bioihbjkbjnl/mcl2 huggingface dataset:
CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects
Condition: Health, Subjective
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares two administration methods of CT-P13. Half of participants will receive
      CT-P13 by pre-filled syringe while the other half will receive CT-P13 by auto-injector.
    

Detailed description: 
      This is a Phase I Study to Compare Pharmacokinetics and Safety between CT-P13 SC Pre-filled
      Syringe and CT-P13 SC Auto-injector in Healthy Subjects. A total of 218 healthy subjects will
      be enrolled.
    

Intervention name(s): CT-P13 SC Auto-injector; CT-P13 SC Pre-filled Syringe
Intervention type(s): Biological; Biological
Intervention description(s): Each subject may receive single dose by subcutaneous administration using Auto-Injector; Each subject may receive single dose by subcutaneous administration using Pre-filled Syringe
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Use of Interim PET Scan to Modify Therapy in Advanced Hodgkin's Lymphoma in Order to Improve Outcomes
Condition: Hodgkin's Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional

Summary: 
      The current standard treatment for advanced Hodgkin's lymphoma 6-8 cycles of ABVD
      chemotherapy-this cures 70-80% patients. Those not cured after 8 cycles of ABVD have a poor
      outcome (<10% survival). More intensive chemotherapy like Escalated BEACOPP (EB) achieve
      higher cure rates have more side effects. Hence the investigators propose to use Interim PET
      CT scan (done after 2 cycles of ABVD) for early identification of poor responders (it is
      known that those with interim PET positive disease have a cure rate of less than 10-15% if
      continued with ABVD alone) and to use EB selectively in this population in an attempt to
      improve treatment outcomes - at the same time to limit side effects of therapy.

      Thus, this study is an attempt to improve the outcome in the small subset of poor responders
      to ABVD chemotherapy by the early use of Escalated BEACOPP chemotherapy
    


Intervention name(s): Escalated BEACOPP
Intervention type(s): Drug
Intervention description(s): Escalated BEACOPP chemotherapy will be delivered for those patients who are interim PET CT positive after 2 cycles of ABVD chemotherapy. The patients will receive 2-4 cycles of Escalated BEACOPP once in 3 weeks. The cycles will be delivered as follows:
Bleomycin 10mg/m2 IV in day 8, Etoposide 200mg/m2 Day 1 to Day 3, Adriamycin 35mg/m2 on Day 1 IV, Cyclophosphamide 1200mg/m2 on Day 1 IV, Vincristine 1.4mg/m2 on Day 8 IV, Cap Procarbazine 100mg/m2 Day 1 to Day 7 PO, T Prednisolone 40mg D1-D7 of a 21 day cycle. With Inj Mesna 400mg/m2 0, 4 and 8 hours on the day of Cyclophosphamide Inj G-CSF will be started routinely from Day 9 till recovery of Absolute neutrophil counts ≥5000/cmm or Total WBC counts≥ 8000/cmm
Other intervention name(s): EB
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin's Lymphoma; PET CT scan; Escalated BEACOPP; ABVD; Response adapted therapy
Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories
Condition: Attention Deficit Disorder With Hyperactivity; Amphetamine-Related Disorders; Substance-Related Disorders
MeSH terms: Hyperkinesis; Substance-Related Disorders; Amphetamine-Related Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to
      learn if NRP104, when injected into a vein, produces a high and any other effects like
      amphetamine and other stimulant drugs that are abused. This information will give some
      indication if NRP104 can be abused. Healthy people, between the ages of 18 and 55 with
      histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs
      that are used most often to treat attention deficit hyperactivity disorder (ADHD) in
      children, to treat narcolepsy (excessive sleepiness) and for weight loss.
    

Detailed description: 
      There is a need for a non-scheduled stimulant medication that can provide symptom control for
      children with ADHD as the conventional stimulant products do.

      Currently, the top line amphetamine product Adderall XR (R) for the treatment of children
      with ADHD involves a once-a-day morning dosing of up to 30 mg per day per Adderall XR (R)
      Package Insert. New River Pharmaceuticals has developed three NRP104 dose strengths of 30 mg,
      50 mg, and 70 mg to provide amphetamine base equivalent to Adderall XR (R) 10 mg, 20 mg, and
      30 mg, respectively. Adderall XR (R) and other amphetamine and methylphenidate containing
      preparations are liable to intravenous abuse.

      As part of the development of NRP104 for treatment of children with ADHD, it is important to
      evaluate the abuse potential of NRP104 given intravenously in comparison to immediate release
      d-amphetamine. This study will conduct relevant information to address appropriately the
      objectives of determining abuse potential of intravenously administered NRP104.
    

Intervention name(s): NRP104
Intervention type(s): Drug
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: d-Amphetamine; Attention Deficit Hyperactivity Disorder; Attention Deficit Disorders with Hyperactivity; Attention Deficit Hyperactivity Disorders; Amphetamine Abuse; Amphetamine Dependence; Amphetamine Addiction; Amphetamine Users; Drug Abuse; Drug Addiction; Drug Dependence; Drug Habituation; Drug Use Disorders; Substance Abuse; Substance Dependence; Substance Use Disorders; Drug Usage; Substance Addiction; Drug Abuse, Intravenous; Intravenous Drug Abuse
Effect of the Sustainable Diet on Gut Microbiota and the Metabolome: a Randomised Crossover Study
Condition: Microbiota; Nutrition, Healthy
Study type: Interventional

Summary: 
      Unhealthy diets are closely linked to non-communicable diseases and constitute higher risk of
      morbidity and mortality than unsafe sex, alcohol, tobacco and drugs use combined. According
      to the World Health Organization (WHO), a healthy diet follows a plant-based pattern with low
      quantities of red meat and a low simple sugar intake. It would also reduce anthropological
      ecologic impact. We hypothesize that a plant-based diet will beneficially modify the gut
      microbiota and metabolome, influencing also Trimethylamine N-oxide (TMAO), a metabolite
      associated to CVD.

      This study has a randomized single blind crossover design that compares a plant-based diet
      towards a control western diet. It is applied to volunteers aged 18-70 years, N=20. Each
      dietary intervention (plant-based and western) would last for 16 consecutive days separated
      by a minimum of 7 weeks washout period (intervention 1-washout-intervention 2). Samples of
      blood urine and faeces will be collected at day 1 and 14 of each intervention. On day 14 will
      be performed L-carnitine challenge with 1200mg of L-carnitine to test the levels of TMAO), in
      for the next 2 consecutive days (24h and 48h post treatment).
    


Intervention name(s): Plant-based diet; Western diet
Intervention type(s): Other; Other
Intervention description(s): 16 days with all foods provided; 16 days with all foods provided
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross-over single-blinded
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Plant-based diet; Western diet; Gut microbiota,; Trimethylamine N-oxide; Human intervention study.
Double-blind Placebo Surgery Trial for Treatment of Parkinson's Disease
Condition: Parkinson Disease; Surgery
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      A double-blind sham surgery-controlled trial was developed to determine the effectiveness of
      implantation of human embryonic dopamine neurons into the putamen of patients with advanced
      Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half
      receiving sham surgery (n = 20). The blind was maintained for 12 months before participants
      were told which surgery they received, at which time those receiving sham surgery could
      request the implant surgery.
    

Detailed description: 
      A double-blind sham surgery-controlled trial was conducted to determine the effectiveness of
      implantation of human embryonic dopamine neurons into the putamen of patients with advanced
      Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half
      receiving sham surgery (n = 20). The goals were to determine whether the cells survived and
      led to improvement of symptoms, and to examine the effect of age on results of the
      implantation. Quality of life of participants and care partners was also examined at each of
      the assessment periods (baseline, 4, 8 and 12 months). The blind was maintained for 12
      months.
    

Intervention name(s): Neural implantation group; Sham surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Cultured mesencephalic tissue from four embryos was implanted into the putamen bilaterally for those receiving the implant; Steel frame affixed to head and four burr holes drilled into forehead of sham surgery patients
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this double-blind study, 20 participants were randomly assigned to the treatment group and 20 to the sham surgery group with the blind being maintained for 12 months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: placebo effect
A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis; Healthy Volunteers
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will try, in 2 separate parts, each using 12 research subjects, to see how a new
      form of the pill CE 224,535 gets released into the bloodstream and whether that is affected
      by food. In each part, subjects will switch among 4 treatment periods to take either
      different forms of the pill(s) or the same form either after fasting or eating a meal. The
      second part will only happen depending on whether the sponsor believes it is needed and will
      use separate subject than the first part.
    


Intervention name(s): CE-224,535; CE-224,535; CE-224,535; CE-224,535; CE-224,535; CE-224,535; CE 224,535; CE 224,535
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): one 250mg tablet, once in the morning in fasted state; 2x250 mg tablets, once in the morning, in fasted state; 4x250mg tablets, once in the morning, in fasted state; 2x250mg tab, once in the morning, after being fed a high fat meal; 4x125 mg tabs, once in the morning, in the fasted state. This arm will only occur as part of Part 2, if needed, pending results of Part 1.; 4x125 mg IR once in the morning after being fed a high fat meal; 2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state; 2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal
Other intervention name(s): Part 1;Treatment A; Part 1;Treatment B; Part 1;Treatment C; Part 1;Treatment D; Part 2;Treatment E; Part 2; Treatment F; Part 2; Treatment G; Part 2; Treatment H
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: pharmacology formulation normal healthy volunteers food effect
Environmental Assessment of Sleep in Youth
Condition: Sleep Disorders in Children; Environmental Exposure
MeSH terms: Sleep Wake Disorders
Study type: Observational

Summary: 
      In this research study, investigators want to learn more about the factors that influence
      children's breathing during sleep and their sleep quality. Specifically, investigators are
      interested in factors that are related to risk of snoring, sleep apnea (a condition where
      breathing stops during sleep), and poor sleep quality.
    

Detailed description: 
      Investigators are doing a research study to gather information to help better understand why
      snoring and sleep problems are so common in the community, and how the home and neighborhood
      environment impacts sleep in children. Investigators want to know if factors such as the
      quality of air, household dust, environmental noise, and family routines impact sleep and
      other health and behavioral factors associated with sleep.

      Investigators want to test how sleep is influenced by factors such as: the quality of air
      inside and outside the child's home (including measuring pollution, second hand smoke, and
      dust); temperature and humidity; family routines and interactions; and characteristics of the
      home. Investigators will ask participants to come in for a one time visit for undergoing
      procedures as well as answering questions regarding general health, asthma and sleep. 10% of
      the participating children will have a second home assessment and sleep monitoring procedures
      performed 6 months after the initial home assessment.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children 6-12 years old who live in the Boston area.
      
Keywords: sleep; sleep in children; children and sleep; environment; environment and sleep; environment and children
Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3
      regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x
      400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area
      under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total
      5-ASA percent of dose excreted (A'e [%]) over the 24-hour period on Day 7.
    


Intervention name(s): Asacol; Asacol; Lialda
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Asacol tablets, 6 tablets per day at 7 am for 7 days; Asacol tablets, 400 mg, 2 tablets at 7 am, 3 pm, and 11 pm for 7 days; Lialda tablets 1.2 g, 2 tablets once a day at 7 am for 7 days
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics
Pilot Study on the Effects of Neuromuscular Taping in Parkinson's Disease Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease (PD) is a degenerative disorder characterized by a symptom triad
      consisting on: tremor, rigidity and bradykinesia . To these symptoms it is often added
      postural alteration that can stand in two different attitudes, such as the camptocormia and
      the syndrome of Pisa . Progressing in its evolution, PD becomes increasingly disabling,
      making it difficult or even impossible daily activities such as washing or dressing.The
      abnormal posture, with alteration of the limbs, the neck and trunk, is a recurring feature in
      PD, with a frequency of about 30%. Between 2% and 12.3% are more severe abnormalities such as
      camptocormia, the syndrome of Pisa and the anterocollis. Several studies disease plug in
      Neuromuscular Taping technique (NMT) among rehabilitative tools in degenerative neurological
      syndromes.

      To the best of our knowledge, no applications were found in PD. Therefore, the current study
      was designed to evaluate quantitatively the effects of the NMT intervention on the trunk
      kinematics during standing position. More specifically, this study aims to compare the trunk
      kinematic variables of patients with PD who were treated with effective NMT versus those of
      the subjects who received only the pharmacological treatment.
    


Intervention name(s): Neuromuscular taping
Intervention type(s): Device
Intervention description(s): NMT applications:
rhomboid major muscle
muscles abdominals
spinal muscles
pectoralis major muscles
gastrocnemius muscle
upper trapezius muscle
anterior muscles of the neck
Other intervention name(s): NMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Neuromuscular taping; Trunk; Posture; Kinematic; rehabilitation
A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, healthy male volunteers will receive a single intravenous administration of
      either PF-05280014 or trastuzumab (United States) or trastuzumab (European Union). During the
      course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in
      the blood, and by comparing these levels among the different administration arms of
      PF-05280014 and the US-licensed and EU-approved trastuzumab products. Safety, tolerability,
      and immunologic response also will be evaluated throughout.
    


Intervention name(s): PF-05280014; Herceptin; Herceptin
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on day 1; Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on day 1; Concentrate for solution for infusion, sterile vial 440 mg, single-dose 6 mg/kg administered as 90-minute infusion on day 1
Other intervention name(s): Trastuzumab-Pfizer; Trastuzumabum (European Union); Trastuzumab (United States)
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Bioequivalence; Biosimilarity; Similarity; PK; Phase I; Trastuzumab; Healthy Male Volunteers; Single-dose; HER-2; Oncology
Ghrelin and Insulin Resistance
Condition: Obesity; Insulin Resistance; Normal Weight,Healthy Controls
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      Ghrelin, a hormone produced in the stomach that stimulates hunger and food intake, declines
      immediately after weight loss surgery. Some studies suggest that ghrelin may worsen an
      individual's ability to respond to insulin. The purpose of this study is to determine if the
      decline in ghrelin levels after weight loss surgery contributes to the improvement of insulin
      sensitivity.
    


Intervention name(s): Ghrelin infusion to assess effects on insulin sensitivity
Intervention type(s): Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Obesity; Insulin resistance; Ghrelin
The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      In patients undergoing lower abdominal surgery, postoperative pain management is frequently
      provided with systemic opioids use or neuraxial methods. Ultrasound-guided TFP block is the
      preferred method to reduce the use of opioids and systemic analgesics for postoperative pain
      management. TFP block provides anesthesia and analgesia in the inguinal region by blocking
      the ilioinguinal and iliohypogastric nerves.

      In this study, we aimed to evaluate the effects of ultrasound-guided TFP Block on
      postoperative pain scores in pediatric lower abdominal surgery.
    


Intervention name(s): Bupivacaine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Ultrasound-guided Transversalis Fascia Plane Block with 0.5 ml/kg %0.25 bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Desvenlafaxine Monotherapy in Dysthymia
Condition: Dysthymic Disorder
MeSH terms: Dysthymic Disorder
Study type: Interventional

Summary: 
      This multi-centred study will be conducted at two centres. The design will be an open label,
      flexible-dose study. This investigation will evaluate the efficacy of Desvenlafaxine
      monotherapy for patients who meet diagnostic criteria for dysthymia.
    

Detailed description: 
      Primary objective: To investigate the efficacy, safety, and tolerability of open-label
      desvenlafaxine monotherapy in dysthymic subjects.

      Secondary objectives: To evaluate the efficacy of desvenlafaxine on clinical measures
      relating to improvement of depressive symptoms, quality of life and occupational functioning.

      It is hypothesized that Dysthymic subjects will show significant improvement in depressive
      symptoms after 8 weeks of treatment with desvenlafaxine. There will be significant
      improvement in measures of quality of life and stress coping at end of treatment, compared to
      Baseline. There will also be significant improvement in measures of occupational functioning
      at end of treatment, compared to Baseline.
    

Intervention name(s): Desvenlafaxine
Intervention type(s): Drug
Intervention description(s): Patients will be initiated on 50 mg/day of Desvenlafaxine. No dose changes will be allowed for the first four weeks. If there is partial or no response after four weeks, dosage will then be increased to 100mg/day, based on tolerability and the Investigator's judgment.
Other intervention name(s): Pristiq
Intervention MeSH terms: Desvenlafaxine Succinate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Desvenlafaxine; Open-label; Flexible-dose; Dysthymic disorder; Anxiety disorders; Generalized anxiety disorder; Social anxiety disorder; Post-traumatic stress disorder