bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy
Condition: Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Interventional

Summary: 
      Background: It has been reported in the current literature that massage has various positive
      physiological effects on the newborn. Also baby massage; It increases the collection and
      excretion of waste products such as bilirubin by accelerating the flow of blood, lymph and
      tissue fluids. Our aim is to investigate the effect of infant massage on hyperbilirubinemia
      in newborns receiving phototherapy.

      Method: The population of the study consisted of babies who were hospitalized in Istanbul
      Haseki Training and Research Hospital Neonatal Intensive Care Unit between October 2021 and
      January 2022 and needed phototherapy. Transcutaneous bilirubin device and data collection
      form were used to obtain the data. 61 newborns who met the study criteria were randomly
      divided into experimental (n=30) and control (n=31) groups. Phototherapy was applied to all
      babies twice a day. In addition to phototherapy, infant massage was applied to the
      experimental group for 10 minutes just before the phototherapy. Bilirubin level measurements
      were made 2 hours after the end of phototherapy for both groups. Diaper changes for both
      groups were carried out 8 times a day, every 3 hours.
    


Intervention name(s): Baby massage
Intervention type(s): Procedure
Intervention description(s): Starting from the baby's face first, then the abdomen and chest, back, upper extremities and finally the lower extremities were massaged with semi-circular movements, respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: infant; baby massage; hyperbilirubinemia; bilirubin
The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules
      oral suspension, once daily (QD), in infants with gastroesophageal reflux symptoms during a
      4-week treatment period.
    

Detailed description: 
      This study will be conducted by approximately 20 investigative sites in the U.S. and Poland.
      Participants who qualify will be randomized in equal proportions to receive either
      lansoprazole Pediatric Suspension (0.2-0.3 mg/kg/day in infants <10 weeks of age or 1.0-1.5
      mg/kg/day in infants >10 weeks of age) or Placebo. This study consists of three periods:
      Pretreatment Period of 7-14 days, Double-Blind Treatment Period of 4 weeks (Dosing), and the
      Post-Treatment Period of 30 days (Follow-Up).
    

Intervention name(s): Lansoprazole microgranules suspension; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lansoprazole microgranules 0.2-0.3 mg/kg/day suspension, orally, once daily for up to 28 days for infants less than 10 weeks;
Lansoprazole microgranules 1.0-1.5 mg/kg/day suspension, orally, once daily for up to 28 days for infants greater than 10 weeks.; Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease; infant; lansoprazole oral suspension; PPI
Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      For decades there have been concerns about patellar resurfacing (PR) in total knee
      arthroplasty (TKA) and the individual preference of the surgeon is still the main determinant
      of whether or not resurfacing is applied. According to preference, surgeons can be
      categorized in 3 main groups of those who usually, selectively or rarely resurface. The aim
      of this prospective, randomized, controlled study to is compare the isokinetic performance
      and clinical outcome of TKAs with PR and without PR.
    

Detailed description: 
      Patients undergoing TKA for primary osteoarthritis of the knee are randomly assigned to
      either the PR or non-PR groups. The differences between groups with respect to age, BMI,
      gender, and preoperative Knee Society Score (KSS), and isokinetic performance are evaluated.
      Patients are evaluated at postoperative 3, 6, and 12 months with KSS and at 6 months and 1
      year with isokinetic measurements.
    

Intervention name(s): patellar component
Intervention type(s): Device
Intervention description(s): patellar resurfacing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: patellar resurfacing; isokinetic testing
A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa
      pharmacokinetics when administered in combination with immediate release levodopa/carbidopa
      or levodopa/benserazide in Parkinson's Disease (PD) patients.
    

