bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures
Condition: Fissure in Ano; Pain
MeSH terms: Fissure in Ano
Study type: Interventional
Phase: Phase 3

Summary: 
      Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal
      pain especially during defecation and for 1 or 2 hours afterwards. There are no approved
      drugs in the United States (US) for this condition and surgery is often the treatment choice.
      Strakan is conducting this confirmatory study so the product can be submitted for regulatory
      approval in the US. Strakan currently markets this product throughout Europe.

      The objective of this study is to determine the effect of nitroglycerin ointment 0.4%
      (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21
      days of treatment in 250 patients.
    


Intervention name(s): Cellegesic; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin.; Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin.
Other intervention name(s): 0.4% nitroglycerin ointment; Rectogesic
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain associated with chronic anal fissure
Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone?
Condition: Glucose Metabolism Disorders; Endocrine or Metabolic Disease
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      Infusion of glucagon-like peptide 2 (GLP-2) during euglycaemia, hypoglycaemia and
      hyperglycaemia and evaluation of the effect on glucagon secretion in healthy subjects.
    

Detailed description: 
      This is a cross-over, randomized, double-blinded study in which 10 participants will undergo
      6 experimental days each. The participants will have their plasma glucose clamped at either
      euglycaemia (fasting level), hypoglycemia (2,5 mmol/l) or hyperglycemia (10 mmol/l) during
      infusion of GLP-2 or saline (placebo)

      The six days will be as follows:

        -  Euglycaemia + Placebo

        -  Euglycaemia + GLP-2

        -  Hyperglycaemia + Placebo

        -  Hyperglycaemia + GLP-2

        -  Hypoglycaemia + Placebo

        -  Hypoglycaemia + GLP-2

      The primary endpoint will be levels of plasma glucagon. Secondary endpoint will be levels of
      GLP-1, GLP-2, Insulin/C-peptide, OXM, Amino acids, CCK, Gastrin, norepinephrine, bile acids,
      FGF-19/FGF-21. Secondary endpoints will also include ultrasound scan of the gallbladder.
    

Intervention name(s): Glucagon-like peptide 2; Saline; Glucose; Insulin
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Human glucagon-like peptide 2; Placebo; 20% (w/v) glucose infusion for regulating plasma glucose; Actrapid (insulin) for lowering plasma glucose
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: GLP-2; Glucagon
Making Decisions About Participating in a Cancer Clinical Trial for Patients With Stage II, Stage III, or Stage IV Pancreatic Cancer or Stage III or Stage IV Colon Cancer or Rectal Cancer
Condition: Colorectal Cancer; Pancreatic Cancer; Psychosocial Effects of Cancer and Its Treatment
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Determining how patients makes decisions about participating in a clinical trial
      may help doctors plan clinical trials in which more patients are willing to participate and
      are satisfied with their decision to participate.

      PURPOSE: This clinical trial is studying how patients with stage II, stage III, or stage IV
      pancreatic cancer or stage III or stage IV colon cancer or rectal cancer make decisions about
      participating in a clinical trial.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the relationship between disease factors, patient factors, and understanding
           of the cancer clinical trial, and preferences for decision control in the decision to
           participate in a cancer clinical trial by patients with stage II-IV pancreatic cancer or
           stage III-IV colon or rectal cancer.

        -  Determine the relationship between disease factors, patient factors, understanding of
           the cancer clinical trial, and preferences for decision control with satisfaction with
           the decision to participate in a cancer clinical trial.

        -  Determine how quality of life, trust, and hope impact the decision to participate in a
           cancer clinical trial and the satisfaction with this decision.

      OUTLINE: This is a cross-sectional study.

      Patients complete 12 questionnaires to assess their symptom burden (e.g., nausea, pain,
      fatigue), sociodemographics, hope, quality of life, trust in the healthcare system, trust in
      health professionals, research decision control, perceived risks, adequacy of research
      information, clinical trial participation, and decision satisfaction.

      PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
    

Intervention name(s): counseling intervention; study of socioeconomic and demographic variables; psychosocial assessment and care; quality-of-life assessment
Intervention type(s): Other; Other; Procedure; Procedure
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: psychosocial effects of cancer and its treatment; stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer; stage II pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer
The MOTHER (Mobile Technologies to Help Enhancing Regular Physical Activity) Trial for Pregnant Women
Condition: Physical Activity
Study type: Interventional

Summary: 
      Obesity among women of childbearing age and excessive weight gain during pregnancy are
      prevalent and steadily increasing health care issues. Regular physical activity is
      recommended to maintain healthy weight gain for pregnant women, however, a majority of
      pregnant women are sedentary. The investigators proposed to conduct a pilot study to estimate
      the potential efficacy of a mobile phone based physical activity intervention in 30
      physically inactive pregnant women.
    


Intervention name(s): Mobile phone-based physical activity; Activity monitor
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive the mobile phone-based physical activity program using the trial app.; Participants will receive an activity monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Cellular phone; exercise; pregnant women; obesity; overweight; physical activity
A Brief Marijuana Intervention for Adolescent Women - 1
Condition: Marijuana Abuse; Sexual Risk Behaviors
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the efficacy of a brief motivational intervention on
      marijuana use and sex-risk behavior in young women.
    

Detailed description: 
      This study holds the promise of developing a brief, efficacious intervention to reduce
      marijuana use and related sexual risk-taking behavior among the large populaton of late
      adolescent women who are regular marijuana users. In the abscence of intervention, these
      women are at heightened risk of contracting HIV and other sexually transmitted infections.
      Therefore it is crucial to develop an intervention that will reduce their marijuana and
      subsequent sexual risk taking behavior. The intervention employed in this study represents a
      novel adaptation of interventions that are well-supported with similar populations. If the
      current intervention is found to be efficacious, it can be readily integrated into a variety
      of treatment settings, particularly other primary care settings. In addition, this study will
      contribute valuable information about the relationship between marijuana use and sexual risk
      taking behavior and about the mechanisms of change in marijuana use in late adolescent women.

      Comparison(s): Participants will be assigned, in this 6 month longitudinal study, to an
      assessment-only group or an assessment plus intervention group. Those in the intervention
      group will receive 2 motivational intervention sessions during the first 3 months of their
      study participation.
    

Intervention name(s): Behavior Therapy; Treatment as Usual
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: marijuana; sexual risk
The Effectiveness and Safety of LIVIA® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering From Primary Dysmenorrhea.
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, controlled, multi-center, single-arm, crossover, double-blind clinical
      study assessing the Livia Transcutaneous Electrical Nerve Stimulation (TENS) in women
      suffering from dysmenorrhea. The study will be conducted at community clinics. Advertisement
      will be used to publish and promote recruitment.

      The study will include 3 visits: Screening visit and two consecutive visits each one after
      monthly menstrual period. Treatment will be self-administrated and during the study, the
      subjects will be requested to complete home diaries.
    


Intervention name(s): Livia
Intervention type(s): Device
Intervention description(s): Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Livia TENS; safety and efficacy; menstruating women
The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy
Condition: Bowel Preparation Quality
Study type: Interventional
Phase: Phase 3

Summary: 
      Although adequate bowel preparation is essential for successful colonoscopy, the 23% of
      patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in
      incomplete examination, increased patient's discomfort, decreased polyp detection rates,
      ultimately leading to repeated colonoscopies. One prior study showed that patients reporting
      their last rectal effluents as brown color or solid stool had a 54% chance of having fair or
      poor preparation. Thus, recent consensus guideline suggested consideration of additional oral
      preparation in patients presenting brown effluents on the day of colonoscopy. However, the
      data supporting additional oral preparation is still spares. Therefore, the investigators
      aimed to examine the impact of additional oral preparation on the quality of bowel
      preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.
    


Intervention name(s): Additional oral preparation (3L of PEG+Asc, "Coolprep®"); Standard oral preparation (2L of PEG+Asc, "Coolprep®")
Intervention type(s): Drug; Drug
Intervention description(s): The interventional or experimental arm will receive 1l of additional PEG+Asc, "Coolprep®" on the day of colonoscopy
* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g; The control arm will receive currently used oral preparation (2l of PEG+Asc, "Coolprep®") for colonoscopy
* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
Other intervention name(s): Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea):3L; Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 2L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of JNJ-31001074
      compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD).
    

Detailed description: 
      This study is being done to assess safety and tolerability and to explore the effectiveness
      of a new, experimental drug in the treatment of attention deficit hyperactivity disorder in
      adults. Approximately 144 adult patients with ADHD will be recruited for the study. Patients
      who meet study criteria will need to stop taking any ADHD medications they are currently
      using. They will be randomly assigned to one of 3 treatment arms; each patient has an equal
      chance of receiving 10 mg JNJ-31001017, 30 mg JNJ-31001074, or placebo. Placebo has no active
      drug. This is a blinded study, i.e. the patient, the study doctor and the study sponsor will
      not know what treatment the patient receives until all patients complete the study. Patients
      will be dispensed a bottle containing study drug for the upcoming week at 4 of the study
      visits. The study doctor and the sponsor will monitor the study for the occurrence of
      possible side effects. In addition to a screening visit, patients will return weekly for 6
      additional study visits including an end of study visit and a follow-up visit. Patients will
      take study drug for a total of 4 weeks. After completing the study, patients may resume other
      ADHD medications. Medical and ADHD history, physical examination, blood pressure, heart rate,
      temperature, weight and ECGs will be checked periodically throughout the study. Blood samples
      will be taken for standard safety laboratory tests as well as for the measurement of the drug
      blood level. Questionnaires relating to ADHD and cognitive testing will be administered
      throughout the study. Each day for four weeks, patients will take orally, at least one hour
      before eating in the morning, 1 tablet containing either 10 mg JNJ-31001074, 30 mg
      JNJ-31001074 or placebo.
    

Intervention name(s): Placebo; JNJ-31001074; JNJ-31001074
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one dose daily for 4 weeks; 10 mg daily for 4 weeks; 30 mg daily for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; JNJ-31001074
DHA Supplementation and Pregnancy Outcome
Condition: Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if increasing DHA intake during pregnancy can
      increase gestation duration and enhance infant and childhood outcomes related to visual
      acuity, stereoacuity, attention, and distractibility.
    

Detailed description: 
      Although numerous trials show benefits of postnatal DHA supplementation for visual acuity and
      others show benefits for cognitive function and/or attention, studies of increased DHA
      exposure during fetal life are needed, especially in the US. Women in the US consume low
      amounts of DHA compared to other world populations, and this likely means less DHA transfer
      to the fetus than in many other populations. Prenatal DHA exposure may be more important than
      postnatal exposure, because animal studies show critical windows for brain DHA accumulation
      in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.
    

Intervention name(s): DHA; Placebo capsule
Intervention type(s): Drug; Other
Intervention description(s): 600 mg DHA; Placebo capsule
Other intervention name(s): docosahexaenoic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      One of the main factors in the success of in-vitro fertilization is the quality of the
      environment of the embryo. In contrast to maternal age, the environment in which the embryo
      develops is a modifiable factor. Many techniques, such as assisted hatching and perfecting
      culture media have been attempted in order to reproduce as much as possible the natural,
      physiological environment of the mother for the embryo in in-vitro fertilization. However,
      the different new culture media used are devoid of growth factors normally secreted by
      uterine cells that enhance the interaction between the embryo and its environment.

      Because the endometrial lining of the uterus secretes many different cytokines necessary for
      growth of the embryo, a new procedure has been developed to mimic the natural environment of
      the growing embryo using autologous (patient's own) endometrial cells in co-culture with the
      embryo. Endocell, a product developed by Genévrier Laboratories, received commercial
      authorization in France in 2011. It is the only system of autologous embryo-endometrium
      co-culture available on the actual market. The process consists of developing the embryo on a
      monolayer of the patient's own endometrial cells in order to favor its growth until the
      blastocyst stage (day 5) and to improve its implantation.
    


Intervention name(s): Endometrial biopsy; Autologous Endometrial Co-Culture; Conventional media culture
Intervention type(s): Procedure; Other; Other
Intervention description(s): A luteal phase endometrial biopsy will be performed in the cycle prior to the patient's In Vitro Fertilization stimulation cycle using a standard Pipelle Endometrial Suction curette in all participants between days ovulation+5 and ovulation+7 of the cycle preceding the stimulation cycle; embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5; embryos are cultured in conventional media
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: In vitro fertilization; Autologous Endometrial Co-Culture
Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of ultrasonic irrigation in improving root
      canal disinfection after chemomechanical procedures.
    

Detailed description: 
      Although chemomechanical procedures promote a drastic bacterial reduction, many root canals
      remain infected, which points to the need for complementary procedures to improve root canal
      disinfection. Thus, this clinical study aims to evaluate the effect of passive ultrasonic
      irrigation as a supplementary disinfection procedure after root canal preparation.
      Microbiological samples of the root canals of 30 single-rooted teeth with apical
      periodontitis will be taken at different stages of the endodontic treatment: before
      preparation (S1), after chemomechanical procedures (S2) and after passive ultrasonic
      irrigation (S3). The samples will be submitted to the quantitative polymerase chain reaction
      for bacterial quantification and to the reverse transcription quantitative polymerase chain
      reaction for bacterial activity analysis. Data will be analyzed using the Wilcoxon test for
      paired samples (p < 0.05).
    

Intervention name(s): Ultrasonic irrigation
Intervention type(s): Procedure
Intervention description(s): Ultrasonic irrigation will be used as a complementary step to chemomechanical procedures to test whether it can improve root canal disinfection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors
Condition: Solid Tumor; Lung Cancer; HCC
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multi-center, multi-cohort, open-label, phase Ib/II study to evaluate the efficacy,
      safety, PK characteristics, immunogenicity and potential biomarkers of AK105 monotherapy in
      the patients with selected advanced solid tumors.
    


Intervention name(s): AK105
Intervention type(s): Drug
Intervention description(s): Anti-PD-1 antibody
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-PD-1; immunotherapy