bioihbjkbjnl/mcl2 huggingface dataset:
Photocil (Topical) for the Treatment of Psoriasis Vulgaris
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B
      (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from
      non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light
      in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the
      safety and efficacy of Photocil in the treatment of psoriasis
    

Detailed description: 
      NB-UVB phototherapy is a common treatment for patients with psoriasis, and has been reported
      to be safe and effective in numerous clinical trials. Clinical trials have reported
      achievement of Psoriasis Area Severity Index (PASI)-75 in 50-70% of patients after 4-6 weeks
      of NB-UVB treatment.

      Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB
      phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks
      or more) performed at a specialized phototherapy clinic combined with high cost and low or no
      reimbursement make compliance and access a major drawback.

      In order to address the drawbacks of phototherapy, we developed a novel topical cream -
      Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with
      natural sunlight, Photocil provides a convenient alternative to traditional clinic based
      phototherapy; thus, has the potential to dramatically increase patient compliance and
      treatment outcome.
    

Intervention name(s): Photocil for Psoriasis; Placebo - Sunscreen (SPF 2)
Intervention type(s): Drug; Other
Intervention description(s): Photocil for Psoriasis; Placebo - Sunscreen (SPF 2)
Other intervention name(s): Photocil for Psoriasis (U.S. FDA NDC: 54841-001-01)
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Diabetes Acute Complications and Health Literacy in Children
Condition: Childhood; Diabetes; Health Literacy
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      In this study, in which education on acute complications of type 1 diabetes is planned with
      board games based on Bandura's social learning theory, children can indirectly learn common
      points that they may hear about acute complications of diabetes by watching board games of
      other group members. In line with this theory, children's knowledge needs regarding acute
      complications of diabetes can be determined, and interventions can be planned to meet the
      determined needs of children. Thus, the level of knowledge of diabetes health literacy for
      acute complications of diabetes can be increased.

      This study will be carried out in a randomized controlled manner to evaluate the effect of
      educational play in children on acute complications of diabetes and health literacy.
    

Detailed description: 
      This study was conducted to determine the Turkish validity and reliability of the "Health
      Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" and to
      provide a diabetes health literacy box game to 8-12 school age children diagnosed with Type 1
      diabetes. It will be carried out in two stages in order to evaluate the effect of educational
      games on acute complications of diabetes and health literacy in children.

      In the first stage of the research, a general screening methodological method will be carried
      out to determine the current situation by quantitative analysis of the data obtained with the
      "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 years)".

      In the second stage; Randomly determined intervention and control groups will be applied to
      the intervention and control groups in a quasi-experimental type at the pre-test and the 1st
      and 3rd months after the training.
    

Intervention name(s): Education intervention
Intervention type(s): Behavioral
Intervention description(s): Board game was created in line with current literature. In each interview, it is expected that the child's negative behaviors will be transformed into positive behaviors.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized control
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Childhood; Diabetes; Health Literacy; Social Learning Theory; Board Game
Acupuncture Intervention for AYA With Cancer
Condition: Palliative Care
Study type: Interventional

Summary: 
      The aim of the study is to innovatively extend acupuncture research in adult oncology to
      adolescents and young adults (AYA) by piloting a tailored acupuncture protocol for pain
      management in AYA in the Children's Hospital of Philadelphia (CHOP's) Center for Integrative
      Health.
    

Detailed description: 
      Acupuncture is an integrative medicine (IM) with a growing evidence base that is often
      incorporated into comprehensive pain management in adult oncology. However, it is
      under-utilized and under-researched in pediatric oncology, especially with adolescents and
      young adults (AYA). Acupuncture is a promising palliative therapy to manage pain and improve
      quality of life (QOL) of AYA. AYA are underserved and typically endure more morbidity and
      longer treatments than younger patients. More than half report at least three debilitating
      cancer-related symptoms and their QOL is significantly lower compared to norms, with symptoms
      being the greatest contributor to poor QOL. Not surprisingly, AYA identify pain management as
      an unmet need, leading a majority of AYA to want information on IM or seek it for treatment.
      Given the potential benefit of acupuncture for addressing unmet needs of AYA by reducing
      physical suffering, and the established difficulty with pain management using conventional
      methods, there is a critical need to establish the efficacy of acupuncture for pain
      management in AYA. The few studies that have evaluated acupuncture in pediatric oncology,
      demonstrating it to be safe, accepted, and associated with symptom relief are uncontrolled,
      retrospective, and/or unprotocolized, and none focus on AYA. To establish the evidence base
      for acupuncture in AYA oncology, research is needed to determine and test optimal acupuncture
      protocols.
    

Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): Acupuncture is a method of Traditional Chinese Medicine that consists of the insertion of thin, sterile, FDA-approved disposable needles on specific acupuncture points (acupoints).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-randomized trial across four time points at one study site
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pain management of adolescent and young adults with cancer
Nadolol for Proliferating Infantile Hemangiomas
Condition: Infantile Hemangioma
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the efficacy and safety of Nadolol in hemangiomas of
      infancy.

      The secondary objective is to assess the feasibility of conducting a randomized controlled
      trial comparing nadolol with corticosteroids and propranolol.
    

Detailed description: 
      Systemic corticosteroids are currently the most frequent used medication for treatment of
      problematic infantile hemangiomas (IH's). Since June 2008, systemic propranolol has been an
      important addition to the therapeutic options for problematic IH, allowing decreased
      dependence on the systemic corticosteroids. So far, we have found excellent response with
      propranolol with minimal short-term side effects. Studies, which compared nadolol and
      propranolol in children with other conditions, suggest that nadolol is safer and more
      efficacious than propranolol. In addition, it has better dosing schedules and less central
      nervous system (CNS) penetration, making it suitable even for patients with suspected or
      proven PHACES syndrome.
    

Intervention name(s): Nadolol
Intervention type(s): Drug
Intervention description(s): Nadolol will be administered orally at home starting at 0.5 mg/kg/day divided into 2 doses. Weekly, if BP and heart rate are acceptable, the dose will be increased by 0.5 mg/kg/day up to 2 mg/kg/day.
Intervention MeSH terms: Nadolol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infantile hemangioma; nadolol
Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine
      over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed
      6-week acute treatment in study NCT00839423 / 11492A.
    


Intervention name(s): Vortioxetine (Lu AA21004)
Intervention type(s): Drug
Intervention description(s): 5 or 10 mg/day; tablets; orally
Other intervention name(s): Brintellix
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Long-term; Safety; Open-label
Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
Condition: Non Elective Cesarean Section and Ketamine Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized double blind study will be conducted in pregnant woman planned for non
      elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous
      0.25 mg/kg and placebo group will receive same amount of normal saline after spinal
      anesthesia prior to skin incision. Postoperative outcomes measures are total opioid
      consumption and pain scores for 24 hrs.
    


Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): the analgesic affects of ketamine will be compared between the experimental and placebo group.; the analgesic requirement will be calculated in placebo group.
Other intervention name(s): ketamine hydrochloride
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Administration Time-dependent Antihypertensive Effects of Low Dose Aspirin in Well-controlled Hypertensive Patients
Condition: Well-controlled Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the influence of aspirin on blood pressure in
      well-controlled hypertensive patients who receive low dose aspirin at different times of the
      day
    

Detailed description: 
      Recent studies showed that low dose aspirin exerts a significant administration
      time-dependent effect on blood pressure in previously untreated hypertensive patients.
      However, this effect has not been confirmed in patients taking low-dose aspirin in
      combination with antihypertensive medications. A multi-center, double-blind randomized,
      cross-over, active-control, comparative clinical study will be conducted to evaluate the
      influence of aspirin on blood pressure in well-controlled hypertensive patients who receive
      low dose aspirin at different times of the day.

      Approximately 192 patients will be enrolled over 4 months in 8 centers nationwide.

      After placebo run-in period, all subjects will be randomized into one of the following 3
      groups.

      Group I & II will take low dose aspirin for treatment period (for first and second 12
      weeks)on awakening or before bed time. Group III will take placebo for treatment period.

      After first 12 weeks' treatment period, the subjects will be informed whether she/he belongs
      to Group III. This will be done without breaking the double blinding in the other 2 groups.

      The primary objective will be the evaluation of the influence of aspirin on blood pressure in
      well-controlled hypertensive patients who receive low dose aspirin at different times of the
      day.

      The secondary objectives will be 1) comparison of the administration time-dependent effects
      of low dose aspirin on blood pressure between dipper and non-dipper patients and 2) the
      evaluation of the effects of low dose aspirin in Korean hypertensive patients.

      A sub-study will be conducted in 3 centers to evaluate the effect of aspirin on endothelial
      function in patients with well-controlled hypertension.
    

Intervention name(s): Aspirin enteric coated pellests 100mg
Intervention type(s): Drug
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: low dose aspirin; Hypertension; administration time dependent effect
Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors
Condition: Cancer Survivors; African Americans; Women; Psychology, Positive; Cardiometabolic Syndrome; Exercise; Feasibility Studies; Breast Neoplasm Female
MeSH terms: Breast Neoplasms; Metabolic Syndrome
Study type: Interventional

Summary: 
      This pilot study will assess the feasibility of a gratitude intervention to promote physical
      activity, and well-being and positively impact biomarkers of health among older African
      American breast cancer survivors. The intervention will also include a goal-setting component
      to promote exercise readiness and examine the cultural phenomena of the Superwoman schema
      among Black women.
    

Detailed description: 
      In this pilot feasibility study, the overall aims are:

      Aim 1. Assess the feasibility and acceptability of a gratitude journaling intervention using
      a pilot randomized controlled trial (RCT) design over eight weeks. We hypothesize that among
      the 28 participants 1) at least 80% of the participants will report the intervention to be
      acceptable, 2) biomarker collection will be completed in at least 80% of the surveys and the
      retention rate will be 80% in each group, and 3) physical activity, health markers,
      gratitude, well-being, and distress will improve over time.

      Aim 2. Describe distributions of outcome variables and effect size for the gratitude
      journaling intervention on dispositional gratitude, spiritual well-being, psychological
      distress, exercise readiness, mental and health behaviors in African American/Black women
      (Superwoman Schema), and inflammatory biomarkers from baseline to post-intervention.
    

Intervention name(s): Gratitude Intervention
Intervention type(s): Behavioral
Intervention description(s): Gratitude journaling and goal setting for exercise readiness over eight weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-group parallel random-assignment experimental design.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: African American Women; Breast Cancer Survivorship; Gratitude; Cardiometabolic Syndrome; Geriatrics; Physical Activity
Effect of Fluconazole on PK of Fluzoparib in Healthy Male Subjects
Condition: Advanced Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Effect of fluconazole on the Pharmacokinetics of
      Fluzoparib in Healthy male Adults
    

Detailed description: 
      Subjects received oral Fluzoparib 20 mg after D1 single meal, D2-D4 for washing period, D5
      started oral fluconazole 400 mg/day/day after meal, continuous administration for 6 days to
      D10, D8 meal After oral administration of fluconazole 400 mg, a single oral dose of
      Fluzoparib 20 mg was given immediately.
    

Intervention name(s): Fluzoparib; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): PARP inhibitor; inhibitor
Intervention MeSH terms: Fluconazole; Fluzoparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Non-invasive Haemodynamic Monitoring in Pregnancy
Condition: Pregnancy Related; Cardiac Output, High; Haemodynamic Instability
MeSH terms: Cardiac Output, High
Study type: Observational

Summary: 
      This prospective and observational trial over 55 pregnant women (third trimester) compares
      non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic
    


Intervention name(s): haemodynamic evaluation
Intervention type(s): Other
Intervention description(s): continous haemodynamic monitoring is performed with digital Nexfin captor in two positions. in the same time transthoracic cardiac ultrasonography is performed to calculate cardiac output using velocity time index of aortic outflow chamber.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non-labouring term pregmant women in their third trimester
Comparative Bioavailability of Risperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, one sequence study to evaluate the steady-state comparative
      bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once daily 4
      mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.
    

Detailed description: 
      This is an open-label, 1-sequence study in subjects who are on stable oral risperidone
      treatment. The study consists of a screening visit, 1 treatment period with inpatient and
      outpatient visits, and a follow-up visit.

      Subjects who are on existing oral risperidone treatment (4 mg) will continue the oral regimen
      for 1 week to achieve steady-state concentrations of risperidone. Following the oral
      risperidone treatment, a single intramuscular (IM) dose of 100 mg risperidone ISM® will be
      administered deeply into the gluteal muscle. A total of 4 IM doses will be given that will be
      separated by 4 weeks.

      Safety assessments and pharmacokinetic (PK) sampling will be performed on each dosing day and
      each outpatient visit. A final follow-up visit will take place to assess each subject for
      safety and to obtain PK samples.

      Approximately 58 subjects will be enrolled, with the intent to complete 41 subjects.
      Fifty-eight subjects were estimated for enrollment based on 41 completers assuming an
      approximate drop-out rate of 30%.

      The primary objective of this study is to evaluate the steady-state comparative
      bioavailability of 100 mg risperidone ISM® injectable every 4 weeks compared to once daily 4
      mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.

      The secondary objective of this study is to evaluate the safety and tolerability of 100 mg
      risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in
      subjects with schizophrenia stabilized on oral risperidone treatment.
    

Intervention name(s): Risperidone ISM® 100 mg
Intervention type(s): Drug
Intervention description(s): 100 mg of risperidone ISM® administered every 4 weeks
Intervention MeSH terms: Risperidone
Intervention model: Sequential Assignment
Intervention model description: This is an open-label, 1-sequence study to evaluate the PK, safety, and tolerability of risperidone ISM® in subjects with schizophrenia who are on stable oral risperidone treatment. The study consists of a screening visit, 1 treatment period with inpatient and outpatient visits, and a follow-up visit.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: risperidone; schizophrenia; long-acting injectable
An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects
Condition: Irritation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to compare the skin irritation potential of eight different
      formulations of vitamin D analogues after repeated applications on intact skin of healthy
      subjects.
    


Intervention name(s): Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.
Intervention type(s): Drug
Intervention MeSH terms: Vitamin D; Calcipotriene
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Keywords: Healthy volunteers
Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Abortion, Spontaneous; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this work is to study the effect of metformin use for reducing early pregnancy
      loss in pregnant patients with Polycystic ovary syndrome (PCOS).
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of
      reproductive age. PCOS produces symptoms in approximately 5 to 10% of women of reproductive
      age (12-45 years old) and is thought to be one of the leading causes of the female
      subfertility

        -  The aim of this work is to study the effect of metformin use for reducing early
           pregnancy loss in pregnant patients with PCOS

        -  Research question:

      In pregnant women with PCOS, does metformin use decreases the rate of early pregnancy loss?

      -Research hypothesis: In Pregnant women with PCOS, metformin may reduce the rate of early
      pregnancy loss.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): 83 patients will continue metformin until end of 1st trimester
Other intervention name(s): cidophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention