bioihbjkbjnl/mcl2 huggingface dataset:
Puerarin Effects on Alcohol Drinking
Condition: Alcohol Abuse
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a
      major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment
      with this compound will reduce alcohol self-administration in a simulated natural settings
      laboratory.
    

Detailed description: 
      Participants will have an opportunity to drink up to 6 beers, plus water and juice, during a
      90 minute afternoon drinking session in our simulated apartment room laboratory. Drinking
      sessions will be conducted in the afternoon after participants take puerarin or placebo for 7
      days.
    

Intervention name(s): Puerarin, Placebo
Intervention type(s): Drug
Intervention description(s): 400 mg, three times a day for 7 days
Other intervention name(s): Puerarin: NPI-031G; Placebo: Sugar beet extract
Intervention MeSH terms: Puerarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune
      persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.
    

Detailed description: 
      Hepatitis A refers to liver inflammation caused by infection with the hepatitis A virus. HAV
      is is one of the most common hepatitis viruses that can cause hepatitis in China. The data
      from the phase 1, 2 and 3 trials suggested that both inactivated hepatitis A vaccine and live
      attenuated hepatitis A vaccine had a clinically acceptable safety and good immunogenicity for
      healthy Chinese people.
    

Intervention name(s): Attenuated HAV Vaccine, H2 Strain; Attenuated HAV Vaccine, L-A-1 Strain; Inactivated HAV Vaccine, Lu8 Strain; Inactivated HAV Vaccine, TZ84 Strain
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).; 6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).; 320EU/Vial in babies aged 18-35 months\320EU/Vial in children aged 3-15 years \640EU/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose; 250U/Vial in babies aged 18-35 months\250U/Vial in children aged 3-15 years \500U/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose.
Other intervention name(s): Hepatitis A (Live) Vaccine, Freeze-dried; Hepatitis A Vaccine; Hepatitis A Vaccine, Inactivated; Hepatitis A Vaccine, Inactivated
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Hepatitis A; Vaccine; Safety; efficacy
Paravertebral Analgesia Associated With Intravenous Morphine PCA After Thoracotomy
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      osteolateral thoracotomy is a painful surgical procedure.Thoracic epidural analgesia (TEA) is
      usually considered as the "gold standard" for postoperative thoracic analgesia.
      Unfortunately, it's not always possible to realize it because of contraindications or because
      of technical failures.Analgesia using a paravertebral block is an alternative to the TEA : it
      provides an unilateral sensitive and sympathetic block using a catheter.In our study, the
      catheter will be placed by the thoracic surgeon at the end of the surgical procedure, under
      direct vision, to insure maximal security also on patients on antiplatelets agents,
      anticoagulants or with haemostasis disorders (the placement of the catheter by the
      anaesthetist with the loss of resistance technique is contraindicated in these
      cases).Patients will be randomized to receive either a continuous 48-hours infusion of
      ropivacaine 0,5% or saline serum in the control group.All patients are connected to a PCA
      pump with intravenous morphine and will receive paracetamol and nefopam.The visual analogic
      scale (VAS) at rest and on movement, total morphine consumption and side effects will be
      recorded during the first 48 hours after surgery. The aim of this study is to prove a
      decrease of pain at rest and on movement, a decrease of the cumulated total morphine dose
      consumption and a decrease of the side effects (nausea, vomiting, pruritus, sedation,
      bradypnea, urinary retention).
    


Intervention name(s): ropivacaine; nacl 0,9%
Intervention type(s): Drug; Other
Intervention description(s): Ropivacaine 0.5% 0.1 ml/kg per hour; saline 0.9% 0.1 ml/kg per hour
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Epidural analgesia; Contraindications; Paravertebral nerve block analgesia; ropivacaine; Visual analogical scale; Morphine; Side effects; Pain and thoracotomy
Study in Non-responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and Ribavirin
Condition: Chronic Hepatitis C; Hepatitis, Viral, Human
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis, Viral, Human; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and efficacy of repeated intravenous
      infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with
      chronic hepatitis C genotype 1.
    

Detailed description: 
      In this study, 28 patients with chronic hepatitis C genotype 1 who have failed previous
      treatment with pegylated interferon plus ribavirin will be treated. The study treatment will
      consist of the same type and doses of pegylated interferon and ribavirin to which the patient
      failed to respond plus EMZ702. EMZ702 will be administered intravenously twice a week during
      the first 12 weeks of treatment. Thereafter and according to viral response, patients will
      continue to receive pegylated interferon and ribavirin only for up to 36 weeks.
    

Intervention name(s): EMZ702
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis C; genotype 1; non-responders; viral hepatitis
The PK/PD Study of SHR7280 Tablets in Healthy Subjects.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the safety, tolerability, pharmacokinetics
      and pharmacodynamics of SHR7280 tablets in healthy subjects.
    

Detailed description: 
      GNRH antagonists can be used to treat sex hormone-dependent diseases, and SHR7280 is an oral
      GNRH antagonist. The purpose of this study is to observe the safety, tolerability,
      pharmacokinetics and pharmacodynamics of multiple oral doses of SHR7280 in healthy subjects.
    

Intervention name(s): SHR7280; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): treatment; blank control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Desidustat in the Treatment of Anemia in CKD
Condition: Chronic Kidney Disease Stage 3; Anemia; Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 5
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled
      clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the
      treatment of anemia in patients with CKD who are not on dialysis. The study will be conducted
      over a period of up to 30 weeks.
    


Intervention name(s): Desidustat Oral Tablet; Darbepoetin Alfa
Intervention type(s): Drug; Drug
Intervention description(s): Desidustat tablet; Darbepoetin injection
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DREAM-ND
A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study is a randomized, double-blind,placebo-controlled, multicenter phase II
      study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe
      active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time
      needed to induce clinical response in active ulcerative colitis patients.

      This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment
      phase, will have the option to enter a blinded active arms 8-week extension phase. Early
      withdrawn subjects during the first treatment phase can not enter the extension phase. The
      total duration of the study participation, including extension and follow-up, will be
      approximately 18 weeks.

      SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal
      transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation.
      Therefore it has the potential to be a treatment for ulcerative colitis.
    


Intervention name(s): SHR0302; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a Janus kinase inhibitor).; Placebo Oral Tablet
Other intervention name(s): Ivarmacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This is a randomized, single-site pilot study incorporating one control group. This research
      involves an exercise group and a non-exercise group (control group).

      The patients who are in the exercise group will be enrolled in the Dallas County Women's
      Adventure Boot Camp. This will require them to undergo exercise training 3 times per week,
      under the direction of an experienced personal trainer in a group setting. All Boot Camp
      personal trainers are trained in basic cardiac life support (CPR) and are trained to watch
      for any signs or symptoms associated with a poor exercise response.

      The investigators hypothesize that randomizing women to a supervised exercise program of core
      conditioning, muscular/circuit training, and short distance running administered during
      neoadjuvant chemotherapy for breast cancer can be performed.

      Patients will continue on study as they are undergoing neoadjuvant chemotherapy for their
      breast cancer. This will be about 4 - 6 months.
    

Detailed description: 
      The exercise protocol will consist of activities including walking/running up to a mile,
      calisthenics (jumping jacks, short relays, rapid punches) and light (no greater than 5
      pounds) weight lifting. The patients who do not receive the exercise program will be allowed
      to do what they would normally do during their neoadjuvant chemotherapy. They are allowed to
      engage in their own exercise regimens and diet modifications.

      Subjects will receive the chemotherapy as directed by their physicians, and then undergo
      surgery as planned. Randomization will occur by drawing cards entitled "exercise" or
      "control" from an envelope and then assigning the patient to this group.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Five woman undergoing neoadjuvant chemotherapy for breast cancer will be randomized to an exercise protocol supervised by an experienced personal trainer. The exercise will be administered three times a week for the 4-6 months of neoadjuvant chemotherapy. The exercise protocol will consist of activities including walking/running up to a mile, calisthenics, and light weightlifting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Breast cancer; neoadjuvant chemotherapy; exercise; Ki-67
Atoguanil BA Study
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial aims to characterise the pharmacokinetic (PK) profile and estimate drug exposure
      from Atoguanil in comparison to Malarone®.
    

Detailed description: 
      After being informed about the study and potential risks, all adult participants giving
      written informed consent will be screened within 30 days prior to entering the trial on Day
      -1 to determine eligibility for study entry. The trial will establish whether the PK profile
      of both atovaquone (ATV), proguanil (PG) and cycloguanil (CG) from Atoguanil is similar to
      Malarone® and whether exposure of ATV from Atoguanil indicates that at least a 2-fold
      reduction in ATV dose compared with Malarone® is feasible (i.e. that the bioavailability of
      ATV in Atoguanil is approximately double that of ATV in Malarone®).
    

Intervention name(s): Atoguanil; Malarone
Intervention type(s): Drug; Drug
Intervention description(s): Atovaquone + Proguanil free base:125 mg: 87 mg, 4 tablets; Atovaquone + Proguanil HCl: 250 mg: 100 mg, 4 tablets
Other intervention name(s): Atovaquone + Proguanil; Atovaquone + Proguanil
Intervention MeSH terms: Atovaquone; Proguanil; Atovaquone, proguanil drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In Period 1, 16 participants will be enrolled and randomised to one of two treatments in a ratio of 1:1, and to the alternative treatment in Period 2, as described below:
Treatment 1: Single dose of Atoguanil . (Atovaquone 500 mg + Proguanil 348 mg administered as 4 tablets of 125 mg: 87 mg).
Treatment 2: Single dose of Malarone® . (Atovaquone 1000 mg + Proguanil HCl 400 mg administered as 4 tablets of 250 mg: 100 mg), Both doses are administered in the fed state and with 240mL of drinking water.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Bioavailability; Malaria prevention; Malaria
South Danish Diabetes Study: Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is:

        -  To investigate whether insulin aspart with meals is better than a standard treatment
           with insulin NPH at bedtime, evaluated by HbA1c.

      The secondary objectives of this study are:

        -  To study if a combination treatment with metformin and/or rosiglitazone and insulin
           aspart with meals is better than a standard treatment with insulin NPH combined with one
           or more of the above oral antidiabetic drugs. According to the hypothesis, special focus
           will be given to the treatment group with insulin aspart combined with metformin and
           rosiglitazone. The treatment effect will be evaluated by HbA1c.

        -  To examine the effects of the treatments on glucose metabolism and beta cell function,
           evaluated by diurnal blood glucose, fasting plasma glucose, insulin, C-peptide, and
           lactate.

        -  To examine the effects of the treatments on cardiovascular risk factors evaluated by
           serum lipid profiles, serum free fatty acids, urine albumin/creatinine ratio, and
           electrocardiogram (ECG).

        -  To quantify and describe the patients' subjective experiences of the two different
           insulin treatments (quality of life assessment)

        -  To examine patients with type 2 diabetes for the presence of variability in a series of
           genes, which are known to or are assumed to:

             -  affect the long term outcome;

             -  determine the responsiveness to treatment with diet, exercise and drugs targeting
                the known risk markers for late diabetic complications; and

             -  after intervention, to analyse the complex interrelationships between genotypes and
                clinical endpoints and the responsiveness to actual treatment modalities.
    


Intervention name(s): Insulin Aspart; Insulin NPH; Metformin; Rosiglitazone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Rosiglitazone; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 diabetes; Insulin Aspart; Insulin NPH; Metformin; Rosiglitazone
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 2

Summary: 
      The main aim of this vaccine is to prevent cervical cancer in women. However, it could also
      be relevant to vaccinate selected groups of males. Therefore, this study is designed to
      evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male
      subjects aged 10-18 years.
    


Intervention name(s): Cervarix vaccine; Engerix-B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.; All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule
Other intervention name(s): HPV vaccine; HBV vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
E-cigarettes and Blood Vessel Function
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and
      sham control, on endothelial function and markers of oxidative stress.
    

Detailed description: 
      Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without
      nicotine, 3) sham control, and undergo a measure of endothelial function called brachial
      artery flow mediated dilatation (FMD). Additionally, oxidative stress will be measured pre
      and post exposure.
    

Intervention name(s): one time exposure to e-cig with nicotine; one time exposure to e-cig without nicotine; one time exposure to empty e-cig
Intervention type(s): Other; Other; Other
Intervention description(s): one time exposure to e-cig vapor with nicotine; one time exposure to e-cig without nicotine; one time exposure to empty e-cig (sham control
Other intervention name(s): sham control
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: nicotine; endothelial function; oxidative stress
PF-04995274 and Emotional Processing in Un-medicated Depression
Condition: Depression, Unipolar
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test whether seven days administration of a serotonin receptor subtype 4
      (5HT4) agonist called PF-04995274 has positive effects on cognition, emotional processing and
      neural activity in unmedicated depressed patients compared to placebo. The study will also
      include a group of patients randomised to seven days administration of citalopram (20 mg),
      which is a standard treatment for depression.
    

Detailed description: 
      This study uses a double-blind, placebo-controlled, randomised between-groups design to test
      if administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has
      positive effects on emotional processing and neural activity in unmedicated depressed
      patients. Participants are patients who fulfill criteria for current episode of Major
      Depressive Disorder (MDD), and they will be randomised to receive 7 days treatment with
      either PF-04995274 (15 mg daily), citalopram (20 mg daily) or a matched placebo. Participants
      will come for a Screening Visit, a First Dose Visit, Research Visit One (including MRI scan)
      and Research Visit Two (including measures of emotional processing and non-emotion
      cognition).
    

Intervention name(s): PF-04995274; Citalopram; Placebo Oral Tablet; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-04995274 tablets; Citalopram capsule; Placebo tablet, identical to PF-04995274 tablet; Placebo capsule, identical to citalopram capsule
Other intervention name(s): Celexa, Cipramil
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly allocated to one of three groups (PF-04995264, citalopram or placebo) and receive their allocated study medication for 7 days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Combination of Cryosurgey and NK Immunotherapy for Recurrent Ovarian Cancer
Condition: Recurrent Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to
      recurrent ovarian cancer.
    

Detailed description: 
      By enrolling patients with recurrent ovarian cancer adapted to enrolled criteria, this study
      will document for the first time the safety and the short and long term efficacy of the
      combined therapy using cryosurgery and natural killer (NK) cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cryosurgery; NK immunotherapy
Intervention type(s): Device; Biological
Intervention description(s): Percutaneous ablation under CT or ultrasound guidance; Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
Other intervention name(s): Argon-helium cryosurgical system
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian Cancer; cryosurgery; NK immunotherapy