bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic Galactosemia
Condition: Classic Galactosemia
MeSH terms: Galactosemias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a first-in-human, randomized, placebo-controlled, 4-Part, single ascending dose
      (SAD) and multiple ascending dose (MAD) study in healthy adult subjects and adult subjects
      with Classic Galactosemia.
    

Detailed description: 
      The study is designed to assess the safety and PK of AT-007 in healthy subjects and subjects
      with Classic Galactosemia as well as the effect of AT-007 on biomarkers of galactose
      metabolism (galactose, galactitol, and other galactose metabolites) in subjects with Classic
      Galactosemia.

      This study consists of 4 parts:

        -  Part A (SAD) in 32 healthy subjects. Once daily oral escalating dose (6 active, 2
           placebo).

        -  Part B and C (MAD for 7 days) in 36 healthy subjects. Once daily multiple daily dosing
           (8 active, 2 placebo per each dose cohort).

        -  Part D (SAD followed by MAD for 27 days) in 18 subjects with Classic Galactosemia. Once
           daily followed by multiple daily oral dosing (6 active, 2 placebo for each dose cohort).
    

Intervention name(s): AT-007; placebo
Intervention type(s): Drug; Drug
Intervention description(s): AT-007 will be administered once daily before breakfast. Up to 4 different dose cohorts in part A; up to 4 dose cohorts in part B, up to 2 dose cohorts for part C, and up to 3 dose cohorts for part D will be enrolled in the study. The starting dose in Part A will be 0.5 mg/kg as a single dose. Subsequent doses in Part A and all doses in Parts B, C, and D will be based on the results of previous cohorts and/or previous parts of the study. Part B will start after all subjects in Part A have completed the study. Cohort C1 will be conducted simultaneously with Cohort B3 and using the same dose as Cohort B2. The dose for Cohort D1 will not be higher than the dose for Cohort B2. The second and third cohorts in Part D (D2 and D3) will not start until after all subjects in Cohorts B3 and B4, respectively, have completed the study and the dose levels will not be higher than those for Cohorts B3 and B4, respectively.; Matching placebo will be administered once in the morning before breakfast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Classic Galactosemia; Aldose Reductase Inhibition; Galactose, Galactitol
Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography
Condition: Supraglottic Airway Efficiency; Airway Complication of Anesthesia; Airway Aspiration; Complication of Anesthesia; Esophagus Injury; Endoscopic Ergonomics; ERCP Airway Management; Bleeding Nose; Bronchospasm
MeSH terms: Bronchial Spasm
Study type: Interventional

Summary: 
      The most common adverse event in endoscopic procedures is hypoxia. Different airway devices
      have been investigated in the literature to prevent hypoxia. This study aimed to compare the
      efficacy and procedural performance of two different airway (GLT and WNJ) devices in ERCP
      procedures.
    

Detailed description: 
      ERCP is a procedure that requires intolerable positioning, prolonged air insufflation, and
      deep levels of anesthesia. The procedure can be performed under general anesthesia or with
      deep sedation. It becomes more difficult to maintain airway patency in the prone position
      under deep sedation. Clinicians prefer supraglottic airway devices developed for endoscopic
      procedures. GLT requires a deeper level of anesthesia. WNJ, on the other hand, can be
      tolerated with less depth levels of anesthesia. It has been reported in the literature that
      GLT and WNJ are effective in maintaining patent airway and preventing hypoxia in ERCP
      procedures. However, both airway devices have not been compared for airway efficiency and
      ERCP procedure condition.

      In this study, the investigators aimed to compare airway efficiency and procedure condition
      using GLT and WNJ.
    

Intervention name(s): Wei Nasal Jet Tube; Gastro Laryngeal Tube
Intervention type(s): Device; Device
Intervention description(s): comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures
airway devices which can use for gastrointestinal procedures; comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures
Other intervention name(s): Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.; Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Wei Nasal Jet Tube; Gastro-laryngeal tube; ERCP; Airway Complication; Hipoxia
Low Carb Diets & Exercise for Cardiovascular Disease (CVD) Reduction
Condition: Obesity
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purposes of this study are:

      To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of
      heart health including blood fats, blood clotting factors, inflammatory markers and levels of
      body fat.

      To investigate the added effect on heart health that regular moderate exercise may have when
      combined with a low carbohydrate diet in obese men.
    


Intervention name(s): low carbohydrate diet; low carbohydrate diet and exercise
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low carbohydrate diet; obesity; moderate exercise; men
Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess the safety and tolerability of AMG 609 when administered
      subcutaneously as single doses in participants with non-alcoholic fatty liver disease
      (NAFLD).
    


Intervention name(s): AMG 609; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of AMG 609 administered as a subcutaneous injection.; Single dose of placebo administered as a subcutaneous injection.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Single ascending dose; NAFLD; AMG 609
A Prospective Randomized Trial Comparing Partial Hepatectomy and TACE Plus PEI for Small Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      Presently,the diagnostic method of small hepatocellular carcinoma has been greatly elevated
      in China.The treatment is being from simplification to diversification,from entirety to
      individualization.Confronting small hepatocellular carcinoma,we not select simple operation
      treatment but select a treatment that have more predominance and more fitting with patients
      in various kinds of treatment methods;including operation ,TACE,PEI,et al.which is better ?
      There are many arguments.
    

Detailed description: 
      randomly put in group standard:

        1. via clinical diagnosis and confirm it is primary liver cancer, and not accept any
           anticancer treatment.

        2. age: 18-70 years.

        3. early hepatocyte cancer，which is single focus of infection diameter ≤ 3 cm.

        4. estimate tumor can gain treatment of curing operation or TACE plus PEI.

        5. better liver function (Child-Pugh，class A or B).

      Case loads: 160 residents with small hepatocellular carcinoma in China

      Therapeutic regimen: under normal rules, the operation group open abdomen to perform
      operation through subtotal incision while the patient has been general anesthesia with
      trachea cannula. The operation range on hepatic tissue of un-tumor tissue around tumor should
      maintain at least 1cm. As for the micro-create treatment combination group, taking TACE all
      through arteria cruralies super-elect arteria hepatica and injecting MITO、FUDR、iodipin. By B
      transonogram guiding to nyxis liver biopsy,and perform per cutem absolute alcohol injection
      treatment.

      Research end-point:

        1. ensemble life span.To compare 1、2 and 3 year overall survival rate in hepatectomy and
           TACE plus PEI for small hepatocellular carcinoma

        2. intraliver recurrence rate; distant metastasis rate; non-tumor life span; band tumor
           life span

      Telephone call at any time
    

Intervention name(s): operation;TACE plus PEI
Intervention type(s): Other
Intervention description(s): Under normal rules, the operation group open abdomen to perform operation through subtotal incision while the patient has been general anesthesia with trachea cannula. The operation range on hepatic tissue of un-tumor tissue around tumor should maintain at least 1cm. As for the micro-create treatment combination group, taking TACE all through arteria cruralies super-elect arteria hepatica and injecting MITO、FUDR、iodipin. By B transonogram guiding to nyxis liver biopsy,and perform per cutem absolute alcohol injection treatment.
Other intervention name(s): surgical resection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: small hepatocellular carcinoma; partial hepatectomy; TACE plus PEI
A Long Term Follow-up Study of Patients From the REP 301 Protocol
Condition: Hepatitis B, Chronic; Hepatitis D, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis D; Hepatitis D, Chronic; Hepatitis
Study type: Observational

Summary: 
      The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B /
      hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In
      this protocol, similar reduction/clearance of serum HBsAg and improved response to
      immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol
      was designed to include a 24 week follow-up period after treatment, however given the strong
      antiviral response against HBV and HDV infection in these patients, it is now important to
      extend the follow-up period in these patients to monitor over a longer period after treatment
      the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in the REP 301
      protocol.
    

Detailed description: 
      The REP 301-LTF is a long-term follow-up, non-blinded study of patients from the REP 301
      protocol. In this study, all eligible patients from the REP 301 protocol will have their
      followup evaluation extended for an additional 3 years, consisting of 6 visits scheduled
      every 6 months following the last follow-up visit scheduled in the REP 301 protocol. During
      each visit a physical examination and documentation of any symptoms, experiences will be
      conducted as well as blood tests for safety and virology as described below. This study will
      examine the long term safety effects in patients who have completed of treatment exposure in
      the REP 301 trial (REP 2139-Ca therapy for 30 weeks and PEG-IFN taken for 48 weeks with a 15
      week overlap in combination) and the duration of suppression of serum HBV and HDV viremia
      observed in the REP 301 protocol. This requires that subjects have completed antiviral
      treatment in the REP 301 protocol and are not immediately transitioned to further antiviral
      treatment unless necessary. The total duration of this study for each subject is 3 years.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients completing treatment exposure in the REP 301 protocol.
      
Biospecimen description: 
      Frozen serum containing viral DNA / RNA
    
Keywords: nucleic acid polymer REP 2139 HBsAg hepatitis B hepatitis D
A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and
      antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon
      alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the
      combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or
      4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily
      (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin
      1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid
      additionally. Anticipated time on study treatment is 24 weeks.
    


Intervention name(s): RO5024048; danoprevir; peginterferon alfa-2a [Pegasys]; ribavirin; ritonavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1000 mg orally bid, 24 weeks; 100 mg orally bid, 24 weeks; 180 mcg weekly, 24 weeks; 1000-1200 mg/kg/day orally in two divided doses, 24 weeks; 100 mg orally bid, 24 weeks
Intervention MeSH terms: Ritonavir; Ribavirin; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rifaximin for Functional Dyspepsia
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Functional dyspepsia is a very common medical condition, which occurs in up to 30% of people
      in the community. However, results of current pharmacological treatment on functional
      dyspepsia are unsatisfactory. Rifaximin is a minimally absorbed antibiotic that has been used
      in treatment of non-constipated irritable bowel syndrome (IBS). In particular, bloating and
      abdominal pain was improved by rifaximin treatment in this group of IBS patients. Whilst
      there is considerable overlap in symptoms of functional dyspepsia and IBS, the investigators
      test whether rifaximin is also effective in curing post-prandial distress symptoms related to
      dyspepsia.
    

Detailed description: 
      The aim of this study is to test the effects of rifaximin, a minimally absorbed antibiotics,
      on symptoms of patients with functional dyspepsia.
    

Intervention name(s): Rifaximin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rifaximin 400mg tid for 2 wk; Placebo for 2 week
Other intervention name(s): Normix
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post-prandial distress syndrome
Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects
Condition: Burn Injury; Soft Tissue Injury; Skin Necrosis; Scars; Congenital Giant Nevus; Skin Tumors
MeSH terms: Necrosis; Wounds and Injuries; Soft Tissue Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is the evaluation of the safety of autologous tissue-engineered
      dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin"
      (second arm) transplanted onto the wound bed in children and adults.
    


Intervention name(s): denovoDerm; denovoSkin
Intervention type(s): Biological; Biological
Intervention description(s): Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin; Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin; Tissue-engineering; Autologous; Dermis; Epidermis
Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter study to evaluate the efficacy, safety and tolerability of Rivastigmine
      patch in patients with mild to moderate Alzheimer's disease switched from Cholinesterase
      Inhibitors.
    


Intervention name(s): Rivastigmine transdermal patch
Intervention type(s): Drug
Intervention MeSH terms: Rivastigmine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rivastigmine; Alzheimer's disease; Transdermal patch
Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression
Condition: Hypertension; Left Ventricular Hypertrophy
MeSH terms: Hypertension; Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional

Summary: 
      Uncontrolled high blood pressure can cause heart muscle 'thickening', and this increases the
      likelihood of complications and death. The high blood pressure explains some but not all of
      this increase in heart size. This study will investigate the other causes, and will measure
      the heart muscle 'thickness' very accurately using the latest and most accurate technique
      called cardiac magnetic resonance imaging (MRI). The best way to treat this heart thickening
      remains to be determined. We hope to be able to show that by specifically targeting the cause
      of heart muscle thickening we can reduce its occurrence more effectively than by other
      standard means of blood pressure treatment
    


Intervention name(s): Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD; Valsartan 160mg OD; Moxonidine 400mcg OD
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amlodipine; Valsartan; Moxonidine; Bendroflumethiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Left Ventricular Hypertrophy
To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar
Condition: Leishmaniasis, Visceral
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether a single bolus of dose of Amphoterin B
      lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal
      Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).
    

Detailed description: 
      Visceral Leishmaniasis, which is progressive and fatal if not treated, is an insidious,
      chronic disease that is characterized by irregular fever, anorexia, weight loss, cough, gross
      enlargement of the spleen and liver, mild anemia and emaciation. This may be preceded by
      rigors and vomiting. If untreated, Kala-azar, which is the most severe form of Leishmaniasis,
      has a mortality rate of nearly 100%.

      The goal of the project is to establish that a single dose of AMPHOMUL® can be used to
      achieve a Definitive cure for Visceral Leishmaniasis leading to a short course therapy. The
      project will also seek to establish that AMPHOMUL ® is safe, at least as effective and more
      affordable than current treatment, and is without the risk of drug resistance.

      The trial is a Prospective, Multicentric, Randomized, Two Arm, Open label Phase III study to
      Assess Efficacy and Safety of Infusion of Amphomul® (Amphotericin B Emulsion) as Compared to
      Liposomal Amphotericin B in Patients of Visceral Leishmaniasis (Kala azar)who are either
      treatment naive or treatment resistant to other antileishmanial drugs.
    

Intervention name(s): Amphotericin B Lipid emulsion; Liposomal Amphotericin B
Intervention type(s): Drug; Drug
Intervention description(s): Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A for treatment of Visceral Leishmaniasis; Liposomal Amphotericin B in visceral leishmaniasis - 15 mg/kg on day 1 in group B
Other intervention name(s): Amphomul; AmBisome
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Black Fever; Kala-Azar; Amphotericin B lipid emulsion; Liposomal Amphotericin B
A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, dose-escalation and expansion, single centre, phase Ia study . In this
      study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride
      liposome injection were studied in patients with advanced solid tumors, to determine the
      dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride
      liposome.
    


Intervention name(s): Irinotecan liposome
Intervention type(s): Drug
Intervention description(s): Irinotecan liposome
Intervention MeSH terms: Irinotecan
Intervention model: Single Group Assignment
Intervention model description: A dose-escalation（3+3 design） and expansion study
Masking: None (Open Label)
Primary purpose: Treatment
Morbidity in Patients With Hypertension and Obstructive Sleep Apnea
Condition: Hypertension; Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
Study type: Interventional

Summary: 
      MORPHEOS is a multicenter, randomized, unblinded study, for patients diagnosed with
      uncontrolled hypertension and at least one antihypertensive medication. Those patients with
      significant sleep apnea wil be randomized to CPAP or nasal strips for 6 months.
    


Intervention name(s): CPAP
Intervention type(s): Device
Other intervention name(s): Continuous positive airway pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: continuous positive airway pressure; hypertension; sleep apnea