bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial For Early SARS-CoV-2 (COVID-19) Treatment
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a randomized, double-blinded, and placebo controlled phase III clinical trial
      which aims to investigate the superiority of hydroxychloroquine, favipiravir or
      hydroxychloroquine + favipiravir treatment, initiated especially in the early period in the
      treatment of COVID-19, over the patients being followed up with placebo in adults aged 18~59
      Years.
    

Detailed description: 
      This study is a randomized, double-blinded, and placebo controlled phase III clinical trial
      in in adults aged 18~59 Years. The study was planned as a multicenter, randomized controlled,
      double-blind, parallel-arm drug study. The purpose of this study is to evaluate the efficacy
      and safety of hydroxychloroquine, favipiravir, or hydroxychloroquine + favipiravir treatments
      that were initiated early in patients who were caught during filiation or who were decided to
      be outpatient due to mild disease findings during hospital admission, after the diagnosis of
      COVID-19 against patients with placebo. It is planned that the study will be conducted with
      two separate arms. Study arms are planned as 2:2:2:1 for 320:320:320:160 patients as follows.
      The dose of Favipiravir has been determined as the standard dose. Hydroxychloroquine will
      also be given without a loading dose.
    

Intervention name(s): Hydroxychloroquine; Favipiravir; Favipiravir + Hydroxychloroquine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval + Placebo [Favipiravir (1600 mg)], as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval.; Favipiravir (1600 mg), as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Placebo [Hydroxychloroquine (200 mg)], as two tablets per day for 5-day interval.; Favipiravir (1600 mg), as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval.; Placebo [Favipiravir (1600 mg)], as two tablet per day at the first day and then Placebo Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval.
Other intervention name(s): Hydroxychloroquine sulfate; Favicovir Film Tablet; Favicovir Film Tablet + Hydroxychloroquine sulfate
Intervention MeSH terms: Hydroxychloroquine; Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COVID-19; Hydroxychloroquine; Favipiravir
Effect of 4-week Oral Administration of a Fermented Dairy Product Containing Lactobacillus Rhamnosus CNCM I-3690, on Subjective State Anxiety Levels in Healthy Women Undergoing Academic Stress.
Condition: Anxious Healthy Subjects
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of Lactobacillus rhamnosus CNCM I-3690
      consumption on subjective anxiety levels in healthy subjects undergoing academic stress.
    


Intervention name(s): Milk product fermented by lactic bacteria or not fermented
Intervention type(s): Other
Intervention description(s): 2 bottles of 100g consumed daily during 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A proof-of-efficacy, randomized, controlled, double-blind, monocentric, parallel arms design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: anxiety, academic stress, healthy women, fermented diary product, randomized controlled trial
Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping
Condition: Alzheimer Disease; Preclinical Alzheimer's Disease; Prodromal Alzheimer's Disease; Alzheimer's Disease (Incl Subtypes); Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Observational [Patient Registry]

Summary: 
      The primary objective of the study is to evaluate whether a set of algorithms analysing
      acoustic and linguistic patterns of speech can detect amyloid-specific cognitive impairment
      in early stage Alzheimer's disease, as measured by the AUC of the receiver operating
      characteristic (ROC) curve of the binary classifier distinguishing between amyloid positive
      (Arms 1 and 3) and amyloid negative (Arms 2 and 4) Arms. Secondary objectives include (1)
      evaluating whether similar algorithms can detect amyloid-specific cognitive impairment in the
      cognitively normal (CN) and MCI Arms respectively, as measured on binary classifier
      performance; (2) whether they can detect MCI, as measured on binary classifier performance
      (AUC, sensitivity, specificity, Cohen's kappa), and the agreement between the PACC5 composite
      and the corresponding regression model predicting it in all Arms pooled (Wilcoxon signed-rank
      test, CIA); (3) evaluating variables that can impact performance of such algorithms of
      covariates from the speaker (age, gender, education level) and environment (measures of
      acoustic quality).
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be identified primarily through data-base searches of the Investigator
        sites.
      
