bioihbjkbjnl/mcl2 huggingface dataset:
FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and tolerability of single and multiple escalating doses of FDL169 in
      healthy male subjects.
    

Detailed description: 
      This study is the first time in human study and consists of two parts.

      Part 1A:

      Part 1 of the study is a randomised, double-blind, placebo-controlled, dose-escalation,
      first-time-in-human study to assess the safety, tolerability and PK profiles following single
      oral administrations of FDL169 to healthy male volunteers. Sixty-four (64) male subjects (8
      per cohort) will be included in Part 1 of the study. Up to eight dose levels of FDL169 are
      planned to be tested in Part 1 of the study.

      Part 1B:

      Open label. Following completion of Part 1A of the study, an additional cohort of 8 subjects
      will receive a single dose of FDL169 in both fasted and fed states

      Part 2:

      Part 2 of the study is a randomised, double-blind, placebo-controlled, dose-escalation study
      to assess the safety, tolerability and PK profiles following multiple oral administrations of
      FDL169 to healthy male subjects. Forty-eight male subjects, in cohorts of twelve, will be
      included in Part 2 of the study. It is planned to test up to four dose levels of FDL169 in
      Part 2.
    

Intervention name(s): FDL169; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hepatocellular carcinoma (HCC) is a major tumor type worldwide, especially in China as the
      sequence of hepatitis B and liver cirrhosis. Activation of the coagulation system occurs
      commonly in patients with malignancy. Several studies have suggested that anticoagulant
      therapy may improve survival in patients with malignancy. The low molecular weight heparins
      (LMWHs) lend themselves to such studies because of their effects in experimental models of
      malignancy and the relative ease of administration compared with unfractionated heparin. The
      purpose of the present RCT was to determine whether addition of LMWH to transarterial
      chemoembolization (TACE) would improve HCC patient outcome compared with TACE alone.
    

Detailed description: 
      100 patients will be randomly assigned to receive either TACE alone or TACE plus LMWH. A
      block of every 4 participants and a stratified randomization according to portal vein cancer
      emboli will be used to restrict randomization. LMWH consisted of nadroparin Ca will be given
      at a dose of 4100 U twice daily during 6 weeks after TACE. The time to progression(TTP) and
      overall survival within two years will be used to evaluate the effect of LMWH on HCC.
    

Intervention name(s): LMWH; TACE
Intervention type(s): Drug; Procedure
Intervention description(s): Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks; transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres，pharmorubicin 20mg，5-Fu 1g and Carboplatin 150mg。
Other intervention name(s): fraxiparine; GlaxoSmithKline; transarterial embolization/chemoembolization
Intervention MeSH terms: Nadroparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Liver Neoplasms; Liver Diseases; Digestive System Diseases; Digestive System Neoplasms; Carcinoma, Hepatocellular; Gastrointestinal Neoplasms; Adenocarcinoma; Hepatocellular carcinoma; Neoplasms; Transarterial chemoembolization; Nadroparin; low-molecular-weight heparin; chemoembolization
Alternate-Day Buprenorphine Administration. Phase VIII - 9
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate open buprenorphine dosing with dose choice.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Intervention model: Crossover Assignment
Primary purpose: Treatment
A Study to Investigate the Effect of a New Postural Bio-feedback Device on Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      A postural bio-feedback device worn by subjects for 4-10 hours a day for 6 days spread across
      6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the
      chronic group. The device records movement and muscle activity data relating to the lower
      back. Bio-feedback is delivered to the subject as an audible tone, visual cue or vibration
      and aims to prompt the subject to alter their posture or position in line with
      recommendations given by the treating practitioner. Four small sensors are adhered to the
      lower back and send data wirelessly to a data logger carried in the pocket by the subject
      (the size of a small mobile phone).
    


Intervention name(s): BSM device with bio-feedback; BSM device with no bio-feedback
Intervention type(s): Device; Device
Intervention description(s): A postural bio-feedback device worn by subjects for 4-10hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group. The device records movement and muscle activity data relating to the lower back. Bio-feedback is delivered to the subject as an audible tone, visual cue or vibration and aims to prompt the subject to alter their posture or position in line with recommendations given by the treating practitioner. Four small sensors are adhered to the lower back and send data wirelessly to a data logger carried in the pocket by the subject (the size of a small mobile phone).; The BSM device is worn as a placebo with no bio-feedback given to the subject. The subjects in the control group wear the device for 4-10 hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group.
Other intervention name(s): ViMove; ViMove with no Feedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dorsavi; vimove; biofeedback; objective movement data; back pain
Selective Block of the Axillary Nerve in Postoperative Pain Management
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In this study the investigators wish to compare the effect of a selective axillary nerve
      block to placebo in patients undergoing arthroscopic shoulder surgery.

      It is the investigators hypothesis that the amount of morphine consumption in the first 4
      hours postoperatively in the intervention group will be significant lower than in the placebo
      group.
    


