bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of SHR-1802 in Patients With Failure of Standard Treatment for Advanced Malignant Tumours
Condition: Malignant Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first study to test SHR-1802 in humans. The primary purpose of this study is to
      see if SHR-1802 is safe and tolerable for patients with locally advanced/unresectable or
      metastatic malignancies that are refractory to available therapy or for which no standard
      therapy is available.
    


Intervention name(s): SHR-1802
Intervention type(s): Drug
Intervention description(s): This study will evaluate the preliminary safety, tolerability, pharmacokinetic characteristics and initial efficacy of SHR-1802 The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of SHR-1802 when administered to patients with locally advanced/ unresectable or metastatic malignant tumours that are refractory to available therapy or for which no standard therapy is available.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
Condition: Pancreatic Cancer Stage II
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment
      approaches to locally advanced pancreatic cancer management.

      Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic
      cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a
      progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting
      activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and
      gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.
    

Detailed description: 
      Study population: Locally advanced unresectable pancreatic cancer patients

      Elegibility criteria:

        -  Written informed consent

        -  Age >18 < 75 years

        -  Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer

        -  At least one lesion measurable with CT or MRI scan

        -  Performance Status (ECOG) 0-1 at study entry

        -  Life expectancy of at least 3 months

        -  Adequate marrow, liver and renal function

        -  Effective contraception if the risk of conception exists (in the Informed Consent for
           the patients the descriptions of possible contraceptives is reported
    

Intervention name(s): Nab-paclitaxel and Gemcitabine; Gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): Chemotherapy will consist of nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle; gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Other intervention name(s): abraxane; gemzar; gemzar
Intervention MeSH terms: Paclitaxel; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pancreatic cancer; locally advanced; unresectable cancer
Frequent Ballgames Training for 9-11 Year Old Schoolchildren
Condition: Body Composition; Echocardiography
Study type: Interventional

Summary: 
      Inactivity among schoolchildren is a challenge to public health and for the municipality in
      particular. This study´s aim is to evaluate the cognitive and physical as well as social and
      fitness adaptations, and learning outcomes of short- and long term ball training for 9-11
      years old girls and boys, and to determine to what extend the organisation (5x12 minutes og
      3x40 minute a week) and type of training (ball games, circuit training or running) influence
      the magnitude of response.
    


Intervention name(s): Football; Running; Circuit training
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Attention Capacity and Before-school Physical Activity Intervention Program
Condition: Physical Activity; Behavior; Child Behavior; Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Despite the evidence and the potential of physical activity related to cognition and academic
      performance in children, the effects of a before-school physical activity program on these
      parameters remains unknown.
    

Detailed description: 
      Despite public health concerns and the extensively documented health benefits of physical
      activity, a large proportion of Chilean children do not meet the physical activity
      recommendations (Aguilar-Farias et al., 2018). Since most children spend a majority of their
      waking hours at school, this environment is appropriate for the implementation of preventive
      interventions, particularly those that include activities promoting physical activity (Naylor
      & McKay, 2009). With the absence of opportunities for physical activity during the school
      day, before-school programs have become a popular option to help children increasing their
      physical activity levels (Stylianou, van der Mars, et al., 2016). Although several recent
      studies support a positive effect of before school-based physical activity on health
      (Westcott, Puhala, Colligan, Loud, & Cobbett, 2015), less literature has evaluate the
      cognitive outcomes (Stylianou, Kulinna, et al., 2016) such as attention capacity.
    

Intervention name(s): Active-Start intervention; No Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supervised exercise training. The intervention is a physical activity intervention that consist of 5 times per week before starting the first school-class (8:00-8:30 a.m.), 5 times per week. Each session was previously planned and described in a manual dedicated to the study. These sessions were designed by the research team and delivered by a graduate in Sport The intervention program included sports games adapted to the age of the participants, playground games, dance and other recreational activities. The intensity of the main part of the sessions was moderate-to-vigorous according to a previous study and this intensity was confirmed by accelerometry. Also, different activities favoring social interactions were designed to facilitate the interactions between the participants at the end of the sessions (cold-down).; No-exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Exercise; Prevention; Attention capacity
Feasibility Trial of a Mobile Adherence Tool for Adolescents With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to assess the feasibility of using a mobile health intervention
      to improve adherence to asthma medication among adolescents in an urban clinic setting. The
      intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile
      phone application to remind and incentivize patients to use their medication. This study will
      assess the feasibility and acceptability of this intervention to patients.
    


Intervention name(s): Inhaler sensor; Mobile application for asthma adherence
Intervention type(s): Device; Behavioral
Intervention description(s): Inhaler sensor strap that tracks inhaler use via a pressure sensitive switch.; Mobile phone application that sends reminders, allows patients to see their medication use, and provides points and other incentives for medication use.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patient Compliance; Mobile Applications; Medication Adherence
Irbesartan/Hydrochlorothiazide National Taiwan University Hospital Listing
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary:

        1. To compare the change in forearm vascular resistance following a 12-week regimen of
           irbesartan/hydrochlorothiazide versus irbesartan

        2. To assess changes of serum proinflammatory cytokine, markers of cardiovascular risks,
           oxidative stress and circulating adhesion molecule including thiobarbiturate acid
           reactive substances (TBARS), C-reactive protein (CRP), interleukin 6 (IL-6), and
           vascular cell adhesion molecule 1 (VCAM-1).

      Secondary:

        1. To compare the reduction in office blood pressure following a 12-week regimen of
           irbesartan/hydrochlorothiazide versus irbesartan

        2. To compare the response rate (defined as office Systolic blood pressure(SBP)/diastolic
           blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate
           (defined as SBP<140 mmHg and /or DBP<90 mmHg)

        3. To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus
           irbesartan when administered once daily

        4. To determine whether angiotensin II type 1 (AT-1) receptor gene polymorphisms (including
           A1166C gene with about 4% of the minor allele frequency in Chinese population and other
           single nucleotide polymorphisms with a higher frequency of about 10% of minor allele) is
           related to reduction of BP
    


Intervention name(s): Irbesartan/Hydrochlorothiazide; Irbesartan
Intervention type(s): Drug; Drug
Intervention description(s): Administration of irbesartan 150 mg/day + hydrochlorothiazide 12.5 mg; Administration of irbesartan 150 mg/day
Intervention MeSH terms: Hydrochlorothiazide; Irbesartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study consists of Part 1 followed Part 2.

      Part 1 The purpose of this phase1 study is to investigate the pharmacokinetics, safety and
      tolerability of a single oral dose of SA001 and active comparator(Rebamipide) in healthy male
      volunteers.

      Part 2 The purpose of this phase1 study is to investigate the pharmacokinetics, safety and
      tolerability of multiple oral dose of SA001 in healthy male volunteers.
    

Detailed description: 
      Part 1(Single dose, dose escalation study, SA001 240mg~1,080mg dose group)

      The starting dose is SA001 240mg, and the maximum dose is 1,080mg. Each dose group is
      assigned to Experimental group (SA001 or SA001 + Active Comparator(Rebamipide)) or Placebo
      group in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its
      metabolite are investigated after a single oral administration.

      Part 2 (Multiple dose, dose escalation study, SA001 360mg~1,080mg dose group)

      The starting dose is SA001 360mg, and the maximum dose is 1,080mg. Each dose group is
      assigned to SA001 or Placebo in a ratio of 3:1. The pharmacokinetics, safety and tolerability
      of SA001 and its metabolite are investigated after a multiple oral administration.
    

Intervention name(s): SA001 240mg + Rebamipide 200mg or Placebo; SA001 480mg or Placebo; SA001 710mg + Rebamipide 600mg or Placebo; SA001 1,080mg or Placebo; SA001 360mg or Placebo; SA001 720mg or Placebo; SA001 1,080mg or Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cohort 1 in the Part1(Single dose): Study drug(SA001 240mg + Rebamipide 200mg), Comparator: Placebo; Cohort 2 in the Part1(Single dose): Study drug(SA001 480mg), Comparator(Placebo); Cohort 3 in the Part1(Single dose): Study drug(SA001 720mg + Rebamipide 600mg), Comparator(Placebo); Cohort 4 in the Part1(Single dose): Study drug(SA001 1,080mg), Comparator(Placebo); Cohort 5 in the Part2(Multiple dose): Study drug(SA001 360mg), Comparator(Placebo); Cohort 6 in the Part2(Multiple dose): Study drug(SA001 720mg), Comparator(Placebo); Cohort 7 in the Part2(Multiple dose): Study drug(SA001 1,080mg), Comparator(Placebo)
Intervention MeSH terms: Rebamipide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Comparison of Two Different Doses of Maternal B12 Supplementation in Improving Infant B12 Deficiency and Neurodevelopment
Condition: Vitamin B 12 Deficiency
MeSH terms: Vitamin B 12 Deficiency
Study type: Interventional

Summary: 
      Supplementation with Iron and folate have been part of a worldwide strategy targeting anaemia
      and neural tube defects for many years. However, vitamin B12 deficiency has received much
      less attention. High prevalence of deficiency in mothers in the antenatal period and in their
      infants, has been documented. Multiple case series document the neurological consequences of
      severe deficiency and their reversal with B-12. Trials on the subject are limited and those
      available have either used an ineffective dose or for a short duration.

      Therefore, we propose this randomised controlled trial to compare the efficacy of two
      different doses (pharmacological and preventive) of maternal Vitamin B-12 supplementation in
      improving infant B12 deficiency and neurodevelopment. We propose to undertake a multi-centric
      trial in India and Nepal given the high prevalence of deficiency reported from these
      countries and to allow a wider socio-demographic spectrum (Pay-for-service hospital catering
      to middle income populace from India and a free-care public hospital catering to lower income
      groups from Nepal). We will recruit 720 vegetarian, pregnant women from the antenatal clinics
      of the Indian and Nepalese centres at their first antenatal visit. Elderly primi mothers,
      taking B12 supplementation, multiple gestations, chronic medical conditions, anticipating
      moving out of the city, treated for infertility or with known psychological illnesses will be
      excluded. In Stage 1, recruited mothers will be randomized into 2 equal groups (360 each).
      Group 1-Daily 250 μg Vitamin B12 supplementation. Group 2-Daily 50 μg Vitamin B12
      supplementation. B-12 will be started in 1st trimester and continue up to 6 months
      post-partum. In Stage 2, the birth and post-delivery course of the new-born will be monitored
      and documented for any morbidity. At 9 months, the neurodevelopmental, complementary feeding
      and home environment will be assessed and infant B12 status will be determined.

      The two groups will be compared for the primary (neurodevelopment) and secondary outcomes
      (biochemical parameters in mother and infant). The results of this study will be used to
      generate scientific evidence on whether B-12 should be supplemented in vegetarian pregnant
      women with a view to preventing B-12 deficiency and its neurodevelopmental consequences in
      the infant.
    


Intervention name(s): Vit B12
Intervention type(s): Drug
Intervention description(s): Vitamin B12 250mcg
Intervention MeSH terms: Hydroxocobalamin; Vitamin B 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Valproic Acid in Subjects With Intact Cognition - Proof of Concept Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of administration and effects of valproic
      acid on clusterin expression in cognitively-intact, healthy, elderly subjects. Clusterin
      mutations have recently been identified as a risk factor for the development of Alzheimer's
      Disease and changes in clusterin expression are seen in the elderly who develop Alzheimer's
      disease irrespective of whether they carry these genetic mutations or not. Valproic acid may
      prevent or reverse these changes.

      Fourteen subjects with normal memory and thinking will participate in this study. Ten of
      these subjects will receive valproic acid and 4 will receive a "placebo" capsule with no
      active medicine. Participants will take study medication or placebo for 28 days and be
      followed for a total 35 days in this trial.
    

Detailed description: 
      This is a placebo-controlled, single-center, multiple ascending dose study. Seven healthy
      volunteers will be enrolled into 2 sequential cohorts, for a total of 14 enrolled subjects.
      The study will be conducted using two doses of valproate (250 mg PO bid, followed by 500 mg
      PO bid). At each dose level, 7 cognitively intact normal elderly subjects will be entered
      into the study with two subjects randomly selected to receive placebo while the other five
      subjects receive the designated dose of valproate.

      Study procedures will include routine assessment of adverse events, safety labs, baseline
      MRI, physical and neurological exams, and cerebrospinal fluid collection.

      Other investigational medication or devices are prohibited during this study.
    

Intervention name(s): Valproic Acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): generic valproic acid tablets packaged in placebo-matched capsules.; Placebo capsule without active study medication in identical capsules as experimental medicine.
Other intervention name(s): VPA; Depakote; Sugar pill
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: cognitively normal elderly population; safety and tolerability
An Open Label Trial of Omega 3(o3mega+Joy)in the Treatment of Social Phobia
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the efficacy of an enteric-coated, eicosapentaenoic
      acid-concentrated fish oil in the treatment of social phobia. A secondary objective is to
      determine if treatment outcome is related to plasma phospholipid essential fatty acid status,
      niacin skin flush and measures of lipid/protein peroxidation.
    

Detailed description: 
      Subjects meeting criteria for Social Anxiety Disorder, will receive enteric-coated,
      eicosapentaenoic acid-concentrated fish oil (O3mega+Joy) for 12 weeks of treatment for social
      phobia. A secondary objective is to determine if treatment outcome is related to changes in
      plasma phospholipid essential fatty acid status, niacin skin flush and measures of
      lipid/protein change.
    

Intervention name(s): Omega 3 Joy enteric coated concentrated fish oil
Intervention type(s): Drug
Intervention description(s): 1500-3000mg; one per day
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eicosapentaenoic acid; fish oil; Omega 3; Social Anxiety Disorder
Comparison of Choosing Free ALT or Free PMT for Reconstruction With Head and Neck Cancer
Condition: Reconstructive Surgery; Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      This study was designed to compare the outcome of the anteromedial thigh (AMT) and
      anterolateral thigh (ALT) flaps in head and neck cancer reconstruction.
    

Detailed description: 
      To compare the results of the AMT and ALT flaps, this study aimed to compare their outcomes
      in head and neck cancer reconstruction under the condition of attenuating baseline patient
      and operative characteristics with the selection of propensity score-matched patient cohorts.
    

Intervention name(s): ALT flap reconstruction; AMT flap reconstruction
Intervention type(s): Other; Other
Intervention description(s): Patients who underwent ALT free flap reconstruction after head and neck cancer surgery.; Patients who underwent AMT free flap reconstruction after head and neck cancer surgery.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A retrospective study was performed on adult trauma patients from the registered free flap
        database and electric medical records of Kaohsiung Chang Gung Memorial Hospital, a
        2,686-bed medical center in Southern Taiwan.
      
Keywords: Anterolateral thigh (ALT); anteromedial thigh (AMT); free flap reconstruction; microsurgery; head and neck cancer; outcomes
Multicentre Phase III Erythropoietic Protoporphyria Study
Condition: Erythropoietic Protoporphyria
MeSH terms: Protoporphyria, Erythropoietic
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a phase III, multicentre, randomised, double-blind, placebo-controlled study, to
      evaluate the safety and efficacy of subcutaneous bioresorbable afamelanotide implants in
      patients with Erythropoietic Protoporphyria (EPP).

      The study was conducted with two parallel study arms with crossover between treatments every
      60 days.

      Eligible patients were randomised to a treatment group, and received implants of active
      treatment (afamelanotide 16mg) or placebo, in an alternating crossover fashion according to
      the following dosing regime:

        -  Group A was administered active implants on Days 0, 120, 240 and placebo implants on
           Days 60, 180, 300

        -  Group B was administered placebo implants on Days 0, 120, 240 and active implants on
           Days 60, 180, 300
    

Detailed description: 
      Afamelanotide is a man-made drug being studied for use as a preventative medication for
      Erythropoietic Protoporphyria (EPP) sufferers. It is a synthetically produced analogue of
      human alpha melanocyte stimulating hormone (alpha-MSH).

      The study will involve the use of an implant, which comes in the form of a small rod to be
      administered under the skin. The implant may contain the study drug afamelanotide or a
      placebo (inactive medication).

      This study aims to provide insight into the effectiveness of afamelanotide under normal
      conditions of use in EPP patients.
    

Intervention name(s): Afamelanotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 16mg subcutaneous implant; Placebo subcutaneous implant
Intervention MeSH terms: Afamelanotide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erythropoietic Protoporphyria; EPP; Afamelanotide