bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The study aims to ascertain whether the sole replacement of tenofovir with abacavir once a
      day improves the immunological response obtained with tenofovir + ddI or whether it is better
      to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint
      formulation) in a single daily dose to achieve these objectives.
    

Detailed description: 
      Different works have shown a high rate of virological failure among patients on abacavir +
      lamivudine + tenofovir or ddI + 3TC + tenofovir, thus rendering the use of these combinations
      actively unadvisable.

      Furthermore, recent studies have also shown that ABC+3TC are associated with a significantly
      higher increase in CD4 than the current treatment standard formed by AZT+3TC. This provides
      us with grounds to suppose that patients with TDF+ddI may recover their CD4 with ABC+3HT.
      Similarly, and recently, the existence of pharmacokinetic interactions between tenofovir +
      abacavir has begun to be questioned.

      Finally, the replacement of tenofovir with abacavir or tenofovir + ddI with abacavir +
      lamivudine does not detract from the potency of HAART, the toxicity profile is different and
      their behaviour at mitochondrial level is similar.

      This study aims to ascertain whether the sole replacement of tenofovir with abacavir once a
      day improves the immunological response obtained with tenofovir + ddI or whether it is better
      to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint
      formulation) in a single daily dose to achieve these objectives.
    

Intervention name(s): Abacavir; Didanosine; Abacavir+Lamivudine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Change tenofovir to abacavir; Increase didanosine dose to 400 mg/day if weight is > 60 Kg. or to 250mg/day if weight is < 60 kg.; Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).
Other intervention name(s): n/h.; n/h.; n/h.
Intervention MeSH terms: Lamivudine; Abacavir; Dideoxynucleosides; Didanosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiretrovirals; CD4 cell count; toxicity
G-POEM for Treatment of Refractory Gastroparesis
Condition: Diabetic Gastroparesis; Idiopathic Gastroparesis; Gastroparesis Postoperative
MeSH terms: Gastroparesis
Study type: Observational

Summary: 
      This study is performed to assess the efficacy and outcomes of Gastric Per Oral Endoscopic
      Myotomy "G-POEM" in patients presenting with gastroparesis.
    

Detailed description: 
      Gastroparesis is a chronic digestive disorder best defined as severe nausea, vomiting,
      bloating, and abdominal pain in the setting of objectively delayed gastric emptying without
      mechanical gastric outlet obstruction. The most common etiology is idiopathic. Some of the
      identifiable etiologies include diabetes and post-surgical.

      Endoscopic techniques to reduce pyloric tone mainly consisted of Botulinum toxin injection
      but failed to demonstrate significant symptom improvement compared to placebo. Another
      endoscopic method was transpyloric stenting which yielded symptomatic relief but is prone to
      stent migration and therefore is unlikely to provide a viable long term solution.

      Surgical pyloroplasty has shown to be effective in reducing gastroparesis symptoms, but is
      associated with a risk of leakage and potential further narrowing of gastric outlet. It also
      carried all the risks of general anesthesia and requires advanced laparoscopic suturing
      skills. Therefore, the development of a less invasive reliable method of improving gastric
      emptying is highly desirable.

      An endoscopic submucosal myotomy technique may be applied to divide the pyloric sphincter
      without surgical access. Such endoscopic technique may provide the benefits of a natural
      orifice procedure, and improve gastric emptying in gastroparetic patients. Gastric Per-Oral
      Endoscopic Myotomy (G-POEM) is feasible and can be performed by using techniques similar to
      those of esophageal per-oral endoscopic myotomy. Endoscopists who are experienced in
      esophageal per-oral endoscopic myotomy should be able to perform G-POEM because both use
      similar techniques, principles, and equipment.

      The investigators theorize that a subset of patients with refractory gastroparesis, diabetic
      gastroparesis or post-surgical gastroparesis, may respond to endoscopic pyloromyotomy.
    

Intervention name(s): Gastric Per Oral Endoscopic Myotomy
Intervention type(s): Procedure
Intervention description(s): Patients will receive Per Oral Endoscopic Gastric Myotomy for Gastroparesis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals who initially approach the study team from outside the institution (e.g.
        responding to the clinicaltrials.gov listing) or patients seen in the gastroenterology
        clinic.
      
Keywords: Gastroparesis; G-POEM; Gastric Per Oral Endoscopic Myotomy
Changes in Vaginal, Cervical and Uterine Microflora With Levonorgestrel Intrauterine Device Placement
Condition: Human Microbiome; Metagenome; Contraception; Cytokine
Study type: Observational

Summary: 
      The goal of this study is to examine changes in the bacterial ecology and inflammatory
      markers of the female genital tract with levonorgestrel intrauterine device placement.

      The specific research objectives of this project include:

        1. Characterization of vaginal, cervical and uterine bacterial species and communities
           prior to and after LNG IUD placement using bacterial DNA microarray analysis. Samples
           will be collected up to 1 week before and 2 months after IUD insertion.

        2. Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to
           and after LNG IUD placement using human RNA microarray analysis. Samples will be
           analyzed from up to one day before and three weeks after IUD insertion.

        3. Establish a tissue bank of vaginal, cervical and uterine specimens for future research.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Caucasian woman aged 18 to 45 seeking intrauterine contraception meeting inclusion
        criteria.
      
Biospecimen description: 
      A total of 648 samples will be collected from 12 participants for bacterial species and human
      cytokine analysis in 9 collection visits. Specimens will be collected up to one week prior to
      IUD insertion and two months after IUD insertion. Vaginal and cervical specimens will be
      collected using FLOQSwabs® (Copan) to maximize bacterial DNA sample collection. Uterine
      samples will be collected by uterine irrigation with sterile saline using an embryo
      replacement catheter.
    
Keywords: Microflora; Vaginal; Cervical; Uterine; Inflammation; Cytokine; Intrauterine Device; Levonorgestrel
Exercise as a Buffer Against Stress-induced Overeating
Condition: Obesity
MeSH terms: Hyperphagia
Study type: Interventional

Summary: 
      The purpose of this study is to examine the psychological benefits of chronic exercise as
      well as the effects of exercise training on eating behaviors and stress-induced overeating in
      overweight and obese women. Participants will be randomized to an 12-week exercise condition
      or a delayed exercise condition. Assessments will occur at baseline, 6 weeks, and 12 weeks
      and will include answering surveys in real-time using smartphones, several assessments of
      eating behaviors and dietary intake, and questionnaire measures of factors which could
      mediate the relationship between exercise and eating. Participants will be compensated for
      completing assessments and for adherence to the exercise protocol.
    


Intervention name(s): Exercise intervention; Delayed exercise intervention
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
US-Guided ESPB Versus TPVB on Acute and Chronic Pain After VATS
Condition: Postoperative Pain; Video-Assisted Thoracoscopic Surgery; Thoracic Paravertebral Block; Erector Spinae Plane Block; Acute Pain; Chronic Pain
MeSH terms: Chronic Pain; Acute Pain
Study type: Interventional

Summary: 
      Postoperative acute and chronic pain is frequently observed in patients undergoing video
      assisted thoracoscopic surgery (VATS). This prolongs the discharge time of patients and
      increases the frequency of postoperative pulmonary complications. Recently, alternative
      analgesic methods such as thoracic paravertebral block (TPVB) and erector spinae plane block
      (ESPB), which are thought to have less side effects than thoracic epidural analgesia, have
      been used. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In
      addition, ESPB application is increasing in patients undergoing VATS. In the literature, the
      number of cases performed with ESPB and randomized controlled prospective studies with ESPB
      are increasing. In this study, it is planned to compare the effects of US-guided TPVB and
      ESPB on postoperative acute and chronic pain in patients undergoing VATS.
    


Intervention name(s): Thoracic paravertebral block vs Erector spinae plane block
Intervention type(s): Procedure
Intervention description(s): Thoracic paravertebral block and erector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic pain; Erector spinae plane block; Thoracic paravertebral block; Acute pain
Clinical, Morphological and Functional Aspects in Myocarditis.
Condition: Myocarditis
MeSH terms: Myocarditis
Study type: Observational

Summary: 
      Cardiac magnetic resonance (CMR) is accurate to identify acute myocardial damage (edema,
      hyperemia, and/or fibrosis) due to acute myocarditis (AM). Recently, two-dimensional strain
      echocardiography was also validated in order to provide important information on myocardial
      dysfunction in patients with AM, even if no wall motion abnormalities are detected. No data
      are available about incidence of longitudinal myocardial dysfunction and its prognostic role
      in AM.
    

