bioihbjkbjnl/mcl2 huggingface dataset:
Art Therapy to Treat Women With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      Effectiveness of an art therapy program for the treatment of pain and improvements in both
      quality of life and body image of patients with fibromyalgia.
    

Detailed description: 
      Fibromyalgia (FM) is a chronic non-inflammatory syndrome characterized by diffuse pain
      throughout the body, sleep disorder, stiffness, fatigue, depression and other psychological
      problems. Patients with FM feel incapable of performing the majority of activities of daily
      living. Medication offers only short-term benefits. Thus, it is necessary to include other
      measures for treatment, such as physical activity and patient education. Art therapy combine
      the field of psychology with artistic activities, working with therapeutic and instructive
      aspects as well as the potential for personal growth contained in all forms of art.
    

Intervention name(s): Art Therapy; Walking
Intervention type(s): Other; Other
Intervention description(s): This group performed dance classes and regarding the art therapy they have art classes where they learn how to use the drawing to express feelings. The classes were twice a week.; The group walked twice a week during one hour.
Other intervention name(s): Rehabilitation, exercise, physical therapy; Rehabilitation, exercise, physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Art Therapy; Pain; Quality of life; Body Image
Psychosis-Associated Neuroinflammation in Schizophrenia
Condition: Schizophrenia; Psychosis
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Observational

Summary: 
      Previous research has suggested central nervous system inflammatory activity to be critically
      involved in disease development and progression in schizophrenia, with a complex interplay of
      inflammatory mechanisms leading to the development of brain abnormalities and medical
      symptoms related to schizophrenia. However, the mutual interactions of different inflammatory
      pathways and their relation to disease course have not been sufficiently studied. This study
      therefore aims to explore the interaction of neuroinflammatory mechanisms in patients with
      schizophrenia and to assess whether the inflammatory activity in schizophrenia is
      state-dependent and occurs mainly during psychotic episodes.
    


Intervention name(s): [18F]-PBR111 Positron Emission Tomography (PET); Cognitive and psychomotor tasks; Blood sampling
Intervention type(s): Radiation; Behavioral; Biological
Intervention description(s): [18F]-PBR111 radioligand to assess binding to TSPO; Cognitive and psychomotor tasks on digitizing tablet; Blood sampling for peripheral inflammatory and neurotoxicity markers
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young schizophrenia patients admitted to psychiatric hospital for acute relapse or
        first-episode of psychosis
      
Biospecimen description: 
      Plasma samples
    
Keywords: Schizophrenia; Psychosis; Neuroinflammation; Microglial activation
RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus,
      aVQ) in patients with gastric cancer receiving oral chemotherapy.
    


Intervention name(s): mistletoe extract; doxifluridine
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injections thrice weekly with 1 ml in 4 increasing doses; 600 - 900 mg per day orally, depending on weight and status of the patient
Other intervention name(s): abnobaVISCUM Quercus 0.02 mg; abnobaVISCUM Quercus 0.2 mg; abnobaVISCUM Quercus 2 mg; abnobaVISCUM Quercus 20 mg; Didox
Intervention MeSH terms: Viscum album peptide; Doxifluridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Quality of Life; QoL; EORTC QLQ-C30; EORTC QLQ-STO22; 5-FU; Viscum album
ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-
Condition: Anemia in Chronic Kidney Disease Patients Not on Dialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of
      anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied
      intermittently.
    

Detailed description: 
      To evaluate the safety and the dose-response of ASP1517 on Hemoglobin (Hb) correction in the
      treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is
      applied intermittently. Patients will receive ASP1517 three times a week (TIW) for first
      6weeks. Patients may have the second-randomization to TIW dosing or once-a-week (QW) dosing
      at Week 6, 8, 10, 12, 14 or 16 if patients meet the criteria.
    

Intervention name(s): ASP1517; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Renal Failure; Renal anemia; ASP1517
Study Evaluating the Effect of Jublia on Dermatophytomas
Condition: Onychomycosis; Dermatophytosis
MeSH terms: Onychomycosis; Tinea
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine how Jublia affects dermatophytomas, which are difficult to treat with
      other therapeutic options.
    

Detailed description: 
      Dermatophytomas are known to be resistant to even long courses of systemic antifungals, and
      have therefore been excluded from both topical and systemic clinical trials for
      onychomycosis, including those for Efinaconazole solution. Efinaconazole (Jublia) 10%
      solution is an FDA approved topical medication indicated for treatment of distal lateral
      subungual onychomycosis (DLSO), and the utility of this medication likely exceeds published
      results. Efinaconazole solution's novel ability to penetrate into the subungual space likely
      accounts for improved treatment results seen in DLSO treated with Jublia. We will investigate
      the utility of topical efinaconazole solution in the treatment of dermatophytomas.
    

Intervention name(s): Jublia (Efinaconazole 10% Topical Solution)
Intervention type(s): Drug
Intervention description(s): Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.
Other intervention name(s): Jublia
Intervention MeSH terms: Efinaconazole
Intervention model: Single Group Assignment
Intervention model description: Topical application of Jublia (Efinaconazole 10% Topical Solution) to patients with distal lateral subungual onychomycosis with dermatophytoma.
Masking: None (Open Label)
Primary purpose: Treatment
Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine
      the effect of ALXN1840 on the metabolism of bupropion, a sensitive cytochrome P450 2B6
      (CYP2B6) substrate, in healthy male and female participants. The safety and tolerability of
      ALXN1840 will be determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured
      via total molybdenum with the coadministration of bupropion.
    

Detailed description: 
      The study is being conducted as a randomized, 2-period, 2-sequence, cross-over study to
      determine the effect of a single dose of ALXN1840 (perpetrator) on the single-dose bupropion
      (victim) kinetics in healthy male and female participants.

      The study has a Screening Period (Day -28 to Day -2), two 11-day study periods (Day 1 to Day
      11) with a minimum of 14 days between doses of bupropion, and an End of Study Visit (Day 15 ±
      2 days) after Period 2 dosing. Participants will report to the clinical research unit on the
      day prior (Day -1) to both dosing periods. All participants will receive 1 treatment in each
      study period; treatment order will be defined based on randomization: Treatments A and B.

      The time between dosing bupropion alone or in combination with ALXN1840 in each treatment
      sequence will be a minimum of 14 days.

      The PK profile of ALXN1840 and bupropion will be determined by blood sampling following
      single dose administration.
    

Intervention name(s): ALXN1840; Bupropion Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): ALXN1840 will be administered orally as a single dose as 4 x 15 mg enteric-coated tablets with 240 milliliters of water (fasting), for a total dose of 60 mg.; Bupropion hydrochloride will be administered orally as a single dose as one 150 milligrams (mg) tablet with 240 milliliters of water (fasting).
Other intervention name(s): WTX101; Bis-choline tetrathiomolybdate; Tiomolibdate choline; Wellbutrin SR 150
Intervention MeSH terms: Tetrathiomolybdate; Choline; Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cytochrome P450; Healthy; ALXN1840
The Incidence of IV Fluid Over-administration in Pediatric Dental Surgeries When Infusion Pumps Are Employed
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      A prospective, analyst-blinded, randomized control trial to assess the incidence of
      intravenous (IV) fluid over-administration in the setting of pediatric dental surgeries.
      Anesthetists will be randomized to either administer their IV fluid through an infusion pump
      or a gravity drip device.
    

Detailed description: 
      In the perioperative setting, IV fluids are administered to mitigate the effects of
      preoperative fasting and sources of fluid loss that are unique to surgical intervention.
      Significant harms have been associated with the over-administration of IV fluid in pediatric
      patients. Infusion pumps have been shown to reduce medication administration errors in
      inpatients receiving continuous IV infusions. In contrast, laboratory experiments have
      demonstrated that gravity driven fluid delivery systems are influenced by numerous extrinsic
      factors. To date, no work has investigated the perioperative incidence of IV fluid
      over-administration in pediatric patients randomized either to infusion pumps (intervention)
      or gravity-fed IV systems (control).
    

Intervention name(s): Hospira plum pump; Gravity drip device
Intervention type(s): Device; Device
Intervention description(s): The Hospira plum pump enables the clinician to program a specific volume of intravenous fluid and define a period of time over which to administer this fluid.; Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pediatric; Perioperative; Intravenous fluid
Nexium Dyspepsia/AST
Condition: Gastrointestinal Disease; Signs and Symptoms, Digestive; Dyspepsia
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Dyspepsia; Signs and Symptoms, Digestive
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during
      an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms
      resolution at the end of a subsequent treatment period of 7 weeks.
    


Intervention name(s): Esomeprazole
Intervention type(s): Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Brain SPECT Following Cialis (Tadalafil ) Administration
Condition: Change in Brain Perfusion
Study type: Observational

Summary: 
      The study will be an open label one and will include 30 patients who underwent ischemic
      stroke 3 month to 3 years prior to the study. All patients will undergone a baseline brain
      SPECT perfusion study. 15 patients will take one dose of 20 mg cialis, and will have a second
      brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor
      matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study
      will be performed 24 hours after the last dose.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients in the age range of 35-75 years.
An Efficacy and Safety Study of CNTO 136 in Patients With Active Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of CNTO 136 administered
      intravenously in patients with active, International Society of Nephrology/Renal Pathology
      Society Class III and IV Lupus Nephritis (LN).
    

Detailed description: 
      This is a multicenter (study conducted at multiple sites), randomized (the study medication
      is assigned by chance), double-blind (neither investigator nor the patient knows the
      treatment that the patient receives), placebo-controlled (an inactive substance that is
      compared with the study medication to test whether the study medication has a real effect in
      clinical study), parallel group (each group of patients will be treated at the same time)
      study of CNTO 136 in patients with active LN. The study consists of 3 phases, ie, the
      screening phase (approximately 8 weeks prior randomization), treatment phase (24 weeks), and
      the follow up phase (through week 40). An 8 week run-in period will be used to establish the
      stability of baseline renal parameters prior to randomization and the first study medication.
      The eligible patients will be randomly assigned in a 5:1 ratio to receive 1 of 2 treatment
      groups in the treatment phase: Group 1: CNTO 136 10 mg/kg intravenous (IV), at Weeks 0, 4, 8,
      12, 16, 20, 24; and Group 2: Placebo infusion, IV, at Weeks 0, 4, 8, 12, 16, 20, 24.
      Patients' medication regimen for LN may be adjusted from the Week 24 visit and afterwards.
      Safety evaluations for adverse events, infections, clinical laboratory tests,
      electrocardiogram, vital signs, physical examination and skin evaluations will be performed
      throughout the study. The follow up phase or the end of study will be the Week 40 visit for
      the last patient randomized, or, in the event that the last patient randomized withdraws from
      the study early, the end of study is defined as the date of the last visit of the last
      patient participating in the study.
    

Intervention name(s): CNTO 136; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Type=exact number, unit=mg/kg, number=10, form=solution for injection, route=intravenous. CNTO 136 is administered once every 4 weeks from Week 0 to Week 24.; Form=solution for injection, route=intravenous. Placebo is administered once every 4 weeks from Week 0 to Week 24.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Lupus nephritis; CNTO 136; Sirukumab; Kidney diseases; Proteinuria; Glomerulonephritis
Compliance With Gluten-Free Diet and Affecting Factors in Adolescents With Celiac Disease
Condition: Celiac Disease in Adolescents; Gluten-Free Diet in the Covid-19 Process
MeSH terms: COVID-19; Celiac Disease
Study type: Observational

Summary: 
      Celiac is a chronic autoimmune disease that is treated with a gluten-free diet. Adolescents
      with celiac disease were affected differently by the restrictions during the COVID-19
      pandemic. The aim of this study was to determine the compliance with a gluten-free diet
      during in adolescents with celiac disease during the Covid-19 pandemic and identify the
      associated factors.

      The sample of this study consisted of 85 adolescents in the 10-19 age group diagnosed with
      celiac disease. Research data were collected by online questionnaires (Google Forms) between
      January and April 2022. Sociodemographic and disease-related data of adolescents who were
      compliant and those who were non-compliant with a gluten-free diet during the COVID-19
      pandemic were compared.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The population of this cross-sectional study of adolescents diagnosed with celiac disease
        in the 10-19 age group, registered to an association. Study sample of 85 participants who
        met the inclusion criteria and agreed to participate in the study.
      
Keywords: Adolescence; Celiac Disease; gluten free diet
Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF)
      and 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony
      defects in chronic periodontitis patients
    

Detailed description: 
      ABSTRACT Background: Regenerative periodontal therapy encompasses the use of various
      bioactive agents that are not only inflammo-modulatory but also osteoclast-inhibitory or
      rather, osteostimulative. The hypolipidaemic Statin group of drugs, particularly Rosuvastatin
      (RSV), are known to be associated with alveolar bone formation and periodontal improvements.
      Platelet analogues like Platelet rich fibrin (PRF), being rich sources of growth factors,
      have also come into widespread periodontal regenerative use. The aim of the study is to
      evaluate and compare the efficacy of open-ﬂap debridement (OFD) with or without PRF or PRF +
      1.2% RSV gel in the treatment of intrabony defects (IBDs) in chronic periodontitis (CP)
      patients.

      Methods: Ninety individuals with a total of 90 IBDs were randomly assigned to one of the 3
      treatment groups: 1) OFD alone, 2) OFD + PRF and 3) OFD + PRF + 1.2% RSV gel placement.
      Plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical
      attachment (CA) level and IBD depth were recorded at baseline and at 9 months
      post-operatively.
    

Intervention name(s): Open flap debridement (OFD); OFD with Platelet rich fibrin (PRF); OFD with PRF and 1.2% Rosuvastatin
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Oral prophylaxis followed by OFD for treating bone defect; Oral prophylaxis followed by OFD with PRF placement into the bone defect; Oral prophylaxis followed by OFD with PRF and 1.2% Rosuvastatin placement into the bone defect
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      Coronary revascularization improves survival for patients with coronary artery disease.
      However,many patients are left with poor physical and mental health. Traditional cardiac
      rehabilitation involves moderate intensity continuous exercise (MICE). Alternatives to
      traditional cardiac rehabilitation programming may however provide superior understudied
      benefits to patients with poor physical and mental health. Nordic walking (NW) and
      high-intensity interval training (HIIT) are two examples of alternative programs for cardiac
      rehabilitation, which may provide superior physical and mental health benefits when compared
      to traditional MICE. The main purpose of this project is, therefore, to determine the short
      and long term physical and mental health benefits of alternative cardiac rehabilitation
      modalities, including NW and HIIT on exercise capacity, quality of life and depression after
      a 12-week program.
    


Intervention name(s): High Intensity Interval Training; Moderate Intensity Continuous Exercise Training; Nordic Walking
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks; Participants will complete supervised exercise sessions. Moderate-intensity continuous exercise training will follow cardiovascular rehabilitation guidelines. Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.; Participants will complete supervised exercise sessions. Participants will attend on-site Nordic walking training two times weekly for 12 weeks
Other intervention name(s): HIIT; MICE; NW
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention (PCI)
Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the long-term safety and efficacy of a dose range of safinamide of 50-200
      mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic
      Parkinson's disease who are currently receiving a stable dose of a single dopamine (DA)
      agonist.
    

Detailed description: 
      The study will consist of 12 months of double-blind treatment. Patients will continue to take
      the original treatment administered in Study 015 (safinamide 100 mg/day, safinamide 200
      mg/day, or placebo).
    

Intervention name(s): Safinamide; Safinamide; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease