bioihbjkbjnl/mcl2 huggingface dataset:
Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions
Condition: Age-related Hearing Impairment 1; Personal Communication
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      Age-related hearing loss is highly prevalent and hearing health care is underutilized. The
      primary objective of the proposed randomized controlled trial is to investigate the efficacy
      of a community health worker (CHW)-delivered hearing loss intervention program. A preceding
      pilot study demonstrated preliminary effectiveness of the intervention program in reducing
      self-reported hearing handicap, and highlighted its acceptability among the target
      demographic. The proposed trial will now expand upon lessons learned through previous pilot
      studies and expand to other affordable residences for low-to-moderate income older adults in
      Baltimore. Primary outcome measurements will investigate intervention effects on hearing
      handicap, with secondary measurements investigating effects on domains such as social
      isolation and quality of life. This trial is a first-in-kind investigation of a novel
      community-based intervention that addresses hearing loss in a vulnerable, urban population.
    


Intervention name(s): Baltimore HEARS; Baltimore HEARS
Intervention type(s): Behavioral; Device
Intervention description(s): Tailored aural rehabilitation for participant and communication partner (if applicable); Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluating Serum Sestrin in Leiomyoma Patients
Condition: Uterine Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Observational

Summary: 
      Leiomyomas are the most common benign neoplasms of women's reproductive system affecting
      20-30% of women within the reproductive ages. Sestrins are serum proteins which are highly
      expressed under circumstances of DNA damage, hypoxia and oxditive stress and play an
      important role in autophagia. The aim of this study is to evaluate the relationship of serum
      sestrin proteins with development of leiomyomas.
    

Detailed description: 
      Leiomyomas are the benign neoplasms of uterus and the role of genetics, estrogen levels and
      obesity has already been shown in their development. Higher levels of serum sestrin proteins
      have already been associated with DNA damage, hypoxia and oxidative stress and sestrin plays
      an important role in autophagia. In order to evaluate the role of serum sestrin in the
      development of leiomyomas 30 patients between 18-45 years of age who were diagnosed with
      uterine leiomyomas with transvaginal ultrasonography will be included in the study group.
      Their serum sestrin levels will be determined and compared with that of 30 healthy subjects
      recruited during the same study period at the same clinic.
    

Intervention name(s): Determination of serum sestrin levels
Intervention type(s): Other
Intervention description(s): Serum sestrin levels will be determined using venous blood samples obtained from the subjects.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 patients diagnosed with uterine leiomyomas within the above mentioned age group
        (reproductive ages) are included in the study group. 30 age matched healthy subjects are
        included in the control group.
Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates PERSERIS at a higher dose than what has been administered in previous
      clinical trials. Subjects with stable schizophrenia on a dose of 5-6 mg oral risperidone will
      be switched to PERSERIS at the higher dose, which is believed to be similar to the oral dose
    

Detailed description: 
      PERSERIS is an extended-release subcutaneous (SC) injectable suspension administered monthly
      for the treatment of schizophrenia in adults. PERSERIS was approved by the FDA at doses
      equivalent to 3 mg and 4 mg oral risperidone. Many patients require doses of 5-6 mg oral
      risperidone and above, and this study will test a higher dose of PERSERIS in order to meet
      this need.

      Eligible subjects will initially be stabilized in the clinical unit on 6 mg oral risperidone
      for 5 days and transition to an approximate dose of PERSERIS by SC injection. PERSERIS will
      be administered every 28 days and subjects will be admitted to the clinical unit the day
      before, and remain in the unit for 3 days after each injection for pharmacokinetics (PK) and
      safety evaluations (a total of 8 days for the first injection including the stabilization
      period). Subjects will return to the clinic between injections for additional PK, safety and
      efficacy assessments at scheduled intervals until the next injection.

      A total of 4 doses of PERSERIS will be administered. The 4th dose will evaluate an alternate
      site for injection, and will be administered in the back of the upper arm.

      Subjects will return to the clinical unit for an end of study visit and will receive a follow
      up phone call to assess for adverse events one week after the end of study visit.
    

Intervention name(s): PERSERIS; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): PERSERIS is an extended-release SC injectable suspension administered once-monthly; Oral risperidone
Other intervention name(s): long acting risperidone; Risperdal
Intervention MeSH terms: Risperidone
Intervention model: Single Group Assignment
Intervention model description: The study will enroll subjects currently on a stable dose of 5 or 6 mg of oral risperidone. After screening, eligible subjects will be admitted to the clinical unit and stabilized on 6 mg daily (3 mg oral risperidone twice a day) for 5 days, followed by an additional 3 days, during which the first injection of PERSERIS will be administered. Subjects will then return to the clinical unit every 28 days for an additional 3 admit periods for subsequent PERSERIS injections (2 injections per visit).
Masking: None (Open Label)
Primary purpose: Treatment
Is Standard 3-degree of External Rotation for Posterior Femoral Cut Relevant for Turkish Population
Condition: Healthy
Study type: Observational

Summary: 
      The aim of this study is to evaluate the posterior condylar angle of the distal femur in
      Turkish population and its concordance with the current standard prosthesis designs used in
      total knee arthroplasty and to evaluate anthropometric features of the distal femur in the
      Turkish population.
    

Detailed description: 
      The investigators would like to measure condylar twist angles(CTA), posterior condylar
      angles(PCA), femoral mediolateral lengths (fML), medial femoral anteroposterior
      lengths(fMAP), lateral femoral anteroposterior lengths (fLAP), distances between trochlear
      groove and fMAP(DBTG-fMAP), distances between trochlear groove and fLAP(DBTG-fLAP), medial
      and lateral posterior condylar cartilage thicknesses(MPCCT/LPCCT) on the Magnetic Resonance
      Images (MRI) of 240 knees of 120 Turkish subjects.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Healty subjects with Turkish ethnic orijin
      
Keywords: posterior condylar angle; total knee arthroplasty; external rotation; anthropometric measurements; 3 degrees; Turkish population
Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
Condition: Mental Fatigue; Cognitive Function; Mood
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to demonstrate the effects of 28-days supplementation with a novel
      probiotic formulation on mental fatigue following a cognitive load in healthy adults. Half of
      the participants will receive the probiotic formulation while the other half will receive
      placebo.
    

Detailed description: 
      A total of 128 participants will be recruited to take part in this trial.

      The supplement contains selected strains of lactobacilli and bifidobacteria which have been
      well studied in human clinical trials. Previous clinical trials have demonstrated
      improvements in cognitive function and mood after supplementation with various combinations
      of lactobacilli and bifidobacteria.

      The specific strains present in the current investigation have been studied in a number of
      clinical trials in which no adverse events were linked to the strains. The benefits of
      probiotic supplements on health is well established, and has led to an increase in use, as
      well as the addition of probiotic strains in dietary supplements. Despite this, only a small
      number of controlled trials have directly investigated the cognitive benefits associated with
      probiotic supplementation.

      The current study therefore aims to investigate the anti-fatigue effects of a probiotic
      supplement after a period of cognitive demand. We will be measuring the effects of the
      probiotic supplement compared to a placebo using assessments of mental fatigue, cognition,
      memory and mood.
    

Intervention name(s): Probiotic formulation; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic capsule; Placebo capsule identical in taste and appearance to probiotic capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Half the participants will receive the probiotic formulation while the other half will receive placebo.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Brief Primary Care Intervention Helps Parents With Discipline
Condition: Discipline
Study type: Interventional

Summary: 
      Play Nicely, is a 40 minute, interactive, media-rich, CD ROM that teaches parents, health
      care professionals, counselors, and child care workers/teachers the basics in aggression
      management for children ages 1-7. For more information about the program and to review
      results of previous studies, see www.playnicely.org. The objective of this study is to
      determine if using this brief intervention during the well child visit can affect parents'
      plans to discipline their children.
    


Intervention name(s): Play Nicely program; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention was the Play Nicely program, a multimedia educational program. Permission to demonstrate the program to multiple viewers was obtained from the copyright holder. English speaking caregivers viewed the 2nd English language edition and Spanish speaking caregivers viewed the Spanish edition. In the program, there are 16 options (20 options in the Spanish version) to respond to the hypothetical situation of witnessing a young child have hurtful behavior toward another child. Caregivers in the intervention group were instructed to view 4 of the interactive options of their choosing. On average, it takes 1 minute to view one option. Parents in the control group received routine primary care with their pediatrician.; Routine primary care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Parents' plans to discipline their children
External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells.
      Giving radiation therapy in different ways may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of external-beam radiation therapy
      followed by implanted radiation therapy in treating patients who have prostate cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the acute and late grade 3-5 genitourinary (GU) and gastrointestinal
      (GI) toxic effects of external beam radiotherapy followed by permanent source brachytherapy
      using interstitial iodine I 125 seeds in patients with intermediate risk, clinically
      localized adenocarcinoma of the prostate. II. Determine the freedom from prostate specific
      antigen (PSA) failure, overall survival, disease specific survival, and local and/or distant
      clinical relapse rates in patients treated with this regimen.

      OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy (EBRT) to
      the pelvis 5 days a week for 5 weeks. Permanent source brachytherapy comprised of
      ultrasound-guided implantation of iodine I 125 seeds into the prostate is performed 2-6 weeks
      after completion of EBRT. Patients are followed at 1, 3, 6, 9, and 12 months, then every 6
      months for 2 years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.
    

Intervention name(s): brachytherapy; iodine I 125; radiation therapy
Intervention type(s): Radiation; Radiation; Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
Noninvasive Assessment of Metabolic Associated Fatty Liver Disease (MAFLD) in Chinese Population
Condition: Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      Attenuation imaging (ATI) technology independently developed by Canon medical is a
      non-invasive examination technology for quantitative detection and analysis of liver
      steatosis. The technique is simple, rapid and quantitative diagnosis, and is suitable for
      screening and popularization of early liver steatosis in MAFLD. As noninvasive and effective
      detection measures of liver inflammation and liver fibrosis, SWD and SWE are more and more
      widely used in the quantitative diagnosis of liver inflammation and fibrosis. Therefore, ATI
      combined with SWD / SWE detection can quantitatively diagnose different pathological stages
      (steatosis, necrotizing inflammation and liver fibrosis) in the development of MAFLD, so as
      to provide an important basis for treatment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        According to the results of HBV surface antigen, the patients were divided into two
        subgroups: (1) HBV surface antigen negative group: pure mafld group; (2) HBV surface
        antigen positive group: mafld combined with hepatitis B group
Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the trial is to compare the efficacy and safety of sublingual seasonal and
      annual immunotherapy in children with allergic rhinitis allergic to grass pollens.
    

Detailed description: 
      Allergen immunotherapy is currently the only one method of cause treatment of the
      IgE-dependent allergic diseases. Sublingual immunotherapy (SLIT) is the method which allows
      to give allergens via alternative oral route in patients home. Due to the possibility of
      avoiding injection this therapy allows to have better relationship with patient, and reduce
      the costs of therapy thanks to reducing the numbers of visits in out-patient clinic.However
      efficacy and safety of sublingual immunotherapy are still important issues, especially in
      children.

      The purpose of trial is to compare the efficacy and safety of sublingual seasonal and annual
      immunotherapy in children with allergic rhinitis allergic to grass pollens.
    

Intervention name(s): sublingual allergen extract; sublingual allergen extract; placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group; Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group; Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group
Other intervention name(s): Staloral 300 IR, Stallergenes, France; Staloral 300 IR, Stallergenes, France
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop
      tumor cells from dividing so they stop growing or die.

      PURPOSE: This phase II trial is studying how well topotecan works in treating women with
      persistent or recurrent cervical cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the antitumor activity of topotecan in patients with persistent or recurrent
           carcinoma of the cervix that failed higher priority treatment protocols.

        -  Determine the nature and degree of toxicity of this drug in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28
      days in the absence of disease progression or unacceptable toxicity.

      Patient are followed for every 3 months for 2 years and then every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-2 years.
    

Intervention name(s): topotecan hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Topotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent cervical cancer; cervical squamous cell carcinoma
Study of Axial Mobility Exercises in Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Compare the benefit of exercise versus usual care (no exercise) on impairments and
      functional limitations in patients with Parkinson disease.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized study. Patients assigned to the Axial Mobility
      Exercise Program participate 3 times a week for 10 weeks. The program consists of
      individualized exercises specifically directed toward restoration of axial mobility in the
      context of functional tasks.

      Patients assigned to the control group receive standard care (no exercise).
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Primary purpose: Educational/Counseling/Training
Keywords: Parkinson disease; Neurologic and psychiatric disorders; Rare disease
The Effect of Psychological First Aid Intervention on Stress and Resilience in Volunteers Working in Kahramanmaraş Centered Earthquakes
Condition: Psychological Resilience; Stress; Earthquake
Study type: Interventional

Summary: 
      Purpose: It was aimed to compare the effectiveness of online psychological first aid
      intervention on stress and psychological resilience in volunteers who took part in
      earthquakes.

      Method: This is a single-blind randomized controlled experimental study conducted to
      determine the effect of online psychological first aid intervention on the stress and
      resilience levels of volunteers who took part in the earthquake.
    

Detailed description: 
      In this study, it is aimed to compare the effectiveness of the online psychological first aid
      intervention on stress and psychological resilience given to the volunteers working in
      various provinces (11 provinces) affected by the Kahramanmaraş Centered Earthquakes.
    

Intervention name(s): psychological first aid
Intervention type(s): Behavioral
Intervention description(s): The effect of psychological first aid on earthquake victims was measured using the resilience scale and the secondary traumatic stress scale.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This research is a single-blind randomized controlled experimental study to determine the effect of online psychological first aid intervention on the stress and resilience levels of volunteers who took part in the earthquake.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: post traumatic stress disorder; psychological first aid; psychological resilience; earthquake victims
Neural Therapy Effect and Bilateral Tubal Ligation
Condition: Tubal Obstruction; Dysmenorrhea
MeSH terms: Fallopian Tube Diseases; Dysmenorrhea
Study type: Observational

Summary: 
      The aim of this study is to evaluate the effect of nebulisation in patients with bilateral
      tubal ligation in the first postoperative year, the amount of dysmenorrhea, dyspareunia and
      menstrual bleeding, recurrent vaginitis and cystitis.

      A retrospective analysis of bilateral tubal ligation with optional modified Pomeroy technique
      in the family planning unit and evaluation of the results of patients who underwent Neural
      Therapy during and postoperatively will be evaluated.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had bilateral tubal ligation with modified Pomeroy technique and had
        complaints such as dysmenorrhea dyspareunia in the first postoperative year
      
Keywords: Bilateral Tubal Ligation; Postoperative Discomforts