Intervention name(s): ropivacaine; Sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): Single shot nerve block with ropivacaine 10-20 ml; 7,5 mg/ml; Single shot nerve block with isotonic sodiumchloride 10-20 ml; 0.9%
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      An intervention consisting of group and home based exercise will be used over 6 months to
      assess whether this is helpful in managing urinary incontinence in elderly village women in
      Bangladesh. This intervention, supplemented by education about managing incontinence, will be
      used in half the villages in the trial. In the other half women will receive only the
      education component.
    

Detailed description: 
      This is a cluster randomized trial in which all women aged 60-75 years reporting symptoms of
      urinary incontinence are randomly assigned, by village of residence, to either exercise plus
      education of to education alone.
    

Intervention name(s): Mobility and pelvic floor exercise; Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mobility and pelvic floor exercises; Education on simple ways to manage incontinence
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Prosthetic Rehabilitation on Nutritional Status of Geriatric Patients
Condition: Nutrition Disorders; Edentulous Jaw
MeSH terms: Jaw, Edentulous; Mouth, Edentulous; Nutrition Disorders
Study type: Observational

Summary: 
      This study examines the effects of prosthetic treatment options applied to edentulous
      geriatric individuals who applied to Marmara University Faculty of Dentistry on chewing
      function, food consumption status, malnutrition status and oral health-related quality of
      life.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients over 50, who were admitted to Marmara University Faculty of Dentistry, Department
        of Oral and Maxillofacial Surgery, to have two implant-supported overdenture prostheses
        made, will be included in the study.
      
Keywords: Aged Nutrition Physiology; Dental implants; Overdenture
Lurasidone Pediatric Bipolar Study
Condition: Bipolar I Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and
      adolescents with bipolar I depression
    

Detailed description: 
      This is a randomized, parallel, double-blind, placebo-controlled study designed to evaluate
      the efficacy and safety of flexibly dosed lurasidone (20 - 80 mg/day) for 6 weeks compared
      with placebo in children and adolescent subjects with depression associated with Bipolar I
      Disorder (bipolar depression).
    

Intervention name(s): Lurasidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lurasidone flexibly dosed 20-80 mg once daily; Placebo Comparator once daily
Other intervention name(s): Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lurasidone, Latuda, Bipolar Depression
KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study evaluates the KONTAKT social skills group training in Australian adolescents on
      the autism spectrum compared to an active control group which is a group cooking class
    

Detailed description: 
      KONTAKT is a manualized Social Skills Group Training program designed for children and
      adolescents with ASD which aims to improve communication, social interaction skills, reduce
      the severity of ASD symptoms, improve the ability to empathise and adapt in a group setting.
      A large randomized controlled trial in Sweden found that adolescents who participated in
      KONTAKT demonstrated improvements in social skills, behaviour, reduced stress and improved
      overall functioning as reported by parents immediately following and at three months after
      the program. However, social skills are at least in part influenced by social cultural
      contexts and there is a need to understand the feasibility, acceptability and effectiveness
      of KONTAKT in an Australian context. Moreover, in the previous studies, the social skills
      groups were compared to treatment as usual groups. Therefore, this study evaluates the
      KONTAKT social skills group training in Australian adolescents on the autism spectrum
      compared to an active control group which is a group cooking class
    

Intervention name(s): KONTAKT Australia; Super Chef
Intervention type(s): Behavioral; Other
Intervention description(s): KONTAKT is a manualized Social skills group training program designed for children and adolescents on the Autism Spectrum aimed at improving communication, social interaction skills, the severity of ASD symptoms, and the ability to empathise and adapt in a group setting. The KONTAKT participants (4-8 participants) meet face to face weekly for 16 weeks for an hour and a half in a group facilitated by two trainers.; The Super Chef is a cooking group designed for this study for adolescents on the Autism Spectrum, aimed at teaching basic cooking skills in a social environment. The Super Chef participants (4-8 participants) meet face to face weekly for 16 weeks for an hour and a half in a group facilitated by two trainers.
Other intervention name(s): KONTAKT; Social cooking group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants will be randomly allocated into an intervention group (KONTAKT Australia) and an active control group (Social cooking group).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: social skills group training; Adolescents; Active control group; Australian
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study was to investigate the safety and tolerability of M5717 and
      to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and
      parasite clearance in healthy participants following infection with Plasmodium falciparum.
    


Intervention name(s): M5717; Placebo; M5717
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants received single ascending oral dose of M5717 after at least 8 hours of fasting together with water on Day 1, followed by a 4-hour post-dose fast; Participants received placebo matched to M5717; Participants received single ascending oral dose of M5717 from Part A after at least 8 hours of fasting together with water on Day 1, followed by a 4-hour post-dose fast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Healthy Participants; M5717; Malaria; Plasmodium falciparum
Safe & Easy for Alzheimer's Disease and Related Pathologies
Condition: Cognitive Deterioration
Study type: Interventional

Summary: 
      All over the world the increasing prevalence of chronic disorders and its impact on
      functional decline is challenging the sustainability of health care systems. Older
      individuals also frequently experience the reversible "frailty syndrome", which overlaps with
      chronic diseases, increasing incidence of disability.

      Building a global system aiming to take in charge all causes leading to loss of autonomy is a
      rather complicated task involving numerous Information and Communication technologies (ICT)
      solutions which are not always easy to use in everyday life.

      The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality
      of life of older people at risk.

      The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation
      aromatherapy automatic fragrance ...) .

      The goal of this study is to validate the acceptability, sensitivity and efficacy of the
      systems.
    

Detailed description: 
      The non pharmacological therapeutic will be install at hospital room :

        -  aromatherapy,

        -  music therapy,

        -  cognitive training in multimedia application offering cognitive games.
    

Intervention name(s): Patient's answer with non pharmacological therapeutic
Intervention type(s): Other
Intervention description(s): Installation at patient's home of :
aromatherapy
music therapy
cognitive training in multimedia application offering cognitive games
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
High Dose of Amoxicillin and Metronidazole Plus Bismuth For Helicobacter Pylori Treatment
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      Amoxicillin and metronidazole （400mg Q.D.S） based quadruple therapy had achieved a high cure
      rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate
      the efficacy and safety of the amoxicillin and metronidazole (400mg thrice a day) based
      triple therapy and the addition of bismuth in the naive patients with helicobacter pylori
      infection.
    


Intervention name(s): Esomeprazole; Amoxicillin, Metronidazole; Bismuth Potassium Citrate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Proton pump inhibitor; Antibiotics for H. pylori eradication; Gastric mucosal protective drug with anti-H. pylori effect
Intervention MeSH terms: Amoxicillin; Metronidazole; Potassium Citrate; Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Helicobacter pylori Therapy
Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg
    

Detailed description: 
      To compare the single-dose bioavailability of Kali's Ondansetron ODt 8 mg with that of
      GlaxoSmithKine's Zofran 8 mg under fed conditions
    

Intervention name(s): Ondansetron; Zofran
Intervention type(s): Drug; Drug
Intervention description(s): ODT, 8 mg, single-dose, fed conditions; ODT, 8 mg, single-dose, under fed conditions
Other intervention name(s): Zofran ODT; Ondansetron ODT
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence; Ondansetron ODT; fed; To determine bioequivalence under fed conditions
Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will explore the dose-response of losartan as well as the safety and tolerability
      in children from 6 months to 6 years of age.
    


Intervention name(s): losartan potassium
Intervention type(s): Drug
Intervention description(s): losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.
Other intervention name(s): Cozaar
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing Health Electronically for Adolescent and Young Adult Oncology
Condition: Risk Reduction Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to modify an existing Seattle Children's Hospital
      investigator-developed, patient-centered, electronic health assessment (eHA) called "Check
      Yourself" for AYAs with cancer. The investigators will then evaluate the new eHA prototype
      for feasibility and acceptability among AYAs with cancer and their oncology providers.
    

Detailed description: 
      Unmet needs among Adolescents and Young Adults (AYAs) with cancer translate to poor physical
      and psychosocial outcomes. This is particularly true when it comes to AYA sexual health. Our
      team has found that intimate relationships and risky health behaviors are common among AYAs
      during their cancer experience, that oncology clinicians rarely ask about these behaviors,
      and that AYAs rarely volunteer to share these behaviors. As a result, AYAs with cancer are
      deprived of the surveillance, anticipatory guidance, and normative support participants would
      have received if participants were well. Currently there is no standard screening process for
      risk behaviors and the recommended psychosocial screening for AYAs in the SCH oncology clinic
      setting. To address this problem, the investigators propose to adapt a validated AYA-targeted
      electronic health assessment (eHA) screening tool for use in oncology clinics.

      The purpose of this study is to modify an existing Seattle Children's Hospital
      investigator-developed, patient-centered, electronic health assessment (eHA) for AYAs with
      cancer. The investigators will then evaluate the new eHA prototype for feasibility and
      acceptability among AYAs with cancer and their oncology providers.

      AIM 1. To evaluate the modified eHA program prototype for feasibility, acceptability, and
      process measures. The investigators will enroll a cohort of N=25 AYAs with cancer and N=10
      providers from our institution to "beta-test" the program.

      Hypothesis 1: There will be applicable and nonapplicable eHA content for AYAs with cancer in
      the current electronic health assessment (eHA) tool in addition to content relative to AYAs
      with cancer that should be developed and added.

      Hypothesis 2: AYAs will report that the modified AYA oncology specific eHA is both useful and
      easy to use. Additionally, oncology providers will report that the eHA tool was useful and
      positively impacted patient care.
    

Intervention name(s): Check Yourself - Oncology
Intervention type(s): Behavioral
Intervention description(s): A validated AYA-targeted electronic health assessment (eHA) screening tool for use in oncology clinics.
Other intervention name(s): Electronic Health Assessment (eHA)
Intervention model: Single Group Assignment
Intervention model description: Single center pilot feasibility study.
Masking: None (Open Label)
Primary purpose: Screening