bioihbjkbjnl/mcl2 huggingface dataset:
Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD
Condition: PVD; Arterial Ulcers
MeSH terms: Intermittent Claudication; Ulcer
Study type: Interventional

Summary: 
      To evaluate the effects of HPIPC for the treatment of symptoms of PAD
    


Intervention name(s): High pressure intermittent pneumatic compression (HPIPC); Excercise
Intervention type(s): Device; Behavioral
Intervention description(s): Apply therapy for 45 minutes twice daily; Treadmill walking 45 minutes once daily
Other intervention name(s): Bio Arterial Plus; Art Assist; Walking on a treadmill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemic ulcers; PAD; Intermittent Claudication Pain
Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer
Condition: Pancreatic Cancer, Resected
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the effect of TG01 and Granulocyte macrophage
      colony stimulating factor (GM-CSF) when given in addition to gemcitabine (chemotherapy) and

        -  Understand any possible side effects of the additional use of TG01/GM-CSF with
           gemcitabine

        -  Investigate whether TG01/GM-CSF when given with gemcitabine can produce an immune
           response

        -  Investigate if the treatment can delay or reduce recurrence of the disease
    


Intervention name(s): TG01; TG01
Intervention type(s): Biological; Biological
Intervention description(s): TG01 and GM-CSF will be administered on days 1, 8, 15, 22 and 36. TG01 alone will also be given on days 36 and 50 for DTH assessment. Gemcitabine will start at least 3 weeks after TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total.
Once chemotherapy is completed, GM-CSF and TG01 injections will resume and will be given every 4 weeks from the end of the chemotherapy period up to week 52 (plus once at week 5 post-chemotherapy) and then every 12 weeks from week 52 to week 104. TG01 alone will be given 8 weeks after the end of chemotherapy for DTH assessment.
TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections.
Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes; For patients not able to start TG01 quickly after surgery, the vaccination can start at the same time as the chemotherapy as long as they start within 12 weeks from surgery. Gemcitabine will start at the same time as TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total.
TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections.
Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic cancer, resected; Vaccine; KRAS
Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates
      of different solutions subcutaneously (SC) infused and preceded by human recombinant
      hyaluronidase (hylenex) 150 units.

      In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR)
      solution. Each subject will receive 500 milliliters (mL) of solution, consisting of NS in one
      thigh and LR in the other thigh. Immediately prior to the infusions, each thigh will have 150
      units of hylenex.

      In Stage 2, the comparison will be NS solution and buffered NS solution.
    

Detailed description: 
      This Phase IV, randomized, double-blinded study in volunteer subjects to evaluate the
      tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and
      preceded by human recombinant hyaluronidase (hylenex) 150 units. The study will be conducted
      in two sequential stages.

      In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive
      simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh,
      consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to
      receive NS and LR will be randomized and double blinded. Immediately prior to the infusions,
      each thigh will have 150 units of hylenex simultaneously injected.

      Tolerability will be assessed based on the subject's self-assessment of discomfort on a
      visual analog scale (VAS). Safety will be assessed by physical examination targeted at
      infusion sites, vital signs, and adverse events. The amount of fluid infused will be assessed
      by weighing the infusion bag, fluid and tubing at designated time points, and allowing the
      determination of flow rate.

      Stage 2 will be conducted only if the observed Stage 1 VAS mean maximum pain score is at
      least 25 mm higher for one solution compared to the other. Stage 2 will evaluate the
      tolerability, safety, and flow rates of subcutaneously infused NS solution and buffered NS
      solution.
    

Intervention name(s): recombinant human hyaluronidase
Intervention type(s): Drug
Intervention description(s): 150 Units in 1mL
Other intervention name(s): Hylenex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hylenex; subcutaneous infusion; hyaluronidase; rHuPH20; recombinant human hyaluronidase
Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years
Condition: Tick-borne Encephalitis
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess:

        -  TBE antibody persistence 2 and 3 years after the third TBE vaccination with FSME-IMMUN
           0.5ml by means of ELISA and neutralization test (NT).

        -  TBE antibody response to a booster vaccination with FSME-IMMUN 0.5ml, by means of ELISA
           and NT.
    


Intervention name(s): FSME-IMMUN 0.5ml
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Prospective Study of Different Digoxin Treatment Regimens in Egyptian Hospital
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      Digoxin is the primary cardiac glycoside in clinical use. Because of the narrow therapeutic
      index and risk of toxicity, therapeutic drug monitoring is highly recommended. In Egypt, most
      cardiologists give digoxin holiday for both atrial fibrillation and heart failure, it is not
      clear if the interrupted digoxin regimens are effective since serum digoxin concentrations
      might fall below the therapeutic range.

      Objective: To evaluate and compare the digoxin serum concentration and patient's quality of
      life in the continuous versus interrupted digoxin dosing regimens.
    

Detailed description: 
      Digoxin is a cardiac glycoside prescribed in heart failure and certain supraventricular
      tachyarrhythmias. It exerts a positive inotropic, neurohormonal, and electro physiologic
      actions on the heart . For heart failure patients, the targeted steady state serum digoxin
      level is between 0.5 and 0.8 ng/ml . Ventricular rate control in atrial fibrillation patients
      will usually require higher digoxin steady state serum concentrations . However, serum
      digoxin level higher than 2 ng/ml is associated with increased incidence of adverse drug
      reactions and should be avoided . Because of inter and intra-patient variability, narrow
      therapeutic index, and risk of toxicity, digoxin doses are calculated based on the patient
      weight, renal status, indications and drug interactions. Due to substantial overlap between
      therapeutic and toxic levels of digoxin, therapeutic drug monitoring is a must especially in
      patients with deteriorating renal function and electrolyte disturbance. In Egypt, most
      cardiologists give a digoxin holiday for patients with atrial fibrillation and /or heart
      failure where patients skip the drug doses on Thursday and Friday or Friday only every week
      to avoid possible drug accumulation and toxicity. It is not clear if these interrupted
      digoxin regimens really offer safer alternative over the continuous dosing regimens without
      compromising the effectiveness. It is anticipated that plasma digoxin levels may fall below
      the therapeutic range during the holiday which may affect patient clinical status and quality
      of life.
    

Intervention name(s): patients take 0.25 mg of digoxin daily except friday; patients take 0.25 mg of digoxin daily except thursday and friday; patients take 0.125 mg of digoxin daily; digoxin dose is calculated using Jusko-Koup method and given daily
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Digoxin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study of HIV 1 Antigen Expanded Specific T Cell Therapy
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, single-site study is to evaluate the safety and immunologic and virologic
      efficacy of ex vivo expanded HIV-1 multi-antigen specific T-cell (HXTC) therapy in
      HIV-infected individuals with viral suppression on antiretroviral therapy (ART).
    

Detailed description: 
      The main hypothesis of this study is that the administration of autologous ex vivo expanded
      HIV-specific T-cells (HXTCs) primed to recognize multiple HIV-1 antigens in HIV-infected
      participants who initiated ART during acute and chronic HIV infection will be safe, increase
      HIV-1 antigen specific T-cell immune responses and decrease low level viremia.

      In addition, secondary objectives are to:

        1. Determine the feasibility of manufacturing HXTC from participants who started cART
           during acute and chronic HIV infection.

        2. Explore the ability of autologous ex vivo expanded HIV-1 specific T-cells (HXTC) to
           increase HIV-1 specific immune responses in participants initiated on cART during acute
           and chronic HIV infection.

        3. Explore the ability of autologous ex vivo expanded HIV-1 specific T-cells (HXTC) to
           impact latent HIV infection as measured by a quantitative viral outgrowth assay (QVOA)
           and integrated proviral DNA quantification, and low level viremia as measured by a
           single copy assay (SCA) in participants initiated on cART during acute and chronic HIV
           infection.
    

Intervention name(s): HXTC infusion
Intervention type(s): Biological
Other intervention name(s): HIV 1 antigen expanded specific T cell
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antigen Expanded Specific T Cell Therapy; HXTC; Antiretroviral Therapy; Acute HIV infection; Chronic HIV infection; Leukapheresis
Effect of Acupuncture on Anti Mullerian Hormone and Assisted Reproduction Outcome in PCOS Patients Undergoing IVF
Condition: PCOS
Study type: Interventional

Summary: 
      Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims
      to compare assisted reproduction outcome between two groups of PCOS patients underwent IVF,
      one group received acupuncture and other group without acupuncture.
    

Detailed description: 
      Follicular phase acupuncture applied for PCOS patients underwent IVF to evaluate the effect
      of acupuncture on anti-mullerian hormone (AMH) and the effect on assisted reproduction
      outcome. It applied at certain acupoints according to the principles of traditional Chinese
      medicine.
    

Intervention name(s): Acupuncture(Hwato®)
Intervention type(s): Device
Intervention description(s): acupuncture using 4cm long disposable stainless steel hair-thin needles manufactured by Suzhou medical appliance factory (China).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; AMH; PCOS
The Effect of Sumatriptan and Placebo on CGRP Induced Headache
Condition: Migraine
MeSH terms: Headache
Study type: Interventional

Summary: 
      To develop a pragmatic migraine model the investigators will induce headache in healthy
      volunteers and in patients with migraine without aura with aCalcitonine Gene Related Peptide
      (CGRP). If the headache responds to sumatriptan, the model can be used to test new drug
      candidates.
    

Detailed description: 
      There remains a great need for more effective anti-migraine drugs with fewer side effects.
      Human experimental models are valuable in early phase development of new anti-migraine drugs
      but useful models have not yet been developed. The investigators' group has shown that
      Calcitonine Gene Related Peptide (CGRP) induce headache/migraine in both healthy volunteers
      and in patients with migraine without aura (MO). To validate this model, the headache must
      respond to specific migraine treatment with sumatriptan.

      Hypothesis: CGRP induces a migraine-like headache in both healthy subjects and in MO-patients
      and induced headache responds to a specific anti migraine drug; sumatriptan.

      Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
    

Intervention name(s): Calcitonin Gene Related Peptide; Sumatriptan 50 mg; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan; CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan; CGRPis given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Other intervention name(s): CGRP; Imigran
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Sumatriptan; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Improving Attention Skills of Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Toddlers with autism have poor joint attention skills. Joint attention skills include
      pointing to objects, following another person's gaze, and responding to invitations to join
      in a social interaction. Improved joint attention skills may lead to better verbal ability as
      the child ages. This study teaches caregivers how to help their toddlers with autism develop
      joint attention skills.
    

Detailed description: 
      Young children with autism show impairment in joint attention. The impairment affects their
      ability to sustain a shared interest in social interaction and to use specific joint
      attention skills, such as pointing and showing. The importance of joint attention is
      underscored by data suggesting these skills are important to later language skills. Targeting
      joint attention deficits in developmentally young children using familiar caregivers may
      result in better child language outcomes. This study will teach caregivers how to initiate
      and maintain episodes of joint engagement with their children.

      Participants will be randomized to either the intervention group or to a wait list control
      group. Each caregiver and child in the intervention group will participate in 24 1-hour
      sessions, 3 times a week for 8 weeks. In these sessions, caregivers will be taught 10
      different modules for teaching joint attention skills to their children. Outcome measures
      will include language and joint attention skills in the child and caregiver adherence to the
      intervention protocols. Children and caregivers will be assessed at baseline, during the
      course of the 8-week intervention, and 10 weeks after the end of the intervention.
      Participants assigned to the wait list group will begin the intervention at Week 12.
    

Intervention name(s): Caregiver joint attention intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Joint attention; Developmental delay; Caregiver interaction
The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients
Condition: Hypoxemia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      High flow nasal cannula (HFNC) delivers oxygen at a flow which exceeds the patient's
      inspiratory flow demand in order to improve oxygenation. Numerous randomized control trials
      and meta-analyses have shown that HFNC improves oxygenation and helps avoid intubation in
      hypoxemic patients, as well as reduce work of breathing, improve ventilation, and decrease
      hypercapnia in COPD patients. Flow settings play a critical role when using HFNC, as
      increased flow can reduce inspiratory effort, improve ventilation, and dynamic lung
      compliance. However, flow rates used in many studies vary widely. The clinical effects of
      different HFNC flow setting, specifically to match or over than a patients' own inspiratory
      flow, is still unknown.
    

Detailed description: 
      High flow nasal cannula (HFNC) delivers oxygen at a flow which exceeds the patient's
      inspiratory flow demand in order to improve oxygenation. Numerous randomized control trials
      and meta-analyses have shown that HFNC improves oxygenation and helps avoid intubation in
      hypoxemic patients, as well as reduce work of breathing, improve ventilation, and decrease
      hypercapnia in COPD patients. Flow settings play a critical role when using HFNC, as
      increased flow can reduce inspiratory effort, improve ventilation, and dynamic lung
      compliance. However, flow rates used in many studies vary widely, from 20-40 LPM in COPD
      patients and 30-60 LPM in hypoxemic patients. The clinical effects of different HFNC flow
      setting, specifically to match or over than a patients' own inspiratory flow, is still
      unknown.
    

Intervention name(s): HFNC flow
Intervention type(s): Other
Intervention description(s): HFNC flow will be titrated based on the hospital's policy or protocol for hypoxemic patients and research protocol for healthy volunteers
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: High flow nasal cannula; Hypoxemia; Flow setting
A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride
      immediate Release (IR) fixed-dose combination.
    


Intervention name(s): Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)
Intervention type(s): Drug
Intervention description(s): Participants will receive canagliflozin + metformin hydrochloride IR fixed-dose combination, 50 milligram (mg) + 500 mg or 50 mg + 1000 mg, will be provided as tablets for oral administration. The study Treatment duration will be of 24 weeks.
Other intervention name(s): JNJ-28431754
Intervention MeSH terms: Metformin; Canagliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations
Condition: Lymphatic Malformations
MeSH terms: Lymphangioma; Lymphatic Abnormalities; Congenital Abnormalities
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      OBJECTIVES:

      I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic
      lymphangioma.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to prior
      treatment (no prior treatment vs prior surgical treatment) and geographic area.

      Patients who meet all study criteria are put in the "Immediate Treatment Group." Patients
      receive an intralesional injection of picibanil (OK432) with the aid of ultrasonography or
      transillumination for localization of cysts. Treatment repeats every 6-8 weeks for a total of
      up to 4 injections.

      After completion of treatment, patients are followed at 6 months, 1 year, and 2 years.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): picibanil
Intervention type(s): Drug
Intervention description(s): Up to .2 mg per injection, given intralesionally every 6-8 weeks
Other intervention name(s): OK432
Intervention MeSH terms: Picibanil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cystic hygroma; lymphangiomas; lymphatic malformations
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed Condition
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5
      mg OD tablets with Zyprexa Zydis 5 mg tablets under fed conditions and to monitor adverse
      events and ensure safety of subjects.
    

Detailed description: 
      An open label, balanced, randomized, two treatment, two-sequence, two-period, single-dose,
      crossover comparative bioequivalence study of Olanzapine 5 mg OD Tablets, of Dr. Reddy's
      Laboratories Limited and Zyprexa Zydis 5 mg Tablets of Cardinal Health in healthy, human
      subjects under fed conditions.
    

Intervention name(s): Olanzapine OD Tablets 5 mg
Intervention type(s): Drug
Intervention description(s): Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Zyprexa Zydis
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment