bioihbjkbjnl/mcl2 huggingface dataset:
Finafloxacin 300 mg Twice a Day (b.i.d.) Versus Ciprofloxacin 250 mg Twice a Day (b.i.d) in Patients With Lower Uncomplicated UTI (uUTI)
Condition: Urinary Tract Infections
MeSH terms: Urinary Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female
      patients with uUTI.
    

Detailed description: 
      Patients with clinical signs and symptoms of uUTI who have a high probability of the required
      number of bacteria in their urine, measured by positive test for nitrite and /or leucocyte
      esterase by means of a dipstick will be enrolled in this study. Only these patients with
      bacterial count equal or more than 10e5 cfu/mL will be included in the efficacy analysis. At
      Baseline, patients will be randomly assigned (2:1) to receive Finafloxacin 300 mg or
      Ciprofloxacin 250 mg, following a double-dummy design, ie Group 1 will receive Finafloxacin
      tablets + Ciprofloxacin placebo capsule while Group II will receive Ciprofloxacin capsule +
      Finafloxacin placebo tablets. The treatment will last in total 3 days. The microbiological
      results will be compared with the baseline microbiology. If the concentration of initial
      pathogen in the urine is equal or more than 10e3 cfu/mL in the post-therapy culture compared
      with the baseline , this will define a bacteriological eradication. Microbiological
      assessment will be performed as well. Evaluation of the bacteria reinfection or relapse will
      be performed, based on the microbiology results. The status of clinical improvement and cure
      will be considered additionally.
    

Intervention name(s): Finafloxacin; Ciprofloxacin
Intervention type(s): Drug; Drug
Intervention description(s): Finafloxacin tablets, 300 mg b.i.d., oral administration; Ciprofloxacin placebo capsule, 1 capsule b.i.d.,oral administration; duration: 3 days; Finafloxacin placebo, 6 tablets b.i.d., oral administration; Ciprofloxacin capsule, 250 mg b.i.d., oral administration; duration: 3 days
Intervention MeSH terms: Ciprofloxacin; Finafloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: uncomplicated Urinary Tract Infection in Women; Antibacterial Chemotherapy; Proof-of-Concept
FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The Nordic FLOX-regime consists of a combination of bolus 5-FU, leukovorin and oxaliplatin
      (Eloxatin®). Cetuximab (Erbitux®) is an antibody against the epidermal growth factor receptor
      (EGFR). The combination of FLOX and weekly Erbitux has been investigated in the Nordic VII
      study where 571 patients were randomized to FLOX (regime A) or FLOX + Erbitux (regime B or
      C). Effect-data has not yet been published but the combination is well tolerated, and other
      studies have shown that Erbitux administered with chemotherapy seem to be more efficient than
      chemotherapy alone.

      The main purpose with this study is to investigate the effect of FLOX and Erbitux given every
      second week as first line treatment for patients with metastatic colorectal cancer and K-RAS
      wildtype tumor.

      The latest accessible data regarding treatment towards EGFR and K-RAS mutations shows that
      patients with K-RAS wildtype responds better to treatment than patients with K-RAS mutations.
    


Intervention name(s): Cetuximab (Erbitux); Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg/m² every second week, intravenous infusion, 8 cycles; Given in combination day 1 and 2, every second week, 8 cycles
Intervention MeSH terms: Leucovorin; Folic Acid; Fluorouracil; Oxaliplatin; Cetuximab; Levoleucovorin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Erbitux; Colorectal cancer; Oxaliplatin; Flox; Fluorouracil + folinic acid; K-RAS
Dermatopharmacokinetic Trial of LEO 80185 Gel
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Given that LEO 80185 gel takes effect in the upper layer of the skin, it is important to
      compare and examine the amount of the drug in the upper layer of the skin with that of
      Dovobet® Ointment. Therefore, a dermatopharmacokinetic study will be conducted in healty
      adult male volunteers to evaluate pharmacokinetics of LEO 80185 gel and Dovobet® Ointment in
      the stratum corneum. In this trial, a single application of LEO 80185 gel and Dovobet®
      ointment will be applied to multiple test sites on the back of healthy Japanese male adults
      and the trial is designed to compare the amount of each of the active ingredients at steady
      state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The amount of
      calcipotriol and betamethasone dipropionate in the stratum corneum will be assessed by use of
      tape stripping.
    

Detailed description: 
      The study consists of two phases:

      The pilot: The first part, known as the pilot study, will include 8 subjects and will
      evaluate pharmacokinetic profile of LEO 80185 gel and Dovobet® Ointment by measuring the
      amount of each of the active ingredients in the stratum corneum.

      Pivotal: The second part, known as the pivotal study, is designed to compare the amount of
      each of the active ingredients at steady state or close-to-steady state between LEO 80185 gel
      and Dovobet® Ointment. The number of subjects in the pivotal study and the number of
      application sites for study medications will be based on the results of the pilot study.

      The number of subjects included in the trial and design of trial is in line with previous
      type of DPK trials in Japan and the Japanese guideline
    

Intervention name(s): LEO 80185 gel; Dovobet(r) Ointment
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Barley Bread and Metabolic Disease
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Metabolic Diseases
Study type: Interventional

Summary: 
      The aim of this study was to compare the metabolic effects of consuming whole barley bread
      and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain
      flour on mineral status.
    

Detailed description: 
      Generally, diet can be improved in order to lower diet-related diseases risk. However, the
      increasing prevalence rates of diet-related diseases indicate that, in practice, people's
      diet does not follow the recommendations. The intake of whole flour foods is consistently
      associated with reduced risk of type 2 diabetes and cardiovascular diseases in
      epidemiological studies, although the mechanisms of this association are unclear. Here the
      aim is to compare the metabolic effects and mineral status of consumption of diet containing
      wholemeal barley bread versus whole meal wheat bread in healthy subjects.

      The intervention was designed as a randomized, cross over trial of 3-weeks duration. A total
      of 14 participants was included in the study. In one period subjects received WBB bread; in
      the second period, subjects received WWB bread. This bread is based on the recipe of Egyptian
      Baladi bread but formed in Danish buns form. Participants incorporated this bread into their
      normal habitual diet with regard to the study restrictions about other cereal food products.
      At the beginning and end of each intervention period blood was drawn and urine collected and
      stored for later analysis.

      The primary outcomes of this study are evaluation of LDL-c, insulin and glucose levels
      evaluated by analysis of fasting blood samples. Furthermore, selected measures to evaluate
      SCFA level in blood is to be evaluated. Secondary outcomes include mineral status.
    

Intervention name(s): Barley bread; Wheat bread
Intervention type(s): Other; Other
Intervention description(s): 120g barley bread per day for 3 weeks.; 120g wheat bread per day for 3 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of PC945
Condition: Aspergillosis
MeSH terms: Aspergillosis
Study type: Interventional
Phase: Phase 1

Summary: 
      PC945 is a new medicine being developed for treatment of fungal lung diseases. The main
      purpose of this study is to investigate the safety, tolerability and pharmacokinetics of
      single and repeat doses of PC945
    


Intervention name(s): PC945 - single doses; Placebo - single doses; PC945 - repeat doses; Placebo - repeat doses
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Safety and tolerability of single doses; Safety and tolerability of single doses; Safety and tolerability of repeat doses; Safety and tolerability of repeat doses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Aspergillus species; Filamentous fungi; 14-alpha Demethylase Inhibitors; Anti-Infective Agents; Antifungal Agents; Enzyme Inhibitors; Aspergillosis; Allergic Bronchopulmonary; Asthma
Protein Supplementation for Chronic Stroke Treatment
Condition: Chronic Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke patients usually have difficulties with moving and are venerable to secondary problems
      such as sarcopenia and strength loss. These problems may accelerate the disability process
      during aging. It is well known that exercise helps to maintain or promote human fitness. This
      study is conducted to explore the beneficial effects of exercise and protein supplement on
      fitness and body composition among patients with chronic stroke.
    

Detailed description: 
      This is a multicenter randomized control trial. Participants will be recruited from 4
      teaching hospitals in Taipei. Participants are randomly assigned to 2 groups:

        1. protein supplementation + exercise (PRO group);

        2. carbohydrate supplementation + exercise (CHO group);

      The 1-hour exercise intervention includes aerobic cycling exercise followed by progressive
      resisted exercise with TheraBand. PRO group receives PS immediately before and after the
      exercise while the CHO group receive sham product (the same calories with no protein). The
      Interventions are arranged 3 sessions a week for 10 weeks. The outcome measurements are
      performed at 0-week, 10-week, and 20-week.
    

Intervention name(s): Dietary supplementation; Exercise training
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Before and after each exercise session, the research assistant will give subjects protein supplement or carbohydrate supplement according to the treatment assignment and ask them to drink it down right away.; Including aerobic cycling training and progressive resisted exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study in Adolescent Females to Explore Cytomegalovirus Infection
Condition: Infections, Cytomegalovirus
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections
Study type: Interventional

Summary: 
      The purpose of this study is to estimate the incidence of Cytomegalovirus (CMV) secondary
      infections (re-infections/re-activations) and the incidence of CMV primary infections in
      adolescent females.
    


Intervention name(s): Blood collection; Urine collection; Saliva collection
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.; Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.; Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Adolescent females; Cytomegalovirus (CMV)
Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
Condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Observational

Summary: 
      To collect characteristics of patients with ADPKD across a broad population, over time to
      better understand disease progression (signs, symptoms and outcomes). Association with total
      kidney volume changes and other measures of disease progression will be determined in order
      to identify a population at increased risk for disease progression. The economic and quality
      life impact of ADPKD will be assessed. Subjects who terminated participation early from
      clinical trials with tolvaptan may also be followed.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be identified by participating clinics (primarily nephrology clinics)
        treating patients with ADPKD.
Picosure Alexandrite Laser and Revlite Nd:Yag Laser for the Treatment of Unwanted Tattoos
Condition: Unwanted Tattoos
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the Picosure and Revlite Laser Systems for the
      treatment of unwanted tattoos.
    


Intervention name(s): Picosure Laser System; Revlite Laser System
Intervention type(s): Device; Device
Intervention description(s): Picosure Laser System for the Treatment of Unwanted Tattoos; Revlite Laser System for the Treatment of Unwanted Tattoos
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PK Study With Pantoprazole in Obese Children and Adolescents
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      Multicenter, comparative single-dose pharmacokinetic (PK) study
    

Detailed description: 
      Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with
      gastroesophageal reflux disease (GERD) following administration of an oral dose of
      pantoprazole.
    

Intervention name(s): Pantoprazole
Intervention type(s): Drug
Intervention MeSH terms: Pantoprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: obese; children; adolescents; GERD; pharmacokinetic
Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA)
Condition: Arthroplasty, Replacement, Hip
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim is to determine if the use of infiltration with an adrenalin solution in the
      operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the
      cumulated volume of bleeding (pre and post operative) without increasing the per and post
      operative risks. At the same time, the effect on the post operational pains is evaluated.
    

Detailed description: 
      This prospective randomized study compares a population receiving a local anaesthetic
      (ropivacaine, adrenalin and physiological serum) in the operative field to a population
      undergoing a standard protocol.

      The cumulated volume of bleeding per and post operative are recorded and complete blood count
      (CBC).
    

Intervention name(s): ropivacaine, physical serum and adrenalin
Intervention type(s): Drug
Intervention description(s): A: experimental group: 235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Arthroplasty, hip; blood losses; pain; local analgesia; epinephrine; Primary total hip arthroplasty
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trail is to investigate if and to what extent BI 409306, BI 425809
      and lamotrigine attenuate ketamine induced cognitive deficits.
    


Intervention name(s): Lamotrigine; BI 409306; Placebo; BI 425809
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet; Film-coated tablet; Tablet, Film-coated tablet; Film-coated tablet
Intervention MeSH terms: Lamotrigine; BI 425809; BI 409306
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3-treatment period design
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Oral Contraceptive (OC) Progestin Dose and Breast Proliferation
Condition: Oral Contraceptive
Study type: Interventional

Summary: 
      The purpose of this research study is to gain a better understanding of the changes that may
      occur in the breast when a woman uses an oral contraceptive (birth control pill). Some
      research indicates that women who use birth control pills with lower amounts of progestin (a
      hormone in the birth control pill) may have lower breast cell growth than women who use birth
      control pills with a higher amount of progestin; this research will examine that in detail.
    


Intervention name(s): Oral Contraceptive: Ortho-Novum® 1/35; Oral Contraceptive: Ovcon Fe®
Intervention type(s): Drug; Drug
Intervention MeSH terms: Contraceptive Agents; Norinyl; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Oral Contraceptives; Breast Tissue
Use of Illustrated Material in Communication With the Patient in the Mechanical Ventilator
Condition: Anxiety; Comfort; Communication
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study was carried out to determine the effect of the use of communication material on
      the anxiety and comfort of the patient in communication with patients receiving mechanical
      ventilators.As a result, the use of communication material reduces anxiety and increases
      patient satisfaction and comfort level. In communicating with intubated patients receiving
      mechanical ventilator therapy, the use of illustrated communication material is recommended.
    

Detailed description: 
      The use ofcommunication material in communication with patients receiving mechanical
      ventilator support increases patient satisfaction and reduces communication difficulties.
      However, there was no randomized controlled clinical study showing the effect of the use of
      these materials on patient care outcomes such as anxiety and comfort level.Patients were
      randomly assigned to the control groups using illustrated communication material and
      intervention and routine communication methods. The research was carried out in three stages:
      preoperative, intensive care and one day after surgery. The primary outcomes of the study
      were pain, anxiety and comfort levels of the patients. Secondary outcomes were the patients'
      satisfaction with hemodynamic parameters and communication method.
    

Intervention name(s): illustrated communication material
Intervention type(s): Behavioral
Intervention description(s): Illustrated communication material was introduced to the patients in the intervention group. In the process (intensive care) that patients received mechanical ventilation support after the operation, agitation and sedation levels were monitored by the intensive care nurse who was to communicate with the patient using the Richmond Agitation Sedation Scale (RASS). According to this scale, having minimum -2 and maximum +2 points was accepted as the starting criteria for communication (Sessler et al., 2002). Communication was established with the illustrated communication material.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was planned as a randomized controlled clinical trial with two arms: Patients who had undergone cardiac surgery were randomly assigned to intervention (illustrated communication material were used) and control (routine methods in the communication were used) groups when they were connected to the mechanical ventilator.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: patient; mechanical ventilator; communication material
Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate whether IN-C004 absorbs oral mucosa in healthy volunteers.
    

Detailed description: 
      An Open-label, Single-dose Clinical Study
    

Intervention name(s): IN-C004
Intervention type(s): Drug
Intervention description(s): One time dose of IN-C004 taken orally.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other