bioihbjkbjnl/mcl2 huggingface dataset:
Tacrolimus Microsampling
Condition: Validate Volumetric Absorptive Microsampling (VAMS) Assay
Study type: Interventional

Summary: 
      This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center.
      Patients who have undergone heart transplantation who meet eligibility requirements will be
      approached to participate in the study. The purpose of this study is to establish a reliable,
      home-based method for collecting samples as well as a standardized method for use of
      small-volume samples on both inpatients and outpatients.
    


Intervention name(s): Mitra Microsampler
Intervention type(s): Device
Intervention description(s): an FDA Class I medical device for direct specimen collection of blood or other biological fluids
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Evaluation of 3D Overlay During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure
Condition: Portal Hypertension
MeSH terms: Hypertension, Portal
Study type: Interventional

Summary: 
      The goal of this study is to evaluate an alternate approach, which involves using a 3D
      puncture path overlay, to access the portal vein during a Transjugular Intrahepatic
      Portosystemic Shunt (TIPS) procedure. The study should determine if the alternate approach
      provides these benefits: improved safety of procedure, and reduced intervention time
      (including reduction of radiation exposure), which benefits both interventional radiologist
      and the patient.

      During a TIPS procedure, a shunt or stent (mesh tube) is passed down the jugular vein (the
      vein above the collarbone in the neck) using fluoroscopy (x-ray) guidance. The shunt then is
      inserted between the portal vein (vein that carries blood from the digestive organs into the
      liver) to a hepatic vein (vein that carries blood away from the liver back to the heart).

      In the standard approach, the interventional radiologist uses two-dimensional guidance (2D -
      having the dimensions of height and width only) to locate the path between the portal vein
      and hepatic vein. However, since these two veins do not connect, this method does not provide
      information on the three-dimensional (3D) relationship between the two veins.

      In the alternate approach, the physician will have the option of using 3D guidance to locate
      the path. An on-table limited (small field of view) CT scan, used in combination with FDA
      approved imaging software, will provide a 3D image demonstrating the relationship between the
      portal vein and the hepatic vein. The 3D image is overlaid on the standard live x-ray images
      to assist in needle guidance during the TIPS procedure.

      The CT scan performed will be in place of the angiograms that are typically performed.
      However, if the portal vein is not adequately seen in the CT images, the angiograms will be
      done and there will be no overlay. The procedure will proceed using the standard approach.
    


Intervention name(s): TIPS with 3D Overlay
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postcoital Testing of the SILCS Diaphragm
Condition: Contraceptive Device
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase I multi-center, randomized study in 40 healthy, sexually active women not at
      risk for pregnancy due to previous female sterilization. The male partners of the
      participants were consented to participate in the study. The clinician evaluating the
      cervical mucus for midcycle characteristics and presence of sperm was blinded as to gel used.
      The product tested was the SILCS diaphragm with Gynol II (spermicide) and the SILCS diaphragm
      with KY Jelly (lubricant). The sequence of diaphragm and gel use was determined by
      randomization. The study was conducted at two centers, Magee-Womens Hospital in Pittsburgh,
      Pennsylvania and CONRAD's Clinical Research Center at the Eastern Virginia Medical School in
      Norfolk, Virginia.

      The study consisted of a screening visit, a baseline cycle, and up to 2 cycles of post-coital
      tests (PCTs) for a total of 7 visits. The first PCT was a baseline PCT, performed without the
      use of any product, in order to demonstrate the subject's ability to produce receptive,
      midcycle cervical mucus. The partner's ability to produce motile sperm capable of penetrating
      the cervical mucus was evaluated in this cycle. Test PCTs were carried out during the second
      and third menstrual cycle using either the SILCS diaphragm with N-9 or the SILCS diaphragm
      with lubricant. Cycles were repeated depending on the characteristics of the cervical mucus
      and the number of sperm found in the vaginal pool and endocervical specimens; thus, some
      women may undergo more than three PCTs. An additional test cycle with a modified polymer
      spring device was performed in a subset of participants.

      Colposcopy was performed during the mucus check and post-coital test visits in all three
      cycles in order to document the baseline condition of the vagina and cervix pre- and
      post-intercourse and, in test cycles, to note the effect of product.

      Vaginal samples were taken from the posterior fornix of the vagina and the cervical os at
      each visit during the baseline and test cycles to measure for the presence of PSA.
    


Intervention name(s): SILCS and lubricant; SILCS and spermicide
Intervention type(s): Other; Other
Intervention MeSH terms: Spermatocidal Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diaphragm; postcoital test; SILCS; nonoxynol-9
Manual Ventilation Versus Pressure Controlled Mechanical Ventilation in Children
Condition: Ventilation
Study type: Interventional

Summary: 
      The investigator will compare the feasibility of manual ventilation and pressure-controlled
      mechanical ventilation during facemask ventilation in children. The hypothesis is that the
      incidence of gastric insufflation would be lower during pressure-controlled mechanical
      ventilation when compared to manual ventilation.
    


Intervention name(s): manual ventilation; Pressure controlled mechanical ventilation
Intervention type(s): Other; Other
Intervention description(s): Facemask ventilation is performed by manual bagging with reservoir bag.; Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Effects of Yoga on Pulmonary Parameters, Posture, Body Awareness and Quality of Life Among Chronic Smokers
Condition: Smoking
Study type: Interventional

Summary: 
      The aim of this study is to examine the effects of practicing pranayam (voluntary regulated
      breathing) and yogasana (standing poses of yoga) with subject education on vital capacity,
      respiratory muscle strength, spinal flexibility, body awareness, quality of life and nicotine
      dependence of smokers and non-smokers.
    

Detailed description: 
      When initial assesments will be completed, volunteers will be assigned to one of two possible
      sequences by their nicotine dependency. Smokers group (SG) or control group (CG).

      All volunteers will receive an exercise program with Asana and Pranayam practices with the
      duration of 4 weeks.

      All subjects will be assessed in terms of functional capacity, pulmonary functions, thoracic
      spine range of motion, postural analysis, respiratory muscle strength, body awareness,
      quality of life and nicotine dependence at the baseline and at the end of the study. Data
      will be collected from all the subjects at baseline and at the end of the study (4 weeks) by
      the same physiotherapist who also will supervise the exercise sessions.
    

Intervention name(s): Asana Practice; Pranayam Practice (Rhythmic regulated breathing); Smoking Education Program
Intervention type(s): Other; Other; Behavioral
Intervention description(s): Yogasana training will be comprised of active movements when standing. Spine and limbs stretches eccentrically respecting the movement patterns of body without pushing limits. Transition in between poses will be synchronized with breathing pattern in zero resistance flow. The exercises will be done 2 days a week online under the supervision of physiotherapist. Total duration of standing poses training will last for 4 weeks.; Breathing exercises will be comprised of diaphragmatic breathing, holding the breath after inhaling deeply and exhaling passively or exhaling actively by contracting abdominal muscles and inhaling passively. The exercises will be done 2 days a week online under the supervision of physiotherapist. Total duration of breathing exercises will last for 4 weeks.; The aim of the education is to increase awareness of subjects who are chronical smokers. The subject education will be performed at least once via face to face interview. Education topics will be covered basic information about harmful effects of habitual smoking and how to reduce the side effects of nicotine withdrawal.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Yoga; Pranayam; Breathing exercise; Asana; Smoking; Spine health; Spinal stretches
HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Observational

Summary: 
      Sustained virological response (SVR) to antiviral therapy in patients with chronic hepatitis
      C genotype 1 according to subtype (1a vs.1b) has not been extensively investigated. This
      observational study was carried out on a large group of "naïve" HCV patients to evaluate
      difference, if any, between HCV genotype 1 subtype 1a and 1b on the response to treatment
      with peginterferon (Peg-IFN) plus ribavirin.
    

Detailed description: 
      Despite the challenging perspective of the new antiviral drugs directly acting on hepatitis C
      viral replication such as protease and polymerase inhibitors, nowadays the standard treatment
      in genotype 1-chronic hepatitis C (CHC) is the combination of peghylated interferon (PEG-IFN)
      and ribavirin for 48 weeks. It has been extensively shown that patients infected with HCV
      genotype 1 have a lower rate of viral response than those infected with genotype 2 and 3. In
      large randomized multinational trials, sustained virological response (SVR) of around 50% has
      been obtained with peginterferon α2a plus ribavirin in the more difficult to treat subgroup
      of patients infected with HCV genotype 1. Furthermore, advanced fibrosis is a predictive
      factor of non response to antiviral treatment in genotype 1 virus [5-7]. Very few studies
      have evaluated SVR difference, if any, between subtypes 1a and 1b.

      We have carried out an observational study on a large cohort of HCV "naïve" patients to
      evaluate the influence of HCV subtypes 1 on the response to treatment with Peg-INF plus
      ribavirin.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Three hundred and eighty-eight patients were included in the study. One hundred and
        sixty-five were HCV genotype 1 subtype 1a (42.5%) while two hundred twenty-three were of
        subtype 1b (57.5%).
      
Biospecimen description: 
      HCVRNA determination was performed quantitatively before the treatment (TaqMan Roche
      Diagnostics). The TaqMan value utilized to determine the response was 15 IU/ml. TaqMan method
      was a standardized method utilized from December 2007 in all the center of the CLEO group.
      HCVRNA value was expressed as log10 IU/ml.
    
Keywords: HCV infection; genotype 1a; genotype 1 b
Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy
Condition: Infantile Spasms
MeSH terms: Muscle Cramp; Epilepsy; Spasm; Epilepsies, Partial; Spasms, Infantile
Study type: Interventional

Summary: 
      The sponsor is developing a new paediatric formulation of vigabatrin to better adjust the
      dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin
      (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6
      years) and 500 mg granules for oral solution sachets (for infants and children below 6
      years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is
      needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often
      required.

      This study is a descriptive, non-randomized, open label multi-centric acceptability study in
      infants and children affected with infantile spasms. The primary objective is to describe the
      adherence to the new formulation. Secondary objectives include:

        -  evaluation of the palatability and user-friendliness of the new treatment,

        -  evaluation of the pharmacokinetic parameters of the new formulation,

        -  PK parameters,

        -  evaluation of the tolerance,

        -  measurement of taurine plasma levels. This study will recruit up to 40 patients with
           infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23
           clinical sites in France.
    


Intervention name(s): Vigabatrin: Vigabatrin new ST formulation then Sabril®
Intervention type(s): Drug
Intervention description(s): first "treatment" phase (V1/D1-V3/D84), in which patients already under Sabril® "granules for oral solution" and naive patients start the new ST formulation; patients already under Sabril® will start at the same dose and regimen as their usual Sabril®. Dose and regimen for naive patients will be chosen according to SPC.
second "treatment" phase (V3/D84-V4/D98) in which the patient is switched to Sabril® "granules for oral solution" (supplied by sponsor) for 15 days at the same dose as under the new ST formulation.
Dose and treatment regimen should be maintained as in first treatment phase.
- At V4/D98, patients who received Sabril® "granules for oral solution" (supplied by sponsor) continue with marketed Sabril® treatment (or switches to another AED, according to the natural evolution of the patient's condition and upon investigator decision).
Intervention MeSH terms: Vigabatrin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infantile spasms; vigabatrin; soluble tablets; acceptability; adherence; pharmacokinetics
Efficacy Optimizing Research of Lamivudine Therapy
Condition: Compensated Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy,
      and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.
    


Intervention name(s): lamivudine; lamivudine; lamivudine, adefovir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104; Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily; patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks
Intervention MeSH terms: Lamivudine; Adefovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis B
Low-Load Blood Flow Restriction Training With Patients Who Underwent a Total Knee Arthroplasty: a Feasibility Trial
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      This project aims to investigate the feasibility of a low load (LL) isokinetic knee flexor
      and extensor strength training (ST) protocol under blood flow restriction (BFR) conditions in
      early postoperative total knee arthroplasty patients.

      The intervention consists in testing an experimental strengthening protocol in the Leukerbad
      Clinic. 12 participants will be recruited and the intervention will last approximatively 3
      weeks and will consist in 3 weekly ST.

      The collected data will then be analysed and interpreted to define if such an intervention is
      feasible or not.
    


Intervention name(s): Low Load Strength Training under Blood Flow Restriction
Intervention type(s): Procedure
Intervention description(s): The first training includes one initiation/warm up set and two sets of normal training. Every set lasts 60 seconds and the patient is asked to bend and stretch the knee with a standard speed of 20°/s.
From the second to the ninth training, the patient will have one warm up set plus three trainings sets. The speed of execution will be increased every training.
The 20-40% range of the 1RM will be applied according to the values of the theoretical maximal strength.
If no strength progression is observed in the three last training sessions, the speed of execution will automatically be increased by 15°/s.
In order to keep the training intensity low and to not overload the knee, participants will be instructed to control the intensity with the Borg CR10. The volunteers will have to keep their efforts between 2/10 and 4/10. They will also be asked to stay in the range defined thanks to the theoretical maximal strength shown by the screen.
Intervention model: Single Group Assignment
Intervention model description: The present study is a feasibility study. The study is based on the Consort Checklist for pilot and feasibility trials. This will be a monocentric study; the patients will be recruited at the Leukerbad Clinic.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: strength training; blood flow restriction; total knee arthroplasty
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the efficacy and safety as well as the
      characteristics of the female hormone and study medications after administration in
      pre-menopausal women with estrogen receptor positive advanced breast cancer who were
      randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot
      group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.
    


Intervention name(s): ZD9393 (Zoladex) 10.8 mg; ZD9393 (Zoladex) 3.6 mg
Intervention type(s): Drug; Drug
Intervention description(s): 10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).; 3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).
Other intervention name(s): Zoladex; Zoladex
Intervention MeSH terms: Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ZOLADEX; Pre-menopausal; Oestrogen Receptor; Advanced Breast Cancer; Progression Free Survival
In Vivo Determination of 3D Patellofemoral Mechanics
Condition: Arthroplasty Replacement Knee; Knee Prosthesis
Study type: Observational

Summary: 
      This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces)
      of participants having a normal knee or a total knee arthroplasty (TKA) using one or two
      different (TKA) devices Low Contract Stress (LCS) Posterior Stabilizing (PS) Rotating
      Platform (RP) Total Knee Arthroplasty (TKA). All knees will be analyzed using an image
      matching technique that will convert a two-dimensional (2D) fluoroscopic image into a
      three-dimensional (3D) image. In conjunction with the fluoroscopic analysis, electromyography
      (EMG) data, and ground reaction force (GRF) data will all be allow for a complete analysis of
      the knee joints. These results will help the orthopaedic community better understand knee
      motion so they can improve testing on existing implants and develop future implants that will
      further enhance patients' lives.
    


Intervention name(s): Subjects implanted with DePuy LCS PS RP TKA; Subjects implanted with DePuy Sigma PS RP TKA
Intervention type(s): Device; Device
Intervention description(s): Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA); Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects recruited from patients chosen from practice of Dr.'s Dennis and Haas at Colorado
        Joint Replacement for implanted knee, having either one of the two kinds of implants
        specified.
A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if AMG 334 is effective in treating migraines in
      patients who have failed other preventive migraine treatments.
    

Detailed description: 
      This study was a double blind, placebo-controlled, randomized trial in adult patients with
      episodic migraine. There was a screening period of 2 weeks to assess initial eligibility, and
      a 4-week baseline period. After randomization, participants entered the double-blind
      treatment epoch (DBTE) and had clinic visits for 12 weeks. All participants who completed the
      DBTE were eligible to enter the Open-Label Treatment Epoch (OLTE) for up to 156 weeks. All
      participants had a 12 week Follow-Up Epoch and a a Follow-Up visit 16 weeks after the last
      dose of AMG334 unless the participant continued on commercially available AMG334.
      Participants who had demonstrated clinical benefit were eligible to enter a Post Trial Access
      (PTA-Open Label Treatment Epoch) of flexible duration for approximately 6 months.
    

Intervention name(s): AMG334 (70 mg) Pre-Filled Syringe (PFS); Placebo Pre-Filled Syringe (PFS)
Intervention type(s): Biological; Biological
Intervention description(s): Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection; Subcutaneous injection of matching placebo
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Migraine; attack; headache; episodic; aura; AMG 334; CGRP receptor agonist; erenumab; adult