bioihbjkbjnl/mcl2 huggingface dataset:
A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian Failure
Condition: Primary Ovarian Insufficiency; Premature Ovarian Failure; Infertility
MeSH terms: Infertility; Primary Ovarian Insufficiency; Menopause, Premature
Study type: Interventional
Phase: Phase 1

Summary: 
      This project will clarify the safety and effectiveness of human amniotic epithelial cells
      transplantation for the treatment of primary ovarian failure (POF) patients and provide a new
      therapeutic method for patients with infertility.
    

Detailed description: 
      POF is a defect characterized by the premature depletion of ovarian follicles. Patients with
      POF suffer from amenorrhea, infertility, low levels of estrogen, and high gonadotropin
      concentration before the age of 40. The early failure of ovarian function leads to lost
      fertility and increases risk of osteoporosis and cardiovascular disease, which has serious
      impact on the patient's physical, mental health and family stability. The etiology of POF is
      complex, and so far there has not been any effective treatment. Recent study showed that
      human amniotic epithelial cells (hAECs), also known as the birth waste, are newly discovered
      adult stem cells. The hAECs have the ability to repair nerve damage, myocardial injury, as
      well as liver damage. hAECs have low immunogenicity and no ethical restrictions. Therefore,
      hAECs are expected to become the new seed cells for regenerative medicine. Our previous study
      was the first to show that human amniotic epithelial cells have the ability to restore
      folliculogenesis in a mouse model with chemotherapy-induced premature ovarian failure. Our
      further studies demonstrated that hAECs either directly transdifferentiated into granulosa
      cells, or inhibited tumor necrosis factor-alpha-mediated granulosa cell apoptosis and reduced
      the inflammatory reaction in ovaries induced by chemotherapeutics, regulating VEGFA and its
      receptors to induce follicular growth related to paracrine activity. Therefore, it is
      necessary to start the clinical study of human amniotic epithelial cells transplantation in
      the POF disease which may offer a novel therapeutic strategy for improving the quality of
      life of POF patients.
    

Intervention name(s): human amniotic epithelial cells (hAECs) transplantation
Intervention type(s): Biological
Intervention description(s): hAECs are prepared and cultured using GMP(Good Manufacturing Practice, GMP) rules, 3×10^7 hAECs in 4.5ml is separately injected into ovarian tissue by bilateral ovarian artery infusion.
Other intervention name(s): hAECs transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary ovarian insufficiency; premature ovarian failure; Infertility; human amniotic epithelial cells transplantation
Pharmacological Activation of HMN for OSA
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Obstructive sleep apnea (OSA) is common and has major health implications but treatment
      options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle
      activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared
      to normal subjects. In this protocol the investigators will test the effect of LTM1201L,
      LTM1201LN, LTM1201LB, LTM1201LD administered before sleep on OSA phenotype traits and OSA
      severity during sleep.
    


Intervention name(s): Placebo oral capsule; LTM1201L; LTM1201LN; LTM1201LB; LTM1201LD
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo capsule before sleep; LTM1201L capsule before sleep; LTM1201LN capsule before sleep; LTM1201LB capsule before sleep; LTM1201LD capsule before sleep
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasonographic Predictors of Hypotension After Induction
Condition: General Anesthesia; Hypotension on Induction
MeSH terms: Hypotension
Study type: Observational

Summary: 
      The purpose of the study is to evaluate the predictive value of the inferior vena cava
      collapsibility index and caval aorta index for detecting hypotension after induction of
      general anesthesia.
    

Detailed description: 
      Since cardiovascular depressant and vasodilatory effects of anesthetic agents, patients may
      be at risk of hypotension after induction of general anesthesia. Previous studies reported
      that, for evaluating volume status, some ultrasonographic measurements such as inferior vena
      cava collapsibility index (IVCCI) could be used. Also some studies stated that measurement of
      aorta diameter index (IVC : Ao index) is reliable to predict hypotension after induction of
      spinal anesthesia. At the study, the investigators aimed to investigate the predictive values
      of the inferior vena cava collapsibility index and caval aorta index under ultrasound
      guidance in predicting post-induction hypotension in patients under general anesthesia.
    

Intervention name(s): Inferior vena cava-Aorta diameter index
Intervention type(s): Other
Intervention description(s): Before the induction of general anesthesia, inferior vena cava-Aorta diameter index and inferior vena cava collapsibility index will be measured.
Other intervention name(s): Inferior vena cava collapsibility index
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients who scheduled for elective non-cardiac surgery under general anesthesia
Influence of Graded Hypercapnia on Endurance Exercise Performance
Condition: Hypercapnia
MeSH terms: Hypercapnia
Study type: Interventional

Summary: 
      The aim of this randomized, single-blind, placebo-controlled crossover trial is to determine
      the effects of graded hypercapnia (0, 2, and 4% inspired CO2) on endurance performance.
      Twelve healthy and fit young adults (men and women) will complete this study. Participants
      will perform experimental trials on 3 separate days (one each breathing 0%, 2%, and 4%
      inspired CO2-all with normal 21% oxygen). During each trial, they will perform 10 minutes of
      submaximal treadmill walking exercise and then complete a self-paced 2-mile treadmill run
      time-trial.
    

Detailed description: 
      Participants will undergo baseline measurements of pulmonary function and maximal oxygen
      uptake (VO2max). They will then complete two familiarization trials, with 10 minutes of
      submaximal exercise (~40%VO2max) followed by a self-paced 2-mile treadmill time trial.
      Lastly, they will complete three experimental trials, repeating the same submaximal and
      time-trial exercise procedures while breathing the test gas (0%, 2%, or 4% CO2-all with
      normal 21% oxygen). During the experimental trials, arterialized capillary blood samples will
      be collected at rest breathing room air, at rest breathing the test gas, and during
      submaximal exercise at 40% VO2max breathing the test gas. The primary outcome is 2-mile
      treadmill time-trial performance. Secondary outcomes include ventilation, metabolic rate,
      heart rate, arterialized capillary pH/PCO2/HCO3, perceived exertion, dyspnea, leg discomfort,
      breathing descriptors, and headache ratings.
    

Intervention name(s): Inspired gas
Intervention type(s): Other
Intervention description(s): Inspired gas content
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, single-blinded crossover design
Masking: Single (Participant)
Primary purpose: Other
Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the effect of metformin on pregnancy complications and pregnancy outcome in
      the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 850 mg x 1 per day for the first week, and 850 mg x 2 per day for the rest of the study period.. Orally. From inclusion (before gestational week 8) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.; Placebo, 2 tablets x 1 daily for the first week, and 2 tablets x 2 for the rest of the study period.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.
Other intervention name(s): metformin from Weifa 425 mg / tablet; Placebo from Weifa
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Metformin; Pregnancy outcome; Androgens
A Survey of Factors Affecting an Early or Delayed Diagnosis of IgA Nephropathy
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Observational

Summary: 
      This is a survey of factors which affect a pathologically defined early or delayed diagnosis
      of IgA nephropathy in Guangdong General Hospital, Guangzhou, China. An early or delayed
      diagnosis of IgA nephropathy is pathologically defined using the recently published Oxford
      classification of IgA nephropathy. The factors to be surveyed include health examination
      including urine test, socioeconomic status of patients including education,etc.
    


Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The consecutive biopsy-proven IgAN patients in Guangdong General Hospital, Guangzhou,China
      
Keywords: diagnosis; IgA nephropathy
Siderophore-profile in Allergic and Non-allergic Subjects
Condition: Allergy; Healthy; Allergic Sensitisation
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      This study aims to profile the siderophore-content in the human gut from allergic and
      non-allergic subjects and to assess their contribution in iron homeostasis.
    

Detailed description: 
      Iron is an essential nutrient for the majority of commensal bacteria, which commonly secrete
      siderophores to liberate iron from their surroundings. In several studies, a misbalanced
      microbiota has been demonstrated in allergics suggesting that also their siderophore profile
      is severely attenuated.

      There are currently no data and very limited knowledge present on the composition of
      bacterial surviving factors in humans, or on their impact on the human immune system.

      As such, 1) the iron status, 2) the microbial biota composition and the 3)
      siderophore-profile in allergics and non-allergics will be assessed.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Allergics and Non-Allergic subjects over 18 years.
      
Biospecimen description: 
      Blood, Stool, Urin samples
    
Keywords: iron; siderophores; allergy; allergic sensitisation; trace elements
A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose
      study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and
      multiple dose study in healthy volunteers.
    

Detailed description: 
      To assess the safety, tolerability and pharmacokinetics of ABT-494 in healthy volunteers and
      in patients with rheumatoid arthritis.
    

Intervention name(s): ABT-494; Placebo; Tofacitinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration of ABT-494 capsules; Oral administration of placebo capsules; Oral administration
Intervention MeSH terms: Upadacitinib; Tofacitinib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Rheumatoid Arthritis; Methotrexate; Tolerability; Pharmacokinetics; Safety; Tofacitinib
A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
Condition: Depressive Disorder, Treatment-Resistant
MeSH terms: Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of switching adult participants with
      treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they
      have not responded) to flexibly dosed intranasal esketamine (56 milligram [mg] or 84 mg) plus
      a newly initiated oral antidepressant compared with switching to a newly initiated oral
      antidepressant (active comparator) plus intranasal placebo, in improving depressive symptoms.
      Efficacy will be assessed by the change from baseline in the Montgomery Asberg Depression
      Rating Scale (MADRS) total score from Day 1 (before randomization) to the end of the 4-week
      double-blind treatment phase.
    


Intervention name(s): Esketamine 56 mg; Esketamine 84 mg; Placebo; Duloxetine (Oral Antidepressant); Escitalopram (Oral Antidepressant); Sertraline (Oral Antidepressant); Venlafaxine Extended Release (XR) (Oral Antidepressant)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will self-administer 56 mg of esketamine as intranasal spray.; Participants will self-administer 84 mg of esketamine as intranasal spray.; Participants will self-administer matching placebo as intranasal spray.; Duloxetine can be selected as the oral antidepressant medication based on investigator's discretion. The minimum therapeutic dose is 60 milligram per day (mg/day).; Escitalopram can be selected as the oral antidepressant medication based on investigator's discretion. Escitalopram will be started at a dose of 10 mg/day and up-titrated to a maximum dose of 20 mg/day.; Sertraline can be selected as the oral antidepressant medication based on investigator's discretion. Sertraline will be started at a dose of 50 mg/day and up-titrated to a maximum dose of 200 mg/day.; Venlafaxine XR can be selected as the oral antidepressant medication based on investigator's discretion. Venlafaxine XR will be started at a dose of 75 mg/day and up-titrated to a maximum dose of 225 mg/day.
Intervention MeSH terms: Duloxetine Hydrochloride; Venlafaxine Hydrochloride; Sertraline; Antidepressive Agents; Esketamine; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pterygomaxillary Disjunction With Interpositional Y-shape Plate in Patients With Temporomandibular Joint Derangement
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      Temporomandibular joint internal derangement (TMJ ID) is the most frequent type of
      temporomandibular disorder (TMDs)which is managed by different therapeutic modalities. it
      begins with conservative methods like medical treatment, physiotherapy, thermotherapy, and
      bites appliance therapy. Surgical intervention is a controversial issue in cases not
      responding to conservative methods. A novel minimally invasive surgical technique which is
      extracapsular trans oral (Pterygomaxillary disjunction) has been advocated as a minimally
      invasive extracapsular technique that preserves TMJ integrity.
    


Intervention name(s): Pterygomaxillary disjunction with interposition Y-shape plate
Intervention type(s): Procedure
Intervention description(s): All patients will be treated under general anesthesia. The pterygoid plate will be fractured, pried up, and pushed backward. A Y-shape plate will be fixed to the lateral maxillary surface with its vertical limb and the other two limbs are turned to fit into the retro maxillary space preventing the reattachment of the fractured pterygoid plate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Weightbearing Assessment of Tarsal Instability
Condition: Adult-acquired Flatfoot Disorder (AAFD)
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      The purpose of this study is to compare the average joint motion and joint axis orientation
      of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder (AAFD)
      and a control group of patients without foot deformity, using weight-bearing CT technology.
    


Intervention name(s): Weightbearing CT
Intervention type(s): Radiation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Adult-acquired flatfoot disorder (AAFD); flexible flatfoot; computed tomography (CT)
Anterior Bridging Cage With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
Condition: Stenosis; Fusion of Spine (Disease)
Study type: Interventional

Summary: 
      The purpose of this study is to evaluation for the pattern of bone bridging of patients who
      undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto
      local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not inferior
      to auto local bone only. In addition, the investigators will analyze anterior new bone
      bridging pattern between anterior bridging cage newly developed and grafted bone in anterior
      disc space.
    

Detailed description: 
      A single center, observational, single arm study to evaluate the efficacy of auto local bone
      mixed with β-calcium phosphate + hydroxyapatite using interbody fusion assessment on
      multi-axial CT scan. Its active comparator is auto local bone.

      Anterior bridging bone between anterior grafted bone and inserted cage will be assessed by
      using newly developed anterior bridging cage as well as interbody bone bridging between two
      vertebral bodies on multi-axial reconstructed CT scan.

      The patients undergoes arthrodesis surgery will have two cages, one augmented with auto local
      bone will be located at left side of disc space and the other cage augmented with auto local
      bone mixed with β-calcium phosphate + hydroxyapatite at right side of disc space.
    

Intervention name(s): transforaminal lumbar interbody arthrodesis
Intervention type(s): Procedure
Intervention description(s): Anterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in right side of disc space and anterior bridging cages augmented with auto bone in left side of disc space in transforaminal lumbar interbody arthrodesis.
Other intervention name(s): β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss); Auto-local bone
Intervention MeSH terms: Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bone bridging; Arthrodesis; Lumbar; Cage
Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Estimate the efficacy of cortisol replacement therapy during the first 12 days
      of life for prevention of bronchopulmonary dysplasia.

      II. Estimate the effect of cortisol replacement therapy on the signs of acute adrenal
      insufficiency.

      III. Evaluate the effects of cortisol replacement therapy on adrenal hormone concentrations
      and on the ability of the adrenal gland to respond to ACTH.

      IV. Determine the effect of this replacement therapy on markers of inflammation in lung
      lavage fluid and peripheral blood leukocytes.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study.
      Hydrocortisone therapy IV or placebo begins no later than 48 hours after birth and continues
      every 12 hours for 12 days. Hydrocortisone is given at 2-4 times the basal cortisol secretion
      rate.

      Tracheal lavage on intubated babies is performed at start of study and on day 4 of life to
      assess concentrations of inflammatory markers.

      If larger babies show appropriate response to ACTH by 15-17 days and the less mature babies
      show a decreased response, then a longer course of therapy is proposed for future studies.
    

Intervention name(s): hydrocortisone
Intervention type(s): Drug
Intervention MeSH terms: Hydrocortisone
Primary purpose: Prevention
Keywords: bronchopulmonary dysplasia; cardiovascular and respiratory diseases; neonatal disorders; rare disease
Cerebral and Renal Oxymetry and Anesthetic Techniques in Newborns
Condition: Cesarean Delivery Affecting Newborn
Study type: Interventional

Summary: 
      Neonatal adaptation to extrauterine life has many physiological changes in neonatal organ
      systems. These adaptative changes may be affected such as type of delivery and anesthesia
      management at birth. near infrared spectroscopy (NIRS) is a popular non-invasive method that
      can be used in newborns thus monitorize tissue oxygenation regularly. In this study we have
      purposed to compare the effects of general anesthesia versus spinal anesthesia on newborn's
      cerebral and renal oxygenation in elective cesarean operations
    

Detailed description: 
      The cases divided into two groups those spinal anesthesia group ( group:1; n:30 ) and general
      anesthesia group (group:2; n:30). The preoperative and intraoperative mean arterial pressures
      (MAP), heart rate (HR), arterial oxyhemoglobin saturation (SpO2), intraoperative blood loss
      values of pregnants and 1st-5th minute APGAR scores, preductal and postductal SpO2, perfusion
      index, heart rates, body temperature, cerebral and renal regional oxygen saturations of
      newborns after birth have been recorded.
    

Intervention name(s): Near infrared spectroscopy (spinal anesthesia); Near infrared spectroscopy (general anesthesia)
Intervention type(s): Device; Device
Intervention description(s): effect of spinal anesthesia on regional renal and cerebral oxygen saturation in newborns; effect of general anesthesia on regional renal and cerebral oxygen saturation in newborns
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cesarean; newborn; cerebral and renal oxygenation; anesthesia