bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Vitamin Supplementation in Treating People With Residual Symptoms of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of folate and B12 supplementation in reducing
      negative symptoms in people with schizophrenia.
    

Detailed description: 
      About 30% of people with schizophrenia suffer from treatment-resistant psychotic symptoms,
      which may include social withdrawal, apathy, and depression. These negative symptoms can
      produce substantial distress for those affected, often disrupting social and occupational
      functioning and resulting in hospitalization. Although atypical antipsychotic medications
      have demonstrated some success in treating negative symptoms, the degree to which many
      negative symptoms respond is unclear. Depression and poor response to antidepressant
      medication have been linked to deficiency in the vitamins folate and B12. It is believed that
      vitamin supplementation with folate and B12 may offer a safe and inexpensive approach to
      improve outcomes for people with schizophrenia who have residual negative symptoms and have
      exhibited poor treatment response. This study will compare the effectiveness of folate and
      B12 versus placebo in reducing negative symptoms in people with schizophrenia.

      Participation in this double-blind study will last 19 weeks. Potential participants will
      undergo initial screening, which will include a medical and psychiatric evaluation, physical
      exam, blood draw, urine sampling, and questionnaires. Participants will also be asked for
      permission to use a portion of the blood sample for genetic analysis. Eligible participants
      will be randomly assigned to take folate with B12 or placebo. Participants will first
      complete a 2-week stabilization phase, followed by the 16-week treatment study. Medication
      visits, occurring every 2 weeks during treatment, will include questions about medication
      side effects and the distribution of study medication. During specified medication visits,
      participants will complete various assessments, which will include questionnaires about
      schizophrenia, tests of learning and memory, repeat blood tests, and pregnancy tests. The
      medication visits will last between 15 minutes and 4 hours, depending on the scheduled
      assessments for that visit.
    

Intervention name(s): Folic Acid; B12; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Folic acid 2mg po daily; B12 400 micrograms po daily; 1 capsule po daily
Other intervention name(s): cobalamin
Intervention MeSH terms: Folic Acid; Vitamin B 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognition; Folic Acid; B12
Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis
Condition: Schistosomiasis
MeSH terms: Schistosomiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label, single arm trial, which aims to assess the safety of the
      vaccine prepared sm14 in healthy subjects. The product immunogenicity will be evaluated by
      conducting serology (anti-sm14 antibodies) and testing of cellular response to the antigen by
      the method ELI-SPOT. Each participant will remain in the study for approximately 4 months.
      The total study duration is 10 months, considering a period of 6 months for inclusion. Will
      be included in the study subjects male and female, between 18 and 49 years, that manifest
      their will to participate in the research by signing an Informed Consent Form. Eligible
      population for the study are subjects who do not present at screening significant changes in
      renal, cardiac and liver functions, complete blood count, clotting, present no acute or
      chronic illnesses, are not in the chronic use of any medication, do not have HIV infection or
      other immunodeficiency. Pregnant or breastfeeding women will not be included. Volunteers will
      receive three doses of vaccine prepared sm14, in doses containing 50 mcg of the antigen,
      associated with adjuvant GLA-SE at a dose of 10 mcg, with an interval of 30 days between each
      application. Twenty volunteers will be included in the study. This is a convenience sample,
      established for the first test of the product in humans, for the initial safety assessment.
    


Intervention name(s): sm14 antigen plus adjuvant GLA
Intervention type(s): Biological
Intervention description(s): Healthy adults will receive 3 doses of the vaccine, on days 0, 30 and 60.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Schistosomiasis; Vaccine; sm14
307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a 52-week, multicenter, open-label study to determine the safety, tolerability and
      pharmacokinetics of TOPROL-XL (metoprolol succinate) extended-release tablets (metoprolol
      CR/XL) in hypertensive pediatric subjects. The study population included school age children
      (age 6 to 12 years < Tanner Stage 3) and adolescents (> 12 years old or > Tanner Stage 3 to
      16 years old) of both genders. Because response to some therapies in adult hypertension
      appears to be different in black and non-black populations, the recruitment will have a
      mixture of black and non-black subjects. Pharmacokinetic measurements were performed on a
      subset of patients. Thirty subjects (15 subjects each in the 6 to 12 year age group and the
      13 to 16 year age group) had a series of blood samples drawn. All subjects had a trough
      plasma level taken 24 hours after the last dose of open-label metoprolol CR/XL (Visit 18)
      with the exception of those subjects who completed Protocol 307B (16 week open-label
      treatment).
    