Detailed description: 
      In this study, the investigators will analyze the effect of acute myocarditis-induced damage
      on LV myocardial deformation and remodeling both in the acute myocarditis phase and follow-up
      period (about 2 years later). The investigators will use a combined approach including strain
      echocardiography to asses left ventricular myocardial deformation and late gadolinium
      enhancement (LGE)cardiac magnetic resonance for the assessment of left ventricular damage.
    

Intervention name(s): post-processing analysis of cardiac imaging (strain echocardiography)
Intervention type(s): Diagnostic Test
Intervention description(s): A dedicated software package for two-dimensional speckle tracking strain analysis (XStrain™, Esaote, Florence, Italy) was used to quantify both ENDO and EPI strains. Our echocardiographic imaging acquisition protocol for 2DSTE consisted in the acquisition of three consecutive cardiac cycles from non-foreshortened apical views (4, 2, and 3 chambers) obtained during breath hold. Frame-by- frame displacement of ENDO and EPI points was automatically evaluated, generating strain curves for each segment.
The tracking quality was verified for each segment, and subsequent manual adjustments were performed, when required. All data were analyzed with the aid of Fourier techniques, which ensure greater accuracy using the periodicity of the heart motion.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Consecutive in-patients with a definite CMR diagnosis of AM having a follow-up CMR
        examination including cine CMR, T1, T2 weighted and LGE images.
      
Keywords: echocardiography; cardiac magnetic resonance; myocarditis
Pilot Study: Age Extension of NHS Breast Screening Programme
Condition: Routine Mammography
Study type: Interventional

Summary: 
      The purpose of this pilot study is to assess the feasibility and acceptability of randomising
      the phasing-in of the age extension of the NHS Breast Screening Programme in six volunteer
      sites in different areas of England.
    

Detailed description: 
      Currently all women are invited for breast screening between the ages of 50 and 70. In 2007
      the Cancer Reform Strategy announced that from 2012 the NHS Breast Screening Programme would
      be extended to cover women between the ages of 47 and 73. This means that all women will get
      two extra screening invitations in their lifetime. It also means that all women will get
      their first invitation before age 50. As capacity does not allow for full immediate roll out
      across the whole of England, the age extension will be phased-in with full coverage from
      2012. Randomising this phasing-in would provide unbiased evidence on the extent to which it
      is beneficial to extend the age range for breast screening and whether an extra screen at
      younger or older ages is more worthwhile. To date there is no clear evidence on this as no
      trial has looked at the added value of one extra screen within an existing screening
      programme. This pilot study will assess the feasibility and acceptability of randomising the
      phasing-in of the age extension in six volunteer sites in different areas of England.
    

Intervention name(s): Invitation for breast screening
Intervention type(s): Other
Intervention description(s): Invitation for breast screening to women in different age groups
Other intervention name(s): Invitation for mammogram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breast screening; Mammogram; Routine screening programme
Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine
Condition: Influenza; Vaccination
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This multi-site study assesses the impact of text message reminders on the receipt of the
      second dose of influenza vaccine, and takes place primarily in practices from the American
      Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.
    

Detailed description: 
      The study is to be conducted over the 1st season (September 2017-April 2018) as an
      effectiveness trial and the 2nd (September 2018-April 2019) as a replication study. This
      approach tests that the intervention effects can be replicated across seasons, during which
      the severity and incidence of influenza disease may vary. Eligible parents will have a child
      who received his/her first vaccine dose and is in need of 2 doses that season. Current
      recommendations require 2 doses for certain children 6 months through 8 years old. Within
      each practice site, parents will be randomized to receive either: 1) text message reminders
      embedded with influenza vaccine health-literacy promoting information, or 2) usual care.
      Randomization is to be stratified by practice site, age (6-23 months, 2-8 years) and language
      (Spanish, English).
    

Intervention name(s): Text message influenza vaccine reminders
Intervention type(s): Behavioral
Intervention description(s): Text message reminders for second dose of influenza vaccination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: text message; Short message service (SMS); mHealth
Clinical Trial to Investigate Efficacy of LAS41004 in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to intra-individually compare the dose-related efficacy of LAS41004
      in a Psoriasis Plaque Test (PPT)
    


Intervention name(s): Experimental: LAS 41004 dosage 1; Experimental: LAS 41004 dosage 2; Experimental: LAS 41004 dosage 3; Placebo Comparator: placebo; Reference
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): dosage 1, once daily; LAS 41004 dosage 2, once daily; dosage 3, once daily; once daily; Active Comparator,once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: psoriasis; topical; PPT
A Novel Sequential Treatment of Salvage and Reduced Intensity Conditioning (RIC) Chemotherapy for Allogeneic Stem-Cell Transplantation (SCT) for Primary Refractory and Relapsed Acute Myelogenous Leukemia (AML)
Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label Phase I study is designed to determine the maximum tolerated dose (MTD) for
      CPX-351 followed by a reduced intensity conditioning regimen and incorporates a
      dose-escalation schedule that sequentially enrolls 6 dosing cohorts. After the determination
      of the MTD, the investigator reserves the option to enroll up to 10 additional subjects in an
      expanded safety cohort(s) at the MTD.

      Refractory and relapsed AML patients who meet standard institutional criteria to undergo
      sequential induction/reduced intensity conditioning allogeneic transplants will be offered a
      transplant from a related or unrelated donor (full match or 1 antigen mismatch). Cord blood
      transplants will not be used in this study.
    


Intervention name(s): CPX-351
Intervention type(s): Drug
Intervention description(s): CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; leukemia; MDS
Safety, Efficacy and Pharmacokinetics of ALD403
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, pharmacokinetics and efficacy of a single
      dose of ALD403 in the prevention of migraine headache in frequent episodic migraineurs for 24
      weeks.
    


Intervention name(s): ALD403; Placebo
Intervention type(s): Biological; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine Disorders; Phase 1; ALD403
Soft Tissue Augmentation Around Dental Implant
Condition: Gingival Atrophy
MeSH terms: Gingival Recession
Study type: Observational

Summary: 
      Patients were randomly distributed into two groups (G1 and G2), all patients were treated by
      a submerged dental implant protocol and free gingival graft (FGG) harvested from the palate
      as follows:

        -  Group 1 (G1), received the FGG two months before implant placement.

        -  Group 2 (G2), received the FGG at the time of second-stage surgery (i.e. at the time of
           healing abutment placement).

      All periodontal and radiographic assessments were done by the same operator who was neither
      involved in the evaluation nor the distribution process. The operator did all the evaluation
      steps and was completely blinded to the treatment protocol.
    

Detailed description: 
      In this investigation, a randomized clinical trial was employed. The patient's randomization
      was completed by one of the department's senior residents, who was not involved in the trial
      and was unaware of any relevant treatment plan. A computer-generated randomization list used
      a randomization table to perform the randomization (SPSS v23.0). Patients were randomly
      distributed into two groups (G1 and G2), all patients were treated by a submerged dental
      implant protocol and FGG harvested from the palate. All patients received a thorough
      description of all procedures involved in the study. Signing a written consent was mandatory
      for being enrolled in the study. Complete medical and dental histories were recorded for all
      patients and complete clinical intraoral and extraoral examinations were done for all
      patients.

      Selected patients were questioned about the cause and time of extractions, whether
      extractions were because of periodontal disease, dental decay or other causes. Previous
      experiences with dental procedures were also discussed. Intraoral photographs were taken to
      record the existing condition of teeth and mucosa before implant placement.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Twenty patients (12 female / 8 male) seeking dental implant placement due to missing teeth
        and deficient keratinized mucosa width were enrolled in this observational study. The study
        population was selected from patients attending the clinic of the Periodontology Department
        of Oral Medicine and Periodontology at Mansoura University. Recruitment occurred from July
        2019 to June 2022..
Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and pharmacokinetics of a single and multiple
      dose of LHT344 in 12 Chinese healthy subjects.

      This study is not recruiting subjects in the United States.
    


Intervention name(s): LHT344
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety, pharmacokinetics, oral, single dose, multiple dose, LHT344, Chinese, healthy subjects