bioihbjkbjnl/mcl2 huggingface dataset:
S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness of three different antibiotic
      regimens against Helicobacter pylori (H. pylori).
    

Detailed description: 
      Prevention of gastric cancer through eradication of H. pylori is one of the most promising
      strategies to reduce the global impact of cancer in the near term. Our long-term goal is to
      prevent gastric cancer by developing and validating an effective, simple, and low-cost
      approach to eradication of H. pylori. Our immediate goal, therefore, is to conduct a
      randomized study to compare the effectiveness of three different drug regimens for H. pylori
      infection. The three study arms are: Standard therapy - 14 day, 3-drug regimen of
      Lansoprazole, amoxicillin and clarithromycin (PACx14); Concomitant therapy - 5 day, 4-drug
      regimen of lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5); Sequential
      therapy - 10 day, 4-drug regimen of lansoprazole, amoxicillin for 5 days, followed by
      lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5).
    

Intervention name(s): PACx14; PACMx5; PAx5/PCMx5
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14); Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5); Sequential Therapy - 10 day, 4-drug regimen: lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5)
Other intervention name(s): Lansoprazole: Prevacid; Lansoprazole: Prevacid; Lansoprazole: Prevacid
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: H. pylori
Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury
Condition: Spinal Cord Injuries; Spasticity, Muscle
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Spasticity is muscle spasms, bouncing (clonus) or stiffness that can negatively impact the
      quality of life of people with spinal cord injury (SCI). In people with spinal cord injury,
      spasticity can limit muscle control of the arms and hands and cause pain, discomfort, and
      frustration. Transcutaneous electrical stimulation has been shown to reduce spasticity after
      SCI. However, this type of stimulation's effects during prolonged, at-home use has not been
      well studied. Additionally, traditional stimulation techniques are often only available in
      the clinic. Therefore, this study aims to identify if wearable intensive nerve stimulation
      decreases spasticity in the legs of people with SCI, and if this intervention is usable and
      desirable to individuals with SCI.
    

Detailed description: 
      Involuntary muscle activation, also referred to as spasticity is a common characteristic of
      spinal cord injuries. It can present as stiffness, clonus, and spasms that can impact a
      person's ability to perform daily tasks. Over half of individuals with spinal cord injuries
      that have spasticity report medication alone does not control the spasticity. Because of this
      clinical research is investigation different ways to manage spasticity.

      Stretching and vibration have demonstrated the ability to reduce spasticity but only for
      short periods of time requiring repeated use of the intervention. Additionally, vibration
      devices are not very practical to implement at home due to their high cost. Due to these
      factors, a solution that could be used multiple times a day and remains cost effective is
      needed.

      Transcutaneous electrical stimulation (TENS) has also demonstrated effectiveness in reducing
      spasticity after one session but shows greater benefit when it is able to be used for
      multiple sessions. A wearable intensive nerve stimulator (WINS) device has been shown to be
      safe for daily wear which makes it a feasible solution to address spasticity at home.
      Research has not yet looked at the efficacy of using the WINS device for spasticity and this
      study proposes to begin to fill that gap.
    

Intervention name(s): Wearable intensive nerve stimulator
Intervention type(s): Other
Intervention description(s): The wearable device consists of 2 leads that provide biphasic, with alternating lead phase, asymmetrical rectangular current at a pulse duration of 0.28 msec, a randomly varying pulse frequency between 60-100 Hz, with a maximum intensity of 100mA.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The investigators investigate if combined progressive aerobic training and resistance
      training improve metabolic control and fat mass in patients with type 2 diabetes who are
      eating a modified paleolithic diet. The investigators randomize 40 participants to two
      groups: 1) Modified paleolithic diet and exercise under observation 3 sessions/week, 2)
      Modified paleolithic diet and general advice about exercise.

      The investigators primary hypothesis is that in patients with type 2 diabetes decreases fat
      mass more with progressive exercise under observation and a modified paleolithic diet than
      with general advice about exercise and a modified paleolithic diet.
    


Intervention name(s): Modified paleolithic diet and exercise under observation; Modified paleolithic diet and general advice on exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Modified paleolithic diet and exercise 3 session/week under observation; Modified paleolithic diet and general advice on exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diet Therapy; Exercise Therapy; Insulin Resistance
To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
Condition: Rhinitis; Allergic; Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of
      Seasonal Allergic Rhinitis
    


Intervention name(s): Levocetirizine dihydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Levocetirizine dihydrochloride; Xyzal tablets
Effect of Low-frequency Electroacupuncture (EA) on Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Low-frequency electroacupuncture (EA) can decrease serum 17-hydroxyprogesterone (17-OHP),
      androstenedione (A) and testosterone (T)of young women with polycystic ovary syndrome in the
      Human chorionic gonadotrophin (HCG) stimulation test ，also，we hypothesize that EA is more
      efficiency in improving ovulation rate and menstrual cycle than sham acupuncture.
    

Detailed description: 
      First, patients will be recruited according to the inclusion criteria and exclusion criteria.

      Second, baseline measurements (including menstrual frequency,human chorionic gonadotropin
      (HCG) stimulation test,physical examination,trans-abdomen ultrasound of the uterus and
      ovaries, serum levels of sex hormone steroids) will be taken.

      Third, each patient will receive 32 sessions of acupuncture in 16 weeks, twice a week.

      Last, the above baseline measurements will be taken again as soon as the treatment is
      finished and menstrual frequency will be recorded during the 12 weeks of follow-up after the
      treatment.
    

Intervention name(s): acupuncture protocol 1; Acupuncture protocol 2
Intervention type(s): Other; Other
Intervention description(s): Disposable, single-use, sterilized needles made of stainless steel, 0.25 x 30 mm and 0.30 x 40/50mm (Wuxi Jiajian Medical Instrument. 251226 Wuxi, China) will be inserted to a depth of 15-35 mm in some acupoints. After getting the needle sensation (de qi), some acupoints will receive electrical stimulation and the others will receive manual stimulation. All participants will receive treatment twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks. Each treatment session lasts for 30 minutes.; Disposable, single-use, sterilized needles (0.20 x 20mm) made of stainless steel will be inserted to a depth of <5 mm at non-acupoints without evoking the needle sensation (Deqi). Electrodes will be attached to the needles and the stimulator will be turned on at an intensity of zero (no active current) in order to mimic EA in the acupuncture protocol 1 group. No manual stimulation of the needles will be performed.
Other intervention name(s): real acupuncture; sham acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electro-acupuncture; HCG stimulation test; Menstrual frequency; polycystic ovary syndrome; Randomized; controlled; trial
A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the reactogenicity, safety and immune response of a
      single intramuscular dose of the respiratory syncytial virus maternal (RSV MAT) vaccine in
      healthy non-pregnant girls 9-17 years of age (YOA) compared to non-pregnant adult women 18-49
      YOA. The combined reduced-antigen-content diphtheria, tetanus and acellular pertussis (dTpa)
      vaccine was planned to be used as an active control for safety and reactogenicity evaluation.

      Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV
      MAT 009), GSK made the decision to stop enrolment and vaccination in this study. Enrolled
      study participants were monitored as part of the study until study completion.
    


Intervention name(s): RSV MAT vaccine; dTpa vaccine
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Single dose of the RSV MAT vaccine reconstituted with NaCl solution was planned to be administered intramuscularly, in the non-dominant arm, at Day 1 or at Day 31, depending on the vaccination schedule.
RSV MAT vaccine was no longer administered to participants at Day 31. No vaccine was administered in the dTpa_RSV-P Group, since there were no participants assigned to it.; Single dose of the dTpa vaccine was planned to be administered intramuscularly, in the non-dominant arm, at Day 1 or at Day 31, depending on the vaccination schedule.
Two formulations of dTpa vaccine are licensed in the US and outside of the US (ex-US), respectively. dTpa-US formulation was administered to participants in centers located in the US, while dTpa-ex-US formulation was planned to be administered to participants in centers ex-US. The dTpa-ex-US formulation was not applicable in this study anymore as no non-US sites were initiated before the decision to stop the study.
The participants in RSV_dTpa-P and RSV_dTpa-A study groups were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
No vaccine was administered in the dTpa_RSV-P Group, since there were no participants assigned to it.
Other intervention name(s): Boostrix
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The interventional study model was planned to be crossover, but this is no longer applicable as there were no more study activities planned.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Respiratory Syncytial Virus Maternal vaccine; Combined reduced-antigen-content diphtheria, tetanus and acellular pertussis vaccine; Reactogenicity; Safety; Immunogenicity; Healthy non-pregnant girl; Healthy non-pregnant adult women
A Study of Neural Circuit Responses to Catechol-O-methyl Transferase (COMT) Inhibitors
Condition: Impulsive Behavior
MeSH terms: Impulsive Behavior
Study type: Interventional

Summary: 
      In this study, we seek to understand the effects of tolcapone, an FDA-approved COMT
      inhibitor, on reward choice and response inhibition, two measures we have previously shown to
      be altered in subjects with alcoholism. We now plan to test the hypothesis that COMT
      regulation of cortical dopamine levels is critical for regulation financial choices.
      Specifically, we propose that the lower levels of cortical dopamine present in individuals
      with the val158val COMT genotype reduces the inhibitory effect of frontal cortical areas on
      impulsive choice; an idea that extends previous hypotheses about the negative consequences of
      decreased prefrontal dopamine levels on inhibitory control. Moreover, this hypothesis
      suggests that inhibiting COMT may slow the degradation of dopamine and thereby decrease
      impulsivity.
    

Detailed description: 
      Drug consumption despite adverse consequences is a defining feature of human addiction
      (DSM-IV-TR, 2004). Impulsivity, a tendency to choose an immediate action despite delayed
      adverse consequences, is a major risk factor for tobacco, psychostimulant, opioid and alcohol
      abuse. In humans, impulsivity can be quantified by presenting subjects with a choice between
      a small immediate monetary reward or a larger but delayed reward. We recently found that the
      val158val allele for the enzyme catechol-O-methyltransferase (COMT), which is associated with
      more rapid cortical dopamine catabolism and thus lower cortical dopamine levels correlates
      with greater impulsivity and greater fMRI blood oxygen level dependent (BOLD) signal in
      dorsolateral prefrontal and posterior parietal cortices.

      The first phase of the study will involve healthy controls. The second phase of the study
      will involve abstinent alcoholics matched for age, education, and gender. Subjects will range
      in age between 18 and 50 years old.
    

Intervention name(s): Tolcapone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Drug: Tolcapone 200mg (single dose) administered at study visit; Placebo (200mg) administered at study visit
Other intervention name(s): Tasmar
Intervention MeSH terms: Tolcapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients
Condition: Kidney Transplantation Recipients
MeSH terms: Cytomegalovirus Infections
Study type: Observational

Summary: 
      CMV is one of the most important opportunistic infection in transplant recipients. In South
      Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity
      for CMV IgG before solid organ transplantation is a laboratory test of choice to stratify the
      risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific
      cell-mediate immune response before solid organ transplantation will further categorize the
      patients into high or low risk of CMV development after solid organ transplantation. The
      investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in kidney transplant
      candidates to predict the development of CMV infection after kidney transplantation.
    

Detailed description: 
      Between Mar 2014 and Mar 2015, all patients admitted in the kidney transplant unit will be
      enrolled in this study. All patients will receive CMV-specific ELISPOT assay and be
      prospectively followed for the development of CMV infection.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Kindeny transplant recipients
Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the extent to which Lu AF35700 enters the
      bloodstream following pill intake and the influence of food on the uptake in healthy men and
      women
    

Detailed description: 
      Each subject will receive a single oral dose of Lu AF35700 on Day 1 in each Period. Subjects
      in Group 1 will be in fasting condition in Period I and in a fed condition in Period II.
      Subjects in Group 2 will be in fed condition in Period I and in fasting condition in Period
      II.

      For Group 1, period 1 only, a single intravenous micro-dose of Lu AF35700 will be given 4
      hours after oral dosing.

      All subjects will be confined to the clinic from one day prior to the first dosing until Day
      6 (120 hours post dose) for each dosing period. Periods I and II will be separated by a
      period of 6 weeks.
    

Intervention name(s): Lu AF35700; Lu AF35700 iv
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg Lu AF35700 single oral dose; 100 μg [14C]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
IPT-A for Adolescents With PTSD Symptoms
Condition: PTSD
Study type: Interventional

Summary: 
      In the present study, the investigators propose to 1) adapt Interpersonal Psychotherapy for
      Adolescents (IPT-A) as an intervention for adolescents who report elevated symptoms of
      posttraumatic stress disorder (PTSD) and/or meet Diagnostic and Statistical Manual of Mental
      Disorders - Fifth Edition (DSM-5) criteria for PTSD; and 2) conduct a small open pilot study
      of IPT-A for PTSD. Ten adolescents ages 13 to 18 who meet DSM-5 criteria for a PTSD diagnosis
      or have elevated symptoms of PTSD (Child PTSD Symptom Scale [CPSS-5] ≥ 31) will be treated
      with 14-16 weeks of an adapted version of IPT-A. If participants have evidenced a decrease in
      PTSD symptoms (CPSS-5 < 31) they will also receive 3 months of once a month maintenance
      treatment and be assessed by a clinician evaluator at the conclusion of the 3 monthly
      sessions. If participants have not evidenced a decrease in PTSD symptoms (CPSS-5 ≥ 31), they
      will be referred for alternative treatments in the community and be assessed by a clinician
      evaluator 3 months following the completion of IPT-A. All evaluations and therapy sessions
      will be done over telehealth platform until able to be done in person.
    

Detailed description: 
      Please see the brief summary for study description.
    

Intervention name(s): Interpersonal Psychotherapy for Adolescents
Intervention type(s): Behavioral
Intervention description(s): IPT-A is a psychosocial intervention for adolescents that focuses on improving interpersonal relationships that seem to be associated with the psychiatric symptoms.
Other intervention name(s): IPT-A
Intervention model: Single Group Assignment
Intervention model description: This is an open clinical trial of an psychosocial intervention for adolescents
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children Undergoing Minor Surgery
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to assess the analgesic efficacy in the prevention of postoperative pain in children
      undergoing minor surgery (herniorraphy, tonsillectomy) and to assess the tolerability of
      Metamizol in this group of patients.
    


Intervention name(s): Magnesium metamizol; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Nolotil
Intervention MeSH terms: Dipyrone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
15 Year Follow-up of New Beginnings Program for Divorced Families
Condition: Mental Disorder; Substance Use
MeSH terms: Substance-Related Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The project is a 15-year follow-up of 240 young adults whose families participated in an
      experimental evaluation of the New Beginnings Program (NBP), a preventive intervention for
      divorced families. The NBP was provided in late childhood; the follow-up occurred in young
      adulthood. Families were randomly assigned to one of three conditions: mother program (MP),
      dual-component mother and child program (MPCP), or literature-control (LC) condition.
      Programs were designed to change several putative mediators of children's post-divorce mental
      health problems using empirically-supported change strategies. The investigators expected
      that the NBP would have either main or risk by program interactive effects on mental health
      and substance use problems and disorders, developmental tasks, parent-young adult
      relationships, physical health problems, and competencies, such that YAs who participated in
      NBP will have better functioning than YAs in the control condition. The investigators
      expected that the NBP will have either main or risk by program interactive effects on
      mothers' mental health; those in the NBP are expected to have fewer mental health problems
      than those in the control condition.
    


Intervention name(s): New Beginnings Program
Intervention type(s): Behavioral
Intervention description(s): A preventive intervention for divorced families.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention; Divorce
Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg
      Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four
      groups of healthy volunteers, injecting two doses with two months interval.
    


Intervention name(s): 50 µg Ag85B-ESAT-6 alone; 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01; 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01; 50 µg Ag85B-ESAT-6 + 625/125 µg CAF01
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL solution for injection x 2 (2 months interval); 0,5 mL suspension for injection x 2 (2 months interval); 0.5 mL suspension for injection x 2 (2 months interval); 0.5 mL suspension for injection x 2 (2 months interval)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: safety; vaccine; tuberculosis; CAF01; Ag85B-ESAT-6; prevention