Intervention name(s): metoprolol succinate
Intervention type(s): Drug
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pediatric hypertension
Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
Condition: Ischemia-Reperfusion Injury; Lung Transplantation
MeSH terms: Reperfusion Injury; Primary Graft Dysfunction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear
      neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Repertaxin
      is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and
      efficacy of repertaxin in preventing the primary graft dysfunction (PGD) after lung
      transplantation.
    

Detailed description: 
      Lung transplantation has become a standard therapy for patients with end-stage lung disease.
      Within last decades, donor management, organ preservation, immunosuppressive regimens and
      control of infectious complications have been substantially improved. In addition, the
      operative techniques of transplantation procedures have been developed to an international
      standard of high quality. However, despite these refinements, significant reperfusion injury
      occurs in up to 10-20% of lung transplant recipients as the consequence of unavoidable
      processes of procurement, preservation and restoring blood flow. This clinical condition,
      recently termed primary graft dysfunction (PGD), remains an important problem after lung
      transplantation, and still represents the single biggest cause of early morbidity and
      mortality for lung recipients. In addition, there is some evidence to suggest a relationship
      between reperfusion injury, acute rejection, and the subsequent development of chronic graft
      dysfunction. In post-ischemia reperfusion, restoration of the blood supply (reperfusion)
      after prolonged tissue ischemia is associated with an inflammatory reaction characterized by
      massive polymorphonuclear neutrophil infiltration into the reperfused tissue. The
      infiltrating inflammatory cells can perpetuate the initial inflammatory reaction and induce
      further injuries. The importance of CXCL8 in lung tissue during the ischemic time and after
      reperfusion has been clearly demonstrated. The current standard of care in preventing this
      clinical condition focuses on prevention by way of surgical techniques in the procurement,
      storage and implantation of graft lungs. The efficacy of repertaxin in preventing
      polymorphonuclear neutrophil infiltration and tissue damage in rat models of kidney
      transplantation and lung transplantation, as well as the safety shown in human phase 1
      studies, provide the rationale for a clinical study aimed at evaluating the effect of
      repertaxin in preventing PGD after lung transplantation.
    

Intervention name(s): repertaxin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Lung transplantation; Reperfusion Injury; Survival
Effect of Food on the Pharmacokinetics of Oral Treprostinil
Condition: Hypertension, Pulmonary; Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic and safety profile of a single
      dose of oral treprostinil following four different meals of varying caloric and fat content.
    


Intervention name(s): Treprostinil diethanolamine; Standardized meals
Intervention type(s): Drug; Other
Intervention description(s): Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth within 10 minutes of consuming each of four standardized meals on Study Days 1, 8, 15, and 22.; Each subject will receive one of four different standardized meals of varying caloric and fat content in a randomized sequence such that all subjects will receive all four meals over the course of the study. Each subject will receive one standardized meal for breakfast on Study Days 1, 8, 15, and 22.
Other intervention name(s): UT-15C; UT-15C SR; Oral treprostinil
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension, Pulmonary; Treprostinil; Pharmacokinetics; Treprostinil Diethanolamine; Pulmonary Arterial Hypertension
Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117)
Condition: Fungal Infection
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of oral posaconazole
      tablets in Chinese participants at high risk for invasive fungal infections. Neutropenic
      participants undergoing chemotherapy for acute myelogenous leukemia or myelodysplastic
      syndromes will be enrolled in the study.
    


Intervention name(s): Posaconazole
Intervention type(s): Drug
Intervention description(s): Posaconazole 300 mg solid oral tablet
Other intervention name(s): MK-5592
Intervention MeSH terms: Posaconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
Condition: Port-Wine Stain
MeSH terms: Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to provide safety information of hemoporfin during the post-marketing period as
      required by China Food and Drug Administration (CFDA) regulations in order to identify any
      potential drug related treatment factors in the Chinese population, such as
      unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine
      drug uses.
    


Intervention name(s): Hemoporfin
Intervention type(s): Drug
Intervention description(s): Hemoporfin mediated photodynamic therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of Enamel Demineralization Using CPP-ACP-NaF Varnish
Condition: Demineralization
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Sometimes when people wear braces, the combination of dental plaque and diets high in sugar
      and acids can lead to white spots on the teeth surrounding the braces. These are commonly
      found in people with braces depending on their diet and care of their teeth. The white spots
      will still be present when the braces are removed. These white spots are the beginning signs
      of cavities and show that mineral has been lost from the tooth. This study will be testing a
      new varnish that is painted on the tooth around the braces to prevent these white spots from
      forming.

      This study will enroll patients who wear braces and have planned teeth extractions. A calcium
      and fluoride releasing varnish will be painted on the teeth planned to be extracted. Braces
      will then be placed on the teeth. In 3-6 weeks, the extraction will occur and the teeth will
      be collected for analysis.
    

Detailed description: 
      This is a randomized split mouth double blinded clinical trial. The CPP-ACP-NaF varnish is
      commercially available and is used for the treatment of tooth hypersensitivity under FDA 510K
      K102808. The placebo for this study is the same product without the CPP-ACP-NaF component.
      Patients with planned orthodontic therapy that include tooth extractions will have
      orthodontic brackets attached to the to-be-extracted teeth. Each patient will have the
      CPP-ACP-NaF varnish and the varnish base (without CPP-ACP-NaF) applied to teeth immediately
      after orthodontic brackets have been applied. The specific teeth (left or right) will be
      randomly determined as to the application of the varnish or placebo. In this experimental
      design each patient has CPP-ACP-NaF applied to one side and placebo applied to the other
      side.

      When the teeth are extracted they are transferred to the Carey Laboratory for in vitro
      evaluations.
    

Intervention name(s): CPP-ACP-NaF varnish
Intervention type(s): Device
Intervention description(s): calcium phosphate containing fluoride releasing varnish to prevent caries
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Stored RBC Transfusion and Immonomodulation
Condition: Infections
Study type: Interventional

Summary: 
      Transfusion of RBC is associated with post operative infections. Our hypothesis is that
      stored blood could be related with increased post operative infection risk. Surgical patients
      transfused during the operation or immediately after will be included in our study. Patients
      will receive fresh or old blood during the whole recovery.
    


Intervention name(s): Fresh RBC; Old RBC
Intervention type(s): Other; Other
Intervention description(s): Patients will receive fresh blood only
Other intervention name(s): Patients will receive blood stored for 14 days or more
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Single-dose, Pharmacokinetics of AMG 853 in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the bioavailability and the effect of food on the pharmacokinetics under fasted
      and fed conditions
    


Intervention name(s): AMG 853
Intervention type(s): Drug
Intervention description(s): Single dose administration of AMG 853 in tablet form to healthy adult subjects
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Amgen; Healthy; Adult
A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of an investigational
      anti-anxiety medication relative to placebo in patients with generalized anxiety disorder
      (GAD)
    


Intervention name(s): Gabitril
Intervention type(s): Drug
Intervention MeSH terms: Tiagabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006)
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effectiveness, safety and tolerability of a range
      of doses of MK-1602 versus placebo in the treatment of acute migraine.
    


Intervention name(s): MK-1602; Placebo-matching MK-1602; Rescue medication
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single 1, 10, 25, 50 or 100 mg dose of MK-1602 taken at onset of migraine of moderate or severe intensity. Dosage form is film coated tablet for oral administration. Dose is provided to participants as a blinded bottle of tablets packaged to achieve the various MK-1602 dose levels to be studied. Participants will be instructed to take all study medication from the bottle when they treat their migraine headache.; Single administration of placebo-matching MK-1602 taken at onset of migraine of moderate or severe intensity. Dosage form is film coated tablet for oral administration. Dose is provided to participants as a blinded bottle of tablets packaged to achieve placebo study medication. Participants will be instructed to take all study medication from the bottle when they treat their migraine headache.; If moderate or severe migraine headache pain continues 2 hours after dose of study medication or if migraine headache comes back within 48 hours,
Participants will be allowed to take their own rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs]), anti-emetics, triptans or other medication not explicitly excluded.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cross-Over Multicentre Study in Adolescents
Condition: Overweight; Hyperlipidemia
MeSH terms: Overweight; Hyperlipidemias
Study type: Interventional

Summary: 
      The main objective of this study is to evaluate the effects of two diets with different
      glycemic index and fibre content on glucose metabolism and plasma lipid profile of 80
      adolescents in 4 European centres.

      Secondary objectives are to evaluate the effects of the two standardized diets on selected
      hormones and variables linked to inflammatory status.
    


Intervention name(s): dietary treatment; dietary treatment
Intervention type(s): Other; Other
Intervention description(s): dietary treatment with a high-glycemic index low-fibre diet (HGI-LF); dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Adolescence; Overweight; Dietary Fiber; Glycemic Index; Healthy lifestyle
The Effect of Sensory-enhanced Beverages on Satiety Following Repeated Exposures
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The study will be a 3-way crossover design: it will assess the impact of consuming a beverage
      enhanced with satiety-relevant properties on subjective ratings of appetite and on energy
      intake compared with a low energy version with the same sensory characteristics, and a
      non-sensory enhanced high energy control.

      In addition, saliva samples will be collected at regular intervals for the identification of
      novel biomarkers of energy intake.
    

Detailed description: 
      The study will be a 3-way crossover design: it will assess the impact of a high-energy,
      sensory-enhanced beverage on energy intake through ad libitum food consumption and subjective
      feeling of appetite using visual analogue scales (VAS) compared to 2 control beverages
      following repeated exposures. Each participant will consume each beverage 10 times. This
      includes 2 satiety-testing sessions on site at Leatherhead Food Research, and 8 occasions
      consuming the product as a mid-morning snack during the participants' normal routine. Each
      participant will attend the Nutrition Unit on 6 different occasions (plus one screening
      visit) before and after repeated exposures to the beverages at home. The order in which
      participants receive the beverages will be counterbalanced and randomised. There will be a
      two-week washout period in which none of the beverages are consumed between the different
      beverage manipulations. Participants will fast overnight before each visit and consume the
      same evening meal before each test day. Participants will be instructed to avoid consuming
      food or calorific beverages for one hour before or after consuming the beverage. Following
      the last satiety testing day participants will be debriefed and open questions will be asked
      about experiences of the beverages in a focus group format.
    

Intervention name(s): Mango-flavour beverage
Intervention type(s): Behavioral
Intervention description(s): The study will be a 3-way crossover design: it will assess the impact of a high-energy, sensory-enhanced beverage on energy intake through ad libitum food consumption and subjective feeling of appetite using visual analogue scales (VAS) compared to 2 control beverages following repeated exposures. Each participant will consume each beverage 10 times. This includes 2 satiety-testing sessions on site at Leatherhead Food Research, and 8 occasions consuming the product as a mid-morning snack during the participants' normal routine. Each participant will attend the Nutrition Unit on 6 different occasions before and after repeated exposures to the beverages at home. There will be a two-week washout period in which none of the beverages are consumed between the different beverage manipulations.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Appetite; Satiety; Energy intake; Saliva; Biomarkers