bioihbjkbjnl/mcl2 huggingface dataset:
Hormonal Replacement Therapy and Small Artery Function
Condition: Menopause
Study type: Interventional
Phase: Phase 3

Summary: 
      Endothelial dysfunction in resistance arteries in women after the menopause is important for
      the development of high blood pressure and cardiovascular disease
    

Detailed description: 
      We aim to study the effects of different hormone replacement therapies (HRT) on the function
      and morphology of resistance arteries, and to look for their mechanistic basis. We expect
      that HRT with estrogens or in combination with MPA may benefit the function of resistance
      arteries and may preserve the morphological integrity of endothelial cells by regulatory
      actions on the cytoskeleton.
    

Intervention name(s): Femanest; gestapuran; placebo; Femanest plus Gestapuran
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2mg/day; 5mg/day; daily; combined daily
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: hormone replacement therapy; endothelial function;
SmartTouch Catheter for Left Anterior Line - SmarT Line Study
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This prospective, randomized study will investigate, if information of the catheter force
      during ablation of a left anterior line does reduce total RF application time by prevention
      of ineffective lesions.
    

Detailed description: 
      Catheter ablation has emerged as a realistic therapeutic option for symptomatic atrial
      fibrillation (AF).

      The three main techniques described for ablation of persistent AF include pulmonary vein (PV)
      isolation, ablation based on electrogram analysis, and left atrial (LA) linear lesions.

      The ideal endpoint of linear lesions should be complete electrical block; however, this is
      technically challenging, time consuming, and potentially hazardous. The ST catheter combined
      with 3D mapping and navigation software, gives physicians a real-time, objective measure of
      tip-to-tissue contact force during the catheter ablation procedure and will allow physicians
      to more safely and effectively treat atrial fibrillation.
    

Intervention name(s): Thermocool Smart Touch Catheter
Intervention type(s): Device
Intervention description(s): Physician informed to contact force
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Smart-Touch; Contact force
PET Imaging in ALS Patients
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and
      monitoring progression of ALS, based on a well established basic science pathway, published
      human autopsy data, preliminary data in ALS mutant mice, and our recently published data
      using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy
      human volunteers.
    


Intervention name(s): PET Scanning
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
Condition: Myopia
MeSH terms: Seizures; Myopia
Study type: Interventional

Summary: 
      Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and
      DAILIES TOTAL1®
    

Detailed description: 
      The aim of this non-dispensing study is to evaluate the fitting performance of MyDay™ 8.4
      base curve, especially for flatter corneas, and compared it with 1-DAY ACUVUE® TruEye® 9.0
      base curve and DAILIES TOTAL1® 8.8 base curve in a range of spherical powers.
    

Intervention name(s): stenfilcon A; delefilcon A; narafilcon A
Intervention type(s): Device; Device; Device
Intervention description(s): contact lens; contact lens; contact lens
Other intervention name(s): MyDay; 1-DAY ACUVUE; DAILIES TOTAL1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Immunogenicity and Safety of Sabin-IPV Replacement Vaccination
Condition: Vaccination
Study type: Interventional
Phase: Phase 4

Summary: 
      This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV
      (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming
      to acquire scientific evidence for the feasibility of immunization involving different viral
      strains replacement.
    

Detailed description: 
      It is required by China Food and Drug Administration (CFDA) that considering in the real
      situation IPV receivers may be immuned by different viral strains of this vaccine, a phase 4
      clinical trial aiming to demonstrate the safety and immunogenicity of the immunization
      schedule should be carried out. To be specific, the subjects were divided into 2 groups.

      Group 1 received Salk-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.

      Group 2 received Salk-IPV+Salk-IPV+Salk-IPV respectively at the age of 2,3,4 months old.

      Blood sample was collected before vaccination and 30 days after the third dose of
      vaccination. Neutralization antibody against type I, Type II and Type III poliomyelitis virus
      were detected to evaluate the seroprotection rates and antibody geometric mean
      concentrations. The safety of both immunization schedule will also been monitored.
    

Intervention name(s): Inactivated Polio Vaccine
Intervention type(s): Biological
Intervention description(s): Inactivated Polio Vaccine at age of 2,3,4 months old, respectively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will
      be evaluated.
    

Detailed description: 
      To evaluate pharmacokinetic (PK) profile, patch wearability (adhesion and skin irritation),
      and safety of AG890-6.5 and AG890-12.5 TCDS.
    

Intervention name(s): levonorgestrel
Intervention type(s): Drug
Intervention description(s): transdermal contraceptive delivery system
Other intervention name(s): patch, transdermal contraceptive delivery system
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PK and Safety
Attention-Bias Modification Treatment for PTSD
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Emerging research implicates biased attention to threat in the pathophysiology of anxiety
      disorders. Recent findings demonstrate significant associations between attention bias and
      stress vulnerability. This work has motivated the development of a novel therapy,
      attention-bias-modification (ABM) treatment . ABM is designed to implicitly modify patients'
      biased threat attendance via computerized training protocols. Emerging evidence indicates
      that ABM is effective in modifying threat-related attention biases and in ameliorating
      anxiety symptoms. However, it is unclear whether ABM is efficacious for posttraumatic stress
      disorder (PTSD). The present pilot study is a double blind trial that seeks to examine
      feasibility, acceptability, safety, efficacy, and risk/benefit ratio of ABM in individuals
      with PTSD. In addition this pilot study seeks to identify specific genes associated with
      anxiety disorders and to examine whether these can predict the success of the ABM.
    

Detailed description: 
      ABM is designed to implicitly modify patients' biased threat attendance via computerized
      training protocols. Emerging evidence indicates that ABM is effective in modifying
      threat-related attention biases and in ameliorating anxiety symptoms.
    

Intervention name(s): Attention Bias Modification (ABM); Attention control training (ACT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contin- gent on the bias measured at pre-treatment. Specifically, for those showing a bias toward the threat, the target appeared at the neutral-face location in 100% of the threat-neutral trials, while for those showing a bias away from the threat, the target appeared at the threat-face location in 100% of the threat-neutral trials.; In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task.
Other intervention name(s): ABMT; ABMT Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Attention Bias to threat; Attention Bias Modification Treatment
Cox-2 Inhibition in Radiation-induced Oral Mucositis
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation
      therapy given for treatment of head and neck cancer. These lesions are painful, compromise
      nutrition and quality of life and may necessitate interruptions in radiation therapy, thus
      adversely affecting cancer therapy outcomes. This study examined the use of an
      anti-inflammatory medicine to reduce pain and severity of oral mucositis.
    


Intervention name(s): celecoxib; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subject was asked to take celecoxib each day that radiation therapy was given.; Subject was asked to take placebo each day that radiation therapy was given.
Other intervention name(s): Celebrex
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Mucositis; Head and Neck Cancer; Head and Neck Neoplasms; Stomatitis
Couple User Preferences in Dual Purpose Prevention Products
Condition: HIV Prevention; Contraception Behavior
Study type: Observational

Summary: 
      MTN-045 is a cross-sectional study that will utilize questionnaires, including
      Discrete-Choice Experiments (DCE) and joint decision tasks, to assess couples' preferences
      related to dual purpose prevention (DPP) products that could be used to prevent unintended
      pregnancies and HIV infection. Post-survey explanatory in-depth interviews (IDIs) will be
      conducted with a subset of participants to explore DPP product-related decisions..
    

Detailed description: 
      MTN-045 is a cross-sectional study that will utilize questionnaires, including DCEs and joint
      decision tasks, and IDIs to assess heterosexual couples' preferences related to DPP products
      that could be used to prevent unintended pregnancies and HIV infection. One main goal of the
      study is to determine heterosexual couples' preferences for a DPP product to inform product
      delivery and future product design to maximize uptake and willingness to use among
      sub-Saharan African heterosexual couples. Another main goal of the study is to assess the
      level of influence of the male partner on a woman's preferences for a DPP product and on her
      decision-making process regarding product preferences and use.

