bioihbjkbjnl/mcl2 huggingface dataset:
Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment
Condition: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Endothelial Dysfunction; Inflammatory Disease Activity
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      The aim of this study is to examine the associations between inflammatory disease activity
      and endothelial function in rheumatoid arthritis (RA) and spondyloarthritis patients treated
      with methotrexate and Tumor Necrosis Factor alpha (TNFalpha)inhibitor in combination or
      methotrexate or TNFalpha-inhibitor alone. Further, to look for improvement in endothelial
      function, and decrease in bone and cartilage destruction during treatment with the
      combination therapy of TNFalpha-inhibitor and methotrexate in RA and Psoriatic Arthritis
      (PSA) patients. Last, examine the TNFalpha inhibitors influence on endothelial function and
      levels of bone and cartilage markers in patients with Ankylosing Spondylitis (AS).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with RA and spondyloarthritis starting with either combination therapy of
        TNFalpha-inhibitor and methotrexate or methotrexate or TNFalpha-inhibitor alone, at
        Lillehammer Hospital for Rheumatic diseases.Decision about treatment modality will be based
        on conventional clinial judgement.
      
Biospecimen description: 
      Whole blood
    
Keywords: Endothelial dysfunction; Bone and cartilage markers; Inflammatory disease activity; Rheumatoid arthritis; Psoriatic arthritis; Ankylosing Spondylitis
Heart Rate Variability (HRV) Analysis in Patients With Nocturnal Epileptic Seizures
Condition: Heart Rate; Nocturnal Seizures; Autonomic Nervous System; Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Observational

Summary: 
      Epilepsy is disabling and costly to patients and the health service. Nearly 400,000 people in
      England suffer from epilepsy. About 40% of these patients are known to have seizures
      predominantly in sleep. All seizures pose risk to the individual both physical and
      psychological. Nocturnal seizures pose extra risk as the diagnosis may be missed or delayed.
      Patients with nocturnal seizures are also thought to be at particular risk of sudden
      unexpected death in epilepsy (SUDEP), especially if their seizures are unobserved. In
      patients with poor seizure control, the risk of SUDEP has been found to be as high as 9 per
      1,000 patient years. Previous studies show that many seizures are associated with changes in
      the Autonomic Nervous System (ANS) tone. The ANS tone can be assessed using heart rate
      variability parameters (HRV). A few studies suggest that ANS tone changes tend to precede the
      onset of epileptic seizure related surface electroencephalographic (EEG) changes, suggesting
      that ANS tone changes could be used in seizure alarm or intervention systems. This
      prospective study intends to focus on seizures from sleep and study HRV parameters in the
      immediate preictal state of the seizure and compare these with resting HRV parameters in the
      same patient with the aim of finding HRV metrics which could help to identify the presence of
      seizures in longterm electrocardiographic (ECG) recordings, or help predict seizure
      occurrence, or provide information about the current risk of seizures. This study will also
      investigate whether there are differences in the alterations of HRV parameters between
      different forms of epilepsy and whether seizure lateralisation has an impact on HRV
      parameters.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with epilepsy admitted for three- to five-day diagnostic or pre-surgery
        video-electro-encephalography and ECG (VT) monitoring in the video telemetry unit at the
        Royal Hallamshire Hospital in Sheffield will be recruited for the study.
Calcium Supplementation for a Healthy Weight-Lite (CaSHeW Lite)
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of the study is to find out if taking calcium and vitamin D supplements, while
      following a low-calorie diet, can help people lose weight.
    

Detailed description: 
      Recent studies suggest that calcium may be important for weight loss, but other studies have
      not had the same results. The purpose of the study is to find out if taking calcium and
      vitamin D supplements, while following a low-calorie diet, can help people lose weight.

      We will use special orange juice with less calories than regular orange juice. Half of the
      subjects in this study will drink the study juice (reduced-calorie orange juice) containing
      extra calcium and vitamin D. The other subjects will drink reduced-calorie orange juice
      without any extra calcium or vitamin D in it.

      Comparisons: We will compare subjects who follow the diet and take calcium and vitamin D
      supplements to those who only follow the diet.
    

Intervention name(s): Reduced energy (lite) OJ fortified with Calcium and Vitamin D; Nutrition Counseling; Reduced energy (lite) OJ without Calcium and Vitamin D
Intervention type(s): Dietary Supplement; Behavioral; Dietary Supplement
Intervention description(s): Three 240ml servings of lite OJ fortified with 350mg Ca and 100U VitD per day.; Individual and group nutritional counseling by a registered dietician.; Three 240ml servings of lite OJ without 350mg Ca and 100U VitD per day.
Other intervention name(s): Minute Maid Light Orange Juice; Minute Maid Light Orange Juice
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Calcium; Vitamin D; Weight Loss; Overweight; Obesity; Lite Orange Juice
The Effect of Conservative Interventions on the Signs and Symptoms of Diastasis Recti
Condition: Diastasis Recti And Weakness Of The Linea Alba
MeSH terms: Diastasis, Muscle
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of two different physiotherapeutic
      interventions (exercise therapy and/or abdominal binding) on the signs and symptoms of
      diastasis recti in post-partum women.
    

Detailed description: 
      This study is investigating the effect of exercise therapy and/or abdominal binding on
      inter-rectus distance, abdominal muscle strength and endurance, lumbopelvic dysfunction,
      urogynecological complaints, perceived function, and body image in post-partum women with
      diastasis recti
    

Intervention name(s): Exercise therapy; Abdominal binding
Intervention type(s): Other; Other
Intervention description(s): Supervised exercise therapy with a 12 week progressive abdominal exercise home program for; Wearing an abdominal binder for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: diastasis recti; physiotherapy; exercise therapy; abdominal binding
A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control
      of their blood sugar.
    


Intervention name(s): MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks; Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Irinotecan and Bortezomib in Children With Recurrent/Refractory Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase One pediatric trial seeks to take advantage of the susceptibility of neuroblastoma
      to proteasome inhibitors, proven in vitro, along with the proven in vitro synergy of
      bortezomib with irinotecan and the successful Phase One pediatric trials of bortezomib to
      create a treatment using these two drugs in combination to treat refractory/recurrent
      neuroblastoma in children and young adults 25 and under.
    

Detailed description: 
      In spite of intensive treatment including high-dose chemotherapy with autologous peripheral
      stem cell transplantation and radiation therapy, the long-term survival of patients with
      high-risk neuroblastoma remains poor. Patients who experience a relapse of their disease or
      fail to achieve complete remission fare even worse. More intense chemotherapy is not the
      answer. The development of new drugs with different mechanisms of action are required.

      Inhibitors of the proteasome have created a considerable interest in their use in cancer
      chemotherapy, either as a single agent or in combination with other chemotherapeutic agents.
      The precise mechanism of action for these class of drugs is unclear, however, inhibition of
      I-kB degradation by VELCADE® (bortezomib) decreases NF-kB activity in neuroblastoma cell
      lines as well as other systems.

      Previous studies have reported the activity of Irinotecan, a strong Topoisomerase-I
      inhibitor, against murine xenografts including those with high-risk features such as MYCN
      gene amplification (MYCN is also called V-Myc Myelocytomatosis Viral Related Oncogene,
      Neuroblastoma Derived). Irinotecan has also been shown to be active against neuroblastoma
      xenografts resistant to vincristine, melphalan, and topotecan, suggesting an alternative
      mechanism of resistance to Irinotecan. In vitro synergy between bortezomib and irinotecan has
      been documented in pancreatic cancer by others and in neuroblastoma by our group.
    

Intervention name(s): Irinotecan and Bortezomib
Intervention type(s): Drug
Intervention description(s): Dose level-1a: IV Irinotecan 30 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-1: IV Irinotecan 35 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-2: IV Irinotecan 40 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-3: IV Irinotecan 45 mg/m2/day, IV bortezomib 1.2mg/m2/day Dose level-4: IV Irinotecan 50 mg/m2/day, IV bortezomib 1.2mg/m2/day
Other intervention name(s): Velcade; Cefpodoxime; Cefixime
Intervention MeSH terms: Cefixime; Cefpodoxime; Irinotecan; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuroblastoma; Irinotecan; Bortezomib
Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis
Condition: HIV Infections
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate adherence and safety of three regimens of chemoprophylaxis for tuberculosis (TB)
      in HIV-infected patients with positive tuberculin skin test.
    

Detailed description: 
      DESINGS: We performed a randomised, comparative and open clinical assay carried out in 316
      HIV-infected patients. The patients were randomly assigned to one of three regimens, 108 to
      isoniazid for six months (6H), 103 to rifampin and isoniazid for three months (3RH), and 105
      to pyrazinamide and rifampin for two months (2RZ).

      RESULTS: The TB rates (cases per 100 persons/year) in the three treatment groups were 3.4 in
      6H, 4.5 in 3RH and 1.9 in 2RZ. The relative risk for TB with 6H as compared with 2RZ was
      1.76, and with 3RH, 2.34. Twenty-seven percent of the patients voluntarily abandoned
      chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects. Seven patients were
      withdraw due to hepatotoxicity (5 in 6H, 2 in 3RH and 0 in 2RZ). No appreciable differences
      were found among the three regimens.

      CONCLUSION: In our study the 2RZ regimen was as safe as the 6H and 3RH regimens. We have nor
      observed a higher incidence of hepatotoxicity in patients who received 2RZ.
    

Intervention name(s): isoniazid, rifampin + isoniazid or rifampin + pyrazinamide
Intervention type(s): Drug
Intervention MeSH terms: Rifampin; Isoniazid; Pyrazinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Tuberculosis; Prophylaxis; AIDS
First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes
Condition: Kidney Diseases; Diabetic Nephropathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Overweight; Diabetes Complications; Endocrine System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy.
      This study is the first time GFB-024 has been used in humans. The first part of the study
      will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers
      and the effect of GFB-024 on the body as compared to an inactive placebo medication. The
      second part of the study will assess the safety of repeated doses of GFB-024 in participants
      with Type 2 diabetes and the effect of GFB-024 on the body as compared to an inactive placebo
      medication.
    

Detailed description: 
      This is a first-in-human study. It is intended to provide the initial safety,
      pharmacokinetics (PK), and pharmacology data for GFB-024 in humans. This study will comprise
      a single ascending dose (SAD) escalation component in healthy overweight and obese volunteer
      participants and a repeat-dose component to confirm repeat-dose safety, tolerability, PK, and
      immunogenicity in participants with Type 2 diabetes mellitus. It will also explore potential
      cannabinoid-1 receptor (CB1) activity, participant selection, pharmacodynamics, and
      differential response biomarkers.
    

Intervention name(s): GFB-024; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody; Matched placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Community Trial of Newborn Skin and Umbilical Cord Cleansing on Neonatal Mortality in Nepal
Condition: Neonatal Mortality
Study type: Interventional
Phase: Phase 3

Summary: 
      Neonatal mortality and morbidity is common in Nepal and the vast majority of women deliver
      babies at home without a skilled birth attendant.

      The purpose of this project is two-fold: 1) to evaluate whether washing a newborn child with
      a dilute antiseptic solution soon after birth can reduce mortality in the first 4 weeks of
      life and 2) to evaluate whether cleaning the umbilical cord and stump with either soap and
      water or an antiseptic solution for the first few days of life can reduce umbilical cord
      infections.
    

Detailed description: 
      While significant progress has been made in reducing preschool child mortality in developing
      countries over the past 20 years, much less progress has been made in reducing neonatal
      mortality and morbidity. Neonatal mortality rates are high in Nepal; a significant proportion
      of which are due to sepsis. In addition, the vast majority of women deliver babies at home
      without a skilled birth attendant and early neonatal care is routinely used in rural areas.
      Previous hospital-based research in Malawi suggested that newborn cleansing with a dilute
      chlorhexidine solution could reduce early infant mortality. This project evaluates the use of
      a simple intervention at the community level and the impact on neonatal mortality.

      Comparisons: Two nested community-based randomized trials are being conducted. The first
      compares the neonatal mortality rates between newborn infants randomized to receive a whole
      body skin cleansing soon after birth with baby wipes impregnated with 0.25% chlorhexidine
      compared with newborns cleaned with baby wipes with a placebo solution. The second trial
      compares the rates of umbilical cord infections among children assigned to three groups:

        -  education of the mother on clean cord care alone;

        -  education of the mother plus routine washing of the cord and stump with soap and water
           solution for the first 10 days of life; -OR-

        -  education of the mother plus routine washing of the cord and stump with a 4%
           chlorhexidine solution.

      Enrolled infants are visited on a regular basis during the first month of life to record
      vital status and grade the cord for signs of infection.
    

Intervention name(s): Newborn skin cleansing with 0.25% chlorhexidine solution; Cleansing of umbilical cord with soap and water solution; Cleansing of umbilical cord with 4% chlorhexidine
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: neonatal mortality; chlorhexidine; newborn cleansing; umbilical cord care; community-based trial; prevention trial; omphalitis
Impulsivity and Parkinson's Disease : a Neuropsychology With Magnetic Resonance Imaging Study
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Impulsive Behavior
Study type: Interventional

Summary: 
      This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).
    


Intervention name(s): magnetic resonance imaging
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section.
Condition: Cesarean Section
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to investigate whether dexmedetomidine used in the
      perioperative period of elective cesarean section can improve maternal mood, improve
      analgesic effect, improve maternal recovery quality, and then make the breastfeeding
      better.At the same time, this experiment attempts to explore the optimal dose of
      dexmedetomidine to produce the above effect.
    

Detailed description: 
      After obtaining the informed consent, parturients were randomly divided into two groups
      according to the computer-generated random number table, namely, dexmedetomidine group and
      the control group.Spinal anesthesia is administered to all maternal women undergoing elective
      cesarean delivery. Immediately after the umbilicus is cut, the infusion of the experimental
      drug was started until the end of the operation, and the PCIA pump with the study medication
      is used during 2 days postoperatively.Continuous follow-up for three days after
      surgery.Follow-up personnel recorded LATCH score, VAS score, quality-of-recovery score and
      other indicators.In the 6th week after caesarean section, the outcome indicators were
      collected by electronic questionnaire and telephone follow-up.This randomized controlled
      trial is aims to prove that dexmedetomidine, used in parturient with elective cesarean
      section, can improve maternal mood and prolong the duration of breastfeeding.
    

Intervention name(s): dexmedetomidine group; control group
Intervention type(s): Drug; Drug
Intervention description(s): After the fetus was delivered, low-dose dexmedetomidine intraoperative infusion, postoperative low-dose dexmedetomidine patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min).; After the fetus was delivered, saline intraoperative infusion, postoperative patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min) without dexmedetomidine.
Other intervention name(s): D group; C group
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cesarean Section; Dexmedetomidine; Breast Feeding; Recovery quality
Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis
Condition: Allergic Bronchopulmonary Aspergillosis
MeSH terms: Aspergillosis; Pulmonary Aspergillosis; Aspergillosis, Allergic Bronchopulmonary
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a research project to evaluate the efficacy and safety of two different treatment
      protocols in Allergic bronchopulmonary Aspergillosis.
    

Detailed description: 
      Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex
      hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. The
      management of ABPA includes two important aspects - institution of immunosuppressive therapy
      in the form of glucocorticoids to control the immunologic activity, and close monitoring for
      detection of relapses. Another possible target is to use antifungal agents to attenuate the
      fungal burden secondary to the fungal colonization in the airways. Oral corticosteroids are
      currently the treatment of choice for ABPA associated with bronchial asthma.They not only
      suppress the immune hyperfunction but are also anti-inflammatory. However, there is no data
      to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids
      have been used in literature.Itraconazole, an oral triazole with relatively low toxicity, is
      active against Aspergillus spp. in vitro and in vivo. The activity of itraconazole against
      Aspergillus spp. is more than that of ketoconazole. The administration of itraconazole can
      eliminate Aspergillus in the airways and can theoretically reduce the allergic responses in
      ABPA. The new triazoles, such as voriconazole, have recently been found effective in the
      treatment of fungal infections. The investigators hypothesize that voriconazole might also be
      useful in the treatment of ABPA. The aim of this prospective randomized controlled trial
      (RCT) is to evaluate the efficacy and safety of voriconazole therapy in patients with ABPA.
    

Intervention name(s): Prednisolone; Voriconazole
Intervention type(s): Drug; Drug
Intervention description(s): Prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma; Voriconazole 200 mg BD for 4 months. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma
Other intervention name(s): Voritek 200 mg twice daily for four months
Intervention MeSH terms: Voriconazole; Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment