bioihbjkbjnl/mcl2 huggingface dataset:
Gustatory Modulators Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy
Condition: Taste Disorders
MeSH terms: Taste Disorders
Study type: Observational

Summary: 
      Identify possible modulators for developing gustatory dysfunction among a sample of depressed
      Egyptian adults (age from 20 to 50 years old) under anti-depressants therapy ( for at least 3
      months) using a questionnaire ( appendix) with a binary measuring unit (yes/no).
    

Detailed description: 
      PECO

        -  P Population: depressed Egyptian adults under anti-depressants therapy

        -  E1 Exposure 1: commonly prescribed tricyclic antidepressants (Imipramine, Amitriptyline,
           Clomipramine HCL)

        -  E2 Exposure 2: commonly prescribed Selective Serotonin Re-uptake inhibitors
           antidepressants ( Fluoxetine, Fluvoxamine, Sertraline, Citalopram, Paroxetine)

        -  C control (non exposure) : non-pharmacological treatment ( psychotherapy)

        -  O Outcome: Identify possible gustatory dysfunction modulators among these patients using
           a questionnaire ( appendix) with a binary measuring unit (yes/no).
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Depressed Egyptian adults under anti-depressants therapy The patients will be recalled
        using their phone numbers recorded in their follow up records in order to come to the
        Diagnosis center at the faculty of Dentistry, Cairo University to be assessed for possible
        gustatory dysfunction modulators and will be given identification numbers and divided into
        three groups, to which the operator shall be blinded.
Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with
      methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with
      inadequate response to methotrexate.
    


Intervention name(s): TAS5315 low dose; TAS5315 high dose; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration for 12 or 36 weeks; Oral administration for 12 or 36 weeks; Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes
Condition: Refractive Errors; Axial Length, Eye; Corneal Wavefront Aberration
MeSH terms: Refractive Errors; Corneal Wavefront Aberration
Study type: Observational

Summary: 
      Aberrations play a significant role in the visual process and can be divided in lower-order
      and higher-order aberrations. The former can be measured using the commercially available IOL
      Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity.
      Higher-order aberrations do not significantly influence visual acuity but affect the quality
      of vision and can cause halos, double vision, and night vision disturbances.

      Background Cataract surgery has become a routine procedure in the developed countries. During
      this surgery, a foldable intraocular lens is usually inserted into the capsular bag. However,
      these lenses do not account for individual optical biometry data or aberrations. Therefore,
      it is important to provide data for ametropic and emmetropic eyes as this information might
      improve future intraocular lens design and lead to individually adapted lenses for yielding
      optimal visual acuity and quality results.

      The aim of the present study is to clarify the correlation between refractive errors/axial
      eye length and spherical aberrations of the cornea.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participants will be selected by the Department of Clinical Pharmacology
Behavioral Effects of Pregabalin and Cannabis
Condition: Cannabis-use Disorders
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Cannabis is the most commonly used illicit drug in the United States, and its use is
      associated with rates of development of abuse and dependence, treatment admission and relapse
      that are comparable to other illicit drugs. Currently there is no effective pharmacological
      treatment for cannabis-use disorders. The purpose of the present study is to evaluate the
      ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a
      medication for cannabis-use disorders.
    


Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): pregabalin 2x daily for duration of study; placebo 2x daily for duration of study
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: marijuana; addiction; treatment; pharmacotherapy; cannabinoid
Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy in Refractory Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Adenocarcinoma
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      This study is a retrospective study to compare the efficacy and safety between
      trifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) with TAS-102 monotherapy in
      refractory metastatic colorectal cancer (mCRC) from November 2020 to October 2022 at the
      Hunan Cancer Hospital.
    

Detailed description: 
      Our retrospective analysis was conducted to explore the efficacy and safety of patients
      treated with at least 1 cycle of TAS-102 with or without BEV in patients suffering refractory
      mCRC from November 2020 to October 2022 at the Hunan Cancer Hospital. Data from the
      electronic medical records were the sources. In TAS-102 monotherapy group, TAS-102 35
      mg/m²orally twice a day on days 1-5 and 8-12, every 28 days were given to patients, while on
      days 1 and 15, every 28 days, patients received bevacizumab (5 mg /kg, intravenously) in
      TAS-102 plus BEV group. The median OS (mOS) was the primary end point.while mPFS, the ORR,
      the disease control rate(DCR) and the incidence of treatment-related adverse events (TRAEs)
      were the secondary end points.
    

Intervention name(s): Trifluridine/Tipiracil; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days; Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days
Other intervention name(s): TAS-102; Lonsurf; S 95005; Avastin
Intervention MeSH terms: Trifluridine; Bevacizumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study population were the patients treated with at least 1 cycle of TAS-102 with or without
        BEV in patients suffering refractory mCRC from November 2020 to October 2022 at the Hunan
        Cancer Hospital.
      
Keywords: Colorectal cancer; trifluridine/tipiracil ; bevacizumab
CCRC: Understanding the Effects of Omega-3 Fatty Acids Versus Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease
Condition: Body Weight; Lipids; Blood Glucose; Insulin
MeSH terms: Cardiovascular Diseases; Body Weight
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma
      inflammatory markers, and insulin sensitivity.

      We hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease
      triglyceride, total and LDL-cholesterol and increase HDL-cholesterol).

      Flaxseed is the richest dietary source of lignan secoisolariciresinol diglucoside (SDG).
      Lignans are estrogens found in plant sources that behave similar to endogenous estrogens and
      have been associated with cardiovascular benefits due to their antioxidant activity.
      Therefore, we also hypothesize that flax-lignans will cause a significant decrease in LDL
      oxidation and in inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6),
      IL-1B, serum fatty acid binding protein 4 (FABP-4), and serum amyloid attached to high
      density lipoprotein (HDL-SAA).
    


Intervention name(s): Flaxseed
Intervention type(s): Dietary Supplement
Intervention description(s): Flaxseed omega-3 fatty acids and lignans
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Flaxseed; Weight loss; Heart health; Diabetes
Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid
      ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of
      patients with very high triglycerides.

      The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of
      adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects
      treated with fenofibrate in lowering serum triglyceride (TG) levels.
    

Detailed description: 
      Three studies comprise this OM5 Program

        -  Study OM5 / LOV111859 (double-blind study) and OM5X / LOV111860 (1st open-label
           extension) are part of this listing on ClinicalTrials.gov - NCT00246636.

        -  Study OM5XX / LOV111821 (2nd open-label extension) is listed as a separate listing on
           ClinicalTrials.gov - NCT00891293
    

Intervention name(s): Antara (fenofibrate) + Lovaza; Antara (fenofibrate)
Intervention type(s): Drug; Drug
Intervention description(s): Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]; Antara (fenofibrate) + placebo
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Very high triglycerides; omega-3-acid ethyl esters; fenofibrate; Lovaza
Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation
Condition: Retinal Oxygenation; Retinal Blood Flow
MeSH terms: Hypoxia; Hyperoxia
Study type: Interventional
Phase: Phase 4

Summary: 
      Adequate perfusion and oxygenation is essential for the function of the inner retina.
      Although it is known that oxygen tension is very well autoregulated in the retina, the
      physiological mechanisms behind this regulation process are not fully explored. The
      development of new instruments for the non-invasive measurement of oxygen tension in retinal
      vessels now allows for the more precise investigation of these physiological processes. The
      current study seeks to evaluate the retinal oxygen saturation in healthy subjects while
      breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.
    


Intervention name(s): 100% oxygen breathing; 15% oxygen in N2 breathing; 12% oxygen in N2 breathing
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100% oxygen breathing - 30 minutes; 15% oxygen in N2 breathing - 30 minutes; 12% oxygen in N2 breathing - 30 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: retinal oxygen saturation; retinal blood flow; hyperoxia; hypoxia
PF-06741086 Multiple Dose Study in Severe Hemophilia
Condition: Hemophilia A or B
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety, tolerability, pharmacokinetics,
      pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of
      PF-06741086 in subjects with severe hemophilia.
    


Intervention name(s): PF-06741086; PF-06741086; PF-06741086; PF-06741086
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): PF-06741086 subcutaneous (SC) injection; PF-06741086 SC injection; PF-06741086 SC injection; PF-06741086 SC injection
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hemophilia
Knowledge and Attitudes Towards Human Papillomavirus Infections and HPV Vaccination
Condition: HPV-Related Cervical Carcinoma
MeSH terms: Papillomavirus Infections
Study type: Observational

Summary: 
      A better understanding of the target audiences about HPV infection and HPV vaccination would
      surely allow for a better spread of this vaccination in Switzerland. In order to know if the
      target audiences are properly informed, we have decided to carry out a study evaluating their
      level of knowledge on a particular audience that are the men and women undergraduate nurse.
    


Intervention name(s): knowledge questioannaire
Intervention type(s): Behavioral
Intervention description(s): , all enrolled undergraduate student received directly on your email the online questionnaire based on the "Fluid Survey tool", which was an on line survey tool (https://fluidsurveys.com/)
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and women above the age of 18 years, currently attending the School of Health Sciences
        of three selected Swiss towns to obtain a nurse or midwife degree
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different
      times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510
      premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at
      hospitals in Philippines, Vietnam, and Morocco.
    


Intervention name(s): Tamoxifen; Surgery: Oophorectomy
Intervention type(s): Drug; Procedure
Intervention description(s): 20 mg po daily x 5 years; Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
Other intervention name(s): Nolvadex®; ovary removal surgery
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asian; Premenopausal; Women; Oophorectomy
Mobility & Vitality Lifestyle Program
Condition: Obesity
Study type: Interventional

Summary: 
      MOVE UP is a weight management program for adults 60-75 in community settings led by trained
      community health workers.
    

Detailed description: 
      MOVE UP is a weight management program designed for adults who desire to lose weight and
      improve their overall health.

      Topics include: Overall Health, Weight management, Healthy eating, Behavior change, Physical
      activity
    

Intervention name(s): MOVE UP
Intervention type(s): Behavioral
Intervention description(s): Weight management behavioral program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical Function
Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the relative bioavailability of 5 new 400 mg tablet formulations (trial
      formulation II prototypes) of BI 207127 compared to the current 200 mg BI 207127 tablet
      formulation (trial formulation I) in healthy male volunteers with the aim to identify the
      best formulation for further drug development (formulation finding part / trial part 1) and
      to investigate the effect of food on the relative bioavailability of the most promising one
      of these trial formulation II prototypes (food-effect part / trial part 2).
    


Intervention name(s): BI 207127 NA (TF-I); BI 207127 NA (TF-II); BI 207127 NA delayed release; BI 207127 NA extended release (10% HPMC); BI 207127 NA extended release (15% PEO); BI 207127 NA extended release (20% HPMC)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200 mg tablet; 400 mg tablet; 400 mg tablet; 400 mg tablet; 400 mg tablet; 400 mg tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in China
Condition: Gestational Diabetes Mellitus in Pregnancy
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional

Summary: 
      Inositol is a type of food additives, which plays an important role in insulin signal pathway
      and is related to insulin sensitivity. Our randomized, double-centered, placebo-controlled
      study is planned to recruit 360 pregnant women who is in high risk for gestational diabetes.
      They will be assumed randomly 1 g of D-chiro inositol per day or placebo from 12-16th
      gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks.
      Perinatal outcomes about delivery time, neonatal weight will be registered.
    


Intervention name(s): D-chiro inositol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Active group receives inositol 1 gram per day as well as health guidance about diet and exercise. From recruitment until OGTT.; Placebo (similar appearance but not containing myo-inositol) 1 gram per day before meals. Similar health guidance about diet and exercise. From recruitment until OGTT.
Intervention MeSH terms: Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Study of Ketamine Administered Intravenously and by Sublingual Wafer
Condition: Pain
Study type: Observational

Summary: 
      To determine the rate and extent of of absorption of racemic ketamine from sublingual wafer
    

Detailed description: 
      1. To determine the apparent rate of disintegration of the sublingual wafer

        2. To determine the overall clinical tolerability of ketamine when administered as a single
           dose via the sublingual route. Tolerability will be assessed using a range of objective
           and subjective parameters as assessed using modified Likert and Bond and Lader scales.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        8 Healthy Male Volunteers
      
Biospecimen description: 
      Whole blood will be drawn into Vacuette brand, lithium heparin separator tubes (green/yellow
      top).
An Open Single Centre Study To Assess Treatment of Chronic Constipation in Children
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment
      of chronic constipation in children.
    

Detailed description: 
      This was a phase III, open, single centre, non-comparative study. All patients were assigned
      to treatment with Movicol for a period of 12 weeks.

      All patients were screened at Day 0 (Visit 1) when baseline assessment of their bowel
      movements over the previous 14 days were made. Patients were dispensed with Movicol to
      commence treatment on the following day (Day 1). During the first 5 days the dose was
      increased on an every second day basis until normal bowel movement was achieved. Thereafter
      until the end of the study the dosage was titrated according to the stool consistency
      (diarrhoea, loose stool, hard stools or no bowel movement for 2 days, respectively).

      Four on-treatment visits were performed on Day 14 (Visit 2), Day 28 (Visit 3), Day 56 (Visit
      4) and Day 84 (Visit 5). At each visit bowel movements over the previous period were assessed
      by the investigator using the patient's daily diary card data.
    

Intervention name(s): Polyethylene glycol 3350 Na bicarbonate NaCl KCl
Intervention type(s): Drug
Intervention description(s): 6.9g sachet, oral
Other intervention name(s): MOVICOL
Intervention MeSH terms: Polyethylene glycol 3350
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Constipation
Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia
Condition: Androgenic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      Nowadays, multiple treatment modalities have been applied clinically to treat androgenic
      alopecia, such as Follicular unit transplantation(FUT), finasteride, platelet-rich plasma
      injection(PRP), etc. In this clinical trial, the investigators aim to analyze the effect of
      nanofat grafting on treating androgenic alopecia in male.
    

Detailed description: 
      The investigators will treat the hair loss area of a patient by processed nanofat grafting.
      The participants were asked to come back 1、3、6、9、12 months after treatment for further
      follow-up.

      Before and after the treatment, the hair and follicular will be assessed subjectively by
      satisfaction assessment, dermatoscope.
    

Intervention name(s): Nanofat grafting
Intervention type(s): Procedure
Intervention description(s): hair loss area will be treated by processed autologous Nanofat grafting
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nanofat; hair loss; prp