bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Vitamin D on in Vitro Fertilization Outcome
Condition: Ongoing Pregnancy Rate; Vitamin D; in Vitro Fertilization
Study type: Observational

Summary: 
      To date, several studies have been done to explore the relationship between Vitamin D level
      and IVF outcome; however, the results are controversial. Sample sizes in these studies
      mentioned above were relatively small. In addition, there are no prospective cohort studies
      in this field. Thus, here the investigators carry this prospective observational cohort study
      to demonstrate the relationship between vitamin D level and IVF outcome.
    

Detailed description: 
      Vitamin D level is measured before the commence of IVF cycle. According to Vitamin D level,
      patients are divided into 3 groups: A, Deficient, <20 ng/mL; B, Insufficient, 20-29.9 ng/mL;
      C, Replete, >30 ng/mL.

      Ongoing pregnancy rate are compared among these three groups after controlling age, number of
      embryos transferred, ect.

      In addition, Vitamin D level is also meassured before embryo transfer in FET cycles with PGT
      treatment. The effect of Vitamin D on IVF outcome is detected in patients transferred with
      Euploid embryos.
    

Intervention name(s): Embryo transfer
Intervention type(s): Procedure
Intervention description(s): For patients in each group after oocyte retrieval, they will have embryo transferred 3 or 5 days after oocyte retrieval. For FET cycles, they will have ET with an euploid blastocyst.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients whose IVF cycles were cancelled due to ovarian hyperstimulation syndrome were also
        excluded);.
      
Biospecimen description: 
      Serum/follicle fluid
    
Keywords: Vitamin D; IVF outcome
The Safety, Tolerability and Pharmacokinetics Study of RAY1216 in Healthy Adult Participants
Condition: COVID-19 (Coronavirus Disease 2019)
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is double-blind,randomized, single and multiple dose trial to evaluate the
      pharmacokinetics(PK), safety, tolerability and drug-drug interaction of RAY1216, and the
      effect of food on RAY1216 Pharmacokinetics.
    


Intervention name(s): RAY1216 dose 1; RAY1216 dose 2; RAY1216 dose 3; RAY1216 dose 4 &ritonavir; RAY1216 dose 5; RAY1216 dose 6; RAY1216 dose 7; RAY1216 dose 8; RAY1216 dose 9; RAY1216 dose 10
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): RAY1216 dose 1 or Placebo; RAY1216 dose 2 or Placebo; RAY1216 dose 3 or Placebo; RAY1216 dose 4 &ritonavir or Placebo; RAY1216 dose 5 or Placebo; RAY1216 dose 6 or Placebo; RAY1216 dose 7 or Placebo; RAY1216 dose 8 or Placebo; RAY1216 dose 9 or Placebo with high fat meal; RAY1216 dose 10 or Placebo with high fat meal
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if denosumab is effective in increasing bone
      mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.
    


Intervention name(s): denosumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60mg subcutaneous injection, single dose; placebo subcutaneous injection, single dose
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: India; dual energy x-ray absorptiometry; bone mineral density; denosumab
Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the benefit of thrombus aspiration in patients with
      ST-elevation myocardial infarction presenting late after symptom onset.
    


Intervention name(s): manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)
Intervention type(s): Device
Intervention description(s): manual thrombus aspiration catheter to be used during percutaneous coronary intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis
Condition: Sinusitis, Acute
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Acute Bacterial Rhinosinusitis (ABRS) is a respiratory inflammation commonly seen in clinical
      practice, which has with respiratory symptoms including nasal congestion, rhinorrhoea,
      postnasal discharge and cough and is associated with headache, cheek pain, facial pressure
      and other conditions. The principal bacterial pathogens in causing ABRS include Streptococcus
      pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis. These three
      bacteria account for approximately 90% of ABRS in children less than or equal to 5 years of
      age. Combination of Potassium Clavulanate (CVA) and Amoxicillin (AMPC) produces higher
      antibiotic activity against beta-lactamase-producing bacteria. The present study is designed
      to assess the clinical efficacy, bacteriological efficacy and safety of CVA/AMPC (1:14)
      administered in children aged from 3 months to less than 15 years with ABRS. It is an
      open-label study consisting of a 7-day treatment phase and a post-treatment follow-up phase
      for 7 to 14 days.
    


Intervention name(s): Amoxicillin-Potassium Clavulanate Combination
Intervention type(s): Drug
Intervention description(s): The drug is available in two sachets (CVA/AMPC Dry Syrup 0.505 g and CVA/AMPC Dry Syrup 1.01 g). CVA/AMPC Dry Syrup 1.01 g sachet contains 42.9 mg of Potassium Clavulanate and 600 mg of Amoxicillin Hydrate. It is a white to yellowish white powder and has strawberry flavor and it is white to yellowish white suspension when it is suspended before use.
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute bacterial rhinosinusitis; Amoxicilin; Infection; Potassium clavulanate
Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Study Of PF-04447943, Co-Administered With And Without Hydroxyurea, In Subjects With Stable Sickle Cell Disease
Condition: Phase 1 Sickle Cell
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of an investigational drug, PF-04447943, in subjects with stable sickle cell
      disease with and without co-administration with hydroxyurea. This study will also aid in
      selecting the doses for future studies and evaluation of substances in the blood which may
      help access the effectiveness of the drug.
    


Intervention name(s): PDE9i; PDE9i; placebo for PDE9i; PDE9i
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral dose, every 12 hours for 28 days; oral dose, every 12 hours for 28 days; oral dose, every 12 hours for 28 days; oral dose, every 12 hours for 28 days
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      It is the aim of this study to detect the effect of Betamethasone on the maternal
      inflammatory parameters C-reactive protein (CRP) and leukocytes of a pregnant woman under
      threat of preterm delivery, for example because of a cervical infection.
    

Detailed description: 
      BACKGROUND

      Cortisone influences the maternal number of leukocytes and CRP of a pregnant woman. Because
      of that, it is difficult to know if the medical treatment of an infection was successful and
      accordingly if the diagnosis was justified.

      METHODS

      In this study, the blood results of 75 pregnant women under threat of preterm delivery (week
      of gestation 23+0 to 34+6), treated with Betamethasone will be analysed. 65 pregnant women
      without complications serve as control group.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant woman admitted to the department of feto-maternal health and obstetrics
      
Biospecimen description: 
      - blood samples
    
Keywords: preterm birth; corticosteroids; inflammatory parameters; betamethasone; leukocytes
Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)
Condition: Asthma, Exercise-Induced
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of an approved medication being studied
      in support of a new approach in the prevention of exercise-induced asthma (a worsening of
      asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have
      a history of worsening asthma after exercise.
    


Intervention name(s): Comparator: Montelukast; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge; Placebo tablet administered orally as a single witnessed dose before exercise challenge
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Resilience Intervention for Critical Care Nurses
Condition: Stress
Study type: Interventional

Summary: 
      The Corporate Athlete® Resilience (CAR) Training Program is a 1-day training program that
      uses a holistic approach that focuses on moving between stress and strategic recovery to help
      build resilience and enable higher performance.

      The purpose of this RCT is to determine whether the CAR Training Program has significant
      impact on nurses' resilience and stress mindset in their personal lives and their working
      environment. Knowledge from this study can be applied to interventions in the future to
      improve resilience behavior.
    

Detailed description: 
      The ongoing nursing shortage in the U.S health care system is a multifaceted issue. One
      factor leading to the nursing shortage is high turnover, particularly among critical care
      nurses due to their experiences with stressful work environments, ethical dilemmas, and high
      rates of patient morbidity and mortality. There is also a high prevalence of psychological
      disorders, such as anxiety, depression, and Post Traumatic Stress Disorder (PTSD) among
      critical care nurses. Consequences of turnover and low nurse staffing include lower quality
      of care, lower patient satisfaction, increased medical errors, increased rates of health care
      associated infections, and higher 30-day mortality rates.

      Resilience is defined as "the ability to adapt to life's ever-changing landscape and recover
      quickly from the stressors and potential stressors". It is a learned psychological
      characteristic that can be used to bounce back after disruption and successfully adapt to
      stressful work experiences in a positive manner.
    

Intervention name(s): Corporate Athlete Resilience (CAR) Training Program
Intervention type(s): Behavioral
Intervention description(s): A 1-day training program developed by the J&J Human Performance Institute (HPI), which uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Resilience; High Performance; Critical Care Nurse
The Effect of Human Prostate Tissue on Platelet Activation
Condition: Prostate Hyperplasia; Coagulation; Intravascular; Thrombotic Disorder
MeSH terms: Prostatic Hyperplasia; Thrombosis; Hyperplasia
Study type: Observational

Summary: 
      Transurethral resection of the prostate (TURP) is a common and standard urological surgical
      procedure for managing benign prostatic hyperplasia (BPH). Although surgical technology
      improved in recent decades, severe complications such as TURP syndrome, hematuria, and
      postoperative hemorrhage were still considerable. Coagulopathy is one of rare but devastating
      complication which may contribute to bleeding during and after TURP. Although the exact
      pathophysiological condition of coagulopathy is not clear, there are several possible
      mechanisms of TURP associated coagulopathy including: urokinase- (u-PA) and tissue-type
      plasminogen activator (t-PA)-related fibrinolysis; absorption of irrigating fluid associated
      dilutional coagulopathy; release of prostatic particles rich in tissue thromboplastins into
      the circulation causing secondary ﬁbrinolysis and disseminated intravascular coagulopathy
      (DIC); sepsis with DIC associated with bacteria entering the circulation due to prostatic
      venous sinuses opening and the using of high pressure irrigation. On the other hand, platelet
      are essential to hemostasis and thrombosis and its activation also contributes to leukocyte
      recruitment and DIC. Furthermore, previous studies demonstrated that activated platelets
      could express TLR4, CD40L, P-selectin and induce platelet-leukocyte aggregation (PLA), which
      were considered important for systemic inflammatory responses and DIC development. Currently,
      no study investigating the association of prostate particle and platelet activation. Here, we
      tested the hypothesis that prostate tissue may induce inflammatory responses through platelet
      activation by measuring the expression of TLR4, CD40L, P-selectin and PLA on platelets.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        40-80 year old male scheduled for transurethral resection of the prostate surgery.
      
Biospecimen description: 
      Prostate tissue; blood sample
    
Keywords: TURP; coagulopathy; DIC; thrombotic disorder
A Phase IIA Trial to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Followed by an MVA HIV-1 Vaccine in HIV-uninfected Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and
      recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen.

      Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled
      at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment of
      up to 10% (approximately 10 additional volunteers) will be permitted in the study.
    


Intervention name(s): DNA.HIVA; MVA.HIVA; MVA.HIVA; MVA.HIVA
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5mg DNA.HIVA or placebo; 5x10^6 pfu MVA or placebo; 5x10^7 pfu MVA or placebo; 2.5x10^8 pfu MVA or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV
A Study On The Effect Of Vitano® On Physiological And Psychological Responses To Psychological Stress
Condition: Mild Stress/Anxiety
MeSH terms: Stress, Psychological
Study type: Interventional
Phase: Phase 4

Summary: 
      A pilot investigation into the stress relieving properties of Vitano® which will assess the
      following hypotheses

      Individuals exposed to Vitano® will demonstrate diminished blood pressure and heart rate
      responses to mental stress compared to individuals in the control condition

      Physiological recovery (BP, HR and cortisol) from mental stress will be enhanced in
      individuals exposed to Vitano® compared to individuals in the control condition

      Vitano® will have positive effects on cognitive functioning.

      Subjective ratings of stress will be reduced in individuals exposed to Vitano® compared to
      individuals in the control condition

      There will be a significant improvement in subjective well-being in individuals taking
      Vitano®.
    


Intervention name(s): Vitano
Intervention type(s): Drug
Intervention description(s): two 200mg tablets per day for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program
      and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the
      treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive
      treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297)
      will allow the subjects who complete Trial 291 to enter this open label trial at the
      investigator's discretion, where additional safety and tolerability data will be collected.
    


Intervention name(s): Aripiprazole IM Depot
Intervention type(s): Drug
Intervention description(s): Aripiprazole IM Depot 400 mg or 300 mg
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia
A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effects of food on how much test drug is able to access the
      circulation and reach the target area (known as bioavailability).

      The test drug, elafibranor (IPN60190), is in development for the treatment of primary biliary
      cholangitis (PBC).

      PBC is a rare, long-term autoimmune disease of the liver. An autoimmune disease occurs when
      the immune (defence) system treats healthy parts of the body as if they were foreign and
      attacks them.

      This study will be in healthy volunteers, so this trial is not to test if the drug helps to
      improve health.
    


Intervention name(s): elafibranor; elafibranor
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet; Oral Tablet
Other intervention name(s): GFT505; IPN60190; GFT505; IPN60190
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Elafibranor
Correlation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient
      vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred
      to by a vascular specialist.
    

Detailed description: 
      The participants were divided randomly into two groups of equal numbers. The study group got
      low-frequency TENS (4 Hz frequency, pulse duration 200 μs) which was administered through
      surface electrodes for 45 min per session, supramaximal stimulation for T12, L1, and L2
      sympathetic ganglions that innervate the lower extremity for 45 min per session, three times
      per week and for 12 weeks. Control Group that received placebo stimulation as provided by the
      same TENS device but with a zero volt after 10 s of stimulation.
    

Intervention name(s): Transcutaneous Electrical Nerve Stimulation(TENS) device
Intervention type(s): Device
Intervention description(s): The Patients in group (A) received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs,burst mode) was be applied through 2 output channels surface electrodes with an E2 TENS device, for 45 min per session, supramaximal stimulation to sympathetic ganglions in T12, L1, and L2, which innervate the lower extremity . For 45 min per session, three times per week, and for 12 weeks.
Other intervention name(s): TENS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This multicentre, randomised, double-blind, 2-parallel group, controlled trial aims to
      investigate whether oral milk protein supplements led to increase in serum Insulin-like
      Growth Factor-I levels (IGF-I) as compared with a control group fed with an iso-caloric
      supplement, in women with anorexia nervosa. Subjects receive either 150g/day of tested
      product or control product for 4-week, followed by a 4-week follow-up.
    

Detailed description: 
      Study centres: 4 active centres in France and 2 active centres in Switzerland
    

Intervention name(s): Oral protein supplement (Tested product); Iso-caloric supplement (Control product)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Test product: oral protein supplement, sweetened flavoured dairy product, type fresh cheese rich in milk protein (15 g/150 grams). Dosage is 2 pots daily, at least 5 days/week for 4 consecutive weeks.; Control product: sweetened flavoured fresh cheese, with low milk protein content (3 g/150 grams). Dosage is 2 pots daily, at least 5 days/week for 4 consecutive weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anorexia nervosa; Protein supplements; IGF-I