bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of PDT, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen
Condition: Polypoidal Choroidal Vasculopathy
MeSH terms: Polypoidal Choroidal Vasculopathy; Vascular Diseases
Study type: Interventional

Summary: 
      The aim of this study is to compare the outcomes of different treatment methods including
      photodynamic therapy (PDT), intravitreal ranibizumab injection (IVR) and combination therapy
      under the "1+PRN" treatment regimen for polypoidal choroidal vasculopathy (PCV) and find the
      optimal treatment for PCV.
    

Detailed description: 
      The optimal treatment for PCV is still under debate. Little knowledge is known about the
      treatment effect of "1+pro re nata(PRN)" treatment regimen for PCV. The aim of this study is
      to compare the outcomes of different treatment methods including PDT, IVR and combination
      therapy under the "1+PRN" treatment regimen for PCV.

      The study is the first prospective randomized controlled trial about different treatment
      methods on PCV under "1+PRN" treatment regimen. The null hypothesis of the study is that
      combination therapy may be the optimal treatment method for PCV. The primary outcome measures
      is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment.
      Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations
      will also be compared between different groups to find the optimal treatment for PCV.
    

Intervention name(s): verteporfin; verteporfin and ranibizumab
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab(0.05mg) will be given to the participants when necessary（every three months）.; Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary.
Other intervention name(s): ranibizumab
Intervention MeSH terms: Ranibizumab; Verteporfin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: polypoidal choroidal vasculopathy; photodynamic therapy; ranibizumab; combination therapy; cost-benefit
Paperless Partograph for Management of Low Risk Labor
Condition: Normal Labor
Study type: Interventional

Summary: 
      Paperless partograph is a technique used for monitoring the progress of labor before
      delivery, and arriving at the accurate time to intervene for ensuring a safe delivery.

      The study will be carried out to find out the effectiveness of paperless partograph in
      management of labor and its effect on maternal and neonatal outcomes
    


Intervention name(s): modified partograph; paperless partograph
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Pilot Study of Between Visit Interaction to Improve Glycemic Control in Pregnancy With Pre-existing Diabetes
Condition: Type 1 Diabetes, Pregnancy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Hypothesis:

      Increased contact with the diabetes care team throughout pregnancy will lead to improved
      glucose control during pregnancy.
    

Detailed description: 
      Patient will have weekly contact through the Mayo Patient On-line Services to send in their
      blood glucose readings and to receive recommendations back regarding insulin dose changes.
      Information will be analyzed regarding the magnitude of change in insulin dosing and in
      glycemic variability.
    

Intervention name(s): Frequent remote contact between clinic visits.
Intervention type(s): Other
Intervention description(s): Subjects will upload diabetes device data onto websites. Website data will be reviewed by study team who will provide feedback to patients without clinic visits.
Intervention model: Single Group Assignment
Intervention model description: Patients were provided help with insulin pump and CGM between visits throughout the pregnancy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Pregnancy; Glycemic variability; Between visit contact
Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy
Condition: Diabetes Mellitus; Essential Hypertension; Renal Failure
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Few studies have reported the effect of alpha1-adrenergic antagonists on 24-h blood pressure
      and regulation of sympathetic nervous activity in hypertensive patients with diabetic
      nephropathy. Using ambulatory blood pressure monitoring devices equipped with spectral
      analysis of heart rate variability, we assess the effects of doxazosin on blood pressure in
      diabetic nephropathy patients and compare the results with those in patients with essential
      hypertension, patients with diabetes mellitus and patients with chronic nephropathy.
    

Detailed description: 
      The study is an open-labeled parallel prospective trial comparing the effects of doxazosin
      (2-8 mg/day) on 24-h blood pressure and autonomic nervous activity. Hypertensive patients
      with non-insulin-dependent diabetic nephropathy, patients with essential hypertension,
      patients with diabetes mellitus and patients with chronic nephropathy undergo ambulatory
      blood pressure monitoring before and after treatment with doxazosin. Simultaneously, spectral
      analysis is performed to calculate the high frequency components as a marker of
      parasympathetic nervous activity, and the low frequency components/high frequency components
      ratios as an index of the sympathovagal balance.
    

Intervention name(s): Effects of doxazosin on morning surge in diabetic patients
Intervention type(s): Drug
Intervention MeSH terms: Doxazosin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ambulatory blood pressure monitoring; doxazosin; alpha1-adrenergic antagonists; sympathetic nervous activity; diabetic nephropathy; essential hypertension; power spectral analysis; morning surge
Cognitive Speed as an Objective Measure of Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Observational

Summary: 
      Tinnitus, commonly referred to as "ringing in the ears", affects 50 million people in the
      United States and is recognized as a major public health concern. Tinnitus is the most
      frequent cause of service-connected disability claims among war veterans. Tinnitus remains a
      subjectively diagnosed entity. There is no standardized objective method of diagnosing
      tinnitus or describing the functional impact of the condition. Currently, physicians have to
      rely on patient-based self reports. Without an objective method of diagnosing tinnitus and
      describing the functional implications, adequate treatment delivery is also hampered since
      there is no way to objectively stratify patients into severity groups and assess response to
      treatment. Because tinnitus is known to negatively affect cognition through the ventral
      attention networks and the prefrontal cortex, measuring cognitive processing speed is a
      possible way to objectively measure tinnitus. This study builds on previous work the
      investigators have done that utilized a quick, easily accessible measure of auditory
      processing speed. That earlier study showed a correlation between that measure and self
      reported measures of tinnitus severity, and this study attempts determine a more precise
      estimate of that correlation. It also better validates those results by including a
      traditional neurocognitive measuring cognitive speed and by controlling for the presence of
      depression and somatoform disorders.
    

Detailed description: 
      This was a cross-sectional study designed to investigate the relationship that self-reported
      tinnitus severity has with cognitive processing speed and psychiatric factors
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will include men and women between the ages of 18-80 years who have
        subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or
        longer.
      
Keywords: subjective; unilateral; bilateral; non-pulsatile; 6 month's duration or longer
Pilot Study of Transcranial Direct Current Stimulation (tDCS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional

Summary: 
      This study will test the tolerability and preliminary efficacy of transcranial direct current
      stimulation (tDCS) combined with a cognitive training program, remotely-delivered using a
      telemedicine protocol in 60 adults with multiple sclerosis (MS). The study will evaluate the
      efficacy of tDCS to evaluate two of the most debilitating symptoms of MS: cognitive
      impairment and fatigue.
    

Detailed description: 
      Transcranial direct current stimulation (tDCS) has been demonstrated to:

        1. successfully treat fatigue in adults with MS, and

        2. improve learning ability and other aspects of cognitive functioning in healthy controls
           and in participants with a range of medical disorders.

      Cognitive impairment in MS remains a major treatment challenge and a trial of tDCS combined
      with a cognitive training program to treat MS-related cognitive impairment is warranted.
      However, one barrier for the study of tDCS has been the need for the participant to travel to
      the study site for each tDCS administration. To address this issue, the biomedical company
      Soterix, has recently designed a remote-delivery tDCS device designed for use in clinical
      trials. Therefore, the primary goal of this study is to establish a protocol for
      remotely-supervised in-home tDCS delivery for studies with MS participants. Established
      safety and feasibility of remotely-supervised tDCS delivery will facilitate the next steps of
      larger controlled trials, in both MS as well as other conditions, to determine efficacy and
      appropriate real-world use.
    

Intervention name(s): Transcranial Direct Current Stimulation (tDCS); Sham Transcranial Direct Current Stimulation; Cognitive Training Program
Intervention type(s): Device; Device; Behavioral
Intervention description(s): tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models; During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Other intervention name(s): Soterix 1x1 tDCS mini-CT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with
      stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular
      effects of intravenous GMI-1070 in the outpatient setting.
    


Intervention name(s): GMI-1070
Intervention type(s): Drug
Intervention description(s): Intravenous GMI-1070 given as two doses over the course of one day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sickle Cell Disease
Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will assess the potential impact of a vaginal ring on condom use by comparing the
      performance (total clinical failure, clinical slippage, and clinical breakage) of a standard
      male lubricated latex condom when the female partner is wearing the vaginal ring and when the
      female partner is not wearing the vaginal ring.
    


Intervention name(s): Placebo Vaginal Ring; Condom
Intervention type(s): Combination Product; Device
Intervention description(s): a silicone elastomer placebo vaginal ring, similar in composition to the dapivirine Ring-004 (which is currently used in IPM's ongoing Phase III program), except that it did not contain any active pharmaceutical agent, and a commercially available standard male latex condom with a silicone-based lubricant.; Male condom
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: IPM 029 is an open-label, randomized, two-period, crossover non-inferiority trial conducted at two research centers in the U.S. to assess condom functionality during vaginal intercourse in healthy, monogamous heterosexual, sexually active couples.
Masking: None (Open Label)
Primary purpose: Other
Optical Coherence Tomography Angiography and Choroidal Osteoma
Condition: Choroidal Osteoma, Bilateral
MeSH terms: Osteoma
Study type: Observational

Summary: 
      This study evaluates the vessel density of choriocapillary vascular network in eyes affected
      by choroidal osteoma and in eyes complicated by choroidal neovascularization, using optical
      coherence tomography angiography.
    

Detailed description: 
      The choroidal osteoma is a rare benign tumor of choroid, it is bilateral in 10%-25% of cases,
      affecting usually young women. Previous studies evaluated the morphologic characteristics of
      tumor-related vasculatures, described as a seafun vascular networks, but none focused on
      study of vessel density of coriocapillary.

      The aim of this study is to investigate the potential role of the optical coherence
      tomography angiography (OCTA) in evaluating the choriocapillary vessel density in order to
      individuate the changes of this vascular network that may influence the onset of choroidal
      neovasculariztion.

      Therefore, OCTA could be useful in the clinical management of the choroidal osteoma
    

Intervention name(s): Optical coherence tomography angiography
Intervention type(s): Diagnostic Test
Intervention description(s): To evaluate the vessel density in choriocapillary vascular networks, using optical coherence tomography angiography
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 50 years with choroidal osteoma. They did not present other
        ophthalmological diseases.
Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques
Condition: Prosthesis User
Study type: Interventional

Summary: 
      This study aimed to evaluate patient satisfaction and OHRQL using two pick-up methods for
      locator retained mandibular overdenture
    


Intervention name(s): implant supported mandibular overdenture
Intervention type(s): Procedure
Intervention description(s): In this crossover study, the patients received overdentures with two successive different pick-up techniques for the locator retentive caps; each technique was evaluated for patient satisfaction with blue and pink retentive inserts.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Group I: Ten overdentures with locator retentive caps and blue inserts were picked up by the indirect method.
Group II: Ten overdentures with locator retentive caps and pink inserts were picked up by the indirect method.
Group III: Ten overdentures with locator retentive caps and blue inserts were picked up by the direct method.
Group IV: Ten overdentures with locator retentive caps and pink inserts were picked up by the direct method.
Masking: Single (Participant)
Primary purpose: Treatment
Traumatic Brain Injury Among Homeless Veterans
Condition: Traumatic Brain Injury; Homelessness
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      Objectives include: 1) establishing a psychometrically sound traumatic brain injury (TBI)
      screening measure for use among homeless veterans; 2) identifying the prevalence of those
      that screen positive for TBI among homeless veterans seeking VA services; and 3) comparing
      psychiatric and psychosocial outcomes between those with and without a history of TBI.
    

Detailed description: 
      Short-term Objectives include:

        1. Establishing the criterion-related validity of the Traumatic Brain Injury-4 (TBI-4)
           questionnaire in the Veteran homeless population using the Ohio State University
           TBI-Identification Method (OSU TBI-ID) (Corrigan et al., 2007) as the gold standard for
           establishing traumatic brain injury (TBI) diagnosis.

        2. Identifying the prevalence of those that screen positive for a lifetime history of TBI
           among homeless Veterans.

        3. Comparing psychiatric outcomes (psychiatric hospitalizations, suicide attempts and
           deaths, and clinical contacts) and psychosocial outcomes between those with and without
           a lifetime history of TBI.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Homeless Veterans
      
Keywords: Traumatic Brain Injury; Homelessness
Nicotine Related Brain Activity: The Influence of Smoking History and Blood Nicotine Levels
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      In this study, we sought to explore brain activity in nicotine-dependent men in response to
      acute intravenous nicotine using pharmacological magnetic resonance imaging (phMRI).
    

Detailed description: 
      phMRI was used to evaluate brain activity in response to 1.5 mg/70 kg intravenous nicotine or
      saline. The nicotine and saline were administered on different visits. The time courses of
      individual subjects' nicotine levels were used as regressors to assess neural activity
      relating to the infusions. The influence of Smoking history and physiological measures on the
      response to nicotine were also investigated.
    

Intervention name(s): Intravenous Nicotine; Saline - placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects received a single infusion of nicotine, 1.5 mg/70kg (New England Compounding Center, Framingham, MA), administered over 1 minute into the antecubital vein 10 minutes into their MRI scans.; Subjects received a single infusion of saline, administered over 1 minute into the antecubital vein 10 minutes into their MRI scans.
Other intervention name(s): IV Nicotine
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring
      systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but
      potential side effects are concerning. Several reports point at extracorporeal photopheresis
      (ECP) as an efficient alternative treatment modality with few and mild side effects. However,
      no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In
      this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.
    


Intervention name(s): Cyclosporine A (CsA); Extracorporeal photopheresis (ECP)
Intervention type(s): Drug; Other
Intervention description(s): 3 mg/kg/day for 4 month; Administered two consecutive days twice a month for 4 month
Other intervention name(s): Sandimmune
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Atopic dermatitis; Ciclosporine; Extracorporal photopheresis
A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the
      efficacy and safety of 10, 20, 40 and 60 mg oral PRAX-114 compared to placebo in the
      treatment of adults with MDD. The study will enroll participants on adjunctive treatment who
      had an inadequate response to their current antidepressant treatment and participants not
      currently being treated with pharmacotherapy for MDD. A sub-study to investigate the
      pharmacokinetics (PK) of PRAX-114 and metabolites when dosed in the evening in participants
      with MDD will be conducted in a subset of participants at selected research sites with serial
      PK sampling capabilities.
    


Intervention name(s): 10 mg PRAX-114; 20 mg PRAX-114; 40 mg PRAX-114; 60 mg PRAX-114; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Once daily oral treatment; Once daily oral treatment; Once daily oral treatment; Once daily oral treatment; Once daily oral treatment
Intervention MeSH terms: Pramoxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mood Disorders; Depressive Disorder; Depression; Depressive Disorder, Unipolar; Depressive Symptoms; Agents, GABA; Receptors, GABA-A; Allosteric Regulation