56-day study period, participants who are
      experiencing a positive clinical benefit from NTZ and who have had no harmful side effects
      may choose to continue taking NTZ for an additional 24 weeks and enter Step 2. Participants
      who do not continue taking NTZ after Day 56 will be followed for 2 additional weeks.
    

Intervention name(s): Nitazoxanide
Intervention type(s): Drug
Intervention MeSH terms: Nitazoxanide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nitazoxanide; Antiprotozoal Agents; Cryptosporidiosis; Cryptosporidium parvum; AIDS-Related Opportunistic Infections; Pharmacokinetics; Drug Adminstration Schedule
Health-connected Devices and Physical Activity Recovery in Bariatric Surgery Patients
Condition: Obesity, Morbid; Bariatric Surgery Candidate
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The goal of clinical trial is to evaluate the impact of use of health-connected devices and
      of an Internet-based Intensive follow-up on physical activity recovery during the 6-month
      period after bariatric surgery in obese patients.
    

Detailed description: 
      90 patients with morbid obesity, having recently benefited from an act of bariatric surgery
      will be recruited for clinical trial if they meet the inclusion and no inclusion criteria.
      This is a single-center, open, controlled, randomized, 2 parallel-groups:

        -  "Mobility Coaching" group

        -  "Diet Coaching" group

      The "Diet Coaching" group will be the "control group" of "Mobility Coaching" group and vice
      versa.

      Patients in both groups will be equipped with a connected-scale and a wristwatch equipped
      with a pedometer connected. The online tools available to patients will be used to motivate
      patients to progress and alert the coaches and the medical team in case of difficulties to
      achieve the objectives.
    

Intervention name(s): Mobility coaching; Diet coaching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intensive follow-up for the patients of "Mobility Coaching " arm will consist on a monthly remote coaching of 20 to 30 minutes led by a "Mobility" coach. The web platform allows self-administration of a questionnaire to establish patient's diagnosis of mobility to enable personalized coaching. The web platform can also track the parameters collected by connected devices (pedometer and connected scale), organize appointments with patients and ensure the traceability of exchanges with patients. A smartphone application tracks different modes of locomotion used.; The intensive follow-up for the patients of "Diet Coaching " arm will consist on a monthly remote coaching of 20 to 30 minutes led by dietitian trained in the care of patients undergoing bariatric surgery.
Other intervention name(s): Mobility; Diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Nutrition; Physical activity; Bariatric surgery; Obesity; Health technology; Health-connected devices
VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)
Condition: Sleep
Study type: Observational

Summary: 
      Sleep is an important contributing factor to people's health. However, over one third of the
      general population has sleep complaints, causing both health related problems, and economic
      impact. Many do not think their problem sleep is serious enough to consult a physician
      (primary care or sleep specialist). For a selection of this population, self-tracking devices
      can be a solution, but these trackers are often activity based and therefore lacking in their
      capacity to give insight into underlying causes of poor quality sleep and daytime fatigue.

      A new options for these confused sleeper is an online questionnaire, developed by Philips and
      Cooperative Research Center (CRC) for Alertness, Safety and Productivity Imagine a troubled
      sleeper awake at 3 am, they search "Why can't I sleep?" and find the survey. From there the
      user takes the sleep survey, which has the ability to assess their most likely sleep problem
      or problems from a list of seven sleep problem categories based upon their responses. At the
      end of the survey, participants will get information about which problem category they will
      fall into, and the level of certainty around that.

      The purpose of the study is to determine the accuracy of the questionnaire in identifying the
      correct sleep problem when compared with the assessment of a sleep physician in a clinical
      sleep center. We hope to enroll 200 participants which was based upon an Initial power
      analyses were completed using pilot data, assuming accuracy rates of 70, 80, and 90% and a
      total sample size of 200. The intervals would be about ± 4.5% (for 90%) to ± 7% (for 70%).
      Participants will complete the survey, be blinded to the results, and then have a
      consultation with a sleep physician who will make an independent assessment.
    


Intervention name(s): Sleep survey
Intervention type(s): Other
Intervention description(s): The Sleep survey was created by the Collaborative Research Center (CRC), a joint effort of the Australian Government, Academia and Industry [including Philips]).
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will be those who are new patients to the sleep lab or those recruited
        from a central recruiter that may or may not have sleep issues.
Extension of Study ZPV-200
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four
      doses of vaginally administered Proellex in premenopausal women with uterine fibroids
      confirmed by ultrasound.
    


Intervention name(s): telepristone acetate 12 mg; telepristone acetate 3 mg; telepristone acetate 6 mg; telepristone acetate 12 mg; telepristone acetate 24 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 12 mg, vaginal capsule, once daily for 4 months; 3 mg, vaginal capsule, once daily for 3 months; 6 mg, vaginal capsule, once daily for 3 months; 12 mg, vaginal capsule, once daily, for 3 months; 24 mg, vaginal capsule, once daily for 4 months
Other intervention name(s): Proellex; Proellex; Proellex; Proellex; Proellex
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of
      etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled
      in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in
      the OLE study.
    


Intervention name(s): Etrolizumab
Intervention type(s): Drug
Intervention description(s): Participants will receive etrolizumab at a dose of 100 mg.
Intervention MeSH terms: Etrolizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biomarkers and Volumetric Capnography in BPD
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Study type: Observational

Summary: 
      The purpose of this study is to assess the association of biomarkers on day 7 of life with
      the development of bronchopulmonary dysplasia in very preterm infants. Additionally a short
      lung function test at 36 weeks postmenstrual age (PMA) will be performed to investigate
      whether certain capnographic indices are able to reflect the degree of lung disease.

      Protocol was amended (under others: additional enrollment of 70 subjects).
    

Detailed description: 
      This is a two-centre prospective cohort study in very preterm infants born below 32 0/7 weeks
      PMA and hospitalised in the neonatal intensive care units at the University Children's
      Hospital Basel and the Inselspital Berne during two years. After informed consent a sample of
      0.5 mL ethylenediaminetetraacetic acid (EDTA) full blood will be taken on day 7 of life (+/-
      2 days) during routine blood sampling. The biomarkers which are planned to measure include
      the C-terminal portion of the proendothelin-1 precursor (CT-proendothelin (proET)-1) and
      other plasma biomarkers of respiratory distress. At 36 weeks PMA, lung function testing will
      be performed during quiet unsedated sleep in supine position approximately 30 minutes post
      feeding. After placement of a facemask, tidal breathing will be recorded at the bedside using
      a commercially available ultrasonic flow meter (Spiroson, Exhalyzer D, Ecomedics, CH)
      according to American Thoracic Society (ATS) and European Respiratory Society (ERS) standards
      of infant lung function testing. Different capnographic indices will be calculated to
      investigate if they reflect the degree of lung disease at 36 weeks PMA.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants born below 32 weeks PMA and admitted to the neonatal intensive care units
        in Basel and Berne, Switzerland.
      
Biospecimen description: 
      Plasma
    
Keywords: Bronchopulmonary dysplasia, preterm infant
Safety and Tolerability of BDB-001 Injection in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to evaluate the safety,tolerability,PK and PD characteristics of BDB-001
      Injection in healthy subjects.
    


Intervention name(s): BDB-001 injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous injection; Intravenous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in Patients With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Observational, longitudinal (retrospective cohort), multicenter, national study aiming to
      evaluate the proportion of women with HR+/HER2- advanced breast cancer treated with
      ribociclib plus non-steroidal aromatase inhibitors who were alive and without disease
      progression at 1 year.
    

Detailed description: 
      The study was conducted in 11 Brazilian sites specialized in the treatment of this condition.
      The study data were collected from the review of medical records by the Investigator (or
      designated).

      The sites must have had adequate medical records to ensure robust medical record review.
      Therefore, a feasibility assessment was carried out at potential site prior to the study
      implementation to assess the adequacy of medical records and the data routinely available.
    

Intervention name(s): Ribociclib
Intervention type(s): Drug
Intervention description(s): Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population was composed only of women aged 18 years or older.
      
Keywords: HR+/HER2-,; advanced breast cancer,; ribociclib,; non-steroidal aromatase inhibitors,; first-line treatment
Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of pharmaceutical services among patients
      starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of
      the study is that pharmacist intervention can improve compliance to antidepressants and
      patient wellbeing.
    

Detailed description: 
      The aim of this study is to evaluate the efficacy of a support program in community pharmacy
      on the improvement of the compliance to antidepressants and the clinic of typical primary
      care patients under normal practice circumstances. That implies that the intervention is made
      by pharmacists without any specific requirement that work in the community pharmacies set up
      in the area of study and on patients following the usual medical circuit. As well, the cost
      of the support program is calculated in order to set the effectiveness of the program.
    

Intervention name(s): Pharmaceutical care program for antidepressant treatment
Intervention type(s): Behavioral
Intervention description(s): The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment.
Other intervention name(s): PRODEFAR group
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Medication adherence; Antidepressive agents; Primary care; Pharmaceutical care
A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan
Condition: Huntington Disease; Alzheimer Disease
MeSH terms: Alzheimer Disease; Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This drug-drug interaction study is being conducted to evaluate the potential effect of
      Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450
      2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.
    


Intervention name(s): Dextromethorphan; Dimebon + Dextromethorphan
Intervention type(s): Drug; Drug
Intervention description(s): Dextromethorphan HCl 30 syrup single dose; Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12
Intervention MeSH terms: Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging
Condition: Cardiac Disease; Heart Failure; Cardiac Ischemia
MeSH terms: Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia
Study type: Interventional

Summary: 
      This prospective study is a pilot study for evaluating a guidance system that aims to
      facilitate high-quality echocardiographic acquisitions.
    

Detailed description: 
      The primary objective of this study is to assess the feasibility for non-expert users
      (medical professionals but non-certified sonographers) to acquire parasternal, apical and
      subcostal views of suitable quality by using an existing ultrasound device (CE-marked,
      available in the market) and an additional guidance system (software prototype + probe motion
      tracking device). Such a system will help the user to place the probe on the patient and
      provide guidance for optimal acquisition of parasternal, apical and subcostal views.

      The secondary objective of this study is to assess the feasibility for non-expert users to
      reproduce a simple clinical protocol by using an existing ultrasound device and the same
      additional guidance system.
    

Intervention name(s): TransThoracic Echocardiography imaging
Intervention type(s): Device
Intervention description(s): ultrasound scanning
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: echocardiography; training; follow-up