bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      No pediatric formulations of quinine exist. Therefore, quinine tablets are broken into 2 or 4
      parts, according to the body weight. Based on the body weight, 1/2 or 1/4 a tablet is
      administered to the child.

      At this moment, quinine sulphate pellets are developed. These pellets enable an adequate
      dosing according to the body weight.

      56 children with malaria will be dosed every 8 hours during 7 days with 10-15mg/kg body
      weight.
    


Intervention name(s): Administration of quinine sulphate taste-masked pellets
Intervention type(s): Drug
Intervention MeSH terms: Quinine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      Introduction. Functional dyspepsia (FD) is a common chronic gastrointestinal disorder with a
      high socio-economic impact. Acotiamide, a new prokinetic agent, was shown to be efficacious
      in the treatment of FD, especially in the postprandial distress syndrome subgroup. To date,
      the exact mechanism of action of acotiamide is incompletely elucidated.

      The aim of this study was to examine the effect of acotiamide on gastric motility, gastric
      emptying rate and gastrointestinal symptom perception in healthy participants in a
      randomized, placebo-controlled, cross-over study design. Participants were treated with
      acotiamide (100 mg t.i.d.) and placebo for 3 weeks, separated by a one-week wash-out period.
      At the end of each treatment period, gastric emptying and motility were assessed on two
      consecutive study days. During gastric motility assessment, epigastric symptom scores were
      collected at multiple time points.
    


Intervention name(s): Acotiamide; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Acotiamide treatment, 100 mg, t.i.d. for three week. Intake 10 minutes before meal.; Placebo treatment, t.i.d. for three week. Intake 10 minutes before meal.
Intervention MeSH terms: Z 338
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Gastric motility; Gastric emptying
The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure
Condition: Fissure in Ano; Diarrhea
MeSH terms: Fissure in Ano; Diarrhea
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Anal fissure define as a superficial tearing in mucosa on the anoderm surface distal to
      dentate line . The most important factor is hard stool passing with trauma to anal mucosa.
      But, diarrhea diarrhea has been another important etiology that happen after some conditions
      like gastroenteritis, laxative over use, during chemotherapy, and ulcerative colitis
      exacerbation . In these conditions, it seems the change of stool PH maybe the main reason of
      inflammation and ulcer in acute phase.

      The treatment of acute is medical management with change in bowel habits and conservative
      therapy such as local lubricant, local vasodilator, and warm sitz bath to improve blood
      supply and wound healing.

      This research clinical trial is designed to show the effect of Asacol suppository in the
      management of acute fissure due to diarrhea. The hypothesis of this research clinical trial
      has been referred to the cause of acute fissure ulcer because of diarrhea.
    

Detailed description: 
      The cases with acute anal fissure after diarrhea will included in this research clinical
      trial. They will be divided in two groups as an interventional group and control by blind
      randomization allocation. The interventional group will have received Asacol suppository 1
      supp every night and Diltiazem jelly (standard management) twice per day. The control group
      will have received Diltiazem jelly and placebo suppository like interventional group. Both
      group will have used warm sitz bath with enough hydration for 10 days. Then the patients will
      have visited by another surgeon after 4 weeks to evaluate the healing of acute anal fissure.
      Pain will have performed if the patients can tolerate.
    

Intervention name(s): Asacol is used to treat and prevent mild to moderate acute fissure disease
Intervention type(s): Drug
Intervention description(s): Comparison of two groups after 2 weeks in fissure wound healing, pain relief, pruritus, burning, bleeding, incontinence. Preliminary results of the study show the rate of fissure improvement 6 weeks after treatment, which is observed by clinical examination. Restoration is defined by complete epithelialization of the fissure site without scarring or residual cracks, and the secondary results will be a reduction in the amount of pain and other symptoms.
Other intervention name(s): Mesalazine is used to treat and prevent mild to moderate acute fissure disease
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups seventy patients aged 18 to 65 years with diarrhea and subsequent acute fissure (with symptoms less than 6 weeks)
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Acute fissure; Diarrhea; Asacol
Different Volumes of Durolane in Knee OA
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the safety and efficacy profiles of new
      single-injection volumes of Durolane in patients with knee OA.
    

Detailed description: 
      To assess the safety and efficacy profiles of different volumes of Durolane in patients with
      knee OA and compare with the current standard single-injection of the product. The study aims
      to investigate whether different volumes of Durolane compared to the standard injection
      volume will improve the benefit/risk profile.
    

Intervention name(s): Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml
Intervention type(s): Device
Intervention description(s): Durolane is an intraarticular hyaluronic acid preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of a Novel Method for Increasing Intraocular Pressure in Healthy Subjects
Condition: Intraocular Pressure
Study type: Interventional

Summary: 
      Adequate perfusion is necessary for maintaining tissue function. This applies also for the
      eye, in which ocular perfusion pressure (OPP) is generally estimated as the difference
      between mean arterial pressure (MAP) and intraocular pressure (IOP). In the latter formula,
      IOP substitutes for central retinal venous pressure (CRVP), which is assumed to be slightly
      higher than IOP to allow blood flow to exit the eye. It has, however, been found that in some
      patients CRVP is elevated and significantly higher than IOP, which would lead to a decrease
      in OPP which is not taken in account with the proposed formula. Therefore, techniques for
      measurement of CRVP are warranted. Recently, a new, method for measurement of this parameter
      without corneal contact has been introduced. Briefly, with this method, IOP is elevated until
      the vein collapses, which then equals CRVP. In the present study this technique will be
      applied in 12 healthy subjects to validate whether the values that are preset by the device
      correlate to measurements obtained with standard Goldmann applanation tonometry. For this
      purpose, IOP will be experimentally increased in steps of approximately 5mmHg until it
      reaches 40mmHg as measured by applanation tonometry. After a resting period of 30 minutes,
      IOP will be again increased stepwise to 40 mmHg while retinal vessel diameters will be
      monitored using dynamic vessel analyzer. During this session CRVP will be measured. After
      another resting period of 30 minutes IOP will be stepwise increased a third time and after
      each step OCT, OCT-A and OCT EDI will be performed.
    


Intervention name(s): IOPstim; Suction Cup
Intervention type(s): Device; Device
Intervention description(s): IOPstim (IMEDOS, Jena, Germany) is a device exerting defined pressure to the sclera and hence increasing IOP.; Suction Cup is a device exerting defined suction to the clear and hence increasing IOP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Fatty Liver Disease and Non-treated Matched Healthy Volunteers as Control Group
Condition: Non Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty
      Liver Disease and non-treated matched healthy volunteers as control group
    


Intervention name(s): SAMe 1000 mg; SAMe 1500 mg; SAMe 2000 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner; 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner; 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Steatohepatitis
Effects of Carnitine Supplementation on Liver and Muscle
Condition: Non-Alcoholic Fatty Liver Disease; Insulin Resistance
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Insulin Resistance
Study type: Interventional

Summary: 
      It will be evaluated whether carnitine, a dietary supplement, reduces liver fat and improves
      metabolism in individuals who have a high concentration of fat within their liver.
      Participants will be given either Carnitine or placebo, together with a meal replacement
      milkshake twice daily for 6 months.
    

Detailed description: 
      NAFLD occurs when too much fat accumulates in liver tissue. This can, over time, cause
      inflammation and scarring of the liver, eventually leading to chronic liver disease and
      cirrhosis. It is strongly associated with diabetes and obesity, both of which are endemic in
      Western societies.

      Carnitine enables cells in the body to use fat as a fuel, and recent studies have suggested
      that carnitine supplementation may reduce liver triglyceride content. Muscle and liver are
      the major sites in the body which coordinate glucose and fat metabolism. As well as assessing
      the effect of carnitine supplementation on liver fat, its effect on metabolic processes
      within these tissues will also be measured
    

Intervention name(s): L-Carnitine tartrate; Meal Replacement Drink; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2g L-Carnitine tartrate as a powder consumed twice a day; 325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day; 2g Maltodextrin powder packaged to mimic carnitine powder consumed twice a day
Other intervention name(s): Slimfast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
UVA1 Light for Treatment of Scleroderma and Similar Conditions
Condition: Scleroderma; Keloids; Other Fibrosing Conditions
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Keloid; Disease
Study type: Interventional

Summary: 
      The purpose of this investigation is to evaluate the effectiveness of an investigational
      device which is similar in appearance to a "tanning bed" but which emits ultraviolet
      irradiation of a specific wavelength known as UVA1. This device has not been approved by the
      FDA for general use in this country, as yet, but it has been used quite successfully in
      Europe for several years in treating such conditions as scleroderma, keloids, and other
      fibrosing conditions of the skin. Your participation in this study may yield important
      information regarding the safety and effectiveness of this form of light therapy for the
      treatment of these skin conditions which, at present, are difficult to treat.
    

Detailed description: 
      Ultraviolet rays from the sun that reach the earth surface are divided into shorter
      wavelength, hence high energy, UVB (290-320nm) and longer wavelength, hence low energy UVA
      (320-400nm). The wavelengths of light that cause sunburn and are associated with skin cancer
      causation is the high energy UVB. UVA wavelengths can be further divided into relatively
      shorter wavelength, hence higher energy UVA2 (320-340nm) and longer wavelength, lower energy
      UVA1 (340-400nm). Phototherapy light boxes used in our clinic for the treatment of psoriasis,
      atopic dermatitis, and pruritus, as well as those used in tanning salons emit both UVB and
      UVA wavelengths of light. The advantages of using UVA1 light source in the treatment of skin
      conditions are 1) lack of skin cancer and sunburn causing rays (UVB/UVA2) and 2) as a
      consequence, the ability to treat patients more safely.

      Keloid, scleroderma, acne keloidalis nuchae, and burn scars are all characterized by
      collagenous thickening of the skin resulting in superficial and deep cutaneous sclerosis.
      Treatments for these disabling conditions are inadequate at present. Recently, in
      non-controlled studies, UVA1 was shown to induce improvement in patients with scleroderma,
      granuloma annulare and urticaria pigmentosa (1-3). The mode of action of UVA1 treatment is
      not completely understood, however, local immuno-modulation appears to be important (4). UVA1
      has also been shown to stimulate collagenase activity in a dose dependent manner in the
      dermis (5,6). We postulate, therefore, that UVA1 in appropriate doses can improve these
      fibrosing skin conditions safely through collagenase-mediated removal of excess dermal
      collagen.
    

Intervention name(s): German manufactured UVA1 light emitting device
Intervention type(s): Device
Intervention description(s): The UVA1 dose will be up to 130 J/cm2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: UVA1; scleroderma; keloids; light therapy; morphea
A Trial of Folate With B12 in Patients With Schizophrenia With Residual Symptoms in Ethiopia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators propose to conduct a randomized Sequential Parallel Design for Double-Blind
      Phase fixed dose, 4-month trial of folate plus B12 as add-on therapy in 200 Ethiopian
      subjects with schizophrenia with stable residual positive or negative symptoms.
    

Detailed description: 
      This is a 16-week, randomized, double-blind, placebo-controlled study of Folate 2mg plus B12
      400mcg, as an adjunctive therapy in approximately 240 consecutive outpatients with
      schizophrenia from Amanuel Hospital, which is based at Addis Ababa, Ethiopia will be enrolled
      and screened for eligibility. The goal is to randomize and complete 200 subjects from the 240
      enrolled. A Sequential Parallel Design for Double-Blind Phase will be utilized. During the
      first phase of double-blind adjunctive treatment, eligible patients (n=200) are randomized to
      adjunctive treatment with either folate and vitamin B12 (n=60) or placebo (n=150), with a
      2:3:3 ratio for random assignment to the treatment sequences drug/drug (DD; n=70),
      placebo/placebo (PP; n=70), and placebo/drug (PD; n=75), while all continue to receive their
      antipsychotic agent for the entire duration of the study. Assuming a 10% drop-out rate during
      the first phase, 126 patients on placebo will complete the first 56-day phase, and 54
      patients on folate and vitamin B12 will complete the first 56-day phase.
    

Intervention name(s): folate with B12; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis
Condition: Surgical Hemostasis
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter, stratified randomized, double-blind, placebo-controlled, phase 3 clinical
      trial.
    

Detailed description: 
      After establishing eligibility, subjects will be randomized in a 2:1 ratio to receive
      rhThrombin (1000 U/mL) or placebo. During a surgical procedure, study participants will be
      treated with blinded study drug (rhThrombin or placebo) in combination with an absorbable
      gelatin sponge at appropriate bleeding evaluation site(s). 510 patients will participate in
      the study.

      In this study, stratified random enrollment was conducted according to the
      condition(experimental group or control group) of the subjects.Stratification factors were
      centered, gender (male/female) and age (18 ≤ age <60/60 ≤ age ≤70).
    

Intervention name(s): recombinant human Thrombin(CHO cell); placebo
Intervention type(s): Biological; Biological
Intervention description(s): 2 rhThrombin, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).; placebo, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).
Other intervention name(s): rhThrombin
Intervention MeSH terms: Thrombin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hepatic resection; rhThrombin,topical
Validation of the Short-term Antimicrobial Action of Transplanted Bacteria
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently
      colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of
      S. aureus skin infections. In addition, research in the investigator's lab has shown that
      these patients have fewer protective antimicrobial Staphylococcal species such as
      Staphylococcal epidermidis (S. epidermidis) that are known to produce antimicrobial peptides
      that play a role in protecting the skin from invading pathogens. In this study, the
      investigator will attempt to decrease S. aureus colonization and increase colonization by
      protective Staph species in AD patients. First the investigator will capture the bacteria on
      subjects' lesional AD skin. Next the investigator will selectively grow the subject's
      antimicrobial Staphylococcal colonies and place them into a base moisturizer. The moisturizer
      plus bacteria will be applied to one of the subject's arms, and the moisturizer alone
      (without bacteria) to the other arm. The investigator will then do a quantitative wash of the
      bacteria growing on each arm one day later in order to determine whether the S. aureus
      abundance was affected by the application of the transplanted bacteria.
    


Intervention name(s): Autologous Microbiome Transplant; Placebo Arm
Intervention type(s): Biological; Other
Other intervention name(s): The placebo arm will have a commercially available moisturizer applied to it.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Microbiome; Bacteria transplant; Atopic dermatitis treatments
Study of an Investigational Pneumococcal Vaccine in Healthy Adult Volunteers
Condition: Pneumococcal Infections; Pneumococcal Pneumonia
MeSH terms: Pneumococcal Infections; Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to evaluate the safety, tolerability, and immunogenicity of three
      doses of an investigational pneumococcal vaccine in healthy adult volunteers.

      Primary Objective:

        -  To evaluate the safety and tolerability of an investigational Pneumococcal vaccine.
    

Detailed description: 
      Each volunteer participant will receive two injections with one of three vaccine doses,
      administered on Day 0 and Day 30, in a dose-ascending manner, pending safety review at each
      dose level. All participants will be monitored for safety for 30 days after each injection.
    

Intervention name(s): Pneumococcal Vaccine; Pneumococcal Vaccine; Pneumococcal Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, intramuscular; 0.5 mL, intramuscular; 0.5 mL, intramuscular
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal Infections; Pneumococcal Vaccines; pneumococcal protein
Beetroot Enriched Bread, Blood Pressure and Vascular Function
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and
      could therefore be an important dietary component in the management of hypertension and
      cardiovascular disease, however consumption is relatively low. We evaluated the effects of
      beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and
      blood pressure response in healthy men.
    


Intervention name(s): Bread
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Beetroot; Blood pressure; Vascular function
Immunogenicity and Safety of GSK Biologicals' FluLaval® TF
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is intended to assess a novel formulation of FluLaval. The idea is to
      obtain preliminary data on the safety and immune response to the FluLaval TF influenza
      vaccine in adults. These data will serve as a basis for further studies involving different
      populations. This protocol posting deals with objectives & outcome measures of the primary
      phase/study.
    


Intervention name(s): FluLaval® TF
Intervention type(s): Biological
Intervention description(s): One IM injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: FluLaval® TF; Safety; Immunogenicity; Influenza