bioihbjkbjnl/mcl2 huggingface dataset:
Concentrated Platelet Rich Fibrin (C-PRF) as Adjunct to Non-surgical Periodontal Therapy
Condition: Periodontal Pocket
MeSH terms: Periodontal Pocket
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is a prospective randomised split mouth study to evaluate the effect of
      concentrated Platelet Rich Fibrin as an adjunct to the scaling and root planing
    

Detailed description: 
      Twelve healthy individuals satisfying the inclusion and exclusion criteria were recruited for
      the study. A detailed, thorough medical and dental history was obtained and each patient was
      subjected to comprehensive clinical and radiological examination. All patients were informed
      about the nature of the study, procedure involved, potential benefits and risks associated
      with procedure and written informed consent were obtained from all patients.

      All the patients underwent scaling and root planing. As it is split mouth study design the
      test site is treated with Concentrated platelet rich fibrin( C-PRF) and the contralateral
      site is not treated with C-PRF. Periodotal pack was placed and patient was recalled after 6
      weeks for the follow up.
    

Intervention name(s): C-PRF
Intervention type(s): Biological
Intervention description(s): thorough scaling and root planing is performed followed by withdraw of 5ml of blood from antecubital vein of patient with consent . Following C-PRF protocol of 3000rpm for 8 min centrifugation is performed. 1ml of plasma is drawn from the test tube just above the red blood cell layer and allowed to clot and the formed clot is placed in the periodontal pocket after scaling and root planing
Other intervention name(s): Concentrated platelet rich fibrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the effect of ISIS 757456 (IONIS-AGT-LRx) on plasma angiotensinogen
      (AGT) and systolic blood pressure (SBP) in uncontrolled hypertensive participants who were on
      two to three antihypertensive medications.
    

Detailed description: 
      This study was a Phase 2, double-blind, randomized, placebo-controlled study in 26
      participants. Participants were randomized in a 2:1 ratio and received a once-weekly
      subcutaneous (SC) treatment with either IONIS-AGT-LRx or placebo, with an additional loading
      dose administered on Study Day 3. The treatment lasted for 8 weeks and the post-treatment
      period lasted for 13 weeks.
    

Intervention name(s): Placebo; ISIS 757456
Intervention type(s): Drug; Drug
Intervention description(s): ISIS 757456-matching placebo solution administered as SC injection.; ISIS 757456 administered as SC injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Hypertensive; AGT; Angiotensinogen; Blood Pressure
Efficacy of Fractional Carbon Dioxide Laser Combined With Platelet-rich Plasma
Condition: Striae Gravidarum
MeSH terms: Striae Distensae
Study type: Interventional
Phase: Phase 3

Summary: 
      This study determined the efficacy of ablative fractional carbon dioxide laser combined with
      autologous platelet-rich plasma versus ablative fractional carbon dioxide laser with placebo
      in the treatment of striae gravidarum of postpartum Filipino women.
    


Intervention name(s): Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma; CO2 laser with PRP; CO2 laser with placebo
Intervention type(s): Procedure; Device; Device
Intervention description(s): Carbon dioxide laser (Smaxel.878.4810) was FDA-approved device used in dermatology practice. PRP was described as having growth factors to be used to promote healing.; CO2 laser with PRP; CO2 laser with placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Striae Gravidarum; carbon dioxide laser; platelet-rich plasma
Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome; Abdominal Pain
MeSH terms: Irritable Bowel Syndrome; Syndrome; Abdominal Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a specific diet may help children with
      irritable bowel syndrome.
    

Detailed description: 
      Many children experience stomach pain or discomfort at some point during their lives. Some
      children have belly discomfort frequently while others rarely have this problem. There have
      been very few studies to test treatments for recurrent stomach discomfort in children.
      Recently, studies in adults with recurrent stomach discomfort suggest that diet changes may
      help. Currently, we do not know if these same diets will work in children with the same
      problem.

      In this study, two different diets will be provided (delivered) for two days with at least 5
      days in between each provided diet. The child's symptoms will be recorded over the two days
      of each diet. Children will be asked to capture samples of their breath during the last day
      of the each two day delivered diet. Stool samples will also be collected.
    

Intervention name(s): Low fermentable substrate diet; High fermentable substrate diet
Intervention type(s): Other; Other
Intervention description(s): Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.; Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: irritable bowel syndrome; children; chronic abdominal pain; recurrent abdominal pain
Safety and Blood Immune Cell Study of Anakinra Plus Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety of administering anakinra plus the physician's chemotherapy choice
      (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with metastatic
      breast cancer (MBC), as well as determining blood immune cell transcriptional signatures in
      patients who undergo IL-1 receptor blockade.
    

Detailed description: 
      In an attempt to reverse the immune suppressive microenvironment and to enhance chemotherapy
      effectiveness, decrease tumor metagenicity and decrease IL-1-induced fatigue, metastatic
      breast cancer (MBC) patients will be treated with chemotherapy plus anakinra. This is a pilot
      safety, single arm, open label trial. The objective is to determine the safety of anakinra
      plus the physician's chemotherapy choice (TPC) of nab paclitaxel, capecitabine, eribulin, or
      vinorelbine in patients with MBC and to define an anakinra-induced anti-IL-1 whole blood
      transcriptional profile.
    

Intervention name(s): Anakinra plus Standard of Care
Intervention type(s): Drug
Intervention description(s): Patients will undergo a 2-week run-in treatment of daily anakinra alone. This will be followed by daily anakinra (100 mg SC) plus the physician's chemotherapy ( TPC) choice of standard of care (SOC) for a maximum of 6 months.TPC choice includes nab paclitaxel (100 mg/m^2 Intravenous on day 1,8 &15 of a 28 day cycle), or capecitabine (1000mg/m^2 per oral; BID choice: 14 days on, 7 days off OR 7 days on, 7 days off of a 21 day cycle), or eribulin (1.4 mg/m^2 intravenous on day 1 & 8 of a 21 day cycle), or vinorelbine (25mg/m^2 on day 1,8,15 of a 28 day cycle). After 6 months, patients may continue their SOC treatment alone until disease progression or intolerable toxicity.
Other intervention name(s): Anakinra: kineret; Nab paclitaxel: Abraxane; Capecitabine: Xeloda; Eribulin: Halaven; Vinorelbine: Navelbine
Intervention MeSH terms: Paclitaxel; Vinorelbine; Capecitabine; Interleukin 1 Receptor Antagonist Protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anakinra; Nab Paclitaxel; Capecitabine; Eribulin; Vinorelbin
iFuse Implant System® Minimally Invasive Arthrodesis
Condition: Sacroiliac Joint Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint
      pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative
      management of the SI joint
    

Detailed description: 
      This study is a multicenter randomized controlled, post-market clinical follow-up clinical
      trial of the iFuse Implant System for SI joint fusion vs. conservative management. Subjects
      assigned to conservative management may cross over to iFuse after a minimum of 6 months of
      conservative treatment. Conservative management does not include interventional procedures
      such as prolotherapy, steroid injections and/or RF ablation.
    

Intervention name(s): iFuse Implant System; Conservative Management
Intervention type(s): Device; Other
Intervention description(s): Placement of iFuse implant system via surgery; Medications for pain, physical therapy, cognitive behavour therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Cladribine Tablets on the PK of Microgynon®
Condition: Relapsing Multiple Sclerosis (RMS)
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the potential effects of cladribine on the
      pharmacokinetics (PK) of monophasic oral contraceptive microgynon® by assessment of its
      constituents, ethinyl estradiol (EE) and levonorgestrel (LNG).
    


Intervention name(s): Cladribine; Placebo; Microgynon®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive cladribine once-daily for 5 consecutive days in treatment period 1 and 2.; Participants will receive placebo matched to cladribine once-daily for 5 consecutive days in treatment period 1 and 2.; Participants will receive Microgynon® tablet once daily for 21 days in treatment period 1 and 2.
Intervention MeSH terms: Cladribine; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Multiple Sclerosis; Cladribine; Microgynon®
Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus
Condition: Pemphigus Disease
MeSH terms: Pemphigus
Study type: Interventional
Phase: Phase 3

Summary: 
      Pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5
      and 10 percent depending on the severity of disease and age of patients.

      The standard of care is high doses of corticosteroids (CS) (usually, prednisone, 1 to 1.5.
      mg/kg/day, which are often associated with immunosuppressive drugs i.e., azathioprine,
      mycophenolate mofetil, cyclophosphamide, cyclosporine, although only one randomised study has
      demonstrated the superiority of the combination of corticosteroids and immunosuppressive
      drugs as compared to corticosteroids alone (9). Because of the low frequency of the disease,
      control trials are difficult to conduct. Evaluation of the different treatment regimens
      proposed, i;e; corticosteroids alone, CS and immunosuppressive drugs, IV immunoglobulins or
      new therapeutic regimens such as rituximab (an anti-CD20 monoclonal antibody directed against
      B- lymphocytes) or immunoadsorbtion.
    


Intervention name(s): General Corticotherapy; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): for patients with severe pemphigus : general corticotherapy Arm : 1.5mg/kg/d for 1 month, then 1.25mg/kg/d for 1 month, then 1mg/kg/d for 1 month, then 0.75 mg/kg/d for 1 month, then 0.5 mg/kg/d for 3 months, then 0.3 mg/kg/d for 3 months, then 0.2 mg/kg/d for 4 months, then 0.1 mg/kg/d for 4 months, for patients with moderated pemphigus : general corticotherapy Arm : 1mg/kg/d for 1 month, then 0.75mg/kg/d for 1 month, then 0.5mg/kg/d for 2 months, then 0.3 mg/kg/d for 2 months, then 0.2 mg/kg/d for 3 months, then 0.1 mg/kg/d for 3 months,; for patients with severe pemphigus : rituximab Arm : 1mg/kg/d for 1 month, then 0.75 mg/kg/d for 1 month, then 0.5 mg/kg/d for 1 month, then 0.3 mg/kg/d for 1 month, then 0.2 mg/kg/d for 1 month, then 0.1 mg/kg/d for 1 month for patients with moderated pemphigus : rituximab Arm : 0.5mg/kg/d for 1 month, then 0.30 mg/kg/d for 1 month, then 0.2 mg/kg/d for 1 month,
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Corticothérapy; Rituximab; therapeutic efficacity; therapeutic tolerance
Patch Test of Benzalkonium Chloride Disinfectant Spray
Condition: Wound Healing
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the irritation potential of benzalkonium chloride
      disinfectant spray when placed in contact with normal human skin.
    

Detailed description: 
      Benzalkonium chloride is recognized as safe and effective for short term use as first aid
      antiseptic drug products. In this study, benzalkonium chloride disinfectant spray will be
      compared to a positive control, and two negative control for irritancy potential on normal
      skin according to Chinese Patch Test Guideline (China Health Authority 2002). The skin
      irritation assessment will characterize the test products individually in terms of
      symptomatology using a 5-point categorical scale ranging from 0 (no visible reaction) to 4
      (Erythema,edema˛ extreme blistering).
    

Intervention name(s): 0.13% Benzalkonium Chloride; SLS Solution; Normal Saline Water; Empty Finn Chamber
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Finn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution; Finn Chamber filled with SLS (0.3% w/v) water solution; Finn Chamber filled with Normal Saline water (0.9% w/v); Empty Finn Chamber
Intervention MeSH terms: Benzalkonium Compounds
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study
Condition: Ketone Body Metabolism; Brain Metabolism
Study type: Interventional

Summary: 
      This project tend to investigate the affection of ketone bodies on brain metabolism. This
      will be done by measuring human cerebral uptake of energy substrates, together with
      functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia in
      healthy subjects by ketone infusion.

      Hypotheses

        1. Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake
           by brain cells contributing to hyperglycaemia.

        2. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood
           flow.

        3. Altered oxygen consumption during hyperketonemia in healthy subjects.
    


Intervention name(s): ketone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3-OHB is infused intravenously.; Saline infusion.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Differential Diagnostics of Etiology of Acute Infections
Condition: Intestinal Infectious Diseases; Neuroinfections
MeSH terms: Infections; Communicable Diseases
Study type: Observational

Summary: 
      Method for diagnostics of the origin of infections (bacterial vs viral) based on the
      identification of activation markers of blood neutrophils and monocytes will be developed.
    

Detailed description: 
      During the study, method for diagnostics of the origin of infections (bacterial vs viral)
      based on the identification of activation markers of blood neutrophils and monocytes will be
      developed.This method will allow to make a diagnosis within an hour after blood sampling.

      The expression of the following markers of activation will be studied using flow cytometry:
      CD11b, CD11c, CD13, CD16, CD32, CD35, CD38, CD62L, CD64, CD66b, CD88, CD284, HLA-ABC and
      HLA-DR.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to the infectious departments of city hospitals.
      
Biospecimen description: 
      Whole blood
    
Keywords: acute Infections, flow cytometry, cell activation
Walking Aids in the Management of Knee Osteoarthritis
Condition: Obesity; Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether the single point cane will relieve pain and
      disability in overweight or obese people with knee OA through altered joint biomechanics and
      what factors influence acceptance of cane use.
    

Detailed description: 
      Knee OA is an important cause of disability and falls in overweight or obese individuals and
      limits their attempts at exercise and subsequent weight loss. Walking aids such as canes have
      been recommended in the management of knee OA in order to decrease pain by reducing loading
      across the knee and to increase physical activity. Little information is available regarding
      the impact of walking aids on psychosocial function and quality of life in individuals with
      limited mobility. No randomized controlled trials have studied the efficacy of walking aids
      on quality of life, pain, and function in overweight or obese individuals with symptomatic
      knee OA (5,6). The proposed research will evaluate the effects of walking aids in knee OA by
      testing the following hypothesis that the use of a single-point cane ipsilateral and
      contralateral to the affected limb will decrease pain from knee OA by altering gait
      biomechanics and will improve walking function and quality of life in overweight or obese
      individuals with symptomatic knee OA.
    

Intervention name(s): Single point cane
Intervention type(s): Device
Intervention description(s): Participants with symptomatic knee osteoarthritis will undergo gait evaluation with and without a single point cane.
Other intervention name(s): Guardian offset handled cane with sure grip
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cane; Gait; Obesity; Osteoarthritis; Walking Aids
A Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100)
Condition: Cancer; Pediatric Solid Tumor; Pediatric AML; Pediatric ALL
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      PARC is an international phase I/II trial evaluating the safety and activity of pegylated
      recombinant human arginase (BCT-100) in children and young people with relapsed/refractory
      leukaemia, neuroblastoma, sarcoma and high grade gliomas (brain cancers).

      Currently the outcomes for these patients are poor and the therapeutic options are limited
      with a significant toxicity burden. Therefore new treatments which work in different ways to
      standard chemotherapy are urgently needed. Research has shown that arginine (a nutrient) is
      important in the survival of cancer cells. BCT-100 is a drug which can deplete arginine
      levels and starve cancer cells - a completely new approach. BCT-100 has been tested in adults
      and shown to be active with almost no side-effects. This trial will test whether this dose of
      BCT-100 is also safe and active in children with relapsed/refractory leukaemia,
      neuroblastoma, sarcoma and high grade glioma. The trial will also study how BCT-100 is broken
      down in the body and look for new biological markers of treatment response. Up to 64 children
      with relapsed cancers will be recruited over 2 years.
    


Intervention name(s): PEG- BCT-100
Intervention type(s): Drug
Intervention description(s): PEGylated recombinant human arginase 1
Other intervention name(s): rhArg1peg5000
Intervention MeSH terms: BCT-100
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arginine; Arginase; Children; Young Adult
Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin.
Condition: HIV; Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Dyslipidemia is highly prevalent among patients with HIV infection and contributes to the
      increased cardiovascular disease risk in this patient population. Atorvastatin lowers plasma
      low-density lipoprotein (LDL) cholesterol levels and is used for prevention of
      artherosclerotic disease. Raltegravir, an HIV integrase inhibitor, could be one of the
      preferred antiretroviral agents in HIV patients with dyslipidemia because it has a beneficial
      lipid profile.

      Theoretically, no clinically relevant drug interaction is expected between atorvastatin and
      raltegravir. However, atorvastatin and raltegravir share similar metabolic pathways which
      could be relevant in the occurrence of pharmacokinetic interactions. In order to be able to
      recommend raltegravir and atorvastatin concomitant use, a pharmacokinetic study in healthy
      volunteers is proposed.
    


Intervention name(s): raltegravir; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Raltegravir 400 mg BID for 7 days; Atorvastatin 20 mg QD for 7 days
Other intervention name(s): raltegravir dosing for 7 days
Intervention MeSH terms: Raltegravir Potassium; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetic; interaction; cholesterol; raltegravir; atorvastatin
Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)
Condition: Dermatitis, Atopic
MeSH terms: Asthma; Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The Early Prevention of Asthma in Atopic Children (EPAAC™). 24 months study to evaluate the
      efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24
      months old children.
    


Intervention name(s): Placebo; Levocetirizine
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Oral drops Route of administration: Oral use; Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use
Other intervention name(s): Xyzal
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: EPAAC; Atopic children; Asthma; XYZAL; Levocetirizine