bioihbjkbjnl/mcl2 huggingface dataset:
Serum Calcium to Phosphorous Ratio (Ca/P) as a Simple, Inexpensive Screening Tool in the Diagnosis of Primary Hyperparathyroidism
Condition: Hyperparathyroidism
MeSH terms: Hyperparathyroidism
Study type: Observational

Summary: 
      Background:

      Primary hyperparathyroidism (PHPT) is often overlooked and underdiagnosed. At present the
      diagnosis of PHPT remains challenging and is based on serum calcium (Ca) and PTH.

      As serum Ca and phosphorous (P) are inversely related in PHPT, the Ca/P ratio might be
      considered a good candidate tool in the diagnosis of PHPT.

      AIM: The aim of this study is to investigate the diagnostic value of the Ca/P ratio in the
      diagnosis of PHPT.

      Study design: Retrospective, observational, cross-sectional, case-control clinical trial will
      be carried out.

      Biochemical measurements will include PTH, Vitamin D, serum Ca, P, albumin, and creatinine.
    


Intervention name(s): No intervention are provided
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with diagnosis of primary hyperparathyroidism
Combined Treatment of Nightmares With Targeted Memory Reactivation and Imagery Rehearsal Therapy
Condition: Nightmares, REM-Sleep Type
Study type: Interventional

Summary: 
      With this protocol, investigators examine whether targeted memory reactivation (TMR), a
      technique used to strengthen memories, can accelerate remission of nightmare disorder. This
      protocol uses TMR during REM sleep to strengthen positive memories generated by Imagery
      Rehearsal Therapy (IRT), a recommended treatment of nightmares. Patients with nightmare
      disorder are asked to perform an initial IRT session and, while they generate a positive
      outcome of their recurrent nightmare, half of the patients are exposed to a sound (TMR
      group), while no such pairing with a sound takes place for the other half (control group).
      During the next two weeks, all patients perform IRT every evening at home and are exposed to
      the sound during REM sleep with a wireless headband, which automatically detects sleep
      stages. Clinical evaluation of the severity of nightmares before and after (2-weeks follow-up
      and 3-months follow-up) this intervention takes place using the validated Nightmare Frequency
      Questionnaire (NFQ, primary outcome measure), which retrospectively identifies the frequency
      of nightmares. We hypothesize that patients treated with IRT and who are exposed, during REM
      sleep and over 14 nights, to a sound that had previously been associated with the new
      positive dream scenario of IRT (TMR group), will have more reduced frequency of nightmares
      compared to participants with stimulation of the same, but non-associated, sound during REM
      sleep (control group).
    


Intervention name(s): Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep; Imagery Rehearsal Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Emerging evidence shows that REM sleep plays a causal role in extinction learning, emotion regulation and consolidation of emotionally positive memories. By using targeted memory reactivation (TMR), a known method where we associate a sound with a waking experience (i.e., a positive outcome of imagery rehearsal therapy in this study) and strengthening it during REM sleep, we want to accelerate the remission of nightmares.; These patients will receive the classic treatment of Imagery Rehearsal Therapy (IRT) for nightmares without any association with a sound.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Efficacy of KOVIR in the Combination Regimen With Background Treatment in COVID-19 Patients (KOVIR)
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The acute pneumonia pandemic caused by a new strain of corona virus 2019 named as COVID-19 by
      the World Health Organization (WHO) is a pandemic caused by SARS-CoV-2 virus. The reported
      symptoms vary from fever or chills, cough, shortness of breath, to muscle aches, headaches,
      loss of taste or smell.

      The hard capsule KOVIR is a product based on the traditional medicine named "Nhân sâm bài độc
      táng" which is used to treat the cold conditions, also known as the initial plague according
      to the theory of traditional medicine.
    

Detailed description: 
      The acute pneumonia pandemic caused by a new strain of corona virus 2019 named as COVID-19 by
      the World Health Organization (WHO) is a pandemic caused by SARS-CoV-2 virus. The reported
      symptoms have included, but are not limited to fever or chills, cough, shortness of breath,
      muscle aches, headaches, loss of taste or smell, diarrhea, dizziness, sore throat, abdominal
      pain, anorexia, and vomiting.

      The hard capsule KOVIR is a product based on the traditional prescription named "Nhân sâm bài
      độc táng" which is used to treat the cold conditions, also known as the initial plague
      according to the theory of traditional medicine.

      The study timeline is expected about 7 months, including enrolment period, 14 days of
      treatment, data entry and analysis.

      The study compares between standard dose regimen of KOVIR combined with background treatment
      in COVID-19 patients and placebo combined with background treatment in COVID-19 patients.

      All participants will be treated and followed up in 14-day period. In case the participant
      meets the discharge criteria before 14 days, discontinuing the study drug will be done at the
      discretion of the investigators.

      Screening procedures occur at Day 1. Periodic assessments are conducted daily from Day 2-14.
      Finally, End of study visit is conducted.
    

Intervention name(s): KOVIR oral capsule; Placebo oral capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg; Placebo
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Impact on the Quality of Life and Persistent Symptoms of Patients Away From Diagnosed and Treated Neuroborreliosis
Condition: Neuroborreliosis, Lyme; Quality of Life
MeSH terms: Lyme Neuroborreliosis
Study type: Observational

Summary: 
      The link between Lyme neuroborreliosis (NBL) and persistent symptoms is debated in the
      medical world. Some report a frequency of post NBL symptoms similar to the general
      population, and others define a specific entity, the PTLDS (Post Treatment Lyme Disease
      Symptoms).

      In France, few studies have evaluated the persistent symptoms and the impact on the quality
      of life of patients after treatment for NBL.
    


Intervention name(s): Non intervention
Intervention type(s): Other
Intervention description(s): Non intervention
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A online questionnaire is completed by the patient concerning socio-demographic date,
        patient history, quality of life scale, persistent neurological symptoms
Extension at 10 Years of the: "Observational Study Evaluating Efficacy and Costs of Secondary Prophylaxis vs On-demand Therapy With Kogenate Bayer in Patients With Severe Haemophilia A."
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      Following the performance of the POTTER observational study, whose primary objective was to
      collect data on the benefits of secondary prophylaxis versus on demand treatment in terms of
      prevention of bleeding episodes, the present study aims to extend the observation time up to
      10 years, of the same population involved in the previous study.

      The present study has been designed to allow a focus on long term disease-related damage at
      joint level in subjects with severe haemophilia A, as well as on the pharmacoeconomics impact
      of the two different treatment regimens.
    


Intervention name(s): Recombinant Factor VIII (Kogenate FS, BAY14-2222); Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Intervention type(s): Drug; Drug
Intervention description(s): Administered 20-30 IU/kg 3 times a week; Administered only for bleeding episodes
Intervention MeSH terms: Factor VIII
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of approximately 50 patients with a diagnosis of severe haemophilia A (FVIII < 1%)
        , who are already on Kogenate Bayer treatment ongoing for long-term secondary prophylaxis
        or on-demand therapy and have properly completed the follow-up in the original Potter study
        are expected to be enrolled.
      
Keywords: Hemophilia A, Congenital
BAY94-9027 PK Study Comparing to Another Long Acting Product
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after
      intravenous administration.
    


Intervention name(s): Damoctocog (Jivi, BAY94-9027); Elocta
Intervention type(s): Drug; Drug
Intervention description(s): 60 international units (IU)/kg, given as a 10 minute injection, 1 dose; 60 IU/kg, given as a 10 minute injection, 1 dose
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject will receive the two treatments. Pharmacokinetic samples will be collected from pre-dose until 120 hours after the end of the injection of the single dose in each treatment arm.
Masking: None (Open Label)
Primary purpose: Basic Science
Acute Effects of Beet Juice Intake on the Vascular Function of Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      To assess the acute effects of only one dose of beet juice on hypertensive subjects treated
      with vascular endothelial function parameters, using the microvascular reactivity method.
    

Detailed description: 
      Systemic arterial hypertension is an established risk factor for cardiovascular disease
      (CVD). Among the main modifiable environmental factors of hypertension, the investigators
      highlight inadequate eating habits, such as low vegetable consumption. Clinical studies have
      shown that inorganic nitrate from beet juice intake has a protective effect against CVD due
      to reduced blood pressure, inhibition of platelet aggregation and prevention of endothelial
      dysfunction. However, there is still no consensus on its benefits of inorganic nitrate in
      vascular health. Associated with this, there are no previous studies in the literature that
      correlate the acute effects of inorganic nitrate intake on endothelial function assessed by
      microvascular reactivity through laser. The objective of the present study is to evaluate the
      acute effects (single dose) of inorganic nitrate, through the ingestion of beet juice, in the
      vascular parameters and endothelial function of treated hypertensive patients of both sexes.
    

Intervention name(s): Beetroot juice
Intervention type(s): Dietary Supplement
Intervention description(s): Thirty-seven hypertension, with age 40-70 years were randomized to receive a 500ml volume of beetroot juice contains 11.5 mmol of inorganic nitrate or mineral water in a single moment.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, crossover, placebo-controlled
Masking: None (Open Label)
Primary purpose: Supportive Care
CO2 Versus Air Insufflation for Single-balloon Enteroscopy
Condition: Intubation Depth
Study type: Interventional
Phase: Phase 4

Summary: 
      Small-balloon enteroscopy is a novel endoscopy system for examination of the deep small
      intestine.Initial reports indicated that CO2 was effective during the colonoscopy
      ,ERCP(endoscopic retrograde cholangiopancreatography) and DBE(double-balloon enteroscopy)
      examination, but it is still uncertain to the SBE(single-balloon enteroscopy) procedure.
    

Detailed description: 
      Currently, air is more frequently used to insufflate gas into the lumen to ensure the
      visualization of the mucosa. However, there're some limitations, for instance, significant
      amounts of air are usually retained in the small bowel, which will lead to the distention and
      the pain of the gastrointestinal tract during and after the procedure.

      Carbon dioxide(CO2), comparing to the air, is rapidly absorbed from the intestine, which
      allows the bowel to decompress more quickly and potentially decreases intraprocedural and
      postprocedural pain, sedation medication requirements, procedure time, and recovery time. It
      is also to the benefit of deeper intubation depth so that higher total enteroscopy rate and
      diagnostic rate will be achieved.

      Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP and DBE
      examination, but it is still uncertain to the SBE procedure
    

Intervention name(s): CO2 insufflation regulator; Air insufflation
Intervention type(s): Device; Device
Intervention description(s): The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.; The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Single-Balloon Enteroscopy
Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to investigate the 5cm^2 and 10cm^2 doses of rivastigmine
      transdermal patch in terms of efficacy and safety in patients with probable Alzheimer's
      Disease (MMSE [Mini Mental State Examination] 10-20). A 52-week extension phase evaluated the
      safety and tolerability of long-term treatment by rivastigmine transdermal patch in patients
      with probable Alzheimer's Disease (AD).
    

Detailed description: 
      Patients were randomly assigned in a double-blind manner to one of the 3 treatment arms
      (placebo, rivastigmine 5 cm^2 and rivastigmine 10 cm^2) in a ratio of 1:1:1. During the
      Double-blind treatment phase, patients entered a 16-week Titration Period followed by an
      8-week Maintenance Period. During the open-label extension phase, all patients started
      treatment with a 2.5 cm^2 patch and the dose was increased to 10 cm^2 over a 16-week
      titration period, followed by a maintenance period of 36 weeks.
    

Intervention name(s): Rivastigmine transdermal patch; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rivastigmine transdermal patch was provided in the following sizes and doses:
2.5 cm^2 (4.5 mg), 5 cm^2 (9 mg), 7.5 cm^2 (13.5 mg), and 10 cm^2 (18 mg). The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day.; Placebo transdermal patch was provided in the following sizes: 2.5 cm^2, 5 cm^2, 7.5 cm^2 and 10 cm^2. The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day.
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: rivastigmine，Alzheimer's Disease, transdermal patch
A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects
Condition: Erythema; Edema
MeSH terms: Erythema
Study type: Interventional

Summary: 
      To evaluate the safety of a personal lubricant when used at least four times weekly for two
      weeks (including at least twice weekly during sexual intercourse for subjects with monogamous
      male partners), in a population consisting of healthy females.
    


Intervention name(s): Trojan "Simply Pleasure" Personal Lubricant
Intervention type(s): Device
Intervention description(s): silicone base without sensate
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
The Effect of a High Protein, High Fiber Dietary Supplement on Weight and Fat Loss
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effect of a high protein, high fiber
      dietary supplement on weight and fat loss in healthy overweight adults. Half of participants
      will receive a high protein, high fiber supplement twice a day for 12 weeks, and half of the
      subjects will receive a placebo (that contains the same amount of calories as the supplement)
      twice a day for 12 weeks.
    


Intervention name(s): High protein, high fiber dietary supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dry powder to be mixed with 10 ounces of cold water; Dry powder to be mixed with 10 ounces of cold water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: protein; fiber; weight loss; fat loss
Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers
Condition: Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      A two (2) part study to evaluate the safety, tolerability and PK of ADX-914
    

Detailed description: 
      Part 1 - SAD:

      It is expected that there will be up to 6 cohorts of 8 participants per cohort. In each
      cohort, participants will be randomly assigned in a 3:1 ratio to receive either ADX-914 or
      matching placebo.

      It is planned that for each cohort in Part 1 a staggered 'sentinel' dose design will be used.

      Part 2 - MAD It is expected that there will be up to 3 cohorts of 8 participants per cohort.
      In each cohort, participants will be randomly assigned in a 3:1 ratio to receive either
      ADX-914 or matching placebo. Doses will occur every 2 weeks, for a total of 4 doses.
    

Intervention name(s): ADX-914; Placebo; ADX-914; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose from 0.1mg/kg to TBD; Matching single dose placebo; Multiple dose from TBD to TBD; Matching multiple dose placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      A large body of evidence confirm the cholesterol lowering effect of red yeast rice,
      phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical
      statins and cholesterol absorption inhibitors, it is plausible that their association will
      provide a more relevant (and safe) LDL cholesterolemia reduction.
    

Detailed description: 
      European Food Safety Authority approves some health claim related to the cardiometabolic
      effects of some nutraceuticals, and in particular of red yeast rice, phytosterols and
      L-tyrosol.

      In a previous study the investigators have already demonstrated the synergistic effect of red
      yeast rice and phytosterols in term of lipid-lowering activity.

      Preliminary data suggest that these nutraceuticals could also exert a positive effect on
      vascular health beyond the direct effects on serum lipids.

      No data are available on the combined effects of these dietary supplement in humans.
    

Intervention name(s): Combined nutraceutical; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Plant sterols 800 mg + Red Yeast Rice containing 5 mg monacolin K + L-Tyrosol 50 mg per daily dose Oral administration: 1 tablet per day; Oral administration: 1 tablet per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Red yeast rice; Phytosterols; L-Tyrosol; Lipids; LDL-cholesterol; Endothelial function
Salvage Living Donor Liver Transplantation for HCC Beyond All Criteria Yield Equivalent Results to Milan Criteria
Condition: Hcc
Study type: Observational

Summary: 
      The present study aims to evaluate the impact of expanding criteria beyond Milan on tumor
      recurrence and patient survival that will help identify the best selection criteria for HCC
      transplanted patients.
    

Detailed description: 
      Introduction:

      HEPATOCELLULAR CARCINOMA (HCC) is the second leading cause of cancer mortality worldwide.
      Living donor liver transplantation (LDLT) for HCC patients has emerged as a rewarding therapy
      for a cure and a successful alternative where a Deceased donor liver transplantation (DDLT)
      program is lacking. Therefore, trials for careful expansion to Milan criteria have been
      adopted.

      Aim of the study:

      To evaluate the impact of expanding criteria beyond Milan on tumor recurrence and patient
      survival that will help identify the best selection criteria for HCC transplanted patients
    

Intervention name(s): living donor liver transplantation
Intervention type(s): Procedure
Intervention description(s): liver graft from a living donor
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients were divided according to the pre-transplant radiological findings of HCC nodules
        number and sizes into 3 groups:

        Group I: comprised 175 patients who fall within the Milan criteria. Group II: included 36
        patients who fall within up-to-7 criteria (the sum of the number of the tumors and diameter
        of the largest tumor not exceeding 7cm) Group III: included 30 patients beyond up-to-7
        criteria and will be termed beyond all criteria (BAC).
      
Keywords: liver transplant; HCC; Extended milan; Living donor liver transplantation