bioihbjkbjnl/mcl2 huggingface dataset:
Functional Disorders of the Musculoskeletal System in People With Multiple Sclerosis
Condition: Multiple Sclerosis; Rehabilitation; Musculoskeletal Complication
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The randomized controlled trial is aimed to study the efficacy of treatment approaches based
      on developmental kinesiology models and its impact on balance, gait and mobility in people
      with mild to severe multiple sclerosis (pwMS). The main goal is to compare two out-patient
      physiotherapeutic methods, that will be attended 1-hour twice a week for one month and once a
      week for next two months (16 therapies in total). The efficacy will be assessed by a blinded
      independent clinical examiner using clinical examination and questionnaire survey one month
      before the therapy programme, immediately before and after the therapy and two months after
      termination of the therapy.
    

Detailed description: 
      The participants were randomly divided into two groups for three-month outpatient
      physiotherapeutic programme.

      One group obtained treatment by MFK Method (Manual physiotherapeutic correction) and the
      second by DNS (Dynamic Neuromuscular Stabilization ). Both treatment methods were developed
      in the Czech Republic. All participants attended 1-hour MFK Method or DNS twice a week for
      one month and once a week for next two months (16 therapies in total).

      The participants were examined three times - before the start of the physiotherapy program,
      immediately after its completion and six months apart.
    

Intervention name(s): Manual physiotherapeutic correction (MFK) Method; Dynamic Neuromuscular Stabilization (DNS) Method
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients undergo ambulatory physiotherapy :1-hour duration, twice a week for one month and once a week for next two months (16 therapies in total). Therapy was undertaken at the ambulatory section of the Department of Neurology, Kralovske Vinohrady University Hospital in Prague.; Patients undergo ambulatory physiotherapy :1-hour duration, twice a week for one month and once a week for next two months (16 therapies in total).Therapy was undertaken at the Department of Rehabilitation and Sport Medicine, Motol University Hospital.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Developmental kinesiology; Physiotherapy; Muscle imbalance; Musculoskeletal disorders
Laparoscopic Total Fundoplication for Duodenogastroesophageal Reflux
Condition: Duodenogastric Reflux
MeSH terms: Gastroesophageal Reflux; Duodenogastric Reflux
Study type: Observational

Summary: 
      After laparoscopic total fundoplication (LTF) 12-15% of patients have persistent reflux
      symptoms and 20-25% develop gas-related symptoms. Reflux symptoms, gas bloating and inability
      to belch occurring after surgery have been associated with mixed (acid and weakly acid) (MR)
      or weakly acidic reflux (WAR). To date, few studies have evaluated functional outcome after
      LTF in patients with MR or WAR, with the majority reporting only short-term results.

      It has been shown that delayed gastric emptying (DGE) might also be an important factor for
      abdominal distension and adverse outcome after LTF.9,10 However, the correlation between poor
      long-term outcome after LTF and DGE is controversial. In addition, the effect of DGE in
      patients with MR or WAR is poorly investigated.
    

Detailed description: 
      In the last years the study of gastro-oesophageal reflux has been revolutionized by the
      development of combined 24-h esophageal pH and multichannel intraluminal impedance (MII)
      monitoring.

      Combined esophageal MII and pH-monitoring allow for the timed correlation of esophageal pH
      changes with reflux events and achieve high sensitivity for the detection of acid (pH <4),
      weakly acidic (pH 4-7) and weakly alkaline (pH >7) reflux episodes. Use of this technology is
      bringing into focus the potential role of weakly acidic and weakly alkaline reflux in
      symptoms that persist despite acid suppressive therapy or anti-reflux surgery.
    

Intervention name(s): laparoscopic total fundoplication
Intervention type(s): Procedure
Intervention description(s): LTF was performed using a standard five-trocar technique in all cases and carried out by two expert surgeons who had previously performed more than 50 laparoscopic fundoplications. A floppy 360° total fundoplication of 2-2,5 cm was constructed after full esophageal mobilization and posterior crural repair with nonabsorbable sutures.
Other intervention name(s): Laparoscopic Nissen fundoplication; Laparoscopic 360° degree fundoplication
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Between June 2002 and June 2007 188 patients with MR and WAR underwent LTF; 172 (91.5%)
        completed the 5-year protocol. Among them, forty-two (24.4%) had preoperative moderately
        delayed GE (DGE).
      
Keywords: Duodenogastroesophageal reflux; Weakly acidic reflux; Gastric emptying; Laparoscopic fundoplication
Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women
Condition: Postmenopause
Study type: Observational

Summary: 
      The purpose of this study is to determine bioequivalence and bioavailability of four
      different Premarin/MPA test formulations versus the current formulation for Prempro.
    


Intervention name(s): Premarin
Intervention type(s): Drug
Intervention MeSH terms: Estrogens, Conjugated (USP)
Observational model: Defined Population
Time perspective: Other
Keywords: bioavailability; bioequivalence; marketed product; Premarin; Medroxyprogesterone acetate; MPA; Postmenopausal; vasomotor symptoms
Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
Condition: Cardiovascular Disorder; Diabetes Mellitus
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy of switching to a combination tablet
      ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose
      in those patients who have cardiovascular disease and diabetes mellitus not adequately
      controlled on simvastatin 20 mg or atorvastatin 10 mg.
    


Intervention name(s): ezetimibe (+) simvastatin; simvastatin 40 mg or atorvastatin 20 mg; Rosuvastatin; atorvastatin 10 mg or simvastatin 20 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.; simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.; rosuvastatin 10 mg tablets, taken once daily for six weeks.; All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.
Other intervention name(s): Vytorin; Lipitor, Zocor; Crestor; Lipitor, Zocor
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cardiovascular disorder
Nutritional State and Intake Nutrients Assessment in Ulcerative Colitis
Condition: Ulcerative Colitis in Remission
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      The purpose of this study is to determine the reason patients are deficient in nutrients
      intake such as antioxidants vitamins.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with Ulcerative Colitis in remission
      
Biospecimen description: 
      Serum
    
Keywords: nutritional state; nutrients intake; ulcerative colitis
Effect of Mental Stress on Platelet Function in Healthy Subject
Condition: Healthy
MeSH terms: Stress, Psychological
Study type: Observational

Summary: 
      Psychological stress is an independent cardiovascular risk factor. Activation of platelets
      plays an important role in atherosclerosis development and it could one of the mechanisms
      linking psychological stress and cardiovascular diseases
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy subjects, aging 18-80 years
      
Keywords: mental stress; cardiovascular risk factor; platelet adhesion
Evaluation of SARS-COV-2 Viral Load of Covid-19 Patients After Rinsing With Oral Antimicrobial Mouthwashes
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The aim of this study is to analyze the efficacy of oral disinfection with 0.075%
      Cetylpyridinium Chloride alone and 0.075% Cetylpyridinium Chloride associated with 0.28% zinc
      lactate in reduction of the viral load of SARS-CoV-2 in the oral cavity. Patients of both
      sexes, in the age-range between 18 and 90 years, diagnosed positive for SARS-CoV-2 by the
      RT-PCR method, and who demand oral hygiene care and other preventive and therapeutic dental
      procedures, will be included in this randomized clinical study.The study will comprise
      patients hospitalized in common beds, without mechanical ventilation - who will be divided
      into three groups. Some of these protocols with the use of antimicrobial solutions are hoped
      to be efficient in reducing the viral load in the oral cavity. This is a factor that could
      contribute to reducing contamination of the environment caused by aerosols resulting from
      dental procedures, in addition to helping with the improvement in biosafety protocols against
      SARS-CoV-2.
    

Detailed description: 
      Each group of patients will receive specific interventions, as follows: 0.075%
      Cetylpyridinium Chloride mouthwash (Group 1); 0.075% Cetylpyridinium Chloride associated with
      0.28% zinc lactate mouthwash (Group 2), negative control, distilled water (Group 3). To
      monitor the viral load, the following procedures will be performed: saliva collection, in
      time intervals before mouth rinsing with the solutions at baseline (T0), immediately after
      (T1), 30 min (T2), and 1 hour after mouth rinses (T3). SARS-CoV-2 will be quantified by Real
      Time quantitative reverse transcription polymerase chain reaction (RT-qPCR) assays.
    

