bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
Condition: Anaemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted in approximately 228 subjects with anemia associated with CKD
      who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1:
      recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are
      currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either
      GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO
      before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the
      control arm. For those randomized to the control arm, the decision around whether the subject
      requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose
      to achieve and maintain Hgb concentrations within the target range should be based on
      Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value
      being considered. The study consists of a screening phase of at least 4 weeks, a 24-week
      treatment phase and a follow-up visit that will occur approximately 4 weeks after completing
      treatment. It is anticipated that the data generated will enable selection of the starting
      dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.
    


Intervention name(s): GSK1278863; rhEPO
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablets containing 0.5 mg, 1 mg, 2 mg, 5mg or matching placebo; Locally sourced rhEPO. All subjects who are randomized to the Control arm will receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, to maintain Hgb levels within the target range. The decision around whether a subject requires rhEPO, selection of the type of rhEPO and rhEPO dose should be based on Investigator clinical judgment, with the historical rhEPO dose (where applicable) and the current Hgb value being considered..
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Prolyl hydroxylase inhibitor; pharmacokinetics; GSK1278863; Anemia; hemoglobin; erythropoiesis stimulating agents; Chronic kidney disease
Bladder Diary for Diagnosing Bladder Oversensitivity
Condition: Bladder Oversensitivity
Study type: Observational

Summary: 
      Urodynamic study is an invasive procedure and applied for diagnosis of bladder
      oversensitivity. Bladder diary is a non-invasive measurement. The aim of this study was to
      elucidate whether bladder diary is a good surrogate for diagnosing bladder oversensitivity.
    

Detailed description: 
      Between July 2009 and December 2020, medical records of all women with lower urinary tract
      symptoms but without cystocele who visited the urogynecological department of a medical
      center for urodynamic evaluation were reviewed. Those women who have no complete data of a
      3-day bladder diary were excluded from this study. Bladder oversensitivity was diagnosed if
      the volume of strong desire was less than 300mL. We compared the urodynamic parameters to
      bladder diary parameters in order to find the best correlation between these 2 measurements
      for the diagnosis of bladder oversensitivity.

      STATA software was used for statistical analysis. Chi2 test, univariate and multivariable
      logistic regression tests were used for statistical analysis as appropriate. A p < 0.05 was
      considered as statistically significant.
    

Intervention name(s): Three-day bladder diary
Intervention type(s): Diagnostic Test
Intervention description(s): A three-day bladder diary for recording voiding-flow pattern of a women
Other intervention name(s): Urodynamic study
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All women with lower urinary tract symptoms but without cystocele who visited the
        urogynecological department of a medical center for urodynamic evaluation were included.
Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing SIRT
Condition: Liver Cancer
MeSH terms: Neoplasm Metastasis
Study type: Observational

Summary: 
      This study is being done to investigate the influence of giving radiation to the liver on
      tumors involving the liver. Investigator is specifically looking at this effect on the blood
      vessels within the tumor. This effect will be measured by studying substances in the blood
      that the tumors produce and that cause blood vessels to grow. The effects seen on these
      substances may help design other treatments to improve the results of the radiation used to
      treat these tumors.
    

Detailed description: 
      Subjects are invited to participate in this study that have undergone a procedure as their
      standard of care. This procedure is known as Selective Internal Radiation Therapy (SIRT), a
      procedure designed for the treatment of cancer in the liver. This includes cancer that has
      started in the liver as well as cancer that has spread to the liver. The purpose of the study
      is to collect blood samples to assess for "biological markers," or substances within the
      blood that may promote cancer growth by causing new blood vessels to form. This study will
      also use a new method of analyzing medical imaging (CT scan, PET scan) to try and better
      understand how cancer in the liver forms new blood vessels. SIRT is standard therapy and not
      part of this study. This study involves blood draws only.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects that have undergone Selective Internal Radiation Therapy for the treatment of
        liver cancer
      
Biospecimen description: 
      Whole blood will be obtained at intervals based on standard of care blood draws. Each sample
      will be analysed for circulating indicators of angiogenesis.
    
Keywords: Pro-angiogenic markers; SIRT; hepatic metastases
Effect of Pranayama on Periodontal Health
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of the study was to evaluate the levels of Peroxisome proliferator-activated
      receptor gamma (PPAR-γ), Nuclear factor-kappa B (NF-kB) and the presence of red complex
      microorganisms (RCM) such as Treponema denticola (T.d), Porphyromonas gingivalis (P.g) and
      Tannerella forsythia (T.f) in the subgingival tissues of chronic periodontitis subjects
      before and after intervention with pranayama as an adjunct to scaling and root planing.
    

Detailed description: 
      Sixty chronic periodontitis subjects were selected out of which 30 subjects (control group)
      were treated with scaling and root planing (SRP) and 30 subjects (pranayama group) also
      underwent SRP and pranayama for 3 months. Clinical parameters were recorded and the presence
      of PPAR-γ, NF-kB and RCM were assessed at baseline and after 3 months
    

Intervention name(s): Pranayama; Scaling and root planing
Intervention type(s): Behavioral; Procedure
Intervention description(s): Pranayama is the breathing exercise through the nostrils. It enhances the systemic immunity which in turn enhances the overall defense mechanism of an individual.; It is a mechanical debridement of dental plaque.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: chronic periodontitis; Nuclear factor-kappa B; Pranayama; Peroxisome proliferator - activated receptor gamma; Red complex microorganisms
Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants
Condition: Phobic Disorders
MeSH terms: Phobic Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Recent advances in animal research have identified pharmacological agents that appear to both
      accelerate and consolidate extinction learning. One cognitive enhancers is Yohimbine
      hydrochloride (YOH). A finding in animal literature is that the administration of YOH during
      extinction trials accelerates fear reduction and may convert ineffective exposures in to
      successful ones. It is thought that the mechanism of enhanced emotional memory is through
      elevated norepinephrine. However, recent findings demonstrate mixed results. In a randomized
      controlled trial claustrophobic participants underwent exposure in combination with YOH or
      placebo. The YOH group showed significantly better results on anxiety improvement than the
      placebo group. In a more recent study with participants with fear of flying no additional
      benefits of YOH were demonstrated. Therefore, we intend to replicate and extend these studies
      by enhancing the dose of YOH in combination with VRET and by extending our experimental
      design with another group which receives propranolol in combination with VRET. Propranolol is
      β-adrenergic receptor antagonist, which has proven to disrupt reconsolidation in healthy
      humans. In this randomized controlled trial a between groups design is chosen to further
      characterize the differential within and between trial extinction and to enhance possible
      between groups effects. Sixty participants with fear of flying or fear of heights will be
      randomly assigned to one of the following three conditions 1) VRET plus YOH, 2) VRET plus
      Propranolol, or 3) VRET plus placebo. Participants in all conditions will be offered three
      sessions of VRET over a period of two weeks.
    


Intervention name(s): Virtual Reality Exposure Therapy (VRET)
Intervention type(s): Behavioral
Intervention description(s): Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phobic Disorders (Fear of Flying and acrophobia); Virtual Reality Exposure Therapy; Fear extinction; propranolol; Yohimbine
Pain and Suction Curettage
Condition: Curettage; Analgesia; Paracervical Block; Paracetamol
Study type: Interventional

Summary: 
      Aim of the study was to investigate the analgesic efficacy of preoperative oral dexketoprofen
      trometamol, intravenous paracetamol, lidocaine spray and paracervical block with ultracaine
      on curettage procedure.
    


Intervention name(s): paracetamol; dexketoprofen trometamol; suction curettage; suction curettage; without drug
Intervention type(s): Drug; Drug; Drug; Drug; Other
Other intervention name(s): two puff xylocain administration; paracervical block with ultracaine
Intervention MeSH terms: Acetaminophen; Dexketoprofen trometamol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Curettage; analgesia; paracervical block; paracetamol; lidocaine; Dexketoprofen trometamol
Adipose Tissue Extract and Platelet-rich Plasma Use for Wound Healing
Condition: Wound Healing Disturbance of
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Adipose Tissue Extract (ATE) has been found to be an autologous source of growth factors with
      proven in vitro angiogenic and adipogenic properties.It is obtained by a simple lipoaspirate
      procedure. We sought to compare the effect of ATE with another known source, platelet-rich
      plasma to compare the wound healing characteristics on skin graft donor sites.
    

Detailed description: 
      The investigators enrolled 24 participants with an indication for skin graft. Two or more
      split-thickness grafts are harvested per patient, one serving as control and the other as
      experimental. The experimental sites were covered with either autologous PRP gel or ATE
      prepared in the OR, which was selected in an unblinded manner due to surgical theater
      convenience. However, donor sites were randomized through a computer generator. Covered with
      a semiocclusive film, wounds were separated and followed up on days 3,5,7,10,14 for wound
      healing and 30 and 60 for scar evaluation. Digital photography and specto-photocutometry was
      employed to know the hemoglobin and melanin content of the wounds, and custom-made software
      was used to calculate the percentage of wound re-epithelialization.
    

Intervention name(s): ADIPOSE TISSUE EXTRACT; PLATELET-RICH PLASMA GEL
Intervention type(s): Biological; Biological
Intervention description(s): Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration; Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
Other intervention name(s): ATE; PRP
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix
Condition: Labor Onset and Length Abnormalities
MeSH terms: Congenital Abnormalities
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed as a randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof
      of Concept Study (section A) with a conditional dose finding follow up (Section B) to
      Evaluate the Efficacy on Cervical ripening, Safety, Tolerability and dose response of
      Subcutaneously Administered Tafoxiparin in Term Pregnant, Nulliparous Women with an unripe
      cervix undergoing Labor Induction. If the efficacy and safety profiles of Section A are
      conclusive in favor of tafoxiparin, the study will continue by adding two additional
      tafoxiparin dose groups in Section B.
    

Detailed description: 
      Primary objective:

      To assess the efficacy of tafoxiparin on cervical ripening.

      Secondary objective:

      To assess the maternal and neonatal safety, tolerability and dose response of tafoxiparin as
      a supplement therapy in term pregnant, nulliparous women with an unripe cervix undergoing
      labor induction

      Methodology:

      Term pregnant, nulliparous women with unripe cervix and planned for labor induction are
      potential study patients unless enrolled in another study. Subjects may be preinformed about
      the stuyd through the use of advertisement or information at the physician/midwife visits
      during pregnancy and at the hospital admission.

      The whole study includes the following steps:

      Screening and Baseline including informed consent and randomization Study treatment and
      Induction of Labor Labor Discharge
    

Intervention name(s): DF01; PL1
Intervention type(s): Drug; Drug
Intervention description(s): The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until labor induction or spontaneous onset of labor. Induction is done according to clinical practice; 1st balloon, 2nd PGE1; The subject receives sc injections once daily of placebo solution for up to 7 days until labor induction or spontaneous onset of labor. Induction is done according to clinical practice; 1st balloon, 2nd PGE1
Other intervention name(s): tafoxiparin; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: labor induction; cervical ripening
Effects of the Eefooton on eGFR and QoL in Chronic Kidney Disease Patients.
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Chronic renal failure is a chronic and progressive disease with a poor prognosis. In recent
      years, it can be found in many literature reports that traditional Chinese medicine therapy
      has obvious effects on early and mid-term chronic renal failure. It can not only improve
      clinical symptoms, but also block or delay the process of renal failure. It is relatively
      rare that compounds such as compounds. The side effects of drugs may be used in combination
      with compound drugs to improve clinical side effects and help patients improve their quality
      of life to complete the treatment course. It can provide clinicians with another choice in
      treatment. A previous study confirmed that the use of Eefooton oral solution of Chinese
      herbal medicine concentrate has a significant protective effect on the kidneys that have not
      undergone hemodialysis. Eefooton is extracted from Rhodiola, Huang Qi, American Ginseng, Dang
      Ginseng, and Ligustrum lucidum by biotechnology. It has immunomodulatory effects,
      anti-oxidation and anti-inflammatory effects, and regulates calcium metabolism. The purpose
      of this clinical observation and research is to evaluate the eGFR changes in the renal
      function of patients with chronic kidney disease with the combination of Eefooton oral
      solution and commonly used chemical drugs.
    

Detailed description: 
      The Blood test items consisted Blood urea nitrogen (BUN), Serum creatinine (SCr), estimated
      glomerular filtration rate (eGFR), serum Uric acid, plasma Albumin (ALB), Hemoglobin (Hb),
      Alkaline phosphatase (ALP), Serum Glutamic-Oxalocetic Transaminase (SGOT), Serum glutamic
      pyruvic transaminase (SGPT), Glucose(AC), Serum sodium, Serum potassium, Corrected calcium ,
      Phosphorus (Blood). Glycated hemoglobin (HbA1c), Triglyceride (TG), Total cholesterol (Chol),
      High-density lipoprotein (HDL), Low-density lipoprotein (LDL). During the entire research
      process did not change diet, lifestyle, habits and the use of drugs.
    

Intervention name(s): Eefooton oral solution
Intervention type(s): Dietary Supplement
Intervention description(s): Check eGFR value, liver and kidney function every month
Intervention model: Single Group Assignment
Intervention model description: Chronic Kidney Disease before dialysis
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eGFR
A Study to Evaluate Tenofovir Disoproxil Fumarate (DF) in Asian-American Adults With Chronic Hepatitis B Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the antiviral activity and safety of tenofovir
      disoproxil fumarate (TDF) in Asian-American adults (self-reported Asian descent, living in
      the United States) with chronic hepatitis B infection. All participants will receive active
      treatment with TDF for 48 weeks.
    

Detailed description: 
      Efficacy of TDF will be evaluated for reductions in serum HBV DNA, changes in liver enzymes,
      and the generation of antibody to the virus. Safety will be assessed by evaluating adverse
      events, laboratory abnormalities, and the development of drug resistance mutations.
    

Intervention name(s): Tenofovir disoproxil fumarate
Intervention type(s): Drug
Intervention description(s): 300-mg tablet (marketed formulation) taken orally once daily
Other intervention name(s): Viread
Intervention MeSH terms: Tenofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B; Hepatitis; Tenofovir disoproxil fumarate; Tenofovir DF; Asian-American
Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate whether an ultrathin endoscope will improve a
      patient's tolerance during the procedure. In addition, this study will look at whether local
      pharyngeal anaesthesia is necessary during ultrathin endoscopy.
    


Intervention name(s): Local pharyngeal anaesthesia; Ultrathin endoscope
Intervention type(s): Procedure; Device
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: upper endoscopy; local pharyngeal anaesthesia; ultrathin endoscope
Evaluation of the Effect of Oil Pulling
Condition: Oral Hygiene; Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      The objectives of this study were to evaluate the inhibitory effect on plaque and the tooth
      discoloration associated with agents used in the chemical plaque control of oil pulling in
      comparison with chlorhexidine-containing mouthwash and water in a four-day plaque regrowth
      model.

      One hundred dentistry students were included in this randomized, parallel-group,
      placebo-controlled clinical study. In this study, participants were divided into 5 equal
      groups: Group 1: Gargling with 0.2% chlorhexidine; Group 2: Oil pulling with coconut oil;
      Group 3: Oil pulling with black cumin oil; Group 4: Oil pulling with terebinth oil; Group 4:
      Gargling with distilled water. Participants were instructed to refrain from mechanical oral
      hygiene and rinse only with the allocated mouth rinse during the four-day period. The
      differences in plaque index, gingival index, and tooth discoloration were evaluated in the
      study.
    


Intervention name(s): Chlorhexidine; Oil Pulling; Distilled Water
Intervention type(s): Drug; Other; Other
Intervention description(s): Gargling with 10 mL 0.2% Chlorhexidine; In oil pulling therapy, a tablespoon of edible oil is placed in the mouth and swirled between the teeth for 15 to 20 minutes; Gargling with 10 mL distilled water
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Chlorhexidine; Oil pulling; Plaque Regrowth model; Coconut oil; Digital spectrophotometer
Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)
Condition: Typhoid Fever
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations
      of Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with
      the currently licensed Vi polysaccharide vaccine
    


Intervention name(s): NVGH Vi-CRM197 12.5 mcg; NVGH Vi-CRM197 5.0 mcg; NVGH Vi-CRM197 1.25 mcg; Vi-polysaccharide vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 1 dose of 0.5 mL; 1 dose of 0.5 mL; 1 dose of 0.5 mL; 1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Typhoid fever; Glycoconjugate vaccine; Vi polysaccharide; Immunogenicity