bioihbjkbjnl/mcl2 huggingface dataset:
Cohort Study of Risk Reducing Salpingectomy
Condition: Sterilization, Tubal; Salpingectomy; Ovary; Prevention & Control
Study type: Interventional

Summary: 
      Women undergoing surgical sterilization will be interested in risk reducing salpingectomy,
      and surgeons performing the procedure will be able to successfully complete the
      salpingectomy.
    


Intervention name(s): Salpingectomy; Traditional sterilization
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double-blind, randomized, placebo- and positive-controlled, parallel group, 3-arm
      study to assess the potential for therapeutic and supratherapeutic concentrations of
      setmelanotide to affect the QTcF interval compared with placebo.
    


Intervention name(s): Setmelanotide; Moxifloxacin; Oral Placebo; SC Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous (SC) setmelanotide: SC injection: 2 mg × 7 days followed by 3, 5, and 7 mg × 3 days per dose level; Moxifloxacin 400 mg capsules for oral administration (active comparator); Placebo capsules for oral administration (identical in appearance to oral moxifloxacin treatment); Placebo for SC injection (vehicle only; identical in appearance to SC setmelanotide treatment)
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Prebiotic Effects of a Polyphenol-rich Food Product
Condition: Dysbiosis
MeSH terms: Dysbiosis
Study type: Interventional

Summary: 
      The specific aim for this project will be to investigate a cranberry beverage as a means to
      restore balance in terms of the relative proportions of the various bacteria that inhabit the
      large intestine.
    


Intervention name(s): Cranberry beverage; Placebo beverage
Intervention type(s): Other; Other
Intervention description(s): During the intervention period, research participants will consume a cranberry beverage daily.; During the intervention period, research participants will consume a placebo beverage daily.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology
Condition: Metastatic Cancer; Cachexia; Cancer
MeSH terms: Muscular Atrophy; Atrophy; Cachexia
Study type: Observational

Summary: 
      This study is designed to gain a better understanding of the mechanisms leading to muscle
      wasting and metabolic abnormalities in skeletal muscle of cancer patients.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study will recruit patients with metastatic cancer with or without evidence of
        cachexia, defined as ≥5% drop in body mass in less than 12 months. Controls without cancer
        but similar in age, sex, and body mass index will be recruited.
      
Biospecimen description: 
      Plasma, serum, and skeletal muscle tissue will be collected.
Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide
Condition: Healthy Normotensive Participants
Study type: Interventional

Summary: 
      This study was conducted to compare the rate and extent of absorption of valsartan and
      hydrochlorothiazide following oral administration as a fixed dose combination tablet and
      concomitant administration of the individual drugs under fasting conditions in healthy
      Egyptian subjects. The study was extended to investigate any potential reaction between VAL
      and HCT.
    

Detailed description: 
      This study comprised 2 separate parts, I and II; each was a single-dose, open-label,
      4-crossover periods separated by a 2 weeks washout, and 4-Treatments. Part I consisted of
      Treatments A (VAL 160 mg alone), B (HCT 12.5 mg alone), C (VAL 160 mg + HCT 12.5 mg) and D
      (VAL / HCT 160 mg/12.5mg) and Part II consisted of Treatments E (VAL 320 mg alone), F (HCT 25
      mg alone), G (VAL 320 mg + HCT 25 mg) and H (VAL / HCT 320 mg/25 mg). Blood samples were
      collected up to 48 hours postdose and plasma was analyzed for VAL and HCT concentrations
      using HPLC. The pharmacokinetic properties of each drug after co-administration of VAL and
      HCT were compared with those of each drug administered alone.
    

Intervention name(s): Valsartan/Hydrochlorothiazide; Valsartan; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Co-administration or fixed dose combination; Valsartan alone; Hydrochlorothiazide alone
Other intervention name(s): Fixed dose combination; Pharmacokinetic interaction
Intervention MeSH terms: Valsartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Fixed dose combination; Pharmacokinetics; Valsartan; Hydrochlorothiazide
Analysis of BPA Concentration in Serum in Women of Reproductive Age With Autoimmune Thyroid Disease
Condition: Hypothyroidism; Hyperthyroidism; Hashimoto Disease; Graves Disease
MeSH terms: Graves Disease; Hypothyroidism; Thyroid Diseases; Hyperthyroidism; Hashimoto Disease
Study type: Observational

Summary: 
      The aim of the study is to assess the relationship between the concentration of bisphenol A
      in serum and selected parameters of thyroid function in women of reproductive age with
      thyroid dysfunction - Hashimoto's disease and Graves' disease.
    


