bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose
      concentration and other glycemic parameters of efficacy, and the safety and tolerability and
      pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2.
      On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of
      RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is
      <50.
    


Intervention name(s): Placebo; RO4998452
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose; single oral doses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder
Condition: Borderline Personality Disorder; Dissociation
MeSH terms: Personality Disorders; Borderline Personality Disorder; Dissociative Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Our study aims at contributing to a valid appraisal of the magnitude of naltrexone efficacy
      as an antidissociative agent by using a double-blind randomized controlled trial.
    

Detailed description: 
      Patients were randomized into two groups starting with either 3 weeks of 50 mg/d naltrexone
      or with 3 weeks of placebo. In either case the active treatment phases (weeks 1-6) were
      followed by one week of placebo. The major purpose of weeks 1-2 and 4-5, respectively, was to
      achieve a steady state during the active treatment. The primary comparisons of
      psychopathology under naltrexone and placebo refer to the weeks following the intended
      achievement of a steady state (weeks 3 and 6, respectively).

      6 weeks of treatment were split into two phases: (A) 3 weeks of pharmacologically active
      treatment with naltrexone and (B) 3 weeks of pharmacologically inactive treatment with
      placebo (cross-over design). The sequence of the two treatment phases was randomized and
      concealed from both the patients and the health care professionals. In both cases, the last
      week ("Week 7") was without pharmacological intervention.

      The primary outcome was based on the DSS, a reliable and valid self-rating instrument to
      assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al.
      2001) Mean scores for intensity (ranging from 0="no" to 9="very strong") and for duration
      (average time during which a particular symptom was present during the last 24 hours (in %))
      were calculated for (a) dissociation (calculated from 21 Likert type items) and of (b)
      aversive inner tension (one item).
    

Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg/d Naltrexone will be administrated during three weeks.; During 3 weeks of the study, Placebo will be administrated (daily)
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Borderline Personality Disorder; Dissociation; Naltrexone
Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability profile of CD388
      Injection, as compared to saline placebo, when dosed by subcutaneous (SQ) administration as a
      single dose to healthy Japanese adult subjects.
    

Detailed description: 
      This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending
      single doses of CD388 Injection administered SQ to healthy Japanese adult subjects. The goals
      are to assess safety, tolerability, and pharmacokinetics (PK) of CD388.
    

Intervention name(s): CD388 Injection; Saline placebo
Intervention type(s): Combination Product; Drug
Intervention description(s): CD388 liquid for injection; Sterile normal saline for injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy of Intravenous Iron Administration in Hemodialysis Patients
Condition: Chronic Renal Failure; Hemodialysis; Renal Anemia; Iron Deficiency Anemia
MeSH terms: Kidney Failure, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the frequency of intravenous iron
      administration has an effect on anemia correction and oxidative stress formation in
      hemodialysis patients.
    

Detailed description: 
      In patients who are on chronic hemodialysis (HD), anemia is a major complication and is
      associated with poor clinical outcomes. Consequently, management of anemia by recombinant
      erythropoietin is reported consistently to improve outcome measures in HD patients. Because
      iron is essential for hemoglobin formation, as is erythropoietin, most patients routinely
      receive iron intravenously (IVIR) for anemia correction. Although IVIR has been shown to
      improve both survival and quality of life of HD patients, it has been suggested that IVIR may
      enhance the generation of hydroxyl radicals in the body through the inflammation process and
      the Fenton reaction. Previously we demonstrated that that serum albumin is highly oxidized in
      HD patients and that IVIR on these patients significantly increased the oxidation status of
      albumin.

      In 2004, the committee on the guidelines of the Japanese Society for Dialysis Therapy (JSDT)
      published the original Japanese "Guidelines for Renal Anemia in Chronic Hemodialysis
      Patients". In the JSDT guidelines 2004, the committee recommended two IVIR schedules for iron
      deficient patients; 1) administer 40 mg of IV iron at the end of dialysis session 3 times a
      week for 4 weeks (total 520 mg of iron), 2) administer 40 mg of IV iron at the end of
      dialysis session once a week for 3 months (total 520 mg of iron). Both administration
      schedules are effective for the correction of iron deficiency and consequently for the
      amelioration of anemia. However, the effect of IVIR frequency (three times a week vs. once a
      week) on the oxidative stress formation has not been investigated before.

      Comparison: the two IVIR schedules recommended by the JSDT guideline 2004 will be compared by
      measuring both hemoglobin and oxidized albumin in chronic HD patients.
    

Intervention name(s): chondroitin sulfate-iron colloid
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intravenous iron administration
Cysteine-lowering Treatment With Mesna
Condition: Obesity; Drug Effect
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the efficacy of the drug Mesna®
      (Uromitexan) in healthy participants with overweight or obesity with respect to change in
      plasma concentrations of total cysteine, following single ascending doses of oral Mesna.
    

Detailed description: 
      In both animal experiments and human studies, cysteine in the blood is strongly associated
      with obesity. In rodents, changes in cysteine induced by dietary means are accompanied by
      changes in fat mass.

      In this phase I, single ascending dose study the investigators will determine the effects of
      Mesna in healthy volunteers with overweight and obesity with focus on its effects on plasma
      total cysteine concentrations. The aim of this dose-finding clinical trial is to determine
      the lowest single oral Mesna dose that will lower plasma total cysteine concentrations by 30%
      using pharmacokinetic (PK)/ pharmacodynamic (PD) modelling. The investigators will further
      evaluate the effect of Mesna on plasma cysteine fractions and related metabolites, urinary
      cysteine excretion, safety and adverse drug reactions, and plasma biomarkers.
    

Intervention name(s): Mesna
Intervention type(s): Drug
Intervention description(s): Administration of a single oral dose, using film-coated tablets of either 400 mg or 600 mg or a combination of maximum 3 tablets up to a maximum of 1600 mg
Other intervention name(s): Uromitexan
Intervention MeSH terms: Mesna
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cysteine; Phase 1; Mesna
Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study will examine the effectiveness of one of two psychoeducation treatments on chronic
      low back pain.
    

Detailed description: 
      This study will examine the effectiveness of one of two psychoeducation treatments on chronic
      low back pain. Participants will be randomized to one of these two treatments.
    

Intervention name(s): Interactive - Psychoeducation; Non-interactive Psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individuals will receive interactive psychoeducation in the lab over the course of a week period. Each session will take approximately 30 minutes.; Individuals will receive non-interactive psychoeducation over the course of a week period. Each session will take approximately 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Pain; Low Back Pain
Liver Cauterization Increases the Postoperative Pain After Laparoscopic Cholecystectomy
Condition: Laparoscopic Cholecystectomy; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      Laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity all
      over the world for gallstone. Although it has low morbidity, postoperative pain is
      challenging situation like every other operation.
    

Detailed description: 
      Postoperative pain after laparoscopic cholecystectomy has a three component: parietal,
      visceral and referring (shoulder) pain. Although intensities of them can be various, all of
      them affects the total pain together. Unintentional liver cauterization during laparoscopic
      cholecystectomy is unwanted, but sometimes unavoidable complication/process. However its
      effect on postoperative pain is not studied with detail in literature.
    

Intervention name(s): Laparoscopic cholecystectomy
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have scheduled for laparoscopic cholecystectomy
A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy
Condition: Pregnancy Prevention
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, single-treatment study. All subjects will receive 12 months of oral
      contraceptive therapy with DR-103. Study participants will receive physical and gynecological
      exams, including Pap smear. During the study, all participants will be required to complete a
      diary.
    


Intervention name(s): DR-103
Intervention type(s): Drug
Intervention description(s): One tablet daily.
Four 91-day cycles of the DR-103 regimen:
42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE.
Other intervention name(s): levonorgestrel/ethinyl estradiol; Quartette®
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception; Oral contraceptives
Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated
      interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants
    

Detailed description: 
      Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected
      with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF
      ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight: <
      75 kg, 1000 mg; ≥75 kg, 1200 mg), the dose modified according to participants tolerability,
      plus 180 μg PegINFα-2 once weekly for 12 weeks.

      Experienced participants included participants with a prior relapse or a null response to
      PegINF/RBV therapy.
    

Intervention name(s): SOF/RBV/PegINFα-2
Intervention type(s): Drug
Intervention description(s): SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV genotype 4; sofosbuvir; Peg-interferon α-2; ribavirin; Egyptian patients; Experinced; Naive
RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation
Condition: Graft Vs Host Disease; Graft-versus-host-disease; Acute-graft-versus-host Disease; Prevention of aGVHD
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II open label study will evaluate the safety and efficacy of repeat doses of
      RGI-2001 in combination with standard of care treatment for the prevention of acute
      graft-vs-host-disease (aGvHD) in subjects following Allogeneic Hematopoietic Stem Cell
      Transplantation (alloHSCT). These subjects will be compared to contemporary controls.
    

Detailed description: 
      This is an open-label, multi-center, single-arm study to evaluate six weekly doses of
      RGI-2001 in combination with standard of care treatment for the prevention of aGvHD in
      subjects following alloHSCT. The study will include a Safety Run-in Phase to assess the
      safety and tolerability of 6 weekly doses of RGI-2001 followed by an Expansion Phase in which
      the potential efficacy of 6 weekly doses of RGI-2001 in addition to standard of care for GvHD
      prophylaxis will be assessed. Comparison will be made to a contemporaneous control group.
    

Intervention name(s): RGI-2001; Standard of Care
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT; Standard of care prophylaxis regimen will be administered according to institutional guidelines
Other intervention name(s): KRN-7000; RGI-7000
Intervention MeSH terms: KRN 7000
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      Prospective study including 6 groups of 20 patients with a total hip prosthesis. Five
      different types of metal-on-metal prostheses are studied, and 1 group with ceramic-on-ceramic
      prostheses acts as control group. Patients undergo a clinical evaluation and blood sampling
      preoperatively, and 3, 6, 12 and 24 months postoperatively.
    


Intervention name(s): metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis
Intervention type(s): Device
Intervention description(s): metal-on-metal total hip prosthesis versus ceramic-on-ceramic total hip prosthesis
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Relationship Between Fasting Time and Delirium
Condition: Delirium; Sedation Complication; Magnetic Resonance Imaging; Fasting
MeSH terms: Delirium
Study type: Observational [Patient Registry]

Summary: 
      We investigated the relationship between fasting times and delirium in children undergoing
      MRI under anesthesia. Paediatric Anaesthesia Emergence Delirium (PAED) scale, last oral
      intake time and type of food (solid-liquid) and fasting time, laryngospasm, desaturation
      (SpO2 <95%), bradycardia, allergy, nausea and vomiting were recorded.
    


Intervention name(s): Paediatric Anaesthesia Emergence Delirium scale
Intervention type(s): Behavioral
Intervention description(s): measure emergence delirium in children
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children between the age group 2-6 years of American Society of Anesthesiologists (ASA)
        physical status I or II, patients undergoing MRI under sedation
      
Keywords: Emergence delirium; pediatric; preoperative fasting; magnetic resonance imaging
Catechin Gargling for Influenza Infection
Condition: Influenza Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human
Study type: Interventional

Summary: 
      The purpose of this study is to clarify the preventive effects of catechin gargling on the
      influenza infection.
    

Detailed description: 
      In-vitro experimental studies have revealed that tea catechin extracts induce preventive
      effects on influenza infection. However, few studies have been conducted on the effects of
      tea gargling on influenza infection, and the clinical evidence is unclear. Also there have
      been no studies reported on the gargling effects with tea catechin extracts on the prevention
      of influenza infection.
    

Intervention name(s): catechin extracts (health food)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: catechins; gargling; healthy volunteers
Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness
Condition: Psychological Distress; Anxiety Depression; Burden, Caregiver; Disorders of Consciousness
MeSH terms: Consciousness Disorders; Caregiver Burden
Study type: Observational

Summary: 
      Caregivers of patients with disorders of consciousness are highly prone to developing mental
      health issues. The aim of this study is to investigate the psychological symptoms and care
      burden of caregivers of patients with disorders of consciousness (DoC), and to examine which
      characteristics of patients were burden predictors to caregivers.
    

Detailed description: 
      This is a multi-center cross-sectional study in China, from August 2021 to October 2022.
      Patients were assessed by Coma Recovery Scale-Revised (CRS-R), and caregivers' anxiety,
      depression, and burden were assessed by State-Trait Anxiety Inventory Form Y (STAI), Beck
      Depression Inventory-II (BDI- II), and Zarit Caregiver Burden scale (ZBI). The comparison
      with patients' age and caregivers' age-matched subjects who were randomly selected and
      without DoC; intra-group comparison of caregivers for DoC was conducted. Descriptive
      statistics were used to illustrate the socio-demographics. One-sample t-test, independent
      sample t-test, one-way ANOVA, Mann-Whitney U test, and Kruskal-Wallis test were executed to
      detect the difference between groups due to the distribution of each variable.
    

Intervention name(s): questionnaires
Intervention type(s): Other
Intervention description(s): Sent questionnaires to caregivers and used CRS-R to assess patients with DoC
Other intervention name(s): Coma Recovery Scale-Revised (CRS-R)
Observational model: Family-Based
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Caregivers of patients with DoC and other diseases
Autologous Bone Marrow Transplant for Children With Acute Myelogenous Leukemia (AML) in First Complete Remission
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study proposes to transfer marker genes (detectable genetic traits or segments of DNA
      that can be identified and tracked) into aliquots of marrow obtained for Bone Marrow
      Transplant (BTM) in patients in remission of Acute Myelogenous Leukemia (AML).
    

Detailed description: 
      The primary objective of this study was to estimate the continuous complete remission rate at
      2 years post transplant for children with AML in first complete remission treated with
      autologous BMT.

      Secondary objectives used transduction of marker genes into autologous marrow to determine
      the following:

        1. whether the source of relapse after BMT for AML is residual malignant cells in the
           harvested marrow or in the patient, and whether marrow purging is therefore rational.

        2. whether the majority of AML, which lack genetic markers, represent abnormalities in a
           multi-lineage progenitor cell, and whether therefore, auto grafting/intensified
           chemotherapy is ever likely to augment the cure rate.

        3. the mechanisms of autologous reconstitution, and the effects of stimuli which modify the
           process.
    

Intervention name(s): Busulfan; Cyclophosphamide; Mesna
Intervention type(s): Drug; Drug; Drug
Intervention description(s): See Detailed Description section for description of treatment plan.; See Detailed Description section for description of treatment plan.; See Detailed Description section for description of treatment plan.
Other intervention name(s): Myleran; Cytoxan, CTX; MESNCX
Intervention MeSH terms: Cyclophosphamide; Busulfan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autologous bone marrow transplant; gene marking