      The MTN-045 study population will consist of approximately 400 heterosexual sub-Saharan
      African couples of reproductive age who have been in a relationship for ≥ 3 months and are
      interested in contraception and/or HIV prevention. Women who are currently using
      contraceptives as well as those not using contraceptives will be eligible. Couples who are
      living together as well as those not living together will be eligible. All participants will
      complete survey questionnaires, first separately from their partner, then followed by a joint
      couples' decision task. Up to 80 participants, i.e., one or both partners from a subset of up
      to 40 couples, will be selected to complete an IDI.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The MTN-045 study population will consist of approximately 400 heterosexual sub-Saharan
        African couples of reproductive age who have been in a relationship for ≥ 3 months and are
        interested in contraception and/or HIV prevention. Women who are currently using
        contraceptives as well as those not using contraceptives will be eligible. Couples who are
        living together as well as those not living together will be eligible.
Effect of Triple Pre-rehabilitation on Radiotherapy for Head and Neck Cancer Patients
Condition: Triple Pre-rehabilitation; Radiotherapy; Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      To evaluate the intervention effect of triple pre-rehabilitation on head and neck cancer
      patients with radiotherapy, and process evaluation to further optimize the intervention
      program.

      The pre-rehabilitation intervention was develped previously based on the process of
      evidence-based-nursing, including interventions of nurtrtion, exercise, and psychology.
    


Intervention name(s): triple pre-rehabilitation; triple rehabilitation
Intervention type(s): Other; Other
Intervention description(s): The triple intervention consisted of exercise, nutrition and psychology. Based on the intervention framework, face-to-face intervention adjustment and intensive intervention measures were carried out from the time of enrollment (T0). Combined with weekly telephone follow-up during the intervention, the intervention content formulated face-to-face last time was reviewed, reinforcement behaviors were performed, and questions were answered during the intervention.; The triple intervention consisted of exercise, nutrition and psychology. Based on the intervention framework, face-to-face intervention adjustment and intensive intervention measures were carried out at the time of the beginning of radiotherapy (T1), and the middle stage of radiotherapy (T2). Combined with weekly telephone follow-up during the intervention, the intervention content formulated face-to-face last time was reviewed, reinforcement behaviors were performed, and questions were answered during the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bournemouth University Resilience Training for Surgeons
Condition: Effect of Training
Study type: Interventional

Summary: 
      The challenges that characterise surgical practice may result in a myriad of stressors that
      impact upon the personal and professional lives of surgeons. This includes a high likelihood
      that surgeons will have to deal with adverse patient outcomes due to surgical complications
      and errors, sometime during their careers. Such stressors can have undesirable effects on the
      surgeon in terms of quality of life and psychological well-being (e.g. anxiety, feelings of
      regret), as well as lowered professional confidence and impaired perceptions of professional
      competence. Furthermore, there is evidence that these kinds of negative impacts can also lead
      to burnout and depression. As well as the detrimental effects on surgeons and those around
      them, this in turn may lead to more errors and poorer outcomes for patients. This study will
      examine the efficacy of an ACT based training intervention to enhance resilience and
      psychological flexibility.
    

Detailed description: 
      Research in a range of occupational settings has indicated that resilience plays an important
      role in ameliorating the impact of adverse events in high pressure environments. This project
      will use a randomised controlled trial research design to assess the efficacy of brief
      one-to-one Acceptance and Commitment Training (ACTr), designed to enhance surgeons'
      psychological resilience. According to the model ACTr is based on, psychopathology is
      primarily the consequence of psychological inflexibility i.e. inability to persist or change
      behaviour according to long-term values due to language and cognition skills, which has
      particular significance when an individual is confronted with stress or adversity.

      The main aim of this research is to assess the efficacy of a brief one-to-one Acceptance and
      Commitment Training course. Researchers wish to ascertain whether such a course can increase
      surgeons' resilience by increasing psychological flexibility, valuing and self-compassion
      (all of which are expected to be positively impacted by this training). This research will
      fill a gap in the relevant research literature; namely that no research project as far as we
      are aware has evaluated ACTr as a means to enhance resilience in surgeons. In fact any
      research conducted on resilience training with a surgical population is rare.
    

Intervention name(s): ACTr (Acceptance and Commitment Training)
Intervention type(s): Behavioral
Intervention description(s): The programme is based on Acceptance and Commitment Training (ACT), a contemporary, empirically supported approach to psychological well-being.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Resilience; Psychological flexibility; Acceptance and Commitment Training
Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate efficacy and safety of a testosterone patch as treatment
      for low libido in surgically menopausal women who are taking estrogen therapy.
    

Detailed description: 
      Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral
      salpingo-oophorectomy and hysterectomy were randomized into a 52-week, multicenter,
      multinational study that included a 24-week, double-blind (DB), parallel-group,
      placebo-controlled period followed by a 28-week open-label (OL) period. Patients were
      stratified based on their use of oral or transdermal ET and randomized to receive placebo or
      testosterone transdermal system. Patients had to maintain a stable dose of estrogen
      throughout the study. Upon completion of the DB period, patients receiving placebo were
      switched to TTS, while the active cohort remained on active treatment. All patients were then
      followed for an additional 28 weeks for safety. Patients who completed the first 52 weeks of
      the study were given the opportunity to participate in an open label extension (Years 2, 3 ,
      and 4), which was added to the protocol by amendment. Safety was assessed by adverse events,
      lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation,
      coagulation testing, and hematology. Physical exam including clinical assessments of facial
      hair and acne were monitored.
    

Intervention name(s): Testosterone Transdermal System; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): testosterone patch, 300mcg/day, changed every 3-4 days for up to 52 weeks; placebo patch,changed every 3-4 days for 24 weeks during double blind phase
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Surgical menopause; HSDD
The Impact of Electroencephalographic (EEG) Seizure Treatment in Neonatal Encephalopathy
Condition: Seizures; Encephalopathy
MeSH terms: Seizures; Brain Diseases
Study type: Interventional

Summary: 
      This is a prospective, randomized, single-center pilot trial of term and near term (≥ 36
      weeks gestation) infants with encephalopathy or seizures comparing a "EEG Seizure Treatment
      Group" or ESG with a "Clinical Seizure Treatment Group" or CSG.

      The investigators hypothesize that the accurate detection and treatment of EEG seizures will
      decrease the seizure burden and improve outcomes in newborn infants with seizures and/or
      hypoxic-ischemic encephalopathy (HIE).
    

Detailed description: 
      This is a prospective, randomized, pilot trial of term and near term (≥ 36 weeks gestation)
      infants with encephalopathy or seizures comparing a "EEG Seizure Treatment Group" or ESG with
      a "Clinical Seizure Treatment Group" or CSG. Eligibility is based on clinical criteria for
      moderate/severe encephalopathy or seizures. We will recruit near term or term infants (≥ 36
      weeks gestation) with a diagnosis of seizures or encephalopathy admitted to the neonatal
      intensive care unit (NICU) at St. Louis Children's Hospital within the first 72 hours of
      life. Infants will be randomized into an EEG Seizure Treatment Group (ESG) or a Clinical
      Seizure Treatment Group (CSG) (n=20 in each group). Patients in both groups will have EEG
      monitoring. While treating physicians will have access to EEG data in the ESG, no EEG data in
      the CSG will be available to the clinician for treatment of seizures. AED treatment will be
      initiated/escalated using stringent EEG seizure criteria (EST) or clinical criteria (CST)
      with the goal being seizure cessation. The specific AED, dosage, and duration of treatment is
      standardized in both groups. Monitoring will continue for a period of upto 96 hours in both
      arms. Other than the anticonvulsant drugs, treatment thresholds and dosing schedules,
      treatment in both arms will be at the discretion of the bedside physician.All infants will
      undergo an assessment of neuromotor disability and neurodevelopmental evaluation at 18 to 24
      months.
    

Intervention name(s): EEG monitoring and treatment of EEG seizures
Intervention type(s): Other
Intervention description(s): Seizures will prompt treatment with loading doses of phenobarbital (20mg/kg), fosphenytoin (20mg/kg),and midazolam (0.05mg/kg bolus and .15mg/kg/hr infusion tapered over 48 hours)in that order for persisting seizures.
Other intervention name(s): EEG monitoring; Anti-epileptic drugs
Intervention MeSH terms: Anticonvulsants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neonatal Seizures; Neonatal encephalopathy