Intervention name(s): Serum BPA
Intervention type(s): Diagnostic Test
Intervention description(s): Serum BPA levels will be compared between women with autoimmune thyroid disease and normal women.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women in the reproductive age from 18 to 45 years of age will be qualified to the study
        group. Women will be recruited from among patients admitted to the University Hospital in
        Krakow. After qualifying for the study, each patient will be collected demographic data,
        information about medical history and medications, as well as anthropometric data.During
        the medical visit, patients will be presented with all information about participation in
        the study and only those who give their informed consent in writing will be qualified for
        the study. Based on the clinical picture and the results of laboratory tests (the level of
        TSH, fT4 in the plasma and the presence of thyroid autoantibodies), the patients will be
        divided into 2 groups - 30 women with hyperthyroidism, 30 women with hypothyroidism. 20
        healthy women without any thyroid dysfunction will be the control group. The groups will be
        matched according to age, body mass index and smoking.
      
Keywords: bisphenol A; BPA; Hashimoto's Disease; Graves' Disease
A Study of HQK-1001 in Patients With Sickle Cell Disease
Condition: Sickle Cell Disease; Sickle Cell Anemia; Sickle Cell Disorders; Hemoglobin S Disease; Sickling Disorder Due to Hemoglobin S
MeSH terms: Anemia, Sickle Cell; Sickle Cell Trait
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of three dose levels of
      HQK-1001 administered once daily for 26 weeks in subjects with sickle cell disease.
    


Intervention name(s): HQK-1001
Intervention type(s): Drug
Intervention description(s): HQK-1001 tablets, once daily for daily 26 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of ID1201 in patients with
      mild Alzheimer's disease
    

Detailed description: 
      ID1201 is a fruit extract of Melia toosendan. ID1201 alleviates Alzheimer's disease-type
      pathologies and cognitive deficit through the various actions of its effective components
      such as α-secretase activation followed to Aβ reduction, RAGE inhibition, neuro-protection,
      and anti-inflammatory activities.
    

Intervention name(s): ID1201
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the role of technologist-performed whole breast
      ultrasound for detecting breast cancer in the screening population of women with dense
      breasts.
    

Detailed description: 
      This is a prospective study designed to evaluate the role of whole breast ultrasound (WBUS)
      in screening for breast cancer. In particular, there is interest in investigating the value
      of using WBUS as an adjunct (supplementary imaging) to Digital Breast Tomosynthesis (DBT)
      based screening of women with dense (heterogeneously or extremely dense) breasts or as a
      primary screening examination in this group of women. Women scheduled for their routine
      mammography that includes a DBT exam who agree to participate in the study and sign informed
      consent will undergo (at the same visit) DBT imaging as part of their clinical exam and whole
      breast ultrasound (WBUS) each year for three rounds of screening plus one year of follow-up.
      The DBT images and WBUS will be interpreted independently by two experienced radiologists
      under standard clinical screening procedures. One radiologist will interpret the DBT and the
      other radiologist will interpret the WBUS. Using a modified "LOGICAL OR" approach
      women/subjects may be recalled for further diagnostic work-up (examinations). If a subject is
      recalled, she will then follow the standard/routine clinical procedures for follow-up and the
      investigators will verify outcomes. If neither radiologist recalls the subject, then the
      subject will follow conventional management and the investigators will verify outcome. The
      findings from the DBT and WBUS examinations, as well as any resulting follow-up, will be
      collected, recorded and analyzed.
    

Intervention name(s): Whole breast ultrasound
Intervention type(s): Device
Intervention description(s): Breast cancer screening with whole breast ultrasound
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: whole breast ultrasound; digital breast tomosynthesis; breast density; breast cancer screening
Microbiome Fructan Metabolism and Symptoms in Childhood IBS
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      This study evaluates whether the gut microbiome is involved in determining whether children
      with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given
      fructans (a sugar often found in wheat). Participants will both receive a diet with fructans
      and a diet without fructans.
    

Detailed description: 
      Fructans (fructo-oligosaccharides) are a type of carbohydrate which can not be hydrolyzed by
      humans. It is commonly found in wheat in the American diet. After ingestion they arrive
      essentially intact into the colon where they are metabolized by the colonic microbiome.
      Fructan avoidance has been found to help decrease gastrointestinal symptoms (e.g. pain) in
      those with IBS.

      However not all individuals with IBS have worsening symptoms when eating fructans in their
      diet. This study seeks to evaluate whether the microbiome is involved in determining whether
      an individual with IBS has worsening symptoms with fructan ingestion.

      Following a one week baseline period, participants will be randomized in a double-blind
      cross-over fashion to either a 72 hour meal period with fructans or a 72 hour meal period
      with maltodextrin (placebo). A washout period of at least 10 days will occur in between.
      Symptoms will be captured using a stool and pain diary. Stool specimens and urine specimens
      will be obtained at baseline and during the dietary interventions. Breath hydrogen testing
      will be obtained during the dietary interventions.
    

Intervention name(s): Fructan; Maltodextrin
Intervention type(s): Other; Other
Intervention description(s): Short-chain oligosaccharide primarily composed of fructose polymers; Polysaccharide produced from starch
Other intervention name(s): fructo-oligosaccharides
Intervention MeSH terms: Levan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults
Condition: Wobenzym; Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial was
      to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults with
      moderate-to-severe osteoarthritis (OA) of the knee.
    


Intervention name(s): Diclofenac; Wobenzym; Placebo
Intervention type(s): Drug; Dietary Supplement; Other
Intervention MeSH terms: Diclofenac; Wobenzym
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine
Condition: Hand, Foot and Mouth Disease
MeSH terms: Enterovirus Infections; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated
      Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.
    

Detailed description: 
      The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed
      on March 2013 in China,and a follow up study for phase III clinical trial has completed on
      March 2014.

      On the basis of phase III, this study is the Phase IV, open-labelled research, in order to
      evaluate the 5-year immune persistence of EV71 vaccine.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The studied subjects are infants aged 6-35 months old infants when enrolled into the phase
        III clinical trial, and they are children aged 6-8 years old five years after the EV71
        vaccine /placebo injection.
      
Biospecimen description: 
      The venous blood was collected for EV71 neutralizing antibody detection
    
Keywords: Inactivated Enterovirus Type 71 (EV71) Vaccine; 5-year Immune Persistence
The Use of Leucocyte Platelet Rich Fibrin (L- PRF) Covered Perforated Guided Tissue Membrane for Treatment of Periodontal Intrabony Defects
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      This study is the first to investigate the effect of leucocyte platelet rich fibrin (L-PRF)
      combined with perforated membrane in order to treat infrabony defects and assess their
      combined effect in clinical attachment level gain and filling of base of the defect (BD). The
      main hypothesis was that if the L-PRF act as a chemoattracttant for a higher number of
      periosteal derived periodontal cells (PDPCs) and gingival mesenchymal stem cells (GMSCs)
      encouraging their passage through the membrane perforations.
    

Detailed description: 
      A randomized (controlled) clinical trial which included forty sites with intrabony
      interproximal defects (2- or 3-wall) premolar/molar teeth assessed for clinical parameters.
      The four treatment modalities were randomly allocated by a predetermined computer generated
      randomization list (www.randomizer.org) into four equal groups; Group I (control group) open
      flap debridement (OFD): included intrabony defects treated by open flap debridement
      (OFD).Group II perforated membrane (PM): included intrabony defects treated by perforated
      membranes.Group III Leucocyte-platelet rich fibrin (L-PRF): included intrabony defects
      treated by leukocytes platelet rich fibrin (L-PRF). Group IV Leucocyte-platelet rich fibrin +
      perforated membrane (L-PRF + PM): included intrabony defects treated by Leucocyte platelet
      rich fibrin & perforated membranes.
    

Intervention name(s): Open flap debridement; perforated membrane; leucocyte - platelet rich fibrin
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Surgical intevention; surgical intervention; surgical intervention
Other intervention name(s): OFD; perforated guided tissue membrane; regenerative surgery; L-PRF; regenerative surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients equally distributed into 4 groups
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: perforated membrane; L-PRF; guided tissue regeneration; vertical defects; Intrabony defects
A Study Investigating Formulations of Vortioxetine Applied Under the Tongue in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates formulations of vortioxetine applied under the tongue
    

Detailed description: 
      Apart from the first two doses, the study design is flexible in terms of doses and
      pharmaceutical formulations and will be decided upon based on an evaluation of the safety and
      tolerability as well as plasma exposure obtained during the study.

        -  The study consists of 5 periods. Single-doses of vortioxetine will be administered in
           all periods.

        -  All subjects will receive the same pharmaceutical formulations of the same dose strength
           in the same period and sequence.

        -  In Period 1, each subject will receive an intravenous (IV) 10 mg dose of vortioxetine
           infused over 2 hours. The exposure obtained after IV administration will serve as the
           reference for the sublingually administered dosage forms.

        -  In Period 2, each subject will receive 5 mg of formulation A (SLA) of vortioxetine in a
           sublingual (SL) formulation with a holding time of 90 seconds. The holding time is the
           time where swallowing of saliva should be avoided.

        -  For the 3 remaining dosing periods, one or more of the following options in
           pharmaceutical formulation, dose, and dosing condition apply to this study:

             -  Increases or decreases in dose (≤25mg) using same formulation

             -  Change from formulation SLA to formulation SLB

             -  Change in the holding time

             -  Change to formulation SLC

             -  Change in swallowing technique of the sublingual dosage forms
    

Intervention name(s): Vortioxetine IV; Vortioxetine SLA; Vortioxetine SLB; Vortioxetine SLC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): an intravenous (IV) 10 mg dose (1 mg/mL) of vortioxetine infused over 2 hours; 5-25 mg of sublingual formulation A of vortioxetine; 5-25 mg of sublingual formulation B of vortioxetine; formulation SLC: solution of vortioxetine, concentrate (12.5 mg/mL-62,5 mg/mL) 200 uL or 400 uL, SL, 5-25 mg
Intervention MeSH terms: Vortioxetine
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug-Drug Interaction Study Evaluating Effects of ASP015K on Rosuvastatin
Condition: Healthy Subjects; Pharmacokinetics of ASP015K
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study will be to assess the effect of multiple-doses of ASP015K on the
      pharmacokinetics of rosuvastatin in healthy adult male and female subjects.
    


Intervention name(s): ASP015K; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet; oral tablet
Intervention MeSH terms: Rosuvastatin Calcium; Peficitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ASP015K; healthy subjects
A Study to Evaluate Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period
Condition: Actinic Keratosis (AK)
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Once or twice daily 12 week treatment in patients with Actinic Keratosis randomized to
      treatment in one of four arms.
    


Intervention name(s): Low dose DFD07 once daily; High dose DFD07 once daily; High dose DFD07 twice daily; Placebo twice daily
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Low dose DFD07 once daily; High dose DFD07 once daily; High dose DFD07 twice daily; Placebo twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Role of Propolis Paste in Preventing Pain After Root Canal Treatment.
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the role of propolis paste as compared to calcium hydroxide (when used
      as intracanal medication) in prevention and treatment of pain after root canal treatment in
      necrotic (infected) teeth. Half of the participants will receive calcium hydroxide, while the
      other half will receive propolis.
    

Detailed description: 
      Propolis is a developing herbal medicament used in various aspects on dentistry. it is
      extremely biocompatible; has flavanoids; which acts as anti-inflammatory and antimicrobial
      components.

      Calcium hydroxide is a synthetic medication which is antibacterial
    

Intervention name(s): Propolis; Calcium Hydroxide
Intervention type(s): Drug; Drug
Intervention description(s): it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.; it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
Other intervention name(s): Bee glue
Intervention MeSH terms: Propolis; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Flare up