Keywords: Alzheimer's disease; Preclinical Alzheimer's disease; Prodromal Alzheimer's disease; Mild Cognitive Impairment; Normal Cognition; Amyloid; Speech; Acoustic; Language; Linguistic; Machine Learning; Artificial Intelligence
Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      randomized clinical study to evaluate 'caries management by risk assessment' Versus
      'international caries classification and management system' Caries Risk Assessment Models
      Acquisition On Treatment Plan In Young Adult Population with null hypothesis that
      International Caries Classification and Management System (ICCMS™) will have the same
      clinical performance as Caries management by risk assessment (CAMBRA)
    

Detailed description: 
      . (ICCMS™) Comprehensive Patient Care Pathway considered as significant development from the
      traditional system of treatment plan. Comprehensive patient care should include all recent
      information related to the biological, social, behavioral, cultural, systemic, and
      dental/oral risk factors which help development and progression of dental caries. (ICCMS™)
      also report all essential decisions that aid to preserve tooth structure; as diagnosis,
      prevention and restoration only if indicated [9]. Moreover ( ICCMS™) deals with caries as a
      disease and not as a lesion, prevent development of initial caries lesions, and restore
      moderate or extensive caries lesions with the aim of preserving of tooth structure as much as
      possible.

      Follow up period is selected to be 12 months, since risk category is changed for better or
      worse over 1-2 year.
    

Intervention name(s): ICCM; CAMBRA
Intervention type(s): Other; Other
Intervention description(s): comprehensive system for caries management; Caries risk assessment model
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: caries prevention; caries management
The Use of Lung Ultrasonography in COVID-19 Patients
Condition: Ultrasonography
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      In COVID-19 patients hospitalized in the intensive care unit due to respiratory failure, lung
      ultrasonography will be tried to be given an appropriate position that will effectively use
      lung capacity and its effect on oxygenation will be investigated.
    

Detailed description: 
      In this study, the COVID-19 patients hospitalized in the intensive care unit due to
      respiratory failure will be evaluated. Participants will be divided into two groups as
      patients undergoing lung ultrasonography (Group Ultrasonography ) and those without lung
      ultrasonography (Group Control).

      While performing lung ultrasonography, each hemithorax will be evaluated using anterior
      axillary line and posterior axillary line into anterior, lateral and posterior region, and
      each region will be divided into 6 quadrants, upper and lower. Each hemithorax will be
      scanned by the investigators, scored in 6 regions using a convex ultrasonography probe with
      the Lung Ultrasound Score (LUS score).

      Participants in both groups will be evaluated by comparing arterial blood gas analyzes before
      examination (with/without ultrasonography), at the 2nd and 12th hours. Is there any change in
      arterial blood gas values such as PO2 and PCO2 at 0, 2 and 12 hours so that oxygenation and
      ventilation between Group Ultrasonograpy and Group Control will be evaluated?
    

Intervention name(s): mechanical ventilator settings and position
Intervention type(s): Behavioral
Intervention description(s): Mechanical ventilation settings and patient position will be re-evaluated
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients will be divided into two groups, those with and without ultrasound.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: lung ultrasonography; intensive care unit; position; COVID-19
The Consistency of Drug Screening in Vitro and Neoadjuvant Chemotherapy Results in Breast Cancer Patients
Condition: Breast Cancer; Drug Effect
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be
      resectable and improve breast conservation rate. Patients with triple negative or Her2
      enriched subtype who achieved pCR after neoadjuvant chemotherapy would have better survival.
      But the overall pCR rate of breast cancer was about 20%. And patients with luminal like
      subtype were less reactive for neoadjuvant chemotherapy. Improving pCR rate maybe could
      achieve better survival. So, different methods have tried to select effective drug before
      chemotherapy.Drug sensitivity screening in vitro for different chemotherapy drugs was a
      promising method. This study will explore whether drug screening by culturing breast cancer
      cells in vitro from breast cancer tissue could consistent with neoadjuvant chemotherapy in
      patients.40 breast cancer patients were recruited.The results of drug sensitivity in vitro
      and pathological evaluation after neoadjuvant chemotherapy were compared whether they were
      consistent.
    

