bioihbjkbjnl/mcl2 huggingface dataset:
Quality Control of CE-Certified Phonak Hearing Aids - 2018_42
Condition: Hearing Loss; Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      Phonak Hearing Systems pass through different development and study stages. At an early
      stage, feasibility studies are conducted to investigate new algorithms, features and
      functions in an isolated manner. If the benefit is proven, their performance is then
      investigated regarding interdependency between all available algorithms, features and
      functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a
      result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing
      Systems undergo a final quality control in terms of clinical trials. This is a pre-validation
      study, investigating optimized algorithms, features, functions and wearing comfort. This will
      be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based
      in Stäfa (Switzerland).
    

Detailed description: 
      In this study one CE-labeled Phonak Receiver-in-the-canal (RIC) devices is investigated. The
      experimental device will be investigated regarding Sound Quality perception ot the T-Coil
      program. A secondary objective of this study is the investigation of the Overall system
      stability in daily life situations. The experimental device contains direct connectivity
      functionality and a T-Coil. The combination of a wireless chip for Bluetooth streaming and a
      T-Coil in one housing can cause audible artifacts on the T-Coil, which shall be investigated
      within this study. This will be a clinical evaluation which will be conducted mono centric at
      Sonova AG Headquarters based in Stäfa (Switzerland).
    

Intervention name(s): Audéo M90-T
Intervention type(s): Device
Intervention description(s): Receiver in the canal (RIC) Hearing aid form Phonak which will be fitted to the participants individual Hearing loss.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.
Condition: Healthy Volunteers, Medical Device
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates how safe the study device DV3395-C1 is when swallowed by healthy men
      and women. By the use of X-ray the device will be followed from the mouth, through the food
      pipe to the stomach and then into the gut. It will be checked if the device activates itself
      in the stomach as planned. Participants will be admitted to the clinic research center on day
      -1 and will receive the device on day 1 after 6 hours fast. The X-ray session will take up to
      5 hours ending with administration of a small amount of contrast agent for better
      visualisation. The participants will stay at the clinic research center for up to 6 days
      until the device has been excreted. A follow-up phone call will take place 1 week after the
      device has been excreted.
    


Intervention name(s): DV3395 C1
Intervention type(s): Device
Intervention description(s): Participants will be exposed to and swallow DV3395 C1 once. The participants will stay at the clinic research center for up to 6 days .
Intervention model: Single Group Assignment
Intervention model description: Including a pilot cohort and a main cohort
Masking: None (Open Label)
Primary purpose: Other
Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Comparative pharmacokinetic study of new oral nicotine replacement therapy products.
    

Detailed description: 
      This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4
      mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with
      respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single
      doses of treatment A, B, C, and D are given once in the morning during separate treatment
      visits scheduled in a crossover setting with randomized treatment sequences, also including a
      fifth treatment visit with either treatment E or F. The study will include 104 healthy
      smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes
      daily during at least one year preceding inclusion. The study will be performed at two sites
      with 52 subjects at each site. Subjects and study personnel will be aware of which treatment
      is administered at a given visit.
    

Intervention name(s): Experimental Nicotine Replacement Therapy (NRT) 2 mg; Experimental Nicotine Replacement Therapy (NRT); Marketed Nicotine Lozenge; Marketed Nicotine Lozenge
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 mg Single-dose of new NRT product (NSL2L); 4 mg Single-dose of new NRT product; 2 mg Single-dose of marketed lozenge; 4 mg Single-dose of marketed lozenge
Other intervention name(s): Not yet marketed; Not yet marketed; NiQuitin™ lozenge; NiQuitin™ lozenge
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation, Nicotine pharmacokinetics
A Study in Men With Overweight to Test How Well Different Doses of BI 1820237 Are Tolerated When Given as an Injection Alone or in Combination With Liraglutide
Condition: Healthy
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate safety, tolerability and pharmacokinetics
      (PK) and pharmacodynamics (PD) of BI 1820237 alone or together with a single low dose of
      liraglutide in male subjects with overweight/obesity (otherwise healthy) following
      subcutaneous administration of single rising doses.
    


Intervention name(s): BI 1820237; Placebo; Saxenda®; Paracetamol-ratiopharm®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BI 1820237; Placebo; Saxenda®; Paracetamol-ratiopharm®
Other intervention name(s): Liraglutide; Paracetamol
Intervention MeSH terms: Acetaminophen; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pharmacokinetic Study of MTC896 Gel in Subjects With Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the pharmacokinetic properties of topically applied
      MTC896 Gel following application of 0.75% (w/w) MTC896 Gel once daily and twice daily and
      1.5% (w/w) once daily over 4 weeks in the treatment of acne.
    


Intervention name(s): 0.75% (w/w) MTC896 Gel Once Daily; 0.75% (w/w) MTC896 Gel Twice Daily; 1.5% (w/w) MTC896 Gel Once Daily
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose, open-label, randomized, crossover study in subjects with severe
      Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY
      14-2222).
    


Intervention name(s): Recombinant Factor VIII (Kogenate FS, BAY14-2222); Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Intervention type(s): Biological; Biological
Intervention description(s): 50 IU/kg single dose using the 3000 IU vial size (600 IU/ml); 50 IU/kg single dose using the 2000 IU vial size (400 IU/ml)
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BAY14-2222; Pharmacokinetics
Spleen Stiffness Measurement With FibroScan
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional

Summary: 
      FibroScan® (Echosens, Paris, France) is an active non implantable medical device marketed in
      Europe since December 2003 and is currently used in many countries. FibroScan® is an
      ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to
      liver stiffness measurement (LSM).

      Several clinical studies have shown the accuracy of LSM by FibroScan® to predict liver
      fibrosis.

      Some other studies have already shown the good correlation between LSM, assessed by
      FibroScan® based on VCTE™ technology, and the presence of portal hypertension (PHT).

      PHT is a clinical condition characterized by a high blood pressure in the portal vein and its
      tributaries and it is defined as a gradient between portal and systemic blood pressure > 6
      mmHg.

      The development of oesophageal varices (OV) in cirrhotic patients, as well as their potential
      bleeding, represent one of the most severe and life-threatening complication of cirrhosis.

      Upper endoscopy is the best diagnostic tool for detecting the presence of OV, gastric varices
      or congestive gastropathy, for estimating the grade of OV and for the recognition of the
      presence of red color signs and wale marks or other indicators of high risk for bleeding.

      However these two methods are quite invasive and associated with some risks; at the same
      time, not all cirrhotic patients present OV at endoscopic screening.

      The aim of this study is the validation of SSM, assessed by a FibroScan® with acquisition
      parameters and algorithm optimized for SSM, as surrogate noninvasive marker for the presence
      of OV in liver cirrhosis patients.
    


Intervention name(s): Fibroscan® examination
Intervention type(s): Device
Intervention description(s): Each patient undergo 1 LSM and at least 1 SSM (2 in more if the patient accept to participate at the ancillary study (intra and inter operator reproducibility of SSM).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cirrhotic patients; Fibroscan; Liver Stiffness Measurement; Oesophageal Varices; Portal Hypertension; Spleen Stiffness Measurement
Alternate Day Versus Daily Oral Iron Therapy in Adolescents
Condition: Iron Deficiency Anemia; Heavy Menstrual Bleeding; Abnormal Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Menorrhagia; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Iron deficiency anemia affects over half of girls and young women with heavy periods and is
      the most common cause of anemia worldwide. Most girls with heavy periods who also have iron
      deficiency anemia are prescribed iron to take by mouth every day by their doctor. There are
      some studies showing that taking iron every other day may actually help the iron be absorbed
      into the bloodstream better. This study is trying to compare how taking iron every other day
      compares to taking iron daily for treatment of anemia.

      The goal of this clinical research study is to learn which of the two methods of care will be
      the best way for girls and young women with iron deficiency anemia to take iron
      supplementation.
    

Detailed description: 
      The research will be conducted at the following location(s):

      Baylor College of Medicine, TCH: Texas Children's Hospital, and TCH: Texas Children's
      Hospital Clinic.

      If patient appears to qualify for the study they will sign and date this consent form, and
      the doctor will confirm that they are eligible for the study. The patient will complete the
      following procedures:

        -  Medical history including prior hospitalizations, lab results, medications, diet, social
           and family history

        -  Physical Examination

        -  Blood samples: The patient will not have any extra blood draws (pokes) for this study.
           However, we will ask to take about 1/2 (0.5) teaspoons (3 mL) of extra blood for an
           extra research test when you have follow up blood test(s) in one month.

      Patient will be on the study for 24 weeks (6 months),and will receive an information sheet
      about how to take iron to help it absorb in the stomach and on iron-rich foods.

      There are 2 different treatments in this study. If a patient enrolls, they cannot choose
      which treatment to receive. Instead, they will be randomly assigned to one of the two
      treatments. That means there is a fifty percent chance they will receive iron medicine to
      take every day and a fifty percent chance they will receive iron medicine to take every other
      day.
    

Intervention name(s): Ferrous sulfate
Intervention type(s): Drug
Intervention description(s): Alternate day dosing of ferrous sulfate
Other intervention name(s): Fer-In-Sol; Feratab; Iron; Feosol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid
Condition: Encephalitis
MeSH terms: Encephalitis
Study type: Interventional
Phase: Phase 1

Summary: 
      AVI-4020 Injection, a phosphorodiamidate Morpholino oligomer (PMO), was found to cross the
      blood-brain barrier during a study of patients with presumptive West Nile virus disease.
      AVI-4065, which was designed to target HCV, is also a PMO; its ability to cross the
      blood-brain barrier is unknown. In this study, a single dose of AVI-4065 will be
      subcutaneously injected, and samples collected to determine if this drug crosses the
      blood-brain barrier. If it does, then additional investigations could be performed in people
      with severe forms of HCV disease in which the brain is affected.
    

Detailed description: 
      AVI-4020 Injection, a phosphorodiamidate Morpholino oligomer (PMO), was found to cross the
      blood-brain barrier during a study of patients with presumptive West Nile virus disease.
      AVI-4065, which was designed to target HCV, is also a PMO; its ability to cross the
      blood-brain barrier is unknown. As the incidence of HCV disease has grown, the knowledge base
      of this disease has likewise increased.

      Encephalopathy is a recognized consequence in some patients with HCV infection. In this
      study, a single dose of AVI-4065 will be subcutaneously injected, and samples collected to
      determine if this drug crosses the blood-brain barrier. If it does, then additional
      investigations could be performed in people with HCV disease in which the brain is affected.
    

Intervention name(s): AVI-4065 Injection
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV; Hepatitis C virus
Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer
Condition: Undernutrition; Gastrointestinal Cancer
MeSH terms: Gastrointestinal Neoplasms; Malnutrition
Study type: Interventional

Summary: 
      Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the
      energy balance that leads to a gradual mobilization of energy reserves in the body and to
      increasing deterioration of the nutritional status of patients. This will thus significantly
      reduce quality of life and survival of patients with a lower tolerance to cancer treatments.
      Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or
      not explored, which could explain that there is still no satisfactory therapeutic solution to
      halt the gradual deterioration of the nutritional status of patients. In this sense, apart
      from preclinical data obtained in animal models, there is currently no clinical study on the
      functioning of skeletal muscle energy metabolism in undernourished patients suffering of
      cancer.
    


Intervention name(s): Samples
Intervention type(s): Other
Intervention description(s): Blood samples, muscle biopsy and sample of hair
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: undernutrition; gastrointestinal cancer; skeletal muscle; energy metabolism
Long-Term Effects of Sucontral(TM) on Mild and Moderate Cases of Diabetes Mellitus (Type 2)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      In patients with diabetes mellitus type 2 stably adjusted to diet long-term intake of
      aqueous-ethanolic extract from Hintonia latiflora over more than 12 months leads to a
      statstically significant amelioration of parameters of glycaemic control (HbA1c, postprandial
      and fasting glucose) not acchievable with diet alone.

      As safety parameters, liver function tests and cardiovascular parameters are to be monitored.
      Adverse events are to be monitored.
    

Detailed description: 
      Objective:

      To evaluate the long term effects of an aqueous-ethanolic extract from the bark of Hintonia
      latiflora (1:4.5, extraction medium 32% ethanol) in mild to moderate cases of type II
      diabetes, especially on parameters of glycaemic control and safety.

      Research Design and Methods:

      The trial was carried out as a controlled single-centre open study. 30 patients stably
      adjusted to diet were treated with the study medication (3 x 2 ml/day before meals) for up to
      36 months. Efficacy parameters were HbA1c and fasting and postprandial serum glucose. As
      parameters for safety, liver function tests, cardiac functions and adverse events were
      assessed.

      Results:

      All three efficacy parameters improved significantly, and the parameters of glycaemic control
      remained stable for the study duration of 36 months. As compared to baseline, after 6 months
      and 18 months of therapy mean fasting glucose was reduced by 23.9 and 21.9 % (1.8 mmol and
      2.0 mmol in absolute values). Mean postprandial glucose was reduced by 24.4 and 16.5 % (2.4
      and 2.0 mmol in absolute values), and the mean HbA1c was decreased by 10.4 and 12.4 % (0.76
      and 1.04% in absolute figures). Improvement was maintained after 18 months. Tolerability was
      excellent. No hypoglycaemic reactions occurred. No adverse effects or change in cardiac and
      liver function tests were observed. There was a tendency towards decreasing triglyceride and
      total cholesterol levels.
    

Intervention name(s): Extract from Hintonia latiflora bark
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hintonia latiflora extract; Diabetes mellitus type 2; HbA1c; Safety; Liver function tests
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients
      with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is
      assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also
      assessed during this period. Patients who completed the first treatment period proceed to the
      second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and
      safety of SK-1403 are also assessed during this period.
    


Intervention name(s): Dose-adjusted SK-1403
Intervention type(s): Drug
Intervention description(s): SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to measure the effects of injection-site cooling on pain experienced after
      knee injections of capsaicin in healthy subjects and in patients with knee osteoarthritis.
    


Intervention name(s): Ice Pack and Cooling Device; CNTX-4975-05 (trans-capsaicin); CNTX-4975-05 (trans-capsaicin); CNTX-4975-05 (trans-capsaicin); Capsaicin
Intervention type(s): Other; Drug; Drug; Drug; Drug
Intervention description(s): A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).; Controlled cooling wrap vs ice pack cooling after single IA injection of 1 mg CNTX-4975-05 in each arm after single IA (15 mL) injection of 2% lidocaine (without epinephrine).; Controlled cooling parameters will be determined after evaluation of data from prior Cohort(s) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.; Controlled cooling with knee device vs no cooling (determined after evaluation of data from previous cohorts) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.; Four intradermal injections of capsaicin, two on each forearm.
Intervention MeSH terms: Capsaicin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Knee Pain
Identification of Genes Involved in Juvenile Idiopathic Arthritis by Wholel Exome Sequencing
Condition: Arthritis, Juvenile Rheumatoid
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      Juvenile idiopathic arthritis (JIA) is considered to be a multifactorial disease caused by a
      combination of environmental factors and predisposing genetic factors. Twins studies found a
      strong heritability (strong genetic factors) but genetic studies such association studies of
      large cohorts of patient (GWAS or Genome Wide Association Study) have elucidated less than 20
      % of the genetic basis of JIA. The vision of the genetics of multifactorial diseases has
      recently changed revealing a large clinical and genetic heterogeneity of these diseases.
      Indeed, the advent of next-generation sequencing identified non-multifactorial genetic
      hereditary disease related to mutations in genes having strong effect on the onset of the
      disease without real impact of environmental factors among the so called "multifactorial
      diseases" (Parkinson's, diabetes, osteoarthritis, Alzheimer's, hypertension ...)The
      investigators propose to study 30 families with several forms of JIA by next-generation
      sequencing. Identifying the genetic basis of JIA in these families will help to better
      understand the physiopathology of this disease and may help to the identification of novel
      therapeutic targets for other patients with JIA.
    


Intervention name(s): Blood sample
Intervention type(s): Biological
Intervention description(s): Blood sample
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Juvenile idiopathic arhtritis; JIA; Gene identification; Whole exome sequencing; Next generation sequencing; Identification of molecular basis; Acceptation of both parents to participate to the study