bioihbjkbjnl/mcl2 huggingface dataset:
Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)
Condition: Moderate to Severe Gout; Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study
      to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients
      with hyperuricemia and moderate to severe gout.
    


Intervention name(s): Combination 400; Allopurinol; Combination 600
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tranilast 300 mg QD; Allopurinol 400 mg QD; Allopurinol 400 mg, QD; Tranilast, 300 mg QD; Allopurinol 600 mg QD
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Moderate to severe gout; Hyperuricemia
Thoracoscopic Versus Endocardial Ablation in Patient With Paroxysmal AF After Failed Initial Endocardial Ablation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators aimed to compare two approaches thoracoscopic epicardial ablation and
      endocardial catheter ablation after failed initial catheter ablation in patients with
      paroxysmal atrial fibrillation.
    


Intervention name(s): Thoracoscopic epicardial ablation; Endocardial catheter ablation; Implantable loop recorder
Intervention type(s): Procedure; Procedure; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lung Cancer Screening Study With Low-dose CT Scan and Blood Biomarker
Condition: High Risk of Developing Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is
      asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already
      have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has
      recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer
      deaths are not prevented with LDCT screening alone.
    

Detailed description: 
      In this trial, the addition of a blood biomarker test is being combined with early LDCT to
      determine if screening with combination may result in detection of more lung cancer at an
      earlier stage of disease.The study will also assess if the blood test is able to detect lung
      cancers in high risk individuals when the LDCT is negative for cancer. There will be
      health-economic costs included in the final analysis of study data.
    

Intervention name(s): CT scan & Early CDT Lung test; CT scan & Early CDT Lung test
Intervention type(s): Radiation; Other
Other intervention name(s): Every study participant receives a CT scan & Early CDT-Lung test (biomarker blood test); for lung cancer screening purposes; CT scan & Early CDT-Lung test (biomarker blood test)for lung cancer screening.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Lung cancer screening; Smokers or former smokers; Family history of lung cancer
A Phase 1, Single-center, Double-blind, Placebo-controlled Study of TNP-2092 Capsules, and the Food Effect Study After Single-dose Oral Administration of TNP-2092 Capsules
Condition: Hyperammonemia
MeSH terms: Hyperammonemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to evaluate the safety, tolerability, and pharmacokinetic
      characteristics of TNP-2092 Capsules in liver cirrhosis patients with hyperammonemia; and to
      preliminarily observe the effects of the study drug on blood ammonia and hepatic
      encephalopathy related clinical symptoms and signs, neuropsychological indicators, and
      quality of life in liver cirrhosis patients with hyperammonemia.
    


Intervention name(s): TNP-2092; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The drug will be administered once in each group.; The Placebo will be administered once in each group.
Other intervention name(s): Rifaquizinone
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Therapeutic Processes in iCBT for SAD
Condition: Social Anxiety Disorder; Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The current study examines therapeutic processes during internet-based cognitive-behavioral
      therapy for social anxiety disorder. Participants will be randomized to either treatment or
      wait-list conditions. Participants in the wait-list condition will receive active treatment
      following the wait-list period.
    

Detailed description: 
      Internet-based cognitive-behavioral therapy (iCBT) is an effective treatment for social
      anxiety disorder (SAD). However, little is known about the processes and mechanisms of change
      in this treatment. Compared to face to face (FTF) treatments, online interventions may
      operate through partially different mechanisms of change due to the text-based nature of the
      interaction and the reduced level of therapist involvement. The present randomized controlled
      trial will examine therapeutic processes during iCBT for SAD including the presence of sudden
      gains and their relationship to outcome, the relationship between anxiety and depressive
      symptoms along the course of treatment, changes in the therapeutic alliance and attrition
      from therapy. Moreover, we will compare iCBT for SAD with a wait-list control group and
      utilize weekly measurements of anxiety, depression, and SAD-related cognitions in both
      groups. This will facilitate comparison between temporal processes in both conditions and
      also shed light on processes occurring in wait-list conditions.
    

Intervention name(s): Internet delivered CBT for social anxiety disorder
Intervention type(s): Behavioral
Intervention description(s): An internet-based CBT for social anxiety based on a protocol from Andersson et al., 2006:
"Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial."
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social anxiety disorder; iCBT; Therapeutic processes
Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
Condition: Cervical Cancer; Endometrial Cancer; Leukemia; Non-Hodgkin's Lymphoma; Uterine Cancer; Vaginal Cancer; Infertility
MeSH terms: Endometrial Neoplasms; Vaginal Neoplasms; Uterine Neoplasms; Infertility
Study type: Observational

Summary: 
      This study aims to learn about the needs and feelings of women who are infertile. Being
      infertile means not being able to have a child without the help of a third party. There are
      other options for building a family. The researchers are interested in the participants'
      thoughts about these options and want to learn about the experiences of infertile women due
      to cancer treatment as well as women who are infertile due to other causes. The researchers
      hope that what they learn will allow them to better care for infertile women in the future.
    

Detailed description: 
      As part of this study, you will be asked to fill out a series of questionnaires. These
      questions will ask about your feelings, sexual function, quality of life, and ideas about
      reproductive options. We will also ask some questions about you, your health, and your
      medical history. You can choose to answer these questions either at one of your doctor visits
      or over the telephone. You can decide the best way to complete this assessment.
    

Intervention name(s): survey instrument
Intervention type(s): Behavioral
Intervention description(s): Participants will be mailed or given a one time survey instrument and data will be collected either in person or by telephone. We expect the study survey to take approximately 35-45 minutes to complete. The domains assessed will include psychological functioning, reproductive knowledge, perception of third party reproduction and concerns, sexual functioning, and quality of life.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cervical cancer, Endometrial cancer, Leukemia, Non-Hodgkin's Lymphoma, Uterine cancer,
        Vaginal cancer survivors and non-cancer infertile women
Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders
Condition: Bipolar Disorders; Metabolic Complication
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary goal of this study is to investigate metabolic changes and maintaining efficacy
      in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.
    

Detailed description: 
      -  reduced treatment adherence due to metabolic side effects

        -  suggested advantages of aripiprazole in metabolic profile over other antipsychotics or
           mood stabilizers

        -  randomized trial of switch from previous drugs to aripiprazole
    

Intervention name(s): aripiprazole
Intervention type(s): Drug
Intervention description(s): dosage form : po recommended dosage : more than 10mg/day duration : 28 weeks
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar disorder; metabolic complication; Aripiprazole; Weight gain; Clinical Trial; Antipsychotic; Metabolic syndrome; Psychopharmacology; Open Label
A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety of different dose strengths of INX-08189 in
      healthy adults. The study will also look at how rapidly the drug breaks down in the body
      (pharmacokinetics or PK). The study objectives include:

        -  To evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects

        -  To characterize the pharmacokinetic (PK) profile of single ascending oral doses of
           INX-08189 in healthy subjects

        -  To assess the food effect on the PK of a single oral dose of INX-08189
    


Intervention name(s): INX-08189; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3, 25 and 100 mg capsules; oral administration, single dose; matching placebo capsules, oral administration, single dose
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Safety and Pharmacokinetics
A Study Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab 600mg in Healthy Adult Male Subjects
Condition: Healthy Adult Male
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is Comparing the Pharmacokinetics of BK-C-0701 320mg, 480mg and Thiocacid HR Tab
      600mg in Healthy Adult Male Subjects.
    


Intervention name(s): Thiocacid HR Tab 600mg; BK-C-0701 320mg; BK-C-0701 480mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 600mg for 1 day; 320mg for 1 day; 480mg for 1 day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of the COVID-19 Pandemic on Mental Health Service Utilization in Children and Adolescents
Condition: Mental Disorder, Child
MeSH terms: COVID-19; Mental Disorders; Neurodevelopmental Disorders
Study type: Observational

Summary: 
      Mental health consequences of the COVID-19 pandemic may be vast and may potentially overwhelm
      the mental health system in a long-lasting manner. Evaluating the effects of the COVID-19
      pandemic on mental health in vulnerable groups such as children and adolescents has become an
      immediate priority. The aim of this study is to evaluate the impact of COVID-19 pandemic on
      use of mental health resources namely 1) prescriptions of psychotropic medications and 2)
      mental health-related outpatient visits, hospitalizations and emergency department visits in
      children and adolescents in France. Secondary aim is to evaluate the impact of the pandemic
      on episodes of fatal and non-fatal self-harm episodes in the same population. This will be a
      population-based cohort study using data from healthcare claims, administrative medical and
      outpatient drug dispensation databases in France between January 1, 2016 and June 1, 2021.
      Findings will inform on the risk of upcoming outbreaks of mental disorders that can result in
      significant morbidity and mortality and guide timely targeted actions to improve mental
      health outcomes and wellbeing in the youngest.
    

Detailed description: 
      Mental health consequences of the COVID-19 pandemic may be vast and may potentially overwhelm
      the mental health system in a long-lasting manner. Evaluating the effects of the COVID-19
      pandemic on mental health in vulnerable groups such as children and adolescents has become an
      immediate priority. The aim of this study is to evaluate the impact of COVID-19 pandemic on
      use of mental health resources namely 1) prescriptions of psychotropic medications and 2)
      mental health-related outpatient visits, hospitalizations and emergency department visits in
      children and adolescents in France. Secondary aim is to evaluate the impact of the pandemic
      on episodes of fatal and non-fatal self-harm episodes in the same population. This will be a
      population-based cohort study using data from healthcare claims, administrative medical and
      outpatient drug dispensation databases in France between January 1, 2016 and June 1, 2021.
      Findings will inform on the risk of upcoming outbreaks of mental disorders that can result in
      significant morbidity and mortality and guide timely targeted actions to improve mental
      health outcomes and wellbeing in the youngest.
    

Intervention name(s): national population-based study
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents aged from 6 to 18 years
      
Keywords: pediatrics; COVID 19 pandemic; mental health; psychotropic drug
Evaluation of a Contraceptive Counseling Intervention in Deprived Neighborhoods: SIRIAN Randomized Controlled Trial
Condition: Contraception
Study type: Interventional

Summary: 
      This study evaluates the effects of a community-based counseling intervention to improve
      contraception among residents in two deprived neighborhoods in Barcelona (Spain). Half of the
      participants received contraceptive counseling at the community setting, while the other half
      acted as a control group.
    

Detailed description: 
      To evaluate the effects of a community-based counseling intervention to improve contraception
      among residents in deprived neighborhoods a randomized controlled trial is performed. Women
      aged 14-49 years and men aged 14-39 years from two low income neighborhoods in Barcelona
      (Catalonia, Spain) who had not undergone an irreversible contraceptive method and aren't
      planning a pregnancy have been recruited in 2011-13. The intervention consists of a
      culturally developed and theoretically-based brief counseling in community settings. The
      primary outcome is the consistent use of very effective contraceptive methods (optimal use).
      Secondary outcomes analyzed are the incorrect use of very effective contraceptive methods and
      use of less effective methods stratified by sex and migrant status. Differences within
      subgroups from baseline to 3 months - follow up are analyzed and intervention effects are
      assessed with adjusted robust Poisson regressions.
    

Intervention name(s): Contraceptive counseling
Intervention type(s): Behavioral
Intervention description(s): A culturally adapted counselling session lasting up to 45 minutes at the community setting. The interview is based in WHO guidelines and communication tools, in social cognitive theory and in motivational interviewing. Along the interview, topics follow easy to read leaflets prepared to discuss the main benefits of contraception from the view of the immigrant communities, with guided discussions on family planning in the life course, the amount of time required to care children, the economic resources that newborn and children need, and an assessment of the knowledge on the contraceptive methods, and of their current use. Contraceptive methods, abortion and emergency contraception are discussed. Primary health care centre and sexual and reproductive health clinic access is reinforced.
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: randomized control trial; contraception; inequalities
Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Observational [Patient Registry]

Summary: 
      Children from two orphanages will be examined for dental caries experience, in comparison to
      parented school children.
    

Detailed description: 
      A total of 156 children were included in this study, they were, residing in governmental
      orphanage, non-governmental orphanage and parented children attending primary school. Written
      informed consent was obtained prior to the start of the study, form legal guardians or
      child's parent. Dental examination was carried out on an ordinary chair beside a window on
      day light. DMF and def indices were used to assess dental caries for primary and permanent
      teeth. Also, unmet treatment need index, care index and significant caries index were
      calculated.
    

Intervention name(s): caries assessment
Intervention type(s): Diagnostic Test
Intervention description(s): the child will examined for dental caries, caries prevalence, caries indices (def and DMF, or DMF)
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        apparently healthy children aged from six to12 years old
Efficacy of Ultrasound-guided Transverse Carpal Ligament Release for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is one of the most common peripheral nerve entrapment
      neuropathies, and it is characterized by pain, numbness, tingling, and weakness in the
      regions innervated by the median nerve (MN). CTS is believed to result from compression of
      the MN as it passes through the narrowed carpal tunnel with regard to gradual ischemia and
      fibrosis.Ultrasound-guided needle release of transverse carpal ligament(TCL) is an effective
      method to decompress the carpal.There are two main approaches to perform the release,
      short-axis or long-axis. However, there is no consensus about the optimal strategy.Thus, this
      study aimed to compare the efficacy of these two approaches for patients with
      mild-to-moderate CTS.
    


Intervention name(s): long-axis needle release; short-axis needle release
Intervention type(s): Other; Other
Intervention description(s): The participants received one session of ultrasound-guided long-axis TCL needle release.; The participants received one session of ultrasound-guided long-axis TCL needle release.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: transverse carpal ligament; ultrasound; carpal tunnel syndrome
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is partly to continue the good experience the investigators have
      with chemotherapy and partly to optimize treatment of inoperable cholangiocarcinoma by adding
      a biological antibody to the treatment of patients with wild-type Kirsten rat sarcoma viral
      oncogene homolog (KRAS).
    

Detailed description: 
      Cholangiocarcinoma is a relatively rare disease. In Denmark approximately 150 patients are
      diagnosed each year. A small part of the patients can be offered surgery, but the operation
      will rarely be radical, and most patients with cholangiocarcinoma are therefore candidates
      for chemotherapy.

      In Denmark the combination therapy of Gemcitabine, Oxaliplatin and Capecitabine has been used
      in recent years. Based on experience with gastrointestinal tumors, however, there seems to be
      an effect of new biological substances, including EGFR antibodies. There are casuistic
      reports on the specific effect of a monoclonal antibody against EGFR in cholangiocarcinoma.

      The effect of EGF is mediated through an intracellular pathway involving the KRAS protein. It
      has been shown that a mutation of KRAS causes the EGF system to be constantly activated.
      Effect in patients with a KRAS mutation is therefore not to be expected. Approximately 50% of
      the patients present this mutation.
    

Intervention name(s): Gemcitabine, Oxaliplatin, Capecitabine,; Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): Gemcitabin: 1,000 mg/m2 day 1 Oxaliplatin: 60 mg/m2 day 1 Capecitabine: 1,000 mg/m2 x 2 daily days 1-7; Gemcitabine: 1,000 mg/m2 day 1 Oxaliplatin: 60 mg/m2 day 1 Capecitabine: 1,000 mg/m2 x 2 daily days 1-7 Panitumumab: 6 mg/kg day 1
Intervention MeSH terms: Gemcitabine; Capecitabine; Oxaliplatin; Panitumumab
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: KRAS wild-type; Cholangiocarcinoma; Inoperable
Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      For subjects in Europe that have already participated in either Study SPD503-315 or
      SPD503-316. This is an extension study that will allow participants access to
      Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the
      sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl
      (SPD503).
    


Intervention name(s): Extended-release Guanfacine HCl (Intuniv, SPD503)
Intervention type(s): Drug
Intervention description(s): Subjects will be dosed orally once-daily in the AM at 1, 2, 3, 4, 5, 6, or 7 mg according to subjects weight and age
Other intervention name(s): Intuniv; SPD503
Intervention MeSH terms: Guanfacine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment