bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
Condition: Ileus
MeSH terms: Ileus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if ipamorelin is safe and effective in the
      management of post-operative ileus.
    

Detailed description: 
      The safety and efficacy of ipamorelin in the management of post-operative ileus
    

Intervention name(s): Ipamorelin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV; IV
Other intervention name(s): ST; ST
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Ileus
Resveratrol's Effects on Inflammation and Oxidative Stress in Chronic Kidney Disease
Condition: Chronic Renal Insufficiency
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      Inflammation and oxidative stress are common findings in patients with Chronic Kidney Disease
      (CKD) undergoing conservative treatment, in addition to being associated with atherosclerotic
      process, are related also to the progression of CKD. In this regard, resveratrol, a phenolic
      compound with recognized antioxidant and anti-inflammatory properties, can play an important
      role in the control of metabolic disorders associated with CKD, since it can modulate the
      mechanisms involved in inflammation and oxidative stress cycle. Resveratrol is capable of
      promoting the activation of the transcription-related factor-2 nuclear factor erythroid
      factor 2 (Nrf2) , a nuclear factor with anti-inflammatory properties, and SIRT-1, a protein
      also associated with the reduction of inflammation. These two factors, in their turn, are
      able to inhibit / antagonize the activity of the nuclear factor κB (NF-kB), a transcription
      factor that participates in the inflammatory response. Although it is a promising treatment,
      there are no studies evaluating the effects of resveratrol supplementation in patients with
      CKD. Thus, this study aims to evaluate the effects of resveratrol supplementation on
      inflammation and oxidative stress in patients undergoing conservative treatment of CKD.
    


Intervention name(s): Resveratrol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): trans-resveratrol
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: resveratrol; oxidative stress; inflammation
Effect of Controlled Diet Combined With a Fermented Milk Product on Gas-related Symptoms
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      To select among different dietary and clinical conditions the most appropriate to assess the
      impact of a fermented milk product on gas-related symptoms
    

Detailed description: 
      To select among different dietary (mild or high flatulogenic diet) and clinical conditions
      (FGID or non-FGID population) as well as different measured parameters (self-completed
      questionnaires assessing gas related symptoms, digestive well-being and bowel functions, gas
      volume distribution in the colon by MRI, volume and composition of gas collected per anus and
      frequency of gas evacuations per anus), the most appropriate to assess the impact of a
      fermented milk product on gas-related symptoms.
    

Intervention name(s): Fermented milk product with probiotics (FMPP)
Intervention type(s): Other
Intervention description(s): 2 pots of 125g FMPP / day
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: flatulence; gas; probiotics; fermented milk; diet; functional gastrointestinal disorders
A Study of A High Concentration Liquid Formulation Versus A Lyophilized Formulation of Gantenerumab in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center, randomized, open-label, single-dose, parallel group study will assess the
      relative bioavailability, tolerability and dose-exposure relationship of a high concentration
      liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832)
      in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of
      either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.
    


Intervention name(s): gantenerumab; gantenerumab
Intervention type(s): Drug; Drug
Intervention description(s): High concentration liquid formulation (HCLF), single dose sc; Lyophilized formulation (LyoF), single dose sc
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Food Effect Study of DDO-3055 Tablets in Healthy Subjects
Condition: Anemia in Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a randomized , open-label, two-stage crossover food effect study of single doses
      of DDO-3055 tablets in healthy subjects. 14 healthy subjects were randomly divided into
      groups A and B, 7 subjects in each group. Two stage washout period is 6 days.
    


Intervention name(s): DDO-3055 tablet
Intervention type(s): Drug
Intervention description(s): DDO-3055 tablet, 2 single doses separated by 6 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial
Condition: Diarrhea-predominant Irritable Bowel Syndrome; Functional Diarrhea
MeSH terms: Irritable Bowel Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial is to assess the effectiveness of three types of acupuncture for patients with
      functional diarrhea comparing to a positive drug control.
    

Detailed description: 
      Outcome measurements:

      The frequency of bowel movement; The bristol stool scale; SF-36 evaluation
    

Intervention name(s): acupuncture; acupuncture group2; acupuncture group3; Loperamide
Intervention type(s): Other; Other; Other; Drug
Intervention description(s): acupuncture group1, acupoints ST25 and BL25 will be used in this trial.; Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.; All acupoints used in acupuncture group1 and group2 will be used in this group.; Loperamide will be used in this group for a dose of 2mg a time, three time a day.
Other intervention name(s): Acupuncture at Shumu acupoints; Acupuncture at He acupoints; Acupuncture at Shumu and He acupoints; Luopaidingan
Intervention MeSH terms: Loperamide; Antidiarrheals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; loperamide; functional diarrhea; IBS
A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR741 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of single and multiple
      intravenous doses of SPR741 when administered to healthy adult volunteers.
    

Detailed description: 
      This Phase 1 First in Human study is designed to assess the safety, tolerability and
      pharmacokinetics of single and multiple intravenous doses of SPR741 when administered to
      healthy adult volunteers. This is a double-blind, placebo controlled, ascending dose,
      multi-cohort trial. A total of ninety-six healthy volunteers will be enrolled in 12 cohorts.
      The study will be conducted in two phases: a single ascending dose (SAD) phase, followed by a
      multiple ascending dose (MAD) phase. In SAD, participants will receive one dose of SPR741 or
      placebo. In MAD, participants will receive multiple doses of SPR741 or placebo for 14
      consecutive days. In both parts, sequential cohorts will be exposed to increasing doses of
      SPR741.
    

Intervention name(s): SPR741; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAD: Double-blind dosing will occur in cohorts 1 through 8. Six participants will receive single doses of SPR741. The dose escalation steps may be altered following review of the safety data upon completion of each cohort.
MAD: The Safety Management Group will evaluate the safety and tolerability data obtained for the participants in Cohorts 1-5 to determine the appropriate dose level of intravenous q8h dosing of SPR741 to be utilized in the first cohort (Cohort 9) in the MAD. Dosing will commence on the morning of Day 1. Three doses will be administered per day at approximately 8 hours apart. Daily dosing will continue for a total of 14 consecutive days.; 0.9% sodium chloride for injection. SAD: Two participants in each cohort will receive matching placebo. MAD: Two participants in each cohort will receive matching placebo.
Other intervention name(s): 0.9% sodium chloride for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics
Simvastatin for the Treatment of Chronic Hepatitis B
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators have shown robust in vitro anti-hepatitis B activity of simvastatin alone
      and synergistic activity with all four FDA-approved anti-hepatitis B oral drugs tested. The
      investigators propose phase 1 studies in 48 chronic hepatitis B human carriers who have never
      been treated before. Doses of drugs will remain at or below FDA-approved dosage levels for
      cholesterol lowering (simvastatin) or hepatitis B (tenofovir or entecavir). Arm 1 will have
      simvastatin monotherapy only. Arm 2 will combine simvastatin with tenofovir. Arm 3 will
      combine simvastatin with entecavir. For maximum safety, the 3 arms and the dose groups in
      each arm will be filled consecutively and not concurrently. The definition of efficacy for
      simvastatin alone will be a 1 log drop of hepatitis B virus in 14 days. Efficacy for
      combination of drugs will require a 2 log drop of hepatitis B virus in 14 days. Numerous
      safety tests and stop rules are noted in the protocol.
    


Intervention name(s): Simvastatin; Tenofovir; Entecavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): daily doses for 14 days; Entecavir
Other intervention name(s): Zocor
Intervention MeSH terms: Tenofovir; Entecavir; Simvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B; simvastatin; HBV DNA
A Clinical Research Studying a Method of Intervention for Children Diagnosed With Anxiety Disorder: Attentional Bias Intervention
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Studies show that children with high levels of anxiety tend to pay more attention to
      threatening stimulus in the environment. They tend to attend to these stimuli and have
      difficulty to disengage from them. These attention biases enhance and maintain the level of
      anxiety. The aim of this study is to test a method of therapeutically intervention which
      focuses on shifting these attentional biases, with the use of a computer game which was
      designed to train the child to focus his/her attention away from the threatening stimuli and
      to focus on natural or positive stimuli. We will recruit 160 children with ongoing anxiety
      disorders who seek treatment. We will first assess threat-related attention bias and anxiety
      symptoms using structured psychiatric interviews and questionnaires. We will then randomly
      assign these children to one of four conditions: training to avoid threatening stimuli and
      attend to neutral stimuli; control placebo-training for threat-neutral stimuli; training to
      attend to positive stimuli and avoid neutral stimuli; and, control placebo-training for
      positive-neutral stimuli. Upon completion of training we will again assess attention bias and
      anxiety.

      Two sets of predictions will be tested, one set concerns the effects of training on
      attention, and the other concerns the effects of training on anxiety. In terms of training
      effects on attention, we hypothesize that children with anxiety disorders can be trained to
      either avoid threat or attend to positive stimuli. In terms of training effects on anxiety
      symptoms, we hypothesize that the experimental training sessions will produce greater
      reduction in symptoms of anxiety than the placebo-control training sessions.
    


Intervention name(s): attention-bias training
Intervention type(s): Behavioral
Intervention description(s): one group recive an attention training away from threat. The second group, the controll group, recive a placebo training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: anxiety; attention-biases; children
Effect of Crestor on Lipoprotein Metabolism in Humans
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this research is to understand how Crestor can effectively reduce the levels
      of the bad cholesterol, LDL, in blood. It is hypothesized that with a low dose, Crestor will
      facilitate the rate of removal of LDL from the blood. At the higher dose, the increased
      potency of Crestor is explained by a reduction in the production of LDL by the liver.
    

Detailed description: 
      Crestor has been demonstrated to be effective in reducing plasma LDL by 20 to 60% in a dose
      dependent fashion. While the primary mechanism of action of this class of agents is the
      increase in the expression of LDL receptor resulting in accelerated clearance of LDL, the
      increase potency of Crestor in comparison to other statins may suggest other mechanisms. We
      propose to study the rate of incorporation of deuterated labeled leucine into VLDL apoB and
      LDL apoB and to determine the effect of two doses of Crestor (5 mg/day and 40 mg/day) on the
      production and clearance of apoB. Participants will be admitted to the General Clinical
      Research Center on three occasions (4 days, 3 nights per admission) for these metabolic
      studies. This is an open-label study design to reflect usual care with the first admission
      taking place while the participant is not on any lipid-lowering therapy. The second admission
      will occur after a minimum of 6 weeks on the low dose (5mg/day). The dose will be increased
      to 40 mg/day at the time of discharge and the third admission will occur after a minimum of 6
      weeks on the higher dose.

      A secondary objective of this study is to examine the rate of production and clearance of
      apoA-I, the major protein in HDL, at the 2 doses of Crestor. In addition to a reduction in
      LDL, Crestor has also been reported to result in a characteristic dose-dependent increase in
      HDL. The mechanism of this increase is not understood.
    

Intervention name(s): Rosuvastatin at 5 mg/day and 40 mg/day
Intervention type(s): Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypercholesterolemia; HMG CoA Reductase Inhibtors; tracer kinetics; Apolipoproteins
A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants
Condition: Healthy Subjects; Drug-drug Interaction; Pharmacokinetics; Quizartinib
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to investigate the one-way drug-drug interaction potential of
      quizartinib on dabigatran etexilate in healthy adult participants.
    

Detailed description: 
      This study will evaluate the potential intestinal inhibitory effect of quizartinib on the
      pharmacokinetics of a Pgp substrate dabigatran etexilate in healthy participants.

      The hypothesis for this clinical study is that quizartinib, as a P-gp inhibitor, may increase
      the systemic exposure (measured by area under the concentration-time curve [AUC] and maximum
      concentration [Cmax]) of P-gp substrates that may be sensitive to intestinal P-gp inhibition.
    

Intervention name(s): Dabigatran Etexilate Mesylate; Quizartinib
Intervention type(s): Drug; Drug
Intervention description(s): Single oral 150 mg capsule dose; Single oral 60 mg dose of quizartinib administered as two 30 mg tablets (26.5 mg free base per tablet)
Other intervention name(s): Pradaxa
Intervention MeSH terms: Dabigatran
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy subjects; Drug-drug Interaction; Pharmacokinetics; Quizartinib; P-gp; Dabigatran Etexilate
Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The general aim is to evaluate the relative oral bioavailability of BI 44370 TA tablets
      during and between migraine attacks as well as Safety, Tolerability and Pharmacokinetic
    


Intervention name(s): BI 44370 TA tablet
Intervention type(s): Drug
Intervention model: Crossover Assignment
Primary purpose: Treatment
The Pharmacokinetics and Safety of Single-dose and Parallel Comparisons in Patients With NSCLC Treated With JS001
Condition: NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to evaluate the similarity of single-dose and parallel comparisons of
      recombinant humanized anti-PD-1 monoclonal antibody injections before and after process
      changes. It is designed to be a single-center, open and parallel controlled phase I study.
      Patients with advanced NSCLC will be enrolled.

      After determining that the patient is qualified, the patient will be assigned to a batch of
      drug use in the order in which they are selected. The dosage of drug was set at 3 mg / kg.
      Planned to recruit subjects each 12 patients (24 cases) to participate in this study, taking
      into account a 20% dropout rate, so that the total of 15 patients (30 patients) subjects in
      each group in this study.

      This study was divided into study phase (single-dose period) and follow-up stage
      (multiple-dose period).Each subject first conducted a single dose safety and pharmacokinetics
      (PK) study.If the subject did not develop adverse events that had significant clinical
      significance as suggested by the investigators within 28 days of the single dose and
      continued reorganization of the humanized anti-PD-1 monoclonal antibody injection to benefit
      the patient , and with the agreement of subjects, the subject will enter the follow-up phase
      (multiple-dose period). The same dose of recombinant humanized anti-PD-1 monoclonal antibody
      injection was administered once every 2 weeks and 4 consecutive cycles of treatment for one
      cycle of continuous period.Until the patient has developed tumor progression or an
      untolerated toxic side effect, the patient voluntarily exits the study or believes that the
      situation is not suitable for continuing treatment. There are follow-up of 90 days after
      treatment.
    


Intervention name(s): Toripalimab
Intervention type(s): Biological
Intervention description(s): To compare the different drug batch number with different process
Other intervention name(s): JS001, TAB001
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PD-1 antibody; phase 1 trial
Epidural Study of Patients With Chronic Lower Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to examine 4 different epidural dosing regimes of local
      anaesthetic solution in a series of 3 epidural injections over a period of 12 months to
      determine the optimum dose of anaesthetic solution for pain relief and to determine the
      nature of any adverse events by measuring anxiety and depression, functionality and any side
      effects of the medication.
    

Detailed description: 
      To determine the optimum dose of local anesthetic and the optimum volume of injected solution
      when used in an epidural steroid injection being given for pain relief to patients with
      chronic lower back pain, using pain scores as an assessment tool.
    

Intervention name(s): Bupivacaine; Bupivacaine; Bupivacaine; Bupivacaine; Depo-Medrol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Low Volume, Low Dose (5cc, 5mg plain Bupivacaine); Low Volume, High Dose (5cc, 10mg plain Bupivacaine); High Volume, Low Dose (10cc, 5mg plain Bupivacaine); High Volume, High Dose (10cc, 10mg plain Bupivacaine); 80mg Depo-Medrol
Other intervention name(s): steroid; steroid; steroid; steroid; methylprednisolone
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Bupivacaine; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: epidural; volume; dose; pain relief; steroid