Detailed description: 
      Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be
      resectable and improve breast conservation rate. Patients with triple negative or Her2
      enriched subtype who achieved pCR after neoadjuvant chemotherapy would have better survival.
      But the overall pCR rate of breast cancer was about 20%. And patients with luminal like
      subtype were less reactive for neoadjuvant chemotherapy. Improving pCR rate maybe could
      achieve better survival. So, different methods have tried to select effective drug before
      chemotherapy.Drug sensitivity screening in vitro for different chemotherapy drugs was a
      promising method. This study will explore whether drug screening by culturing breast cancer
      cells in vitro from breast cancer tissue could consistent with neoadjuvant chemotherapy in
      patients.40 breast cancer patients who would receive neoadjuvant chemotherapy were
      recruited.Breast cancer tissues were obtained before chemotherapy. The breast cancer cells
      were cultured in unadhesive dishes. Chemotherapy drugs were put in dishes and drug
      sensitivity were evaluated. Patients received operation and pathological evaluationc after
      neoadjuvant chemotherapy. The results of drug sensitivity in vitro and pathological
      evaluation after neoadjuvant chemotherapy were compared whether they were consistent.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients in this study were invasive early breast cancer patients who were candidate for
        neoadjuvant chemotherapy.
      
Biospecimen description: 
      blood sample were retention
Treadmill Training and Quality of Life in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease (PD) causes motor and non-motor impairments that affect the quality of
      life of the subjects. The purpose was to assess the effects of treadmill walking training
      with additional body load on the quality of life and motor symptoms of the subjects with PD.

      Methods: Nine subjects with PD, Hoehn and Yahr stages 2 through 3, not demented and with
      capability to ambulate independently voluntarily participate in this study. The training
      program was divided into three phases (A1-B-A2): treadmill training with additional body load
      (A1), control condition (conventional physical therapy group) (B) and treadmill training with
      load again (A2). Each phase lasted six weeks. The quality of life and motor symptoms were
      assessed by PDQ-39 and UPDRS, respectively. Both evaluations and training were performed
      during on-phase of the medication cycle.
    


Intervention name(s): Treadmill walking training with additional body load
Intervention type(s): Other
Intervention description(s): The training program was divided into three phases (A1-B-A2):
treadmill training with additional body load (A1),
control condition (conventional physical therapy group) (B). and
treadmill training with additional body load again (A2).
Each phase lasted six weeks, totaling 18 weeks. Both evaluations and training were performed during on-phase of the medication cycle.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treadmill training; body load; quality of life; Parkinson's disease; Motor Symptoms
Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      comparing two local anaesthetic agents, Bupivacaine 0.5% versus Oxybuprocaine used topically
      to provide surface anaesthesia before IVI procedures.
    

Detailed description: 
      In preparation zone, we will cannulate the patients, connect them to the pulse oximetry and
      we will start providing appropriate surface anaesthesia for an adequate period of time before
      the patient administration of the injection, by applying the anaesthetic agents, 3 times with
      5 minutes interval, for 15 minutes and then waitng the injection

      All patients are informed that they are going to receive topical anaesthetic agent before the
      IVI.

      pain is monitored during the injection by using the 11 points verbal numerical pain scaling
      as zero is for no pain and 10 is for severe unbearable pain.
    

Intervention name(s): bupivacaine 0.5% and oxubuprocaine
Intervention type(s): Drug
Intervention description(s): using each drug as surface anesthesia before intravitreal injections
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blinded randomized syudy
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
ABILITY - TelerehABILITation: TechnologY-enhanced Multi-domain at Home Continuum of Care Program
Condition: Cognitive Impairments; Dementia; Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The Ability research project, funded in Italy within the Smart Cities and Smart Communities
      funding program (MInistry of University and Research, Operational Regional Programme,
      Lombardy, Axis 1, Operational Regional Programme - European Funding for Regional Development
      2007-2013), aims at developing and testing the efficacy and the impact of a Personal Smart
      Health Community able to provide innovative trajectories for people with cognitive
      impairment, putting them at the core of a continuous and intertwining treatment and support
      from both formal (e.g. physicians) and informal (e.g. near relatives) caregivers, with
      special focus on home-based care.

      Within this framework of the Ability project the investigators test the efficacy of the
      home-based motor-cognitive rehabilitation program delivered with two different approaches:
      the Ability platform versus the usual care program
    


Intervention name(s): Ability platform program; Usual care program
Intervention type(s): Other; Other
Intervention description(s): The Ability program is an at home participant-tailored and technology-enhanced platform a) delivering tablet-based intensive (five days/a week for six weeks) motor and cognitive activities; b) monitoring from remote vital and physical health parameters (i.e., weight, Heart Rate, O2 saturation, daily steps, sleep activity).; Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Hypo-fractionated Postoperative IMRT in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for
      prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP
      or diagnosis of biochemical relapse were included. Patients received 62.5 Gy to the prostate
      bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was
      prescribed based on NCCN risk categories. Median follow-up was 30 months.
    

Detailed description: 
      To report the outcome of hypo-fractionated radiation therapy after radical prostatectomy (RP)
      for prostate cancer (PCa) using intensity-modulated radiation treatment with simultaneous
      integrated boost (IMRT-SIB).

      One hundred and twenty-four patients with PCa at high risk of relapse after RP or diagnosis
      of biochemical relapse were included in this phase II study (adjuvant: 106 patients, salvage:
      18 patients). All patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis
      nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk
      categories. Acute and late toxicities were recorded and evaluated according to RTOG
      (Radiation Therapy Oncology Group) criteria and RTOG-EORTC (European Organization for
      Research and Treatment of Cancer) scale, respectively.

      Median follow-up was 30 months (13-92).
    

Intervention name(s): Hypo-fractionated postoperative IMRT-SIB
Intervention type(s): Radiation
Intervention description(s): intensity-modulated radiation treatment with simultaneous integrated boost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adjuvant; hypofractionation; IMRT; phase I-II; prostate neoplasms; radiotherapy
Step by Step: A Tailored Walking Intervention for Breast Cancer Survivors
Condition: Sedentary Lifestyle; Breast Neoplasms; Survival Rate (Survivorship)
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm
      randomized walking intervention. All intervention materials will be delivered electronically.

      The investigators hypothesize that at the end of 12-weeks, participants randomized to the
      intervention group will engage in more weekly steps than those participants randomized to the
      comparison group.
    

Detailed description: 
      More than two-thirds of breast cancer survivors are physically inactive. Inactivity is known
      to negatively impact both morbidity and mortality, and is especially pronounced among cancer
      survivors. Self-directed interventions targeting inactivity among breast cancer survivors
      often report clinically insignificant behavior change. More successful behavior change
      interventions have suggested that tailoring and, more recently, the fostering of intrinsic
      motivation, may have improved outcomes. However, no interventions to date have utilized these
      approaches to increase physical activity among sedentary cancer survivors.

      AIM 1: Develop and test intervention (tailored) and comparison group (targeted) messages in a
      sample of sedentary women to determine message acceptability.

      AIM 2: Determine the efficacy of a 12-week tailored intervention to increase the number of
      weekly steps taken among sedentary post-treatment breast cancer survivors compared to a
      12-week, targeted intervention.
    

Intervention name(s): Tailored Email; Targeted Email
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive tailored emails.; Participants will receive targeted emails.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
First In Human Study Of Increasing Oral Doses Of PF-04634817
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the hypothesis that at doses and plasma concentrations which affect
      pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound
      is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic
      profile is robust and consistent with a once or twice a day therapeutic administration.
    


Intervention name(s): PF-04634817 Placebo; PF-04634817; PF-04634817; PF-04634817; PF-04634817; PF-04634817; PF-04634817; PF-04634817; PF-04634817; PF-04634817; PF-04634817 Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral solution, placebo, single dose; Oral solution, 1mg, single dose; Oral solution, 3mg, single dose; Oral solution, 10mg, single dose; Oral solution, 30mg, single dose; Oral solution, 100mg, single dose; Oral solution, 300mg, single dose; Oral solution, 600mg, single dose; Oral solution, 900mg, single dose; Oral solution, up to 900mg, single dose after food; Oral solution, placebo, single dose after food
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase1; pharmacokinetics; safety; toleration; pharmacodynamics