bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Adalimumab in Patients Who Showed an Unsatisfactory Response to Etanercept
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will provide data on additional therapeutic benefits in administering Adalimumab
      in patients with plaque psoriasis that showed an unsatisfactory response after at least 3
      months of treatment with etanercept.
    

Detailed description: 
      A total of 50 patients with psoriasis vulgaris who showed an unsatisfactory response to
      etanercept 50 mg twice a week followed by 50 mg once a week and a total of 50 patients who
      showed an unsatisfactory response to etanercept 50 mg twice a week without dose reduction
      will be recruited. All patients will receive adalimumab 40 mg every other week (EOW) for 12
      weeks. Patients who fail to reach a physician's global assessment (PGA) of clear or almost
      clear at week 12 will have an increase in adalimumab to 40 mg every week (EW) for an
      additional 12 weeks. Patients who reach a PGA of clear or almost clear at week 12 will
      continue to receive adalimumab at 40 mg EOW for an additional 12 weeks. Patients will be
      evaluated for safety and efficacy every 4 weeks for a total of 24 weeks. PASI, BSA and PGA
      will be performed at each visit. Routine chemistry, hematology and urinalysis will be
      performed every 4 weeks.

      The percentage of patients achieving a physician's global assessment (PGA) of clear or almost
      clear after at least 12 weeks of adalimumab will be calculated for patients who had shown an
      unsatisfactory response to 3 months of etanercept at 50 mg twice a week without dose
      reduction as well as for patients who had shown an unsatisfactory response to 3 months of
      etanercept at 50 mg twice a week followed by 50 mg once a week.

      A physician's global assessment (PGA) of clear is defined by no plaque elevation over normal
      skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules,
      diffuse faint pink or red coloration.

      A physician's global assessment (PGA) of almost clear is defined as follows: It is possible
      but difficilt to ascertain whether there is a slight elevation above normal skin. There is
      scaling in the form of surface dryness with some white coloration. Erythema is up to a
      definite red coloration.
    

Intervention name(s): Adalimumab every other week; Adalimumab Every Week
Intervention type(s): Drug; Drug
Intervention description(s): Adalimumab 40mg injection every other week for 24 weeks; Adalimumab 40mg injection every week for the last 12 weeks of study.
Other intervention name(s): HUMIRA; HUMIRA
Intervention MeSH terms: Adalimumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adalimumab
KinectROM Application for Assessing Range of Motion in Upper and Lower Extremity: A Development and Validation Study
Condition: Range of Motion
Study type: Interventional

Summary: 
      The aim of the study is to investigate the validity and reliability of KinectROM application
      for objectively evaluating range of motion (ROM)
    

Detailed description: 
      The application KinectROM called has been developed for assessing ROM with Kinect controller
      by our team. So, shoulder, elbow, knee, hip and ankle ROM measurements will be made with
      universal goniometer and developed KinectROM application.
    

Intervention name(s): Assessment of Range of Motion with Kinect Controller
Intervention type(s): Device
Intervention description(s): A ROM measurement method called as KinectROM by us has been developed with Kinect Controller
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: range of motion; upper extremity; lower extremity
Oral Dydrogesterone in the Management of Preterm Labor
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the addition of oral dydrogesterone to standard treatment in the
      treatment of preterm labor. Half of participants will receive oral dydrogesterone and
      standard treatment, while the other half will receive oral placebo and standard treatment.
    


Intervention name(s): Dydrogesterone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): dydrogesterone capsule; placebo capsule
Intervention MeSH terms: Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Research Study of How Different Amounts of a New Medicine NNC0148-0287 C (Insulin 287) Works on the Blood Sugar of People Who Are Japanese With Type 1 Diabetes When Given Once a Week
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will look at how insulin 287 works, if it is safe and the side effects in people
      who are Japanese with type 1 diabetes. The study will test how insulin goes through your
      blood, how long it stays there and how the blood sugar is lowered. Insulin 287 is a new
      medicine. Insulin glargine is already approved to treat diabetes. The study doctors can
      prescribe insulin glargine. The participants will get both of the insulins in a random order.
      The participants will get 8 weekly doses of insulin 287 and 14 daily doses of insulin
      glargine. There will also be a run-in period of 2 days to 7 weeks when the participants
      inject insulin glargine every day before they start insulin 287 period or insulin glargine
      period. All doses will be injected under the skin. During the run-in period, the participants
      adjust the insulin glargine dose and make their blood sugar levels stable. From the run-in
      period, the participants will take insulin aspart as bolus insulin. The study will last for
      about 16 - 28 weeks. The participants will have 24 visits with the study doctor. There will
      be 3 glucose clamps where the participants' blood sugar is tested over time. The participants
      cannot be in the study if the study doctor thinks that there are risks for their health.
    


Intervention name(s): insulin icodec; Insulin glargine U100
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous (s.c.) injections of insulin 287 once weekly for 8 weeks; Participants will receive s.c. injections of insulin glargine once weekly for 2 weeks
Other intervention name(s): Insulin 287
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1 PK Study of Tolperisone in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, single-blind, single and multiple dose crossover subjects in healthy
      adult subjects
    

Detailed description: 
      This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD
      crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to
      the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects
      will be on a standard diet during each inpatient treatment period; study drug will be
      administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period.
      Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There
      will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period
      2, and between the last dose in Period 2 and the first dose in Period 3.
    

Intervention name(s): Tolperisone
Intervention type(s): Drug
Intervention description(s): tablets
Intervention MeSH terms: Tolperisone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: sequence randomized
Masking: Single (Participant)
Primary purpose: Other
An Open-label, Single-dose, Non-randomized Study of IV 14C-labeled PER977 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose, non-randomized study in healthy male subjects to
      characterize the mass balance, metabolic disposition, and identification of the metabolites
      and general metabolic pathways following administration of a single dose of IV solution
      containing 200 mg of PER977 plus a tracer amount of 14C PER977 in health male subjects.
    


Intervention name(s): 14C PER977
Intervention type(s): Drug
Intervention description(s): Open-label, single dose
Other intervention name(s): ciraprantag
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PER977; metabolic disposition; mass balance; metabolites; radiolabeled
Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury
Condition: End-Stage Renal Disease; Kidney Failure; Graft Reperfusion Injury
MeSH terms: Kidney Failure, Chronic; Renal Insufficiency; Reperfusion Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Study of eculizumab ability to correct the reperfusion injury of the kidney allograft.
    

Detailed description: 
      Based on experimental data and supportive observations in humans associating complement gene
      upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key
      step in the pathogenesis of ischemic reperfusion injury following transplantation. It was
      further hypothesized that eculizumab, antibody that blocks C5 cleavage in humans will be an
      effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients.
      For testing this hypothesis, this study is a pilot prospective study to test the efficacy of
      eculizumab in preventing the development of reperfusion injury and contribute graft survival.
    

Intervention name(s): eculizumab
Intervention type(s): Drug
Intervention description(s): Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
Other intervention name(s): Soliris
Intervention MeSH terms: Eculizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: eculizumab; kidney transplantation; reperfusion; rejection; infection
Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to compare the effects of higher dose vitamin D with
      commonly recommended dose in pregnant women to see which is better in achieving and/or
      maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well
      as improving growth in the infant.
    

Detailed description: 
      Three dosages of Vitamin D will be administered; 400IU, 2000IU and 4000IU per day to pregnant
      women starting at less than 16 week gestation continued until delivery. The dose will be
      provided using a randomized control method. Serum levels of 25 hydroxy D will be measured in
      mothers at 12, 16, 28 and delivery. Cord blood 25 hydroxy D and the infants' birthweight,
      length and head circumference will be measured at birth.
    

Intervention name(s): Prenatal Vitamin; Cholecalciferol (Vitamin D3); Cholecalciferol (Vitamin D3)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery; Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery; Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
The Role of Endothelium Dysfunction in Progression of CKD (Chronic Kidney Disease) After AKI (Acute Kidney Injury)
Condition: Acute Renal Failure; Chronic Kidney Failure; Endothelial Dysfunction; Hemolytic-uremic Syndrome (HUS)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury; Renal Insufficiency; Hemolytic-Uremic Syndrome; Kidney Failure, Chronic; Hemolysis
Study type: Observational

Summary: 
      To understand how AKI (Acute Kidney Injury) leads to chronic kidney disease so therapies can
      be found to alter the progression of events thereby significantly impacting the long-term
      outcomes of children who develop AKI.
    

Detailed description: 
      This research study is designed to study what happens to the kidneys after they have an
      injury. There is some evidence that even if there appears to be great improvement of kidney
      function, an injury can put patients at risk for long-term problems with their kidney
      function and increase their risk to have high blood pressure. We want to collect information
      from participants to help explain why this injury can cause future problems, including
      Chronic Kidney Disease (CKD) which may help us prevent these health problems.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children 2-20 years old with history of acute kidney injury
      
Keywords: Endothelium; Chronic Kidney Disease; Acute Kidney Injury; Hemolytic-uremic syndrome (HUS)
Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum
Condition: Deformity Knee; Deformity of Limb
MeSH terms: Genu Varum; Congenital Abnormalities
Study type: Interventional

Summary: 
      Genu-varum is a common problem encountered in pediatric orthopedic. Correction of
      pathological deformity is mandatory to ensure normal load transfer through the knee. In this
      study, the investigators describe a new technique of osteotomy osteoclasis in order to
      evaluate if it is an effective and reliable method in management of infantile genu varum
    

Detailed description: 
      Seventy children with 122 legs suffering significant infantile genu-varum were treated by
      percutaneous osteotomy-osteoclasis technique. The mean age was 46 months. Genu varum was
      bilateral in 52 children and unilateral in 18 with a mean preoperative proximal medial tibial
      angle 66.67 ± 2.670. Under general anesthesia, transverse osteotomy osteoclasis was performed
      below the tibial tuberosity. Follow-up radiograph was done within the first post-operative
      week and then every two weeks to assess alignment and consolidation.
    

Intervention name(s): osteotomy
Intervention type(s): Procedure
Intervention description(s): osteotomy osteoclasis of upper tibia
Intervention model: Single Group Assignment
Intervention model description: prospective randomized study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genu varum, mini-invasive, osteotomy, osteoclasis
Fluid Coloading and the Incidence of Hypotension
Condition: Complications; Cesarean Section; Anesthesia; Adverse Effect, Spinal and Epidural; Other Fluid Overload
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's
      solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access
      line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for
      caesarean section.
    

Detailed description: 
      Background: Spinal anaesthesia for caesarean delivery is often associated with hypotension.
      This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's
      solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access
      line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for
      caesarean section.

      Methods: We studied 90 women with uncomplicated pregnancies undergoing elective caesarean
      section under spinal anaesthesia. Intravenous access was established in all with two
      peripheral intravenous lines, the first being used for the baseline volume infusion.
      Immediately after induction of spinal anaesthesia, Lactated Ringer's solution (Group L) or
      HES (Group C) infusions were started at the maximal possible rate via the second line in
      groups L and C respectively. The third group (Group E) patients received lactated Ringer's
      solution at a 'keep vein open' rate to maintain the double-blind nature. The incidence of
      hypotension, ephedrine requirements, total amount of volume and side effects were recorded.
    

Intervention name(s): Cristalloid and colloid coloading
Intervention type(s): Biological
Intervention description(s): Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator
Other intervention name(s): Cristalloid coloading (Group L); Colloid coloading (Group C); No coloading (Group E)Placebo Comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anaesthesia Spinal; Ephedrine; Fluid Therapy; Hypotension
Effects of Physical Inactivity on Insulin Sensitivity, Appetite, Energy Balance, and Cardiovascular Responses in Humans.
Condition: Sedentary Behavior
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Physical inactivity is a significant predictor of major non-communicable diseases such as
      type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some
      cancers, and has been proposed to be the 4th leading cause of death worldwide. Reduced
      physical activity leads to an impaired function of the hormone insulin and increased
      adiposity. Thus, the elimination of physical inactivity would remove between 6% and 10% of
      the major non-communicable diseases and increase life expectancy. The aim of the study is to
      investigate the effects of a short-term (2-day) period of reduced physical activity, with and
      without a proportional decrease in energy intake, on the action of insulin to regulate blood
      sugar fluctuations, appetite, and cardiovascular parameters (heart rate, cardiac output,
      stroke volume, blood flow, arterial blood pressure, peripheral vascular resistance) in
      response to food ingestion.
    


Intervention name(s): Control; SIT+E; SIT=E
Intervention type(s): Other; Other; Other
Intervention description(s): Normal physical activity and standard energy intake; Reduced physical activity and standard energy intake; Reduced physical activity and reduced energy intake
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Targeting Burdensomeness Among Clinic Referred Youth
Condition: Perceived Burdensomeness Toward Others
Study type: Interventional

Summary: 
      This study will develop and pilot test a novel intervention module targeting perceived
      burdensomeness toward others in 30 clinic referred youths who experience anxiety or
      depression and elevated levels of burdensomeness. All participants will be assigned to
      receive the intervention in this open trial.
    

Detailed description: 
      Suicidal ideation is prevalent and impairing in youth, with approximately 15% of high school
      students reporting seriously considering a suicide attempt and making a specific plan for
      suicide in the past 12 months. Substantial evidence documents perceived burdensomeness
      towards others, or the belief that one is a burden or drain on others, as a risk factor for
      suicide ideation in youth. This evidence highlights the potential promise of perceived
      burdensomeness as a novel intervention target to prevent suicide ideation in youth. The
      current study will develop and preliminary evaluate a novel, brief behavioral treatment
      module targeting perceived burdensomeness in youth that can be embedded within existing
      psychosocial treatments. The study will use an open trial design. The first aim of this
      proposal is to develop a novel, brief psychosocial intervention module (the GIVE module)
      targeting perceived burdensomeness towards others that can be embedded within existing CBT
      protocols for youth internalizing problems. The second aim is to collect data relevant to
      client satisfaction and reductions in perceived burdensomeness. Participants will be N=30
      clinic-referred youth ages 10 to 17 years with anxiety or depressive disorders in a
      university-based research clinic, who display elevated levels of perceived burdensomeness. In
      the context on ongoing CBT for anxiety or depression, participants will complete the GIVE
      module at sessions 6 and 7 of the CBT protocol. It is hypothesized that perceived
      burdensomeness will be significantly lower after the GIVE module is administered, and that
      client satisfaction will be high. Data collected in this study will provide the foundation
      for a subsequent randomized controlled trial of the GIVE module.
    

Intervention name(s): GIVE Module
Intervention type(s): Behavioral
Intervention description(s): The GIVE Module is a brief cognitive behavioral intervention targeting youths' beliefs that they are a burden or drain on others. It consists of two sessions embedded within a larger CBT protocol for anxiety or depression.
Intervention model: Single Group Assignment
Intervention model description: open label pilot study
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Dietary Factors on Physiological Subjective Stress Responses
Condition: Chronic Stress
Study type: Interventional

Summary: 
      The study aims to investigate the role of dietary factors in chronically stressed subjects.
      Previous studies have shown that milk proteins, B vitamins and probiotics may influence on
      subjective well-being in stressed subjects.
    


Intervention name(s): Yogurt-like snacks
Intervention type(s): Dietary Supplement
Intervention description(s): twice a day 120 g for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: milk protein; probiotics; stress; cortisol; heart beat