bioihbjkbjnl/mcl2 huggingface dataset:
Use of CAM by Hospice Oncology Patients During Ambulatory Palliative Care
Condition: Complementary Alternative Medicine; Complementary Alternative Therapy; Hospice Care
Study type: Observational

Summary: 
      The aim of the study is to assess Prevalence of complementary and alternative therapy use by
      adult patients from the area of Silesian agglomeration (Poland) with advanced, metastatic
      cancer disease who were admitted to "Pro Salute" Hospice for ambulatory palliative care
      between July 2017 and September 2018
    

Detailed description: 
      The research team developed the CAT (complementary and alternative therapy) screening tool to
      obtain information about CAM use from patients. The screening tool was based on a The
      National Center for Complementary and Alternative Medicine's (NCCAM) classification of CAM.
      CAT were grouped into five main categories: (1) biologically based therapies , (2) mind/body
      therapies, (3) manipulative and body-based therapies, (4) Energy therapies and (5)
      alternative medical systems.

      The questionaire was tailored to meet the objectives of this study and to be adjusted to
      hospice patients specifics. It was piloted on the group of 25 patients, resulting in some
      vocabulary changes. The final questionnaire consists of 25 multiple-choice, semi-structured
      questions and takes about 15 min to complete. For each general CAM category the detailed
      information was collected on the type of specific therapy that was used. Patients were
      considered as CAM users if they have used at least one therapy from at least one of the
      categories during the period of 12 months prior to the screening. Patients were asked to
      specify the reasons for CAT usage, experienced effects of the therapy, stage at which
      patients considered using CAM
    

Intervention name(s): complementary and alternative therapy
Intervention type(s): Dietary Supplement
Intervention description(s): complementary and alternative therapies were grouped into five main categories: (1) biologically based therapies , (2) mind/body therapies, (3) manipulative and body-based therapies, (4) Energy therapies and (5) alternative medical systems.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult patients from the area of Silesian agglomeration (Poland) with advanced, metastatic
        cancer disease who were admitted to "Pro Salute" Hospice for ambulatory palliative care
        between July 2017 and September 2018
      
Keywords: complementary alternative medicine; cancer; complementary alternative therapy; hospice care; palliative care
The Efficacy of Serum Pepsinogen for Prediction of Metachronous Gastric Neoplasm
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      After endoscopic resection of early gastric cancer (EGC), there remained concerned about the
      development of the metachronous gastric neoplasm (MGN). The aim of this study was to evaluate
      the role of H. pylori eradication for reducing MGN after ESD and the efficacy of serum
      pepsinogen (PG) for predicting development of MGN after endoscopic submucosal dissection
      (ESD) for EGC and to evaluate other risk factors for the incidence of MGN. The investigators
      enrolled the participants who were tested serum PG I and II at the time of ESD for EGC, from
      January 2007 to May 2013 in single tertiary center, retrospectively. The baseline
      characteristics of the participants, H. pylori status, and serum pepsinogen were analyzed for
      the development of the MGN.
    


Intervention name(s): H pylori eradication
Intervention type(s): Drug
Intervention description(s): The regimen of H. pylori eradication was like that: 1-week conventional proton pump inhibitor (PPI) based triple therapy (lansoprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and amoxicillin 1 g b.i.d. for a week) after confirmation of H. pylori infection. If the participants who initially failed to respond to the first eradication, they recommended to underwent second-line eradication therapy with the regimen of 7-day bismuth containing quadruple regimen [lansoprazole 40 mg b.i.d., tripotassium dicitrate bismuthate (Denol; Greencross Co., Seoul, Korea) 300 mg q.i.d. (three tablets 30 min before meals and one tablet 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d. for 1 week]
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study was designed to enroll patients in our ESD data registry, prospectively.
        Finally, we analyzed the data retrospectively. We enrolled about more than 1000 patients in
        our ESD registry. For this cohort study, we enrolled about 800 patients for analysis.
      
Biospecimen description: 
      Serum pepsinogen, serum HP IgG
    
Keywords: Early gastric cancer; endoscopic submucosal dissection; serum pepsinogen; Helicobacter pylori
BioWave High-frequency Neurostimulation Versus TENS for the Treatment of Chronic Low Back Pain
Condition: Chronic Pain; Lumbar Pain Syndrome; Low Back Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      This will be a multicenter randomized crossover clinical trial comparing the therapeutic
      efficacy of BioWave therapy versus TENS for the management of chronic low back pain. This
      study also aims to evaluate the impact of these therapies on physical activity, patient
      perception of therapeutic efficacy, and activities of daily living.
    

Detailed description: 
      This will be a multicenter randomized crossover clinical trial comparing the therapeutic
      efficacy of BioWave therapy versus TENS for the management of chronic low back pain. This
      study also aims to evaluate the impact of these therapies on physical activity, patient
      perception of therapeutic efficacy, and activities of daily living. Patients will start a 30
      minute treatment session with either BioWave therapy or TENS device followed by a 30 minute
      washout and ending with a final 30 minute treatment. Patients will then be instructed to
      perform two 30 minute treatment sessions daily at home for 2 weeks. Follow-up will be after 2
      weeks and the patients will be assessed in clinic for physiologic measures of pain response.
      A washout period of 2 weeks will follow and the patients will crossover to receive the
      alternative treatment.
    

Intervention name(s): BioWave; TENS
Intervention type(s): Device; Device
Intervention description(s): The BioWave device is called BioWaveGO. It is a FDA 510(k) cleared high frequency sinusoidal neurostimulator; The TENS device is called Intensity 5000. It is a FDA 510(k) cleared TENS device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Low Back Pain; Lumbar Pain Syndrome
Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the project is to evaluate whether therapy with leukotriene may be a valid
      therapeutic approach in children with adenotonsillar hypertrophy and with mild and moderate
      obstructive sleep apnea syndrome (OSAS) and to evaluate whether leukotriene is less, equally
      or more efficient than nasal steroid.
    

Detailed description: 
      The aim of the project is to evaluate whether leukotriene is less, equally or more efficient
      than nasal steroid in children with adenotonsillar hypertrophy and with mild and moderate
      OSAS checking if leukotriene administrated for 24 weeks improves overnight oximetry,
      polysomnography and checking if leukotriene as anti-inflammatory of upper airway really
      reduces the tonsils and adenoids dimensions.
    

Intervention name(s): budesonide (Aircort 50 nasal spray); montelukast (Singulair)
Intervention type(s): Drug; Drug
Intervention description(s): 50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months; Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older
Other intervention name(s): Aircort 50 nasal spray; Singulair
Intervention MeSH terms: Budesonide; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive sleep apnea syndrome; snoring; adenotonsillar hypertrophy; polysomnography; intranasal steroids; Anti-leukotrienes
A Study of Lasmiditan in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to investigate the blood concentrations of dabigatran
      etexilate and rosuvastatin when taken alone compared to when taken together with lasmiditan
      in healthy participants. The safety and tolerability of dabigatran etexilate or rosuvastatin
      in combination with lasmiditan will also be evaluated in healthy participants. The study has
      two parts. Each part will last up to 17 days, not including screening.
    


Intervention name(s): Lasmiditan; Dabigatran Etexilate; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.
Other intervention name(s): LY573144
Intervention MeSH terms: Dabigatran; Rosuvastatin Calcium; Lasmiditan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug Interaction Study
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with
      balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee
      peripheral artery in-stent restenosis.
    


Intervention name(s): Turbo Elite Laser and Turbo Tandem Laser Guide Catheters; Balloon angioplasty
Intervention type(s): Device; Procedure
Intervention description(s): application of laser energy to remove blockage followed by standard balloon angioplasty; standard balloon catheters for PTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: peripheral arterial disease; in stent restenosis; peripheral vascular disease
A Study of Aripiprazole in Children and Adolescents With Aspergers and Pervasive Developmental Disorder.
Condition: Asperger's Disorder; Pervasive Developmental Disorder
MeSH terms: Developmental Disabilities; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Asperger Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to develop a better tolerated and more effective pharmacologic
      treatment for individuals with Asperger's Disorder and Pervasive Developmental Disorder. This
      is an open-label investigation of aripiprazole in the management of the maladaptive behaviors
      of autistic disorder. We hypothesize that aripiprazole will be effective for reducing
      aggression and repetitive behavior.
    

Detailed description: 
      Pervasive developmental disorders (PDD) are characterized be severe impairments in social
      interaction and communication in addition to restricted patterns of interests and activities.
      Research suggests that a dysregulation of the dopamine and serotonin systems contributes to
      these interfering behaviors in individuals with PDD. After benefits of typical neuroleptics
      were reported in subjects with PDD's, research shifted to the atypical antipsychotics, which
      have been shown to be better tolerated and effective in this population. However, the
      atypical antipsychotics have also been associated with adverse effects. Thus there remains a
      need for a novel pharmacotherapy that would be safe and effective for children and
      adolescents with PDD's including Asperger's disorder and PDD Not Otherwise Specified (PDD
      NOS). We hypothesize that aripiprazole will be effective for reducing aggression and
      repetitive behavior. We also hypothesize that aripiprazole will be well tolerated, with low
      risk for extrapyramidal symptoms, hyperprolactinemia, weight gain, or corrected QT interval
      (QTc) prolongation. In addition, this open-label study will serve to stimulate more
      definitive, controlled research.
    

Intervention name(s): aripiprazole
Intervention type(s): Drug
Intervention description(s): Aripiprazole 5 mg per day for 2 weeks, then can be increased to 10mg per day if tolerated for 2 weeks, then can be increased to 15 mg per day for 4 weeks.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aggression; Behavioral symptoms
Placebo-Controlled Crossover Study to Evaluate Donepezil and MK-3134 for Reversal of Cognitive Impairment Associated With Scopolamine Administration (3134-005)(COMPLETED)
Condition: Dementia
MeSH terms: Dementia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The drug, scopolamine, can result in short-term impairments of cognitive function, attention,
      and memory that resemble those seen in aging and Alzheimer's disease. This study tested the
      capability of both individual and combined doses of MK-3134 and the current standard
      treatment: donepezil (Aricept), to reverse such impairments, following a single dose of
      scopolamine. Participants were evaluated after each of 5 different treatment periods (in a
      cross-over, double-dummy design): A: placebo to match both donepezil (oral [PO]) and MK-3134
      (PO) followed by placebo scopolamine (subcutaneous [SQ]); B: placebo to match both donepezil
      (PO) and MK-3134 (PO), followed by scopolamine SQ; C: MK-3134 (PO) followed by scopolamine
      SQ; D: donepezil (PO) followed by scopolamine SQ; E: MK-3134 (PO) and donepezil (PO) followed
      by scopolamine SQ. The doses of MK3134, donepezil, and scopolamine were the same over all
      treatment arms in which the specified drug was administered. There were 8 total visits for
      each treatment period, including 5 Treatment Visits requiring 14-day intervals between visits
      for study-drug washout. Participants were assessed for cognitive function before and after
      each treatment period during the Treatment Visits.
    


Intervention name(s): A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine; B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg; C: MK-3134 25 mg + Scopolamine 0.5 mg; D: Donepezil 10 mg + Scopolamine 0.5 mg; E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.; Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.; A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.; A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.; A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
Other intervention name(s): Aricept (donepezil); Aricept (donepezil)
Intervention MeSH terms: Scopolamine; Donepezil; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dementia, cognitive impairment, neurodegeneration, Alzheimer's, acetylcholine, AchE
Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
Condition: Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of romiplostim
      in thrombocytopenic patients with ITP.
    


Intervention name(s): Romiplostim; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): AMG 531; NPLATE
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part A was a sequential cohort dose escalation study. Part B was a randomized, placebo-controlled parallel group study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Immune Thrombocytopenic Purpura; Idiopathic Thrombocytopenic Purpura; Thrombocytopenic; Thrombocytopenia; ITP
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      single intravenous doses of ASP5354 in healthy, adult Japanese male participants.
    

Detailed description: 
      This study is comprised of 3 parts. Part 1 and Part 2 will be conducted in a parallel manner
      while Part 3 will be conducted subsequentially. Participants will be residential for a period
      of 3 days/2 nights. Participants will be discharged from the clinical unit on day 2 on the
      condition that all required assessments have been performed and that there are no medical
      reasons for a longer stay in the clinical unit.
    

Intervention name(s): Pudexacianinium chloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous; Intravenous
Other intervention name(s): ASP5354
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: ASP5354; Pharmacokinetics
A Study of the Safety, Tolerability, and Absorption, Metabolism, and Excretion of PA-824 in Healthy Adult Male Subjects.
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, single-center, open-label, single-dose study to evaluate (1) the
      absorption, metabolism, and excretion patterns of a single dose of [14C] PA-824, and (2) the
      pharmacokinetics, safety, and tolerability of a single oral-suspension dose of unlabeled
      PA-824 in healthy adult male subjects. Unlabeled PA-824 and [14C]-PA-824 will be administered
      together in an oral-suspension formulation. Enrollment is planned for one dose group of 6
      subjects. All 6 subjects will receive the same treatment.
    


Intervention name(s): PA-824
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tuberculosis, PA-824
An Evaluation of Weekly Tafenoquine
Condition: Falciparum Parasitaemia
MeSH terms: Parasitemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy
      of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of
      P. falciparum in Nyanza Province, western Kenya.
    

Detailed description: 
      Subjects were treated for 3 days with halofantrine to clear any existing parasitaemia. At the
      end of the clearance period, subjects free from malaria parasitaemia were randomized and
      received a loading dose of the study treatment (tafenoquine 200 mg, Mefloquine 250 mg or
      placebo) for tree days, followed by study treatment (tafenoquine 200 mg, mefloquine 250 mg or
      placebo, respectively) once a week for 24 weeks. After the treatment period subjects attended
      weekly follow-up safety visits until week 28.
    

Intervention name(s): Tafenoquine; Mefloquine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.; Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks.; Placebo for three days followed by placebo once a week for 24 weeks
Intervention MeSH terms: Mefloquine; Tafenoquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Falciparum Parasitaemia, Malaria
Efficacy of Nasal Spray Calcitonin on Recurrence of Aggressive Central Giant Cell Granuloma
Condition: Central Giant Cell Granuloma
MeSH terms: Granuloma, Giant Cell; Granuloma
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this randomised clinical trial is to is to compare the frequency of
      recurrence between patients who received nasal spray calcitonin after curettage of Central
      Giant Cell Granuloma and without it.
    

Detailed description: 
      A total of 24 patients with aggressive Central Giant Cell Granuloma (CGCG )will be selected .
      All examinations were performed by calibrated clinicians and gender, age, medical history,
      symptoms, lesion size and site, disease duration and form of treatment were recorded for all
      participant. Radiographic examination with cone beam computed tomography (CBCT) and panoramic
      radiograph was done for all patients. All patients were randomly assigned to one of two
      treatment groups; 2 weeks after the biopsies were taken.

      The case group (n =12 with) underwent 200 IU/day ones a day for 3 months after the surgeries.
      conservative curettage surgical procedure was done for them. while placebo was treated by
      curettage of CGCGs and received a placebo ones a day for 3 months after surgeries.. Patients
      were followed up by a maxillofacial surgeon who did not participated in surgeries.None of
      surgeons did not aware about the research before and during the operations.Patients were
      blinded from the drugs which they received after surgeries.

      All patients were follow up for 5 years after operations. Recurrence lesions were documented
      by clinical and radiographical examinations and proved by histopathological evaluation.
    

Intervention name(s): nasal spray calcitonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): recurrence rate of aggressive CGCG will be recorded after the use of nasal spray calcitonin
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment