bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Men to Find the Best Formulation of BI 685509 and to Test How it is Taken up in the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to select a formulation and to optimize the identified
      formulation of BI 685509, if needed.
    


Intervention name(s): R1: Reference Product X; T1: Test Product M; T2: Test Product N; T3: Test Product O; T4: Test Product O; R2: Reference Product Y; T5: Test Product P; T6: Test Product P; T7: Test Product Q; R3: Reference Product Z; T8: Test Product S; T9: Test Product S; T10: Test Product U
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): under fasted conditions; under fasted conditions; under fasted conditions; under fasted conditions; under fed conditions; under fasted conditions; under fasted conditions; under fed conditions; under fasted conditions; under fasted conditions; under fasted conditions; under fed conditions; under fasted conditions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Study in up to three parts:
Trial part 1: five-period crossover Optional trial part 2: four-period crossover Optional trial part 3: four-period crossover
Masking: None (Open Label)
Primary purpose: Treatment
Compensatory Mechanisms in Parkinson Disease (PD)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease is characterized by a large number of non motor, especially
      neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and
      serotoninergic systems dysfunction is suggested by several studies. In addition, the
      serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies
      have analyzed the abnormalities of these two neurotransmission systems at disease onset, in
      de novo PD patients. Furthermore, the parallel evolution of the degeneration of the
      dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the
      present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective role
      of the serotoninergic and dopaminergic systems dysfunction in motor and non motor
      manifestations in PD, at different evolution stages.
    


Intervention name(s): PET
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Parkinson; serotonin; dopamine; non motor; progression; PET
Home Based Environmental Adherence Trial
Condition: Asthma; Lung Diseases
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      To conduct a randomized trial in asthmatic children to compare the effectiveness of a
      home-based allergen control program with a customary educational program delivered in offices
    

Detailed description: 
      DESIGN NARRATIVE:

      Two-hundred-forty children, 6 to 17 years of age, were recruited to participate in the study.
      Following the collection of baseline data, all families in the study received standard
      environmental control education prior to randomization to the control or experimental group.
      This education provided parents and children with information about such topics as the
      child's sensitivity profile, the relationship between exposure to allergens and asthma, and
      the risks of passive smoking. All families were given information on how to receive
      environmental control aids and services available by mail at no or reduced costs.

      Once families were randomized, those in the control group received no additional
      intervention. Those in the experimental group received a home-based allergen control
      intervention delivered by trained environmental counselors. Primary outcomes were changes in
      asthma-related quality of life and changes in targeted allergen levels in the home. Secondary
      outcome measures included self-efficacy for environmental allergy control, FEV1, and
      parent-reported health care utilization.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I/II trial to study the effectiveness of irinotecan in treating patients who
      have progressive or recurrent malignant glioma.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicities of
      irinotecan in patients with progressive or recurrent malignant glioma. II. Define the safety
      profile of every 3 week dosing of irinotecan in these patients. III. Characterize the
      pharmacokinetic profile of this regimen in these patients. IV. Assess evidence of antitumor
      activity in these patients. V. Determine the efficacy of irinotecan in these patients as
      measured by 6 month progression-free survival and objective tumor response. VI. Evaluate
      further the safety profile of irinotecan in these patients during phase II study.

      OUTLINE: This is a dose escalation study. Patients are stratified according to concurrent
      enzyme-inducing antiepileptic drugs (EIAEDs)(yes vs no). Group A (without EIAEDs): Patients
      receive irinotecan IV over 90 minutes on day 1, followed by up to 3 weeks of rest. Group B
      (with EIAEDs): Patients receive the same treatment but dose escalation is performed in
      cohorts of 3 patients. The maximum tolerated dose (MTD) is defined as the dose below that at
      which 2 of 6 patients experience dose limiting toxicities. The Phase I MTD is the starting
      dose recommended for use in the Phase II portion of the study. Treatment continues every 3
      weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
      Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months
      for 1 year, then every 6 months until disease progression. Patients are then followed every 4
      months for survival.

      PROJECTED ACCRUAL: Up to 30 patients will be accrued for phase I within 10 months. A total of
      48 patients will be accrued for phase II within 6-8 months.
    

Intervention name(s): irinotecan hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Irinotecan
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult brain stem glioma; adult oligodendroglioma; adult mixed glioma; adult diffuse astrocytoma
Study to Assess Clearances and Bio-compatibility of ELISIO Dialyzer
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Today, haemodialysis is a recognized standard treatment for patients with chronic kidney
      disease stage 5. During the haemodialysis treatment session, blood passes from the patient
      through the extracorporeal circuit and is then returned. The dialyzer represents the greatest
      surface are of the extracorporeal circuit, as dialysis treatment is essentially based on the
      removal of small molecular weight solutes down along a concentration gradient, and this
      depends upon surface area. The ELISIO-H dialyzer differs in design to our current standard
      dialyzer, the FX100, by having fibers of a greater internal diameter, which potentially
      allows more internal haemofiltration, leading to an improved clearance of larger molecular
      weight solutes. It is now thought that these so called "middle molecular weight" solutes are
      more important in contributing to the clinical condition termed azotaemia, rather than
      smaller solutes such as urea.

      The investigators therefore wish to study the clearance of middle sized molecules between the
      different dialyzers.
    

Detailed description: 
      Stable chronic kidney dialysis patients, currently dialyzing on the main Royal Free hospital
      dialysis unit will be asked to participate in the study. It is aimed to recruit 15 patients
      currently dialysing using the Fresenius FX100 dialyzer, who have used Fresenius polysulphone
      membranes for > 3 months.

      During a mid week dialysis session, dialysis adequacy will be assessed by on line clearance,
      and samples of both blood and dialysate taken to assess, both clearances and
      bio-compatibility.

      Thereafter patients would be switched to dialyse using the ELISIOTM-H dialyzer, but continue
      with the same dialysis prescription, and after 3 months, measurements repeated

      Assessments Primary Clearances : on-line Kt/V, dual pool Kt/V, phosphate, b2microglobulin,
      cystatin C Secondary Serum :isoprostane generation complement activation platelet activation
      - coagulation activation - thrombophilic markers - Other Anticoagulation requirements &
      clotted circuits erythropoietin requirements, phosphate control therapy CRP
    

Intervention name(s): ELISIO dialyzer; Fresenius FX100 dialyzer
Intervention type(s): Device; Device
Intervention description(s): 3 x week dialysis using ELISIO dialyzer for 12 weeks
Other intervention name(s): ELISIOTM-H dialyzer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solute clearances
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250mg/5 ml Oral Suspension Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250mg/5 ml fasting
      conditions.
    


Intervention name(s): Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria); Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cefdinir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotic
Endoscopic Stomach and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery
Condition: Obesity
Study type: Interventional

Summary: 
      The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in
      the United States. Despite initial weight loss, some patients experience weight regain that
      may be related to an increase in the size of the gastric pouch and/or stoma. A second
      surgical procedure to reduce the size of the pouch and/or stoma is typically associated with
      a higher risk of death or complications than the original gastric bypass procedure. This
      study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a
      means of producing weight loss in patients who have regained weight following gastric bypass.
    


Intervention name(s): endolumenal surgery
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Evaluation of the Effectiveness of Daily Pulse Lavage Therapy in Chronic Wounds
Condition: Chronic Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts
      in chronic wounds.
    

Detailed description: 
      Pulse lavage irrigation is an effective method of cleaning both acute and chronic wounds. The
      major drawback to pulse irrigation is that it is extremely messy and can easily contaminate
      the patient's surroundings, putting other patients and the person operating the device at
      risk. In order to obtain the benefits of pulse lavage, we have created a device that will
      contain the water spray from the lavage and protect both the patient and their surroundings.
      Due to the fact that frequent (multiple times daily) pulse lavage therapy has not been
      possible previously, it is unknown how effectively serial pulse lavage irrigation reduces
      bacterial counts. This study evaluates the effectiveness of serial pulse lavage therapy in
      decreasing bacterial counts in chronic wounds.
    

Intervention name(s): Pulse lavage treatment; Dressing changes
Intervention type(s): Procedure; Other
Intervention description(s): A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments).; Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments).
Other intervention name(s): Pulsed lavage (Stryker Pulsavac Plus); Wound containment apparatus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic wound treatment; pulse lavage; serial pulse lavage; wounds; bacterial colonization of wounds
Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: A Randomized, Phase III Trial
Condition: Cancer
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      In a previous study, we found that acupuncture may decrease fatigue. The aim of this study is
      to determine whether acupuncture is helpful in reducing fatigue in cancer patients treated
      with chemotherapy. We will also study how fatigue, quality of life, mood, level of physical
      activity. This study will involve about 88 patients.
    

Detailed description: 
      Primary objective:

      To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively
      than placebo

      Secondary objectives:

        1. To examine the long-term effects of acupuncture treatment on fatigue

        2. To examine predictors of response to acupuncture treatment in terms of baseline
           symptoms, hemoglobin, age, sex, time since chemotherapy and concurrent treatment

        3. To examine the effect of acupuncture on levels of physical activity and quality of life.
    

Intervention name(s): Acupuncture and questionnaires; placebo acupuncture
Intervention type(s): Procedure; Procedure
Intervention description(s): Acupuncture once weekly for six weeks Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Treatment scale. Patients will repeat the BFI and FACT-G at seven and eight weeks after randomization, approximately one and two weeks after their final treatment. HADS will be repeated at week seven. At the end of the study, patients will be asked to state whether they were thought they on true or placebo acupuncture and why.
On the day of the final session of acupuncture treatment (approximately day 35), blood samples will be collected and tested for hemoglobin, thyroid function tests, as described in pretreatment evaluation. The results will be designated "posttreatment" values. Actigraphic monitoring will be conducted in week seven. Patients will be asked to wear the device for seven days just like during baseline evaluation.; During the placebo phase, placebo acupuncture needles (68) will be applied a few mm away from the points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. However, the needle does not penetrate the skin and instead moves upward inside the handle. Needles will be applied after sterile swabbing of the skin and kept in place for 20 minutes in both group.Patients in the placebo group will be offered true acupuncture after receipt of the week seven and eight fatigue diaries.
Patients will complete the BFI, HADS and FACT-G at baseline, approximately two weeks before randomization and their first treatment. The BFI and FACT-G will be repeated after seven days, that is, one week before randomization. The use of repeat measurement decreases intrapatient variability and hence increases the precision of the baseline measure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Cancer; Fatigue
The Effects of Lowering Dietary Carbohydrates on Health, Exercise Performance and Wellbeing-related Outcomes
Condition: Obesity; Diet Modification
Study type: Interventional

Summary: 
      The aim of the study is to investigate the long-term effects of the ketogenic diet and
      exercise (including interactions) on health markers, exercise performance and wellbeing
      outcomes in sedentary overweight individuals.
    

Detailed description: 
      Intentional nutritional ketosis induced by the low carbohydrate diet is an intensively
      discussed topic of many scientific as well as non-scientific discussions throughout the areas
      of healthy living, the sports sciences and often used now for the prevention and treatment of
      chronic diseases. It has been demonstrated that long-term low-carbohydrate diet is more
      effective for weight loss and cardiovascular and metabolic risk factor reduction than a
      low-fat diet. In light of conflicting theories of best practice surrounding a polarized topic
      that impacts human health and daily work performance, the primary aim of this research
      project is to examine how low-carbohydrate ketogenic diets affect health markers, exercise
      performance and wellbeing outcomes in sedentary overweight individuals. Each study subject
      will be randomized into one of the four arms of the study and will undergo a 12-week
      intervention, with the exception of the study subjects in the control group, who will undergo
      no intervention for the period of 12 weeks.

      The project outcomes are of immense importance for the investigator's global human health,
      focus on a unique holistic perspective and have the potential to contribute towards
      much-needed adjustments in public health recommendations.
    

Intervention name(s): Ketogenic diet; Exercise HIIT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The study subjects randomized for this intervention will observe the ketogenic diet, as prescribed by the protocol.; The study subjects randomized for this intervention will observe the HIIT exercise programme, as prescribed by the protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study subjects will be randomized into four study groups, one of which will be the control group.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ketogenic diet; carbohydrates; chronic diseases; physical activity; fatigue; mood; wellbeing
Fluid Resuscitation in Burn Patients
Condition: Severe Burns; Fluid Resuscitation
MeSH terms: Burns
Study type: Interventional
Phase: Phase 3

Summary: 
      Balanced solutions with low chloride concentration could represent an alternative to high
      chloride concentration solutions. Such balanced solutions contain other acid as buffers (i.e.
      acetate and/or gluconate). However, acetate has been associated with alteration of cardiac
      function when used as buffer in dialysate when high acetate concentrations are used and could
      promote the development of metabolic acidosis if it accumulates. Therefore, the safety of
      such solutions remains poorly explored. Because critically ill patients receive large amount
      of fluid during the early phase of resuscitation, large amount of acetate are to be
      administrated if such solutions are used. While acetate-containing solutions have been
      suggested to be safe in this setting, studies are still lacking regarding clearance and
      accumulation in critically ill patients.

      It is expected to include 28 patients, the objective to analyze the data of 20 patients.
    

Detailed description: 
      The main objectives of the study is 1) to determine whether Plasmalyte® promote the
      development of metabolic acidosis in comparison with an acetate-free balanced solutions:
      Ringer lactate (chloride concentration of 111 mmol/L) and 2) to determine Acetate & gluconate
      clearance during fluid resuscitation of severely burn patients Plasmalyte® (chloride
      concentration of 98 mmol/L) . Severely burn patients will be randomized to receive
      Plasmalyte® or Ringer Lactate for initial fluid resuscitation during the first 5 days
      following admission.
    

Intervention name(s): Plasmalyte; Ringer lactate
Intervention type(s): Drug; Drug
Intervention description(s): Parenteral administration of Plasmalyte initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring.
Each patient will receive this solution up to 5 days.; Parenteral administration of Ringer lactate initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring.
Each patient will receive this solution up to 5 days.
Other intervention name(s): PLASMALYTE VIAFLO; RINGER LACTATE VIAFLO
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Plasmalyte® is a balanced solution containing a low chloride concentration (i.e. 98 mmol/L) which may overcome overwhelm the potential risks associated with hyperchloremic solutions. Plasmalyte® also contains acetate (27 mmol/L) and gluconate (23 mmol/L) as buffer solutions.
Ringer Lactate® is also a balanced solution containing a low chloride concentration (i.e. 111 mmol/L)
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Burns; Critically ill; Acid-Base status