bioihbjkbjnl/mcl2 huggingface dataset:
An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the efficacy and safety of the study drug known
      as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin
      infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes
      mellitus.
    


Intervention name(s): Human regular U-500 insulin (CSII); Human regular U-500 insulin (MDI)
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY041001; LY041001
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insulin pumps; concentrated insulin; OmniPod
A Safety, Tolerability, Pharmacokinetics and Immunogenicity Trial of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051
Condition: Corona Virus Infection
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, first-in-human (FIH), single site, randomized, double-blind,
      placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and
      immunogenicity of single ascending doses of a co-administered (1:1, w/w) combination of
      REGN3048 and REGN3051 mAb's, administered IV in healthy adult volunteers. Study duration of
      approximately 16 months. Approximately 48 evaluable subjects will be enrolled in the study,
      eight (8) subjects in each one of 6 sequential ascending IV dose cohorts. In each cohort,
      subjects will be randomized to receive mAb's REGN3048 and REGN3051 (6 subjects) or placebo (2
      subjects). Primary Objective: To assess the safety and tolerability of REGN3048 and REGN3051
      following co-administration of single, ascending IV doses of 1.5, 5, 15, 25, 50, and 75 mg/kg
      of each of the two mAb's.
    

Detailed description: 
      This is a Phase 1, first-in-human (FIH), single site, randomized, double-blind,
      placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and
      immunogenicity of single ascending doses of a co-administered (1:1, w/w) combination of
      REGN3048 and REGN3051 mAb's, administered IV in healthy adult volunteers. Study duration of
      approximately 16 months. Approximately 48 evaluable subjects will be enrolled in the study,
      eight (8) subjects in each one of 6 sequential ascending IV dose cohorts. In each cohort,
      subjects will be randomized to receive mAb's REGN3048 and REGN3051 (6 subjects) or placebo (2
      subjects). Primary Objective: To assess the safety and tolerability of REGN3048 and REGN3051
      following co-administration of single, ascending IV doses of 1.5, 5, 15, 25, 50, and 75 mg/kg
      of each of the two mAb's. Secondary Objectives: 1) To assess the pharmacokinetic (PK)
      profiles of REGN3048 and REGN3051 following co-administration of single IV doses (1.5, 5, 15,
      25, 50, and 75 mg/kg of each of the two mAb's); 2) To assess the immunogenicity of REGN3048
      and REGN3051 following co-administration of single IV doses (1.5, 5, 15, 25, 50, and 75 mg/kg
      of each of the two mAb's)
    

Intervention name(s): Placebo; REGN3048; REGN3051
Intervention type(s): Other; Biological; Biological
Intervention description(s): Placebo; REGN3048 is a fully monoclonal antibody (mAbs) which binds to the S protein of MERS-CoV.; REGN3051 is a fully human monoclonal antibody (mAb) which binds to the S protein of MERS-CoV. It can reduce virus titers and ameliorate MERS-CoV-induced lung pathology when given post infection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adults; Evaluate; Healthy; Immunogenicity; MERS-CoV; Pharmacokinetics; Phase I; Placebo; REGN MERS; Safety; Tolerability
Bevacizumab Versus Docetaxel/Erlotinib on Tumor Metrics in Patients With Previously Untreated Advanced Non Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for
      treating patients with the diagnosis of advanced Non-Small-Lung-Cancer.
    

Detailed description: 
      In 2008, the Hellenic Co-operative Oncology group (HeCOG) initiated a randomized phase II
      study to determine the comparative efficacy of intermittent docetaxel/erlotinib chemotherapy,
      with erlotinib given for twelve consecutive days either before (group A) or after (group B)
      docetaxel, in chemotherapy-naive patients with advanced non small cell lung cancer. Docetaxel
      chemotherapy was considered one of the valid non-platinum containing therapeutic options at
      that time and today represents one of the approved second-line treatment options after
      failure of first-line platinum based chemotherapy. The trial was terminated early due to slow
      accrual after enrollment of 51 patients and was published in 2014, showing no clinically
      meaningful difference between the two treatment arms.

