bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of BIA 5-1058 in PAH
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to assess the safety and tolerability of the individual highest tolerated
      zamicastat doses, achieved in the study BIA-51058-201, during long-term treatment in
      Pulmonary Arterial Hypertension (PAH) disease.
    

Detailed description: 
      This is an extension study with Pulmonary Arterial Hypertension (PAH) patients who are under
      treatment with zamicastat as adjunctive therapy in the study BIA-51058-201.

      For patients participating in this extension study, visit "Maintenance Period Visit 3" (MPV3)
      of the study BIA-51058-201 will also be the first visit (V1) of this extension study
      (BIA-51058-202). Their treatment with zamicastat will be continued at their individual
      highest tolerated dose (HTD) for an additional 12 weeks (50 mg, 100 mg, 150 mg or 200 mg).

      Further visits will be performed 20 ±3 days (V2, telephone), 41 ±3 days (V3, on-site), 62 ±3
      days (V4, telephone) and 83 ±3 days (V5, on-site) after V1. At V5, patients will have the
      opportunity to continue treatment with zamicastat in a compassionate use program. Patients
      who will not participate in this compassionate use program will come to the following
      follow-up visit(s):

        -  Follow-up (FU) down-titration (telephone, 14 ±2 days after V5); only applicable in
           patients taking 150 mg or 200 mg zamicastat

        -  FU visit (on-site, 14 ±2 days after last investigational medicinal product (IMP)
           intake).

      The data and safety monitoring board (DSMB) will periodically review the safety data and will
      issue a recommendation if the study can be continued as planned.
    

Intervention name(s): Oral zamicastat
Intervention type(s): Drug
Intervention description(s): Tablets for oral administration under fed conditions containing 100 mg of zamicastat. Zamicastat has to be taken in the morning after breakfast.
Intervention MeSH terms: Zamicastat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PAH; BIA 5-1058; Zamicastat; Bial; Bial - Portela & Ca, S.A.; dopamine ß-hydroxylase (DßH) inhibitor; vascular obstruction; pulmonary arteries; right-heart catheterisation (RHC); idiopathic; rare lung disease
A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children
Condition: Magnetic Resonance Imaging
Study type: Interventional
Phase: Phase 1

Summary: 
      In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has
      already been approved for application in adults, will be investigated in children and
      adolescents. MRI is a modern and safe examination method without delivering radiation burden
      using magnetic fields to produce cross-sectional images of the human body. A special computer
      program then puts these images together and creates a two or three-dimensional image of the
      inner organs thus facilitating the detection and evaluation of pathological changes. In
      contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the
      examination which results in a stronger contrast in the examined area. Therefore,
      pathological changes can be more easily detected and evaluated compared to non-enhanced MRI.
      The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called
      Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine.
      Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e.
      in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney
      disease. Gadavist was examined in more than 2,900 adults within the framework of clinical
      studies during development and has been used after its marketing authorization in meanwhile
      more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only
      conducted with adults so far. Diseases requiring MRI examinations, however, often occur in
      children, too. Therefore, many contrast agents are already used on a regular basis in MRI
      examinations of children, some of these contrast agents being authorized already. Within the
      framework of this study the pharmacokinetic characteristics of Gadavist in children or
      adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in
      the body. In addition, safety and tolerability will be evaluated in order to demonstrate that
      Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents.
      Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body
      weight also for this population group.
    

Detailed description: 
      Please note that the present study is allocated two study phases, i.e. phase I and phase III.
    

Intervention name(s): Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention type(s): Drug
Intervention description(s): In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Contrast-enhanced MRI; MR angiography (MRA) Children 2-17 years
Aerobic Exercise Verus Acupuncture on the Quality of Life in Women Suffering From Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      To compare the effect of aerobic exercise and the acupuncture on the quality of life in women
      with irritable bowel syndrome
    

Detailed description: 
      Patients with IBS have a higher prevalence of migraine, fibromyalgia and depression.

      Donald et al. have shown that physically active elderly participants were less likely to be
      constipated than their less active counterparts.

      On the quality of life Physical activity has also been shown to reduce mouth-to-anus transit
      time and among individuals with constipation, higher levels of physical activity were found
      to be associated with improved physical functioning and health perceptions. Similarly, other
      finding studies are not consistent with some small observational studies which have failed to
      report positive associations between exercise and constipation, reported that orocecal
      transit time was accelerated during mild exercise. Of some relevance to the findings reported
      here is a recent randomized controlled trials (RCT) that found walking to be an effective
      intervention for improving the degree of bowel cleansing in preparation for a colonoscopy.
      There is a contradiction between studies.

      However, study results on acupuncture in IBS are mixed, and more larger trials are needed to
      fully support the claims of acupuncture in helping with IBS there's a contradiction between
      the studies so, the present study will be conducted to compare the effect of aerobic exercise
      and acupuncture on women with irritable bowel syndrome and to solve the contradiction. .
    

Intervention name(s): Aerobic excise; acupuncture
Intervention type(s): Other; Other
Intervention description(s): the treadmill exercises three times a week for 12 weeks) based on the Following protocol: Intensity exercise: determined by karvonen formula: Exercise heart rate = [(A-B) × desired intensity] + B [A represents maximum heart rate (220-age) and B for resting heart rate (average of three measurements)]. The desired intensity will be at 50- 70%. Heart rate was measured by pulse-meter to detect pulse rate before exercise (Resting HR)].; the acupuncture needles will be inserted through the adhesive pads. The acupuncture needles used in the study are 40 mm in length and 0.30 mm in diameter and manufactured by Suzhou Hwato Medical Instruments Co. Ltd (Suzhou, China). The following acupoints will be used: DU20 (Baihui), ST36 (Zusanli), ST37 (Shangjuxu), SP6 (Sanyinjiao), ST25 (Tianshu), and LR3 (Taichong).
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acupuncture; Aerobic exercise; Quality of life
Effects of Dietary Fiber on Affective Processes
Condition: Emotions; Stress; Fear
Study type: Interventional

Summary: 
      The effects of dietary fiber on psychobiological processes are examined in a sample of
      healthy volunteers.
    

Detailed description: 
      The study is an interventional triple-blind, placebo-controlled, parallel group design with 2
      arms (placebo, dietary fiber). Healthy male participants adhere to their normal eating habits
      for the duration of the study (32 days). At the baseline study visit, measurements are taken
      in the lab, including biological samples and psychophysiological measurements. Participants
      then consume placebo or dietary fiber for 4 weeks and revisit the lab on day 32 for a second
      measurement of the outcomes of interest. Specifically, we investigate the effect of dietary
      fiber on affective processing, including stress sensitivity and fear-related processes (e.g.
      extinction learning). Volunteers also respond to questionnaires in relation to mood and GI
      symptoms, and provide biological samples (saliva, blood, faecal, and urine samples) for
      analysis of cortisol levels, circulating short chain fatty acids and serum BDNF, faecal SCFA
      and microbiota composition, and intestinal permeability, respectively.
    

Intervention name(s): Dietary fiber; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fermentable cereal bran; Refined cereal flour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Reading Performance With a Video Magnifier
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      The most common goal for patients with vision loss who present for vision rehabilitation is
      to be able to read. The video magnifier (a device which combines a video camera and a screen
      to view the print being magnified) is the device which most often allows low-vision
      individuals to read successfully for extended periods of time. Previous studies on the
      outcomes of vision rehabilitation have not identified which components of the vision
      rehabilitation are effective. The hypothesis of this project is that providing a video camera
      magnifier, with basic training in operating the device, will allow patients to enhance both
      objective reading ability and subjective report of reading competence.
    

Detailed description: 
      Patients will be given a video magnifier at initial consultation or at the end of vision
      rehabilitation
    

Intervention name(s): Video camera magnifier
Intervention type(s): Behavioral
Intervention description(s): reading with video camera magnifier
Other intervention name(s): Optelec video magnifier
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy
      
Keywords: AMD; vision rehabilitation; video camera magnifier; IVI; DASS
An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)
      in patients with depression.

      The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to
      placebo in patients with depression.

      The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy
      of saredutant on disability and quality of life in patients with depression, and to evaluate
      blood levels of saredutant.
    

Detailed description: 
      The study is a multicenter, US, randomized, parallel-group, double blind, placebo and
      paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a
      1-week, placebo, single-blind period and Segment B is an 8-week, double blind period.
      Patients completing Segment B may be eligible for enrollment into Segment C, a 44-week,
      double blind extension. All randomized patients must complete a post-study telephone visit
      and a post-study office visit 3 days and 1 week, respectively, after intake of the last dose
      of study medication.
    

Intervention name(s): Saredutant succinate (SR48968C)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: depression; antidepressive agents; controlled clinical trial
Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia
Condition: Lymphoplasmacytic Lymphoma; Waldenstrom's Macroglobulinemia
MeSH terms: Lymphoma; Waldenstrom Macroglobulinemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H
      antibody in the treatment of lymphoplasmacytic lymphoma.
    

Detailed description: 
      -  Patients will receive 3 test doses of Campath-1H (3mg, 10mg, 30mg). If the patient
           tolerates these three test doses, then they will receive a total of 6 weeks of
           Campath-1H therapy three times a week.

        -  After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose
           they will be re-assessed by blood testing. If it is determined that their disease has
           progressed in the period of time while the patient was on Campath-1H, the patient will
           be removed from the study.

        -  If it is determined that the patient has achieved a complete remission after 6 weeks of
           Campath-1H treatment a bone marrow biopsy will be performed to confirm complete
           remission and the patient will not receive any additional treatment but will be followed
           for a period of 2 years.

        -  If the disease has remained stable or partial response has been achieved the patient
           will enter the second phase of therapy in which they will receive an additional 6 weeks
           of Campath-1H therapy. The patient will then be reassessed as described above.

        -  No additional therapy (as part of this study) will be performed after a 12 week course
           of Campath-1H.

        -  While the patient is on Campath-1H blood test will be performed at 3-6 month intervals
           over a period extending for 2 years following the last treatment. Bone marrow biopsies
           and/or aspirations will be conducted as necessary.
    

Intervention name(s): Campath-1H
Intervention type(s): Drug
Intervention description(s): Participant will receive three test doses of Campath-1H (3, 10, and 30mg). If this is tolerated then they will receive Campath-IH three times a week for 6 weeks.
Intervention MeSH terms: Alemtuzumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoplasmacytic lymphoma; Waldenstrom's Macroglobulinemia; Antibody; Campath-1H
Early Diabetes Intervention Program
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control
      in early Type 2 diabetes mellitus.
    

Detailed description: 
      A double blind, randomized, placebo-controlled clinical trial of acarbose in subjects with
      type 2 diabetes (an FDA-approved indication). Subjects were identified who had diabetes by
      glucose tolerance test criteria but non-diabetic fasting glucose concentrations. Treatment
      interventions were assessed for their ability to delay worsening of fasting glucose control.
    

Intervention name(s): Acarbose; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): acarbose 100 mg PO once daily; acarbose placebo
Other intervention name(s): Precose
Intervention MeSH terms: Acarbose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes acarbose alphaglucosidase prevention
Efficacy Study of a Novel Skin Health Product to Reduce an UVB Induced Erythema
Condition: Erythema; Sun Damaged Skin; Skin Inflammation
MeSH terms: Erythema; Dermatitis; Inflammation
Study type: Interventional

Summary: 
      The aim of this study is to determine the erythema-reducing efficacy of a test product in two
      concentrations on a light sunburn induced by a sun simulator compared to an untreated control
      and a placebo product.
    


Intervention name(s): Topical Placebo Cream; Topical Cream with 0.5% Active; Topical Cream with 1% Active
Intervention type(s): Other; Other; Other
Intervention description(s): Application of test products before and after irradiation; Application of test products before and after irradiation; Application of test products before and after irradiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Retrospective Study of Radiotherapy Combined With EGFR-TKI for Stage III EGFR Mutant Lung Cancer
Condition: The Primary Study Metric is Progression-free Survival (PFS)
MeSH terms: Disease Progression
Study type: Observational

Summary: 
      Objective: To investigate the efficacy and safety of radiotherapy combined with EGFR-KI in
      the treatment of stage III EGFR mutant lung cancer. Methods: Stage III EGFR mutant lung
      cancer cases who underwent radiotherapy combined with EGFR-TKI from December 2014 to December
      2022 at the People's Hospital of Laibin, the First People's Hospital of Yulin, the Affiliated
      Hospital of Guilin Medical College, and the Park East Hospital of Guangxi Medical University
      Kaiyuan were collected, and the primary index of the study was progression-free survival
      (PFS), and the secondary indexes were objective remission rate, overall survival, recurrence
      pattern, and adverse events. Survival analysis was performed using the Kaplan-Meier method
      with Log rank test for univariate analysis and Cox proportional risk model for multifactorial
      analysis of prognosis.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients diagnosed with lung cancer by pathology,genetic testing for EGFR mutation type
Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blinded, double-dummy, parallel group, 48-week
      study to evaluated the efficacy and safety of DKF-313 (dutasteride and tadalafil) in patients
      with benign prostatic hyperplasia.
    

Detailed description: 
      This study is conducted to access whether DKF-313 once daily for 48 weeks is superior to
      dutasteride 0.5 mg once daily and tadalafil 5 mg once daily each in improving BPH-LUTS as
      measured by changes in IPSS total scores.
    

Intervention name(s): DKF-313; Dutasteride; Tadalafil; DKF-313 placebo; Dutasteride placebo; Tadalafil placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Combination of dutasteride 0.5 mg and tadalafil 5 mg once daily for 48 weeks; Dutasteride 0.5 mg once daily for 48 weeks; Tadalafil 5 mg once daily for 48 weeks; Once daily for 48 weeks; Once daily for 48 weeks; Once daily for 48 weeks
Other intervention name(s): Avodart; Cialis
Intervention MeSH terms: Tadalafil; Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Study of ALN-TTR02 (Patisiran) for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Who Have Already Been Treated With ALN-TTR02 (Patisiran)
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of long-term dosing with
      ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).
    


Intervention name(s): ALN-TTR02 (patisiran) administered by intravenous (IV) infusion
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RNAi therapeutic
Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.
Condition: Sexual Dysfunction, Physiological
MeSH terms: Sexual Dysfunction, Physiological
Study type: Interventional
Phase: Phase 1

Summary: 
      The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical
      system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a
      control unit. Output data is collected on a PC. By measuring the clearance of heat from the
      heated probe, a direct measure of absolute blood flow can be obtained. The study will assess
      changes in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
    

Detailed description: 
      Medical Device Development
    

Intervention name(s): Vaginal Heat Wash-Out Device
Intervention type(s): Device
Intervention description(s): No drug administered. Device tested three times with each subject.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other