bioihbjkbjnl/mcl2 huggingface dataset:
Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture
Condition: Bile Duct Disease
MeSH terms: Bile Duct Diseases; Constriction, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the feasibility, easy removability, safety, and
      migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring
      FCSEMS for benign biliary stricture.
    

Detailed description: 
      Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of
      uncovered metallic stents has been associated with failure related to mucosal hyperplasia.
      Fully covered self-expanding metal stent(FCSEMS) placement was reported as a useful method
      for BBS. However, stent migration was a frequent complication of CSEMS placement. Recently,
      flared end FCSEMS was developed to decrease stent migration, and anchoring CSEMS was newly
      developed.
    

Intervention name(s): Bona stent® (Flared end FCSEMS); Hanarostent® (Anchoring FCSEMS)
Intervention type(s): Device; Device
Intervention description(s): Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.; Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.
Other intervention name(s): Bona stent® (Sewoon medical Co., LTD., Seoul, Korea); Hanarostent® (M.I.Tech, Seoul, Korea)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metal stent; Bile duct stricture; Stent migration; Feasibility; Safety; Removability
Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
Condition: Advanced Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      i. Project Background Patients with advanced lung cancer have a high symptom burden and low
      quality of life. Early palliative care improves patient outcomes in newly diagnosed advanced
      lung cancer patients, but previously tested models are not feasible for widespread adoption.
      Hence, the aim of this study is to pilot a more sustainable nurse-led intervention -
      Enhancing Quality of life in Patients (EQUIP).

      ii. Hypothesis / Aim The aims of this study are three-fold. Firstly, the investigators aim to
      determine the feasibility and acceptability of the EQUIP intervention itself. Secondly, the
      investigators aim to obtain a tentative estimate of efficacy of the EQUIP intervention.
      Thirdly, the investigators aim to determine the data completion rate of patient reported
      outcome measures in the context of the EQUIP trial.

      iii. Methods Patients with newly diagnosed stage 3 or stage 4 lung cancer will be recruited
      and randomized to the EQUIP intervention or usual care (control) group. Patients randomized
      to the EQUIP intervention group will receive four face-to-face sessions with a palliative
      care nurse. The content of these educational sessions will equip patients with the knowledge
      and skills to manage the three commonest symptoms of fatigue, breathlessness and anxiety.

      All participants will complete the Functional Assessment of Cancer Therapy - Lung (FACT-L),
      the Hospital Anxiety and Depression Scale (HADS) and the stigma subscale at four time points:
      baseline, 4, 8 and 12 weeks after recruitment. Measures of healthcare use will also be
      recorded. Additionally, participants in the intervention group will complete a feedback
      survey after each intervention session.

      A total sample of 60 patients (30 in each arm) will be recruited.

      Clinical Significance

      If successful, this study will lead to a larger scale phase III trial which tests various
      components of the EQUIP intervention, in order to develop a sustainable and effective model
      for the provision of palliative care to advanced lung cancer patients.
    


Intervention name(s): EQUIP
Intervention type(s): Other
Intervention description(s): Patients in the EQUIP intervention group will receive four face-to-face sessions. The focus of these sessions is to equip patients with the skills and strategies needed to cope with common symptoms experienced by lung cancer patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, double-blind (sponsor-unblinded), randomized, placebo-controlled,
      single- and repeat-dose escalation study including a weekly oral dose (MAD) cohort and a
      relative bioavailability (RBA) and food effect (FE) cohort to investigate the safety,
      tolerability and PK of VH3739937 in healthy participants. This is a three part study. Part 1
      and Part 2 is designed to gain information on the safety, tolerability, and pharmacokinetic
      (PK) properties of GSK3739937 when administered as powder-in-a-bottle (PiB). Part 3 will
      evaluate the RBA of the GSK3739937 PiB and GSK3739937 Tablet and the safety, tolerability and
      PK parameters of the tablet formulation when administered under fasting and fed conditions.
    


Intervention name(s): GSK3739937 (PIB); Placebo; GSK3739937 (Tablet)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK3739937 will be administered as oral suspension.; Placebo will be given orally during each dosing day.; GSK3739937 Tablet will be administered via oral route.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study while Part 3 is a 3-period crossover design.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; First-time-in-human; Pharmacokinetics; Safety; Tolerability
Plant Stanols and Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      In type 1 diabetes (T1D) coronary artery disease (CAD) is an important cause of morbidity and
      mortality. Although serum cholesterol concentrations are not always elevated in T1D,
      cholesterol metabolism is different from non-diabetics, so that cholesterol absorption is
      enhanced. The aim of this study is to investigate the effects of plant stanol esters on serum
      lipid and lipoprotein lipid concentrations, plant sterol and cholestanol concentrations as
      well as cholesterol metabolism in T1 diabetics on statin use. The study will give new
      information about how addition of plant stanol esters on statin use improve hypolipidemic
      effects in type 1 diabetes.
    

Detailed description: 
      In type 1 diabetes (T1D) coronary artery disease (CAD) is an important cause of morbidity and
      mortality. Although serum cholesterol concentrations are not always elevated in T1D,
      cholesterol metabolism is different from non-diabetics, so that cholesterol absorption is
      enhanced. Thus, theoretically, the best way to reduce serum cholesterol concentrations is to
      reduce cholesterol absorption. However, statins are recommended to T1 diabetics at the same
      LDL cholesterol levels as for type 2 diabetics to reduce risk to CAD.

      The aim of this study is to investigate the effects of plant stanol esters on serum lipid and
      lipoprotein lipid concentrations, plant sterol and cholestanol concentrations as well as
      cholesterol metabolism in T1 diabetics on statin use.

      Altogether, twenty-four T1 diabetics (HbA1c <9%) on stabile statin use will be recruited to
      the study from an announcement in the local newspaper and from Kuopio University Hospital and
      Harjula Hospital. The study is carried out with a randomized, double-blind and parallel
      design. The intervention group (n=12) consumes spread enriched with plant stanol esters (3
      g/d stanols) and the control group (n=12) the same spread containing no added stanols for 4
      weeks. The fasting blood samples are taken at weeks 0, 3 and 4. From blood samples
      concentrations of serum lipids, squalene and non-cholesterol sterols will be analyzed.
    

Intervention name(s): Vegetable oil based margarine with plant stanol ester enrichment
Intervention type(s): Dietary Supplement
Intervention description(s): 3 g plant stanols/ day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Plant stanols; type 1 diabetes; sterol metabolism; cholesterol
Personalized Quantum Sonotherapy in Regional Anesthesia
Condition: Pain, Postoperative; Anxiety
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The objetive of the study is to evaluate the effect of personalized quantum sonotherapy on
      the level of anxiety and pain in outpatients schedule for orthopedic surgery under regional
      anesthesia in a second level center. The investigators believed that personalized quantum
      sonotherapy could reduce the levels of anxiety and pain before and after surgery evaluated
      through hemodynamic variables and scales for pain (analogous visual scale) and anxiety (STAI
      Spielberger anxious state questionnaire).
    


Intervention name(s): Personalized quantum sonotherapy; Placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): Quantum sonotherapy is an alternative non-pharmacological treatment that effects a molecular reorganization that occurs after the sound stimulus. The audible words and their waves have the ability to generate vibrations and stimulate the psycho-neuro-endocrine chain, independent of the semantic meaning of the words. It is an alternative therapy that uses non-musical sound waves.; Headphones will be place in patients without playing quantum sonotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Personalized quantum sonotherapy; Regional anesthesia; Peripheral nerve block
A Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Injection In Healthy Japanese Subjects
Condition: Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      metronidazole following single and multiple intravenous infusion in healthy Japanese adult
      subjects.
    


Intervention name(s): metronidazole IV 500 mg
Intervention type(s): Drug
Intervention description(s): On Day 1, subjects will receive a single dose of 500 mg metronidazole by intravenous infusion over 20 minutes. On Day 3 to Day 7, subjects will receive multiple doses of 500 mg metronidazole by intravenous infusion over 20 minutes 4 times a day (every 6 hours) for 5 days.
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metronidazole infusion
Dutasteride for the Reduction of Alcohol Use in Male Drinkers
Condition: Alcoholism; Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate whether dutasteride is safe and effective for
      reducing alcohol use in male drinkers who want to stop or reduce their drinking. The
      investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and
      that, compared to placebo treatment, dutasteride will result in a greater reduction in the
      amount of alcohol consumed per week. The study sample size is of a pilot scale and is
      designed to provide additional support for the study hypothesis and provide an estimate of
      likely effect sizes in order to design a more definitive study.
    


Intervention name(s): Dutasteride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period; placebo capsules in same number as active drug, daily for 8-week treatment period
Other intervention name(s): Avodart; Lactose
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized Trial; Medication for Heavy Drinking; Dutasteride Treatment
Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with interstitial cystitis who meet eligibility requirements will be randomized to
      one of four treatment arms (3 RTX, Placebo). Study drug is administered as a single
      instillation within the urinary bladder. Study duration is 12 weeks.
    

Detailed description: 
      RATIONALE:

      Topical resiniferatoxin (RTX) administrated to the bladder may be effective in decreasing the
      symptoms associated with interstitial cystitis through its action on pain sensing neurons.

      PURPOSE:

      Randomized, double-blind, placebo-controlled, Phase 2 trial to determine the safety and
      efficacy of RTX in patients with interstitial cystitis.
    

Intervention name(s): H&P; ECG; Blood tests; voiding diary; Cystoscopy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Interstitial Cystitis; Bladder
Pilates Mat Versus Cervical Stabilization Exercises on Balance in Young Adults With Forward Head Posture
Condition: Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      see if there will be no statistical significant difference between the effects of Pilates mat
      versus cervical stabilization exercises on dynamic balance in young adults with forward head
      posture.
    

Detailed description: 
      In modernized time, extended use of mobile phone and computers has increased anterior weight
      bearing of cervical spine leading to a variety of musculoskeletal disorders related to the
      neck by changing the biomechanical stress of cervical spine. Additionally, forward head
      posture (FHP) alters the center of gravity (COG) of the body that lead to mechanical
      modifications related to postural control in the torso and every joint. The body attempts to
      adapt to these changes by altering its balance control mechanisms; these adaptations decrease
      balance ability while performing different activities and increase the risk of falling and
      musculoskeletal injury.
    

Intervention name(s): Pilates mat exercises; cervical stabilization exercises; conventional physiotherapy
Intervention type(s): Other; Other; Other
Intervention description(s): Pilates mat exercises: Each Pilates session will last for one hour and commence with a 10 minute warm up and finish with a 10 min cool down. The subjects will be taught the 5 key elements of Pilates (lateral costal breathing, centring which is a neutral position of the lumbar spine with activation of the core muscles, ribcage placement, shoulder blade placement and neutral position of the cervical spine with slight upper cervical flexion at the cranio-cervical junction).
Pilates exercise program will consist of warm up exercises, main treatment program (10 level) and cooling down exercises.; training of deep cervical flexor muscles with pressure biofeedback unit, 20 min/day, 3 days/week for 12 weeks.; 10 min hot pack on cervical area range of motion exercises and isometric neck exercises as a home program 3 days/week for 12 weeks
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Balance; Craniovertebral angle
Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ZYIL1 Following Oral Administration in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      ZYIL1 is a novel oral selective NLRP3 inflammasome inhibitor which prevents NLRP3-induced ASC
      oligomerization, thus inhibiting NLRP3 inflammasome pathway. ZYIL1 is expected to show
      benefit in patients demonstrating cytokine, like IL1β flare, including those exhibiting
      cytokine storm related to COVID-19 and other viral inflammatory diseases.
    

Detailed description: 
      It is an open label, study designed to evaluate safety, tolerability, pharmacokinetics (PK)
      and pharmacodynamics (PD) following a single-oral dose administration of ZYIL1 to healthy
      subjects aged between 18-55 years old (Both Inclusive).

      It will be conducted in up to 7 cohorts of 6 subjects each. Each cohort will be enrolled
      within a 28 day screening period to ensure subjects meet all the inclusion criteria and none
      of the exclusion criteria. Subjects will be administered single oral dose of ZYIL1 on Day 1.

      In this study each cohort containing six subjects will be given a single oral dose of ZYIL1
      in ascending manner. Initially, up to 3 cohorts of 18 subjects will be enrolled and dosed.
      Interim analysis will be done after completion of three cohorts and submitted to Central
      Licensing Authority of India(CLA). Further cohorts (i.e. cohort S4 onwards) will be conducted
      after obtaining approval of CLA.

      This is the first administration of ZYIL1 in humans; therefore, study design adjustments may
      be made based on emerging data from each dose cohort based on review of preliminary safety,
      tolerability, and PK results.
    

Intervention name(s): ZYIL1 capsule
Intervention type(s): Drug
Intervention description(s): NLRP3 inflammasome inhibitor
Intervention model: Single Group Assignment
Intervention model description: A phase 1, prospective open label, single dose, single arm study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID 19; NLRP3; NLPR3 Inflammasone inhibitor
A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical trial study to determine the effect of an investigational drug (SEP-363856) has on
      the way that the drug Metformin travels through the body in people with schizophrenia. This
      clinical trial will have approximately 24 subjects both male and female 18 year of age and
      older. This study will be conducted in approximately 2 study sites in the United States.
    

Detailed description: 
      This is a randomized, single-blind, two-period crossover study in which each subject will
      receive both treatments and therefore act as their own control to minimize confounding
      covariates within the study population. Randomizing subjects to treatment sequence will
      assist with reducing the potential order effects that might confound the findings if all the
      subjects received the same treatment sequence. The single-blind method is used to keep
      subjects blind to treatment assignment throughout the study period, in order to avoid
      possible influence of the psychological factors of subjects on study assessments. This
      clinical study will evaluate whether SEP 363856 influences the PK of a concomitantly
      administered OCT2 substrate, metformin.
    

Intervention name(s): placebo; SEP-363856; metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose of placebo; single dose of SEP 363856 100 mg; metformin-HCl 850 mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, single-blind, two-period crossover study in adults with schizophrenia
Masking: Single (Participant)
Primary purpose: Treatment
Clinical Efficacy of Atomoxetine for Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to examine the ability of atomoxetine compared to placebo to
      increase time to relapse in methamphetamine dependent volunteers. Our hypothesis is that
      atomoxetine will increase time before (if) the participant relapses.
    

Detailed description: 
      During the study participants will spend the initial 2-weeks of the study at an inpatient
      facility. This will help participants initiate withdrawal. During the following 8-weeks the
      participant will come in for 3-4 visits each week. Three of these visits will be with the
      research assistants and one visit will be with a therapist in order to work with the
      participant using a cognitive behavioral therapy approach. Therapy visits are typically
      scheduled on a day that the participant is coming for clinic anyways so the number of visits
      per week is typically 3. During the 10-week period the investigators will collect various
      measures, including vitals, cognitive assessments, mood assessments, urine drug screens,
      weekly use reports of methamphetamine, and any reports of symptoms or side effects. This will
      tell the investigators if atomoxetine is safe and if a participant lapsed or relapsed.
    

Intervention name(s): Atomoxetine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7); participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.
Other intervention name(s): strattera; "sugar pill"
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: methamphetamine; addiction; relapse; atomoxetine
Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      According to traditional Chinese medical theories, a variety of acupuncture formulas can
      treat diseases such as pain. For example, stimulating acupoints either local or distal to the
      pain site has been proposed under some conditions. We hypothesize that stimulating acupoints
      contralateral to the pain site can successfully treat chronic shoulder pain.
    


Intervention name(s): Acupuncture; Control
Intervention type(s): Procedure; Other
Intervention description(s): Acupuncture in the following acupoints on the contralateral side of pain site: Jiantong, Zhongzhu, Houxi, and Quchi. The patient will receive 5 treatments (each lasts 30 min) per week for four weeks.; Patients in the waiting list group received conventional orthopaedic therapy including physical exercise, heat or cold therapy. 50 mg diclofenac daily could be taken when the patient suffered from the pain. Injections or cortisone applications of any kind were not allowed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: shoulder pain; acupuncture