bioihbjkbjnl/mcl2 huggingface dataset:
Investigating Hearing Aid Frequency Response Curves 2
Condition: Hearing Loss, Sensorineural; Hearing Loss, Bilateral
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
Study type: Interventional

Summary: 
      Internal research on the manufacturer's hearing aid products has idenitfied areas in which
      the investigators can improve the hearing aid frequency response curve. Based on the
      conclusions of the first study, we have identified areas that require further analysis and
      testing prior to implementing of the proposed frequency response curve into our products.
      This study aims to investigate the current freqeuncy response curve in the manufacturer's
      products to variations of these curves to determine if hearing aid users prefer the
      variations over the manufacturer's standard curve.
    

Detailed description: 
      Internal testing has identified areas in which the investigators can improve the performance
      of the manufacturer's hearing aid products. This should potentially lead to increased hearing
      aid user satisfaction due to an improvement in sound quality and listener comfort. Therefore,
      a study is proposed in which hearing aid users will compare the manufacturer's current
      frequency response curve to variations made to the curve and determine which one they prefer
      while listening to live speech/music or while streaming speech/music and while in different
      listening enviroments.
    

Intervention name(s): Hearing Aid - Standard Curve; Hearing Aid - Variation #1
Intervention type(s): Device; Device
Intervention description(s): Our current hearing aids which will be programmed to our standard frequency response curve.; Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hearing Loss; Hearing Aids; Frequency Response Curves
Strength Training in Female Runners With Patellofemoral Pain
Condition: Patellofemoral Syndrome
MeSH terms: Patellofemoral Pain Syndrome
Study type: Interventional

Summary: 
      Patellofemoral pain (PFP) is a common running-related injury that is often referred to as
      runner's knee. The condition typically presents with pain in the front of the knee that is
      located around or behind the knee cap. This injury occurs twice as frequently in females and
      is often associated with weakness of the muscles of the thigh and hip, as well as altered
      running form. Heavy-weight strength training is needed in order to improve muscle weakness;
      however, this puts a significant amount of load on the knee joint and it is difficult for
      individuals with PFP to train at this level without experiencing increased pain and joint
      discomfort. Blood flow restriction training (BFRT) is a promising alternative method to
      safely improve muscle weakness while reducing knee joint loading. With BFRT, a pressurized
      band is applied to the thigh in order to partially restrict blood flow as a patient exercises
      in order to decrease the amount of oxygen delivered to the muscle. Lack of oxygen to the
      muscle combined with strength training creates an environment within the muscle that results
      in the ability of low-weight strength training to provide the same results as heavy-weight
      strength training.

      This study will evaluate how low-weight strength training with and without BFRT affects thigh
      and hip strength, and consequently pain, function, running ability, and running form in
      female runners with PFP. The hypothesis is that 10 weeks of low-weight strength training with
      BFRT will lead to greater thigh and hip strength, reduced pain, improved knee function,
      improved running ability, and improved running form compared to low-weight strength training
      without BFRT. The expected results will have a significant impact within the running
      community by providing a safe and effective treatment that increases strength and improves
      running form while reducing pain and joint loading. This will also have an impact on the
      larger field of sports medicine by providing an alternative method to improve strength, as
      well as improve function when heavy-weight strength training is not well tolerated or unsafe
      due to injury.
    


Intervention name(s): Blood Flow Restriction Training (BFRT); Sham Blood Flow Restriction Training (Sham BFRT)
Intervention type(s): Other; Other
Intervention description(s): A pressurized cuff is applied to the proximal thigh in order to partially occlude blood flow as the patient exercises.; A minimally pressurized cuff is applied to the proximal thigh in order to mimic the active blood flow restriction unit as the patient exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Blood Flow Restriction; Running; Patellofemoral Pain
Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.
Condition: Cesarean Delivery Affecting Newborn
Study type: Interventional

Summary: 
      Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its
      Effects on Newborn.
    

Detailed description: 
      Patients who will undergo caesarean section under general anesthesia will be included in the
      study.

      In the study; preoxygenation is applied to the caesarean sections under general anesthesia in
      two ways. Group1 includes preoxygenation masked patients.
    

Intervention name(s): high flow nasal oxygen device (POİNT); Face mask
Intervention type(s): Device; Device
Intervention description(s): With POINT device (peri-operative insufflatory nasal therapy); patients are heated at higher flow and applied to humidified oxygen.; In order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: high flow nasal oxygen (POİNT)
Effects of Roux-en-Y Gastric Bypass on Gastro-intestinal Hormone Secretion and Brain Responses Food Pictures
Condition: Obesity
Study type: Observational

Summary: 
      This is a cross-sectional study enrolling

        -  11 weight-stable, formerly obese female patients 1-5 years after Roux-en-Y gastric
           Bypass (RYGB)

        -  11 age- and weight-matched female subjects

        -  10 normal weight (Body Mass Index 19-25 kg/m2) subjects The following measurements will
           be performed in each participants in basal conditions (after an overnight fast) and
           after ingestion of a standard meal

        -  electroencephalographic recordings of visually evoked potential after presentation of
           food- or non-food pictures

        -  plasma concentration of metabolites (glucose, fatty acids), glucoregulatory hormones
           (insulin, glucagon), gastro-intestinal hormones (Gastric Inhibitory Polypeptide (GIP),
           Glucagon-like Peptide-1 (GLP1), ghrelin,Cholecystokinin (CCK), and bile acids Aims of
           this observational study are

        -  to evaluate the effects of RYGB on brain perception of food related visual stimulation

        -  to search for relationships between RYGB effects on brain responses and
           gastro-intestinal hormone secretion
    


Intervention name(s): standard test meal
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Formerly obese patients attending the obesity clinics of Lausanne University Hospital and
        healthy subjects resident in the Lausanne area
      
Keywords: roux-en-Y-gastric bypass; brain responses to food; gastrointestinal hormones; bile acids
Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract
Condition: Respiratory Syncytial Virus Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effect of presatovir on respiratory
      syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant
      (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).
    


Intervention name(s): Presatovir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube; Placebo to match presatovir administered orally or via nasogastric tube
Other intervention name(s): GS-5806
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Respiratory Syncytial Virus (RSV); Antiviral; Hematopoietic Cell Transplant (HCT); Lower respiratory tract infection
Patient Education on Labor Analgesia Options
Condition: Labor Analgesia
MeSH terms: Agnosia
Study type: Observational

Summary: 
      The purpose of this study is to learn how the investigators can better educate pregnant
      patients about the options open to them for pain relief during labor. Patients will receive
      educational pamphlet during prenatal clinic visit and again on admission to labor and
      delivery. The options for analgesia will be discussed by anesthesia care provider. Patient
      will be asked to complete a survey on the post partum unit.
    

Detailed description: 
      Many analgesic options exist for laboring parturients, but labor may not be the best time to
      start informing patients of their options. Many patients begin the labor process with a plan
      in place for their analgesia. Unfortunately, internet resources regarding labor analgesia
      that are available to the lay parturient are poor and often lead to misconceptions about the
      options and their risks. A significant number of patients refuse neuraxial analgesia based on
      misunderstandings, concerns about the procedure, or a lack of faith in the provider. Some
      women want a "natural childbirth" and/or control over their labor experience. Our study aimed
      at providing information and alternatives for labor analgesia in a simple written format.

      The investigators will provide information of available labor analgesia options (epidural,
      combined spinal/epidural, spinal, remifentanil patient-controlled analgesia, and intravenous
      opioids) to expecting mothers. Using a pamphlet written in English or Spanish disseminated to
      pregnant women in clinic and upon arrival in the labor and delivery unit, the procedures and
      their risks and benefits will be explained in simple terms. In the Labor and Delivery Unit
      the patients will have an opportunity to ask questions of the anesthesia care giver regarding
      the options for analgesia. After delivery while on F Green, patients will be asked to
      complete a questionnaire addressing their thoughts about the pamphlets and their overall
      satisfaction with their labor analgesia. The analysis will focus on the utility and effect of
      education materials on maternal informed consent for labor analgesia, on maternal choice of
      analgesia modality, and on maternal anxiety regarding their labor analgesia plan.
    

Intervention name(s): educational information
Intervention type(s): Other
Intervention description(s): patients will receive pamphlet on labor analgesia options.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pregnant females in prenatal clinic and labor suite
Longitudinal Assessment of Transient Elastography in Cystic Fibrosis
Condition: Cystic Fibrosis Liver Disease
MeSH terms: Cystic Fibrosis; Liver Diseases; Fibrosis
Study type: Observational

Summary: 
      To determine if transient elastography (TE), when combined with ultrasound (US) pattern
      characterization can improve the prediction of progression to a nodular pattern on US.

      To confirm the feasibility of obtaining TE measurements in children with Cystic Fibrosis (CF)
      To prospectively assess whether TE data are associated with conventional laboratory markers
      of hepatic fibrosis To determine the variability of TE measurements taken at different sites
      in the same patient
    

Detailed description: 
      A noninvasive assessment of hepatic fibrosis is desperately needed to advance the care of
      children with CF significant liver disease and to provide for measurements during clinical
      trials. That global assessment might serve as both a predictor/descriptor of disease course
      but also as a critical biomarker for clinical research. FibroScan® measurement of liver
      stiffness has great potential to fill this void. The underlying hypothesis of this proposal
      is that elastography in addition to US can improved the prediction of the development of a
      nodular liver on US and development of portal hypertension over time in children and young
      adults with CF.
    

Intervention name(s): Transient Elastography (TE)
Intervention type(s): Procedure
Intervention description(s): Participants enrolled in Cystic Fibrosis Liver Disease Network (CFLD NET)Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis (PUSH) study in longitudinal follow up at centers with Fibroscan available (currently 8/11 centers)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants enrolled in CFLD NET PUSH study in longitudinal follow up at centers with
        Fibroscan available (currently 8/11 centers) All racial and ethnic groups will be included.
      
Keywords: Cystic Fibrosis Liver Disease; Pancreatic insufficiency; Cystic Fibrosis; Transient Elastography
Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects
Condition: Resistant Hypertension; Difficult to Control Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled multiple ascending dose study in hypertensive
      subjects on stable doses of at least three hypertensive drugs for at least 6 weeks prior to
      Screening. The study will consist of screening, PK-unit admittance, and safety follow up
      periods.

      Subjects will be randomized at a 6:2 ratio of either MANP or placebo and will be stratified
      by race in each dosage cohort. The entire first Cohort will be given the lowest dosage with
      subsequent cohorts progressing sequentially to the higher doses depending on safety and
      tolerability of the previous cohort.

      Endpoints not related to the safety reviews will be analyzed after the last patient last
      visit (LPLV).
    


Intervention name(s): MANP; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Novel designer peptide to represent a pGC-A/cGMP therapeutic; Placebo Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to allow patients who have participated in the precursor study
      of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01)
      to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination
      with an increased dose of BCI-049.

      The safety and tolerability of this higher dose of the combination will be evaluated, as will
      the treatment effect in reducing symptoms of depression in patients with MDD.
    

Detailed description: 
      Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion
      criteria may be enrolled in the study.
    

Intervention name(s): Combination Product: BCI-024 + BCI-049
Intervention type(s): Drug
Intervention description(s): BCI-024 and BCI-049 once a day at bedtime for 6 weeks
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; combination
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, safety and tolerability of
      cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD
    


Intervention name(s): Cariprazine; Placebo; Antidepressant Therapy (ADT)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cariprazine capsules 1.5 to 4.5 mg/day; Dose-matched placebo capsule once per day; ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.
Intervention MeSH terms: Cariprazine; Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MDD; Major Depressive Disorder
Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) in Patients With Primary Axillary Hyperhidrosis and the Assessment of Long-term Efficacy and Safety of Topical Administration of 1% GPB Cream in Patients With Primary Axillary Hyperhidrosis.
Condition: Primary Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to investigate the efficacy and safety of 1% GPB cream after 4 weeks
      of treatment compared with placebo with a sufficient number of patients to obtain
      statistically significant results, and to assess the long-term safety of 1% GPB cream.
    


Intervention name(s): WO3970; Placebo (WO3988)
Intervention type(s): Drug; Drug
Intervention description(s): Application of cream to each axilla; Application of cream to each axilla
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Excessive sweating
Introduction Seminar About Patient Participation and Treatment Options for Psychiatric Patients on Waiting List
Condition: Mental Disorders
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Patient participation is a central concept in Norwegian health policy. It is mandatory in
      hospitals and emphasised as one of the most prioritised areas by the Government. Studies from
      Norway have repeatedly found that patients who seek help in community mental health centres
      ("DPS") are dissatisfied with the information they receive and about their possibility for
      real influence in their treatment.

      One way to improve individual patient participation might be to give patients information
      before they start their treatment. This can be done as group based patient education to
      reduce the resources needed. Furthermore, as there are waiting lists for treatment, such
      introduction seminars could be held while patients are waiting to use this time in a
      meaningful way.

      The present study therefore aims at testing the effect of an introduction seminar for
      patients on waiting list in a community mental health centre.
    


Intervention name(s): Introduction seminar; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): The seminar will be held over two half days, each lasting 2.5 hours. Up to 30 patients can participate in each seminar. The details of the content of the program will be developed based on study one. The preliminarily plans are to give general information about the community mental health centre, the available treatment options and patients rights by presentations from health personnel and user representatives. At the end of each day, the patients will be divided into small groups mentored by health personnel were they can discuss the presentations and ask questions. In the breaks, literature and other type of information for patients will be on display. All participants will get a folder with details of the program and leaflets from patient organisations and governmental agencies.; Usual care
Other intervention name(s): psychoeducation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Introduction seminar; Psychoeducation; Waiting list; Patient participation; Mental disorders