bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Nicotine on Arousal, Cognition and Social Cognition in Young and Elderly Healthy Subjects.
Condition: Schizophrenia; Cognition Disorders
MeSH terms: Schizophrenia; Cognition Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study in young and elderly healthy subjects will investigate the effect of nicotine on
      arousal, cognitive task and social cognition after acute dose administration.
    

Detailed description: 
      This is a double-blind (neither physician nor subject knows the name of the assigned drug),
      placebo-controlled, randomized (study drug assigned by chance), three-way-crossover trial
      (participants may receive different interventions sequentially during the trial) in young and
      elderly healthy volunteers. The three-way-crossover treatment phase will consist of three
      blinded treatment periods separated by a wash out period (the period allowed for the entire
      administered drug to be eliminated from the body) of 2 to 7 days. The study duration for each
      volunteer will be approximately 8 weeks. Each volunteer enrolled will be randomized to
      receive Treatment A (1mg nicotine per dosing), Treatment B (2mg nicotine per dosing) or
      Treatment C (placebo) during one of their treatment period. The study drug (nicotine or
      placebo) will be administered three times daily on Day 1 of each treatment phase as a mouth
      spray, separated 2 to 3 hours from each other (i.e. 0h; and 2 to 3h; and 4 to 6h post first
      dosing). Three different blocks of cognitive assessments will follow, one after each drug
      administration. Safety evaluations include adverse event monitoring, vital signs and clinical
      laboratory tests. Each volunteer participating will receive 3 identical study drug
      administrations per dosing day (2 to 3 hours from each other), resulting in an overall dose
      of 3 mg nicotine (Treatment A), 6 mg nicotine (Treatment B) or 0 mg nicotine (Treatment C)
      per dosing day. By the end of the study, after the 3-way crossover, each volunteer will have
      received 9 mg nicotine via mouth spray.
    

Intervention name(s): A643 (nicotine); placebo; A643 (nicotine)
Intervention type(s): Other; Drug; Other
Intervention description(s): 2mg oromucosal nicotine spray- three times daily during each treatment period; placebo - three times daily during each treatment period; 1mg oromucosal nicotine spray- three times daily during each treatment period
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: symptomatic treatment; cognition; cognitive deficits; Schizophrenia
Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Observational [Patient Registry]

Summary: 
      The mechanisms that regulate appetite in the morbidly obese are multifactorial and not
      well-known. Different peripheral signals (such as ghrelin or cholecystokinin) play an
      important role in the central regulation of appetite and hunger. Postprandial ghrelin and
      cholecystokinin (CCK) response has also an effect on gastric emptying that, in turn, has an
      effect on satiety sensation.

      On the other hand, bariatric surgery is supposed to affect hunger and satiety in and also
      promotes changes in gastric emptying which are not clearly defined.

      Aim: To better understand the physiologic mechanisms involved in the regulation of hunger and
      satiety in morbidly obese individuals, especially those related with gallbladder and gastric
      emptying, as well as those related with the response of the gastrointestinal hormones
      ghrelin, CCK and glucagon-like peptide-1 (GLP-1), before and after bariatric surgery (sleeve
      gastrectomy). Methodology: Three groups of individuals will be studied and compared: group A)
      non obese healthy subjects, group B) morbidly obese subjects and group C) morbidly obese
      subjects who had had a previous sleeve gastrectomy. In all subjects a standard meal test
      after a fasting night will be administered and appetite, satiety and hormonal response
      (ghrelin, CCK, GLP-1 and insulin) during 4 hours post-ingestion assessed, as well as
      postprandial gallbladder and gastric emptying by means of ultrasonography and the paracetamol
      absorption technique.
    


Intervention name(s): Sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic vertical gastrectomy as a bariatric procedure.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group A: non obese healthy individuals Group B: morbidly obese individuals Group C:
        individuals who had had a previous sleeve gastrectomy as a bariatric procedures
VTD Followed By MPT Maintenance As a First Line Treatment For The Patients With MM Who Are Non-Transplant Candidates
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Multiple Myeloma is a incurable disease. Recently developed targeted therapy gave new hope
      for the patients with multiple myeloma. Velcade in combination with other agents are
      currently in trials for the newly diagnosed patient, we designed sequential treatment with
      VTD and MPT for the patients who are not transplant candidates. This would be expected to
      result in maximal tumor control, and thus, in maximal survival benefit, equivalent to high
      dose therapy with autologous transplantation in younger population
    

Detailed description: 
      The two effective and non-cross resistant regimens, VTD and MPT, will be applied sequentially
      to the patients with multiple myeloma who are not transplant candidates. This would be
      expected to result in maximal tumor control, and thus, in maximal survival benefit,
      equivalent to high dose therapy with autologous transplantation in younger population
    

Intervention name(s): Velcade
Intervention type(s): Drug
Intervention MeSH terms: Bortezomib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple myeloma
Resiliency Training on the College Campus
Condition: Psychotic Disorders; Mood Disorders; Anxiety Disorders
MeSH terms: Anxiety Disorders; Psychotic Disorders; Mood Disorders
Study type: Interventional

Summary: 
      This is a waitlist controlled study examining the initial efficacy of Resilience Training
      among college students at an elevated risk for a severe mental illness.
    


Intervention name(s): Resilience Training
Intervention type(s): Behavioral
Intervention description(s): A 4 session group-based behavioral intervention which delivers the following skills: mindfulness, metallization, and self-compassion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Waitlist controlled design
Masking: None (Open Label)
Primary purpose: Prevention
Phase I Open Label Dose Escalation Study to Investigate the Safety & Pharmacokinetics of AZD5312 in Patients With Androgen Receptor Tumors
Condition: Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first time in man (FTIM), Phase I study to determine the Maximum Tolerated Dose,
      Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a
      multicentre study with sites in the United States and United Kingdom. Approximately 90
      patients are expected to be enrolled in this study.

      The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion.
    

Detailed description: 
      This is a first time in man (FTIM), Phase I study to determine the Maxiimum Tolerated Dose,
      Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a
      multicentre study with sites in the United States and United Kingdom. Approximately 90
      patients are expected to be enrolled in this study.The study involves two parts, Part A, Dose
      Escalation and Part B, Dose Expansion.

      AZD5312 will be given intravenously (IV) as an infusion, over one hour. For the purpose of
      planning, each 4 week period (28 days) will be called a Cycle. AZD5312 will initially be
      administered 4 times within the first 11 days, (on Days [1, 4, 8 and 11]± 2), with no dosing
      on sequential days. Patients will receive weekly treatments on Days 15 and 22 to complete
      Cycle.

      1. During the subsequent cycles, patients will receive weekly treatment on Days 1, 8, 15 and
      22 (±2). The AZD5312 dose will not change unless dose reductions are required due to
      treatment-related toxicity. Patients will continue to receive AZD5312 until disease
      progression, intolerable toxicity, or discontinuation criteria have been met. Toxicity,
      Pharmacokinetics and biomarker data will be assessed throughout the study. Alternative
      infusion durations and/or treatment schedules may be explored if preliminary data suggest
      these would be more appropriate.
    

Intervention name(s): AZD5312
Intervention type(s): Drug
Intervention description(s): AZD5312 is a generation 2.5 antisense oligonucleotide (ASO) which is designed with the purpose of specifically suppressing human Androgen Receptor (AR) expression, thereby providing potential therapeutic benefit for the treatment of mCRPC and other AR-dependent cancers.
Other intervention name(s): ISIS 560131
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solid tumor, prostate cancer, breast cancer, bladder cancer, ovarian cancer, gastric cancer, salivary duct cancer
Hybrid Closed-Loop Control With Prandial Insulin Dosing Informed by Insulin Sensitivity in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the safety and feasibility of a smart bolus
      calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity
      (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during
      an active week of diabetes camp.
    

Detailed description: 
      This is a single center, double-blind, randomized, crossover trial. The study team will
      target enrollment of 30 adolescents (age 12 - <18 years) with T1D who currently manage their
      diabetes with an insulin pump and a continuous glucose monitoring (CGM) system. Participants
      will be randomized 1:1 to the use of the standard HCL system (USS Virginia) vs. the HCL
      system with the smart bolus calculator first. The trial will be held at a local camp facility
      and will consist of EITHER a weeklong (6 day/5 night) camp OR two long weekends (4 day/3
      night) separated by a washout period of about one week.
    

Intervention name(s): Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI; Standard Hybrid Closed Loop Control (USS Virginia)
Intervention type(s): Device; Device
Intervention description(s): Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI; Standard Hybrid Closed Loop Control (USS Virginia)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insulin Sensitivity (SI); Adolescent; Insulin Pump; Continuous Glucose Monitor (CGM); Hybrid Closed Loop (HCL); Diabetes Camp
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Study type: Observational

Summary: 
      This observational study will evaluate the use in clinical practice and efficacy of Mircera
      (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis
      receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be
      followed for 24 weeks.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic kidney disease on dialysis receiving treatment with Mircera for
        chronic renal anemia
Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)
Condition: Clinical Trial ,Phase I
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be performed as a multi-center, randomized, double-blind study in 60 healthy
      women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a
      COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor
      modulator (PRM) vilaprisan.
    


Intervention name(s): Vilaprisan (BAY 1002670); Vilaprisan Placebo; Microgynon; Microgynon Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.; Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.; Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21); For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91).
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is develop recipes containing CHO less than ICR, prepare new snacks
      alternatives that could be consumed without need for additional insulin doses, and evaluate
      the glycemic and insulinemic responses of these recipes. A randomized crossover trial will
      include 15 healthy adults aged 19-30 years. All participants will consume 3 test foods and
      reference food (glucose solution, 2 times) in a random order. Blood samples will be collected
      at time points 0,15, 30, 45, 60, 90 and 120 min. Glucose and insulin analyzes will be
      performed from blood samples. The results of these time points will be marked on the chart
      and the incremental area under the curve (iAUC) will be calculated for both glucose and
      insulin.
    


Intervention name(s): Blueberry Cake; Snacks with Cheese; Spicy Crackers; Glucose Solution First Repeat; Glucose Solution Second Repeat
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Blueberry cake containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.; Snacks with cheese containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.; Spicy crackers containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.; The glucose solution will be prepared by dissolving 25 g of glucose in 250 ml of water. Participants consume the glucose solution within 15 minutes after 10-hours fasting. Blood samples will be collect at time points 0,15, 30, 45, 60, 90 and 120 min.; The glucose solution will be prepared by dissolving 25 g of glucose in 250 ml of water. Participants consume the glucose solution within 15 minutes after 10-hours fasting. Blood samples will be collect at time points 0,15, 30, 45, 60, 90 and 120 min.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Glycemic index; Insulinemic index; Low carbohydrate; Snack; Type 1 diabetes
Comparative Study of the Effect of Dysport and Botox
Condition: Aging
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and
      EMG activity.
    


Intervention name(s): botulinum toxin type A
Intervention type(s): Drug
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: botulinum toxin type A; Dysport®; Botox®; hyperfunctional forehead lines; randomized controlled trial; double-blinded trial; electromyogram (EMG)
Trial of New Pretreatment Method in Transnasal Endoscopy
Condition: Pretreatment Method of Transnasal Endoscopy
Study type: Interventional

Summary: 
      This study designed for compare efficacy of following two anesthetic method for transnasal
      endoscopy

        -  "Catheter-free method"

        -  "Catheter-insertion method"
    

Detailed description: 
      1. Check of the medical history (both method)

             1. underlying systemic disease

             2. drug allergy

             3. anticoagulant or antiplatelet use

        2. Premedication (both method)

             1. taking premedication contain dimethylpolysiloxane, pronase, sodium bicarbonate for
                improved endoscopic visualization

             2. spraying naphazolin acetate into nasal cavity for decrease secretion

        3. Different anesthetic method for transnasal endoscopy

             1. "Catheter-free method" : spraying epinephrine into nasal cavity

             2. "Catheter-insertion method" : spraying both epinephrine and lidocaine into nasal
                cavity
    

Intervention name(s): pretreatment method for transnasal endoscopy
Intervention type(s): Procedure
Intervention description(s): Catheter-free method : The patient then takes simethicone (10cc). After that, the nasal cavity is sprayed with epinephrine (1cc) and lidocaine HCL (4%, 4cc).
Catheter inesertion method: After preparation steps the same as in the 'catheter-free' method, a 14 Fr. flexible catheter is coated with 2% lidocaine HCL gel and 8% lidocaine HCL spray. After that, the catheter is inserted into the patient's nasal cavity, and maintained about 1 minute for anesthesia. A 16 Fr. catheter is prepared by the same method with as the 14Fr. catheter. After the 14 Fr. cathter has been removed from the patient's nasal cavity, the 16 Fr. catheter is inserted into the patient's nasal cavity.
Other intervention name(s): Catheter-free method/Cathter insertion method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transnasal endoscopy; pretreatment method
Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence
Condition: Adult Hepatocellular Carcinoma; Recurrent Hepatocellular Carcinoma; Adverse Reaction to Drug; Vascular Endothelial Growth Factor Overexpression
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 2

Summary: 
      This single-centered phase II clinical study is to obtain preliminary information on 1-year
      recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in
      combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore
      biomarkers(VEGF/bFGF) for thalidomide response.
    

Detailed description: 
      After liver resection to remove the hepatocellular carcinioma completely, the patients with
      high risk of tumor recurrence will be enrolled into this study. The high risk of tumor
      recurrence depends on tumor characteristics. The risk factors of tumor characteristics
      included tumor size >5 cm in diameter, abscence of encapsulation, vascular invasion and
      presence of daughter nodules. The patients with high risk of tumor recurrence will have 1 to
      3 risk factors. When the patients are enrolled into the study, oral thalidomide in
      combination with tegafur-uracil will be applied to prevent tumor recurrence. The patients
      will be fillowed uo erevy 3 mnoths.
    

Intervention name(s): thalidomine; tegafur-uracil
Intervention type(s): Drug; Drug
Intervention description(s): thalidomine (400mg/day) for 1 year to prevent HCC recurrence; tegafur-uracil (2 tablelet twice a day) for 1 year to prevent HCC recurrence
Other intervention name(s): thado; ufur
Intervention MeSH terms: Tegafur
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients
Condition: Gnathic (Skeletal) Mesial Occlusion
Study type: Observational

Summary: 
      The primary purpose of this study was to evaluate the immediate and previous results of the
      effectiveness of non-surgical orthopedic treatment in children aged 12-14 years with gnathic
      forms of mesial occlusion by the method of dentoalveolar compensation using a permanent
      apparatus with a palatal expanding screw.
    


Intervention name(s): dentoalveolar compensation method; face mask
Intervention type(s): Device; Device
Intervention description(s): orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw; orthopedic treatment was performed using a face mask.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        To evaluate the early and late results of the non-surgical orthopedic treatment efficiency
        in 12-14 years old children with the gnathic forms of mesial occlusion by the dentoalveolar
        compensation utilizing a permanent device with a palatal expanding screw.
      
Keywords: early adolescence; orthodontic practice; orthodontic treatment
Caloric Titration Method of Weight Loss and Maintenance
Condition: Healthy
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Study examined the effectiveness of daily self-weighing to prevent age related weight gain.
    

Detailed description: 
      Were given scales to weigh themselves daily. Change in weight was measured at the beginning
      and end of the two year observation period.
    

Intervention name(s): Frequent Self-Weighing
Intervention type(s): Other
Intervention description(s): Were given scales to weigh themselves daily. Change in weight was measured at the beginning and end of the two year observation period.
Other intervention name(s): Daily weighing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention