bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study of Cabergoline for the Treatment of Cocaine Dependence
Condition: Cocaine Dependence; Cocaine Abuse; Cocaine Addiction; Substance Abuse
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of treatment with cabergoline, compared
      to treatment with placebo, on cocaine induced craving and subjective effects in
      cocaine-dependent human volunteers.
    

Detailed description: 
      Secondary aims are to clarify the genetics of substance abuse, potentially leading to
      improved methods to diagnosis those at risk and to help develop better therapeutic
      interventions and to develop a new saliva-based test for the detection and measurement of
      drugs of abuse. As an additional aim, we will also collect blood samples for analyzing a
      number of genetic polymorphisms.
    

Intervention name(s): Placebo; Cabergoline
Intervention type(s): Drug; Drug
Intervention description(s): Enrolled volunteers will be randomized on Day 8 to receive placebo (n=2) or study medication (n=8). Placebo serves only to maintain the blind and is not a comparator.; Enrolled volunteers that receive study medication (n=8) will receive cabergoline 0.25 mg twice weekly.
Other intervention name(s): Sugar pill; Dostinex; Cabaser
Intervention MeSH terms: Cabergoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Cocaine; Cabergoline
Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and tolerability of HFB30132A when it is
      given by intravenously to healthy participants. Blood tests will be done to check how much
      HFB30132A is in the bloodstream and how long the body takes to eliminate it. Participation
      may include up to ten visits to the study center.
    

Detailed description: 
      This is a Phase I, first time in human, randomized, double-blind, placebo-controlled, and
      dose escalation study in healthy volunteers.

      The study will comprise of:

        1. A Screening Period of up to 30 days (Day -30 through Day -1);

        2. A Treatment Period during which participants will be resident at the Observation Unit
           from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day
           1) until at least 24 hours after IMP administration, will be discharged on Day 2 after
           all safety and/or pharmacokinetic (PK) evaluations have been completed, and

        3. A Follow up Period lasting 180 days after the IMP dose. The study will be conducted at a
           single study center in Cincinnati.
    

Intervention name(s): HFB30132A; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants randomized to HFB30132A will be administered dose 1 in cohort 1. Participants in Cohort 2 and 3 will receive HFB30132A doses 2 and 3, respectively.; Participants randomized to placebo will receive the same volume of solution as participants on active treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Effectiveness of Flaxseed for Reducing High Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Flaxseed, a rich source of fiber, may be a significant component of a cholesterol-reducing
      diet. The purpose of this study is to evaluate the safety and effectiveness of flaxseed in
      reducing high cholesterol.
    

Detailed description: 
      Hypercholesterolemia is an established risk factor for atherosclerotic cardiovascular disease
      (ASCVD). The National Cholesterol Education Program estimates that 65 million Americans with
      hypercholesterolemia could be treated with diet and exercise alone. Flaxseed is a potential
      component of cholesterol-reducing diet regimens. Flaxseed contains significant amounts of
      soluble fiber and is a rich source of both alpha-linolenic acid and phytoestrogenic ligands,
      which have been implicated in the prevention of ASCVD. However, flaxseed's phytoestrogenic
      ligands may have undesirable hormonal effects. This study will systematically evaluate the
      safety and efficacy of ground flaxseed ingestion in both men and women with
      hypercholesterolemia.

      Participants will be randomized to receive flaxseed or a matching wheat bran control. The
      test dose of flaxseed will be 40 grams administered in baked products (muffins, bread, or
      bars). The first 6 study weeks are a diet stabilization phase, followed by a 10-week study
      phase in which participants are expected to eat two servings of the test food daily. Blood
      and urine are collected for analysis, which will include measurement of low density
      lipoprotein cholesterol (LDL-C), post-prandial triglycerides, and urinary isoprostane
      secretion.
    

Intervention name(s): Flaxseed-supplemented diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Flaxseed; Cholesterol
Metabolic Syndrome and Gen-polymorphs Influence on Weightloss Among Children in Treatment for Overweight
Condition: Childhood Obesity; NAFLD (Non-alcoholic Fatty Liver Disease); Hypertension; Hyperlipidemia; Insulin Sensitivity
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight; Metabolic Syndrome; Insulin Resistance; Hyperlipidemias; Pediatric Obesity; Weight Loss
Study type: Observational

Summary: 
      Definition:

      the overall objective is to examine childhood obesity with focus on NAFLD and its treatment.
      Further, we aimed to investigate the impact of genetic variation on obesity.

      The specific aims are to;

        -  describe the degree of NAFLD among overweight and obese, Danish children. (hypothesis;
           the degree for pediatric NAFLD among Danish Children was equal that found in other
           Caucasian paediatric study populations).

        -  investigate the effect of a multidisciplinary intervention treatment of 1 year on liver
           fat content.

      (hypothesis; the intervention could reduce the liver fat percentage and a reduction in BMI
      SDS would associate with a reduction in liver fat content) - Analyze changes in liver fat
      content in relation to changes in levels of fasting blood variables to see if any of them
      could be used as a clinical tool for monitoring hepatic steatosis in the clinic.

      (hypothesis; serum aminotransferases (separately and their ratio, respectively), serum
      insulin, and HOMA-IR could predict improvement in liver fat content

      - Investigate the association between genetic variants and obesity.
    


Intervention name(s): Chronic care multidisciplinary intervention of childhood obesity
Intervention type(s): Other
Intervention description(s): Overweight and obese Children, 5-20 Years old, followed by Paediatricians and other Health Personals (multidisciplinary team). Included at their first visit in the clinic (baseline)and follow-up after ~ 1 Year.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Overweight and obese Children. 5-20 Years old. Paediatric Department, University Hospital
        Holbaek,Region Zealand, University of Copenhagen, Denmark
      
Biospecimen description: 
      Blood samples of Whoole Blood.
The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve
Condition: Antimullerian Hormone; Ovarian Cysts; Antral Follicle Count
MeSH terms: Cysts; Ovarian Cysts
Study type: Observational

Summary: 
      The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy.

      The secondary objective is the analysis of predictors of change in the ovarian reserve after
      surgery
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with bening ovarian cyst and requiring surgical removal
      
Biospecimen description: 
      Blood
A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases
Condition: Osteoarthritis
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      The study is to investigate the effect of a soft robotic glove approach providing continuous
      passive motion of fingers (flexion and extension) on degenerative arthritis patients. The
      approach may help reduce pain, maintain mobility and flexibility and to improve hand
      function.
    

Detailed description: 
      The aim is to investigate the effect of soft robotic gloves in providing continuous passive
      motion of the fingers (finger flexion and extension) of degenerative arthritis patients, for
      the purpose of providing pain relief and alleviating stiffness at the finger joints.
      Specifically, we intend to 1) observe the changes in range of motion of the fingers using the
      Total Active Motion (TAM) measure; 2) observe the changes in grip strength and pinch
      strength; and 3) record changes in the patients' perception of performance in activities of
      daily living using the Canadian Occupational Performance Measure (COPM).

      The hypothesis is that a soft robotics approach in providing continuous passive motion of the
      finger joints of degenerative arthritis patients can reduce pain, maintain mobility and
      flexibility of the joints, and to improve hand function. The soft robotics approach and the
      standard hand therapy is better than the standard hand therapy alone.

      The proposed soft robotic glove is capable of providing continuous passive motion (flexion
      and extension) of the fingers, and in addition, it is also designed to be portable and easy
      to operate, with minimal supervision. It is aimed at the home therapy of degenerative
      arthritis patients. In this study, by using the soft robotic glove and in observing changes
      in finger range of motion, grip and pinch strength, as well as perception of performance in
      daily activities. This is important in establishing this device as a viable means to
      ultimately slow down the progression of degenerative arthritis, and to significantly improve
      the patients' abilities in carrying out activities of daily living, which had been impaired
      by degenerative arthritis.
    

Intervention name(s): Control Group; Soft Robotic Glove Group
Intervention type(s): Other; Device
Intervention description(s): Patients receive standard care; This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparing the control group and intervention group
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Degenerative Arthritis, Rheumatic Diseases
Performance and Safety of Hyalo Gyn Gel on the Treatment of Vaginal Atrophy in Postmenopausal Women
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      This clinical investigation evaluates the performance and safety of Hyalo Gyn, a hyaluronic
      acid derivative based vaginal gel for the treatment of symptoms of vulvo-vaginal atrophy in
      post-menopausal women.
    


Intervention name(s): Hyalo Gyn gel in prefilled applicators
Intervention type(s): Device
Intervention description(s): One vaginal application of Hyalo Gyn gel every 3 days to a total of 12 consecutive weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyaluronic Acid; Post-menopause
Learning and Ear Stimulation
Condition: Learning; taVNS
Study type: Interventional

Summary: 
      This study aims to determine how non-invasive ear stimulation affects learning. During this
      study, participants will be asked to complete surveys and come to a lab for about 2.5 hours.
      Researchers will measure brain waves and other body responses (heart rate), while while the
      ear is stimulated. Participants also will be asked to complete computer tasks. Because brain
      activity will be measured, participants will be asked to come to the study with clean, dry
      hair. The study is at MUSC in Charleston. Participants will be compensated for their time. To
      be eligible, participants must be 18-65 years old, be able to commit 2.5 hours of time to the
      study, and be able to wear sensors on their hands, arms, and head and sit quietly at a
      computer.

      There are some risks to completing this study. Some questions in the surveys ask about
      personal thoughts and feelings. The ear stimulation may cause tingling sensations or
      irritation around the ear.

      There are no direct benefits to participants. This study will help researchers improve this
      ear stimulation as a treatment method.
    


Intervention name(s): transcutaneous auricular vagus nerve stimulation (taVNS) 15 minutes; taVNS 30 minutes; taVNS 45 minutes; taVNS 60 minutes; taVNS 75 minutes; taVNS 0 minutes
Intervention type(s): Device; Device; Device; Device; Device; Device
Intervention description(s): Sham 60 minutes and taVNS active stimulation for 15 minutes; Sham 45 minutes and taVNS active stimulation for 30 minutes; Sham 30 minutes and taVNS active stimulation for 45 minutes; Sham 15 minutes and taVNS active stimulation for 60 minutes; Sham 0 minutes and taVNS active stimulation for 75 minutes; Sham taVNS 75 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Screening and Prevalence of Adolescent Idiopathic Scoliosis in Selected Urban and Countryside Schools in Egypt
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Early detection of scoliosis and determination of which areas are more affected urban or
      countryside will help in early management. Also, this will guide the government and the
      community for early intervention to decrease the factors that leads to this postural
      abnormality. This also will guide another clinician to search for the cause of these posture
      deformities and to concentrate screening for special areas with special cultures.
    

Detailed description: 
      Scoliosis may have an impact on the Egyptian society as children between 10-15 years old
      represent 9.5 % of the population which is the third large category appendix (3). So without
      the early detection of adolescent idiopathic scoliosis for that age group, bad impacts will
      be implemented for Egyptian society by causing disabilities and psychological problems for
      these children.

      The early detection of scoliosis is of a great importance as curve detection before skeletal
      maturation gives a good opportunity for early treatment or prevention of curve progression.
      Scoliosis has a bad effect on cosmetic appearance, quality of life, Psychological well-being,
      disability, back Pain, breathing function. It may also progress in adulthood and need further
      treatment. So a multidimensional and comprehensive evaluation of scoliosis patients is
      necessary to design a complete therapeutic approach.
    

Intervention name(s): procedure1; procedure2
Intervention type(s): Other; Other
Intervention description(s): The students will be asked to bend forward with his knees straight, feet together and hands freely and loosely hanged. if there was scoliosis the rib cage rotated and a hump appeared. Positive test indicated the presence of a rib hump and negative if there was any hump appeared; Measurement of the angle of trunk rotation (ATR) by using a scoliometer HD smartphone application.
Other intervention name(s): Adam's forward bend test; Angle of trunk rotation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: scoliosis, prevalence; screening, Egypt
Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty
Condition: Corneal Ulcer; Leukoma
MeSH terms: Corneal Ulcer
Study type: Interventional

Summary: 
      In this study the safety and effectiveness of biosynthetic cornea, comprising
      interpenetrating networks of recombinant human collagen and phosphorylcholine, will be tested
      in patients with severe corneal pathology (corneal ulcers or corneal opacification from
      corneal injury, burn or infection) - diseases, where human donor cornea transplantation (the
      only widely accepted treatment) carries a high risk of rejection.
    

Detailed description: 
      Collagen-phosphorylcholine corneal substitute will be implanted in patient's corneas with
      severe pathology (corneal ulcer, corneal leukoma after burn, trauma or infection) using
      anterior lamellar keratoplasty technique, i.e. when patient's diseased cornea is removed it
      will be substituted with proposed transparent implant. Usually these patients are grafted
      with human donor cornea, but the latter frequently fails due to graft-versus-host problems.
      We will test the safety (incidence of adverse events, biocompatability) and the effectiveness
      (ability to promote healing and increase vision) of developed biosynthetic corneas in 10
      patients with corneal pathology, where human donor cornea carries a high risk of rejection.
      The patients will be follow-uped for 12 months.
    

Intervention name(s): Collagen-MPC cornea
Intervention type(s): Device
Intervention description(s): Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection will be created. Trephine diameter will depend on ulcer or leukoma maximal size. Alternatively a femtosecond laser may be used to create the dissection. A collagen-phosphorylcholine cornea 250-500 microns thick and equal or 0.25 mm larger diameter is placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens will be removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brain Computer Interface for Communication in ICU: a Feasibility Study
Condition: Tetraplegia; Guillain-Barre Syndrome
MeSH terms: Quadriplegia; Guillain-Barre Syndrome
Study type: Observational

Summary: 
      The main objective of this study is to evaluate the usability of a system to assist verbal
      communication based on BCI system using the P300 wave in patients with tetraplegia who can no
      longer communicate because of severe engine damage (tetraplegia) and respiratory damage
      requiring invasive mechanical ventilation (intubation or tracheostomy) preventing verbal
      communication.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Quadriplegia, also known as tetraplegia, is paralysis caused by illness or injury to a
        human that results in the partial or total loss of use of all of their limbs and torso;
        paraplegia is similar but does not affect the arms. The loss is usually sensory and motor,
        which means both sensation and control are lost.
      
Keywords: brain computer interface; P3Speller; P300; Event Related potential; tetraplegia; Guillain barre syndrome; Feasibility; Speed of spelling; Accuracy
The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Non-specific chronic low back pain (LBP) can be managed with a variety of treatments such as
      educational programmes, behavioural therapy, acupuncture, medication, electrophysical agents,
      manual therapy and exercise therapy. Although the above therapies are widely used, they show
      limited effect at best, with frequent recurrences of LBP. There is insufficient data to prove
      that one type of exercise is superior to another. Manual therapy is a common therapeutic
      method used in the treatment of LBP. Therefore, we hypothesised that manual therapy combined
      with therapeutic exercises would lead to a greater reduction in back pain and improvement in
      functional status. The aim of the study was to evaluate the effect of 6 weeks of manual
      therapy combined with therapeutic exercise on pain and functional status in subjects with
      chronic non-specific low back pain.
    

Detailed description: 
      The individuals with chronic non-specific low back pain participated in the study. Subjects
      were randomly divided into two groups: physiotherapy and manual therapy. All the participants
      received 12 intervention sessions. In addition, all subjects exercised at home 5 days a week.
      Subjects' back static strength endurance was assessed by the ITO test, abdominal muscle
      static strength endurance was assessed by the Kraus-Webber test, fear of movement by the
      TAMPA kinesiophobia test, torso mobility by the Schober test, pain by the numerical analogy
      scale. Functional status was assessed by Oswestry and Roland-Morris questionnaires.
    

Intervention name(s): Manual therapy; Exercise therapy
Intervention type(s): Other; Other
Intervention description(s): 6 weeks, 12 sessions in total, 2 times a week of manual therapy: spinal manipulation, specific mobilisations and stretches. Manual therapy treatments are carried out by a physiotherapist with more than 10 years of experience.
In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.; 6 weeks, 12 sessions in total, 2 times a week therapeutic exercise programme under the supervision of a physiotherapist. The exercise programme consisted of muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.
In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: low back pain; manual therapy; exercise therapy