bioihbjkbjnl/mcl2 huggingface dataset:
Oocyte Retrieval Progesterone Levels and IVF
Condition: Hormone Disturbance
MeSH terms: Endocrine System Diseases
Study type: Observational [Patient Registry]

Summary: 
      Objective: To assess whether basal hormonal level can predict the elevation of P4 on the day
      of oocyte retrieval, as well as to examine the impact of P4 elevation on the day of oocyte
      retrieval on the outcome of assisted reproduction.

      Design: Prospective cohort study Setting: Department of In Vitro Fertilization, Gynecology
      and Obstetrics Institute, Clinical Center of Serbia Patient(s): One hundred sixty four
      patients enrolled in the ART procedure Main Outcome Measure(s): Pregnancies, miscarriages,
      biochemical pregnancies and deliveries
    

Detailed description: 
      A prospective clinical trial was conducted at the Clinic for Gynecology and Obstetrics
      Clinical Center of Serbia from January 1st to December 31st 2015. The study included 164
      patients enrolled in the ART procedure at the Clinic.

      Basal hormonal status - serum levels of estradiol (E2 - pg/ml), progesterone (P4 - ng/ml),
      follicle-stimulating hormone (FSH - mIU/ml), luteinizing hormone (LH - mIU/ml) and
      anti-Mullerian hormone (AMH - ng/l) were measured on the 2ndor 3rd cycle day before
      stimulation commencement. During COS levels of estradiol were determined, while levels of
      progesterone were determined on the day of oocyte retrieval i.e. aspiration. Blood samples
      were taken by Vacutainer tubes (BD Vacutainer Systems) and centrifuged according to the
      manufacturer's instructions for the preparation of the serum samples. AMH value (Gen II ELISA
      ref. No. A79765; Beckman Coulter) in serum was measured by ELISA (enzyme-linked immunosorbent
      assay), 1 ng / ml). FSH, LH, estradiol, and progesterone were analyzed by chemiluminescent
      immunoassay (Access 2 immunoassay system, Beckman Coulter).

      The main outcome measures were the procedure success as well as the pregnancy outcome.
      Pregnancy was confirmed by a positive finding of serum β-hCG (>25 MIU/ml) 14 days after
      embryo transfer. Clinical pregnancies were confirmed by transvaginal ultrasound findings of a
      gestational sac with a vital embryo at the 6th gestational week.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study evaluated 164 patients undergoing ART procedure - oocyte retrieval and embryo
        transfer in our Clinic. Patients in average had 34.66 ± 3.39 years, mean BMI was 22.23 ±
        2.65, and their infertility mostly lasted for 4.86 ± 2.61 years (range 1 to 17 years).

        The mean P4 values on OR day were 1.26 ± 0.46 ng/ml in group P4 <2ng/ml, while in the group
        of patients with P4 values ≥2ng/ml, the average P4 was 3.74 ± 1.62 ng/ml.
The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)
Condition: Hypercholesterolemia; Coronary Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to compare the efficacy, safety, and tolerability of
      ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of
      simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.
    


Intervention name(s): Ezetimibe/Simvastatin 10/20 mg; simvastatin 40 mg
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet containing 10 mg of ezetimibe and 20 mg of simvastatin per day for 6 weeks; 1 tablet containing 40 mg of simvastatin per day for 6 weeks
Intervention MeSH terms: Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Stepping Stones and Creating Futures Intervention Trial
Condition: IPV; Sexual Violence
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates whether the behavioural/structural interventions of Stepping Stones and
      Creating Futures can reduce the incidence of intimate partner violence in urban informal
      settlements amongst young people. Half the participants will receive the interventions, while
      the other half will be in a control wait-list, only receiving the intervention after final
      data collection.
    


Intervention name(s): Stepping Stones and Creating Futures
Intervention type(s): Behavioral
Intervention description(s): Stepping Stones consists of 10 sessions. It seeks to strengthen relationships and to transform views on gender and in the process impact on exposure to, or participation in, gender-based violence and HIV risk. These cover gender and peer influences our actions; sex and love; conception and contraception; STIs and HIV; safer sex and condoms; GBV; motivations for behaviour (including influences of alcohol and poverty); and communication skills.
Creating Futures is a facilitated group intervention of eleven sessions. It seeks to strengthen livelihoods. The key sessions include: setting medium term livelihood goals, the need for assets and coping with crises; social resources for livelihoods (trust and community participation); getting and keeping jobs; and savings and spending.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: informal settlements; poverty
Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)
Condition: Papillomavirus Infections; Coronavirus Disease (COVID-19)
MeSH terms: COVID-19; Coronavirus Infections; Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study to evaluate the safety and immunogenicity of a 2-dose regimen of
      9vHPV vaccine, where the first dose is administered concomitantly with a first dose of a
      2-dose regimen of mRNA-1273 vaccine versus nonconcomitant administration of 9vHPV and
      mRNA-1273 vaccines in boys and girls 9 to 11 years of age.
    


Intervention name(s): 9vHPV Vaccine; mRNA-1273 Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection; mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
Other intervention name(s): V503; GARDASIL®9; SILGARD®9; SARS-CoV-2 Vaccine; Moderna COVID-19 Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Safety Research of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans
Condition: Rabies; Healthy
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of Freeze-dried Rabies Vaccine （MRC-5
      Cell) in healthy humans aged from 10-60 years old, according to the traditional Essen methods
      (1-1-1-1-1) vaccination.
    


Intervention name(s): 2.5IU/ml in rabies vaccine （MRC-5 Cell) humans aged 10-20 years old; 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans aged 21-60 years old; 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 10-20 years old); 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 21-60 years old)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Freeze-dried Rabies Vaccine（MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval; Freeze-dried Rabies Vaccine（MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval; Freeze-dried Rabies Vaccine（vero Cell) of 2.5IU/ml,5 doses,4 weeks interval; Freeze-dried Rabies Vaccine（vero Cell) of 2.5IU/ml,5 doses,4 weeks interval
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: safety; rabies vaccine; MRC-5 cell
Monitoring of the Mitochondrial Function of Circulating Myeloid Cells in Patients Hospitalized in the Intensive Care Unit of Dijon University Hospital
Condition: Septicaemia
MeSH terms: Sepsis
Study type: Observational

Summary: 
      Severe infections (sepsis) are a common cause of admission to the intensive care unit. They
      represent a significant health risk for patients in the short and medium term. They are
      particularly linked to a change in the function of immune cells. In some patients, a state of
      pseudo-dormancy of monocyte and macrophage-type immune cells, called immunosuppression of
      myeloid cells, is observed. This situation leads to a worsening of the infection, so it
      should be avoided because it represents a danger for the patient even when they ar receiving
      antibiotics. At present, these events are still very poorly understood. Research is essential
      to understand how this state of immunosuppression of myeloid cells is established in order to
      adapt existing treatments or find new ones.

      Laboratory studies on animal models of septicaemia have shown that this state of
      immunosuppression of myeloid cells is closely linked to a change in the production of energy
      by myeloid cells (monocytes and macrophages). The functioning of the mitochondria ("energy
      factory" of the cells) in these cells is impaired. Thus, restoring mitochondrial function in
      myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells
      during severe septicaemia.

      The objective of this study is to verify whether alterations in mitochondrial function in
      myeloid cells also occur in patients with bacterial infection compared to patients without
      bacterial infection.
    


Intervention name(s): blood examination
Intervention type(s): Biological
Intervention description(s): use of the remaining 1-2 ml of blood in samples taken as part of routine care to study mitochondrial function
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients hospitalized in the ICU with or without sepsis.
Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      For children and adolescents, how does SPD503 compare to placebo for the treatment of
      Attention-Deficit/Hyperactivity Disorder (ADHD).
    


Intervention name(s): Extended-release Guanfacine Hydrochloride; Atomoxetine Hydrochloride; Placebo Comparator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet, once daily, optimised dose (1mg to 7mg based on age and weight), 6-week maintenance duration on optimised dose.; Capsule, once daily, optimised dose (10mg to 100mg based on weight), 8-9-weeks maintenance duration on optimised dose; Placebo
Other intervention name(s): Intuniv; Strattera
Intervention MeSH terms: Guanfacine; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD
Prospective, Randomised Study: Metabolic and Functional Effects of Bariatric Surgery Accessed Using PET and MRI.
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The objectives of this study are to measure effect of obesity on brain structure and
      molecular pathways, food-stimuli mediated brain activation response, on hormones affecting
      both feeding and energy balance as well as on bone metabolism and bone marrow fat. In the
      first phase the studies are performed at baseline before bariatric surgery and in the second
      phase post-operatively after 6 months. Regional free fatty acid uptake are studied with PET
      and 14(R, S)-[18F]-fluoro-6-thia-heptadecanoic acid ([18F]FTHA). Changes in body fat
      distribution are investigated with magnetic resonance imaging (MRI) Brain reward system
      response to food stimuli is assessed using functional MRI (fMRI) and white and grey matter
      volumes using diffusion tensor imaging (DTI). Brain neurotransmitter system will be measured
      with [11C]raclopride and [11C]carfentanil and PET. In the second part of the study the same
      variables are studied after bariatric surgery: either laparoscopic sleeve gastrectomy or
      Roux-en-Y gastric bypass.
    

Detailed description: 
      Regional free fatty acid uptake in myocardium, skeletal muscle, subcutaneous fat, visceral
      fat, pancreas, liver, brain, intestine and the bone are studied with PET and 14(R,
      S)-[18F]-fluoro-6-thia-heptadecanoic acid ([18F]FTHA). Changes in body fat distribution are
      investigated with magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).
      Brain reward system response to food stimuli is assessed using functional MRI (fMRI) and
      white and grey matter volumes using diffusion tensor imaging (DTI).

      The study consists totally of 60 study subjects. Of these 40 are morbidly obese adults, BMI
    

Intervention name(s): Bariatric surgery
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in Cervical Radiculopathy
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      To determine the effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral
      Movements (PAIVMs) and Active strength training in the management of cervical radiculopathy.
      To compare the effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral
      Movements (PAIVMs) and Active strength training in the management of cervical radiculopathy.
    

Detailed description: 
      Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve
      roots near the spinal cord. Some factors that may increase the risk for developing cervical
      radiculopathy include age. The risk for cervical radiculopathy tends to increase with age.
      This study is based on three interventions (Manual Cervical traction, Passive Accessory
      Intervertebral Movements (PAIVMs) and Active Strength Training) individually on three
      separate but equal groups of participants. It will determine the most effective intervention
      and which intervention is superior to the other for treating cervical radiculopathy and to
      assist future practitioners and researchers.
    

Intervention name(s): Manual Cervical Traction; Passive Accessory Intervertebral Movements; Active Strength Training
Intervention type(s): Other; Other; Other
Intervention description(s): Time: 20 minutes Duration: thrice a week for 4 weeks.
Position:
The patient is in supine lying. The head and neck of patient are held in the hands of the practitioner, and then a gentle traction of a pulling force is applied. Intermittent periods of traction can be applied, holding each position for about 10 seconds. Traction is usually applied at about 20-30 degrees of neck flexion.; Time: 20 minutes Duration: thrice a week for 4 weeks
Position:
Patient lying in prone. Therapist stands to side of patient placing their pisiform/ulnar surface of hand over the selected spinous process (SP) with their wrist in full extension.
Other hand placed on top of hand to reinforce. Therapist's shoulders should be directly above the SP with elbows slightly bent. Therapist uses their body weight to apply a PA force to the selected SP by leaning their body over their arms and performing rocking movements to provide oscillatory movements of the vertebra.; Time: 20 minutes Duration: thrice a week for 4 weeks. The progression of exercises will be done using different colors of Thera-band indicating varied resistance. (A) Resistive lateral flexion of uninvolved side.
Position:
The patient is in sitting position. By the help of thera-band patient will actively flex the neck against resistance on the uninvolved side.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Labor Induction After Cesarean Section: Outcome, Hormonal Trends
Condition: Induction of Labor; Previous Cesarean Section; Hormonal Changes
Study type: Interventional

Summary: 
      Objectives- To compare changes in labour-associated maternal and fetal hormone levels during
      breast stimulation, balloon induction and spontaneous labour. To compare efficacy and safety
      of labour induction methods in women with previous caesarean section.

      Design- Participants were randomized to undergo induction of labour by breast stimulation or
      intracervical balloon compared to spontaneous labour (controls).

      Setting- A single tertiary hospital Population- women at term, with previous caesarean
      section
    

Detailed description: 
      Maternal serum levels of oxytocin, prostaglandin F2α, prostaglandin E2, prolactin, estradiol
      and cortisol levels were analyzed at 0, 3 and 6 hours post induction initiation, including
      the two groups catheter balloon and breast stimulation and controls in spontaneous labor.
      Fetal umbilical cord hormones were measured in the three mentioned above groups. Clinical
      outcomes were documented in the two induction groups.
    

Intervention name(s): induction of labor by breast stimulation; induction of labor by catheter balloon
Intervention type(s): Device; Device
Other intervention name(s): breast stimulation; catheter balloon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: labor induction,; previous caesarean section; hormonal levels; breast stimulation; intracervical balloon
Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59
Condition: Influenza A Virus, H5N1 Subtype
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to assess the ability of H5 influenza virus vaccines and
      adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to
      generate an immune response to homologous and to antigenically distant heterologous H5
      influenza virus strains.

      The study is designed to evaluate the safety and immunogenicity of vaccination strategies
      with homologous or antigenically distant heterologous H5 influenza virus vaccines
      administered with AS03 or MF59 adjuvant.
    


Intervention name(s): VN; IN; dk/BANG; gf/WA; bhg/QL; AS03 adjuvant; MF59 adjuvant
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose; 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose; 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose; 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose; 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose; 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose; 0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
Other intervention name(s): A/Vietnam/1203/2004 vaccine antigen strain H5N1; A/Indonesia/05/2005 vaccine antigen strain H5N1; A/duck/Bangladesh/19097/2013 vaccine antigen strain H5N1; A/gyrfalcon/Washington/41088-6/2014 vaccine antigen strain H5N8; A/barheaded goose/Qinghai Lake/1A/2005 vaccine antigen strain H5N1
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine; adjuvant; Influenza in Birds; MF59; AS03
Mindfulness-Based Reduction Stress Program
Condition: Cancer; Caregiver Stress; Quality of Life
Study type: Interventional

Summary: 
      The participants consisted of 1332 caregivers of patients diagnosed with cancer, who applied
      to Atatürk University Health Research and Application Center, Outpatient Chemotherapy Unit
      between December 2022 and March 2023. In the power analysis, the sample of the research;
      According to Cohen, a total of 108 people, 54 of whom were in the experimental group and 54
      in the control group, with a medium effect size of 0.5%, an error margin of 0.05% and a
      confidence interval of 0.95%, were 95% representative of the universe. Against the
      possibility of data loss, 20% backup sample was included in this number and the study was
      planned with a total of 124 people, 62 in the experimental group and 62 in the control group.
      20 participants were excluded on the basis of inclusion and exclusion criteria. 104
      participants formed the sample
    

Detailed description: 
      Pretest measurements (T1) were made to the individuals in the experimental and control
      groups. 8-week mindfulness-based interventions were administered online to caregivers of
      cancer patients (Table 1). Before starting the MDI program in the experimental group, visual
      and written materials about the sessions prepared by the researchers were distributed. The
      program was implemented 4 days a week, 1 session a day, and each session was implemented in
      groups of 10-15 people for 60-90 minutes. After the 8-week MDI Program of the experimental
      group was completed, the data collection forms were re-applied to the individuals in the
      experimental and control groups, and posttest-1 measurements (T2) were made. 4 weeks after
      the posttest-1 measurements, the posttest-2 measurements (T3) of the individuals in the
      experimental and control groups were performed.
    

Intervention name(s): Mindfulness Based Stress Reduction Program
Intervention type(s): Behavioral
Intervention description(s): In each session, three sections were discussed and reviewed: (1) last week's experiences, (2) training, and (3) practice. Each session usually began with mindfulness and meditation exercises, followed by group discussion, review of homework activities, and introduction to new exercises. Participants were asked to complete 15-30 minutes of daily practice each week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care