Intervention name(s): CPC+ZN; CPC; Negative Control
Intervention type(s): Other; Other; Other
Intervention description(s): In patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of the solution for 30 s; In patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of the proposed solution for 30 s;; In patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of distilled water for 30 s.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
A Study to Evaluate the Efficacy and Safety of ALH-L1005 in Patients With Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients
      with chronic periodontitis
    


Intervention name(s): ALH-L1005 600mg/day; ALH-L1005 1,200mg/day; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ALH-L1005 300mg 2 tablet and placebo 2 tablet; ALH-L1005 300mg 4 tablet; Placebo 4 tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: periodontitis
Associations Between Depression and Cardiovascular Disease - a Study of Patients With Late Onset Depression
Condition: Depression; Major Depressive Disorder; Cardiovascular Disease; Coronary Artery Disease
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      Studies show that depression is a risk factor for the development of coronary artery disease
      (CAD). Furthermore there is an increased occurrence of depression in patients with CAD. Among
      other mechanisms atherosclerosis is believed to play a central role regarding these notable
      associations between depression and CAD. Moreover, patients with late onset major depression
      have an increased number of small lesions found in the white matter of the brain, the
      so-called white matter lesions. The main goal of this project is to examine if CAD is
      associated with depression and/or white matter lesions. CAD is evaluated using coronary CT
      angiography. Depression is evaluated using a semi-structured diagnostic interview. White
      matter lesions are quantified using cerebral magnetic resonance.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Psychiatric treatment facilities (e.g. psychiatric hospital, private psychiatrist).
      
Biospecimen description: 
      Whole Blood
    
Keywords: Depression; Major depressive disorder; Coronary artery disease; White Matter Hyperintensities; White Matter Lesions; Coronary artery calcification
The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
Condition: Multi-drug Resistant Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant
Study type: Interventional
Phase: Phase 4

Summary: 
      WHO has recommended that multidrug-resistant tuberculosis (MDR-TB, defined as resistance to
      at least isoniazid (H) and rifampicin (R) be addressed as a public health crisis and enhance
      capacity to deliver effective treatment and care. According to the 2018 WHO TB Report, the
      overall treatment success rate of MDR-TB is 55% while much lower in China at just only 41%
      with the 24-month regimen. In order to further verify the safety and efficiency of optimizing
      shorter 18-month regimen containing 6 anti-TB drugs with MDR-TB patients,500 more patients
      will be enrolled and observed.
    

Detailed description: 
      1. Design: the study is a multi-center,open, single arm trial.

        2. Population:patients with sputum culture positive and confirmed as MDR-TB via drug
           resistance of isoniazid(H),rifampicin(R),ethambutol(E)and pyrazinamide or patients with
           GeneXpert confirmed RR-TB.

        3. Investigational regimen:3Am-Mfx-PZA-X-Y-Z/3Am3-Mfx-PZA-X-Y-Z/12 Mfx-PZA-X-Y-Z.X、Y、Z are
           the drugs susceptible or possibly susceptible to mycobacterial bacilli(The candidated
           drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium
           para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid).The
           abbreviation of the name of the 3 drugs in the regimen is explained as follows:
           PZA-pyrazinamide，Am-Amikacin，Mfx-moxifloxacin）and the total duration of the regimen is
           18 months.

        4. Primary and secondary outcome measures:

           The primary outcome measures include 1.the treatment success rate.2. Death rate.

           The secondary outcome measures include 1.sputum conversion rate at the end of month 2,
           month 3,intensive phase of 6 months and treatment completion of all enrolled
           patients.2.Frequency of adverse drug reaction occurring during treatment.3.Radiological
           manifestation change of TB lesion or cavity during treatment.

        5. Sample size: 500 eligible patients will be enrolled.
    

Intervention name(s): 18-month regimen containing 6 anti-TB drugs
Intervention type(s): Drug
Intervention description(s): Investigational regimen:3Am-Mfx-PZA-X-Y-Z/3Am3-Mfx-PZA-X-Y-Z/12 Mfx-PZA-X-Y-Z.X、Y、Z are the drugs susceptible or possibly susceptible to mycobacterial bacilli(The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid).The abbreviation of the name of each drug in the regimen is explained as follows: PZA-pyrazinamide，Am-Amikacin，Mfx-moxifloxacin）and the total duration of the regimen is 18 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Vitamin D in Parkinson's Disease (PD)
Condition: Parkinson Disease; Accidental Falls
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls,
      strength, and cognition in persons with Parkinson's disease.
    

Detailed description: 
      The proposed study is a randomized, double-blinded, placebo controlled intervention trial to
      measure the effects of vitamin D at (10,000IU/day) versus placebo on balance and falls in
      Parkinson's disease. The investigators will measure static, dynamic, and ambulatory balance,
      as well as strength, falls, and cognition before and after 16 weeks of therapy. Dynamic
      posturography will be used to measure static and ambulatory balance, a device called
      iMOBILITY will measure a timed up and go, and strength will be measured with the Biodex
      machine checking knee flexion and extension. Multiple quality of life and cognitive tests
      will also be performed.
    

Intervention name(s): Vitamin D3; calcium; Placebo
Intervention type(s): Drug; Dietary Supplement; Other
Intervention description(s): Vitamin D3 at 10,000 IU a day; 1000mg calcium daily; A placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D; Parkinson disease; accidental falls
Revatio Special Investigation for Long-term Use in Pediatric Patients
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension
Study type: Observational

Summary: 
      Secondary data collection study: safety and effectiveness of Revatio in pediatric patients
      under Japanese medical practice
    

Detailed description: 
      The objective of this study is to obtain the information on dosage and administration,
      safety, and efficacy of Revatio when it is administered for a long period of time (1 year)
      under the actual use after the approval of the dosage and administration in pediatric
      patients (aged 1 year or older, weighed 8 kg or more) .
    

Intervention name(s): Sildenafil
Intervention type(s): Drug
Intervention description(s): [REVATIO® Tablets / REVATIO® OD Film] Adults Usually, sildenafil 20 mg is orally given three times daily. Children aged 1 year or older In children weighing 20 kg or more: Usually, sildenafil 20 mg is orally given three times daily.
[REVATIO® Dry Syrup for Suspension] Adults Usually, sildenafil 20 mg is orally given three times daily. Children aged 1 year or older In children weighing 8 kg or more but less than 20 kg: Usually, sildenafil 10 mg is orally given three times daily.
In children weighing 20 kg or more: Usually, sildenafil 20 mg is orally given three times daily.
Intervention MeSH terms: Sildenafil Citrate
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients aged 0 to under 15 years who were confirmed to have received Revatio
        after the approval date of dosage and administration of Revatio for pediatric patients
      
Keywords: Revatio; Pulmonary arterial hypertension; Pediatric patients
Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study
Condition: Neonatal Seizures
MeSH terms: Seizures
Study type: Observational

Summary: 
      The purpose of this study is to examine whether the duration of treatment with phenobarbital
      has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family
      well-being, after neonatal seizures.
    


Intervention name(s): Surveys; EEG
Intervention type(s): Other; Other
Intervention description(s): Regarding development, epilepsy, and family impact
Other intervention name(s): Former Neonatal Seizure Registry Subjects
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Newborns with seizures who were admitted at one of the participating children's hospitals
      
Keywords: Phenobarbital; EEG; family impact; neurodevelopment
A Single Dose Study Of PF-04620110 In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The
      primary purpose of this trial is to evaluate the relative bioavailability of three different
      oral dose formulations of PF-04620110.
    


Intervention name(s): PF-04620110
Intervention type(s): Drug
Intervention description(s): The five treatments are:
A) single dose of 5 mg immediate release tablets in the fasted state; B) single dose of 5 mg modified release osmotic capsule with a short duration of modified release 1 (MR1) in the fasted state; C) single dose of 5 mg modified release osmotic capsule with a long duration of modified release 2 (MR2) in the fasted state; D) single dose of 5 mg modified release osmotic capsule with a short duration of modified release 1 (MR1) in the fed state; E) single dose of 5 mg modified release osmotic capsule with a long duration of modified release 2 (MR2) in the fed state.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Single Dose Study in Healthy Subjects
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of
      TEV-48125 (at 225 mg once monthly [except for a loading dose of 675 mg for CM patients] or at
      675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine
      patients
    


Intervention name(s): TEV-48125; TEV-48125
Intervention type(s): Drug; Drug
Intervention description(s): TEV-48125 will be administered subcutaneously once every 4 weeks.; TEV-48125 will be administered subcutaneously once every 12 weeks.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment