bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the corrected QT interval change(automatic-reading) after single oral
      administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean
      Adults.
    

Detailed description: 
      Randomized, Open-label, Placebo-controlled, 4-way crossover study
    

Intervention name(s): Escitalopram; Quetiapine; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Escitalopram; Quetiapine; Moxifloxacin; Placebo
Other intervention name(s): Escitalopram 20 mg (Lexapro, Tablet); Quetiapine 100 mg (Seroquel, Tablet); Moxifloxacin 400 mg (Avelox, Tablet); Water intake
Intervention MeSH terms: Moxifloxacin; Dexetimide; Quetiapine Fumarate; Citalopram; Norgestimate, ethinyl estradiol drug combination; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Corrected QT interval prolongation; Psychotropic drugs
Preoperative Nutritional Assessment of The Patients Undergoing Major Gastrointestinal Surgery and Their Immediate Postoperative Outcome
Condition: Preoperative Nutritional Status and the Postoperative Outcome
Study type: Observational

Summary: 
      It was a prospective observational study, where preoperative nutritional status and early
      postoperative complications <30 days (infectious or noninfectious) were studied. The patients
      admitted between July 2015 to May 2017, who underwent major GI surgeries were included in the
      study. The study was designed to check if BMI and NRI can predict the postoperative outcomes
      in these patients.
    

Detailed description: 
      It was a prospective observational study. This study was done at NAMS, Bir Hospital,
      Kathmandu, Nepal between July 2015 to May 2017. All the patients who underwent major GI
      surgery, under general anesthesia, were included in the study. Major was defined as surgery
      involving >2hrs and excluded were an emergency major operation, gallstone disease operations,
      patients with cough, fever, and chest infections respectively. The sample size was calculated
      using the formula z2pq/d2. Twice the number of sample calculated was taken into consideration
      and the maximum tolerable error was taken as 5%. BMI and NRI were two independent categorical
      variables. The dependent variables were the postoperative outcome in terms of infectious and
      noninfectious complications. All the preoperative parameters were of the patients were
      recorded. The immediate postoperative complications were documented and categorized as
      infectious and noninfectious complications.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All the patient who underwent major GI surgery in NAMS Bir Hospital (a tertiary level
        hospital of Government of Nepal) between 2015 to 2017.
      
Keywords: Nutritional Risk Index; Body mass Index; Postoperative Complications; Length of Hospital Stay and Cost.
A Study to Assess the Effect of Food on the Pharmacokinetics of TY-9591 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetics of TY-9591 tablets and Osimertinib Mesylate tablets after a
      single fasting administration and the effect of food on the pharmacokinetics of TY-9591
      tablets in healthy volunteers.
    

Detailed description: 
      This is a single center, randomized, open label, two phases study in healthy adult
      volunteers. The first phase is a two-sequence, two-period crossover trial. The volunteers
      will be randomly distributed into two groups and given either TY-9591 tablets or Osimertinib
      Mesylate tablets on a single fasting administration. In the second phase, all volunteers will
      be administrated TY-9591 tablets after a high fat meal. The washout between each treatment is
      no less than 21 days.
    

Intervention name(s): TY-9591 Tablets under Fasted Condition - Arm1; Osimertinib Mesylate Tablets under Fasted Condition - Arm1; TY-9591 Tablets after a High-fat Meal - Arm1; Osimertinib Mesylate Tablets under Fasted Condition - Arm2; TY-9591 Tablets under Fasted Condition - Arm2; TY-9591 Tablets after a High-fat Meal - Arm2
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Phase 1 (period 1) fasted from 10 hours prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.; Phase 1 (period 2) fasted from 10 hours prior to dosing with 80 mg Osimertinib Mesylate Tablets (p o, once) and 4 hours after dosing on day 1.; Phase 2 (period 3) allocated high-fat meal prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.; Phase 1 (period 1) fasted from 10 hours prior to dosing with 80 mg Osimertinib Mesylate Tablets (p o, once) and 4 hours after dosing on day 1.; Phase 1 (period 2) fasted from 10 hours prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.; Phase 2 (period 3) allocated high-fat meal prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.
Other intervention name(s): TY-9591; AZD9291; TY-9591; AZD9291; TY-9591; TY-9591
Intervention MeSH terms: Osimertinib; Complement Factor H
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Evaluation of Omega-3 Fatty Acid
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol will determine the pK profile of two different omega-3 fatty acid supplements
      on plasma EPA and DHA levels.
    

Detailed description: 
      This protocol is to assess the omega-3 blood levels of DHA and EPA following a single dose
      administration of study products by means of pharmacokinetics over a 24 hour period of time
      (post-dose).
    

Intervention name(s): OM3-supplement 1; OM3-supplement 2
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1g of OM3-supplement 1 will be given to subjects to look at DHA/EPA blood absorption; 1g of OM3-supplement 2 will be given to subjects to look at DHA/EPA blood absorption
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Post Marketing Observational Study (PMOS) to Assess Quality of Life in Swedish Hidradenitis Suppurativa (HS) Patients
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Observational

Summary: 
      The objective of this study is to assess quality of life (QoL), skin pain, work
      productivity/activity and health related problems in Swedish patients with moderate to severe
      HS before and after 6 months treatment with Adalimumab. Participants will be treated in
      accordance with normal routine clinical care.
    


Intervention name(s): Adalimumab
Intervention type(s): Biological
Intervention description(s): Adalimumab
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients with moderate or severe Hidradenitis Suppurativa
      
Keywords: Quality of life
A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
Condition: Allergic Asthma; Atopic Dermatitis; Allergic Rhinitis; Healthy Volunteers
MeSH terms: Rhinitis; Rhinitis, Allergic; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study to evaluate the safety of MEDI4212.
    

Detailed description: 
      A Phase 1, randomized, placebo-controlled, dose-escalation study to evaluate the safety and
      tolerability of ascending single subcutaneous and intravenous doses of MEDI4212 in subjects
      with immunoglobulin E (IgE) greater than or equal to (>=) 30 international units per
      milliliters (IU/mL).
    

Intervention name(s): Placebo; Omalizumab; MEDI4212 5 mg Subcutaneous; MEDI4212 15 mg Subcutaneous; MEDI4212 60 mg Subcutaneous; MEDI4212 150 mg Subcutaneous; MEDI4212 300 mg Subcutaneous; MEDI4212 300 mg Intravenous
Intervention type(s): Other; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.; A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.; A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.; A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.; A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.; A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.; A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.; A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic; Atopic Dermatitis; MEDI4212
Combination Chemotherapy, Radiation Therapy, and RSR13 in Treating Patients With Stage III Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation
      therapy, and RSR13 in treating patients who have stage III non-small cell lung cancer that
      cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES: I. Determine the one year survival rate, two year survival rate, and median
      survival rate in patients with locally advanced unresectable non-small cell lung cancer
      treated with paclitaxel and carboplatin followed by radiotherapy plus RSR13. II. Determine
      the complete and partial response rates and progression free interval in the chest (radiation
      portal) of these patients on this regimen. III. Determine the time to disease progression
      outside of the radiation portal in these patients on this regimen. IV. Determine the toxic
      effects and adverse events associated with this regimen in these patients.

      OUTLINE: This is a multicenter study. Induction chemotherapy: Patients receive paclitaxel IV
      over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses. Radiotherapy:
      Beginning 3 to 4 weeks after induction chemotherapy, patients receive RSR13 IV over 30
      minutes, followed by fractionated radiotherapy 5 times weekly for 6-7 weeks. Patients are
      followed monthly for 2 months and then every 3 months thereafter until disease progression or
      death.

      PROJECTED ACCRUAL: A total of 46-48 patients will be accrued for this study.
    

Intervention name(s): carboplatin; chemotherapy; efaproxiral; paclitaxel; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Radiation
Intervention MeSH terms: Paclitaxel; Carboplatin; Efaproxiral
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer
Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To study the acute effect of acetazolamide (AZA) on pulmonary hemodynamics in patients with
      pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation
      (RHC).
    

Detailed description: 
      Pulmonary hypertension (PH) of various etiologies causes dyspnea, impairs exercise
      performance and is associated with reduced quality of life (QoL) and survival. Treatment
      options include therapy for any underlying causes, pulmonary vasodilator drugs, oxygen and,
      in selected cases, pulmonary endarterectomy or lung transplantation. Unfortunately, PH
      specific drugs are expensive, associated with side effects and even combined pharmacological
      treatment is often not sufficient to achieve clinical benefits. Therefore, novel therapeutic
      drugs are needed. The investigators have recently demonstrated that sleep related breathing
      disorders, which are common in PH patients, can be improved by both nocturnal oxygen therapy
      and acetazolamide (AZA). AZA is a carbonic anhydrase (CA) inhibitor that acts as a
      respiratory stimulant thereby improving oxygenation and possibly PH. There are even data
      suggesting that CA-inhibitors have a direct pulmonary vasodilator effect. However, the
      potential role of AZA in the treatment of PH has not been conclusively studied. Therefore,
      the purpose of the current project is to investigate, the acute hemodynamic clinical effects
      of AZA in PH patients.
    

Intervention name(s): Acetazolamide; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acetazolamide; Hemodynamics
Evaluation of a New Orange-Based Beverage Enriched With Polyphenols in Adult Humans
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of a new orange juice-based beverage
      enriched in fiber and selected phenolic compounds (mainly flavanones) on features of
      metabolic syndrome and cardiovascular disease risk factors related to inflammation and
      antioxidant defense system in overweight and obese adult humans. This study hypothesizes that
      consumption of an orange juice-based beverage enriched in fiber and selected phenolic
      compounds (mainly flavanones)would improve lipid levels and lipid metabolism,blood pressure
      and the Homeostatic Model Assessment (HOMA) index.
    


Intervention name(s): Orange juice based beverage enriched in polyphenols
Intervention type(s): Other
Intervention description(s): 2 daily doses (250 ml each) during 3 months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study of Sc-FOS for Pouchitis Prevention
Condition: Pouchitis
MeSH terms: Pouchitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective is to compare prebiotic therapy with placebo for the prevention of
      pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal
      anastomosis. This study will also characterize the effects of prebiotics on the fecal
      microbiota and fecal microbial metabolites and correlate these effects with the primary
      outcome of development of pouchitis.
    


Intervention name(s): Short-Chain Fructooligosaccharide; Maltodextrin
Intervention type(s): Drug; Drug
Intervention description(s): 4 chews (8.0 g scFOS) orally for 12 months; 4 chews (maltodextrin) daily for 12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
The Effect of Preoperative Warming on Postoperative Hypothermia
Condition: Preventing Hypothermia; Perioperative Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      36 patients American society of anesthesiology (ASA) physical status I,II and III undergoing
      general anesthesia for elective transurethral resection of the prostate (TUR-P) surgery will
      be included in the study. Patients will be randomized into two groups; first group(control
      group) and second group (forced-air warming). Resistive heating will start when patients are
      transferred to the operating room table; forced-air warming will start before preoperative 30
      minute.
    

Detailed description: 
      The primary aim of this study was to compare the effect of prewarming on perioperative
      hypothermia in elderly patients undergoing TURP under general anesthesia. In addition, we
      aimed to evaluate the effects of prewarming on hemodynamic variables, PACU output time,
      tremor, patient comfort and satisfaction. The investigators plan to enroll 36 patients in 2
      groups. Body temperature will be measured at the core temperature, hemodynamic variables.
      Shivering will be graded by visual inspection. Thermal discomfort scale, patient satisfaction
      will be evaluated. The investigators hypothesize will decrease the forced air prewarming
      incidence of perioperative hypothermia.
    

Intervention name(s): forced air warming group; control group
Intervention type(s): Other; Other
Intervention description(s): 30 minutes before the preoperative will use forced air warming; do not heating group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: forced-air; hypothermia; TUR-P surgery; core temperatures; prewarming; general anaesthesia
Effects of Psychoeducation of Relatives to Patients With Serious Mental Illness
Condition: Mental Disorder; Depressive Disorder; Schizophrenia
MeSH terms: Schizophrenia; Depressive Disorder; Mental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of psychoeducation for relatives to
      patients with serious mental illness.
    

Detailed description: 
      The main aim of the study is to compare the effects of group psychoeducation for relatives to
      patients with serious mental illness with a waiting list control group. The main hypothesis
      is whether psychoeducation in groups has effects on the stress experience and coping style in
      the relatives. The relatives will receive group education in 6 weekly sessions. We will
      measure stress experience, coping style and the relatives' health condition before the
      sessions, after the sessions and at one year follow-up.
    

Intervention name(s): Psychoeducation
Intervention type(s): Behavioral
Intervention description(s): Structured disorder-related educational program for relatives
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Family; Coping Skills; Psychoeducation; Stress, Psychological; Health Education
Safety and Effectiveness of the "YOLO TOUCH" LLLT for Circumference Reduction of the Waistline
Condition: Reduction of the Waist Circumference
Study type: Interventional

Summary: 
      The YOLO TOUCH consists of a console and multi-probes that are placed on the treatment area
      that emit laser light to reduce the circumference waistline.
    

Detailed description: 
      The YOLO TOUCH device is class II device intended for use in circumference reduction of the
      waist as a non-invasive, non-thermal, and low energy laser. Typical area of the body for use
      with the YOLO TOUCH is the abdominal area.

      The YOLO TOUCH low-level therapy device consists of a main console and 8 multi-probes that
      are constructed so that each probe contains 12 laser emission diode sources at a power output
      of 35mW per diode.
    

Intervention name(s): YOLO TOUCH Low Level Laser
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Plasma and Hemodynamic Markers During Hepatectomy
Condition: Hepatorenal Syndrome, Liver Regeneration
MeSH terms: Hepatorenal Syndrome
Study type: Observational

Summary: 
      Introduction Liver resection is considered the only curative treatment option for mCRC
      patients without extrahepatic disease and is accepted practice. Despite substantial
      improvements in surgical techniques, postoperative morbidity and mortality remain an
      important concern after major resections. Complications of liver resection, although rare,
      include liver failure and acute kidney injury as indicated by oliguria and increased serum
      creatinine. The underlying pathophysiological pathways of post-operative renal alteration
      following liver resection is an increase in portal venous pressure, based on observations in
      animal models or small cohorts. The corpus of data is derived from patients with liver
      cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot
      distinguish between metabolic changes, portal hypertension and impaired liver function in the
      elucidation of the pathogenesis of renal alterations. Liver resection is therefore a potent
      model to evaluate the impact of portal hypertension on the kidney despite stable liver
      function.

      The most significant factor determining morbidity and mortality following hepatectomy is the
      ability of the remnant liver to regenerate. In this context, several growth factors were
      shown to regulate the highly orchestrated process of liver regeneration (LR).

      Hypothesis The investigators will therefore test the hypothesis that liver resection leads to
      a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal
      impairment, correlating with the quantity of resected liver.

      Furthermore, the investigators will examine the relationship between postoperative liver
      regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based
      on the preclinical data the investigators hypothesize that a circulating growth factor levels
      will be associated with delayed liver regeneration, an increased incidence of postoperative
      liver dysfunction and concomitant worse clinical outcome.
    


Intervention name(s): Liver resection
Intervention type(s): Procedure
Intervention description(s): Liver resection of patient with neoplastic hepatic tumors
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient with neoplastic liver tumors undergoing hepatectomy.
      
Biospecimen description: 
      perioperative plasma samples
    
Keywords: hepatorenal syndrome, liver regeneration, liver dysfunction
Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective was to explore the relative bioavailability of increasing doses of BILR
      355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with
      ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses.

      A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355
      (SDS)
    


Intervention name(s): BILR 355 - D1; BILR 355 - D2; BILR 355 - D3; BILR 355 - D4; Ritonavir; high fat breakfast
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention MeSH terms: Ritonavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment