bioihbjkbjnl/mcl2 huggingface dataset:
Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart
Condition: Suicidal Ideation Active; Suicidal and Self-injurious Behavior
MeSH terms: Suicidal Ideation; Self-Injurious Behavior
Study type: Interventional

Summary: 
      This is a randomized controlled trial comparing the use of new clinical intervention (the
      "Collaborative Assessment and Management of Suicidality--CAMS") versus enhanced care as usual
      for suicidal Soldiers who are seen at outpatient mental health clinics at Ft. Stewart GA.
    

Detailed description: 
      This is a randomized controlled clinical trial of 148 suicidal active-duty US Army Soldiers.
      Participants were randomized to on-site providers who were trained in the Collaborative
      Assessment and Management of Suicidality (CAMS) vs. providers doing their own routine
      care--referred to as Enhanced Care as Usual (E-CAU) within an outpatient military treatment
      center. The CAMS Rating Scale (CRS) was used to reliably verify fidelity between treatment
      conditions and the adherence by CAMS providers to the model. Participants received informed
      consent to be randomly assigned to treatment arm and were ask to complete study assessments
      at baseline, 3 months, 6 months, and 12 months after the start of treatment. Recruitment is
      complete and all study assessments were completed as of March 2016. The study is in a second
      year of no cost extension; outcome data analyses and moderator analyses are currently
      underway to develop manuscripts for submission to peer-review scientific journals.
    

Intervention name(s): The Collaborative Assessment and Management of Suicidality; Enhanced Care as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intensive outpatient, suicide-focused, psychotherapy designed to target and treat the "drivers" of suicidal ideation and behaviors.; This is just standard outpatient mental health care that is routinely provided in the study site outpatient clinic
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Suicide; Assessment; Intervention; CAMS
MicroRNAs in Patients With Neurofibromatosis Type 1
Condition: Glioma; Neurofibromatosis Type 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Observational

Summary: 
      MicroRNAs are small molecules which have recently been discovered in cells. They are known to
      be responsible for the normal development of cells and when they are disrupted can contribute
      to the development of cancer. Many previous studies have been done evaluating the expression
      of microRNAs in normal tissues as well as in a wide variety of cancers.

      Recently, microRNAs from tumor cells have been detected circulating in the blood of patients
      with cancer. This presents a novel opportunity to assess the utility of microRNAs in the
      blood as an early predictor of cancer as well as a marker of response to therapy. No previous
      studies have been performed evaluating microRNAs in archived tumor tissue and blood of
      patients with Neurofibromatosis type 1 (NF-1). The investigators propose a feasibility study
      to evaluate the presence of microRNAs in archived tumor tissue and the blood of patients with
      NF-1. If the investigators are able to identify circulating microRNAs in this population of
      pediatric patients, they will build upon this data in proposing a future study.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participation in the study will be offered to patient's ages 2 years to 21 years seen for a
        routine visit in the Neurofibromatosis Clinic at Children's Memorial Hospital and Lurie
        Children's Hospital in Chicago.
IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda
Condition: Non HIV Infected Pregnant Women
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study will address the question whether the use of IPT using SP in pregnancy is
      efficacious in Rwanda, where it is going to be used for the first time, in areas with high
      levels of SP resistance. While the implementation of the new policy will take place in areas
      at low SP resistance level, where we expect pregnant women and newborns to benefit from it,
      it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high
      SP drug resistance and at what level of SP resistance this strategy is still efficacious. As
      bed nets are a part of the actual control strategy of malaria in pregnancy all women will
      receive a bed net at enrolment
    

Detailed description: 
      The present study will address the question whether the use of IPT using SP in pregnancy is
      efficacious in Rwanda, where it is going to be used for the first time, in areas with high
      levels of SP resistance. While the implementation of the new policy will take place in areas
      at low SP resistance level, where we expect pregnant women and newborns to benefit from it,
      it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high
      SP drug resistance and at what level of SP resistance this strategy is still efficacious. As
      bed nets are a part of the actual control strategy of malaria in pregnancy all women will
      receive a bed net at enrolment.

      This will be a randomized blinded placebo controlled trial: women in the 16-28th week of
      gestation will be offered enrolment into the study and randomized to receive IPT/SP regimen
      or placebo once during the second and once in the third trimesters.

      The study will be conducted in Mashesha (estimated SP drug resistance 20%, 12% in 2000),
      Kicukiro (40% SP resistance) and Rukara (60% SP resistance). In each of these sites there are
      about 1000 deliveries per year. According to DHMT data, over 75% of pregnant women attend
      antenatal clinics, usually booking between 15 and 25 weeks of gestation. Based on this study
      we expect to find placental malaria prevalence over 50% in all sites.
    

Intervention name(s): Sulfadoxine-Pyrimethamine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.; The control group receives placebo similar in taste and appearance to to the experimental arm
Other intervention name(s): fansidar
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregnancy malaria prevention
Electric and Manual Toothbrushes in Nursing Homes
Condition: Oral Health
Study type: Interventional

Summary: 
      Effect of electric toothbrush on oral hygiene in nursing home residents tested I randomized
      clinical trial for 2 months and followed up 12 months after baseline
    

Detailed description: 
      Patients in nursing homes often have many natural teeth with exposed root surfaces,
      bifurcations, a complexity of dental restorations like partial prostheses, bridges/crowns,
      fillings and implants. In addition they have a limited physical ability, like reduced
      muscular strength, rigidness in the neck and spine. All these factors contribute to make it
      difficult, both for themselves and their nursing staff to maintain good oral hygiene.

      Electrical toothbrushes have been proved effective in removal of dental plaque. There have
      also been reports from nursing homes that approves of electrical toothbrushes as a helpful
      aid among the nursing staff.

      The present study examine if the overall oral hygiene actually improves with the use of
      electric toothbrush.

      Material and method: The study is a randomized clinical trial (RCT) that includes patients
      from nursing homes in Oslo. The recording dentist is blind to the type of tooth brush
      Inclusion criteria.

        -  Patients living in nursing home in Oslo

        -  Provide written informed consent prior to enrolment (from relatives when patients were
           assessed by physician to be without ability to give written consent.

      Participants in the experimental group use an electrical toothbrush. Participants in the
      control group use a standard manual toothbrush.

      Registration of oral hygiene and plaque score at baseline 0 and after 2 months intervention.

      After the RCT trial the participants were free to choose toothbrush, electric or manual. The
      study includes a follow-up study 10 months after the end of the RCT trial.

      The study is a part of the PhD programme for Katrine Gahre Fjeld Cand. Odont.

      Supervisors:

      Tiril Willumsen Dr Odont, The Dental Faculty, University of Oslo Hilde Eide Dr. Philos,
      Department of Nursing, Buskerud University College Morten Mowe Dr med, The Medical Faculty,
      University of Oslo
    

Intervention name(s): Electric toothbrush; Control
Intervention type(s): Other; Other
Intervention description(s): Manual toothbrush
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: nursing home; gerodontology; oral hygiene
Effect of Galactose Ingestion on Postprandial Lipemia
Condition: Cardiovascular Risk Factor; Lipemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      This study aims to assess the postprandial triglyceride response to the ingestion of a
      high-fat meal with co-ingestion of either galactose, or glucose.
    


Intervention name(s): Galactose; Glucose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Co-ingestion of d-galactose with a high-fat meal; Co-ingestion of d-glucose with a high-fat meal
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, blinded crossover design.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
Condition: Encephalitis, Tick-Borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the immunogenicity, safety and interchangeability of
      two different TBE vaccines in children aged 1-11 years, the first and second vaccination with
      either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with
      FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28
      and 360 days).
    


Intervention name(s): Tick-Borne Encephalitis (TBE) Vaccine (Inactivated); Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Intervention type(s): Biological; Biological
Intervention description(s): Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360; Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Masking: Single (Participant)
Primary purpose: Prevention
Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B
Condition: HBeAg-Positive Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, double blind, active-controlled, randomized, parallel group study to
      demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for
      patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48
      days.
    


Intervention name(s): Baracle Tab.®; Baraclude Tab.®
Intervention type(s): Drug; Drug
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
GlyT-1 Inhibitor Treatment for Refractory Schizophrenia
Condition: Schizophrenia; Treatment Refractory
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      The etiology of schizophrenia remains unclear In recent one decade, hypofunction of
      N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of
      schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for
      schizophrenia treatment.

      To date, refractory schizophrenia (particularly clozapine-resistant) is still a difficult
      clinical issue. However, the effect of NMDA treatment in refractory schizophrenia is still
      unknown. Therefore, the primary goal of this study is to investigate the efficacy and safety
      of NMDA adjuvant therapy in refractory schizophrenia, and to identify the predictors for
      treatment response to NMDA enhancers.
    

Detailed description: 
      The etiology of schizophrenia remains unclear. In recent one decade, hypofunction of
      N-methyl-D-aspartate (NMDA) receptor has been implicated in the pathophysiology of
      schizophrenia. Hence, enhancing NMDA neurotransmission was considered as a new approach for
      schizophrenia treatment. To date, there have been a few pilot studies exploring the efficacy
      of NMDA enhancers as adjuvant therapy for schizophrenia, for instance, D-serine (an
      endogenous agonist of the NMDA-glycine site). They were not only well-tolerated but also
      synergistic in improving positive, negative and cognitive symptoms in those receiving typical
      and atypical antipsychotics (except clozapine).

      Refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical
      issue at present. Previous studies revealed that add-on treatment of D-serine or other
      agonists of NMDA receptor failed to give significant benefits in such patients. The primary
      goal of this study is to investigate the efficacy and safety of glycine transporter(GlyT)-1
      inhibitor adjuvant therapy in refractory schizophrenia, and to identify the predictors for
      treatment response to NMDA enhancers.
    

Intervention name(s): GlyT-1 inhibitor-1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GlyT-1 inhibitor-1(500) 4# BID; starch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: N-methyl-D-aspartate receptor; glycine transporter; schizophrenia
High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. It is not yet known if radiation therapy plus chemotherapy is more effective than
      radiation therapy alone in treating patients with head and neck cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation
      therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head
      and neck cancer who have undergone surgery to remove the cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine whether the addition of cisplatin to high-dose postoperative
      radiotherapy increases the disease-free survival rate of patients with locally advanced head
      and neck carcinomas at high risk of recurrence following radical surgery.

      OUTLINE: Randomized study. Patients are registered and randomized to treatment within 25 days
      of surgery. Arm I: Radiotherapy. Irradiation of the preoperative primary tumor site with a
      boost to areas at high risk for recurrence using Co60 equipment, 4-6 MV linear accelerators,
      or 6-12 MeV electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation as in
      Arm I; plus Cisplatin, CDDP, NSC-119875.

      PROJECTED ACCRUAL: A total of 338 evaluable patients will be studied.
    

Intervention name(s): cisplatin; low-LET cobalt-60 gamma ray therapy; low-LET electron therapy; low-LET photon therapy
Intervention type(s): Drug; Radiation; Radiation; Radiation
Intervention MeSH terms: Cobalt
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx
A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy
      participants.
    

Detailed description: 
      This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics
      in healthy adult participants after single and multiple subcutaneous injections of
      pegilodecakin.
    

Intervention name(s): Pegilodecakin
Intervention type(s): Biological
Intervention description(s): Pegilodecakin Alone
Other intervention name(s): LY3500518; AM0010
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparing Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of GAD
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Meta Cognitive Therapy (MCT) has been introduced as a new specific treatment for generalised
      anxiety disorder. So far, no studies have examined CBT and MCT in comparison with each other
      in a randomised controlled trial. Sixty patients with a diagnosis of generalised anxiety
      disorder will be selected and randomised into three treatment conditions. The first group
      (N=20) will be treated with CBT, the second group (N=20) with MCT, and the third condition is
      a waiting list control (N=20). The patients in both groups will have full treatment, in
      accordance to treatment manuals developed by the originators. Patients in the waiting list
      control will be randomly allocated to either CBT or MCT after 12 weeks of waiting period.

      The patients will be assessed with the primary measures at pre-treatment, at the end of
      treatment, and at follow-up after one and two years. In addition they will be assessed weekly
      on symptom measures and worry outcome diary. The therapist will be treating equally amount of
      patients in both conditions to control for any biased distribution connected to the
      therapist's characteristics.

      Measures will be used on at least three main sources; self-report inventories (including
      symptom diaries), clinical assessments by independent raters and psycho-physiological
      assessments.

      We aim to (1) evaluate and compare the effectiveness of CBT and MCT, (2) investigate the
      patterns of change and the mechanisms of action involved during treatment in each of the
      conditions and, (3) evaluate pre and post-treatment somatic change by psycho-physiological
      assessments as a response to CBT and MCT.
    


Intervention name(s): Cognitive-Behavioural Therapy; Meta-Cognitive Therapy; Waiting list
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 12 sessions with Cognitive-Behavioural Therapy (CBT), and waiting list will be over 12 weeks, and then allocated into Meta-Cognitive Therapy.; 12 sessions with Meta-Cognitive Therapy (MCT), and waiting list will be over 12 weeks, and then allocated into Cognitive-Behavioural Therapy .
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study of Caffeine for Apnea of Prematurity
Condition: Apnea of Prematurity
MeSH terms: Apnea; Premature Birth
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present Phase III study is to evaluate the safety, efficacy and
      pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.
    


Intervention name(s): NPC-11 for intravenous or oral administration.
Intervention type(s): Drug
Intervention description(s): NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine).
Other intervention name(s): caffeine citrate
Intervention MeSH terms: Caffeine; Caffeine citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: caffeine; apnea; prematurity
Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy male volunteers were administered alone and in combination with dapoxetine 30mg
      mirodenafil 100mg for three times, respectively and the pharmacokinetic interaction was
      compared between the two drugs.
    

Detailed description: 
      Healthy male volunteers were randomized into one group among 6 sequential groups and were
      administered alone or in combination with dapoxetine 30mg mirodenafil 100mg in each period.
      Bloods were obtained at each time for pharmacokinetic analysis. Safety evaluation was also
      done during entire study period.
    

Intervention name(s): Dapoxetine 30mg; Mirodenafil 100mg
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, Orally administered; Table, Orally administered
Intervention MeSH terms: Mirodenafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dapoxetine; Mirodenafil; DDI study