bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS,
      combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are
      safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines
      can prevent malaria infection.

      The RTS,S vaccine contains a malaria protein in combination with a portion of the
      commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria protein.
      The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are done at study
      days 0, 28 and 84, followed by a malaria challenge approximately 14 days after the 3rd
      vaccination.
    


Intervention name(s): FMP1/AS02; RTS,S/AS02; AS02 adjuvant alone; Malaria challenge
Intervention type(s): Biological; Biological; Other; Other
Intervention description(s): The vaccine antigen FMP1 consists of a recombinant histidine-tagged (His6) fusion protein expressed in E. coli. The lyophilized pellet contained per vaccine vial 62.5 μg merozoite surface protein-142 (MSP-142) with 3.1% lactose as cryoprotectant in each 3 ml monodose vial. The pellet was reconstituted with AS02.; The vaccine antigen RTS,S, is a recombinant subunit vaccine produced in, and purified from yeast cells. The final lyophilized pellet contained 62.5 μg RTS,S with 3.15% lactose as cryoprotectant per 3 ml monodose vial. The pellet was reconstituted in AS02 and each 0.5 ml dose contained 50 μg RTS,S.; AS02 adjuvant contains 50 μg monophosphoryl lipid A (MPL) and 50 μg Quillaja saponaria 21 (QS-21), 250 μl of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 ml.; Experimental challenge homologous strain of P.falciparum sporozoites. Mosquitoes infected with malaria approximately 17 to 19 days earlier and that contained sporozoites in their salivary glands. For each volunteer, five mosquitoes were allowed to feed over five minutes, after which they were dissected to confirm how many were infected, and the salivary glands scored.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: P. falciparum; vaccine; healthy volunteers
A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical research study is to assess the bioavailability and
      pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and
      injectable diazepam after intravenous (I.V.) administration
    

Detailed description: 
      Diazepam is a medication that is used for the treatment of seizures. It was approved by the
      Food and Drug Administration (FDA) for use in the United States and is currently sold as
      Valium® tablets, Diazepam Injection and Diastat® rectal gel.

      This study will evaluate two intranasal (nasal spray) formulations of diazepam which will be
      supplied by Neurelis, Inc. The purpose of this clinical research study is to assess the
      bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal
      spray) and injectable diazepam after intravenous (I.V.) administration. "Bioavailability" is
      a measure of how much drug is absorbed and present in the blood. "Pharmacokinetics" means to
      study the way a drug enters and leaves the blood and tissues over time
    

Intervention name(s): Diazepam; Diazepam
Intervention type(s): Drug; Drug
Intervention description(s): Diazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose.; IV diazepam will be given as a 5 mg dose. The two nasal formulations will be given as 10 mg doses.
Other intervention name(s): Brand names include: Valium, Diastat; Valium Injectable, Diastat Rectal Gel
Intervention MeSH terms: Diazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations
Condition: Insomnia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, randomized crossover study being conducted in three
      cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of
      three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose
      of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random
      sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.
    


Intervention name(s): E2006
Intervention type(s): Drug
Intervention description(s): 2.5 mg, 10 mg, and 25 mg E2006 tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Cancer is second leading cause of death worldwide. The psychological issues are related to
      all stages of the disease affecting outcome of treatment and overall quality of life. The
      study evaluated the effectiveness of yoga counselling among prostate cancer patients on their
      quality of life and psychological outcomes.
    


Intervention name(s): Counselling based on yoga; Chemotherapy
Intervention type(s): Behavioral; Drug
Intervention description(s): Counseling sessions were given as one-on-one and group to patients based on yoga philosophy and therapy.; Usual Care group had standard chemotherapy regimens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Danhong Injection in the Treatment of Acute Ischemic Stroke
Condition: Acute Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Danhong injection is effective in the
      treatment of acute ischemic stroke.
    


Intervention name(s): Danhong injection; Standard medical care; placebo
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower. 40ml Danhong injection added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion; Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.; 0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Ischemic Stroke; Randomized Controlled Trial; Traditional Chinese Medicine
The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This project is part of several studies exploring situations, where glucagon potential has
      lesser glucose elevating effect. Exercise can be one of these situations as exercise may
      reduce liver glycogen depots.

      The investigators aims are:

        1. To compare the increase in plasma glucose after 200µg glucagon given either after
           exercise or after resting for 45 minutes.

        2. To determine whether a subcutaneous glucagon injection just before exercise has a
           greater impact on hepatic glucose production and thereby is superior to an injection
           after exercise in preventing hypoglycemia during and two hours after exercise.

        3. To compare the accuracy of two Dexcom G4 continuous glucose monitors, (CGM) placed at
           either the abdominal wall or on the upper arm.
    

Detailed description: 
      Design:

      A randomized placebo-controlled single-blinded study will be conducted. The subjects do not
      know if they get glucagon or placebo but the investigator know if the subject get glucagon or
      placebo. Study participants have to complete three study days and serve as their own
      controls. After participants have given an informed consent, they will go through three
      steps:

        1. Screening day

        2. Run-in period

        3. Three study days in a random order:

             -  Exercise and glucagon injected after cycling/or during cycling in case of
                hypoglycemia

             -  Resting and glucagon after resting

             -  Exercise and glucagon subcutaneous before cycling

      47-49 hours before the study visits one CGM device is placed on the abdominal wall on the
      participant at least 7 cm from the site of the insulin pump infusion set. One CGM is placed
      on the non-dominant upper arm between 10 cm from elbow and 10 cm from shoulder on the
      posterior/lateral side on the arm. The CGMs will be in place for seven days. The CGM readings
      on the CGM placed at the abdominal wall are not blinded for the participant. The CGM readings
      on the CGM placed on the arm is blinded for the participant. In the period from the study
      visits to 4 days after the study visits the participant will do self-monitoring of blood
      glucose 8 times a day on standardized times.
    

Intervention name(s): Glucagon before exercise; Glucagon after exercise; Glucagon after resting
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
NeisVac-C Single Prime Study in Infants
Condition: Neisseria Meningitidis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C
      in infants (at either 4 or 6 months of age), as determined by immune response.
    


Intervention name(s): Meningococcal group C polysaccharide conjugate vaccine; Pneumococcal 13-valent conjugate vaccine; Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL dose, subcutaneous administration in right anterolateral thigh; 0.5 mL dose, subcutaneous administration in right anterolateral thigh; 0.5 mL dose, subcutaneous administration in right anterolateral thigh
Other intervention name(s): NeisVac-C; Prevenar 13; Infanrix hexa
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study Comparing the Effectiveness and Convenience of Dietary Therapy for Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Irritable bowel syndrome is a functional lower gastrointestinal disorder characterised by
      abdominal pain and altered bowel habit in the absence of organic pathology to explain the
      symptoms. Irritable bowel syndrome has a prevalence of approximately 10% in adults, shows a
      female preponderance, and is more common in younger individuals. In clinical practice,
      Irritable bowel syndrome accounts for almost a third of all gastroenterology cases seen in
      primary care, with a subsequent third of these being referred onto secondary-care for further
      evaluation. The economic burden of Irritable bowel syndrome, in terms of medical expense,
      work absenteeism and loss of productivity, is considerable.

      The exact cause of irritable bowel syndrome is unknown. Accordingly there has been a huge
      surge in interest for dietary therapies to help manage Irritable bowel syndrome. To date,
      there are only a handful of small randomized controlled trials evaluating the efficacy of
      dietary therapy in Irritable bowel syndrome. In light of this we plan to conduct the first
      randomized controlled trial directly comparing the effectiveness of the low-FODMAP diet,
      British Dietetic Association diet, and the gluten free diet in Irritable bowel syndrome.
      Moreover, such a trial allows for a direct comparison of nutritional and gut microbial
      changes, both of which can suffer detrimental consequences following the implementation of
      restrictive dietary therapies. This study is also unique in that it takes into consideration
      the patients' perspective with regards to the convenience and cost-effectiveness of
      implementing such diets into routine day-to-day life. The study will aim to recruit 100
      patients from Sheffield Teaching Hospitals gastrointestinal clinics. Following recruitment
      patients will be seen by a hospital dietitian where they will be randomized to one of the 3
      diets. Participants will complete a questionnaire portfolio weekly for one month as part of
      the study
    


Intervention name(s): dietary therapy
Intervention type(s): Other
Intervention description(s): participants will undertake a four week diet as part of their IBS treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Autologous Stem Cell Transplantation in Acute Myocardial Infarction
Condition: Acute Anterior Wall Myocardial Infarction
MeSH terms: Myocardial Infarction; Anterior Wall Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Objectives

      Intracoronary transplantation of different cell populations have been used in acute
      myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study
      is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells
      (mBMC) improve left ventricular ejection fraction (LVEF) after anterior wall AMI.

      Design

      The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with
      acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute PCI are
      randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 days
      after PCI or to control. Left ventricular function, exercise capacity, biochemical status,
      functional class, quality of life and complications are validated at baseline and during a
      12-month follow up.
    


Intervention name(s): Intracoronary aotologous stem cell transplantation
Intervention type(s): Genetic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Myocardial infarction; bone marrow cells; cell transplantation
Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single doses of
      SBI-087 in Japanese subjects with rheumatoid arthritis.
    


Intervention name(s): SBI-087; SBI-087; SBI-087; SBI-087
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IV, Single dose; IV, Single dose; SC, Single dose; SC, Single dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects Of High Intensity Interval Training On Speed And Explosive Strength In Sprinters
Condition: Sprinters
Study type: Interventional

Summary: 
      High Intensity Interval Training (HIIT) is a type of exercise that alternates between short
      bursts of high and low intensity activity. The physical components may be improved very
      effectively and efficiently with this kind of training. The choice of an effective practice
      strategy could be very beneficial because boosting an athlete's performance is correlated
      with improving their physical components. The significance of this study was that HIIT is
      helpful in increasing strength, endurance and agility. Thus it could be useful for athletes
      for their physical fitness in less duration as compared to the conventional protocols.
    

Detailed description: 
      According to researchers knowledge there is lack of sufficient literature on "The Effect Of
      High Interval Intensity Training On Speed And Explosive Strength In Sprinters." The past
      trials do not address speed and strength in relation to HIIT and this study will help
      identify the need to practice this training in order to enhance the skills and athletic
      performance of sprinters and will uplift their anaerobic fitness.
    

Intervention name(s): EFFECTS OF HIGH INTENSITY INTERVAL TRAINING IN SPRINTERS
Intervention type(s): Other
Intervention description(s): EFFECTS OF HIGH INTENSITY INTERVAL TRAINING ON SPEED AND EXPLOSIVE STRENGTH IN SPRINTER
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome
Condition: Fragile X Tremor/Ataxia Syndrome
MeSH terms: Ataxia; Cerebellar Ataxia; Tremor; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine if citocoline is effective for balance
      abnormalities and to stabilize cognitive decline in patients with fragile X-associated tremor
      ataxia syndrome. The study will test 1000mg twice daily of citocoline for 12 months in an
      open label pilot study, with study visits at baseline, 3, 6, and 12 months.
    

Detailed description: 
      The purpose of this study was to determine if citicoline was safe for the treatment of tremor
      and balance abnormalities and to stabilize cognitive decline in patients with fragile
      X-associated tremor ataxia syndrome. Ten participants with diagnosed FXTAS were administered
      1000 mg of citicoline once daily for 12 months. Outcome measures and neurological examination
      were performed at baseline, 3 months, 6 months, and 12 months. The primary outcome was
      safety. Secondary outcomes included change in FXTAS Rating Scale score, a battery of
      neuropsychological tests, an instrumented Timed up and go test, computerized dynamic
      posturography, 9-hole pegboard test, and balance confidence and psychiatric symptom
      questionnaires.
    

Intervention name(s): citocoline
Intervention type(s): Drug
Intervention description(s): Ten subjects will receive 1,000mg once daily of citicoline. Each subject will stay on the study drug for 12 months. The outcome measures will be assessed at baseline and then again at the end of month 3, month 6, and month 12. The subjects will continue taking the same study drug at the same dose throughout the entire trial.
Other intervention name(s): CDP-choline
Intervention MeSH terms: Choline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer
Condition: Bulky Stage IIIC and IV Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the role of an additional intraperitoneal
      chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.
    

Detailed description: 
      This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal
      chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in
      the first-line therapy for ovarian cancer.
    

Intervention name(s): PEip (weekly) and TCiv; TCiv
Intervention type(s): Drug; Drug
Intervention description(s): IP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5; IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
Other intervention name(s): platinum; VP 16; taxane; taxane; platinum
Intervention MeSH terms: Taxane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian Cancer; intraperitoneal chemotherapy