bioihbjkbjnl/mcl2 huggingface dataset:
Lipid-lowering Effects of an Astaxanthin Supplement in Volunteers With Mild Dyslipidaemia
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether astaxanthin supplementation can impact
      triglyceride plasmatic concentrations in volunteers presenting mild dyslipidemia.
    


Intervention name(s): Astaxanthin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
4-Day-A-Week Treatment Plan for HIV Infected Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine if taking anti-HIV drugs 4 days a week will control HIV-1 viral
      replication in patients who have already had at least 6 months of documented viral
      suppression with full-time treatment. If this strategy is shown to be safe in this study, a
      larger study will be undertaken to determine if the strategy can decrease overall drug
      exposure and help young people adjust more easily to a chronic medication schedule.
    

Detailed description: 
      HIV infected adolescents who require therapy face a lifetime of antiretroviral treatment.
      Highly active antiretroviral therapy (HAART) is associated with short- and long-term
      complications, and concerns are mounting about the cumulative effect of these complications
      as adolescents enter the third and fourth decade of life. A management strategy that can
      suppress the virus and decrease overall drug exposure is needed. In addition, the scheduling
      requirements for antiretroviral therapies interfere with the socialization and independence
      that an adolescent must accomplish to gain skills for a successful adult life. Not
      surprisingly, nonadherence to prescribed medications is common in teens. This multicenter,
      prospective, proof of concept trial will evaluate Short Cycle Therapy (SCT) in adolescents
      with sustained viral suppression of at least 6 months. While maintenance of viral load
      suppression can be viewed as either a safety or efficacy endpoint, the trial is constructed
      as an assessment of safety.

      Eligible participants who have been on standard HAART therapy consisting of a Protease
      Inhibitor will switch to SCT therapy(4 days on treatment, 3 days off treatment each week) at
      entry. Participants will be seen in the clinic every other Monday during the first month,
      then monthly up to 24-weeks and then once every two months until the end of the 48-week study
      period. Plasma HIV RNA levels and CD4 cell counts will be performed at every visit.
      Medication adherence by self-report will be conducted every 2 weeks until week 24 and every
      4-weeks thereafter until week 48. Fasting serum triglycerides and cholesterol will be
      measured at baseline, at week 24 and at the end of the study.
    

Intervention name(s): Short Cycle Antiretroviral Therapy
Intervention type(s): Procedure
Intervention MeSH terms: Anti-Retroviral Agents
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment experienced; Treatment interruption
MIND Programme for Cancer Patients
Condition: Cancer
Study type: Interventional

Summary: 
      This investigation aims to apply and test the acceptability of an acceptance, mindfulness and
      compassionate-based intervention structured for cancer patients. MIND programme for cancer
      thus comprises 8 weekly group sessions, lasting 1 and a half hour each, run in small groups
      at an Oncology Service at the Coimbra's University Hospital. For each week participants have
      assigned homework (e.g., mindfulness exercises). This programme mainly aims to increase
      participants' physical and psychosocial quality of life, and attenuate depressed mood and
      anxiety.
    

Detailed description: 
      The sample will include diagnosed cancer patients recruited at an Oncology Service at the
      Coimbra's University Hospital. Patients will be approached by their doctor to assess their
      level of interest in the investigation. Patients who demonstrate interest will go through a
      Screening interview conducted by a licensed psychologist that aims explain the structure and
      arms of the investigation, to collect demographic data, and whether the patient meets the
      inclusion criteria for the study. Patients who meet the inclusion criteria and demonstrate
      interest in participating in the study, will sign an informed consent. All ethical
      requirements for research with humans are guaranteed.

      Afterwards, participants will be allocated in two groups (experimental and control group).
      Both groups will maintain the medical treatment as usual (TAU). Additionally, the
      experimental group will enroll in the MIND programme for cancer patients, also provided by a
      licensed psychologist.

      Both groups will concurrently complete a protocol of self-report measures and their medical
      data will be collected by the medical staff of the Hospital.
    

Intervention name(s): MIND programme for cancer patients; Treatment as Usual (TAU)
Intervention type(s): Behavioral; Other
Intervention description(s): Psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for cancer patients Other: Cancer Treatment as Usual; Standard personalized treatment of cancer
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Flow Restriction Training in Patients With Weight Bearing Restrictions After Knee Surgery
Condition: Cartilage, Articular; Tibial Meniscus Injuries
MeSH terms: Tibial Meniscus Injuries
Study type: Interventional

Summary: 
      After a cartilage or meniscus repair in the knee joint, the patients experience a pronounced
      and persistent decrease of knee-extension strength in the operated leg, which negatively
      affect patients' functional performance and quality of life. A possible novel exercise
      modality to increase muscle strength early is a moderate blood flow restriction with low-load
      strength training (BFR-LLST) exercise. BFR-LLST involves application of a wrapping device to
      restrict the blood flow to the muscle(s) during exercise. BFR- LLST requires much less load
      than traditional strength training and has shown to produce positive training adaptations
      such as muscle hypertrophy and strength in the lower extremity in healthy subjects and
      patients with a knee surgery. To our knowledge, early rehabilitation with BFR-LLST has never
      been investigated in a population with weight bearing restrictions, such as patients
      recovering from cartilage or meniscus repair in the knee joint. Fear of symptom exacerbation
      and adverse events have precluded BFR-LLST early after knee surgery. The purpose of this
      study is to examine the feasibility of 9 weeks of supervised rehabilitation with BFR-LLST
      early after cartilage or meniscus repair in the knee joint.
    


Intervention name(s): Physical therapy with BFR-LLST
Intervention type(s): Other
Intervention description(s): The criteria-based rehabilitation protocol for the patients with cartilage or meniscus repair may vary according to the surgical procedures.
Patients will attend 5 individual treatments, and a 6-week supervised group-based rehabilitation program with BFR-LLST (Blood Flow Restriction - Low Load Strength Training) twice a week at the rehabilitation centre. Patient will be instructed to perform BFR-LLST 5 times a week in total (twice supervised, 3 times at home).
During each BFR-LLST session, patients are encouraged to perform 4 sets of 30 repetitions, 15 repetitions, 15 repetitions, and 15 repetitions (or to fatigue in the final set), respectively.
The exercise intervention will adhere to TIDieR (template for intervention description and replication).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menisci, Tibial; Cartilage, Articular; Blood Flow Restriction Training; Resistance training; Physical Therapy Modalities; Feasibility Studies
A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This first open-label study in a pediatric population was designed to evaluate aliskiren
      safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with
      hypertension.
    


Intervention name(s): Aliskiren 3.125 mini-tablets
Intervention type(s): Drug
Intervention description(s): Oral mini-tablets (3.125 mg) of aliskiren once each morning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aliskiren; pediatric; hypertension; pharmacokinetics (PK); pharmacodynamics (PD); plasma renin activity; mini-tablet formulation
Adolescent Vaccination in Pharmacies
Condition: Evaluating Attitudes Toward HPV Vaccinations in Pharmacies; Evaluating the Provision of HPV Vaccines in a Pharmacy
Study type: Observational

Summary: 
      The study aims to expand the evidence supporting pharmacy provision of adolescent vaccines,
      including human papillomavirus (HPV) vaccine. In the first part of the study, we will
      characterize parents' attitudes and support for pharmacy provision of adolescent vaccines in
      a national survey. In the second part of the study, we will provide HPV vaccines and other
      vaccines (Tdap, meningococcal, varicella, influenza) to 200 adolescents in a local community
      pharmacy in Chapel Hill, North Carolina. This portion of the study will identify the systems
      and workflow needed to provide vaccines effectively and safely, characterize parents' and
      their adolescents' attitudes toward receiving vaccine services in a pharmacy, and
      characterize pharmacists' attitudes toward providing adolescent vaccine services in a
      pharmacy.
    


Intervention name(s): HPV vaccine
Intervention type(s): Drug
Other intervention name(s): Gardasil
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        National survey: Parents of adolescents ages 11-18. Pharmacy sample: Parents of adolescent
        boys and girls, ages 11-18 whose families reside in the Chapel Hill area, and their
        adolescents.
      
Biospecimen description: 
      N=1200 anticipated in national study N=100 anticipated in pharmacy demonstration project
    
Keywords: Adolescent vaccines; HPV vaccine; Pharmacies
Immunogenicity AND Safety Study of the 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)
Condition: HPV Infection; HPV-Related Cervical Carcinoma
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      A total of 480 Chinese women aged 18-26 years old were enrolle，experimental group and the
      control group were randomly assigned in a ratio of 3:1. 360 Chinese women in the experimental
      group and 120 in the control group. All subjects enrolled in the upper arm deltoid muscle
      were injected with 3 doses of test vaccine or control vaccine according to the 0, 2, and 6
      months immunization program.
    


Intervention name(s): Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha); 9-valent HPV vaccine（Gardasil 9）
Intervention type(s): Biological; Biological
Intervention description(s): Inject vaccine produced by ChinaVaccineSerum, containing HPV antigen protein, 270μg/1ml per bottle; Inject Gardasil 9 , containing HPV antigen protein, 270μg/0.5ml per bottle
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Multi-Center Feasibility Study of Trans-oral Endoscopic Restrictive Implant System (TERIS) for Treatment of Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The Barosense Trans-oral Endoscopic Restrictive Implant System (TERIS) is an investigational
      system being evaluated for safety The system uses endoscopic guidance to trans-orally implant
      a restrictive reservoir for food entering the stomach in obese and morbidly obese subjects to
      induce early and prolonged satiety. The Intended Use of the system is for the treatment of
      obesity.
    

Detailed description: 
      Obesity is now considered to be epidemic through most of the industrialized world. The
      consequences of obesity on long-term health of individuals is now well documented. While
      lifestyle changes in diet and activity level are the key instruments to arresting or
      reversing this condition, conventional medically supervised programs have proven only
      marginally effective. Bariatric surgery has shown to be a reliable long-term treatment for
      reducing excess body weight. Though surgical techniques have evolved and complication rates
      have been reduced, surgery on these patients still carries significant mortality and
      morbidity.

      Techniques and instruments are now being developed to allow for Endoscopic approaches to
      these procedures that will aim to reduce the complications associated with open or
      laparoscopic technique for these procedures.

      The primary objective of this study is to evaluate the safety of the Trans-oral Endoscopic
      Restrictive Implant System (TERIS) procedure for the treatment of obesity over a six month
      follow-up period.

      A secondary objective is to perform a preliminary evaluation of the efficacy of the TERIS
      procedure in order to guide the design of future studies, including a pivotal trial.

      This is a prospective feasibility study at up to 3 investigational sites of up to 40 subjects
      who are obese and have failed standard obesity therapy of diet, exercise, behavior
      modification, and pharmacologic agents either alone, or in combination. Up to 60 subjects may
      be enrolled, and undergo baseline evaluation in order to obtain a final total of up to 40
      subjects appropriate for trans-oral implant. Barosense intends to use data from this study in
      support of subsequent investigational studies, including a pivotal trial
    

Intervention name(s): TERIS procedure
Intervention type(s): Device
Intervention description(s): The implantation of the restrictive implant
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Instrument Assisted Soft Tissue Mobilization in Female Patients With Myofascial Pain Syndrome
Condition: Myofascial Pain; Instrument Assisted Soft Tissue Mobilization
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      The primer aim of this study is to demonstrate the effecti of instrument assisted soft tissue
      mobilization on pain, functionality, quality of life and depression in the treatment of
      female patients with myofascial pain syndrome due to active trigger points in the upper
      trapezius muscles
    

Detailed description: 
      Myofascial Pain Syndrome (MAS); It is a non-articular, non-inflammatory regional
      musculoskeletal pain syndrome characterized by myofascial trigger points located at muscle,
      fascia or tendon insertion sites and the spread of pain to reference areas by palpation of
      these points.

      h The effectiveness of massage therapy in MAS is known. In this study, investigators will
      apply instrument assisted deep tissue mobilization (graston massage). Instrument-assisted
      soft tissue mobilization massage, which is a type of massage, will be applied by a
      physiotherapist who has a certificate on this subject and takes part as an assistant
      researcher in our study.

      Soft tissue mobilization is a unique soft tissue mobilization combined with active mobility
      and stretching exercises already prescribed for patients with musculoskeletal injuries.

      The various sizes and beveled edges of the stainless steel instruments allow physiotherapists
      to tailor treatment to different muscle structures facing myofascial constraints.

      Localized increases in blood flow and soft tissue realignment lead to muscle function,
      increased normal joint motion, and decreased pain.

      It has been investigated in the literature for many different diseases (trigger finger,
      nonspecific low back pain, myofascial pain syndrome) and found to be effective.CF
    

Intervention name(s): Instrument Assisted Soft Tissue Mobilization; Sham Instrument Assisted Soft Tissue Mobilization; Home exercises programe
Intervention type(s): Other; Other; Other
Intervention description(s): Instrument Assisted Soft Tissue Mobilization with graston tecnique and Home exercises programe; Instrument Assisted Soft Tissue Mobilization to be applied superficially so it is not like a real graston tecnique and Home exercises programe; Only Home exercises programe
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: miyofascial pain; Instrument Assisted Soft Tissue Mobilization; Quality of life
Prognostic Value of Plasma Thrombospondin-1 Levels After Acute Intracerebral Hemorrhage
Condition: Cerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      The current study was designed to investigate the change of plasma thrombospondin-1 levels
      and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients
      with acute intracerebral hemorrhage.
    

Detailed description: 
      Thrombospondin-1 acts as an anti-angiogenic factor and its expression in rat brain is
      upregulated after intracerebral hemorrhage. The current study was designed to investigate the
      change of plasma thrombospondin-1 levels and assess the prognostic predictive effect of
      plasma thrombospondin-1 levels in the patients with acute intracerebral hemorrhage. About 110
      patients will be recruited. All blood samples from the patients at admission were collected.
      Thrombospondin-1 levels in plasma were measured using sandwich immunoassays. The patients
      will be followed up till 6 months after intracerebral hemorrhage. The relationships between
      plasma thrombospondin-1 levels and 1-week mortality, 6-month mortality, 6-month overall
      survival, 6-month unfavorable outcome (modified Rankin Scale score >2) and disease severity
      reflected by hematoma volume and National Institutes of Health Stroke Scale score were
      assessed using multivariate analysis. It is proposed that elevated plasma thrombospondin-1
      levels are independently associated with disease severity and clinical outcomes. It will be
      suggested thrombospondin has potential to be a good prognostic biomarker of intracerebral
      hemorrhage.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients with acute spontaneous basal ganglia hemorrhage admitted to the Jinhua
        People's Hospital within the first 24 h from stroke were enrolled.
      
Biospecimen description: 
      All blood samples from the patients at admission were collected in the separator tubes and
      centrifuged within 30 minutes at 1,000*g for 15 minutes. The plasma was removed and frozen at
      -70°C until measurement.
Enteral Nutrition in Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Malnutrition is frequently occurring in patients with liver cirrhosis and is associated with
      a poorer outcome, as it determines life quality and affects both morbidity and mortality.

      Long term prognosis after liver transplantation also depends on the nutritional status.

      Therefore, the early diagnosis and intervention for malnutrition is an important issue in the
      clinical management of liver cirrhosis. However, oral intake has been shown to be
      insufficient due to disease related anorexia or concomitant drowsiness and confusion.

      Specific aims: To investigate the effect of early nutritional intervention via tube feeding
      on nutritional status, functional status (hand grip strength and peak flow), life quality and
      disease related complications such as intestinal permeability, and oxidative stress, as well
      as liver function.
    


Intervention name(s): High Protein Energy, Fresenius-Kabi (nutritional intervention)
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: liver cirrhosis Child B or C
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure
Condition: Heart Failure, Systolic
MeSH terms: Heart Failure; Heart Failure, Systolic; Systolic Murmurs
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study
      in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.
    


Intervention name(s): ITI-214; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
Condition: Migraine; Healthy
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The placebo effect is a phenomenon that has experienced major advances of its understanding
      in the last decade. However, mechanisms of placebo analgesia in chronic pain patients have
      yet to be compared to healthy subjects. The investigators study aims to investigate the
      magnitude of placebo response and related opioid release in patients that suffer from
      episodic migraines as compared to healthy controls. In particular, the investigators are
      looking to map brain activity during placebo analgesia using modern brain imaging techniques
      such as functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET).
      The investigators hypothesis is that placebo response and the availability of opioid
      receptors is reduced in chronic migraine patients.
    


Intervention name(s): Placebo
Intervention type(s): Other
Intervention description(s): Placebo will be compared to No Intervention.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: migraine, headache, episodic, chronic, pain