bioihbjkbjnl/mcl2 huggingface dataset:
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to characterize the safety and tolerability of long-term
      administration of evolocumab in adults with known coronary artery disease and
      hypercholesterolemia.
    


Intervention name(s): Evolocumab
Intervention type(s): Biological
Intervention description(s): Administered by subcutaneous injection once a month
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Fascial Manipulation in Rotator's Cuff Surgery Patients
Condition: Cuff Rotator Syndrome
Study type: Interventional

Summary: 
      The purpose is to evaluate the effectiveness of fascial manipulation treatment in terms to
      reduce pain and improve physical functionality after rotator's cuff surgery. The technique
      involves deep friction manipulation of fascia's specific spots. Distant from surgical site.
    

Detailed description: 
      To evaluate the effectiveness of fascial manipulation treatment associated with standard
      physiotherapies treatment in rotator's cuff surgery patients, we'll randomize about 60
      patients for arm's of study. Both arm's will receive 10 standard physiotherapies treatments
      in 2 weeks while the experimental arm will receive 3 manual intervention on deep fascial
      tissues, according to fascial manipulation technique, providing a specific motor and manual
      assessment, and a deep manual intervention over specific fascial alteration.

      To evaluate the effectiveness of fascial manipulation treatment we'll use 2 type of outcome
      measure and we will compare the result of both arms of study.
    

Intervention name(s): fascial manipulation; standard physiotherapies treatment
Intervention type(s): Other; Other
Intervention description(s): • 3 manual intervention on deep fascial tissues, according to fascial manipulation technique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.; 10 standard treatments in 2 weeks
Deltoid and infraspinatus muscles electrotherapy
Chair for passive continue mobilization at allowed range of motion (ROM). ½ h per day
Scar massage
Upper limb, cervical spine and scapula massages
Passive and assisted/active shoulder mobilization exercises
Scapula micro-mobilizations
Gleno-humeral decoaptation
Elbow, wrist and hand active mobilization
Proprioceptive exercise with and without the aid of the mirror
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Dose Escalation Study to Evaluate the Effect of RT234 in Subjects With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter, open label, Phase 2a study is designed to evaluate the effect of inhaled
      RT234 delivered in a dose escalation manner on the change in pulmonary vascular resistance
      (PVR) in subjects with Pulmonary Arterial Hypertension (PAH) undergoing Right heart
      catheterization (RHC).

      This study is also known as Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase
      2a (VIPAH-PRN 2a) study
    

Detailed description: 
      The drawbacks of current therapies and the lack of an approved as needed (PRN) treatment for
      PAH that improves exercise ability and quality of life, form the basis for development of
      RT234 (inhaled vardenafil). The current study will identify the effective dose(s) of RT234 to
      acutely improve pulmonary vascular hemodynamics when delivered in a dose escalation manner in
      subjects with World Health Organization (WHO) Group 1 PAH undergoing RHC. In addition, this
      study will also provide valuable efficacy and safety insights into the interactions between
      RT234 and background disease-specific PAH therapy on pulmonary hemodynamics and right heart
      function.
    

Intervention name(s): Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)
Intervention type(s): Combination Product
Intervention description(s): RT234 is a drug/device combination product composed of vardenafil hydrochloride as the drug constituent and will utilize RS01 DPI device.
Other intervention name(s): vardenafil inhalation powder; inhaled vardenafil
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Vascular Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Vardenafil Dihydrochloride; Vasodilator Agents; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action
CO2-laser Treatment for Caesarean Section Scars
Condition: Cicatrix
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      Fractional Co2-laser for treatment of mature caesarean section scars.
    

Detailed description: 
      Randomized split scar study to document improvement of caesarean section scars as compared to
      untreated control scar.
    

Intervention name(s): Fractional Co2-laser
Intervention type(s): Device
Intervention description(s): laser treatment
Other intervention name(s): Ablative fractional laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
"Dumpling Suture Method" Versus Traditional Suture Method of Protective Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Via Stoma: a Retrospective Comparative Study
Condition: Ileostomy; Complications
Study type: Interventional

Summary: 
      Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from
      the abdominal cavity without any incisions, has attracted much attention in recent years, and
      it has been widely popularized in the treatment of rectal cancer because of its postoperative
      non-incision, advantages of less trauma, quicker recovery, and postoperative aesthetics.
      Anastomotic fistula is a serious complication of rectal cancer surgery. For patients at high
      risk of anastomotic fistula, prophylactic ileostomy is often performed intraoperatively to
      divert feces and protect the anastomosis. For such patients, rectal anterior resection
      surgery with specimen extraction via stoma (NOSES with specimen extraction via stoma) is
      usually performed, borrowing a prophylactic stoma incision to retrieve the specimen, and also
      realizing the absence of additional abdominal incision. However, this procedure is prone to
      stoma infection and has a high complication rate (20-40%), which limits the popularization of
      NOSES surgery and is an urgent clinical problem. Our center has proposed a new stoma closure
      method (Dumpling Suture Method), which reduces the size of the incision by folding the suture
      to achieve the effect of hiding the skin incision and reduce stoma infection. The study aimed
      to introduce the "Dumpling suture method" of protective loop ileostomy in laparoscopic
      anterior resection and compare this new method with the traditional method. From August 1st
      2019 to August 1st 2023, 22 cases of the new procedure were completed in our center, and 30
      patients with stoma closure by the traditional method were included in the same period for
      control purposes. A retrospective analysis was conducted on 52 patients in the study center,
      and the intraoperative details and postoperative outcomes of the two groups were measured.
    


Intervention name(s): Suturing of ileostomy using "Dumpling suture method"; Suturing of ileostomy using Traditional suture method
Intervention type(s): Procedure; Procedure
Intervention description(s): Suturing of ileostomy using "Dumpling suture method"; Suturing of ileostomy using Traditional suture method
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ileostomy; complications; NOSES; stoma suture
Study of 18F-Thretide PET/CT in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients
      with biopsy proven prostate cancer who has no any form of therapy against prostate caner or
      suspected recurrence of prostate cancer who have negative or equivocal findings on
      conventional imaging.
    

Detailed description: 
      Prostate-specific membrane antigen (PSMA) is overexpressed in most cases of prostate cancer
      and is potentially associated with metastasis and progression of prostate cancer. Compared
      with 68Ga, the PET radionuclide 18F exhibits several advantages. 18F-Thretide (18F-labeled
      PSMA ligand) has been studied for preclinical evaluation and Pilot Clinical Study. This study
      evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with with
      biopsy proven prostate cancer who has no any form of therapy against prostate caner or
      suspected recurrence of prostate cancer who have negative or equivocal findings on
      conventional imaging.
    

Intervention name(s): A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide
Intervention type(s): Drug
Intervention description(s): The patients will be intravenously injected with 18F-Thretide and undergo PET/CT scan at 60~120 min after the injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders
Condition: Urea Cycle Disorder
MeSH terms: Urea Cycle Disorders, Inborn
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label study consisting of a transition period to RAVICTI, followed by a
      safety extension period for at least 6 months and up to 24 months of treatment with RAVICTI,
      depending on age at enrollment. It is designed to capture information important for
      evaluating safety, pharmacokinetics and efficacy in young children.

      Subjects who are followed by or referred to the Investigator for management of their UCD.
      Subjects eligible for this study will include patients ranging from newborn to < 2 years of
      age with either a diagnosed or clinically suspected UCD.
    


Intervention name(s): RAVICTI
Intervention type(s): Drug
Other intervention name(s): HPN-100; Glycerol Phenylbutyrate; GPB
Intervention MeSH terms: Glycerol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urea Cycle Disorder; UCD; Buphenyl; Glycerol Phenylbutyrate; Ravicti; Hyperammonemia; Sodium Phenylbutyrate; GPB; HPN-100
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-1 Patients
Condition: Chronic Hepatitis C; Genotype
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purposes of this study are:

        1. To evaluate whether treatment with peginterferon and ribavirin for 24 weeks is
           sufficient to achieve a sustained virological response (SVR) rate comparable to that
           observed with the standard treatment duration of 48 weeks, in hepatitis C virus genotype
           1 (HCV-1) patients achieving a rapid virologic response (RVR; <50 IU/mL HCV RNA at week
           4) at 4 weeks.

        2. To investigate the role of on-treatment virological responses among patients with 24 or
           48 weeks treatment.
    

Detailed description: 
      Peginterferon and ribavirin combination treatment has been recommended for all patients
      infected with HCV, but the treatment duration varies depending on the HCV genotype.
      Recommended treatment for patients with HCV-1 infection is pegylated interferon plus
      ribavirin for 48 weeks and 24 weeks for HCV-2/3. A RVR is a strong predictor of SVR. Previous
      studies have demonstrated that for HCV-2/3 patients who had a RVR, a shorter duration of
      treatment with peginterferon plus standard dose of ribavirin over 14 weeks is as effective as
      a 24-week treatment regimen. These findings have questioned whether shorter treatment
      duration can yield high SVR rates for HCV-1 pts with an RVR.

      The primary aim of the present study is to evaluate whether treatment with peginterferon and
      ribavirin for 24 weeks is sufficient to achieve an SVR rate comparable to that observed with
      the standard treatment duration of 48 weeks, in HCV-1 patients achieving an RVR at 4 weeks.

      The secondary aim is to investigate the role of on-treatment virologic responses among
      patients with 24 or 48 weeks treatment.
    

Intervention name(s): pegylated interferon alpha 2a and ribavirin; Pegylated interferon alfa-2a and ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): pegylated interferon alpha 2a 180 mcg/week and ribavirin 1000-1200 mg/day for 48 weeks; Pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
Other intervention name(s): PEGASYS®; PEGASYS®
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis C; genotype 1; rapid virological response; sustained virological response; peginterferon; ribavirin; treatment duration
Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
Condition: Pyoderma Gangrenosum
MeSH terms: Pyoderma; Pyoderma Gangrenosum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to explore the efficacy and safety of anti-Interleukin-(IL)17
      therapy (secukinumab, administered weekly for 4 weeks followed by four-weekly administration
      until week 16) for the treatment of pyoderma gangrenosum.
    


Intervention name(s): Secukinumab
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combined Effects of Energy Density and Eating Rate on Appetite
Condition: Appetite
Study type: Interventional

Summary: 
      This study will examine the independent and combined effects of energy density and eating
      rate on appetite and endocrine mediators of appetite. Increasing eating rate and energy
      intake are expected to additively increase energy intake.
    


Intervention name(s): Eating rate
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Modifiable environmental; behavioral factors
Risperidone Alone Vs. Risperidone Plus Valproate in the Treatment of Patients With Schizophrenia and Hostility
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an eight-week open-label randomized parallel group clinical trial focusing on the
      comparison of risperidone alone with risperidone plus valproate among hospitalized adult
      patients diagnosed with schizophrenia who also exhibit problems with hostility. Patients may
      have already been receiving risperidone or valproate (but not both) at study entry. Patients
      not receiving valproate at study entry were randomized to receive either risperidone alone or
      risperidone with valproate. For patients already receiving valproate at study entry, their
      antipsychotic medication(s) was switched to risperidone, and they were followed for a
      four-week lead-in period prior to baseline assessment and randomization to receive
      risperidone alone or continue with risperidone and valproate. We hypothesized that
      risperidone alone has an antiaggressive/antihostility effect, and that this effect is
      augmented by the co-administration of valproate.
    

Detailed description: 
      Background: Patients with schizophrenia who also exhibit hostile behavior pose a formidable
      challenge for clinicians. Hostile behavior is a frequent reason for psychiatric admission,
      and is an obstacle for the successful reintegration of patients back into the community.
      Current treatment approaches have generally not been assessed under controlled conditions.

      Method: This is an eight-week open-label randomized parallel group clinical trial focusing on
      the comparison of risperidone alone with risperidone plus valproate among hospitalized adult
      patients diagnosed with schizophrenia who also exhibit problems with hostility. Patients may
      have already been receiving risperidone or valproate (but not both) at study entry. Patients
      not receiving valproate at study entry were randomized to receive either risperidone alone or
      risperidone with valproate. For patients already receiving valproate at study entry, their
      antipsychotic medication(s) was switched to risperidone, and they were followed for a
      four-week lead-in period prior to baseline assessment and randomization to receive
      risperidone alone or continue with risperidone and valproate. Blinded raters completed a
      battery of assessments, including the Positive and Negative Syndrome Scale, Buss-Durkee
      Hostility Inventory, Barratt Impulsiveness Scale, and the Overt Aggression Scale. We
      hypothesized that risperidone alone has an antiaggressive/antihostility effect, and that this
      effect is augmented by the co-administration of valproate.
    

Intervention name(s): Risperidone, divalproex
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Hostility; Impulsivity; Aggression
WINROP Algorithm Validation for Retinopathy Screening in a Cohort of Premature Infants
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Observational

Summary: 
      When a child was born too early, it is more likely to develop an alteration of its visual
      function than in the case of term birth. Significant visual disturbances are found in 3% of
      children born prematurely, but visual impairment can be very severe, up to the loss of vision
      in case of retinopathy of prematurity (ROP) in the most immature infants. The introduction of
      screening surveillance systems, such as WINROP software, might reduce the need for stressful
      eye examination in low risk neonates. This retrospective study aimed at validating the WINROP
      algorithm in a cohort of premature infants, born below 32 weeks of gestation, who had
      systematic eye examination for ROP screening over 4 year period.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All infants, born from July 2012 to July 2016, from 24 to 32 weeks gestation had
        hospitalized in our level III NICU having had eye examination up to 40 weeks post menstrual
        age.
      
Keywords: very premature infants; screening; retinopathy
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
Condition: Homozygous Familial Hypercholesterolemia HoFH
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To describe the safety and tolerability of evolocumab in participants with homozygous
      familial hypercholesterolemia (HoFH) in India. All participants will receive evolocumab over
      an 8-week period.
    

Detailed description: 
      An open-label, multicentre, phase 4 study to describe the safety and tolerability of
      evolocumab in 30 Indian participants with HoFH. Subjects who meet the inclusion/exclusion
      criteria and laboratory assessments at screening will be enrolled and will be required to
      maintain their current lipid-lowering drug therapy throughout the duration of the trial.
      Participants will receive evolocumab 420 mg subcutaneous (SC) once monthly (QM) and study
      visits will occur approximately every 4 weeks. Apheresis participants will receive evolocumab
      420 mg SC every 2 weeks to correspond with their apheresis schedule. Final administration of
      evolocumab (for all participants) will occur at week 8. The end of study (EOS) visit will
      occur at week 12 for all participants.
    

Intervention name(s): evolocumab
Intervention type(s): Drug
Intervention description(s): Administered by SC injection via autoinjector (AI)/pen
Other intervention name(s): Repatha®; EvoMab
Intervention MeSH terms: Evolocumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Evolocumab; Hypercholesterolemia
Effects of Calcium and Phytate on Zinc Absorption
Condition: Dietary Zinc Absorption
Study type: Interventional

Summary: 
      This study is determine the effects of dietary calcium and phytate on zinc absorption.
    

Detailed description: 
      Zinc absorption is tested from 2 days of consuming each of four diets with zinc-65 isotope,
      followed by retention monitoring in a whole body scintillation counter for 4 weeks. All four
      4 experimental diets are tested with each subject, in randomized order, for a total of 16
      weeks.
    

Intervention name(s): Moderate Calcium, Low phytate Diet; Moderate Calcium, High Phytate Diet; High Calcium, Low Phytate Diet; High Calcium, High Phytate Diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants consumed diet containing 700 milligrams calcium and 440 milligrams of phytate for 4 weeks; Participants consumed diet containing 700 milligrams calcium and 1800 milligrams of phytate for 4 weeks; Participants consumed diet containing 1900 milligrams calcium and 440 milligrams of phytate for 4 weeks; Participants consumed diet containing 1900 milligrams calcium and 1800 milligrams of phytate for 4 weeks
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dietary zinc absorption; dietary phytic acid; dietary calcium