bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies:
      Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2
      (SS2) will be open label and enroll subjects with compensated cirrhosis.
    


Intervention name(s): ABT-450/r/ABT-267; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; ABT-450 coformulated with ritonavir and ABT-267; Tablet
Other intervention name(s): ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ritonavir also known as Norvir; VIEKIRAX Combination Tablets; Qurevo; Technivie; VIEKIRA Combination Tablets
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; Genotype 1b; Cirrhotic; Treatment Experienced; Treatment Naive; Japanese; ombitasvir; paritaprevir; ritonavir; VIEKIRAX Combination Tablets
Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures
Condition: Proximal Humerus Fractures
MeSH terms: Fractures, Bone; Humeral Fractures
Study type: Interventional

Summary: 
      Primary purpose of this study was to compare functional outcomes after displaced and proximal
      humerus fracture between nails and locked plates.

      The hypothesis is that intramedullary nails provides satisfactory fixation and functional
      outcome compared to locked plate.
    

Detailed description: 
      : Proximal humerus fractures have a higher occurrence in elderly patients and therefore
      represent a public health problem.

      Prognosis depends on greater and lesser tuberosity status, where rotator tendons of the
      shoulder have their insertion site.

      Surgical treatment is recommended in case of tuberosities displacement. Goals are their
      anatomic reduction and stable primary fixation that will allow good bone healing and early
      mobilization. It has been demonstrated that an extended immobilization can result in
      stiffness by capsular retraction. On the contrary a too early mobilization can lead to
      secondary displacement of tuberosities and malunion.

      These sequelae can be responsible for real disability when occuring in active patients, in
      particular when dominant limb is affected.

      Internal fixation by locking intramedullary nails is currently the first choice technique
      because less invasive. However it doesn't always provide a good bone fixation, leading to
      tuberosities displacement or longer immobilization that decrease shoulder function prognosis.
      Locking plates represent a good alternative to avoid these complications by offering a better
      fixation of tuberosities in osteoporotic bone.

      Though there is no existing randomised study comparing these techniques regarding functional
      outcomes, complications rates, and patient satisfaction.
    

Intervention name(s): Intramedullary nail; Locked plate
Intervention type(s): Procedure; Procedure
Intervention description(s): the fracture was reduced and fix by an intramedullary humeral nail (Multilock, SYNTHES, Switzerland) using an open surgery. An anterolateral approach will be performed, the patient sit in beach chair position under general anesthesia. If required additional sutures will be authorized to fix the tuberosities.; the fracture was reduced and fix by a locking plate using an open surgery (SURFIX, Integra, France). A deltopectoral approach will be performed, the patient sit in beach position under general anesthesia. If required, additional sutures will be authorized to fix the tuberosities.
Other intervention name(s): SURFIX, Integra; Multilock, SYNTHES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Humerus; fracture; nail; plate; tuberosity
Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal
      vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine
      antibody response against meningococcal serogroup C disease.
    

Detailed description: 
      The study has 2 study groups. One group will receive one dose of GSK Biologicals' vaccine GSK
      134612 and the other group will receive one dose of licensed MenC-CRM197 vaccine. All
      subjects will have 2 blood samples taken: just before vaccination and one month after
      vaccination.
    

Intervention name(s): GSK Biologicals' meningococcal vaccine GSK134612; Menjugate
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular administration, 1 dose; Intramuscular administration, 1 dose
Other intervention name(s): MenC-CRM197vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Conjugate vaccine; Meningococcal disease; Immunogenicity; Meningococcal vaccine; Safety
Osteopathic Manipulative Treatment Induces Functional Connectivity Changes
Condition: Osteopathic Manipulative Treatment
Study type: Interventional

Summary: 
      Osteopathic Manipulative Treatment (OMT) is a whole-body intervention mainly focused on
      correcting the somatic dysfunctions present in different regions of the body. Osteopathic
      research to date has mostly been concerned with various clinical conditions such as
      musculoskeletal disorders and primary headache. The neurophysiological effects underlying
      clinical improvements are still under debate. Although models explaining the therapeutic
      effects of OMT include the potential for higher brain mechanism, OMT effects on functional
      brain connectivity is not fully understood and still lacking in healthy adults. Magnetic
      resonance imaging (MRI) research includes several different approaches to estimate cortical
      functions. Several of these approaches have demonstrated functional brain changes associated
      with OMT. Using Arterial Spin Labeling MRI, recently was demonstrated that the treatment of
      somatic dysfunctions induces cerebral perfusion changes in asymptomatic young participant.
      Thus, the aim of this study is to explore the neural correlates associated with OMT effect in
      terms of cerebral functional connectivity, as derived by complex network analysis of resting
      state fMRI data recorded in asymptomatic young volunteers with somatic dysfunctions
    


Intervention name(s): OMT; MP
Intervention type(s): Other; Other
Intervention description(s): OMT techniques were focused on correcting the dysfunctions found during the initial physical examination and included articular and myofascial techniques, balanced ligamentous tension, visceral manipulations and osteopathy in the cranial field; MP treatment was performed by the same osteopaths who performed OMT and was carried out in the same hospital setting. P treatment consisted of a passive touch without joint mobilization in a protocolled order. The osteopaths were standing next to the bed, they touched lumbar and dorsal spine of the subjects in prone position for 10 minutes, and then in supine position, they touched for 10 minutes the shoulders, the hips, then the neck, the sternum and the chest were touched for 5 minutes each. Another researcher on the placebo protocol specifically trained the osteopaths.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is planned to evaluate the safety (in terms of occurrence of any serious adverse
      events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to
      develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants
      aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and
      in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study
      will be performed in four European countries (France, Poland, Spain, and Portugal). The
      Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      This is a Phase 3b study.

      Each study group is further stratified into two sub-groups depending on the gestational age
      at birth of the subject:

        -  Stratum I: very pre-term infants, born after a gestational period of 27-30 weeks
           (189-216 days) (20% of enrolment).

        -  Stratum II: mild pre-term infants born after a gestational period of 31-36 weeks
           (217-258 days) (80% of enrolment).

      The study will be conducted in a double-blind manner with respect to the HRV vaccine and
      placebo. The study will not be blinded with respect to the type of concomitantly administered
      routine infant vaccination.

      In accordance with the local National Plan of Immunisation schedule in each of the respective
      participating countries, GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib), Infanrix Quinta™
      (DTPa-IPV-Hib), Infanrix™+IPV+Hib (DTPa+IPV+Hib) and/or Engerix-B™ (HBV) will be
      co-administered (at a maximum interval of two days from each other) with each HRV vaccine or
      placebo dose.

      Hepatitis B and Bacille Calmette-Guérin vaccines (BCG) at birth are allowed if included in
      the local National Plan of Immunisation schedule in participating countries.

      At the discretion of the investigator the following vaccines may be administered during each
      subject's study participation:

        -  Vaccine against Streptococcus pneumoniae (Prevenar®) in France and Spain (concomitantly
           with HRV vaccine/Placebo).

        -  Vaccine against Neisseria meningitidis (Neis Vacc C®) is allowed if there is at least
           14-days interval with respect to the administration of the HRV vaccine/Placebo.
    

Intervention name(s): Rotarix™; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Two-dose oral vaccination.; Two-dose oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Time-Restricted Feeding Plus Resistance Training in Active Females
Condition: Healthy Active Females
Study type: Interventional

Summary: 
      The objective of this study is to examine the effects of time-restricted feeding (TRF;
      consuming all calories within an 8-hour period of time each day) and resistance training,
      with or without the addition of the dietary supplement HMB, on body composition, muscular
      performance and physiological outcomes in active females.
    


Intervention name(s): Beta-hydroxy beta-methylbutyrate; Resistance Training; Protein Supplementation; Time-Restricted Feeding
Intervention type(s): Dietary Supplement; Other; Dietary Supplement; Behavioral
Intervention description(s): 3 grams per day of the calcium salt form of beta-hydroxy beta-methylbutyrate (HMB).; Performing supervised resistance training three times per week.; Consuming a protein supplement daily.; Consuming all calories within a specified 8-hour period of time each day.
Other intervention name(s): HMB; Intermittent Fasting
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
TeleRehabilitation Following ACL Reconstruction
Condition: ACL Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed
      at patients' home utilizing video telecommunication services with real-time synchronous
      exchange of information. The advantages of telerehabilitation include reducing unnecessary
      travel to the hospital and person to person contact while maintaining social distancing.
      While some of the patients are truly staying at remote areas, others are unable to manage
      travel in the lockdown period. Telemedicine offers the opportunity to deliver rehabilitative
      services in the patients' home, closing geographic, physical, and motivational gaps.
      Punctuality on either side is also assured since the travel times are saved on both the ends.

      The purpose of the proposed study is to evaluate telerehabilitation vs. in-person
      rehabilitation following ACL reconstruction. Objectives include assess return to sport and
      patient reported functional outcomes.
    


Intervention name(s): Telerehabilitation Therapy; In-person Rehabilitation Therapy
Intervention type(s): Other; Other
Intervention description(s): Rehabilitation services will be dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information - Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.; Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study About Treatment of Newly Diagnosed Non Cutaneous Peripheral T Cell Lymphoma
Condition: Peripheral T Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter randomized trial evaluating induction treatment with
      VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T
      cell lymphoma.
    

Detailed description: 
      Induction therapy:

      ARM 1: 6 Chemotherapy courses = 3 VIP alternated with 3 ABVD ARM 2: 8 Chemotherapy courses =
      CHOP every 21 days

      Consolidation therapy:

      For all patients if CR = radiotherapy 40GY / 5X1,8 GY per week
    

Intervention name(s): CHOP21; VIP/ABVD; Radiotherapy consolidation
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): CHOP regimen:
cyclophosphamide 750 mg/m2 intravenously (IV) day 1
doxorubicin 50 mg/m2 IV day 1
vincristine 1,4 mg/m2 (maximum 2 mg) day 1
prednisone 100 mg/m2/D from D1 to D5.; VIP regimen:
etoposide 100 mg/m2/D IV from D1 to D3
ifosfamide 1000 mg/m2/D from D1 to D5
cisplatinum 20 mg/m2/D as a continuous infusion from D1 to D5
ABVD regimen:
doxorubicin50 mg/m2/D on D1 and D14
bleomycin 10 mg/m2/D
vinblastine 10 mg/m2/D
dacarbazine 375 mg/m2/D; The treatment of Ann-Arbor stage I/II and stage III/IV patients with an initial bulky tumor (diameter ≥ 5 cm) was systematically completed by an irradiation plan. Forty grays were delivered (1,8 gray/day) over four weeks on the involved field.
Other intervention name(s): CHOP 21 arm; VIP/ABVD Arm; Consolidation treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chikungunya Vaccine (V184) Study in Previously Exposed Adults (V184-006)
Condition: Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      Safety and immunogenicity of the investigational V184 chikungunya vaccine will be tested in
      participants with history of chikungunya infection. Initially 21 to 50 year old participants
      will be enrolled; after favorable review of safety data, participants aged 51 to 65 will be
      enrolled.
    

Detailed description: 
      This will be a randomized double-blind interventional clinical study. This study proposes to
      evaluate the safety and immunogenicity of the investigational V184 live recombinant
      measles-vectored chikungunya vaccine delivered in 2 vaccinations, 28 days apart compared with
      saline placebo. After providing informed consent, individuals will be screened for
      eligibility including verification of previous exposure to chikungunya virus. They will then
      be randomized in a double-blind fashion to receive either V184 or saline placebo in a 1:1
      ratio.
    

Intervention name(s): V184; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Recombinant live Schwarz-strain measles-vectored vaccine expressing chikungunya virus structural proteins. Liquid frozen, life attenuated, measles vectored V184 vaccine administered via IM injection at 5 × 10^5 TCID50 (+/- 0.5 log) per dose.; Sterile physiological saline for IM injection
Other intervention name(s): MV-CHIK; MV-CHIK vaccine; MV-CHIK/DP (drug product)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-controlled, randomized, double-blinded, interventional, safety study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Cerebral Palsy
Condition: Cerebral Palsy; Spastic Hemiplegic Cerebral Palsy; Bilateral Spastic Cerebral Palsy; Gait Disorders, Neurologic
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      In children with cerebral palsy, the quality of walking decreases due to a decrease in the
      ability to control limbs, including walking, and coordination among various activities of
      daily living due to a decrease in functional independence and quality of life. Gait disorder
      is one of the important therapeutic goals of children with cerebral palsy, and recently
      robot-assisted gait training (RAGT) induces changes in brain plasticity, so it will help
      improve gross motor control and coordination control.
    


Intervention name(s): robot-assisted gait training; conventional locomotion therapy
Intervention type(s): Device; Behavioral
Intervention description(s): RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.; locomotion exercise, postural control training, balance training, electrotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
Condition: Healthy; Chronic Stable Illness
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of the study are:

        -  To evaluate the extent of effect, if any, of REGN10933+REGN10987 administration on
           vaccine-induced neutralizing antibody responses to SARS-CoV-2 by Moderna mRNA-1273

        -  To evaluate the time interval required between REGN10933+REGN10987 administration and
           Moderna mRNA-1273 vaccination, to ensure no meaningful impact on vaccine-induced
           neutralizing antibody responses to SARS-CoV-2

      The secondary objectives of the study are:

        -  To quantify the alteration of antigen specificity of vaccine-induced SARS-CoV-2 antibody
           responses when administered with different dose regimens of REGN10933+REGN10987

        -  To evaluate the safety and tolerability of REGN10933+REGN10987 and Moderna mRNA-1273
           vaccine when administered in close succession

        -  To assess the concentrations of REGN10933 and REGN10987 in serum over time in
           participants who receive REGN10933+REGN10987 and Moderna mRNA-1273 vaccine

        -  To evaluate the immunogenicity of REGN10933 and REGN10987 over time
    


Intervention name(s): casirivimab+imdevimab; Moderna mRNA-1273 vaccine
Intervention type(s): Drug; Biological
Intervention description(s): Wave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration; Single intramuscular (IM) injection
Other intervention name(s): REGN10933; REGN10987; REGN-COV2; REGEN-COV™; Ronapreve™
Intervention MeSH terms: Casirivimab and imdevimab drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Intensive Language Therapy
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Due to Parkinson's Disease (PD) speech and language (SL) deficits may occur. Further, the
      literature reports that PD patients, who have not undergone deep brain stimulation (DBS),
      have deficits regarding voice quality (e.g. loudness and intelligibility of their voice),
      while PD patients who have undergone DBS suffer from deficits in word retrieval and speech
      apraxia symptoms. To-date, therapeutic approaches focusing specifically on SL deficits
      observed in PD-DBS patients are yet to be developed and evaluated.

      Therefore, this study investigates the short-and longterm effectiveness of specific and
      intensive, high-frequency speech-language therapy in terms of reducing SL-deficits compared
      to a nonspecific and non-verbal sham treatment (i.e. a rhythmic balance-movement training
      (rBMT)) as well as to a 'no-therapy' condition.
    

Detailed description: 
      In the course of Parkinson's disease (PD) speech and language (SL) deficits may often emerge.
      In addition, severe verbal fluency (VF) decline has been repeatedly observed in the context
      of deep brain stimulation (DBS) in PD. Interestingly, while PD non-DBS patients have deficits
      with respect to loudness and intelligibility of their voice, PD patients who have undergone
      DBS (PD-DBS) suffer rather from difficulties in semantic and phonemic word retrieval, and
      from speech apraxia symptoms.

      However, to-date and to the best of our knowledge, therapeutic approaches focusing
      specifically on SL deficits observed in PD-DBS patients are yet to be developed and evaluated
      regarding their effectiveness. Thus, this study investigates the short-and longterm
      effectiveness of specific and intensive, high-frequency speech-language therapy in terms of
      reducing SL-deficits compared to a nonspecific and non-verbal sham treatment (i.e. a rhythmic
      balance-movement training (rBMT)) as well as to a 'no-therapy' condition.
    

Intervention name(s): Specific SL-therapy; Rhythmic Balance-Movement Training (rBMT)
Intervention type(s): Other; Other
Intervention description(s): Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.; Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.
Other intervention name(s): Specific, intensive and high-frequency SL-therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Word Retrieval; Apraxia Symptoms; Dysarthria