bioihbjkbjnl/mcl2 huggingface dataset:
Prevention for the Development of Liver Tumorigenesis by the Oral Supplementation of Branched-chain Amino Acids
Condition: Liver Cancer
MeSH terms: Carcinogenesis; Cell Transformation, Neoplastic
Study type: Interventional

Summary: 
      The long-term outcomes of branched-chain amino acid (BCAA) administration in patients
      undergoing hepatic resection remain unclear. The aim of this study is to assess the impact of
      oral supplementation with BCAA on the prevention for the development of liver tumorigenesis
      in patients undergoing liver resection.
    

Detailed description: 
      This study might demonstrate a tendency of the improvement in the cumulative tumor recurrence
      rate after hepatectomy for liver neoplasm in the Livact group compared to that in the Control
      Group. The investigators believe that BCAA seems to be a remarkable benefit for liver
      resection, especially on its reduction in the recurrence of liver cancer. This treatment
      regimen has potential to offer benefits for clinical use selectively, especially for patients
      with chronic liver diseases.
    

Intervention name(s): LIVACT
Intervention type(s): Drug
Intervention description(s): LIVACT contains 13.0 g of free amino acids
Other intervention name(s): branched-chain amino acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Tongue Advancement for Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The objective of this study is to assess the feasibility, safety and effectiveness of tongue
      stabilization using Aspire Medical Advance™ System for the treatment of obstructive sleep
      apnea (OSA). Success is defined as a statistically significant reduction in AHI measured by
      polysomnography (PSG) from baseline to 6 months.
    

Detailed description: 
      Obstructive sleep apnea (OSA) is a major health problem in the United States and can result
      in excessive daytime sleepiness and cardiovascular problems. The primary treatment for OSA
      today is continuous positive airway pressure (CPAP). Many patients however are unable to
      tolerate sleeping with a CPAP machine. Surgery is one of the main treatment options available
      today to these CPAP-intolerant patients. However, current methods of sleep surgery are
      painful, morbid, and/or lack decent effectiveness.

      This trial will measure the effectiveness of the Advance System, an implantable medical
      device to treat OSA. In the trial, patients who meet the study entry criteria receive a
      baseline sleep study (PSG). The Advance System is then implanted and 6 months after
      implantation, another PSG is performed. The trial will compare the baseline and the 6 month
      apnea-hypopnea indices
    

Intervention name(s): Aspire Medical Advance System
Intervention type(s): Device
Intervention description(s): The treatment includes a device that is surgically implanted in the tongue and lower jaw. The purpose of the implant is to prevent obstruction of the upper airway thereby improving breathing during sleep.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive sleep apena; tongue; surgery
Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
Condition: Hepatitis C; HIV Infections
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether pegylated interferon therapy is effective
      to treat acute hepatitis C infection in HIV-coinfected individuals.
    

Detailed description: 
      Background:HIV-infected individuals are at higher risk of developing a chronic course of
      hepatitis C after infection. Moreover, chronic hepatitis C is less well treatable in
      HIV-Coinfected than in hepatitis C monoinfected patients. There is basic research and
      clinical data on hepatitis C mono-infection supporting high sustained response rates of
      hepatitis C when treatment is started in the acute phase of infection.

      Aim of the study: To determine whether pegylated interferon therapy is effective to treat
      acute hepatitis C infection in HIV-coinfected individuals.

      Methods: Prospective, open-label, historical controlled trial. Eligible subjects are treated
      over 24 weeks with a pegylated interferon at standard dose. Weight-adjusted ribavirin
      comedication is recommended for HCV-genotypes 1 and 4. Treatment will be withheld for 12
      weeks in order to allow spontaneous resolution in subjects with clinical symptomatic
      hepatitis C infection.
    

Intervention name(s): pegylated interferon
Intervention type(s): Drug
Intervention description(s): Pegylated interferon alfa-2a or -2b in standard dosage Ribavirin in case of genotype 1 or 4 at 1000 or 1200 mg/d according to body weight ist recommended.
Other intervention name(s): Pegasys; PegIntron; Copegus; Rebetol
Intervention MeSH terms: Interferons
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute hepatitis C; HIV; pegylated interferon
A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers
Condition: Healthy Volunteer
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug
      concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing
      under fed conditions.
    

Detailed description: 
      To establish bioequivalence between Form IV and Form XLI of AG-013736 tablets
    

Intervention name(s): AG-013736; AG-013736
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions); single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)
Intervention MeSH terms: Axitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence Pharmacokinetics
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and
      safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive
      leuprolide acetate administered subcutaneously once monthly during 3 months.
    


Intervention name(s): leuprolide acetate FluidCrystal® injection depot; leuprolide acetate
Intervention type(s): Drug; Drug
Other intervention name(s): CAM2032; Eligard
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate cancer; leuprolide
Surgical Treatment of Progressive Scoliosis With "NEMOST" Growing Rod
Condition: Progressive Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the performance of the device "NEMOST" on
      maintaining of the correction of the scoliosis with growth preservation and avoiding
      iterative surgeries.

      Objective of this study is to evaluate the performance of the growing device "NEMOST"
      associated to physiotherapy at 12 months postoperatively in patients treated for progressive
      scoliosis and to evaluate its safety.
    

Detailed description: 
      A number of scoliosis in the child remain progressive despite conservative treatment well
      conducted. Nowadays the most used treatment is early surgical treatment by the spinal
      instrumentation without graft called "growing rods". The use of growing rods in patients with
      progressive scoliosis requires several repeated surgeries (every 6 to 12 months) in order to
      follow the growth of children. These repeated surgeries lead to a significant increased risk
      of complications, that's why many teams around the world have been seeking solutions which
      allow to obtain a rod expansion without repeated surgery.

      The purpose of our study is the evaluation of the use of medical device that will perform the
      correction of scoliosis and, at the same time, preserve the growth of the child's spine. In
      addition, the purpose of clinical investigation is to test the theory that distraction effort
      may be exercised without surgery thanks to traction manoeuvres and physiotherapy. This could
      allow to obtain in patients with progressive scoliosis, correction of spinal deformity while
      avoiding many repeated surgeries. Our reference device is growing rod "NEMOST". When
      implanted, NEMOST rod is immediately turned on, for correcting and maintaining the correction
      of spinal deformity. After implantation, depending on development in Cobb angle, one or more
      elongations can be made by sliding the notched portion of the rod in its tunnel by a
      distraction effort (traction equipments and physiotherapy).

      Therefore, the growth device NEMOST will allow to continue, on request, the correction of
      spinal deformity by performing a distraction by external manoeuvres on the notched part
      without the need for surgery.
    

Intervention name(s): 2 NEMOST rods : bilateral vertebral-pelvic implantation; 1 NEMOST rod :unilateral vertebral-pelvic implantation
Intervention type(s): Device; Device
Intervention description(s): Implantation of two NEMOST rods (bilateral vertebral-pelvic implantation); Implantation of one NEMOST rod (unilateral vertebral-pelvic implantation)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: NEMOT device; pediatrics; surgery; progressive scoliosis
An Observational Study of Distress, Immune Function, and Pain in HIV.
Condition: Chronic Pain; HIV; Distress, Emotional; Immune System and Related Disorders; Central Sensitisation
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      This case-control study focuses on pain in HIV, which is common despite antiretroviral
      therapy and compromises quality of life, mental health and daily functioning. Specifically,
      it will investigate the relationships between psychosocial distress, inflammation and pain in
      HIV.
    

Detailed description: 
      We plan to recruit 100 people and follow them for 6 months, taking repeated measures.
      Participants who report persistent pain at enrolment will be assessed at 0 (baseline), 2, 4,
      and 6 months. Participants who report no pain at enrolment will be assessed at 0 (baseline)
      and 6 months. All participants will also be invited to participate in weekly remote
      assessment of selected self-reported outcomes.
    

Intervention name(s): Pain
Intervention type(s): Other
Intervention description(s): As above
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic in South Africa.
      
Keywords: Chronic pain; HIV; Innate Immune Response; Mental health; Hyperalgesia, secondary
Comparison of Medical Nutritional Supplements
Condition: Elderly
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to verify changes in protein metabolism after ingesting a oral
      medical nutritional supplement.
    


Intervention name(s): Oral medical nutritional supplement; Experimental oral medical nutritional supplement with AN777
Intervention type(s): Other; Other
Intervention description(s): orally over a three hour period; orally over a three hour period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder
Condition: Bipolar Disorder; Depression
MeSH terms: Depression; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of
      cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the
      depressive episode in participants with bipolar I disorder. The safety and tolerability of
      the fixed-dose regimens will be evaluated.
    


Intervention name(s): Cariprazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cariprazine capsule one per day orally.; Matching placebo capsule one per day orally.
Other intervention name(s): Vraylar
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Oocyte Cryopreservation Comparing Fresh and Vitrified Sibling Oocytes
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Vitrification is a method to cryopreserve biological specimens that are sensitive to chilling
      injury such as oocytes and embryos, and it has been employed with increased survival rate and
      live births (Hong et al., 1999; Kuleshova et al., 1999; Yoon et al., 2000; Chung et al 2000;
      Wu et al., 2001: Kuwayama et al 2006). In their study the researchers propose to directly
      compare oocyte survival, fertilizaton and embryo development between sibling oocytes.

      The Cryotop method of vitrification, which the researchers aim to investigate in their study,
      has been reported as the most efficient method for human oocytes cryopreservation (Kuwayama
      et al, 2005, Antinori et al, 2006, Lucena et al, 2006, Cobo et al, 2008). Follow up of over
      200 infants conceived from vitrified oocytes (Chian et al, 2008) indicate that the mean birth
      weight and the incidence of congenital anomalies are comparable to that of spontaneous
      conceptions in fertile women or infertile women undergoing IVF treatment.
    

Detailed description: 
      The necessity to cryopreserve human oocytes successfully, with the goal of achieving term
      pregnancies at rates equivalent to those obtained with fresh oocytes is urgent.
      Cryopreservation of oocytes is desirable because: 1) it would allow infertility patients to
      store excess oocytes instead of embryos, eliminating some of the ethical and religious
      concerns that accompany embryo storage; 2) permit storage of donor oocytes in egg banks,
      analogous to existing sperm banks. This option would allow the cryopreserved oocytes to be
      quarantined until screening for infectious diseases is completed, and would also avoid
      donor-recipient synchronization difficulties; and 3) can help cancer patients preserve their
      fertility before they face sterilization due to chemotherapy or radiation. Oocyte
      cryopreservation is therefore gaining in popularity as an option for infertility treatment as
      well as fertility preservation.

      This is a pilot study to evaluate the outcomes of oocyte vitrification using the Cryotop
      method in women undergoing IVF, by simultaneously evaluating embryos derived from vitrified
      and fresh oocytes coming from the same stimulated cycle.

      The primary outcome measures that will be tracked and tabulated are oocyte survival,
      fertilization and cleavage rate, and subsequent embryo development, compared between
      vitrified and fresh oocytes. Secondary outcomes are implantation, clinical pregnancy,
      miscarriage and live birth rates using embryos derived from the vitrified oocytes for
      transfer.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Center for Advanced Reproductive Services patient population
      
Biospecimen description: 
      Embryos
    
Keywords: Oocyte cryopreservation; vitrification
This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this trial is to investigate tolerability, safety, pharmacokinetics and
      antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks
      in Japanese treatment-naive patients with chronic GT-1 HCV infection.
    


Intervention name(s): BI 207127 NA; peginterferon; Ribavirin; Ribavirin; BI 207127 NA; BI 201335 NA; BI 201335 NA; peginterferon
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): one fix dose; per package insert; per weight BID; per weight BID; one fix dose; high dose; low dose; per package insert
Intervention MeSH terms: Ribavirin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexamethasone & Bupivacaine vs Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Perioperative Analgesia in Patients Undergoing Lower Limb Surgeries
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8
      hours. Increasing the duration of local anaesthetic action is often desirable because it
      prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong
      regional blockade. Vasoconstrictors can be used to constrict vessels, thereby reducing
      vascular absorption of the local anaesthetic. Additives like opioids, clonidine and verapamil
      were added to local anaesthetics, but the results are either inconclusive or associated with
      side effects. Steroids when used intrathecally are reported to cause arachnoiditis, but there
      is no evidence suggesting any neuritis when steroids are used in low concentration in
      peripheral nerve blocks.

      Steroids have powerful anti-inflammatory as well as analgesic properties. Perineural
      injection of steroids is reported to influence postoperative analgesia. They relieve pain by
      reducing inflammation, and blocking transmission of nociceptive C-fibres and by suppressing
      ectopic neural discharge. The addition of 5 mg of dexamethasone to 10 ml of 0.5%
      levobupivacaine in interscalene brachial plexus block showed improvement of postoperative
      analgesia for arthroscopic shoulder operation without any specific complications.

      The objective of this study is to compare the effects of combining of dexamethasone and
      bupivacaine versus bupivacaine alone in combined femoral and sciatic nerve block in patients
      undergoing lower limb vascular surgeries. The effects will be studied in terms of:

        -  Onset of sensory blockade and motor blockade

        -  Duration of analgesia / first request for analgesic

        -  Duration of motor blockade
    


Intervention name(s): Perineural Dexamethasone and bupivacaine; Systemic Dexamethasone plus perineural bupivacaine; intravenous saline plus perineural bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: regional anesthesia; dexamethasone; bupivacaine; femoral; sciatic
Phase I One-month Safety, PK, PD, and Acceptability Study of IVR Releasing TFV and LNG or TFV Alone
Condition: HIV; Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety of the TFV/LNG intravaginal ring (IVR),
      TFV-only IVR, and placebo IVR, evaluate pharmacokinetics (PK) of TFV and LNG, evaluate
      pharmacodynamic (PD) surrogates of contraceptive efficacy of LNG, and to evaluate
      acceptability of the IVRs.
    


Intervention name(s): TFV IVR; TFV/LNG IVR; Placebo IVR
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Tenofovir Intravaginal Ring; Tenofovir Levonorgestrel Intravaginal Ring; Placebo Intravaginal Ring
Intervention MeSH terms: Tenofovir; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; LNG; IVR; Contraception; Prevention
Insulin Modelling Based on Plasma Glucose Measures Via a Minimally-Invasive Glucose Sensor
Condition: PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The study aims to evaluate insulin as a potential biomarker for prediabetes in Singapore
      Chinese subjects.
    

Detailed description: 
      The prevalence of type 2 diabetes (T2DM) in Singapore is expected to increase from 400,000 to
      1,000,000 individuals by 2050, resulting in nearly US$2 billion in economic costs.
      Pre-diabetes is defined as an intermediate state of hyperglycemia where blood glucose levels
      are elevated but are below the diagnostic levels of diabetes. In Singapore, approximately 1
      in 7, or 430,000 residents are estimated to be pre-diabetic, and globally this number is
      estimated at 7.3% of adults (equivalent to 352.1 million individuals). Up to 70% of
      pre-diabetics eventually develop overt T2DM; however, pre-diabetes may be reversible with
      early detection, providing a window for opportune disease interception.

      While blood glucose is currently used to detect pre-diabetes, homeostatic mechanisms can
      maintain normal blood glucose levels and mask the detection of pre-diabetes until overt
      hyperglycemia is exhibited. In contrast, numerous studies have demonstrated that insulin
      levels increase markedly in pre-diabetes, even as marginal changes are observed in glucose
      levels. In this study, the investigator aims to determine if dynamic insulin levels observed
      during an oral glucose tolerance test are more sensitive than glucose alone in detecting
      prediabetes in a Singapore Chinese population.
    

Intervention name(s): Single dose of 75 grams glucose in 200ml water
Intervention type(s): Other
Intervention description(s): Consume single dose of 75 grams glucose in 200ml water
Intervention model: Single Group Assignment
Intervention model description: The study will be carried out as a single-arm, unblinded, intervention study. The total duration of the study is 4 hours and 30 minutes over one day, excluding screening and enrolment time (up to 1 hour).
Masking: None (Open Label)
Primary purpose: Basic Science