bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis; Motor Neuron Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This study will test the hypothesis that noninvasive ventilation (NIV) as prescribed in
      current medical practice for use in amyotrophic Lateral Sclerosis (ALS) patients fails to
      deliver adequate breathing support over a night of use in the patient's home. ALS patients
      who come to the ALS Center for their routine 3 month follow up exam and are currently using
      NIV will be asked to complete questionnaires regarding their quality of sleep, quality of
      life and general level of function, and to undergo a home sleep study, using a safe,
      comfortable and reliable breathing monitoring system during a night of sleep. If the
      questionnaires or the sleep study show failure of the breathing device, the investigators
      will work with the patient to fix the problem and then offer a second study to make sure that
      the changes were helpful. The results of this study may help to develop subsequent studies
      and to improve the guidelines used for care of ALS patients.
    

Detailed description: 
      Amyotrophic Lateral Sclerosis (ALS), also known as "Lou Gehrig's Disease", is a fatal
      disorder that causes breathing failure due to progressive weakness of the muscles of
      breathing. Breathing assist devices known as noninvasive ventilation (NIV) are offered to ALS
      patients when their breathing function worsens. These devices deliver breathing assistance
      via a mask on the nose or nose and mouth, and are thought to be particularly important to be
      used during sleep, when breathing often becomes more shallow and irregular. However, although
      these devices have become the standard of therapy in ALS patients once their lung function
      worsens, it remains unclear how effective these devices actually are when a patient is
      sleeping, partly because of the practical difficulties in applying the device properly and
      keeping it applied throughout the sleep period, and partly because they are most commonly
      prescribed without objective evidence regarding how much breathing support the patient needs
      as the disease progresses and the breathing muscles weaken further.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ALS who are using nocturnal noninvasive ventilation to treat respiratory
        insufficiency will be screened for eligibility as below.
      
Keywords: noninvasive ventilation
Macular Buckle With Three-armed Silicone
Condition: High Myopia; Posterior Staphyloma
MeSH terms: Myopia
Study type: Interventional

Summary: 
      High myopia is characterized by prolonged axial length and posterior staphyloma, which result
      in choroid-retinal degeneration and vision decrease. At present, vitrectomy can lead to
      anatomical improvements, but an higher axial length and the presence of a sever posterior
      staphyloma remains to be the two most important risk factors for poor visual outcomes. For
      these reasons, a different surgical approach, including macular buckling, might be considered
      in those patients with extremely high degree of myopia, in order to counteract the traction
      exerted by the posterior staphyloma. Macular buckling with or without pars plana vitrectomy
      had been proved to be an effective way to resolve myopic staphyloma related foveoschisis,
      macular hole, and associated retinal detachment. In this study, we sought to investigate the
      safety and efficacy of a macular buckling technique using a three-armed silicone capsule to
      support the posterior staphyloma in high myopia.
    

Detailed description: 
      1. This study plans to recruit 11 participants with 6 months follow-up to assess the safety
           and efficacy of a newly designed macular buckle device;

        2. The macular buckle device, surgical procedure, and participants registry had been
           reviewed and approved by Ethics committee of Zhongshan Ophthalmic Center;

        3. Only those patients are diagnosed with severe posterior staphyloma are registered.

        4. All participants are fully informed before register;

        5. All the surgeries are performed by single qualified doctor (Lin Lu);

        6. After operation, all participant could contact the researcher via telephone, and could
           be assessed for any surgical related complications. If there is severe complication
           happened, or any person that could not tolerant the macular buckle, the implanted device
           will be removed;

        7. Specially assigned staff (Jinge Lu) is responsible for data collection, data management,
           adverse events reporting, and participant communication.
    

Intervention name(s): macular buckle
Intervention type(s): Procedure
Intervention description(s): macular buckle with a three-armed silicone capsule
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: macular buckle; high myopia; posterior staphyloma
Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%
Condition: Corneal Edema; Intraocular Pressure
MeSH terms: Corneal Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective study was performed to compare two ophthalmic viscosurgical devices,
      DisCoVisc (hyaluronic acid 1.6% - chondroitin sulfate 4.0%) and hydroxypropylmethylcellulose
      2% in terms of their overall clinical performance during phacoemulsification.
    


Intervention name(s): Hyaluronic Acid and hydroxypropylmethylcellulose
Intervention type(s): Drug
Intervention description(s): Hyaluronic Acid 1.6% was used to performed phacoemulsification in one eye and hydroxypropylmethylcellulose 2% was used in the fellow eye.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phacoemulsification; Corneal Edema; Corneal Endothelium; Viscoelastic Substances
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)
Condition: Age Related Maculopathy
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the
      supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the
      optical density (OD) of macular pigment in patients with non- exudative age related
      maculopathy.

      Furthermore, it is to be examined whether changes of the optical density are different
      dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD
      patients are studied. The measurement of optical density of macular pigment uses the 1-
      wavelength reflection method recording reflection images at 460 nm by a fundus camera. The
      patients are investigated at baseline and are followed up over one year in four more visits.
      In addition to the OD- measurement each examination includes standardized visual acuity test
      (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and
      autofluorescence) and a blood sample.
    


Intervention name(s): Lutein/ Zeaxanthin + Omega-3-FA; Lutein/ Zeaxanthin + Omega-3-FA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year; 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year; 0 mg Lutein, Zeaxanthin, Omega-3-FA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Urinary 8-isoprostane is Elevated in Acute Childhood Asthma
Condition: Childhood Asthma; Oxidative Stress
MeSH terms: Asthma
Study type: Observational

Summary: 
      Oxidative stress is seen in children with asthma, but is hard to measure. The investigators
      exploring the utility of using a commercially available assay to measure oxidative stress in
      the urine in asthmatics. Additionally, the investigators will attempt to prove that oxidative
      stress is higher in children with acute asthma compared to those with stable asthma and that
      this stress is also higher in children with more severe clinical asthma exacerbations
      compared to less severe ones.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group 1:

        25 subjects will be recruited from among the children seen at the Stony Brook University
        Pediatric Pulmonary and Allergy Clinic.

        Group 2 25 subjects will be recruited from among the children admitted to Stony Brook
        University Hospital with a diagnosis of acute asthma exacerbation or reactive airway
        disease from Monday at 12 AM to Friday at 5 PM.
      
Biospecimen description: 
      urine
    
Keywords: Childhood Asthma; Oxidative stress; Urinary 8-isoprostane
Relation of Obesity With Frequency of Meals (MST 0557)
Condition: Obesity; Insulin Resistance; Fatty Liver
MeSH terms: Fatty Liver; Obesity; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to test the relationship between frequency of meals and hepatic
      fat content and insulin sensitivity. We, the researchers at Rockefeller University,
      hypothesize that low plasma insulin levels (as achieved by periods of fasting) will prevent
      insulin resistance and reduce hepatic lipid content. In contrast, frequent, carbohydrate-rich
      meals will predispose to hepatic steatosis (non-alcoholic) and insulin resistance.

      This is a 6 week inpatient study.
    

Detailed description: 
      The hypothesis will be tested by studying two groups of normal subjects who will receive a
      defined weight maintenance diet: one group will be given meals twice a day and other group
      will be given eight meals (snacks) per day. At the beginning of the study period and after 4
      weeks following the specified frequency of meals, the study subjects will have their whole
      body insulin sensitivity and hepatic fat content measured by the euglycemic-hyperinsulinemic
      clamp and MRI of the liver, respectively.
    

Intervention name(s): high frequency of meals; twice a day meals
Intervention type(s): Other; Other
Intervention description(s): high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.; high carbohydrate diet i.e. 65% carbohydrate, 15% protein, 20% fat for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Non-Alcoholic hepatic steatosis
Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)
Condition: Hygiene
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate the safety of the gynecological formulation in
      normal and usual usage condition of Dermacyd Femina Delicata.
    


Intervention name(s): Lactoserum
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature
Condition: Urologic Diseases
MeSH terms: Urologic Diseases
Study type: Interventional

Summary: 
      Hypothermia occurs frequently during general anesthesia. This study is to evaluate the
      efficacy of 10 minutes of prewarming and warmed fluid during urologic surgery.
    

Detailed description: 
      During general anesthesia, vasodilation distributes body heat and leads to hypothermia.
      Especially during urologic operation (transurethral resection of bladder and prostate),
      bladder irrigation worsens hypothermia. Hence, various methods are used to maintain core
      temperature during operation.

      Previous studies have demonstrated that prewarming of the patient is effective in maintaining
      core temperature perioperatively. However, more than 50% of patients who have applied
      prewarming for more than 30 minutes preoperatively are reported to fall in hypothermia.
      Hence, developing simple and effective method to prevent hypothermia is expected.

      Hence, the investigators planned to examine the effect of active warming (10 minutes of
      prewarming preoperatively and prewarmed intravenous fluid intraoperatively) on hypothermia in
      patients undergoing urologic operation under general anesthesia.
    

Intervention name(s): prewarming and warmed fluid infusion
Intervention type(s): Other
Intervention description(s): prewarming with forced air warming system and warmed fluid infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: hypothermia
Insulin Sensitivity Response to High-Intensity Training in Insulin Resistance During Pregnancy
Condition: High Intensity Interval Training; Diet, Healthy
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Insulin Resistance is one of the common complications that occur during pregnancy. Early
      intervention is essential to prevent the development of the diseaseThere is evidence that
      physical inactivity increases the risk of a lot of adverse health problems, including
      coronary heart disease, type 2 diabetes, breast and colon cancers. It also shortens life
      expectancy. Pregnancy is a period in the life of women that is often associated with
      decreased daily physical activity and decreased participation in sports and exercise . In the
      first few weeks of pregnancy, maternal carbohydrate metabolism is affected by a rise in
      maternal levels of estrogen and progesterone that stimulates pancreatic β-cell hyperplasia
      and insulin secretion. As pregnancy progress, pancreatic islet cell hypertrophy continues and
      there is an increased insulin response to glucose or meal stimulation.
    

Detailed description: 
      This study was carried out upon twenty multigravida pregnant female between 5-6 months
      gestation with IR calculated by HOMA test (fasting blood glucose× fasting insulin) ÷ 22.5.
      Fasting blood glucose was assessed by the method approved by (7, 13) .The test materials for
      this method were supplied as kits by "Diamond Diagnostics," while Insulin concentrations were
      stated in formerly frozen and defrosted serum samples by enzyme immunoassay using the human
      Insulin ELISA kits.
    

Intervention name(s): moderate restricted diet (1800-2000 kcal/day) for four weeks
Intervention type(s): Dietary Supplement
Intervention description(s): high intensity interval training 3 sessions for four weeks
Other intervention name(s): high intensity interval training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: group (A) received HIIT and low diet for four weeks, 3 sessions weekly. While the control group received diet only.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Training; Insulin Resistance; Pregnancy
Metformin in Pregnant PCOS Women
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

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 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study; Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
Other intervention name(s): metformin from Weifa 500 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: PCOS; metformin; pregnancy; preeclampsia; diabetes; preterm delivery
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
Condition: Chronic Kidney Disease (CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The primary objective of this clinical study is to evaluate the preliminary safety and
      effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF)
      including coiling of the brachial vein during the index procedure in patients requiring
      chronic hemodialysis.
    


Intervention name(s): Endovasccular AVF (EndoAVF)
Intervention type(s): Device
Intervention description(s): The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access
Other intervention name(s): FLEX
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic kidney disease; Arteriovenous fistula; Hemodialysis; Vascular access
Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the absorption of apixaban (BMS-562247) into the
      bloodstream of healthy volunteers, when administered as sprinkle capsules compared to
      tablets. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and
      will receive a single oral dose of apixaban twice during the course of the study.
    


Intervention name(s): Drug: Apixaban sprinkle capsules; Experimental: Apixaban tablets followed by apixaban sprinkle capsules
Intervention type(s): Drug; Drug
Intervention description(s): Single dose (25 x 0.1 mg capsules), oral administration; Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration
Other intervention name(s): •BMS-562247; •Eliquis; •BMS-562247
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Sodium Bicarbonate on Time-to-exhaustion at Critical Power in Endurance Athletes
Condition: Performance
Study type: Interventional

Summary: 
      During endurance exercise in the heavy and severe intensity domains, the rate at which
      metabolites that have been associated with the fatigue process (e.g. Pi, ADP, H, and
      extracellular K) accumulate increases. possibly leading to exercise cessation. Sodium
      bicarbonate, as a nutritional supplement, has gained attention over the past decades, because
      it might delay of offset fatigue. To date, there is a controversial discussion about which
      delivery mode (amount and frequency) might be best in optimizing endurance performance. Since
      the high ion load consequent to multiple ingestions might increase plasma volume, and
      consequently decrease bicarbonate concentrations, single acute ingestion could be more
      beneficial. However, in multi-day competitions or tournaments it might be necessary to use
      the supplement on a daily basis. Here, the investigators aim at investigating the effects of
      single dose or multiple dose (on five consecutive days) administration of bicarbonate vs.
      placebo increases endurance performance and acid-base homeostasis in trained male endurance
      athletes.
    


Intervention name(s): Sodium bicarbonate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ergogenic effect; Placebo effect
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Prediction of Early Recovery of Liver Function After LDLT in Children: An Ambispective Cohort Study
Condition: Liver and Biliary Tract Disorders in Duration of Pregnancy; Other End-stage Liver Diseases in Children
MeSH terms: Liver Diseases; End Stage Liver Disease; Biliary Tract Diseases
Study type: Observational [Patient Registry]

Summary: 
      The investigators included children with living donor liver transplantation (LDLT) from
      January 1, 2018 to July 31, 2022 as a retrospective cohort, and the group from August 1, 2022
      to June 30, 2023 as a prospective cohort. The investigators collected the demographic and
      clinicopathological data of donors and recipients, and determined the risk factors of early
      postoperative delayed recovery of hepatic function (DRHF) by univariate and multivariate
      Logical regression analyses.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The investigators included children who underwent LDLT in this center from January 1, 2018
        to June 30, 2023.
Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers
Condition: Healthy Adult Subjects; Healthy Elderly Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult
      and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK)
      and pharmacodynamics (PD) of BIIB118
    

Detailed description: 
      This study was previously posted by Pfizer. In March, 2020, sponsorship of the trial was
      transferred to Biogen.
    

Intervention name(s): BIIB118; Melatonin
Intervention type(s): Drug; Drug
Intervention description(s): Multiple ascending doses of BIIB118 (50 mg, 150 mg, 450 mg and 900 mg) as extemporaneously prepared solution/suspension administered once daily over 2 weeks; Positive control used to assess the validity of DLMO as pharmacodynamic endpoint.
Other intervention name(s): PF-05251749
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Multiple Ascending Dose Study; Safety and Tolerability; Pharmacokinetics; Pharmacodynamics; Melatonin; Plasma; Dim Light Melatonin Onset