      Based on the aforementioned trial population,a parallel radiological study was conducted,
      evaluating sequential tumor metrics on computed tomography performed at baseline and after
      each cycle of treatment in patients receiving either bevacizumab or docetaxel/erlotinib.
      Given the differential mechanism of action of these agents, it was hypothesized that the
      different parameters of radiological tumor response evaluation, namely the maximum diameter,
      tumor volume and tumor density, would respond differently for each therapeutic category (a
      chemotherapeutic agent, a molecular agent and and an anti-angiogenic agent). For bevacizumab,
      in particular, it was hypothesized that its unique mechanism of action, inducing central
      tumor necrosis and subsequent shrinkage, would lead to completely different tumor metrics as
      compared to the other two agents. Herein the final results of this analysis are presented,
      showing the comparison of the three agents in terms of tumor response metrics, as evaluated
      in CT scans performed at baseline and after each cycle of treatment
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with non small cell lung cancer evaluated with Computed Scan or Magnetic
        Resonance Imaging.
A Study of IBI311 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      It is designed for Multi-center, double-masked, randomized, placebo- control study with dose
      escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles
      of a single intravenous injection of IBI311 in healthy volunteers.
    


Intervention name(s): placebo; IBI311; IBI311; placebo; placebo; IBI311; IBI311; placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Dose4 placebo of single IV injection; Dose2 IBI311 of single IV injection; Dose4 IBI311 of single IV injection; Dose3 placebo of single IV injection; Dose1 placebo of single IV injection; Dose1 IBI311 of single IV injection; Dose 3 IBI311 of single IV injection; Dose2 placebo of single IV injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software
Condition: Validation Studies
Study type: Interventional

Summary: 
      Integration of the REM-verification within the fitting workflow will enable the hearing care
      professional to easily run real ear measurements. The purpose of the two study parts is to
      prove that an integrated cooperative system, consisting of fitting software and measurement
      system, matches desired responses for certain stimuli faster, more reliably and more
      precisely at the ear drums of hearing instrument wearers than current best practice
      processes.
    


Intervention name(s): Real-Ear Measurement system integrated in hearing aid fitting software
Intervention type(s): Device
Intervention description(s): The subjects individual response of the ear canal gets measured with the help of a probe tube and a following hearing aid fitting.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Dry Heat Application for Menstrual Symptoms
Condition: Reproductive Health
Study type: Interventional

Summary: 
      This randomized controlled trial was to determine the effect of dry heat applied on foot base
      of the 65 nursing students on menstrual symptoms and pain. A statistically significant
      difference was found between the three-day Visual Analog Pain Scale in both intervention and
      control groups. However, there was no difference between Menstruation Symptom Scale subscale
      and total score avg of the intervention and control groups. Applying hot pack to the sole of
      the foot can be expressed as an effective method to reduce pain. However, due to premenstrual
      syndrome is a complex process, the reduction of pain in the later days of the menstrual cycle
      in both groups can be psychological or be explained for physiological reasons.
    

Detailed description: 
      The study was conducted as a randomized controlled trial, a non-blinded between 30 September
      2019 and 29 November 2019. In the first stage of the present study, the Premenstrual Syndrome
      Scale was used for all participants and the study was continued with the students with
      premenstrual syndrome symptoms based on the data acquired from the Premenstrual Syndrome
      Scale. This stage was used only for restricting the sample group, rather than diagnosing or
      treating the students. In the second stage, the randomization of students included in the
      sample group was presented according to the CONSORT diagram. The population of the study
      consisted of 452 female nursing students studying in the faculty of health sciences in a
      university. The students (n=75) who were absent in the school, took analgesics during the
      study, and did not agree to participate in the study, were excluded from the study. The
      students, who had no diagnosis of psychiatric disorder and history of endometriosis, stated
      that they menstruated regularly (between 22-35 days), did not use complementary and
      alternative treatments such as analgesics or massage throughout the study, had no diabetes or
      neuropathic problem causing nerve injury, did not take oral contraceptives, were over 18
      years, and agreed to participate in the study, were included in the study.
    

Intervention name(s): Dry heat application
Intervention type(s): Behavioral
Intervention description(s): Self- dry heat application on the foot during menstrual period with pain.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Menstruation; Hot pack application; Pain
Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients
Condition: Dyslipidaemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients
      with dyslipidemia.
    


Intervention name(s): TAP311 capsules; Placebo
Intervention type(s): Drug; Drug
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: safety; tolerability; pharmacokinetics
Effect of Exercise and Omega-3 on Metabolic Health in Elderly
Condition: Metabolism Disorder; Adiposity; Inflammatory Response
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The aim of this project is to investigate in elderly women, the effect of combined aerobic
      and resistive training and concomitant supplementation with omega-3 fatty acids on
      adipogenesis, metabolic functions and pro-inflammatory status of adipose tissue and on
      systemic metabolic profile.
    

Detailed description: 
      Aging is associated with development of disturbances of lipid and carbohydrate metabolism and
      with systemic pro-inflammatory state similarly to the alterations observed in obese
      individuals. Metabolic and immune dysfunction of adipose tissue has been suggested as an
      important contributing trigger to this condition. EXODYA project is a clinical study in
      elderly individuals that aims to establish benefits of lifestyle intervention and nutritional
      supplementation -either alone or in combination- for the amelioration of systemic and adipose
      tissue metabolic and immune disturbances. Effects of 4 months´ intervention with combined
      aerobic plus resistive exercise training and supplementation with omega-3 polyunsaturated
      fatty acids on systemic metabolic profile and molecular characteristics of adipose tissue
      will be investigated in elderly women. Thus, a proof-of-concept will be provided for novel
      recommendations and guidelines for lifestyle interventions in elderly population
    

Intervention name(s): Exercise training; omega 3 supplementation; placebo
Intervention type(s): Behavioral; Dietary Supplement; Dietary Supplement
Intervention description(s): Combined aerobic and resistive training 3 times a week for 4 months. The strength training will be performed at moderate intensity (i.e., 50-60% of RM), and moderate volume (i.e., 2 to 3 sets per exercise). Endurance training will be performed at moderate- to high-intensity (i.e., 60-85% of VO2max) in the form of continuous and interval training (for high intensities), respectively. The training intensity will be prescribed individually on the basis of the initial exercise testing. Subjects will be thoroughly instructed on effective home-based exercise and advised to exercise in total 5 days a week.; Capsules with high content of omega 3 fatty acids (Calanus oil) will be taken every day with lunch meal. The content of omega-3 fatty acids (EPA, DHA) per day should reach 250 mg.; Capsules with content of omega 6 fatty acids (sunflower oil) will be taken every day with lunch meal.
Other intervention name(s): Calanus oil; sunflower oil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The exercise training intervention with or without omega-3 supplementation (Calanus oil) will be prescribed to non-trained sedentary elderly women
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: elderly; exercise training; adipose tissue; omega-3 polyunsaturated fatty acids; inflammation; diferentiation of preadipocytes
Effects of Hatha Yoga on Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Hatha Yoga is a traditional system of exercises, used in India for the relief of painful
      condition since centuries and gaining more and more interest in Europe and the US. While
      studies have demonstrated benefits of Hatha Yoga for patients with chronic low back pain, no
      studies regarding chronic neck pain are available until now. The purpose of this study is to
      determine if Hatha Yoga can ameliorate chronic neck pain and related restrictions.
    

Detailed description: 
      Hatha Yoga is a traditional system of exercises, used in India for the relief of painful
      condition since centuries and gaining more and more interest in Europe and the US. The
      efficacy of Hatha Yoga for relieving chronic low back pain has been repeatedly demonstrated
      in clinical trials, while there are no studies in the literature regarding chronic neck pain.
      The aim of this study is to investigate, whether a 9 weeks-course of Hatha Yoga reduces
      subjective pain ratings and disability in patients suffering from chronic neck pain.
      Furthermore, as neck pain patients have been shown to suffer from impaired sensory processing
      and proprioception, along with restricted range of motion, the study aims to test if Hatha
      Yoga can improve these variables. Therefore, tests regarding cervicocephalic proprioception,
      active range of motion and the processing of mechanical, vibration and pain stimuli will be
      included.

      58 patients with chronic nonspecific neck pain will be randomized to either Hatha Yoga group
      or control group, receiving information regarding exercises for chronic neck pain. The
      control group will be offered to take part in a Yoga class after the end of the study.
    

Intervention name(s): Hatha Yoga; Information regarding exercises and behaviour
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 9 weeks of Hatha Yoga, designed for treating chronic neck pain, as a group intervention.
One class of 90 minutes per week, 10 minutes training at home each day.; 9 weeks of exercises practiced at home.
Patients receive detailed information regarding appropriate exercises and behaviour for chronic neck pain patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: neck pain; yoga; proprioception; sensory thresholds; randomized controlled trial
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Subjects
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects
    


Intervention name(s): TA-8995; TA-8995; TA-8995; TA-8995; TA-8995; Placebo; Placebo; Placebo; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug: TA-8995 1mg; Drug: TA-8995 2.5mg; Drug: TA-8995 5mg; Drug: TA-8995 10mg; Drug: TA-8995 25mg; Placebo (TA-8995 1mg); Placebo (TA-8995 2.5mg); Placebo (TA-8995 5mg); Placebo (TA-8995 10mg); Placebo (TA-8995 25mg)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MT-8995; Dyslipidemia; Cholesteryl ester transfer proteins
Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of this study is to assess the safety and tolerability of one 25 mg dose of
      psilocybin in participants with anorexia nervosa based on adverse events (AEs), changes in
      vital signs, electrocardiograms (ECGs) and clinical laboratory tests. The secondary
      objectives are to explore the efficacy of a single 25 mg dose of psilocybin on eating
      disorder symptoms and behaviors, body image, anxiety, food related obsessions and rituals,
      and body weight.
    

Detailed description: 
      Because there are no proven treatments that normalize core symptoms in adult anorexia
      nervosa, a disorder with high chronicity, many individuals seek out alternative approaches to
      care. Recent evidence has suggested that anxiety, obsessive compulsive disorder, and
      diminished reward or motivation play key roles in the development and maintenance of
      dysfunctional eating, and poor outcome. In recent years, a growing number of studies have
      demonstrated the safety and preliminary efficacy of psilocybin in clinical trials for a range
      of psychiatric illnesses including treatment resistant depression, obsessive compulsive
      disorder, addiction, and anxiety. Psilocybin may represent a promising new treatment for
      anorexia nervosa. However, no studies have tested psilocybin in this eating disorder
      population. Accordingly, this study aims to establish the safety, tolerability and dosing of
      psilocybin in adult patients with anorexia nervosa, as well as gather pilot data on possible
      efficacy.

      For this study, the investigators will recruit adults who currently have a DSM-V diagnosis of
      anorexia nervosa. Participants will undergo medical and psychological screening and those who
      are deemed eligible will partake in a maximum of 7 study visits, lasting from 4-8 weeks. On
      dosing day, participants will receive a single 25 mg dose of psilocybin along with
      psychotherapeutic support, which includes preparation and integration sessions surrounding
      the experience. There will be a follow-up period of one month following the psilocybin
      session during which a range of psychological measures (questionnaires and interviews) will
      be collected.
    

Intervention name(s): Psilocybin
Intervention type(s): Drug
Intervention description(s): Psilocybin-assisted psychotherapy
Intervention MeSH terms: Psilocybin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anorexia; Anorexia Nervosa Signs and Symptoms; Eating Disorders; Mental Disorders; Psilocybin; Hallucinogens; Physiological Effects of Drugs; Psychotropic Drugs; Psychedelic Drugs
Efficacy and Safety of an Ectoine-containing Cream in the Treatment of Mild to Moderate Atopic Dermatitis
Condition: Mild to Moderate Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      This study evaluates the efficacy of the topical used ectoine-formulation EHK02-01 compared
      to Atopiclair. Patients are examined at visit 2 (baseline visit). The patient topically
      applies EHK02-01 or Zarzenda® twice daily on two symmetric lesional areas over 28 days.
      Response to therapy is recorded at each visit.
    


Intervention name(s): Atopiclair; EHK02-01
Intervention type(s): Device; Device
Intervention description(s): topical applied cream, twice daily; topical applied cream containing 7% ectoine
Other intervention name(s): Zarzenda; MAS063DP; Atopiclair non-steroidal cream; ectoine-containing cream,; 7% Ectoin
Intervention MeSH terms: Glycyrrhetinic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic dermatitis; Ectoine; Treatment; Atopiclair; Medical device