bioihbjkbjnl/mcl2 huggingface dataset:
Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain
Condition: Chronic Low Back Pain; Neck Pain
MeSH terms: Back Pain; Low Back Pain; Neck Pain
Study type: Interventional

Summary: 
      To investigated whether an ambulant intervention program with a behavioral therapy approach
      would exert a long-term effect on chronic unspecific back or neck pain. Specifically, the
      effect on patients with pronounced fear avoidance behavior and/or with psychosocial
      limitations was addressed.
    

Detailed description: 
      BACKGROUND: Sustained success of ambulant intervention programs consisting of individual and
      group physiotherapy in patients with with chronic unspecific back or neck pain (cBP) has not
      been conclusively proven. It's still not clear whether one can achieve such success by
      devoting greater attention to psychosocial factors.

      OBJECTIVE: We investigated whether an ambulant intervention program with a behavioral therapy
      approach would exert a long-term effect on cBP. Specifically, the effect on patients with
      pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.

      DESIGN: Prospective, randomized controlled trial

      SETTINGS, INTERVENTION: 64 patients were assigned to intervention group (IG) and 57 to
      control group (CG). All were examined, informed about cBP, and were encouraged to stay active
      and perform exercises according to specific instructions provided in a neck- or back-book.
      The IG received 9 units of physiotherapy and 2 units of occupational therapy, conducted with
      a behavioral therapy approach. Efficacy of treatment was evaluated after 6 and 58 weeks.

      MEASUREMENTS: Pain (VAS), quantity of painkillers consumed, sick leave days,
      Oswestry-Disability-Index (ODI), SF-36, FABQ.
    

Intervention name(s): Physiotherapy and occupational therapy
Intervention type(s): Behavioral
Intervention description(s): Members of the training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour. Every patient of the IG was trained to perform a neck or back intervention program specifically suited to his/her needs. The training was conducted in a single session by one of three experienced physiotherapists (with mean work experience of 6 years). After this training the patients completed eight group training units consisting a maximum number of 8 participants, each unit with a duration of one hour, over a maximum period of six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: outpatient intervention program; behavioral therapy approach; unspecific back pain; unspecific neck pain; chronic pain; physiotherapy; occupational therapy; psychosocial aspects; fear avoidance beliefs; health-related quality of life
Evaluation of Healing Process After Laser Asissted Gingivectomy Techniques
Condition: Gingival Enlargement
MeSH terms: Gingival Hyperplasia; Gingival Hypertrophy; Gingival Overgrowth
Study type: Interventional

Summary: 
      Objective: The aim of this study was to evaluate and determine clinical and biochemical
      comparison of 3 different methods including Er:YAG laser, diod laser, and conventional
      techniques.

      Method: This study was conducted on 32 female, 13 male, a total of 45 individuals (study
      group patients) with an indication of resective gingival surgery in the anterior region of
      the maxillar anterior regions and 11 female, 4 men, a total of 15 individuals (negative
      control group patients) with a healthy gingiva. Clinical periodontal parameters, gingival
      crevicular fluid (GCF) KGF-2 and VEGF-A levels and gingival temperature levels were recorded
      before the investigation and during operations with 3 different techniques, gingival
      temperature was measured. Gingival temperature and epithelization levels in 3, 7, 14 and 21
      days; GCF KGF-2 and VEGF-A levels in 14 and 21 days and pain levels between 1-7 days of
      post-operative healing process were evaluated. Preoperative anxiety and postoperative
      satisfaction were evaluated through questionnaires
    

Detailed description: 
      Objective: The aim of this study was to evaluate and determine clinical and biochemical
      comparison of 3 different methods including Er:YAG laser, diod laser, and conventional
      techniques commonly used in resective gingival surgeries in terms of preoperative anxiety,
      postoperative satisfaction, epithelization, gingival temperature, inflammation and pain
      levels in post-operative healing process.

      Method: This study was conducted on 32 female, 13 male, a total of 45 individuals (study
      group patients) with an indication of resective gingival surgery in the anterior region of
      the maxillar anterior regions and 11 female, 4 men, a total of 15 individuals (negative
      control group patients) with a healthy gingiva. Clinical periodontal parameters, gingival
      crevicular fluid (GCF) KGF-2 and VEGF-A levels and gingival temperature levels were recorded
      before the investigation and during operations with 3 different techniques, gingival
      temperature was measured. Gingival temperature and epithelization levels in 3, 7, 14 and 21
      days; GCF KGF-2 and VEGF-A levels in 14 and 21 days and pain levels between 1-7 days of
      post-operative healing process were evaluated. Preoperative anxiety and postoperative
      satisfaction were evaluated through questionnaires
    

Intervention name(s): Resective Gingival Surgery
Intervention type(s): Procedure
Intervention description(s): Gingivectomy and gingivoplasty:Resective gingival surgical procedured
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Investigators will test the superiority of Superiority Trial of Fluticasone-Vilanterol as
      needed in mild asthma compared to standard of care
    

Detailed description: 
      single centre randomised control trial with the aim of comparing the superiority of
      effectiveness and safety of fluticasone-vilanterol versus usual care. In this study there is
      random allocation of participants to usual care (Any ICS or SABA combination) or
      fluticasone-vilanterol daily single dose for the relief of symptoms.
    

Intervention name(s): fluticasone-vilanterol; Standard Preparation
Intervention type(s): Drug; Drug
Intervention description(s): LABA-ICS combination Inhaled Long acting Beta agonist and inhaled corticosteroid; inhaled SABA or Inhaled corticosteroid
Other intervention name(s): standard of care
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Investigators will compare the superiority of effectiveness and safety of fluticasone-vilanterol versus usual care. In this study, there is a random allocation of participants to usual care (Any ICS or SABA combination) or fluticasone-vilanterol single daily use for the relief of symptoms.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; fluticasone; LABA; fluticasone-vilanterol; Long acting Beta agonist
Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis
Condition: Leishmaniasis; Leishmaniasis, Mucocutaneous
MeSH terms: Leishmaniasis; Leishmaniasis, Mucocutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether miltefosine is effective in the treatment
      of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.
    

Detailed description: 
      Mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients
      with cutaneous leishmaniasis in the New World. It causes deformities and may be lethal if not
      treated. It is part of the neglected tropical diseases because on the past sixty years there
      was few progress regarding other treatment options or improvement at quality of life of its
      patients. Also, there was little interest from the pharmaceutical industry and government
      authorities to develop new researches. The standard treatment, meglumine antimoniate, is
      toxic, invasive, requires trained personnel and has many adverse effects and restrictions. On
      the other hand, miltefosine is the first oral drug to demonstrate efficacy against
      mucocutaneous leishmaniasis. Few clinical trials have being performed in Central and South
      American countries, but so far, just one involved mucosal leishmaniasis patients, and
      compared miltefosine to amphotericin B. None studies comparing its efficacy to the standard
      treatment have being done.
    

Intervention name(s): Miltefosine; Standard Treatment Meglumine antimoniate
Intervention type(s): Drug; Drug
Intervention description(s): 1 Capsule of 50mg, taken orally 2 times a day for 28 days; 20mgKg daily intravenous Meglumine antimoniate as oriented by the Brazilian Ministry of Health
Other intervention name(s): Impavido; pentavalent antimonial
Intervention MeSH terms: Miltefosine; Meglumine Antimoniate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leishmaniasis; Mucocutaneous Leishmaniasis; Therapeutics; meglumine antimoniate; miltefosine
Effects of Single-task Versus Dual-task Training on balancePERFORMANCE
Condition: Balance Impairment
Study type: Interventional

Summary: 
      Background: Impairment in the control of balance is a common problem among elderly patients
      especially whom with osteoarthritis (OA).

      Aim: The aim of this study was to compare the effects of single-task and dual-task training
      on balance performance in the elderly osteoarthritic patients with balance impairment.
    

Detailed description: 
      Fifty elderly osteoarthritic patients with balance impairment were included into this study.
      Patients were randomly assigned to single task balance training (Group 1) or dual-task
      balance training (Group 2) groups. Balance activities were given to both groups for 3 times a
      week for 4 weeks. Patients in group 2 also performed cognitive tasks simultaneously with
      these exercises. Patients were evaluated with Berg balance scale (BBS), kinesthetic ability
      trainer (KAT 2000) static and dynamic scores, timed up and go test (TUTG) and walking speed
      for single and dual tasks, number of stopping and Activities Specific Balance Confidence
      (ABC) Scale at the baseline and at the end of 4 weeks.
    

Intervention name(s): single task balance training; dual task balance training
Intervention type(s): Other; Other
Intervention description(s): single task balance training; dual task balance training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism
Condition: Primary Aldosteronism
MeSH terms: Hyperaldosteronism
Study type: Observational

Summary: 
      To compare the diagnostic value of three confirmatory tests for primary aldosteronism.
    

Detailed description: 
      This is a prospective study involving 240 hypertensive patients who underwent primary
      aldosteronism screening. Every patient will undertake four confirmatory tests to compare the
      diagnostic accuracy of the oral sodium loading test with captopril challenge testing (CCT)
      and Seated saline infusion test(SSST)using the fludrocortisone suppression testing (FST) as
      the reference standard, and to investigate the optimal cutoff of oral sodium loading test
    

Intervention name(s): Oral sodium loading test,Seated saline infusion test and Captopril challenge test
Intervention type(s): Diagnostic Test
Intervention description(s): Oral sodium loading test : Patients received 6g oral sodium every day for 3 days.
Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture.
Captopril challenge test: Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 2 h. Blood samples were drawn at time zero and 2 h after the challenge.
Intervention MeSH terms: Captopril
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        hypertensive patients being suspicious of PA in a single tertiary hospital center
      
Biospecimen description: 
      Serum, plasma and complete blood cell. 24-h urine, etc
    
Keywords: primary aldosteronism,; oral sodium loading test; captopril challenge test,; Saline infusion test
Safety and Tolerability of Autologous Non-hematopoietic Peripheral Blood Stem Cells Therapy in Healthy Adult Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      SANTANA Study is a phase 1, prospective, monocentric, open-label clinical trial involving
      healthy adult volunteers, with the objective to evaluate the safety and tolerability of the
      compressor nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).
    

Detailed description: 
      The study was conducted in Abu Dhabi Stem Cells Center (ADSCC), and the cell processing and
      investigational product formulation were performed at the same center according to Good
      Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs). Participants received
      the investigational therapy through compressor (jet) nebulization (two doses divided on Days
      0 and 1). The primary endpoint was the safety assessment, to be measured as Adverse Reactions
      (ARs) incidence [by the World Health Organization - Uppsala Monitoring Centre (WHO-UMC)
      causality assessment system], and the nebulization tolerability rate (Days 0 and 1). The
      Laboratory testing profile was evaluated before treatment (Day 0 or -1) and on Days 14 and
      28. Two thorax radiography tests (chest X-rays - CXR) were assessed: before the therapy (Day
      0 or -1) and on Day 7. An electrocardiogram (ECG) assessment was performed on Days 0 (or -1),
      14, and 28. The application of the validated St. George's Respiratory Questionnaire (SGRQ) on
      Days 0 and 28 was a surrogate safety endpoint. The whole clinical assessment in SANTANA Study
      was daily recorded until Day 28, taking into account the ARs incidence. The secondary
      endpoint was the tolerability assessment, measured by nebulization tolerability rate (Days 0
      and 1), and Adverse Events (AEs) tolerability within 28-days. The trial was approved by the
      ADSCC Research Ethics Committee, and written informed consent was obtained from all
      participants. SANTANA Study was conducted following the Declaration of Helsinki principles
      and Good Clinical Practices (GCPs), and the authors are responsible for designing the trial,
      compiling, and analyzing the data.
    

Intervention name(s): Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).
Intervention type(s): Biological
Intervention description(s): Participants received the investigational therapy through compressor (jet) nebulization, in two doses divided on Days 0 and 1. Each dose contains 10 mL of peripheral blood-derived stem cells CD45-/CD90+/CD133+.
Other intervention name(s): UAECell19
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nebulization; Autologous non-hematopoietic peripheral blood stem cells
D-amino Acid Oxidase Inhibition (DAAOI-1) add-on Treatment for Chronic Schizophrenia
Condition: Schizophrenias; Psychoses; Psychotic Disorders; Schizophrenic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Adjuvant N-methyl-D-aspartic acid (NMDA)-enhancing agents, such as GlyT-1 inhibitors and
      NMDA-glycine site agonists have been demonstrated to be beneficial for chronic schizophrenia
      patients. The purpose of this study is to evaluate efficacy and safety of add-on treatment of
      an inhibitor of D-amino acid oxidase (DAAOI), DAAOI-1, in chronically stable schizophrenia
      patients who have been stabilized with antipsychotics.
    

Detailed description: 
      The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive
      symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system
      hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the
      pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission has
      been regarded as a novel treatment approach. To date, several reported trials on adjuvant
      NMDA-enhancing agents, including glycine, D-amino acids (D-serine, D-alanine), and sarcosine
      (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive
      and negative symptoms.

      DAAOI-1 is a D-amino acid oxidase (DAAO) inhibitor which can elevate synaptic concentration
      of D-amino acids. The aim of this project is to examine the efficacy and safety of add-on
      treatment of DAAOI-1 in chronically stable schizophrenia patients who have been stabilized
      with antipsychotics.

      In the study, 60 schizophrenic patients are recruited into the 6-week trial and randomly
      assigned into the two groups (1 gm/dDAAOI-1, or placebo) with a double-blind manner. Positive
      and Negative Syndrome Scale (PANSS), Scales for the Assessment of Negative symptoms (SANS),
      Global Assessment of Function (GAF), quality of life (QOL), Hamilton Depression rating scale
      17(HAM-D 17), Clinical Global Impression(CGI)and side effects are evaluated every two weeks
      during the trial. Cognitive function ("7 domains of Measurement and Treatment Research to
      Improve Cognition in Schizophrenia" [MATRICS])are assessed at weeks 0 and 6. The efficacies
      of two groups are compared.
    

Intervention name(s): D-amino acid oxidase inhibition (DAAOI-1); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1g/day(500mg BID), oral, for 6 weeks; 1# BID, oral, for 6 weeks
Other intervention name(s): DAAOI-1; starch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
Condition: Multidrug-resistant Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to determine whether delamanid is effective in the treatment of
      multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during
      6 months of treatment.
    

Detailed description: 
      The primary objective of this trial is to evaluate the efficacy of delamanid administered
      orally as 100 milligrams (mg) twice daily (BID) for 2 months followed by 200 mg once daily
      (QD) for 4 months in combination with an optimized background treatment regimen (OBR) versus
      placebo with OBR during the 6-month Intensive Period of MDR TB treatment. Following the
      6-month Intensive Period, OBR was administered alone during the Continuation Period for 12 to
      18 months (from Month 7 up to Month 24). The trial also included a post-treatment follow-up
      period of 6 to 12 months (Month 19 to Month 24 to the end of Month 30). OBR given throughout
      the study was administered as per World Health Organization (WHO) guidelines and national
      treatment norms.

      This trial is a multicenter, randomized, double-blind, stratified, placebo-controlled trial
      that was conducted globally in 2 parallel groups at 17 sites in 7 countries qualified to
      treat MDR TB.
    

Intervention name(s): Delamanid + OBR; Placebo + OBR
Intervention type(s): Drug; Drug
Intervention description(s): The assigned doses of delamanid were administered with an OBR. The selection and administration of the OBR were based on WHO's guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country.; Matching placebo was administered with an OBR. The selection and administration of the OBR were based on WHO's guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Multidrug-resistant tuberculosis
POC Study of Pipamperone Added to Stable Treatment With RIS or PAL in Chronic Schizophrenia
Condition: Chronic Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase I/IIa Proof-of-Concept (PoC) trial is designed to assess the effect of adding a
      single and repeated low dose (15mg/d) of pipamperone (PIP) for 6 weeks to stable treatment
      with an effective dose of risperidone (RIS) or paliperidone (PAL) on functional MRI tests and
      clinical outcome of chronic schizophrenic patients with residual, so-called 'positive'
      symptoms, as well as on cognition, motivation, subjective well-being of patients, negative
      symptoms, general psychopathological symptoms and safety/tolerability.
    

Detailed description: 
      This exploratory study of 7 weeks was intended to be performed in 40 to 60 patients in up to
      10 centers in Belgium. In a subset of patients, the 6-week treatment phase will be preceded
      by a single-dose cross-over phase with 1 week of wash-out. While the objective of the study,
      due to its exploratory design, is to assess any effect of the study medication on MRI or
      clinical outcome, the study medication is expected to improve the residual (remaining)
      positive symptom(s) of patients. In addition, genetic and pharmacokinetic testing may be
      performed to learn more about the disorder and its treatment.
    

Intervention name(s): Pipamperone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 15 mg PIP once daily per os on top of continued stable treatment with RIS or PAL; matching placebo sugar pill once daily per os on top of continued stable treatment with RIS or PAL
Other intervention name(s): Risperdal, Invega and Xeplion
Intervention MeSH terms: Pipamperone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment