bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-541468 Can Affect the Fate in the Body (Amount and Time of Presence in the Blood) of Rosuvastatin
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy male subjects to investigate whether administration of ACT-541468 can
      affect the fate in the body (amount and time of presence in the blood) of rosuvastatin
    


Intervention name(s): Rosuvastatin; ACT-541468
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg tablet; 25 mg hard capsule
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Video-Assisted Instruction in Type 2 Diabetes Patients
Condition: Education, Patient
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study of examine the effect of video-assisted instruction on Type 2 diabetes
      patients' insulin treatment self-management and insulin administration skills. The research
      will be conducted as a single group pre-test post-test quasi-experimental study. The sample
      of the study will be consisted of 50 patients with Type 2 Diabetes. Before the training, the
      patients will be self-injected a dose of insulin. After giving verbal training, the patients
      will watch a video recording of insulin treatment and administration. The author will be
      evaluated the patients' insulin treatment self-management and insulin administration skills
      after the training.
    

Detailed description: 
      The aim of the study of examine the effect of video-assisted instruction on Type 2 diabetes
      patients' insulin treatment self-management and insulin administration skills. The research
      will be conducted as a single group pre-test post-test quasi-experimental study. The sample
      of the study will be consisted of 50 patients with Type 2 Diabetes. Before the training, the
      patients will be self-injected a dose of insulin. After giving verbal training, the patients
      will watch a video recording of insulin treatment and administration. The author will be
      evaluated the patients' insulin treatment self-management and insulin administration skills
      after the training.
    

Intervention name(s): Video-assisted training
Intervention type(s): Other
Intervention description(s): Patients will be given training on insulin therapy and management using lecture, question-answer, video and demonstration methods.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: self-management; Type 2 diabetes mellitus; video-assisted instruction
Exercise Test and Cardiac Injury
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Strenuous exercise in apparent healthy individuals increases plasma (high sensitive) troponin
      levels. The underlying mechanism is not yet elucidated, but could be explained by changes due
      to a mismatch in oxygen demand and supply that mimic those of ischemia and reperfusion
      injury. If the mechanism underlying the troponin release during exercise is similar to that
      of ischemia reperfusion injury (IRI), than it should be susceptible to remote ischemic
      preconditioning (RIPC) as RIPC is a well validated technique to reduce IRI. To test this
      hypothesis healthy volunteers underwent a strenuous exercise test with or without preceding
      RIPC.
    


Intervention name(s): remote ischemic preconditioning (RIPC)
Intervention type(s): Other
Intervention description(s): RIPC protocol which consist of three 5-min cycles of bilateral forearm ischemia
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise induced (high sensitive) troponin release; Ischemia reperfusion injury; Remote ischemic preconditioning
Accuracy, Satisfaction and Usability of a FGM System Among Children and Adolescents Attending a Diabetes Summer Camp
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The aim of this study was to assess accuracy, satisfaction and usability of the FGM among
      children and adolescents with T1DM. The primary outcome was to assess the accuracy of the FGM
      system. Secondary outcomes included satisfaction and usability of the device as well as
      assessment of sensor-related issues.
    

Detailed description: 
      The aim of this study was to assess the accuracy, satisfaction and usability of a Flash
      Glucose Monitoring system (FGM) in children and adolescents with type 1 diabetes mellitus
      (T1DM) and attending a 1-week diabetes summer camp, supervised by a multidisciplinary team of
      health care providers. The camp comprised a structured daily routine with five fixed meals:
      breakfast, lunch, afternoon snack, dinner and evening snack. Capillary blood glucose (BG)
      values were measured in parallel with unmasked Flash Glucose measurements (FGM) using the FGM
      reader's built-in glucometer at breakfast, lunch and dinner. Additional measurements were
      taken before snacks, between the meals or overnight and BG was measured only in cases of low
      (<4.0 mmol/L) or high (>15.0 mmol/L) FGM values or when symptoms were discordant with sensor
      readings. Sensor-related issues were documented and a questionnaire assessing satisfaction
      and usability of the FGM was completed by patients and caregivers at study completion.
    

Intervention name(s): Flash Glucose Monitoring
Intervention type(s): Device
Intervention description(s): The camp comprised a structured daily routine with five fixed meals: breakfast, lunch, afternoon snack, dinner and evening snack. Capillary blood glucose (BG) values were measured in parallel with unmasked Flash Glucose (FG) measurements using the FGM reader's built-in glucometer at breakfast, lunch and dinner. Additional measurements were taken before snacks, between the meals or overnight and BG was measured only in cases of low (<4.0 mmol/L) or high (>15.0 mmol/L) FG values or when symptoms were discordant with sensor readings. Sensor-related issues were documented and a questionnaire assessing satisfaction and usability of the FGM was completed by patients and caregivers at study completion.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents, aged 6-18 years old, with type 1 diabetes mellitus, participating
        at the diabetes summer camp.
      
Keywords: Flash Glucose Monitoring; Children; Adolescents
Efficacy/Safety of Imprime PGG® Injection With Bevacizumab and Paclitaxel/Carboplatin in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The Phase 2 study described in this protocol will serve to evaluate the antitumor activity,
      safety and pharmacokinetic profile of Imprime PGG when combined with bevacizumab and
      concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced
      NSCLC. Additionally, this study will provide guidance for the design of more definitive
      efficacy studies of Imprime PGG in NSCLC patients.
    


Intervention name(s): Imprime PGG® Injection; Bevacizumab; Paclitaxel; Carboplatin
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): 4 mg/kg, i.v. over 2 hr, weekly until progression or discontinuation; 15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle; 200 mg/m2, i.v. over 3 hr, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.; AUC of 6 mg./mL · min based on the Calvert formula; i.v. over 30 min, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSCLC; Phase 2; Randomized; Efficacy; Safety; Imprime PGG; Bevacizumab
Quality of Life in Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      This is a non-interventional study evaluating quality of life in schizophrenic patients
      treated with atypical antipsychotics, in the ambulatory setting. This is a 9-month,
      observational, multicentric prospective study.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ambulatory patients
      
Keywords: Schizophrenia; atypical antipsychotic; quality of life; ambulatory setting
Efficacy and Safety of Tabetri on Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This study is a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical
      trial in order to evaluate the efficacy and safety of tabetri on osteoarthritis.
    

Detailed description: 
      This study is prospectively conducted to investigate the efficacy and safety of tabetri in
      patients diagnosed with osteoarthritis at 4 locations of Jaseng Hospital of Korean Medicine
      (Gangnam, Haeundae, Daejeon, and Bucheon).
    

Intervention name(s): Tabetri capsule; Placebo capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1,000 mg/capsule (Taheebo extract 600 mg/day); 1,000 mg/capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
Condition: Dementia With Lewy Bodies (DLB)
MeSH terms: Dementia; Lewy Body Disease
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate change of cerebral glucose metabolism by donepezil
      therapy and to associate change of glucose metabolism and symptoms.
    


Intervention name(s): Donepezil; Donepezil
Intervention type(s): Drug; Drug
Intervention description(s): Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks
Intervention MeSH terms: Donepezil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Dementia with Lewy bodies (DLB); FDG-PET
A Bengali Dietary Salt Study to Control Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess the benefits of using low-salt and healthy eating
      educational programme, designed specifically for Bangladeshi kidney patients, compared to the
      usual diet advice given by the clinic dietitians.
    

Detailed description: 
      We conducted an exploratory study initially to learn about the East London Bangladeshi (ELB)
      kidney patients salt intake. Furthermore, we assessed their educational needs to inform the
      development and implementation of an educational programme to reduce dietary salt intake in
      line with the Department of Health recommendations for a good blood pressure control. The
      educational programme will be tested in a randomized controlled trial. We are interested in
      salt because studies have shown that salt is one of the causes of high blood pressure.
      Scientific studies have also shown that the longer a person has high blood pressure the more
      the damage to the kidneys.
    

Intervention name(s): Low-salt educational programme; Low-salt Bangladeshi educational programme; Low-salt Bangladeshi educational programme
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects will attend a health promotion cooking programme and receive written tailored low-salt Bengali educational tool. This tool has been developed specifically for this population group from Phase 1 and 2 study.; A multi-component low-salt educational programme tailored to the Bangladeshi kidney disease patients delivered in the community.; A multi-component Low-salt educational programme tailored to the Bangladeshi kidney disease patients residents in Tower Hamlets delivered over 5 months.
Other intervention name(s): Low-salt health education; Intervention group; Intervention group/ Educational group / Low-salt group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood pressure
A Trial to Learn How a New Liquid Form of BAY1817080 is Tolerated and Taken up by the Body of Healthy Male Participants (Part A). By Labeling BAY1817080 With a Radioactive Substance (Carbon 14) Researchers Want to Learn How the Study Drug is Processed and Excreted by the Body After Dosing (Part B)
Condition: Endometriosis Related Pain; Overactive Bladder; Diabetic Neuropathic Pain; Refractory or Unexplained Chronic Cough
MeSH terms: Neuralgia; Endometriosis; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a new way to treat people suffering either from a condition where
      the bladder is unable to hold urine normally (overactive bladder), or a condition in which
      tissue similar to the tissue that normally lines the inside of the womb grows outside the
      womb (endometriosis) or a condition where the cough lasts longer than 8 weeks in adults
      (chronic cough). BAY1817080 is a new drug that is in development as a potential treatment for
      these conditions.

      In this trial, the researchers want to learn how a new liquid form of BAY1817080 is taken up
      by the body in a small number of healthy participants. The trial will include men who are
      aged 18 to 54.

      The trial will have 2 parts: A and B. The participants in Part A will stay at the trial site
      for about 5 days. During this time, the participants will take 1 dose of a liquid form of
      BAY1817080 by mouth. The doctors will take blood and urine samples and check the
      participants' health. Part A will be done so the researchers can see how much BAY1817080 gets
      into the participants' blood. The participants in Part B will stay at the trial site for
      about 16 days followed by a maximum of 4 re-admission visits over 24 hours at intervals of 7
      days. These participants will take 1 dose of a liquid form of BAY1817080 labeled with a
      radioactive substance (carbon 14), which means it is "radiolabeled". This allows the
      researchers to understand how BAY1817080 moves through and leaves the body. During Part B,
      the doctors will take blood, urine, stool, and vomit samples if applicable. They will also
      check the participants' health.
    


Intervention name(s): BAY1817080; [14C]BAY1817080
Intervention type(s): Drug; Drug
Intervention description(s): Oral single dose; Oral single dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; Pharmacokinetics (PK)
Raspberries and Postprandial Metabolism
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Raspberries are high in several phytochemicals, vitamin C and B vitamins and have been shown
      to be potent antioxidants and anti-inflammatory agents. However, human interventional studies
      reporting the effects of raspberries in obesity, T2DM and associated oxidative stress and
      inflammation are limited. Aims, objectives and methods:

      Aim 1: To assess the effects of raspberries in postprandial glycemia and lipemia following a
      high-fat fast-food style meal challenge versus control group Objectives: to execute this aim,
      the investigators will conduct analyses of serum glucose, insulin and lipids (total
      cholesterol, LDL-cholesterol, triglycerides, VLDL-cholesterol and HDL-cholesterol) at fasting
      (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast
      consumption. The investigators will also calculate homoeostasis model assessment of insulin
      resistance (HOMA-IR) at these time points using serum glucose and insulin values.

      Aim 2: To assess the effects of raspberries in postprandial vascular functions (blood
      pressure and artery elasticity) and inflammation following a high-fat fast food style meal
      challenge versus control group

      Objectives: to execute this aim, the investigators will measure C-reactive protein (CRP) and
      the following parameters of vascular function associated with CVD at fasting (baseline) and
      at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption:

        -  systolic blood pressure and diastolic blood pressure

        -  large artery elasticity index and small artery elasticity index

        -  systemic vascular resistance
    


Intervention name(s): Raspberries
Intervention type(s): Other
Intervention description(s): 250g frozen whole red raspberries
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Volunteers
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to evaluate the effect of food on the pharmacokinetics of
      extended-release (ER) OROS paliperidone in healthy Japanese adults and to assess the safety
      and tolerability.
    

Detailed description: 
      This study was designed as a randomized, open-label, single-center, crossover study to
      evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS
      paliperidone in healthy Japanese adults. Of the 20 Japanese volunteers who are to be
      enrolled, at least 6 are to be men and 6 are to be women. All volunteers will receive single
      doses of 3 mg ER OROS paliperidone with and without a standard Japanese breakfast. There will
      be a 1-week washout between treatments, for a total treatment duration of approximately 2
      weeks. Volunteers are to be randomly assigned to 1 of 2 treatment sequence groups (fed and
      fasted; fasted and fed). The pharmacokinetics of paliperidone will be assessed for 96 hours
      after each dosing. Safety and tolerability will be monitored throughout the study. Prior to
      initiating clinical trials in Japan, a food effect study is required to evaluate the effect
      of food on the pharmacokinetics of ER OROS paliperidone in Japanese adults.

      3 mg tablets, single oral dose, once under fasting and once under fed conditions
    

Intervention name(s): ER OROS paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia, mood stabilizers, antipsychotics; ER OROS paliperidone
Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The aim of this study is to analyse the efficacy of MACS technique for the selection of
      spermatozoa and its effects on implantation, pregnancy and miscarriage rate. This study will
      be performed by two IVI clinics (IVI Sevilla and IVI Madrid) with the purpose of finding new
      techniques that allow us to better select spermatozoa and improve the results of assisted
      reproduction techniques.
    


Intervention name(s): MACS technique
Intervention type(s): Other
Intervention description(s): MACS is a technique that allow us to tag and detect apoptotic spermatozoa. These apoptotic spermatozoa have phosphatidylserine in their membranes, so we add magnetic beads with Annexin V, which binds specifically to phosphatidylserine. The spermatozoa are then tagged and can be retained in a magnetic field, allowing us to collect just the non-apoptotic spermatozoa.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: Magnetic activated cell sorting (MACS); Artificial insemination with donor sperm (AID); Spermatozoa; Sperm
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to evaluate the effect of erenumab compared to placebo on the change from baseline in
      monthly migraine days in participants with episodic migraine.
    

Detailed description: 
      The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline phase,
      a 12-week double-blind treatment phase (DBTP), an open-label treatment phase (OLTP) for up to
      256 weeks, and an 8-week safety follow-up (12 weeks after the last dose of investigational
      product [IP]).

      In the DBTP participants were to be randomized in a 3:2:2:2 ratio to placebo, erenumab 7 mg,
      erenumab 21 mg, or erenumab 70 mg.

      During the open-label treatment phase, participants were to receive erenumab 70 mg QM from
      week 12 to week 264. After implementation of Protocol Amendment 3 (07 April 2016),
      participants remaining in the OLTP increased their dose to erenumab 140 mg QM up to week 264.
      The safety follow-up increased from an 8-week safety follow-up to a 12-week safety follow-up
      (16 weeks after the last dose of investigational product).

      During the OLTP participants enrolled at sites in the United States could enroll in an
      optional clinical home use (CHU) substudy, per a country-specific protocol amendment dated 20
      June 2016. Participants in the CHU substudy were to be randomized 1:1 into 1 of 2 treatment
      groups: erenumab 140 mg using a prefilled syringe or erenumab 140 mg using an
      autoinjector/pen. Day 1 of the CHU substudy corresponded with any OLTP study visit up through
      Week 256, as long as the participant had received at least 2 doses of erenumab 140 mg. During
      the CHU substudy, participants initially self-administered IP under site supervision on
      substudy day 1, and then self-administered IP at home on substudy days 29 and 57.
    

Intervention name(s): Erenumab; Placebo; Erenumab PFS; Erenumab AI/Pen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered by study site staff once a month (QM) as a subcutaneous injection; Administered by study site staff once a month (QM) as a subcutaneous injection; Erenumab supplied in a single-use prefilled syringe for self-administration in the CHU substudy; Erenumab supplied in a single-use autoinjector/pen for self-administration in the CHU substudy
Other intervention name(s): AMG 334; Aimovig™
Intervention MeSH terms: Erenumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the DBTP participants were randomized to one of four arms. In the optional CHU substudy participants were randomized into one of two treatment groups.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: migraine, headache, prevention, prophylaxis