bioihbjkbjnl/mcl2 huggingface dataset:
Injection Therapy for Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      Shoulder, neck, back and temporal pain and herpes zoster pain are neuropathic pain.
      Preliminary clinical studies have confirmed that injection of freshly prepared HA35 can
      relieve neuropathic pain. This clinical study is a prospective repeated experiments. The
      purpose of this study was to verify the effectiveness of HA35 injection therapy.
    

Detailed description: 
      In this study, the recombinant human hyaluronidase PH20 and neutral hyaluronidase (PH20) of
      bovine testicular sperm acrosomes were used to cleave macromolecular HA. Regardless of the
      cutting time, the HA fragment HA35, with an average molecular weight of 35 kDa, was produced
      (Registration number L20200708MP07707, Ministry of Health, Mongolia). Hyaluronidase is often
      used to improve the penetration and absorption of other injectable drugs. Hyaluronidase
      injection is also used off label to degrade excessive components used in cosmetic injections,
      such as cross-linked macromolecular HA fillers
      (https://www.realself.com/news/hyaluronidase-dissolve-fillers). In this study, HA35 was
      prepared by mixing hyaluronidase extracted from bovine testis (hyaluronidase for injection,
      H31022111) and HA (sodium hyaluronate for injection, H20174089) at room temperature for 20
      minutes. The analgesic effect of HA35 on herpes zoster and shoulder, neck, back, and temporal
      pain was studied. This was a single-arm, open-label prospective clinical study in which
      patients were evaluated before and after treatment.
    

Intervention name(s): Freshly manufactured 35 kDa hyaluronan fragment
Intervention type(s): Drug
Intervention description(s): This mixture of high molecular weight HA and hyaluronidase containing 100 mg of HA was locally injected at the pain point or where the nerve trunk innervates the pain point. Then, the pain scale (NPRS) was used to evaluate pain, and the pain relief of patients before and after treatment was recorded.
Each time, according to the amount of high molecular weight HA containing 100 mg HA and hyaluronidase mixture, the pain point area and pain point area of the nerve trunk innervation of the local multipoint injection. Then, the pain scale was used to evaluate pain, and the pain relief of patients before and after treatment was recorded.
Other intervention name(s): HA35
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Microbial Community Transplantation on the Armpit/Foot
Condition: Heavy, Bad Body Odour From Armpit; Heavy, Bad Body Odour From Foot
MeSH terms: Body Odor
Study type: Interventional

Summary: 
      The malodour generation of a person's armpit/foot is caused by the bacteria thriving on that
      armpit/foot. In order to alter or reduce once bad body odour or foot odour, the living
      microbial community on the foot/armpit of a non-malodorous person will be transmitted (or up
      scaled and transmitted) to the foot/armpit of a malodorous person. The odour is evaluated by
      a trained smelling panel, the bacteria living on the armpit/foot is examined by means of
      molecular techniques. The microbial transplantation and its follow-up happens under the
      supervision of a doctor.
    


Intervention name(s): Microbial transplant
Intervention type(s): Biological
Intervention description(s): Every subjects has 2 armpits and 2 feet. One armpit/foot is treated, the other is not treated.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)
Condition: Active Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID 2x
      500 mg mesalazine in the treatment of patients with acute ulcerative colitis
    


Intervention name(s): Mesalazine - TID 1000 mg; Mesalazine - TID 2x 500 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of an Intervention to Prevent Frailty in Obese Elderly People (PRE-FROB)
Condition: Fragility; Sarcopenia; Obese; Elderly
MeSH terms: Sarcopenia; Frailty
Study type: Interventional

Summary: 
      Rationale: There is increasing evidence that obesity may be a risk factor for frailty in the
      elderly. Obesity favors a state of chronic inflammation and insulin resistance, involves a
      fatty infiltration of the muscle and an increased cardiovascular risk and, in addition, obese
      people usually perform less physical activity. All this favors the loss of mass and muscular
      function (sarcopenia), a key component of the fragility and the functional deterioration.

      Objectives: To evaluate the effectiveness of a multimodal intervention to lose weight in the
      prevention of frailty in obese elderly people, as well as to know the main mechanisms
      involved in the frailty process.

      Methodology: Design: Controlled, randomized, open-label clinical trial with two parallel
      intervention arms and 2 years follow-up. Study population: People between 65 and 75 years of
      age, obese (BMI ≥30), without criteria of fragility and living in the community. Study
      intervention: multimodal and personalized intervention with the support of a "personal
      trainer" that has two main axes of action: a) diet: assessment of nutritional status and
      nutritional requirements and establishment of personalized nutritional plan with monthly
      dietetic controls and b) physical exercise: a multi-component physical exercise program that
      will include aerobic exercise and strengthening, balance and flexibility exercises as well as
      a weekly group session of health education, during six months. Main outcome measures (to be
      evaluated annually for 2 years): Fragility (according to the L Fried criteria) and Sarcopenia
      (according to the criteria of the European Working Group on Sarcopenia in Older People
      -EWGSOP). Sarcopenia is considered if there is a decrease in gait velocity or muscle grip
      strength (measured with a dynamometer) and a decrease in muscle mass assessed by bioimpedance
      (BIA). Intermediate outcome measures (at 6, 12 and 24 months): a) weight loss, b) changes in
      body composition and distribution of body fat, c) glycemic control (HbA1) and insulin
      resistance (by HOMA index (HOmeostasis Model Assessment)), d) cardiovascular risk according
      to the REGICOR algorithm, e) functional capacity (according to Barthel Index and 2 Minute
      Walking Test), f) inflammatory markers (IL-6, CRP(C reactive protein), TNF(Tumor Necrosis
      Factor)-alpha and leptin) and g) anabolic hormones (IGF-1, ghrelin and testosterone).
    


Intervention name(s): Intervention
Intervention type(s): Other
Intervention description(s): Diet and physical exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention; frailty; obese; elderly; physical exercise
Prevalence, Etiology and Effects on Oral Health and Life Quality of Molar Incisor Hypomineralization
Condition: Molar Incisor Hypomineralization; Oral Health; Child, Only; Pediatric ALL; Dental Caries; Dental Plaque; Dental Diseases
MeSH terms: Dental Caries; Dental Plaque; Molar Hypomineralization; Dental Enamel Hypoplasia; Stomatognathic Diseases
Study type: Observational

Summary: 
      Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral
      health-related quality of life (OHRQoL).
    

Detailed description: 
      Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral
      health-related quality of life (OHRQoL). The aim of this study was to determine the
      prevalence, etiology and impacts of MIH on oral health status and OHRQoL.

      Six hundred and fifty-five parents and their children aged 9 years were included in the
      study. After parents completed the questionnaire about the etiology of MIH, children's OHRQoL
      was measured by the Child Perceptions Questionnaire (CPQ8-10). Children were evaluated for
      presence and severity of MIH, dental caries experience and oral hygiene status. Qualitative
      data were analyzed with the Pearson chi-square and Fisher's exact tests. For the quantitative
      data, if the normal distribution was not satisfied, Kruskal Wallis/Mann-Whitney U tests were
      used. Also, Binominal logistic regression analysis was performed and p<0.05 was statistical
      significant.

      .
    

Intervention name(s): survey application
Intervention type(s): Other
Intervention description(s): Children's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Oral examination of children were conducted for presence and severity of MIH, dental caries experience and oral hygiene status.
Other intervention name(s): oral examination
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        9-year-old children who were enrolled in the primary schools in the city of Rize, Turkey.
      
Keywords: Molar Incisor Hypomineralization; oral health; MIH; Oral health related lif quality; Child Perceptions Questionnaire; OHRQoL; CPQ
A Multicenter, Observational Study to Evaluate Clinical Manifestation, Diagnosis and Treatment of Primary Hemifacial Spasm in Chinese Patients
Condition: Hemifacial Spasm
MeSH terms: Hemifacial Spasm; Spasm
Study type: Observational

Summary: 
      To determine the clinical manifestation, diagnosis and treatment options of primary
      hemifacial spasm in Chinese outpatient subjects
    

Detailed description: 
      About 1000 outpatient subjects will be recruited. The inclusion criteria include clinically
      diagnosed primary hemifacial spasm, male or female 18 to 80 years old and informed consent
      has been obtained. The exclusion criteria include secondary hemifacial spasm, other
      involuntary facial movement disorder, history of surgery of microvascular decompression of
      the facial nerve and so on. The outcome measures include the percentage of the treatment
      methods of HFS in outpatient subjects, aggrevated and relieved factors of HFS symptom,
      concomitant symptoms of HFS and adverse events of botulinum toxin treatment in HFS patients.
    

Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        About 1000 Outpatient subjects from 15 centers across China.
      
Keywords: hemifacial spasm; observational study; clinical manifestation; treatment; Chinese
Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational [Patient Registry]

Summary: 
      The multi-centered, cross-sectional investigations shall be conducted in this study with the
      objective of identifying the ownership ratio of gBRCAm on the newly diagnosed patients with
      epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.
    

Detailed description: 
      This multi-centered, cooperative and epidemiological observation study is so designed to
      investigate the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial
      ovarian cancer, primary peritoneal cancer or fallopian tube cancer because such a ratio has
      not yet been adequately clarified in Japan.

      The newly diagnosed eligible patients with epithelial ovarian cancer, primary peritoneal
      cancer or fallopian tube cancer shall be asked to participate in this study in order of
      diagnosis. After obtaining their consents by the written informed consent following
      appropriate explanation, investigations about the demographic information including the
      cancer family history shall be performed. Subsequently, blood is collected for investigation
      about gBRCAm. In addition, histological classification shall be conducted based on the
      resected tumor tissues.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or
        fallopian tube cancer in Japan.
      
Biospecimen description: 
      From all the eligible subjects who have already attached the signature to the written
      informed consent, blood samples shall be collected. By using an assigned 10-mL EDTA-added
      blood collecting glass tube, 7 mL of the blood is sampled. The blood samples are to be
      recovered together with the specified test request form by Myriad and presence or absence of
      gBRCAm shall be centrally determined by US Myriad Genetics. Treatments of the samples,
      handling procedures and recovery methods are precisely described on the testing manual.

      The physician responsible for institutional study has the responsibility to notify the gBRCAm
      results to all the patients who underwent the tests. However, this responsibility needs not
      to be observed if the patients themselves refuse such a notification about gBRCAm test
      results. This responsibility shall be assumed by the physician responsible for institutional
      study in each participating institute.

      Incidentally, the genetic test results of the patients should
    
Keywords: ovarian cancer, gBRCAm
Acupuncture Combined With Nimodipine for Prevention of Post-stroke Dementia
Condition: Post-stroke Dementia
MeSH terms: Stroke; Dementia
Study type: Interventional

Summary: 
      To observe the clinical efficacy of TCM acupuncture combined with western medicine nimodipine
      for prevention of post-stroke dementia by comparing with clinical conventional treatment
      methods.
    


Intervention name(s): The control group received oral nimodipine tablets
Intervention type(s): Drug
Intervention description(s): The control group received oral nimodipine tablets
Intervention MeSH terms: Nimodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: randomized controlled trial; post-stroke dementia; Acupuncture; nimodipine
Olmesartan Medoxomil Versus Losartan in Patients With Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of oral administration of
      olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.
    


Intervention name(s): olmesartan medoxomil; losartan potassium
Intervention type(s): Drug; Drug
Intervention description(s): olmesartan medoxomil oral tablets, once daily for up to 12 weeks; losartan oral tablets, once daily for up to 12 weeks
Intervention MeSH terms: Losartan; Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the tolerability, pharmacokinetic profile of BIA
      3-202 and its metabolites, and the pharmacokinetic and pharmacodynamic interaction between 4
      different single doses of BIA 3-202 (50 mg, 100 mg, 200 mg and 400 mg) and a single dose of
      standard levodopa 100 mg/benserazide 25 mg (Madopar® 125) in adult male and female healthy
      volunteers.
    

Detailed description: 
      This was a single centre, double-blind, randomised, placebo-controlled, single-graded-dose,
      crossover study with five single-dose treatment periods. The washout period between doses was
      15±2 days. For each of the five treatment periods, volunteers were to be admitted at the UFH
      on the day before the treatment day. On each treatment period, the pre-dose assessment were
      to be completed, BIA 3-202/Placebo was to be administered concomitantly with the dose of
      Madopar® 125 and post-dose assessments were to be completed. Subjects were discharged 30 h
      post-dose. Subjects should attend five treatment periods and were to receive a different dose
      of BIA 3-202 or placebo during each of these treatment periods.
    

Intervention name(s): BIA 3-202; Placebo; Madopar® 125
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The study consisted of 5 treatment periods. Eligible subjects were admitted to the UFH on the morning of the day prior to receive the trial medication (dosing day) and remained in the unit for at least 30 h post-dose.
Subjects were to receive BIA 3-202 50 mg, 100 mg, 200 mg, 400 mg and placebo at 5 separate treatment periods.; Placebo dose consisted of 5 tablets matching BIA 3-202 100 mg tablets; oral route.; Levodopa 100 mg/benserazide 25 mg capsules (Madopar® 125, marketed by Roche products Limited); oral route.
Intervention MeSH terms: Benserazide, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Nebicapone
A Practical Model to Transform Childhood Asthma Care - Spirometry Training in the Primary Care Setting
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Spirometry is a recommended component of asthma diagnosis and treatment in the primary care
      setting, however, few primary care providers report routine use of spirometry in the
      provision of care for their asthma patients. Even when spirometry is used to aid in asthma
      severity classification, primary care providers have a high rate of failing to meet the
      quality goals for testing established by the American Thoracic Society.

      The goal of this study is to evaluate the effectiveness of a virtually delivered quality
      improvement (QI) program. The program is designed to train primary care providers and their
      medical staff in the use of spirometry to improve pediatric primary care management for
      children with asthma.
    

Detailed description: 
      A cluster randomized trial with matched practice pairs. All practices receive a spirometer
      and standard vendor training. Those randomized to the intervention group receive a 7-month QI
      program, which includes:

        1. Spirometry Fundamentals™ CD-ROM;

        2. Case-based, interactive webinars; and

        3. an Internet-based spirometry quality feedback reporting system.
    

Intervention name(s): Virtually delivered spirometry quality improvement program
Intervention type(s): Behavioral
Intervention description(s): Sites in the intervention arm receive the virtually delivered QI program.
The program includes:
Spirometry Fundamentals™ CD-ROM, a computer-based CD-ROM training program that teaches primary care providers and their staff techniques required to perform high-quality spirometry tests, and proper interpretation of spirometric data;
Case-based, interactive webinars; and
an Internet-based spirometry quality feedback reporting system.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Asthma; Spirometry; Pediatric; Primary Health Care; Education, Distance
Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      In western Kenya the prevalence of malaria in <5 year olds has fallen from 70% in 1997 to 40%
      in 2008, where it has now stagnated. Innovative approaches are needed to continue towards
      elimination. Ivermectin is a broad spectrum antiparasitic endectocide widely used for the
      control of onchocerciasis and lymphatic filariasis at a dose of 150-200 mcg/kg. Ivermectin at
      this dose has a potent, but short-lived effect for 6-11 days on mosquito survival,
      egg-laying, and parasite sporogony. Higher doses are needed to prolong its mosquitocidal
      effects. Previous studies have shown ivermectin is very well tolerated and safe even up to
      2,000 mcg/kg. This dose finding study will evaluate the transmission blocking effect of
      high-dose ivermectin to define the optimal dose for future use of ivermectin in combination
      with artemisinin-based combination therapy (ACT) for mass drug administration (MDA). It
      explores a research question of global relevance. A prolonged transmission blocking effect of
      ivermectin could have substantial consequences for malaria control in the next decades. The
      results are expected to inform national malaria control programs in malaria endemic
      countries, to inform WHO guidelines, and to contribute to the regulatory process.
    


Intervention name(s): ivermectin; placebo; dihydroartemisinin-piperaquine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo for ivermectin.
Intervention MeSH terms: Ivermectin; Piperaquine; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: malaria; plasmodium; dihydroartemisinin-piperaquine; ivermectin
Study to Evaluate the Safety of Lactobacillus Rhamnosus GG ATCC 53103 (LGG) in Elderly Subjects
Condition: Healthy; Elderly
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open label clinical trial to evaluate the safety of Lactobacillus
      rhamnosus GG (LGG) in elderly subjects. Lactobacilli are part of the normal flora of the
      intestine. LGG is one of several strains of Lactobacilli that is used as a probiotic or
      microorganism administered to confer "health benefits". Our research is focused on studying
      the possible therapeutic effects of LGG. The study hypotheses are:

        -  LGG administered twice daily will be safe and well tolerated in elderly subjects

        -  LGG will colonize the stool of elderly subjects and will modify the diversity and
           richness of the microbiota in their nasopharyngeal and stool specimens
    


Intervention name(s): Lactobacillus Rhamnosus GG, ATCC 53103 (LGG)
Intervention type(s): Biological
Intervention description(s): 1x10^10 CFU by mouth twice daily for 28 days
Other intervention name(s): Culturelle
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Probiotics; Safety; Elderly; Lactobacillus; LGG