bioihbjkbjnl/mcl2 huggingface dataset:
Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease
Condition: Behcet Syndrome; Behcet Disease; Mucocutaneous Ulceration
MeSH terms: Behcet Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of natural human interferon
      alpha (IFN alpha) on size, number, incidence and pain of oral ulcers associated with Behçet's
      Disease (BD).
    

Detailed description: 
      Behçet's disease is a severe chronic relapsing inflammatory disorder marked by oral and
      genital ulcers, uveitis and skin lesions, as well as varying multisystem involvement
      including the joints, blood vessels, central nervous system, and gastrointestinal tract. Oral
      ulcers are the initial symptom for most of Behçet's cases and are the single manifestation of
      the disease required for an official diagnosis, along with two other hallmark symptoms.

      Ninety (90) patients will be enrolled in a randomized, parallel, double-blind,
      placebo-controlled study to evaluate the effectiveness of low dose natural human IFN α
      administered by the oral mucosal route in reducing the number, size, incidence and pain of
      oral ulcers in patients with Behçet's disease.

      The clinical trial will consist of 3 groups of patients randomized in a 1:1:1 ratio to twice
      daily receive 2 lozenges containing 500 IU IFN α(2,000 IU daily, n=30), one active (500 IU)
      and one placebo lozenge (1,000 IU daily, n=30) or 2 placebo lozenges (n=30). Subjects will be
      monitored weekly over an initial 4 weeks of treatment and then bi-weekly over an additional 8
      weeks of treatment. Medication will be self-administered as 2 lozenges taken twice daily
      (morning and evening). Oral lesions will be counted and measured at each study visit, and
      patients will answer a series of questionnaires. Results will be subjected to statistical
      analysis at the completion of the study, with change in total ulcer burden of a patient, a
      measurement of the total oral mucosal surface area involved with ulcerous lesions at each
      visit, serving as the primary endpoint. The total ulcer burden from each treated visit will
      be compared to the baseline total ulcer burden and the amount of change determined. Patients
      with a 75% decrease in total ulcer burden will be considered responders.
    

Intervention name(s): Veldona,
Intervention type(s): Biological
Intervention description(s): Very low dose oral natural human interferon alpha lozenges
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions
Condition: Nutritional and Metabolic Diseases
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to identify microbial signatures associated with remission and
      recurrence of idiopathic malodor and PATM conditions.
    

Detailed description: 
      Human odorprints, mostly owing to the microbiome, have proven their value as biomarkers of
      health and environmental exposures. In recent years, microbial networks responsible for
      localized malodors such as halitosis or axillary odor have been mapped by using next
      generation sequencing approaches. Intestinal microbes responsible for psychologically
      debilitating systemic malodor (whole-body and extraoral halitosis), however, remain to be
      identified. Even a relatively straightforward disorder of choline metabolism
      trimethylaminuria (TMAU) is thought to exhibit complex host-gene microbiome interactions and
      has not been sufficiently studied.

      Proposed controlled pilot study aims to explore the dynamics of microbial communities in
      remission and flare-up periods. Better knowledge of the important aspects of disease
      fluctuation should enhance patient care and, combined with our prior data, will help to
      develop new therapies and treatments.
    

Intervention name(s): Nutritional counselling; Stress-reduction counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral nutritional counselling delivered via the Internet.; The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: systemic malodor; body odor; bad breath; PATM; microbiome; TMAU; Malabsorption; Dysbiosis
General or Regional Anesthesia for Hip Surgery
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether general anaesthesia or regional anaesthesia
      is best for patients undergoing Total Hip Arthroplasty.
    

Detailed description: 
      A randomized controlled trial (RCT) with a follow up time of 48 hrs. Patients scheduled for
      primary Total Hip Arthroplasty. A total of 120 patients randomly assigned to one of the two
      alternatives (general anaesthesia (GA) or regional anaesthesia (RA)).

      General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital
      stay (LOS) for patients undergoing total hip arthroplasty (THA).

      Primary endpoint:

      LOS.

      Secondary endpoints:

      Postoperative pain? Postoperative orthostatic function (dizziness) Time until the patient
      meets the discharge criteria from PACU How many patients will need at least one urinary
      bladder catheterisation
    

Intervention name(s): GA-arm, remifentanil; RA-arm
Intervention type(s): Drug; Drug
Intervention description(s): Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm; Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.
Other intervention name(s): GA: TCI consisting of remifentanil an propofol; Regional anesthesia
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anaesthetic techniques; subarachnoid; analgesia
Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Condition: Hyperinsulinism
MeSH terms: Hyperinsulinism
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Determine the dose of recombinant human insulin-like growth factor I that minimizes or
      decreases the need for exogenous glucose support without causing hypoglycemia.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a dose escalation study. Patients receive an escalating dose of
      recombinant human insulin-like growth factor I (IGF-I). IGF-I is given subcutaneously twice a
      day. The dose of IGF-I is increased each day for 4 days. Glucose is administered
      intravenously, when necessary, to prevent hypoglycemia.

      Following the study treatment patients resume prior medication and may undergo surgery.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): insulin-like growth factor I
Intervention type(s): Drug
Intervention MeSH terms: Mitogens
Primary purpose: Treatment
Keywords: endocrine disorders; hyperinsulinism; rare disease
The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding
Condition: Contraception
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The Copper intrauterine device is the most common method of reversible contraception
      worldwide. Abnormal uterine bleeding and pain are the most common medical indications for the
      discontinuation of the intrauterine device.

      Excessive prostaglandin release in the endometrial cavity appears to play an important role
      in both bleeding and pain related to copper intrauterine devices.There are many types of
      prostaglandin metabolites that present in the endometrium one of them is prostacyclin which
      causes vasodilatation and inhibits platelet aggregation. Another one is thromboxane which has
      two types; A2 which is active and rapidly converted into B2, which is inactive. Thromboxane
      causes vasoconstriction and blood clotting.

      Non-steroidal anti-inflammatory drugs (NSAIDs) are prostaglandin synthetase inhibitors acting
      by decreasing production of endometrial prostaglandins; they can improve both heavy uterine
      bleeding and pain. Since its discovery; several drugs in NSAIDs class have been used to treat
      heavy uterine bleeding and pain associated with copper intrauterine device use such as
      mefenamic acid, ibuprofen and naproxen.

      The most recent systematic review found NSAIDs is the most widely studied drugs for reduction
      of the menstrual blood and pain associated with copper intrauterine device. The Cochrane
      Review also found that NSAIDs are the most effective treatment to reduce the bleeding with
      copper intrauterine device use.
    


Intervention name(s): Ibuprofen
Intervention type(s): Drug
Intervention description(s): The women will receive 400mg ibuprofen 3 times per day from the first day of the cycle for 5 days
Intervention MeSH terms: Ibuprofen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents
Condition: Smoking
MeSH terms: Marijuana Use
Study type: Interventional

Summary: 
      To study feasibility and implementation of a education videogame and the effects on
      adolescents knowledge and beliefs around tobacco products.
    

Detailed description: 
      The goal for sub-study 4 is to learn more about how an educational videogame can feasibly be
      implemented and disseminated in youth programs. For this sub-study we will further develop,
      expand, and refine the smokeSCREEN game and increase the game's reach on a national platform.
      The study will conduct the proposed evaluation by: working with game developers to develop a
      web- based version of the game, creating a pre-post survey to measure the effect of the game
      and building that into the smokeSCREEN game to anonymously collect information on players'
      knowledge and beliefs around tobacco products, and collaborating with youth programs to pilot
      test how the game can be implemented in real world settings.
    

Intervention name(s): smokeSCREEN game
Intervention type(s): Behavioral
Intervention description(s): smokeSCREEN is web-based videogame intervention focused on tobacco use prevention in teens. The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products.smokeSCREEN. Guided by the social cognitive theory and the theory of planned behavior, smokeSCREEN addresses a range of challenges that teens often face involving peer pressure and the use of tobacco products. Participants are provided access to the smokeSCREEN game through a private, password-protected website link and instructed to complete the game.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Copeptin Levels in Elective Cesarean Section With Different Anesthetic Technique
Condition: Fetal Distress
MeSH terms: Diabetes Insipidus; Fetal Distress
Study type: Interventional

Summary: 
      In this study, investigators aimed to investigate the effects of general and spinal
      anesthesia techniques on copeptin levels during cesarean section and their relation with
      fetal distress.
    

Detailed description: 
      During the delivery process, the mother and the baby generate some endocrine responses to
      this emotional and physical stressful action. Arginin-Vasopressin prohormone (copeptin),
      which is more stable and measurable in blood, is used as an endogenous stress indicator.
      Copeptin levels have been shown to be significantly increased in vaginally delivery when
      compared to cesarean section (c / s). In a caesarean section; it is a known fact that when
      the general anesthetic method and the used anesthetic substances are taken into
      consideration, it gives a significant stress to the mother and the baby. Spinal anesthesia
      with no impaired fetal oxygenation and without orotracheal intubation and neuromuscular
      blockers may reduce fetal distress. However, there was no study investigating the effect of
      the anesthesia techniques in elective cesarean section on the fetal stress and the level of
      copeptin, in the literature review. Therefore investigators aimed to compare spinal and
      general anesthesia technique in elective cesarean section, to evaluate level of copeptin and
      their relation with fetal distress.Investigators hope that this study will guide the
      anesthesia method that can be chosen primarily in caesarean section.
    

Intervention name(s): Copeptin
Intervention type(s): Other
Intervention description(s): Level of copeptin in maternal blood and umbilical cord blood
Other intervention name(s): Fetal distress
Intervention MeSH terms: Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: copeptin levels; Cesarean section; general anesthesia; spinal anesthesia
Brief Religious Alcohol Intervention
Condition: Heavy Drinking
Study type: Interventional

Summary: 
      This study is a trial of a brief alcohol intervention, a brief expressive writing
      intervention that incorporates religious identity.
    


Intervention name(s): Expressive Writing
Intervention type(s): Behavioral
Intervention description(s): The participants are asked to write for a period of time about specific concepts so that they think carefully and cognitively process the information they are generating.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to either an intervention condition, where they will write about how their drinking relates to their religious identity, or to a control condition, where they will write about how their drinking relates to their age.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the clinical efficacy and safety of combination
      therapy with guselkumab and golimumab in participants with moderately to severely active
      ulcerative colitis (UC).
    


Intervention name(s): Guselkumab Dose 1; Guselkumab Dose 2; Golimumab Dose 1; Golimumab Dose 2; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Guselkumab Dose 1 will be administered as IV infusion.; Guselkumab Dose 2 will be administered as SC injection.; Golimumab Dose 1 will be administered as SC injection.; Golimumab Dose 2 will be administered as SC injection.; Placebo will be administered.
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pendant Position and Traditional Sitting Position for Successful Spinal Puncture in Spinal Anaesthesia
Condition: Pregnancy, Caesarean Section
Study type: Interventional

Summary: 
      The aim of this study was to compare the successful spinal puncture among patients with
      pendant position in comparison with those who used traditional sitting position for caesarean
      section.
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study.
      Subjects were divided into Group A for traditional sitting position (n=154) and Group B for
      pendant position (n=154). The outcome parameters recorded were the number of attempt for the
      successful spinal puncture, the number of spinal needle-bone contact and the duration to
      perform spinal puncture. Data were analyzed by using Statistical Package for Social Scientist
      (SPSS) version 21.0. Numerical data was served in median with minimal and maximal value.
      Numerical data was analyzed by using Mann-Whitney test. Categorical data was served by using
      relative risk (RR) with 95% confidence interval (95% CI) and was analyzed by using Chi-Square
      test.
    

Intervention name(s): Traditional sitting position; Pendant position
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects were set on traditional sitting position before spinal anesthesia begun.; Subjects were set on pendant position before spinal anesthesia begun.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: spinal, anesthesia, pendant, spinal-bone contact, puncture
Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability study of tacrolimus
      capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under fasting
      conditions and to monitor safety of subjects
    

Detailed description: 
      An open label, randomized, two period, two treatment, two sequence, crossover, balanced,
      single dose, comparative evaluation of relative bioavailability of tacrolimus capsules 5 mg
      with that of 'prograf' capsules 5 mg in healthy adult human subjects under fasting
      conditions.
    

Intervention name(s): Tacrolimus Capsules
Intervention type(s): Drug
Intervention description(s): Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Prograf capsules of Astellas Pharma US, Inc.,
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability, crossover, tacrolimus
HIV/STD Safer Sex Skills Groups for Men in Drug Treatment Programs - 1
Condition: Behavior Therapy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate a five-session Human Immunodeficiency Virus/Acquired
      Immune Deficiency Disease (HIV/AIDS) group therapy designed specifically for heterosexual
      men. This therapy is compared to standard HIV/AIDS education, which generally consists of a
      single session of HIV education.
    


Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: behavioral intervention
Assessment of the Acceptability of a Humanoid Robot at Home for Children With Cochlear Implants - H2R2
Condition: Cochlear Implantation
Study type: Interventional

Summary: 
      The quality of the rehabilitation of deafness in children with cochlear implantation is a
      major prognostic factor for the outcome on speech comprehension and oral expression. This
      rehabilitation is carried out cooperatively by the hospital cochlear implantation team, and
      by a speech therapist located near the child's home. The multi-weekly sessions represent a
      constraint for the child and his parents. Complementary training work at home would make it
      possible to balance the equity in the distribution of care in the territory, and should
      promote the progress of the child, who is more inclined to use a tool available at home.
    

Detailed description: 
      The humanoid robot should allow an ecological approach to this additional rehabilitation.
      Before developing this approach, it is necessary to study the acceptability of the humanoid
      robot at home, both by the parents and by the cochlear implanted child. The main objective of
      this study is to assess the acceptability by the child and his family, of a humanoid robot
      installed at home for one month.

      The secondary objectives are to describe the acceptability of the child and his family that
      is the relationship to technology, the intention of use, expectations, perceived utility,
      perception of the robot and facilitating conditions before then after 1 month of using the
      robot at home,

      - describe the child's acceptability with respect to his experience, his fun and the emotions
      felt when he uses the robot at home
    

Intervention name(s): Interaction with humanoid robot
Intervention type(s): Device
Intervention description(s): A humanoid robot will be installed for 30 days in children. It has a touchscreen tablet, allowing manual interaction complementing the voice interaction. The robot speaks, hears, and has facial and voice identification.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cochlear implantation; humanoid robot