bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      An unmet medical need exists for patients with moderate and severe asthma who continue to
      demonstrate symptoms despite being on standard of care medications, and are not eligible for
      other biologic therapies developed or in development for T2-high(allergic/eosinophilic)
      asthma. The purpose of this study was to determine if CJM112, an anti-IL-17A antibody,
      displayed the clinical efficacy and safety profile to support further development in patients
      with inadequately controlled moderate to severe asthma with low IgE and low circulating
      eosinophil levels.
    

Detailed description: 
      After an initial screening visit, run-in period and baseline assessments, the eligible
      subjects entered the treatment period and were randomized in a 3:2 ratio to one of the two
      treatment groups:

        -  300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by
           once every two weeks up to Week 12 (Day 85) + standard of care treatment.

        -  Matching placebo + standard of care treatment. After completion of the last dose on Day
           85 of treatment period, subjects returned for the final efficacy assessment on Day 92.
           Following the treatment period, all subjects entered a 13-week safety follow-up period,
           including the End of Study (EoS) visit on Day 176.
    

Intervention name(s): CJM112; Placebo to CJM112
Intervention type(s): Drug; Other
Intervention description(s): 300 mg CJM112 (Study treatment) s.c. injection received per week for the first 4 weeks, followed by once every two weeks up to Week 12 (Day 85) + standard of care treatment.; Placebo to match CJM112 + standard of care treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma, allergic, eosinophilic, non-T2 high, allergy triggered asthma, reactive asthma, asthma attack, difficulty breathing
Clinical Trial of Astaxanthin Formulation With Exercise in Sarcopenia Elderly
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The primary objective of this trial is to evaluate the effect of oral administration of an
      Astaxanthin formulation compared to placebo after one month alone and after an additional 3
      months of exercise training on mitochondrial and skeletal muscle function in elderly subjects
      with evidence of mitochondrial dysfunction/sarcopenia.
    


Intervention name(s): Astaxanthin formulation; Placebo; Exercise training
Intervention type(s): Other; Other; Other
Intervention description(s): Astaxanthin formulation containing AstaReal® astaxanthin (Haematococcus pluvialis algae extract), tocotrienol, and zinc will be orally administered starting on Day 1 until Day 120; Placebo will be orally administered starting on Day 1 until Day 120.; The subjects will undergo interval treadmill incline protocol (target 85% HR max, 3 times a week for 40 to 60 minutes) starting on Day 31 until Day 120.
Other intervention name(s): AstaMed MYO
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sarcopenia, muscle function, muscle endurance, fatigue
Physiotherapy Applications in Upper Extremity Lipedema
Condition: Lipedema
MeSH terms: Lipedema
Study type: Observational [Patient Registry]

Summary: 
      Lipedema which causes excessive accumulation of fat in the subcutaneous tissue, is a rare,
      progressive disease. This disease generally affects women, following puberty or early
      adulthood and usually results in the slow increase of the circumference of the legs and/or
      arms, bilaterally. In a typical presentation of lipedema, the enlargement of the lower
      extremities is disproportionately greater than that of the trunk and upper extremities When
      first described in 1940, lipedema was thought to exclusively affect the lower extremities.
      However, as the disease has been recognized over the years, lipedema has been reported to
      affect the upper extremities. Upper extremity lipedema, with no involvement of the lower
      extremities is an extremely rare incident.
    

Detailed description: 
      Due to the hypertrophy in adipose tissue, the link between lymphatic dysfunction and the
      progression to lipo-lymphedema, lipedema is conservatively treated with physiotherapy, manual
      lymph drainage and compression, also known as complex decongestive physiotherapy.
      Furthermore, the consensus of the International Society of Lymphology has stated that
      intermittent pneumatic compression is an optional treatment which may be applied as an
      adjuvant therapy to complex decongestive physiotherapy. All participants included in the
      study were included in a treatment protocol consisting of complex decongestive physiotherapy
      and intermittent pneumatic compression. The Perometer was used in the measurement of upper
      extremity volume and circumference before and after treatment.
    

Intervention name(s): Complex decongestive physiotherapy
Intervention type(s): Procedure
Intervention description(s): Each patient received a treatment protocol of Complex decongestive physiotherapy for 5 days a week until they were discharged from the clinic. All patients fully completed all components of the treatment routine daily. The treatment was performed by a physiotherapist who was certified with Manual Lymph Drainage Combined Decongestive Physiotherapy. After the daily treatment protocol was completed, patients wore standard or individually sized compression grade II or III medical compression stockings for the rest of the day.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between the age of 18-65 who have lipedema affecting the upper extremities and no
        accompanying diagnosis of lymphedema, deep vein thrombosis or any disease which causes
        edema in the upper extremities.
      
Keywords: Upper extremity lipedema; Lymphatic drainage
A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 (Dalazatide) in Active Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to examine safety outcomes in active plaque psoriasis
      patients after systemic administration of dalazatide. Clinical outcome measures will also be
      assessed.
    

Detailed description: 
      The primary purpose of this study is to examine safety outcomes in active plaque psoriasis
      patients after systemic administration of dalazatide. Clinical outcome measures will also be
      assessed.
    

Intervention name(s): dalazatide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.; placebo, Subcutaneous injection twice per week for a total of 9 doses
Other intervention name(s): ShK-186
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: ShK-186; dalazatide; psoriasis; Kv1.3,; autoimmune
The System Fammeal With Tailored Recommendations and Gamification for Parents to Counteract Childhood Obesity
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      The investigators aim to test an evidence-based intervention, allocated to a mobile app
      designed to parents and their children with 3 to 6 years old, identified by family doctors or
      nurses at well-child care visits as overweight or obese for age.

      This intervention aims to improve parent's perceptions and attitudes regarding children's
      weight status and food intake, leading to better dietary intake and children's' eating
      behaviors through positive parental child-feeding practices. In this study, the investigators
      aim to assess the feasibility of the intervention and explore its impact on the beliefs and
      attitudes of parents.
    

Detailed description: 
      The investigators will enroll parents and their children with 3 to 6 years old, identified by
      family doctors or nurses at well-child care visits as overweight/obese for age.

      Participant's eligibility will be assessed. Participants will be randomized to: 1) control
      group; 2) intervention group. The control group will receive treatment as usual. Parents in
      the intervention group will be provided with the app and invited to use it for 4 weeks.
      During the 4 weeks, the administrator monitors the app usage and call once to parents to
      improve it, if needed.

      Both groups will perform a pre- and post-test, evaluating parent's perceptions and attitudes
      regarding children's weight status and food intake; eating behaviors and parental
      child-feeding practices.
    

Intervention name(s): Parenting education program
Intervention type(s): Behavioral
Intervention description(s): Parenting education program through the app Fammeal. It includes educational content, tailored to parents and centered on positive parenting child-feeding practices. The app will also include a virtual-pet game for children, in order to help them self-regulate their intake.
Through the app, parents will:
Fill in a registration questionnaire, which will tailor recommendations.
Receive information and video content recommendations.
Set goals related to their child's lifestyle and tracking progress.
Earn points by watching the contents.
Invite children to play a serious game.
Exchange messages with other users.
The investigators created a support website that connects to the main server to get data gathered from the mobile app and game.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Childhood Obesity; Nutrition; mHealth; Parenting
Open-Label Safety, Tolerability, PK Study of IV CXA-10 Emulsion in Subjects in Chronic Kidney Injury
Condition: Acute Kidney Injury (Nontraumatic)
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this trial is to demonstrate the safety, tolerability and
      pharmacokinetics (PK) of CXA-10, at potentially therapeutic doses, in the target patient
      population comprised of subjects with Stage 3 and 4 chronic kidney injury (CKI). In addition,
      associated pharmacodynamic (PD) effects of CXA-10 will be investigated.
    

Detailed description: 
      This will be a multi-center, open-label study, single-dose study with CXA-10 in subjects with
      CKI. At total of 12 subjects will be enrolled into two equal groups according to their
      baseline estimated glomerular filtration rate (eGFR: 15 - 39 or 40 - 59 mL/min/1.73m2). All
      subjects will receive a single dose infusion of CXA-10 emulsion. Since this is the first
      administration of CXA-10 to a non-healthy volunteer population, a conservative approach is
      being taken to ensure safety. Thus, the first 2 subjects from each group will be dosed at one
      dose level below the highest safe dose level administered in the FIH study. If this dose is
      found to be safe in this specific subject population, the remainder of the 4 subjects in each
      group will receive the highest safe dose from the FIH study; otherwise, the remainder will
      receive the initial dose. The doses administered in this study will not exceed the highest
      exposures achieved in the FIH study, and doses may need to be adjusted to lower levels, based
      on further evaluation of current pharmacokinetic data, to ensure the appropriate the exposure
      level. Safety, PK and PD assessments will be conducted over approximately 18 days following
      each dosing session. There will be a follow-up visit approximately 1 week after dosing.
    

Intervention name(s): CXA-10
Intervention type(s): Drug
Intervention description(s): CXA-10 Injectable Emulsion is a sterile emulsion containing CXA-10 in a formulation containing soybean oil, medium chain triglycerides oil, egg phospholipids, sucrose, and disodium EDTA. CXA-10 Injectable Emulsion will be administered intravenously. The active emulsion will be diluted in a vehicle emulsion.
Intervention MeSH terms: CXA-10
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Genotypic Tropism Testing In Proviral Dna To Guide CCR5 Antagonist Treatment In Subjects With Undetectable HIV-1 Viremia
Condition: HIV
MeSH terms: Viremia
Study type: Interventional
Phase: Phase 4

Summary: 
      CCR5 antagonists might be an adequate alternative for HIV-1-infected individuals with
      suppressed viremia who experience antiretroviral-related toxicity. The assessment of HIV-1
      tropism in proviral DNA could be helpful to inform in which of these subjects CCR5
      antagonists could be efficacious.
    

Detailed description: 
      The assessment of HIV-1 tropism is needed before starting treatment with a CCR5-antagonist.
      Several phenotypic and genotyping tropism tests have been developed in the recent years.
      Phenotypic assays (i.e. TrofileTM and ES-TrofileTM) have been used.in most clinical trials.
      Genotypic tropism testing, however, is easier, cheaper and faster than phenotypic methods,
      and can be performed in a local HIV laboratories.

      Viral RNA amplification is difficult in subjects with HIV-1 RNA levels <500-1000 copies/mL.
      In these cases, the optimal source of genetic material is peripheral blood mononuclear cell
      (PBMC)-associated proviral DNA. Whereas genotypic tropism testing in proviral DNA is
      technically feasible, it has not been validated as a tool to predict sustained virological
      response to CCR5-antagonist therapy in subjects with undetectable viremia.

      As of today, maraviroc is the only CCR5-antagonist approved for HIV treatment. It has few
      drug interactions and a good security profile, particularly in terms of lipid and glucose
      metabolism. Therefore, it might be an adequate alternative for HIV-1-infected individuals
      with suppressed viremia who experience antiretroviral-related toxicity or metabolic problems.

      This study will evaluate 48-week virological outcomes in aviremic subjects with an R5 virus
      by proviral genotypic tropism testing who switch the "third drug" of their regimen to
      maraviroc.
    

Intervention name(s): Unique
Intervention type(s): Drug
Intervention description(s): Change of PI, NNRTI or integrase inhibitor to CCR5 antagonist (maraviroc)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV; TROPISM; PBMC; GENOTYPE; 454 SEQUENCING
Efficacy and Safety of Alogliptin in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily
      (QD), in adults with type 2 diabetes.
    

Detailed description: 
      There are approximately 19 million people in the United States who have been diagnosed with
      diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies
      among racial and ethnic populations and has been shown to correlate with age, obesity, family
      history, history of gestational diabetes, and physical inactivity. Over the next decade, a
      marked increase in the number of adults with diabetes mellitus is expected.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of
      2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2
      diabetes.

      The aim of the current study is to evaluate the efficacy of alogliptin in subjects with type
      2 diabetes mellitus who are inadequately controlled and who have failed treatment with diet
      and exercise. Individuals who participate in this study will be required to commit to a
      screening visit and up to 14 additional visits at the study center. Study participation is
      anticipated to be about 34 weeks (or 8.5 months).
    

Intervention name(s): Alogliptin; Alogliptin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.; Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.; Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Other intervention name(s): SYR110322; SYR-322; SYR110322; SYR-322
Intervention MeSH terms: Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Dyslipidemia; Drug Therapy
Pharmacokinetics Study in Patients With Impaired Renal Function and Subjects With Normal Renal Function
Condition: Patients With Impaired Renal Function
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the pharmacokinetics of ASP015K in patients with
      impaired renal function and subjects with normal renal function.
    


Intervention name(s): ASP015K
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: Peficitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ASP015K; impaired renal function; Pharmacokinetics
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
Condition: Idiopathic Thrombocytopenic Purpura
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy, safety and tolerability of
      eltrombopag in children with previously treated chronic immune thrombocytopenia who are
      between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized
      to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will
      enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.
    

Detailed description: 
      This is a two part, double-blind, randomized, placebo-controlled and open-label Phase III
      study to investigate the efficacy, safety and tolerability of eltrombopag in pediatric
      patients with previously treated chronic ITP. In Part 1, patients will be randomized to
      receive eltrombopag or placebo in a 13-week double-blind, placebo-controlled treatment
      period. After completing Part 1, patients will begin Part 2, in which they will receive
      eltrombopag in an open-label manner during a 24-week treatment period.
    

Intervention name(s): Eltrombopag; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Thrombopoietin receptor agonist; Placebo with no active pharmaceutical ingredient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: immune thrombocytopenic purpura; pediatrics; chronic ITP; idiopathic thrombocytopenic purpura; eltrombopag; Chronic Immune Thrombocytopenia; platelet disorder; thrombocytopenia
Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients
Condition: Severely Immunocompromised HIV Patients
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The current available antiretroviral (ARV) agents make possible a successful treatment of
      virtually all HIV-infected patients, but some problems related to early mortality are still
      of concern, mainly in resources-limited settings. There are several published reports showing
      that such patients are at a significantly higher risk of death during the first months of
      treatment, in comparison with the observed outcomes in developed countries. One of the
      consistently detected risks for early mortality across these reports is the baseline low CD4
      count, although it does not seem to be the only reason for such outcome. In Brazil and other
      developing countries, there is still a large proportion of AIDS patients who are diagnosed
      with AIDS, or only seek health care for HIV infection late in the course of disease.
      Dolutegravir (DTG), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The
      available evidence suggest it promotes a faster decline in HIV-1 plasma viremia, and a higher
      increase in CD4 cells count, in comparison with those in Efavirenz (EFV) arm. The
      investigators propose to compare the impact of DTG versus EFV in the early mortality rates
      for severely ill (CD4+ cells count <50 cells/mm3) patients starting ARV therapy.
    


Intervention name(s): Dolutegravir 50 mg; Efavirenz-based regimens
Intervention type(s): Drug; Drug
Intervention description(s): Use of Dolutegravir -based regimens: patients will receive a Dolutegravir -based ART regimen (RAL 400 mg BID + TDF 300 mg QD + 3TC 150 mg BID); Efavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD)
Other intervention name(s): Tivicay; Efavirenz
Intervention MeSH terms: Efavirenz; Dolutegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment