bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Study of Profile of Hepatic Osteodystrophy in Patients With Non-Choleastatic Liver Cirrhosis and Impact of Bisphosphonate Supplementation
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Background and Objectives: Patients with liver cirrhosis are more prone to develop reduced
      bone mineral density i.e. hepatic osteodystrophy (HOD). It includes both osteopenia and
      osteoporosis and may lead to increased fracture risks. There is scanty data on prevalence of
      HOD in Indian population and its treatment outcome. The investigators aimed to determine
      prevalence of HOD, factors associated with it and the impact of bisphosphonates on bone
      mineral density in patients with liver cirrhosis.

      Patients and Methods: Consecutive patients with liver cirrhosis admitted at Sir Ganga Ram
      Hospital, New Delhi between August 2012 and July 2013 were enrolled. Patients with chronic
      kidney disease, hyperparathyroidism and those on steroids were excluded. Bone mineral density
      (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) at the lumbar spine and femoral
      neck. Osteopenia and osteoporosis were defined according to WHO criteria. All patients also
      underwent 25-hydroxy-vitamin-D, sex hormone (testosterone in male and LH and Estradiol in
      female) and parathyroid hormone (PTH) along with routine investigations. Transient
      elastography was also done in all patients. Ibandronic acid 150 mg per day orally for six
      months was given in patients with osteoporosis and DEXA scan repeated.
    


Intervention name(s): Treated with Ibandronic acid as per protocol
Intervention type(s): Drug
Intervention description(s): treated with Ibandronic acid at a dose of 150 mg once a month for six months
Intervention MeSH terms: Ibandronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Binge Drinking Among Youngs is a Risk Factor for Alcohol Use Disorders
Condition: Binge Drinking
MeSH terms: Alcoholism; Binge Drinking
Study type: Observational

Summary: 
      The purpose of this study was to assess drinking habits and patterns of alcohol consumption,
      smoking habits, use of illicit drugs and the prevalence of binge drinking and alcohol use
      disorders among Italian young students. Furthermore to investigate the correlation between
      binge drinking and alcohol use disorders.
    

Detailed description: 
      This study was performed on 2,704 subjects attending high school, through the administration
      of questionnaires regarding socio-demographic data, anthropometric characteristics, pattern
      and amount of alcohol intake, smoking habits, use of illicit drugs and physical activity were
      administered to students. Moreover mood and anxiety were evaluated through AUDIT, STAI-Y1,
      STAY-Y2 and ZUNG. The aim of the study was to assess drinking habits and patterns of alcohol
      consumption, smoking habits, use of illicit drugs and the prevalence of binge drinking and
      alcohol use disorders among Italian young students. Furthermore to investigate the
      correlation between binge drinking and alcohol use disorders.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        2,704 subjects attending high school in three italian cities
A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional

Summary: 
      The purpose of this study is to assess pregnancy outcomes, and maternal, as well as neonatal
      events of interest in healthy pregnant women and their new-borns. The study will also
      determine incidence of lower respiratory tract illness (LRTI) caused by respiratory syncytial
      virus (RSV) in the new-borns during their first year of life.
    


Intervention name(s): Blood sample collection; Cord blood sample collection; Maternal Diary Card; Nasal Swab collection; Infant Diary Card
Intervention type(s): Procedure; Procedure; Other; Procedure; Other
Intervention description(s): Venous blood samples will be collected from the maternal subjects at Day 1 and Day 56 of the study and at delivery.; Collection of cord blood samples from maternal subjects will occur, at delivery; Completion of Diary Card about health by pregnant woman/ mother, from enrolment through week 6 post delivery.; Collection of nasal swabs from infants with potential LRTIs, from birth to 12 months of age.; Completion of Diary Card about health of infant from birth to 12 months of age.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment is selected because this is a low-interventional, epidemiological study. As such, the study does not have multiple groups/treatment arms that will be compared against one another statistically in the way two study arms would be compared against each other in a clinical trial. Instead, the study will longitudinally follow pregnant women through a 42-day post-delivery period and will also follow the infants born to these women. It should be noted that these are the two populations listed in the protocol, but these are not two groups that will compared against one another. Statistical analyses will be conducted within each group and some analyses will be done across the two groups. However, these two groups should not be considered equivalent to two study arms. This explains why a single group assignment is appropriate while two study groups (mothers and infants) will be examined.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: third trimester; Respiratory Syncytial Virus (RSV) illness; Pregnancy; Maternal Immunization; Pregnant Women; Neonates; Respiratory Tract Illness
Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects
Condition: HIV-1-infection
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of Elsulfavirine following administration of single
      oral ascending doses in HIV-negative, healthy subjects.
    

Detailed description: 
      This study is a double-blind, placebo-controlled, outpatient study of single oral ascending
      doses of Elsulfavirine to evaluate the safety, tolerability, and pharmacokinetics of
      Elsulfavirine and its active metabolite VM-1500A in HIV-negative, healthy subjects. Eight (8)
      subjects (6 active, 2 placebo) per dose level will be enrolled. Within each of the three
      cohorts consisting of 8 subjects, 6 subjects each will receive single oral doses of
      Elsulfavirine at 20 mg, 40 mg, or 80 mg in an escalating manner, and 2 subjects will receive
      matching placebo.
    

Intervention name(s): Elsulfavirine
Intervention type(s): Drug
Intervention description(s): Elsulfavirine (Elpida®) 20 mg capsules for oral administration
Other intervention name(s): VM-1500
Intervention MeSH terms: Elsulfavirine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HIV-1
The Role of Kinesiophobia in the Functional Recovery After Hip Replacement
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis, Hip; Kinesiophobia
Study type: Observational

Summary: 
      Several authors explain as the kinesiophobia plays an important role for the recovery after
      orthopaedic surgery. The aim of the investigators study is to investigate if the
      kinesiophobia is able to influence the early recovery after total hip arthroplasty. The early
      recovery will be measured by the ILOA Score. The Tampa Scale of Kinesiophobia will measure
      the fear level of movement. All the other variable that could influence the ILOA Score are
      identified and collected: age, sex, body max index, ability of patient pre-surgery, type of
      anesthesia, length of stay, pain, haemoglobin, possible complications.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Total hip arthroplasties patients following chronic joint disease
      
Keywords: hip replacement,; rehabilitation,; early ambulation,
Detection of Neonatal Bradycardia
Condition: Apnea; Bradycardia
MeSH terms: Apnea; Bradycardia
Study type: Observational

Summary: 
      Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with
      short term complications and alterations in neurodevelopment. Duration and amplitude of the
      bradycardias depend on the time delay between the beginning of the bradycardia and the
      intervention of the nurse.

      The purpose of the study is to test a new method set for early detection of bradycardia in
      preterm infants.
    

Detailed description: 
      Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with
      short term complications and alterations in neurodevelopment. Duration and amplitude of the
      bradycardias depend on the time delay between the beginning of the bradycardia and the
      intervention of the nurse.

      The purpose of the study is to test in clinical units and in real life a new method set for
      early detection of bradycardia in preterm infants.

      Each preterm infant cardio-respiratory traces will be recorded during two 4-hours periods of
      time (the first one at the time of occurrence of apnea-bradycardias and the second one during
      the following week). During those periods, the alarms of the monitors usually used in the
      units will also be recorded through automatic detection and these alarms will be compared
      with the alarms generated by the algorithm tested, for false positive and precocity of the
      detection. A false positive alarm is a detection which is not associated with a bradycardia
      of less than 80 bpm. The system will be considered efficient if it allows an earlier
      detection of severe bradycardias without increasing the number of false positive detection.
    

Intervention name(s): No intervention
Intervention type(s): Device
Intervention description(s): The recordings will be performed in neonatal units with the preterm infant remaining in usual condition with limitations of external stimulation during the study period. The usual monitor will remain in function. The intervention of the nurses in case of apnea will not be modified during the study period. The recording will be obtained from derivation of the signal usually recorded by the monitor in use completed in one centre by a polysomnographic recording (Medtronics France SA), in order to test a possible influence of the sleep status on the detection.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants born before 33 weeks of gestational age with a post conceptional age of
        less than 36 weeks.
      
Keywords: apnea-bradycardias; preterm infants
Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
Condition: Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      Safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese
      paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis will be evaluated.
      And secondarily, efficacy and systemic exposure of GW685698X (55 µg/day, q.d.) nasal spray
      over a period of 12 weeks in Japanese paediatric subjects ages 2 to < 15 years with perennial
      allergic rhinitis will also be evaluated.
    


Intervention name(s): Fluticasone furoate
Intervention type(s): Drug
Intervention description(s): 55 mcg/day, intranasal, 12 weeks
Intervention MeSH terms: Fluticasone; Xhance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Men to Test How BI 1810631 is Taken up and Processed by the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A - the primary objective is to assess the mass balance and total recovery of
      [14C]-radioactivity in urine and faeces after oral single dose administration of BI 1810631
      (C-14) (test treatment T1) in healthy male subjects.

      Part A - the secondary objective is to assess concentrations of BI 1810631 and
      [14C]-radioactivity in plasma.

      Part B - the primary objective is to investigate the absolute bioavailability of BI 1810631
      administered as film-coated tablet (test treatment T2, not radio-labelled) compared with BI
      1810631 (C-14) (reference treatment R) administered as intravenous microtracer.
    


Intervention name(s): BI 1810631 (C-14) formulation 1; BI 1810631; BI 1810631 (C-14) formulation 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 1810631 (C-14) formulation 1; BI 1810631; BI 1810631 (C-14) formulation 2
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) Given by Mouth in Healthy Volunteers
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the safety and tolerability of Risdiplam (RO7034067)
      in healthy people. The study will assess what the body does to Risdiplam (RO7034067) and what
      Risdiplam (RO7034067) does to the body. Risdiplam (RO7034067) will be given by mouth in
      gradually increasing doses. The data from this study will help to define the dose to further
      explore Risdiplam (RO7034067) in patients with Spinal Muscular Atrophy.
    


Intervention name(s): Itraconazole; Placebo; Risdiplam
Intervention type(s): Drug; Other; Drug
Intervention description(s): Itraconazole will be administered as an oral 200 mg dose twice daily from Day 1 to Day 8 in Part 3.; In Part 1 of the study matching oral placebo will be administered once on Day 1.; Single ascending oral doses of Risdiplam will be administered on Day 1 of Part 1. In Part 2 a single dose of Risdiplam will be once administered under fasted and once under fed conditions. In Part 3 a single dose of Risdiplam will be once administered alone (Period 1) and once concomitantly to itraconazole (Period 2).
Other intervention name(s): Sporanox®; RO7034067
Intervention MeSH terms: Itraconazole; Risdiplam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional

Summary: 
      We aimed to evaluate the hypothalamus-pituitary-adrenal axis in autosomal dominant polycystic
      kidney disease (ADPKD) patients. Twenty two ADPKD patients and 27 healthy subjects were
      enrolled.
    

Detailed description: 
      CONTEXT: Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary
      kidney disease and extrarenal manifestations may be observed in many organ systems.
      Hypothalamus-pituitary-adrenal axis in patients with ADPKD was not evaluated extensively.

      OBJECTIVE: We aimed to evaluate the hypothalamus-pituitary-adrenal axis in ADPKD patients.

      METHODS: Twenty two ADPKD patients and 27 healthy subjects were enrolled. Basal
      dehydroepiandrosterone-sulfate (DHEAS) levels and cortisol and dehydroepiandrosterone
      responses to low dose short adrenocorticotropin stimulation test were assessed. Correlation
      analyses of these parameters with glomerular filtration rates, renal volumes and pain
      characteristics in patients with ADPKD were done.
    

Intervention name(s): Tetracosactin
Intervention type(s): Drug
Intervention description(s): 1 microgram tetracosactin, intravenous injection, once for the test
Other intervention name(s): Synacthen
Intervention MeSH terms: Cosyntropin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Autosomal dominant polycystic kidney disease; Adrenal functions; Renal volume; Glomerular filtration rate; Adrenal Cortex Function Tests
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety
      and immunogenicity of Cervarix in HIV infected females aged 15 to 25 years as compared to
      Merck's HPV vaccine (Gardasil). For comparative purposes, a group of HIV negative females
      will also be evaluated. All subjects will receive the HPV vaccine (either Cervarix or
      Gardasil) according to a three-dose schedule (Day 0, Week 6, Month 6).
    


Intervention name(s): GSK Biologicals' HPV vaccine 580299; Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
Intervention type(s): Biological; Biological
Intervention description(s): Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.; Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Other intervention name(s): Cervarix; Gardasil
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cervarix; Gardasil; Immunogenicity; Cervical cancer; Safety; HPV vaccine
Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn
Condition: Breastfeeding
Study type: Interventional

Summary: 
      Breastfeeding is the physiological and recommended way of feeding newborns as indicated by
      the World Health Organization, Health Canada and the politics of perinatality 2008-2018 in
      Quebec. Despite these, mothers who exclusively breastfed their babies are rare. According to
      Statistics Canada, the first month of life is the most at risk time to wean because of
      technical difficulties (53% of weaning) including mechanical issues. In Quebec city, despite
      a supportive network of health care professionals including lactation consultant, many babies
      are weaned. Lactation consultant are often feeling helpless when facing these mechanical
      difficulties.

      The purpose of this study is to determine the efficiency of an osteopathic treatment for
      newborns presenting breastfeeding mechanical difficulties. The investigators' hypotheses is
      that an osteopathic treatment integrating in the usual care is more efficient than usual car
      alone to help healing mechanical breastfeeding issues.

      The investigators propose a randomized clinical trial on a sample of 90 babies (45 in each
      group), under six weeks, presenting sucking dysfunctions, in Quebec city (Canada). The
      control group will receive usual care with a lactation consultant and the intervention group
      will receive usual care plus an osteopathic treatment. It is a simple blind clinical trial:
      the osteopath finds out, prior to evaluating the patient, what intervention should be
      delivered to the baby (assessment alone or standardized osteopathic treatment for infant).

      The results will ultimately lead to improvements in the existing knowledge on the fields of
      osteopathy and lactation support, allowing implementation of osteopathic care in the
      perinatal network.
    


Intervention name(s): osteopathic treatment; usual breastfeeding counselling
Intervention type(s): Other; Other
Intervention description(s): Treatment duration range between 30 to 40 minutes. The infant entire body is evaluated and then manipulative procedures are provided following palpatory results.; breastfeeding counselling and support by lactation consultant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: breast feeding; sucking; dysfunction; Latch assessment tool; visual analogic scale; infant physiology
The Impact of the Previous Exposure to Covid-19 Virus Infection on the Outcome of ICSI Cycles
Condition: COVID-19; IVF
MeSH terms: COVID-19; Virus Diseases
Study type: Observational [Patient Registry]

Summary: 
      Whilst the global COVID-19 pandemic is still evolving and there are many unknowns about the
      long-term effects of the virus on fertility and pregnancy, we found ourselves in need to
      offer some evidence-based guidance, that's why we decided to go for this study, to evaluate
      the relation of the covid-19 and the outcome of IVF/ICSI cycles. we found that there is no
      clear evidence that the previous exposure to Covid-19 virus infection can affect the outcome
      of ICSI cycles significantly.
    

Detailed description: 
      This is an observational study, for 122 ICSI cycles conducted in Al- Baraka Fertility
      Hospital, Manama, Bahrain, and Al-Manea hospital, KSA between August 2020 and May 2021, and
      it was approved by the ethical committees. We compared the outcome results of those patients
      who got recovered from previous exposure to covid-19 (study group) with results of
      non-infected comparable patients (control group) After comparison of the basal
      characteristics in both groups, and we got assured that there is no significant difference
      regarding the demographic criteria between both groups, we found that there is no significant
      difference regarding the duration of stimulation, the total dose of stimulation, number of
      oocytes retrieved, number of metaphase 2 oocytes (MII), number of grade1-2 embryos, number of
      transferred embryos, day of embryo transfer and fertilization rate.

      Although the fertilization rate was higher in Covid-19 free patients (52% vs. 50.6%),
      however, this difference is not statistically significant.

      In the same way, the pregnancy rate was also higher in the covid-19 negative group (45.1% vs.
      36.4%); however this difference was not statistically significant.
    

Intervention name(s): covid-19
Intervention type(s): Other
Intervention description(s): viral infection
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All women underwent individualized antagonist protocol