bioihbjkbjnl/mcl2 huggingface dataset:
Exercise Program Based on Motor Learning and Forward Head Posture Correction
Condition: Musculoskeletal Abnormalities; Deformity
MeSH terms: Musculoskeletal Abnormalities
Study type: Interventional

Summary: 
      The aim of this study is to investigate the efficiency of an exercise program based on
      principles of motor learning in correction of Forward Head Position (FHP) in asymptomatic
      patients.
    

Detailed description: 
      Epidemiological studies have shown that bad posture and poor body control occurs at puberty,
      with forward head posture (FHP) and rounded shoulders being the most common biomechanical
      deviations in sagittal plane. The FHP is defined as an anterior displacement of the head with
      hyperextension of the cervical spine and this is associated with a reduction in the length of
      the upper portion of the trapezius, posterior portion of the cervical extensor muscles, the
      sternocleidomastoid and the levator scapulae. FHP can be evaluated by measuring
      craniovertebral angle (CVA) which is defined as the angle between a horizontal line passing
      through C7 and a line extending from the tragus of the ear to C7.

      CVA, smaller than 50 degrees, constitute a criterion of abnormal posture of cervical spine,
      suggesting FHP. People with FHP present incomplete balance control, thereby affecting the
      position of the center of gravity and motor control of the body. The establishment of altered
      motor control strategies could lead to balance disorders, neck muscle imbalances, chronic
      neck pain and even respiratory dysfunction.

      Despite the efforts of researchers to create effective treatment programs based on strength
      training and stretching exercises, positive long-term results have been a problem in FHP
      correction. For this reason, re-education of posture and body alignment, through exercise
      programs based on motor learning, with cognitive elements (attention, motivation, feedback,
      reasoning), could be proved a more effective therapeutic strategy.
    

Intervention name(s): Exercise program based on motor learning principles
Intervention type(s): Other
Intervention description(s): The exercise program will include simple activities exposing volunteers in various environmental conditions with a view to adjust their head posture in such conditions. The progressiveness of exercises will be based on the two-dimensional classification system of Gentile (1987). Furthermore, external attentional focus will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck; motor control; motor learning
A Phase II Study for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma
Condition: Indolent Non-follicular; Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, multicenter phase II trial designed to determine efficacy and safety
      of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with
      advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).
    

Detailed description: 
      This is a prospective, multicenter phase II trial designed to determine efficacy and safety
      of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with
      advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).

      The study includes and induction phase and a consolidation phase.
    

Intervention name(s): Bendamustine
Intervention type(s): Drug
Intervention description(s): INDUCTION PHASE
Rituximab - Bendamustine (RB): cycles 1 to 4 (0, 4, 8, 12 week):
Rituximab: 375 mg/sqm iv, day 1*
Bendamustine: 90 mg/sqm iv, days 1-2 or days 2-3 according to istitutional/patient/physician choice
Repeat cycles every 28 days for a total of 4 cycles
*In cycle 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8.
CONSOLIDATION PHASE
Rituximab - Bendamustine (RB): cycles 5 to 6 (16, 20 week):
Rituximab: 375 mg/sqm iv day 1
Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to istitutional/patient/physician choice
Rituximab two monthly doses
Rituximab: 375 mg/sqm iv week 24 and 28
Other intervention name(s): RIBOMUSTIN
Intervention MeSH terms: Bendamustine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: INFL; Indolent non-follicular; untreated INFL
The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this study is to measure the metabolic phenotype of a range of body weights in
      individuals with and without type 1 diabetes.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Young adults with type 1 diabetes diagnosed greater than or equal to 1 year prior to
        screening, or control young adults without diabetes, both within a range of BMI
        classifications (18-39.9 kg/m^2).
      
Keywords: Obesity; Overweight
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1323495 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of BI 1323495
      in plasma when given as oral single dose together with multiple oral doses of itraconazole
      (Test,T) as compared to when given alone as oral single dose (Reference, R).
    


Intervention name(s): BI 1323495; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; Oral solution
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Next Generation Sequencing Screening for Embryonic Ploidy Status
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      To evaluate the benefits of using next generation sequencing to assess embryonic aneuploidy.
      All viable blastocysts will be biopsied and cryopreserved for future transfer. After the
      final embryo is cryopreserved, patients will be randomized to either the intervention group
      or the control group. Patients and doctors are blinded to the randomization until study
      completion. A Double Embryo Transfer (DET) will be performed with either screened or
      unscreened embryos depending on randomization. A Single Embryo Transfer (SET) may occur in
      cases where only one embryo is available for transfer.
    


Intervention name(s): Comprehensive Chromosome Screening; Morphologically Best
Intervention type(s): Other; Other
Intervention description(s): On day 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS), will be performed via next generation sequencing and results will be available at the time of study completion.; Patients in this arm of the study will not receive CCS in selection of their embryo for transfer. The best looking embryo (morphology) will be transferred
Other intervention name(s): PGD; CCS; Unscreened; No CCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Next generation sequencing; Embryonic aneuploidy
A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (XP19986)
      versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms despite
      therapy with approved doses of a Proton Pump Inhibitor (PPI).
    


Intervention name(s): arbaclofen placarbil-Cohort 1; Placebo-Cohort 5; arbaclofen placarbil-Cohort 2; arbaclofen placarbil-Cohort 3; arbaclofen placarbil-Cohort 4; PPI
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 20 mg QD) for 7 weeks including titration and taper periods; After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (placebo) for 7 weeks including titration and taper periods; After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 40 mg QD) with for 7 weeks including titration and taper periods; After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 20 mg BID) for 7 weeks including titration and taper periods; After the 4 week screening period, eligible subjects will be randomized to adjunctive study treatment (arbaclofen placarbil 30 mg BID) for 7 weeks including titration and taper periods; Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40 mg QD, Omeprazole/sodium bicarbonate 20 mg or 40 mg QD, Dexlansoprazole 30 mg or 60 mg QD
Other intervention name(s): XP19986; XP19986 matching placebo; XP19986; XP19986; XP19986; Proton Pump Inhibitor
Intervention MeSH terms: Arbaclofen placarbil; Baclofen; Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GERD
Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will
      increase the progression-free survival (PFS) in patients with first line metastatic breast
      cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with
      definable metastatic disease, 6 or more months after primary treatment.
    

Detailed description: 
      This is a phase 2, single arm study. Participants will be treated with combination Gemzar,
      Abraxane and Avastin therapy until disease progression. Each treatment cycle is 28 days.
    

Intervention name(s): Avastin; Gemcitabine; Abraxane
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Bevacizumab; Gemzar; Albumin-Bound Paclitaxel Formulation
Intervention MeSH terms: Paclitaxel; Bevacizumab; Gemcitabine; Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer
Early TIPS With Polytetrafluoroethylene (PTFE) Covered Stents for Acute Variceal Bleeding in Patients With Advanced Cirrhosis
Condition: Decompensated Cirrhosis; Bleeding Varices
MeSH terms: Liver Cirrhosis; Hemorrhage; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether early use of transjugular intrahepatic
      portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to
      prolong the survival in patients with advanced cirrhosis and acute variceal bleeding.
    


Intervention name(s): TIPS treatment; Medical treatment
Intervention type(s): Procedure; Drug
Intervention description(s): A 8 mm Fluency stent will be used. The aim will be to reduce the portal pressure gradient (PPG) below to 12 mm Hg or 25-75% of baseline.
Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices.
After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.; Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (propranolol) will be started with an initial dose of 40 mg, the dose of propranolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm, or 25% reduction of basal heart rate or up to the maximum tolerated dose of propranolol.
The second elective session of endoscopic band ligation will be performed within the first 7-14 days after the initial endoscopic treatment. The following sessions will be performed at 14 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed.
Other intervention name(s): Transjugular intrahepatic portosystemic shunt (TIPS); Non-selective beta blocker + Endoscopic variceal ligation
Intervention MeSH terms: Adrenergic beta-Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transjugular intrahepatic portosystemic shunt; TIPS; variceal bleeding; liver cirrhosis; hepatitis B
Traumacel FAM Trium in the Post-market Surveillance Phase
Condition: Bleeding; Surgical Wound
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide
      haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric.
      It is used as an adjunct to stop capillary, venous, or small arterial bleeding, and also to
      prevent early postoperative bleeding. It can be used in all areas of stopping diffuse
      bleeding from resection surfaces such as parenchymatous organs, muscles or defined body
      cavities. The wide scope of application allows the use for classical, robotic surgery and
      endoscopic treatments (e.g. laparoscopic).

      The main objective of the study is to compare the efficacy and safety of Traumacel FAM Trium
      and regenerated oxidized cellulose based fibrous haemostat when used in accordance with their
      intended purpose. The partial objectives are: identification of any previously unknown
      side-effects and monitoring of known side-effects; identification and analysis of potentially
      newly emerging risks; confirmation of the acceptability of the benefit-risk ratio;
      identification of any systematic misuse of the device or off-label use of the device in order
      to verify the correctness of its intended purpose.
    


Intervention name(s): Traumacel FAM Trium; Surgicel Fibrillar
Intervention type(s): Device; Device
Intervention description(s): Absorbable Hemostat (oxidized non-regenerated cellulose); Absorbable Hemostat (oxidized regenerated cellulose)
Other intervention name(s): Traumastem FAM Trium; EMOXICEL FAM Trium; Traumastem Fibrillar; Celstat Fibrillar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oxidized cellulose; Haemostatic agent
Safety & Efficacy of TC-5619 in Adults With Inattentive-predominant Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Study is to assess if TC-5619 improves symptoms for adults diagnosed with the
      inattentive-predominant subtype of ADHD over a 4-week treatment period.
    

Detailed description: 
      A 3-arm, double-blind, randomized, placebo-controlled, multicenter, fixed dose study to
      assess efficacy and safety of TC-5619 in adults with inattentive-predominant attention
      deficit/hyperactivity disorder (ADHD) utilizing the Connor's Adult ADHD Rating
      Scale-Investigator Completed Version (CAARS-INV) inattentive subscale scores through 4 weeks
      of treatment.
    

Intervention name(s): TC-5619-238 5mg; TC-5619-238 25mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TC-5619-238 5mg capsule taken once daily for 4 weeks; TC-5619-238 25mg capsules taken once daily for 4 weeks; Placebo capsules will be taken once daily for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD
Single and Multiple Ascending Dose Study With EP395
Condition: Adult ALL
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to asses the safety and tolerability of single and multiple ascending doses
      of EP395, administered by oral capsules, in healthy subjects with the aim to determine the
      safe dose range of EP395 for further clinical development
    

Detailed description: 
      This is a study to asses the safety and tolerability of single and multiple ascending doses
      of EP395, administered by oral capsules, in healthy subjects with the aim to determine the
      safe dose range of EP395 for further clinical development. The study consists of two parts,
      part A where single-ascending doses will be assessed and part B where multiple-ascending
      doses will be assessed. The primary objective being safety and tolerability as well as the
      pharmacokinetic properties of EP395.
    

Intervention name(s): EP395; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule for oral treatment; capsule for oral treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single and multiple ascending doses
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Observational Registry for Basal Insulin Treatment Study (ORBIT)
Condition: Diabetes
Study type: Observational [Patient Registry]

Summary: 
      The scientific use of basal insulin is of great help to individuals and the government.
      However, there are few studies to investigate the real world use, effect, safety and
      influence factors of basal insulin in China. This study is to evaluate the use of first basal
      insulin in China patients with type 2 diabetes with inadequate glycemic control on oral
      antidiabetic agents (OADs) from the naturalistic clinical practice.
    

Detailed description: 
      This is a 6-month multicentre, observational, prospective, registry study. About 200
      hospitals from different parts of China will take part in this study, and about 20,000
      patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with OADs and
      willing to accept basal insulin (BI) treatment will be consecutively enrolled during a 12
      months period.

      The study participants will include at baseline (0 month), 3 month and end point (6 month) to
      collect the study information. The project will probably last for about 18 months.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients meet the following criteria, either from in-patient or out-patient department,
        will have chance to be enrolled in this study.
      
Keywords: diabetes; basal insulin; effectiveness and safety; oral antidiabetic drugs; real world clinical practice
Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain
Condition: Osteoarthritis, Knee / Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to
      placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients
      with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate
      the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.
    

Detailed description: 
      The blind will be maintained, including for the study sponsor, until the key code is opened
      after the data have been fixed for all subjects in Week 24. In addition, in order to
      eliminate any bias that could affect the study assessments, to the extent possible, the blind
      will be maintained with respect to the study site and the subject even after the opening of
      the study sponsor key code.
    

Intervention name(s): MT-5547; MT-5547-matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for injection in pre-filled syringe; Solution for injection in pre-filled syringe
Other intervention name(s): Fasinumab
Intervention MeSH terms: Fasinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prehabilitation Intervention to Maximize Early Recovery (PRIMER) in Liver Transplantation
Condition: Liver Diseases; End Stage Liver Disease; Frailty
MeSH terms: Liver Diseases; End Stage Liver Disease; Frailty
Study type: Interventional

Summary: 
      This is a single center, 2-arm, patient-randomized study evaluating the feasibility and
      potential efficacy of the PRIMER intervention in improving physical function and reducing
      frailty in adult Liver Transplant candidates. The intervention will consist of a
      patient-tailored prehabilitation program designed to reduce frailty, improve physical
      function and nutritional status, and optimize pre- and post-transplant outcomes.
    

Detailed description: 
      The investigator will pilot-test a two-arm, randomized trial of a prehabilitation
      intervention in 38 pre-liver transplant patients with End Stage Liver Disease (ESLD). The
      investigator estimates an attrition rate of 20%, resulting n=30 participants; 10 participants
      in Arm 1 (control arm) and 20 participants in Arm 2 (intervention arm). To be eligible,
      patients must be waitlisted or "Penn-Ready" with a MELD-Na less than or equal to 25,
      English-speaking, able to safely participant in an exercise program, have a smartphone, and
      be identified as frail. The purpose of this trial is to develop and implement a program of
      medical optimization, physical activity, and nutrition recommendations specifically tailored
      to ESLD and designed to reduce frailty, improve physical function, and optimize pre- and
      post-transplant outcomes.
    

Intervention name(s): Nokia GO Wearable StepTracker; Medication Reminder; Weekly Check-in appointment with study team or provider
Intervention type(s): Device; Other; Other
Intervention description(s): All participants will be provided with a Nokia GO step tracker to monitor daily step counts. The device is not subject to FDA regulation.; Medication reminders are sent to participants in Arm 2 on a daily basis.; Virtual meeting or telephone call between participants and study team to assess study involvement, adherence to procedures, and following of medical care recommendations.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigator will conduct a patient-randomized, two-arm pilot study of 38 participants with a predicted attrition rate of 20% resulting in 30 total participants; n=10 in Arm 1 and n=20 in Arm 2. Arm 1 will serve as the control arm and Arm 2 will serve as the intervention arm.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: liver transplantation; malnutrition; exercise; prehabilitation; nutrition; sarcopenia