bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction.
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional
Phase: Phase 4

Summary: 
      It will be evaluated the clinical efficacy of Diclofenac 50mg (NSAID) compared to its
      association with Codeine 50mg (opioid) administered in 50 patients requiring extraction of
      two third molars. After assessing the research parameters, a comparative data analysis, along
      with the proper application of statistical tests, will provide the basis for an evaluation of
      both efficiency medications used.
    

Detailed description: 
      This research will evaluate the clinical efficacy of Diclofenac 50mg (NSAID) compared to its
      association with Codeine 50mg (opioid) administered in 50 patients aged less than 18 and
      requiring extraction of two third molars (with very similar positions, whose degree of
      difficulty is high). It will be assessed the following parameters: 1) onset and duration of
      surgery after administration of local anesthetic, 2) open mouth prior to surgery, on the 2nd
      day after the operation and on the 7th day after surgery (removal points), 3) subjective
      assessment of pain using a visual analog scale, 4) measurement of facial edema in the second
      day after the operation and on the 7th day after surgery (as compared with the measurements
      obtained before surgery) and 5) the incidence, type and severity of adverse reactions. The
      analysis comparative data, along with the proper application of statistical tests, provide
      the basis for an evaluation of both efficiency medications used.
    

Intervention name(s): Codeine + Diclofenac; Diclofenac
Intervention type(s): Drug; Drug
Intervention description(s): The patients will receive codeine and diclofenac as pain relief medicine after the surgery; The patients will receive only diclofenac
Other intervention name(s): Lower third molar surgery; Pain control; NSAID associated with Opioids; Lower third molar surgery; Pain control; NSAID
Intervention MeSH terms: Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Codeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: codeine; diclofenac; impacted third molar tooth
Sun Protection Factor (SPF) Efficacy Assay
Condition: Sunscreen Agents
Study type: Interventional

Summary: 
      Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection
      Factor (SPF) on the skin of human subjects.
    


Intervention name(s): BAY987516; SPF 15 Control
Intervention type(s): Drug; Drug
Intervention description(s): 2.00 mg/cm2 ± 0.04 mg/cm2; 2.00 mg/cm2 ± 0.04 mg/cm2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Linagliptin and Mesenchymal Stem Cells: A Pilot Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the present study is to gather pilot data on the effects of linagliptin on the
      concentration of the long and short forms of SDF1-α (stromal cell-derived factor alpha) in
      humans, and to demonstrate the feasibility of such a study in patients with psychosis in our
      setting.
    

Detailed description: 
      This study is a 13-week, open-label study of 8 participants with schizophrenia and minimal
      thought disorder; they will have 12 weeks of treatment and week for assessment. They will
      receive linagliptin, 5 mg by mouth once per day, while continuing their antipsychotic
      treatment. The principal outcome measures will be the concentrations of the long and short
      forms of SDF1-α (stromal cell-derived factor alpha) in blood.
    

Intervention name(s): Linagliptin
Intervention type(s): Drug
Intervention description(s): 12 weeks of treatment and week for assessment. Linagliptin, 5 mg by mouth once per day for 12 weeks, in combination with continued antipsychotic treatment.
Other intervention name(s): Tradjenta
Intervention MeSH terms: Linagliptin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: DPP-4 Inhibitor; Linagliptin; SDF1-α
Longterm Outcome of Inpatient Cognitive and Behavioral Therapies for Agoraphobia
Condition: Agoraphobia
MeSH terms: Agoraphobia
Study type: Observational

Summary: 
      While cognitive therapy and exposure therapy are both proven to be effective for panic
      disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (Gould
      et al., 1995) the scientific knowledge about long-term course of these disorders is still
      scanty. Although several long-term outcome studies have been conducted, the quality of these
      studies has been questioned.

      The aim is to conduct a follow-up study of patients with either panic disorder with history
      of agoraphobia or agoraphobia without history of panic disorder. the patients were treated in
      a group format at Modum Bad during the years 1989 to 1997. Four subsamples will be included
      in the study. Subsample 1 (76 patients treated in 1989 and 1990) received combined cognitive
      and psychodynamic treatment. Subsample 2 and 3 (46 patients treated in 1992 - 1993) were
      allocated to either cognitive therapy or guided mastery treatment. Subsample 4 (45 patients
      treated in 1994 - 1996) received cognitive and schema focused therapy.

      In the follow-up study the participants will be requested to complete the same self report
      measures as they completed at intake, discharge and at previous follow-up times. the
      participants will also be interviewed using the SCID-I and II as they were at the previous
      assessments.

      The present sample is relatively unique in having received pure psychosocial experimental
      treatments. The very long term efficacy of cognitive therapy relative to behavioural
      treatmetns for agoraphobia can be evaluated, and the potential moderating effects of
      personality disorders can be assessed.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with panic disorder with or without agoraphobia and/or agoraphobia
        without history of panic disorder who have accepted treatment at an inpatient psychiatric
        hospital
      
Keywords: Long term outcome
An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and efficacy of duloxetine in participants
      with osteoarthritis and knee pain. The study will last for 1 year.
    


Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): LY248686; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HaemoCerTM Application in Breast Cancer Surgery
Condition: Breast Neoplasm Female; Mastectomy, Segmental
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      HaemoCer is a hemostatic agent to control bleedings during surgical procedures by
      accelerating natural hemostasis and is frequently applied during breast conserving surgery in
      women with breast cancer. There is however no adequate data available on the efficacy of
      HaemoCer regarding seroma formation or drainage output. The objective of this study is to
      investigate whether the intraoperative application of haemostatic powder (HaemoCer) in
      breast-conserving surgery in breast cancer patients reduces the postoperative drainage output
      and number of days until drain removal (number of hospitalization days).
    


Intervention name(s): HaemoCer
Intervention type(s): Other
Intervention description(s): Randomized application of 3g haemostatic powder (HaemoCer) in the wound site during breast-conserving surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparison of Cyanocobalamin in Avocado Oil Cream With Steroid Combination Ointment
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A randomized clinical trial with two groups. Group A Group B Group A is being treated with
      conventional Steroid combination ointment for the treatment of chronic Plaque Psoriasis.

      Group B is being treated with Cyanocobalamin in Avocado Oil cream for the treatment of
      chronic Plaque Psoriasis.

      Each group having 45 patients.
    

Detailed description: 
      Outcome is being measured by PASI Score calculation with monthly follow up.
    

Intervention name(s): Potent topical steroid
Intervention type(s): Combination Product
Intervention description(s): Cyanocobalamin in Avocado Oil Cream
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
Pilot Study on Withdrawal of Spironolactone Among Heart Failure With Improved Ejection Fraction
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The study is a randomized controlled pilot trial to evaluate whether withdrawal of
      spironolactone is safe and associated with re-deterioration of left ventricular function in
      patients with heart failure with improved ejection fraction. The aim of current trial is to
      test the hypothesis that withdrawal of spironolactone would not be associated with relapse of
      significant clinical deterioration of left ventricular systolic function.
    


Intervention name(s): Withdrawal of Spironolactone; Continuation of spironolactone
Intervention type(s): Drug; Drug
Intervention description(s): Other recommended medications for heart failure than spironolactone will be continued for withdrawal group.; Specific dose of spironolactone for continuation group is on each physician's discretion with acceptable range of 12.5 mg - 50 mg once or twice daily.
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder
Condition: Urogynaecology
MeSH terms: Urinary Bladder, Overactive
Study type: Observational

Summary: 
      The concept of organisms living on or in the human body without causing overt signs of an
      infection is common in medicine and has been termed a microbiome. Urine from patients with
      Overactive bladder (OAB) grows different organisms from controls without OAB. However, it is
      not known if the bacteria that have been identified are innocent commensals or pathogenic
      organism responsible for the symptoms of OAB. Previous data suggests that treatment with
      antibiotics does lead to an improvement in overactive bladder symptoms in a large number of
      patients. On this basis the investigators now treat are patients with similar antibiotic
      regimes. If antibiotics improve symptoms it would be expected that they would return the
      microbiome back to how it is in patients without OAB. This study aims to identify the effects
      of antibiotics on the urinary microbiome and to identify/confirm if antibiotic treatments
      cause improvement in OAB.
    

Detailed description: 
      This study is a consecutive cohort study. Subjects will be recruited from Urogynaecology
      clinics at Medway NHS Foundation Trust. Patients will be identified from previous records and
      also prospectively from new patients. They will be sent information regarding the trial
      before attending their first appointment.

      Patients attending urogynaecology clinics will provide a fresh clean catch specimen of urine.
      A conventional hospital Mid stream speciemn of urine (MSU) will be sent. Urine will be
      dipsticked for nitrites and leucocyte esterase. The urine will then be spun and undergo
      microscopy using a special stain (looking for intracellular organisms in shed urothelial
      cells). The urothelial cells will be cleaned with antibiotics. The cells will then be lysed
      and their contents cultured. The contents will undergo Polymerase Chain Reaction (PCR)
      sequencing to identify bacteria. Sensitivity testing will be used to assess and deliver the
      appropriate antibiotic regime.

      Women will be treated with a 6 week course of antibiotics as per their usual treatment. Broad
      spectrum antibiotics will be prescribed to all women based on the previous successful
      therapeutic regime as described by Vijaya. Six weeks after the end of antibiotic therapy
      patients will be reviewed and their urine retested.
    

Intervention name(s): None - this is a prospective observational study. Patients will be prescribed their usual treatment (antibiotics) and the effect on urine studied
Intervention type(s): Other
Intervention MeSH terms: Anti-Bacterial Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women with overactive bladder syndrome
      
Keywords: infection overactive bladder
BGS Neonatal Pilot Study
Condition: Pain From Heel Sticks
Study type: Interventional

Summary: 
      This is a pilot, randomized, safety and efficacy study of an investigational device (i.e.
      BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain
      subject feedback, assess device performance; and ascertain potential harm in healthy adult
      volunteers.
    


Intervention name(s): BabyGentleStick; Standard Lancing Device
Intervention type(s): Device; Device
Intervention description(s): Experimental device.; HMC standard of care.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Device Feasibility
Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults
Condition: Influenza Vaccine
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study
      evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza
      vaccine delivered IN alone or concomitantly with inactivated influenza vaccine (IIV)
      delivered IM to a healthy adult population age 65 to 85 years at time of enrollment.
    

Detailed description: 
      This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study
      evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza
      vaccine delivered IN alone or concomitantly with IIV delivered IM to a healthy adult
      population age 65 to 85 years at time of enrollment. Eligible subjects will be randomized
      concurrently in a 3:3:3:1 ratio to receive one administration of Cam2020 M2SR alone (Cohort
      1, n=90), Cam2020 M2SR along with IIV (Cohort 2, n=90), IIV alone (Cohort 3, n=90), or
      placebo (Cohort 4, n=30).
    

Intervention name(s): Cam2020 M2SR H3N2 influenza vaccine; Fluzone HD IIV; IN Placebo; IM Placebo
Intervention type(s): Biological; Biological; Other; Other
Intervention description(s): Administered intranasally on Day 1; Administered intramuscularly on Day 1; Administered intranasally on Day 1; Administered intramuscularly on Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects assigned randomly to one of four cohorts concurrently
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Acupuncture for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Little is known about acupuncture's efficacy for Irritable Bowel Syndrome (IBS). This trial
      uses a manualized acupuncture treatment format that closely follows clinical practice and
      allows flexibility in designing individualized treatments. In addition, a second parallel
      qualitative study will follow a subgroup of patients throughout the trial to explore the
      relationships between patients' interpretations and understandings (what anthropologists call
      "meaning") of irritable bowel and their response to treatment. Cortisol levels (an important
      stress hormone) will also be assessed.

      This will be a 3-arm trial: Active acupuncture, placebo acupuncture, and wait list.
    


Intervention name(s): Acupuncture
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Acupuncture
Impact of an Online Behavioral Weight Loss Program
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      This study was designed to test the impact of a 12-week online behavioral modification
      program for weight loss, with or without a fortified beverage. Subjects are randomized to
      four conditions: 1) Online Basic Lifestyle Counseling (OBLI); 2) Online Lifestyle Counseling
      (OLC); 3) OBLI plus a beverage (BEV); 4) OLC + BEV. The three hypotheses were: 1)after 12
      weeks, individuals in the OLC condition would lose more weight than those in OBLI; 2) after
      12 weeks, the OLC + BEV condition would lose more weight than the OLC condition; and 3) after
      12 weeks, the OBLI + BEV condition would lose more weight than the OBLI condition.
    

Detailed description: 
      This study tests the impact of an innovative combination of a fortified beverage (a diet cola
      containing green tea extract, soluble dextrin fiber, and caffeine) and an online support
      weight loss program in a multi-center randomized clinical trial. The study compares the
      impact of all combinations of the beverage and the online behavioral modification treatment
      program over 12 weeks at three treatment center in the US and EU.
    

Intervention name(s): online lifestyle counseling and a fortified diet beverage
Intervention type(s): Behavioral
Intervention description(s): The fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overweight; Obesity
Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension
Condition: Hypercholesterolemia; Hypertension
MeSH terms: Hypertension; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo
      in participants with hypercholesterolemia and hypertension.
    


Intervention name(s): ETC-1002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ETC-1002 capsules taken once daily; Placebo capsules taken once daily
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LDL; Cholesterol
A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes
Condition: Healthy Volunteers; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is investigating the safety and tolerability of the new investigational product
      NNC0363-0845, its concentrations in the blood and its effect on the blood sugar for the
      treatment of diabetes. The study consists of 3 parts. The first part of the study is
      conducted in healthy people, while the second part involves people with type 1 diabetes
      (T1D). Part 3 of this trial involves also people with T1D.

      The study will test how NNC0363-0845 is tolerated by the body, how it is taken up in the
      blood, how long it stays there and how much the blood sugar is lowered. Healthy volunteers
      will either get NNC0363-0845 or placebo - which treatment is decided by chance. Participants
      with type 1 diabetes will either get NNC0363-0845 or insulin degludec (Tresiba®), also
      decided by chance. It is the first time that NNC0363-0845 is tested in humans. Participants
      will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left
      thigh. Participation in the study will last for up to 6 weeks. There will be one Informed
      Consent visit and 6 clinic visits with the study doctor. Healthy volunteers will have blood
      sampling to measure blood sugar and the concentration of the investigational product in the
      blood. Participants with type 1 diabetes will have a clamp experiment where the blood sugar
      is measured and controlled for up to 42 hours.

      For Part 3, the total duration of the trial for each individual is expected to be
      approximately 3-9 weeks.

      Participants cannot be in the study if the study doctor thinks that there are risks for their
      health. Women can only take part in the study if they are of non-child bearing potential.
    


Intervention name(s): NNC0363-0845; Placebo (NNC0363-0845); Insulin degludec
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose administered s.c. (subcutaneously, under the skin); A single dose administered s.c.; A single dose administered s.c.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1 will be a placebo-controlled trial in healthy subjects; Part 2 will be an active-controlled trial in subjects with T1D.
Part 3 of this trial, will be an open-label, two-period cross-over, randomised, single dose trial in subjects with T1D.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Evaluating Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 and Etomidate for Induction of Anesthesia in Healthy Male Subjects
Condition: General Anesthetic; Sedation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed as an open label, single dose combination of HSK3486 and etomidate in
      healthy adult male subjects. The study will evaluate the anesthetic/sedation effect of the
      combination of the 2 drugs and the safety profile including pain on injection, hypotension,
      tachycardia or bradycardia effects (HSK3486), and involuntary muscle movements, nausea and
      vomiting potential and adrenal suppression (etomidate).

      All subjects will be administered HSK3486 plus etomidate. Subjects will be confined to the
      study unit from the evening of Day -1 until the morning of Day 2, then will be required to
      return for a follow up visit on Day 7.

      Intensive PD, PK, safety and tolerability and assessments will be performed prior to dosing
      on Day 1 until 24 hours post-dose (Day 2).
    


Intervention name(s): HSK3486+ etomidate
Intervention type(s): Drug
Intervention MeSH terms: Etomidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment