bioihbjkbjnl/mcl2 huggingface dataset:
Study of STG-001 in Subjects With Stargardt Disease
Condition: Stargardt Disease-1
MeSH terms: Stargardt Disease; Macular Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, multicenter study in subjects with Stargardt disease, comparing 2
      doses of STG-001 with regard to safety, pharmacokinetics and pharmacodynamics.
    

Detailed description: 
      This is an open-label, multicenter, active treatment study in approximately 12 subjects aged
      18 to 55 years (inclusive) with STGD1, genotyped with a minimum of two ABCA4 gene mutations.
      Treatment course of STG-001 at Dose 1 (Cohort 1) or Dose 2 (Cohort 2) testing doses will be
      administered once daily for 28 days. Cohorts will run in parallel. Subjects will receive
      their designated dose daily for 28 days and be monitored for safety measures during the
      dosing period and for an additional 28 days after dosing (through Day 56).
    

Intervention name(s): STG-001
Intervention type(s): Drug
Intervention description(s): Dose 1 or Dose 2 of STG-001 will be administered daily for 28 days to compare safety, pharmacokinetics and pharmacodynamics in Stargardt disease subjects.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The current randomized controlled trial is a pilot study that will assess the effectiveness
      and feasibility of a mobile phone application intervention. The objective is to determine
      whether the use of a mobile health application for patient self-management of depression
      improves patient-provider engagement for patients diagnosed with major depressive disorder.
    

Detailed description: 
      This pilot study will be a randomized, real-world effectiveness study. Patients diagnosed
      with major depressive disorder starting a new prescription for an antidepressant monotherapy
      will be eligible for participation. The study will enroll 40 patients (20 in an observational
      arm of usual care and 20 with access to a mobile health application). No intervention will
      occur in the usual care arm. The intervention in this study is a mobile health app, which
      provides patients with a way to track emotional wellbeing and depression symptoms, set up
      medication reminders, track adherence to medications, record side effects experienced, and
      take surveys/tests to assess cognitive symptoms and depression. Patient reported outcomes and
      clinical data will be collected at baseline and at study primary endpoint (18 weeks) to
      assess changes over time and between groups for: patient-provider engagement, disease
      severity, quality of life, employment productivity, cognitive function, resource utilization,
      and medication adherence. Additionally, resource utilization will be assessed at the one year
      time point. A Student's t test, if allowed for by the data distribution, will be used to
      assess between group differences in patient reported outcome scales assessing
      patient-provider engagement.
    

Intervention name(s): Mobile App
Intervention type(s): Behavioral
Intervention description(s): The intervention in this study is a mobile health app, which provides patients with a way to track emotional wellbeing and depression symptoms, set up medication reminders, track adherence to medications, record side effects experienced, and take surveys/tests to assess cognitive symptoms and depression.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Observational

Summary: 
      This study is being done to evaluate the efficacy of robotic approach for staging of
      endometrial cancer as compared to an equivalent abdominal approach. The primary objective is
      to measure and compare postoperative pain at rest at several time points between two groups
      of patients undergoing either robotic or open laparotomy approach for staging of endometrial
      cancer.
    

Detailed description: 
      The primary objective is to measure and compare postoperative pain at rest at several time
      points (24 +/-4hours, 48 +/-4hours, and 72 +/-4hours) between the two groups of patients
      undergoing either robotic or open laparotomy approach for staging of endometrial cancer. Post
      operative Quality of Life will also be collected at several time points. The total amount of
      post operative opioid requirements during the first 24hours between patients undergoing
      either robotic or open laparotomy approach surgery. The survival status every four months for
      the first two years will be monitored, then every 6 months for up to 5 years. The primary
      endpoint is the mean difference in post operative pain VAS scores reported by subjects at
      rest at the following time points: 24+/-4, 48+/-4, and 72+/-4 hours between both groups after
      surgery has been completed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Female subjects ages 18-85 years old, Pre operative diagnosis of clinical stage I or II
        endometrial cancer, Subject able to tolerate use of opioids for pain management, Eastern
        Cooperative Oncology Group (ECOG)0-3.
      
Keywords: endometrial; pain
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 3

Summary: 
      Octreotide capsule is a novel, orally-administered formulation of the commercially-available
      injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide
      capsules demonstrated sustained biochemical response up to 13 months in patients with
      acromegaly previously managed with somatostatin analog injections (ref).

      The objective of this study was to compare the efficacy, safety, and patient reported
      outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands
      (SRLs).
    

Detailed description: 
      This was phase 3, randomized, open-label, active controlled, multicenter study to evaluate
      the maintenance of response, safety and patient reported outcomes (PROs) in acromegaly
      patients treated with octreotide capsules and in patients treated with standard of care
      parenteral somatostatin receptor ligands (SRLs), who previously tolerated and demonstrated
      biochemical control on both treatments.

      The core study consisted of three phases: a Screening phase, Run-in phase and a Randomized
      Controlled Treatment (RCT) phase.

      Eligible patients who were biochemically controlled on parenteral SRLs were switched to
      octreotide capsules for a 26-week period Run-in phase. During this phase the effective dose
      for each patient was determined through dose titration.

      Patients whose acromegaly has been controlled biochemically on octreotide capsules at the end
      of the Run-in phase entered a 36-week open-label RCT phase, where they randomized to continue
      on octreotide capsules or switch back to their injectable SRL treatment (as received prior to
      Screening).

      Following the completion of the core study (Screening, Run-in and RCT phases), eligible
      patients were offered to enter the Study Extension phase and receive octreotide capsules
      until product marketing or study termination.

      A Sub-study, performed in selected non-European sites, allowed patients with inadequate
      biochemical control on octreotide capsules during the Run-in phase to enter a Combination
      phase and receive co-administration of octreotide capsules with cabergoline tablets for a
      total of 36 weeks.
    

Intervention name(s): Octreotide capsules
Intervention type(s): Drug
Other intervention name(s): Injection SRLs
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Octreotide Capsules; Acromegaly; somatostatin receptor ligands (SRLs); Mpowered; OOC-ACM-302
Chemotherapy, Vaccine Therapy, and Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Vaccines made from a person's cancer cells may make the body
      build an immune response to kill cancer cells. Peripheral stem cell transplantation may be
      able to replace immune cells that were destroyed by chemotherapy. Combining chemotherapy with
      vaccine therapy and peripheral stem cell transplantation may be effective in treating
      multiple myeloma.

      PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by vaccine
      therapy and peripheral stem cell transplantation in treating patients who have newly
      diagnosed multiple myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of induction chemotherapy followed by autologous tumor cell
           vaccine and autologous peripheral blood stem cell transplantation in patients with
           multiple myeloma.

        -  Determine the safety of this regimen in these patients.

      OUTLINE: Autologous tumor cells are harvested. The vaccine is prepared in vitro by mixing
      autologous tumor cells with a bystander cell expressing sargramostim (GM-CSF). Patients
      receive induction chemotherapy followed by autologous tumor cell vaccination (ATCV) once.
      Patients then undergo autologous peripheral blood stem cell transplantation. At 6 weeks after
      transplantation, patients receive additional ATCVs every 3 weeks for a total of 8
      vaccinations.

      PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
    

Intervention name(s): GVAX; Autologous transplant
Intervention type(s): Biological; Procedure
Other intervention name(s): Autologous tumor vaccine; Auto BMT; Auto SCT
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma
Effects of Butyrate Against Pediatric Obesity
Condition: Obesity, Childhood
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Worldwide obesity is a public health concern that is defined by the World Health Organization
      as abnormal or excessive fat accumulation that may impair health. The main drivers of obesity
      pathogenesis seem to be a long-term of energy discrepancy between too many calories consumed
      and an increase of sedentary behavior. A growing body of evidence suggests that the set of
      microbes that live within the digestive tract, making up the gut microbiota (GM), play a
      metabolic role in energy regulation and substrate metabolism. Various factors can impact GM,
      one of these are dietary compounds that deeply affect the growth and metabolism of gut
      bacteria, since fermentation of nutrients is one core function of the intestinal microbes.
      Among fermentation products an array of small organic metabolites are short-chain fatty acids
      (SCFAs) acetate, propionate and butyrate. Among SCFAs, the C-4 fatty acid butyrate, the main
      fuel for the colonocytes, might have a potential in alleviating obesity and related metabolic
      complications. Butyrate could act as a regulator of body weight: a reasonable speculation is
      that butyrate acts on components of the energy balance, promoting energy expenditure and/or
      reducing energy intake. Preclinical studies have shown that butyrate supplementation prevent
      high-fat diet-induced obesity and it is able to treat obesity. With the sharp increase of
      obesity prevalence seen in the pediatric population, novel insights are necessary to
      counteract this epidemic disease, the outcome of the study is to see whether oral butyrate
      supplementation could exert similar effect in obese children.
    


Intervention name(s): butyrate; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): sodium butyrate (20 mg/kg body weight/day); cornstarch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Higher Cutting Rate in Microincision Vitrectomy for Proliferative Diabetic Retinopathy
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Observational

Summary: 
      The medical records of 393 eyes of 326 patients with severe proliferative diabetic
      retinopathy were reviewed. Higher cutting rate instruments (5000 cut per minute) were used in
      174 eyes and conventional instruments in 219 eyes (2500 cut per minute). The visual outcome
      and incidences of intraoperative and postoperative complications were compared.
    


Intervention name(s): Vitrectomy for proliferative diabetic retinopathy
Intervention type(s): Procedure
Intervention description(s): 25-gauge vitrectomy
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients who underwent 25-gauge vitrectomy for proliferative diabetic retinopathy with
        higher cutting rate instruments or conventional instruments
      
Keywords: diabetic retinopathy
VIDEOLARYNGOSCOPY STUDY OF THE LPEC
Condition: Laryngoscopy
Study type: Observational

Summary: 
      Check the intubation conditions during laryngoscopy without external mobilization of the
      larynx, with Sellick manoeuvre or with low paratracheal esophagal compression.
    

Detailed description: 
      Check the intubation conditions during laryngoscopy without external mobilization of the
      larynx, with Sellick manoeuvre or with low paratracheal esophagal compression.
    

Intervention name(s): mobilization of the larynx
Intervention type(s): Procedure
Intervention description(s): Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults patients undergoing general anaesthesia
Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of the new formulation of
      zolpidem hemitartarate orodispersible tablet 3.5 mg in male and female healthy volunteers.
    

Detailed description: 
      This is a phase I study of zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and
      postprandial administration. Sample size is 28 volunteers, male and female, aged from 18 to
      50 years old.

      This is an open-label, randomized, crossover study. Each volunteer will be randomized to one
      of the following sequencies:

        -  Sequency 1: zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting (period 1)
           and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 2)

        -  Sequency 2: zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial (period 1)
           and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting (period 2)
           Formulation will be administered in a single dose, orally in each period. The volunteers
           will be admitted in two different periods of 36 hours each, when investigational product
           will be administered and blood samples will be collected at pre-determined periods of
           time up to 24 hours for pharmacokinetics evaluation.

      Primary objective is to evaluate the pharmacokinetics of the new formulation of zolpidem
      hemitartarate orodispersible tablet 3.5 mg in healthy volunteers. As a secondary objective,
      it will be evaluated if there is any pharmacokinetics difference between genders.
    

Intervention name(s): zolpidem hemitartarate tablet 3.5 mg (fasting + post-prandial); zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting)
Intervention type(s): Drug; Drug
Intervention description(s): zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial; zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: volunteers; Pharmacokinetics
Gastro Intestinal Tele Endoscopy Project
Condition: Investigate the Potential Network Limitations; Validate the Technology for Later Clinical Use; Evaluate System Integration of EndoAlpha
Study type: Observational

Summary: 
      Synchronous Tele-Endoscopy: A clinical feasibility study of gastrointestinal tele-endoscopy
      by implementing and evaluating synchronous tele-endoscopy using ENDOALPHA in a hospital based
      endoscopy unit. EndoAlpha will be used on the hospitals existing Intranet/LAN and the
      possibilities of tele-endoscopy on WAN through existing network, on separate dedicated line
      or through new established transmission lines, will be evaluated. The EndoAlpha system will
      be integrated in a highly advanced endoscopy procedure room. The system will integrate
      through LAN with doctor office, clinic conference and lecture room and GI pathologist room.
      Through either LAN or WAN, connection will be establish to a referral GI center in Denmark.
      Through WAN, connection will be established to doctor home and to an expert Spanish center.
    

Detailed description: 
      Evaluate the potential network (LAN +WAN) limitations for video transmission image quality
      and audio transmission (two-way) quality. Validate the tele-endoscopy technology for
      consulting and second opinion in diagnostic endoscopy and therapeutic endoscopy (teaching,
      training and supervision of basic and advanced therapeutic procedures).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective gastrointestinal endoscopy procedures
      
Keywords: telemedicine, tele-endoscopy
Interplay Between Adherence to the Mediterranean Diet, Lipid Profile and Blood Pressure: a Comparative Survey Among Healthcare and Non-Healthcare Female Workers
Condition: Diet Habit; Hypercholesterolemia; Hypertension
MeSH terms: Hypercholesterolemia
Study type: Observational

Summary: 
      The study aims at testing the level of adherence to the Mediterranean diet among
      health-workers, comparing this aspect to the extra-working physical activity, anthropometric
      measures and prevalence of cardiovascular, metabolic and neoplastic diseases previously
      diagnosed.
    

Detailed description: 
      The study had a cross-sectional setting and included employees of both genders currently in
      service.

      Baseline data collection was structured as follows:

        -  Clinical assessment and pathological history

        -  Anthropometric measurements;

        -  Haematochemical examinations;

        -  Screening to adherence to Med-Diet by using "MedDietScore" questionnaire

        -  Assessment of the Harvard Cancer Risk Index for the evaluation of risk factors,
           modifiable and not, of the most frequent oncological diseases in Italy (colon, lung,
           breast and prostate). The index provides an estimate of individual cancer risk and is
           not equivalent to a cancer diagnosis. In addition, the Harvard Cancer Risk Index itself
           can allow the doctor to advise the worker on useful measures to reduce it;

        -  International Physical Activity Questionnairre (IPAQ)

        -  Major anthropometric and haematochemical data also allow to obtain one of the most used
           risk indexes for cardiovascular diseases in the scientific literature the Framingham
           Score.
    

Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Evaluation of adherence to the Mediterranean diet through the administration of the Med Diet Score questionnaire.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        One hundred and forty-seven subjects were randomly recruited at the Operating Unit of
        Occupational Medicine of the University Polyclinic Hospital of Bari in the last quarter of
        2019. The whole sample included only female employees of public companies with at least 16
        years of schooling, and subject to health surveillance by the occupational physicians of
        the above Operating Unit, subdivided as follows: fifty-nine HCWs (doctors and professional
        nurses) employees at the University Hospital of Bari, and eighty-eight employees of other
        public companies but not operating in the field of healthcare (non-HCWs).
      
Keywords: Mediterranean Diet; Lipid profile; Healthcare workers
Fatigue and Sleep Quality in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional

Summary: 
      This study was planned to examine the effect of reiki application on fatigue and sleep
      quality in patients with multiple sclerosis.
    

Detailed description: 
      Fatigue and Sleep Quality in Multiple Sclerosis Patients: Does Reiki Application Affect?
    

Intervention name(s): Reiki
Intervention type(s): Other
Intervention description(s): Reiki is applied touching the energy centers of the body (chakras). There are seven main and many small chakras on a body. Chakras are located on the front and back sides of the body in a vertical line that runs along the middle of the body in humans. A complete Reiki therapy includes all the chakras and organs.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The research will be conducted as a randomized, experimental study with a pretest-posttest control group.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Reiki; Fatigue; Sleep quality; Nursing