bioihbjkbjnl/mcl2 huggingface dataset:
Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
Condition: Peptic Ulcers
MeSH terms: Peptic Ulcer; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US
      setting, using a lower dose of ASA. It is expected that this study will not only confirm the
      results of the 258 study but show that the incidence of UGI ulcers on celecoxib is
      significantly less than on traditional NSAIDs and the incidence of UGI ulcers on celecoxib
      increases with the addition of ASA, but still is lower than traditional NSAIDs plus/minus
      ASA. This 7-day study is designed to compare the incidence of gastroduodenal ulcers
      associated with celecoxib 200 mg QD and low dose aspirin 81 mg QD and with naproxen 500 mg
      BID plus low dose aspirin 81 mg QD in healthy adults(50-75 years of age).
    


Intervention name(s): Celecoxib; Naproxen; ASA
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Celecoxib; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess two treatment strategies (leuprorelin treatment and
      active surveillance without androgen deprivation) for indolent prostate cancer and to compare
      their therapeutic benefit for management of patients with low-risk, localized prostate
      cancer.
    

Detailed description: 
      The drug being tested in this study is called leuprorelin. Leuprorelin is being tested to
      treat people who have prostate cancer. Study assessments will include adverse events,
      prostatic-specific antigen (PSA) levels, and prostate biopsies.

      The study will enroll approximately 120 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to a treatment group that will receive leuprorelin 11.25 mg (as
      one injection) or to an untreated observation group. Patients in the leuprorelin group will
      also receive bicalutamide 50 mg, a non-steroidal antiandrogen, once daily for 15 days to
      prevent a flare-up.

      This multi-center trial will be conducted in France. The overall time to participate in this
      study is 12 months. After the screening visit, participants will make 6 visits to the clinic.
    

Intervention name(s): Leuprorelin; Bicalutamide
Intervention type(s): Drug; Drug
Intervention description(s): Solution for injection; Bicalutamide tablets
Other intervention name(s): Enantone ®; Casodex ®
Intervention MeSH terms: Bicalutamide; Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults
Condition: Ketamine-Induced Brain Activity Changes; Psychotic-like Symptoms
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether ketamine-induced brain activity changes are
      modulated by TAK-063 administration using neuroimaging battery tests.
    

Detailed description: 
      The drug being tested in this study is called TAK-063. This study will look at brain activity
      changes and treatment of psychotic-like symptoms induced by ketamine, in people who take
      TAK-063.

      The study will enroll approximately 27 participants. Participants will be randomly assigned
      to one of treatment sequences-which will remain undisclosed to the participants during the
      study (unless there is an urgent medical need). Participants will receive the following study
      medications by the end of the study:

        -  Ketamine intravenous infusion (IV) AND

        -  Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
           no active ingredient AND

        -  Two doses of TAK-063 at one of three dose levels All participants will be asked to take
           3 tablets and will receive a ketamine IV on the first day of 3 separate study periods.
           Participants will then be assessed for brain activity changes and other symptoms. This
           single-center trial will be conducted in the United States. The overall time to
           participate in this study is up to 7 weeks. Participants will make 6 visits to the
           clinic.
    

Intervention name(s): Ketamine; TAK-063; TAK-063 Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ketamine intravenous administration.; TAK-063 tablets; TAK-063 placebo-matching tablets
Other intervention name(s): Ketalar™
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Drug therapy
Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      In this prospective study, the investigators would like to show whether ovarian stimulation
      with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle,
      is possible.
    

Detailed description: 
      A recently accepted study demonstrated that raised progesterone levels can be normalized
      through administration of a GnRH antagonist during three subsequent days prior to the start
      of gonadotropin stimulation in a GnRH antagonist protocol. This regimen, after normalisation
      of the progesterone value, allows controlled ovarian hyperstimulation (COH). Since this
      regimen is valid in case of elevated progesterone, GnRH antagonists pretreatment may prove to
      be a valid tool for scheduling IVF treatment in patients with normal progesterone values on
      day 2 of the cycle. In this prospective randomised trial, the investigators study the impact
      of administration of a GnRH antagonist during 3 consecutive days at initiation of the cycle.
    

Intervention name(s): ovarian stimulation; ovarian stimulation
Intervention type(s): Drug; Drug
Intervention description(s): rFSH with GnRH antagonists; GnRH antagonist, rFSH, GnRH antagonist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: IVF; ICSI; GnRH antagonist; pretreatment
The Evaluation of Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume
Condition: Aging; Healthy
Study type: Interventional

Summary: 
      Stylage® XL Lidocaïne is a CE-marketed hyaluronic acid gel indicated for the restoration or
      augmentation of facial volume by injection into the deep dermis or subcutaneously. Lidocaine
      hydrochloride is intended to reduce the pain associated with the injection.

      In this study 40 healthy subjects between the age of 30 and 65 years, presenting a volume
      deficit on the face as evaluated by the investigator at inclusion in the study, who have
      given his/her informed consent and met all the eligibility criteria, will be enrolled.

      Subjects will come to a total of 6 visits over a period of 18 months and a screening visit
      prior to baseline injection. The facial volume variation after baseline injection will be
      assessed. Treatment responders rate, Global Aesthetic Improvement, volume on the cheekbones,
      volume on the chin and chin angle (for applicable subjects), subject's satisfaction and
      safety will be also assessed.
    

Detailed description: 
      This is a prospective, uncontrolled, single site study with a blinded evaluator assessing the
      efficacy of Stylage® XL Lidocaïne on FVLS and GAIS clinical scoring.

      The study duration by subject is 18 months with a screening visit (V0) before injection, the
      baseline visit (injection of Stylage® XL Lidocaïne, V1) and 5 follow-up visits after 1, 3, 6,
      12 and 18 months (V2 to V6). At 1 month (V2) an optional touch-up may be done (if needed).

      The primary endpoint is the facial volume variation from baseline (D0) to 6 months after
      treatment initiation measured by an independent evaluator on photographs using FVLS (Facial
      Volume Loss Scale).

      Facial volume variation (evaluated by an independent evaluator) & treatment responder rate,
      Global Aesthetic Improvement (evaluated by the patient and the doctor), volume on the
      cheekbones and chin & chin angle (for applicable subjects), subject's satisfaction will be
      measured at all time-point with a FVLS, GAIS,3D QuantifiCare system, FACE-Q questionnaire
      (cheekbones and chin) respectively. Safety will be also assessed.
    

Intervention name(s): Stylage® XL Lidocaïne
Intervention type(s): Device
Intervention description(s): On V1 (D0), a total volume of 8 mL maximum can be used per subject on the whole face.
On V2 (M1), a possible touch-up can be made according to the injector and subject's opinion which cannot exceed 4 ml.
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: augmentation; restoration; dermal filler; face; cheekbone; chin; mandibular angle; hyaluronic acid
Tdap Vaccination for Infant Caregivers
Condition: Pertussis; Vaccination
MeSH terms: Whooping Cough
Study type: Observational

Summary: 
      This study evaluates whether offering Tetanus, diphteria and acellular pertussis (Tdap)
      vaccine to caregivers of newborn infants during pediatric well child visits increase the
      caregivers' vaccination rates.
    


Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Mothers and Other infant caregivers are surveyed at the end of the 2 week newborn well child visit about whether they chose to receive the Tdap vaccine at the pediatrician's office.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        18-64 year old men and women who are mothers or other infant caregivers of 2 week old
        infants
      
Keywords: Pertussis, Vaccination, Adult
Effects of Mineralocorticoid Receptor Stimulation on Cognition
Condition: Individuality
Study type: Interventional

Summary: 
      In this study the effects of mineralocorticoid stimulation on social cognition will be
      investigated in healthy young individuals.
    

Detailed description: 
      80 healthy young individuals (40 females and 40 male) will be recruited an randomized to
      either placebo or 0.4 mg Fludrocortison before testing. Tasks will on emotion recognition,
      Task Switch, visual spacial memory and decision making will be conducted.
    

Intervention name(s): Fludrocortisone
Intervention type(s): Other
Intervention description(s): effects of fludrocortisone on cognition compared to placebo
Other intervention name(s): Florinef (Squibb & Sons Limited)
Intervention MeSH terms: Fludrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, in Patients With EGFRm+ NSCLC
Condition: Non Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of
      epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer
      (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase
      inhibitor (TKI) agent.

      Part A will assess the effect of rifampicin on the pharmacokinetic (PK) parameters of AZD9291
      and metabolites AZ5104 and AZ7550 following multiple oral dosing of both rifampicin and
      AZD9291 in a fasted state.

      Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will
      provide for additional safety data collection. All patients who complete Part A will be able
      to enter part B, and continue to receive AZD9291 80 mg once daily until: disease progression;
      they are no longer deriving clinical benefit; or any other reason.
    


Intervention name(s): Pharmacokinetic sampling - AZD9291; Rifampicin; AZD9291 tablet dosing; Pharmacokinetic sampling - rifampicin; Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention type(s): Procedure; Drug; Drug; Procedure; Procedure
Intervention description(s): Blood sampling to measure AZD9291; Rifampicin (CYP inducer) 600mg taken once daily from Day 29 to Day 49 (Part A); Part A: AZD9291 80mg tablet taken daily from Days 1 to 77. Part B: AZD9291 80mg tablet taken daily for 12 months.; Blood sampling to measure rifampicin levels; Blood samples to measure levels of AZ5140 and AZ7550
Intervention MeSH terms: Rifampin; Osimertinib
Masking: None (Open Label)
Primary purpose: Other
Keywords: oncology, cancer, non small cell lung cancer, anticancer drug, pharmacokinetics, AZD9291, rifampicin, CYP P450 inducer, EGFR genes
Melissa Officinalis L. Supplementation for Emotional Health and Sleep Disturbance
Condition: Depression; Anxiety; Stress; Insomnia
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      This study is aimed to investigate if Lemon Balm Extract supplementation is beneficial for
      the relief of stress, depression and anxiety in healthy adults.
    

Detailed description: 
      Lemon balm (Botanical name: Melissa officinalis L.) is a herbal plant belongs to the
      Lamiaceae (mint) family, and currently of wide scientific interest as possible adjuvant for
      calming effect. Lemon balm is one of the most popular and widely used medicinal herbs in
      central and southern Europe, the Mediterranean region, and west Asia. The European Scientific
      Cooperative on Phytotherapy (ESCOP) recommends the use of lemon balm to relieve of mild
      symptoms of anxiety, including mental stress, restlessness, and irritability. Historically,
      Lemon balm has been widely used in Asian traditional medicine as a sedative to treat many
      psychiatric disorders, such as stress, depression, anxiety, and insomnia. Lemon balm has
      shown anti-depressant, anxiolytic, and anti-insomnia effects both in human clinical trials
      and in animal model studies.
    

Intervention name(s): Lemon Balm Supplement; Matched Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral 200 mg Lemon Balm supplement tablet Twice a day for three-weeks; Matched placebo tablet Twice a day for three-weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Anemia Etiology Evaluation in Ethiopia
Condition: Anemia
MeSH terms: Anemia
Study type: Observational

Summary: 
      The AnemEE study is a population-based anemia etiology survey in six regions of Ethiopia. The
      primary aim of the study is to evaluate the relative contribution of risk factors for anemia
      among children, women of reproductive age, and adult men. The study data are intended to
      inform evidence-based decision-making on anemia control interventions.
    

Detailed description: 
      The AnemEE study is a population-based cross-sectional survey of children (6-59 months),
      adult women of reproductive age (15-49 years) and adult males (15-49 years) in six regions of
      Ethiopia (Afar, Amhara, Tigray, Oromia, Southern Nations, Nationalities and Peoples' Region
      and Addis Ababa). The study will enroll approximately 5,100 participants and will be
      conducted in two survey rounds; one survey round in the Belg season and one survey round in
      the Meher season. All participants will have hemoglobin assessed and will have standardized
      questionnaires administered to assess sociodemographic, diet, morbidity, and other
      health/nutrition factors. All participants will also have assessments of anthropometric
      measures, malaria, and soil transmitted helminth infection. A subset of participants will
      also have serum ferritin, CRP, AGP, vitamin B12, and folate concentrations assessed. The
      study data will be used to determine the relative contributions of risk factors for anemia.
    

Intervention name(s): Risk factors for anemia
Intervention type(s): Other
Intervention description(s): Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children (6-59 months); Women of reproductive age (15-49 years); Adult men (15-49 years)
Study for the Treatment of Ulcerative Colitis With Adacolumn
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn
      Apheresis System to treat the signs and symptoms of ulcerative colitis.
    

Detailed description: 
      Trial Features:

        -  Non-drug therapy

        -  Most patients can remain on current treatment regimen, including prednisone, budesonide
           and medications such as Asacol (mesalamine), Pentasa (mesalamine), Colazal (balsalazide
           disodium) and Dipentum (olsalazine sodium) throughout the study

      Components of the Study:

        -  Study length is 24 weeks, which includes a screening visit, ten treatment visits over
           nine weeks and 4 follow-up appointments

        -  Physical exams, laboratory tests and disease assessments conducted at no charge to the
           patient

        -  2:1 Randomization (treatment:sham)
    

Intervention name(s): Adacolumn Apheresis System
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Ulcerative Colitis, Apheresis
Impact of Two Genetic Variants of OATP1B3 or MRP2 or Rifampin on Systemic Disposition and Biological Efficacy of CCK-8
Condition: Gastrointestinal Hormones
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the impact of genetic variants of OATP 1B3 or MRP 2
      on the systemic disposition of endogenously formed CCK-8 and to determine the influence of a
      single-dose of the transporter inhibitor rifampin (600 mg) on the systemic disposition of
      endogenously formed CCK-8. Endogenous CCK-8 secretion will be induced by a single-dose
      standardized liquid mixed meal.
    


Intervention name(s): mixed meal; Rifampin
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 250 ml Fortimel compact (chocolate); oral rifampin administration (600 mg EREMFAT®)
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to determine the relative
      bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when
      injected under the skin.
    


Intervention name(s): liraglutide; placebo; liraglutide; liraglutide; insulin human; insulin human; liraglutide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data; Single dose by inhalation. Progression to open-label trial part will be based on safety data; Single dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order; Single dose 6 mcg/kg injected subcutaneously. Subjects receive treatment in random order; Single dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order; Single dose 0.08 IU/kg injected subcutaneously. Subjects receive treatment in random order; 24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation
Other intervention name(s): NNC 90-1170
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
Condition: Narcolepsy
MeSH terms: Narcolepsy; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter,
      4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of
      excessive sleepiness in adult subjects with narcolepsy.
    


Intervention name(s): JZP-110; Placebo oral tablet
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment