bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin E Level in Buccal Cells of Arsenicosis Patients
Condition: Chronic Arsenic Poisoning
MeSH terms: Arsenic Poisoning; Poisoning
Study type: Interventional

Summary: 
      To understand the pathogenesis of chronic arsenic toxicity, the investigators need to know
      the levels of vitamin E in patients chronically exposed to high concentration of arsenic and
      if changes are found, what happens when supplemented with vitamin E. The buccal cells and
      serum of patients will be collected for the estimation of vitamin E both before and after
      supplementation with vitamin E. Similar samples will be collected from similar number of
      arsenic exposed controls and healthy volunteers for comparison.
    

Detailed description: 
      Chronic consumption of arsenic through water (drinking and cooking) and food leads to
      accumulation of arsenic within the cell. We usually give emphasis on the skin manifestations
      (melanosis and keratosis) of arsenicosis that is diagnosed first. Other manifestations remain
      un-diagnosed or diagnosed later. The severe form is the development of cancer in different
      organs mainly skin, lungs and urinary bladder. To understand the pathophysiology of the
      development of clinical manifestations appearing in the skin first, we need to understand
      interior of cells other than skin. One of the dietary supplements, vitamin E is found to be
      effective in improving the clinical signs/symptoms of melanosis and keratosis. Buccal cells
      are also exposed to arsenic and easy to collect. To understand the pathogenesis, we need to
      know the levels of vitamin E in patients of arsenicosis and if changes, what happens when
      supplemented with vitamin E. The buccal cells and serum of 20 patients will be collected for
      the estimation of vitamin E both before and after supplementation with vitamin E (200 IU,
      caplet) daily orally for 20 weeks. Similar samples will be collected from 20 arsenic exposed
      controls and 20 healthy volunteers for comparison.
    

Intervention name(s): Vitamin E
Intervention type(s): Dietary Supplement
Intervention description(s): vitamin E (200 IU, caplet) daily orally for 20 weeks
Intervention MeSH terms: Vitamin E
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Arsenic; Arsenicosis; Buccal cells; Serum; Vitamin E; Cholesterol
Vitamin D in Healthy Adults After Strenuous Endurance Exercise
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of vitamin D supplementation on
      biochemical response and aerobic capacity after strenuous endurance exercise (SEE).
    

Detailed description: 
      All participants conducted a graded exercise test on an ergometric bicycle to determine the
      maximal oxygen consumption (VO2max) before and after supplementation, and the speed
      equivalent to 65% VO2max was conducted for a SEE test by ergometric bicycle for 2 hours,
      followed by increasing 100 RPM until exhaustion. Venous blood samples were drawn before,
      immediately after, 2-hour after, 4-hour after, 8-hour after, and 24-hour after the SEE test
      to determine the concentrations of biomarkers. Data was analyzed by Two-way mixed design
      ANOVA.
    

Intervention name(s): Vitamin D; Medium-chain triglycerides
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants received 5,000 IU of vitamin D orally twice daily for 4 weeks; Participants received the same amount of placebo matching vitamin D orally twice daily for 4 weeks
Other intervention name(s): Liquid Shield Vitamin D3+E
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy male participants were divided into vitamin D group and placebo group.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Iloperidone is an atypical antipsychotic drug, FDA-approved for the acute treatment of
      schizophrenia in adults in 2009 (Marino et al., 2010); moreover, some of its pharmacological
      features seem to be very promising in treating symptoms like anger and anxiety (Fava et al.,
      1997; Wang et al., 2010). The investigators therefore feel that an adequately sized, well
      powered, double-blind, placebo-controlled, randomized, cross-over study of iloperidone
      augmentation of SSRIs among MDD outpatients in partial remission with residual anger and
      irritability is warranted at this point to evaluate its efficacy, safety and tolerability on
      residual anger, irritability and depressive symptoms.

      Main hypothesis: Adults with MDD in partial remission, who are experiencing residual symptoms
      of anger and irritability, assigned to treatment with iloperidone will demonstrate a
      significantly greater reduction in the total score of the Anger/Hostility Scale of the
      Symptom Questionnaire from baseline to endpoint than those assigned to placebo using the
      cross-over design.
    


Intervention name(s): Iloperidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Iloperidone 1-8 mg for 4 weeks; Placebo
Intervention MeSH terms: Iloperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Growth and Body Composition in Children
Condition: Growth; Child Development; Disability, Developmental
MeSH terms: Developmental Disabilities
Study type: Observational

Summary: 
      This study is planned to measure and compare body composition indexes and growth between
      typically developing children and those with disabilities in South Korea for understanding
      the nutritional and growth status.
    

Detailed description: 
      -  Inclusion criteria for typically developing children

             1. typically developing children in 5th and 6th grades of elementary schools

             2. children whose parents checked the agreement form distributed by schools

        -  Inclusion criteria for children with disabilities

             1. children and adolescent who are in special schools

             2. children whose parents checked the agreement form distributed by schools

             3. children who were able to cooperate during the body composition analysis

        -  Exclusion criteria for both groups

             1. those whom do not have written informed consent

             2. who are not able to stay calmly during the body composition analysis

        -  All measurements done at two elementary schools on the day of the annual physical
           examination

        -  Measurement of height and body weight for growth

        -  Measurement of body composition index: Inbody 770 and Inbody S10, body composition
           analyzers
    

Intervention name(s): Measurement of growth and body composition
Intervention type(s): Diagnostic Test
Intervention description(s): Growth (height and body weight), and body composition were measured. For the body composition, Inbody 770 and Inbody S10 were used.
Other intervention name(s): Using Inbody 770, Inbody S10
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        1. Typically developing children who are in the 5th and 6th grades of elementary schools

          2. Children with neurodevelopmental disabilities in a special school
      
Keywords: growth; Body Composition
Does Induction Dosage in Latent Phase Affect Active Phase of Labor?
Condition: Oxytocin; Induction of Labor
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the need of oxytocin therapy in active phase of labor. there will be two
      groups treating with oxytocin in latent phase.One group will be treated with low dose
      oxytocin therapy and the other group will be treated with high dose oxytocin therapy.
      oxytocin treatment will be ceased at the beginning of the active phase of labor. the need of
      oxytocin treatment in active phase of labor will be compared between two groups.
    

Detailed description: 
      Oxytocin treatment in active phase of labour is used with respect to clinicians preference
      and best approach has not been described. We want to investigate the effect of oxytocin
      treatment by using different regims in latent phase of labor when oxytocin treatment is
      ceased in active phase of labour. In our trial we discontinued oxytocin in active phase of
      labour and investigate which group needs oxytocin therapy due to inadequate uterine
      contractions and arrest of labor.
    

Intervention name(s): oxytocin
Intervention type(s): Drug
Intervention description(s): one group will be treated with low dose oxytocin and the other group will be treated with high dose oxytocin for augmentation of labor induction.
Other intervention name(s): synpitan
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Behavioral parent training is an evidence-based treatment for ADHD. The intervention can be
      implemented individually, or in groups. Currently, group-based parent training programs
      require considerable coordination, including ascertainment of a large physical space, the
      coordination of all families traveling to the same location at the same time, and the require
      for the provision of childcare. Innovations in online connectivity and ease of implementation
      of online support applications (e.g., Zoom) may reduce these barriers. However, it is
      necessary to investigate the feasibility and promise of the online approach to ensure it
      supports parents effectively.
    

Detailed description: 
      This study will utilize a pre-post, open trial design as the primary aim is to investigate
      feasibility. Approximately sixty parents will complete prepost ratings of parenting behaviors
      and measures of child functioning. They will also complete post treatment measures of
      satisfaction and open-ended questions about feasibility and suggestions for future iterations
      of the approach. Process measures will include data collection related to attendance and
      engagement in the activities. Risks include breach of confidentiality and a lack of
      effectiveness of the intervention for the child's presenting problems. Benefits include the
      parent receiving an effective intervention.
    

Intervention name(s): COPE parent training
Intervention type(s): Behavioral
Intervention description(s): Weekly 1.5 hour parent training meetings for eight weeks
Intervention model: Single Group Assignment
Intervention model description: Open, single-group trial
Masking: None (Open Label)
Primary purpose: Treatment
The Prediction for Postoperative Pain
Condition: Pain, Postoperative; Nociceptive Pain; Analgesia, Patient-Controlled; Analgesics
MeSH terms: Pain, Postoperative; Nociceptive Pain
Study type: Interventional

Summary: 
      If the individual patient's pain is assessed and the amount of analgesic needed after surgery
      is predicted, appropriate injection of pain control and excessive injection of narcotic
      analgesic can be prevented. Therefore, investigators try to evaluate the degree of pain
      during surgery and the amount of analgesic use for management of postoperative pain.
    

Detailed description: 
      Post-operative pain not only alleviates patient discomfort, but also delays recovery and thus
      prolongs the hospital stay. There are many ways to control postoperative pain, but analgesic
      infusion through venous route, patient controlled analgesia (PCA), especially narcotic
      analgesics, is often used to control the infusion when needed. However, because PCA is based
      on only age, weight, and underlying diseases, there are limitations in effective analgesia,
      and excessive sedation due to excessive infusion. Therefore, if the individual patient's pain
      is assessed and the amount of analgesic needed after surgery is predicted, appropriate
      injection of pain control and excessive injection of narcotic analgesic can be prevented. The
      noxious stimuli during surgery may have a negative effect on the healing process and surgical
      outcome of the wound due to stress reaction and catabolism, secretion of pituitary hormone,
      activation of the sympathetic nervous system, and immunological changes. Therefore, proper
      analgesia is needed during general anesthesia. A non-invasive, non-invasive analgesic device
      is currently available for Surgical pleth index (SPI) to assess the status of intraoperative
      analgesia. SPI = 100- (0.3 * heart beat interval + 0.7 * photoplethysmographic pulse wave
      amplitude) is automatically and continuously calculated from the waveform of peripheral
      oxygen saturation.

      In the postoperative pain prediction study with SPI, the SPI value at the end of the
      operation was found to be proportional to the pain in the recovery room. However, only the
      pain score immediately after the operation was confirmed in these studies. Therefore,
      investigators try to evaluate the degree of pain during surgery and the amount of analgesic
      use for management of postoperative pain.
    

Intervention name(s): surgical pleth index
Intervention type(s): Device
Intervention description(s): All patients applied surgical pleth index after recovery of spontaneous breathing at the time of peritoneum and skin closure under Bispectral index score <=60.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Calf Muscle Strength and Standing Efficiency in Children With Spastic Diplegia
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      It will be hypothesized that strengthening the calf muscles will improve standing efficiency
      in children with spastic diplegia.
    


Intervention name(s): Strengthening exercise + Electrical stimulation of calf muscle; selected physical therapy program
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy; standing; strengthening
A Study to Evaluate the Irritation Potential of Tazarotene Foam on Skin in Healthy Volunteers
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the irritation level of tazarotene foam after 21
      days of exposure on the skin of healthy volunteers.
    

Detailed description: 
      This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to
      evaluate the potential of tazarotene foam to induce cutaneous irritation using a 21 day
      cumulative irritation assay in healthy adult volunteers. Approximately 40 healthy male and
      female volunteer subjects aged 18 to 65 years will be enrolled. All subjects will be exposed
      to patches containing tazarotene foam, vehicle foam, sodium lauryl sulfate 0.5% (positive
      control), and distilled water (negative control). Each set of patches will be applied to the
      same randomized sites once daily for 21 days; patches will be removed after 24 ±1 hours and
      the patch sites will be evaluated for signs inflammatory skin responses (eg, erythema, edema,
      papules) and superficial effects.
    

Intervention name(s): Tazarotene Foam; Vehicle Foam; Sodium Laural Sulfate; Distilled Water
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tazarotene Foam; Vehicle Foam; Sodium Laural Sulfate; Distilled Water
Intervention MeSH terms: Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Volunteer Subjects
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the
      pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of
      oral semaglutide in subjects with various degrees of impaired renal function compared to
      subjects with normal renal function.
    


Intervention name(s): semaglutide
Intervention type(s): Drug
Intervention description(s): Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of Alvimopan in Major Spine Surgery
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The Investigator has chosen to study the reconstructive spinal surgery patient population
      because it is believed that the use of alvimopan in these patients at the University of
      Virginia will give the scientific community significant insight into the broader
      applicability of this drug into other surgical populations, the impact of this drug on the
      perception of pain (as opposed to simply the consumption of opioids), and its impact on total
      hospital charges, resource utilization, and functional outcomes.
    

Detailed description: 
      Pain control following major spine surgery is difficult to achieve. Opiates are often
      necessary in high doses, and may be associated with significant side effects. Such side
      effects may include urinary retention, altered mental status, depressed respiratory drive,
      and constipation, and may lead to reduced nutritional intake in the postoperative period.
      Importantly, post-operative nutrition may impact the incidence of complications following
      spine surgery.1 Alvimopan is a peripheral-acting opiate antagonist designed to decrease the
      gastrointestinal complications of perioperative systemic opioid administration.

      Pain control following major spine surgery is difficult to achieve. Opiates are often
      necessary in high doses, and may be associated with significant side effects including
      constipation. Alvimopan is a drug approved by the Food and Drug Administration (FDA) and is
      used to help the bowel recover more quickly in patients who are having bowel surgery, so that
      they can eat solid foods and have regular bowel movements. Alvimopan is in a class of
      medications called peripherally acting mu-opioid receptor antagonists. It works by protecting
      the bowel from the constipation effects of opioid (narcotic) medications that are used to
      treat pain after surgery.

      The purpose of this study is to determine if the use of alvimopan in major spine surgery
      reduces the time to first bowel movement. By assessing the use of alvimopan in reconstructive
      spinal surgery patients, researchers hope to give the scientific community insight into the
      broader use of this drug in other surgical populations, as well as gathering information on
      the impact of hospital charges and overall post-operative patient satisfaction.
    

Intervention name(s): Alvimopan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Alviimopan 12 mg twice daily up to 15 doses; Placebo twice daily up to 15 doses
Other intervention name(s): Entereg
Intervention MeSH terms: Alvimopan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
Condition: Mammaplasty; Radiotherapy; Complications; Breast Implant; Complications; Transplant Failure
Study type: Observational

Summary: 
      For patients with breast cancer subject to a mastectomy, preserving the morphology of the
      breast with immediate reconstruction is a crucial aspect to preserve the quality of life.

      There are several types of breast reconstruction: prosthetic in one or two stages and
      autologous reconstruction.

      Adjuvant radiotherapy has shown an improvement of the overall survival and of the local
      control for patients with positive lymph nodes.

      Despite the undoubted cancer benefits, several studies have shown the negative impact of
      radiotherapy on breast reconstruction.

      However, there are few studies with a significant number that evaluate the effect of
      radiotherapy on the three types of reconstruction.

      In particular, given the extreme variability in clinical approaches, there is no certainty
      about the best reconstructive timing compared to radiotherapy, the iterations with dermic
      matrices as well as the usefulness of ancillary procedures such as autologous adipose
      grafting.

      The aim of this study is to compare retrospectively these three types of reconstruction
      techniques to evaluate the effect of radiotherapy on different reconstructive modes.
    


Intervention name(s): Adjuvant Radiotherapy
Intervention type(s): Radiation
Intervention description(s): PMRT
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients of some Breast Units in Italy