Detailed description: 
      This was a three-centre, double-blind, randomised, placebo-controlled, crossover study with
      four consecutive single-dose treatment periods in PD patients treated with immediate release
      100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide
    

Intervention name(s): BIA 9-1067; BIA 9-1067; BIA 9-1067; Placebo; Levodopa/Carbidopa; Levodopa/Benzerazide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): BIA 9-1067 - 25 mg single-dose; BIA 9-1067 - 50 mg single-dose; BIA 9-1067 - 100 mg single-dose; single-dose; Levodopa 100 mg Carbidopa 25 mg; Levodopa 100 mg Benzerazide 25 mg
Other intervention name(s): OPC, Opicapone; OPC, Opicapone; OPC, Opicapone; PLC; Sinemet; Madopar®/Restex®
Intervention MeSH terms: Levodopa; Carbidopa; Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease; BIA 9-1067
Study of Safety and Efficacy of Letrozole Monotherapy as Second-line Endocrine Therapy in Postmenopausal Patients With Advanced Breast Cancer Who Received Previous Anti-estrogen Treatment
Condition: Postmenopausal Women With Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      -  Safety and efficacy of letrozole 2.5 mg/day monotherapy as second-line endocrine therapy
           in postmenopausal patients with advanced breast cancer who received previous
           anti-estrogen treatment

        -  To investigate changes in blood drug concentrations and blood hormone kinetics.

        -  To investigate gene polymorphisms of CYP2A6, an enzyme involved in the metabolism of
           letrozole
    


Intervention name(s): Letrozole
Intervention type(s): Drug
Other intervention name(s): FEM345
Intervention MeSH terms: Letrozole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aromatase inhibitor; letrozole; breast cancer
The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Condition: Breast Cancer; Reconstructive Surgery
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Hypothesis:

      1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast
      reconstruction

      Secondary hypotheses:

        1. The complication rates following staged breast reconstruction using Alloderm or
           Dermamatrix are higher if the patient requires radiation compared to those who do not
           require radiation.

        2. Dermal matrix incorporation is not altered in patients requiring radiation compared to
           those who do not require radiation.

        3. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix

      Specific aims:

        1. Evaluate the complication rates in women undergoing staged breast reconstruction with
           acellular dermal matrix with or without radiation

        2. Compare the complication rates between the two types of acellular dermal matrix

        3. Evaluate the histologic characteristics of the dermal matrix exposed to radiation
           compared to that not exposed to radiation.

        4. Compare the rates of incorporation of the dermal substance into surrounding tissues of
           those patients undergoing radiation to those not undergoing radiation
    


Intervention name(s): Implantation of Dermal Matrix substitute
Intervention type(s): Procedure
Intervention description(s): Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
Other intervention name(s): Dermamatrix; Alloderm; Dermal Matrix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Breast Cancer; Cancer of Breast; Reconstructive Surgery
Feasibility Bowel Dysfunction Program After Low Anterior Resection
Condition: Rectal Cancer; Low Anterior Resection
MeSH terms: Rectal Neoplasms; Intestinal Diseases
Study type: Interventional

Summary: 
      This study will facilitate a better understanding of the overall experience of our rectal
      cancer survivors after Low Anterior Resection for rectal cancer. Studies have demonstrated
      that the development of bowel and genitourinary dysfunction after this procedure is very
      distressing to patients and can have a significant impact on overall quality of life. By
      providing interventions that can be performed at home, investigator may alleviate these
      symptoms in hopes of improving the experience of patients undergoing Low Anterior Resection.
      By acknowledging these potentially debilitating symptoms in a systematic way, the
      investigator hopes to reinforce the importance of symptom management in the survivorship
      phase after treatment has been completed and ultimately facilitate an individual's return to
      routine activities.
    

Detailed description: 
      Subjects will be recruited from patients presenting to the surgical oncology clinic at Fox
      Chase Cancer Center. These patients will have already undergone Low Anterior Resection with a
      diverting stoma (colostomy or ileostomy) and will be planning on undergoing reversal of their
      stoma in the near future. Subjects will be recruited over a period of 1 year. Such clinic
      patients' medical records will be reviewed to determine whether they are possible candidates
      for inclusion in the study. They will be identified based on their diagnosis of either Stage
      II or III rectal cancer as stated in prior clinic notes, pathology reports, or radiologic
      image reports. Participants must have previously undergone Low Anterior Resection with a
      diverting stoma and the surgical plan must be for them to undergo ostomy reversal. They will
      be approached during a clinic visit by either a co-investigator or a member of the surgery
      team (fellow or surgeon) or a research coordinator delegate and asked to participate in the
      research study. They will be given a document for informed consent that will describe the
      study and potential risks and benefits to the patient. The investigators plan to enroll 10
      patients at Fox Chase Cancer Center. Subjects will receive no monetary compensation
    

Intervention name(s): Stoma reversal
Intervention type(s): Procedure
Intervention description(s): Patients will receive a comprehensive intervention to addresses bowel, sexual, and urinary dysfunction. Patients meeting appropriate inclusion criteria will be approached at a clinic visit with their surgeon. If they agree to participate, they will complete an initial baseline questionnaire. Questionnaires will be distributed on iPads during their clinic visit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Bowel Dysfunction; Low Anterior Resection; Rectal Cancer
The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To evaluate the effectiveness of nutrition education and dietary counselling to improve the
      nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA)
      attending an HIV treatment facility in Bangkok Thailand.
    

Detailed description: 
      To evaluate the effectiveness of nutrition education and dietary counselling to improve the
      nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA)
      attending an HIV treatment facility in Bangkok Thailand. This will be achieved by determining
      if dietary counselling and nutrition education has an effect on nutritional status (weight,
      lean body mass and fat mass), dietary intake, food security, quality of life, biochemical
      parameters (including total cholesterol, LDL/ HDL cholesterol and Triglyceride), experience
      of symptoms and patient satisfaction
    

Intervention name(s): Nutrition Counselling
Intervention type(s): Behavioral
Intervention description(s): Clients will receive ongoing nutrition assessment and dietary counselling. The intervention arm will receive all baseline assessments and individual nutritional assessment, counselling and nutrition management plans using standards of practice
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Nutritional status; Nutrition counselling; Nutrition assessment; HIV; Alternative Medicine; Complementary Medicine
A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis
Condition: Multiple Sclerosis, Remittent Progressive; Multiple Sclerosis, Primary Progressive; Relapsing-Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter study conducted in 3 parts. Part A is a double-blind placebo-controlled
      parallel-group period, and Part B and C are open-label extension periods. The primary
      objective of the double-blind study (Part A) is to assess the effect of Prolonged-Release
      Fampridine treatment on walking speed as measured by the T25FW (timed 25 foot walk) in
      Japanese participants with Multiple Sclerosis. The secondary objective of the double-blind
      portion of the study is to evaluate the safety and tolerability of prolonged-release
      Fampridine in this study population. The primary objective of the open-label extension study
      (Part B) is to evaluate the long-term safety profile of prolonged-release Fampridine. The
      primary objective of the additional open-label extension (Part C) is to provide participants
      who complete the study with continued access to prolonged-release fampridine until marketed
      drug can be used at the applicable site or until sponsor decision to discontinue the study.
    


Intervention name(s): Placebo; BIIB041 (fampridine)
Intervention type(s): Drug; Drug
Intervention description(s): matching placebo tablets; fampridine prolonged-release tablets
Other intervention name(s): Fampyra; prolonged-release fampridine; dalfampridine; Ampyra
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Japan
The Effect of White Noise In High Noise Environment
Condition: Insomnia
Study type: Interventional

Summary: 
      Many patients complain to clinicians that they have difficulty sleeping appears to be due to
      environmental noise. There is a common perception that acute noises are more troublesome than
      continuous noises in the effect on individual sleep quality. Therefore the goal is to use a
      Marpac white noise maker with a continuous noise to see its effect on individuals that have
      difficulty sleeping in a high noise environment.
    

Detailed description: 
      Insomnia patients will be recruited based on their perception of high noise in their
      apartment. The investigators will screen patients during the first meeting using The Mini
      International Neuropsychiatric Interview 6.0 (MINI 6.0). At baseline, an Insomnia Severity
      Index will be administered.

      The study will consist of a one week baseline period in which noise levels will be monitored
      using spectral analysis and decibel levels and sleep duration will be recorded using a
      subjective sleep log and wrist actigraphy for objective measurement. At the end of the first
      week an Insomnia Severity Index will be administered.

      During the second week, a treatment period with a white noise machine using a fixed decibel
      level will be installed in the bedrooms of the subjects. The room noise will continue to be
      monitored via spectral analysis as well as decibel levels while the patients are wearing
      actigraphs and keeping a sleep log. At the end of the second week an Insomnia Severity Index
      will be administered.

      During the third week, the white noise machine will be removed and the rooms will still be
      monitored for sound via spectral analysis and decibel levels and the subject will wear an
      actigraph and keep a sleep log. At the end of the third week an Insomnia Severity Index will
      be administered.

      The investigators will use Analysis of Covariance (ANCOVA) with baseline vs. white noise to
      analyze differences. The investigators will use an Acute Noise Index, in which noise spikes
      of 2 standard deviations from the mean of the entire nights decibel levels count as a noise
      event.

      Noise levels in subjects bedroom will be collected throughout the study along with subjects
      sleep activity using an actigraph and sleep log.
    

Intervention name(s): white noise
Intervention type(s): Other
Intervention description(s): exposure to white noise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Behavioral Treatment for Cocaine Dependent Women
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the efficacy of Community Reinforcement Approach (CRA) and 12-Step Facilitation
      (TSF) counseling and of voucher based reward therapy (VBRT) and a yoked, non-contingent
      voucher control (VC) for the treatment of cocaine dependent pregnant women or women with
      young children.
    

Detailed description: 
      Subjects were randomly assigned to 1 of 4 treatment groups (CRA+VBRT, CRA+VC, TSF+VBRT,
      TSF+VC). VBRT voucher value increased for each successive cocaine-free urine sample obtained
      twice weekly during the 1st 12 weeks and was faded from the final earned value to $5 during
      the last 12 weeks. All subjects earned vouchers for attendance at scheduled twice weekly
      counseling sessions. Manual-guided CRA and TSF were provided by experienced clinicians.
    

Intervention name(s): Behavioral therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Community reinforcement approach; Contingency management; 12-step facilitation counseling; Cocaine dependence; Women
Bioavailability of BI 1356 After Co-administration With Ritonavir Compared to the Bioavailability of BI 1356 Alone in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effect of the P-gp and cytochrome P450 (CYP) 3A4 inhibitor ritonavir
      on the pharmacokinetics of BI 1356
    


Intervention name(s): BI 1356; Ritonavir
Intervention type(s): Drug; Drug
Other intervention name(s): Norvir®
Intervention MeSH terms: Linagliptin; Ritonavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases
Condition: Primary Myelofibrosis (PMF); Post-Polycythaemia Vera; Essential Thrombocythaemia Myelofibrosis
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to test study drug AZD1480 to see how it may work to treat
      myeloproliferative diseases. The main purpose of this study is to determine the safety and
      tolerability of AZD1480. This is the first time the drug has been given to humans and is
      classed as a first time in man study. Its main purpose is to establish a safe dosage of the
      drug and provide additional information on any potential side effects this drug may cause.
      The study will also assess the blood levels and action of AZD1480 in the body over a period
      of time and will indicate whether the drug has a therapeutic effect on myeloproliferative
      diseases.
    


Intervention name(s): AZD1480
Intervention type(s): Drug
Intervention description(s): Oral capsule 2.5 mg, 10 mg and 40 mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Primary Myelofibrosis (PMF); Post-Polycythaemia Vera/Essential Thrombocythaemia Myelofibrosis (Post-PV/ET MF); Myeloproliferative diseases; Phase I; Phase II; Bone marrow
Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term
Condition: Labor Induction at Term
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a titrated solution of oral Misoprostol is
      safe and effective at inducing labor at term, regardless of Bishop Score.
    


Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): titrated oral misoprostol solution
Intervention MeSH terms: Misoprostol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: labor induction at term using a titrated oral misoprostol solution