bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD
Condition: Adult Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of Daytrana® in the
      treatment of attention deficit hyperactivity disorder (ADHD) in adults who have abused
      stimulants in the past. Daytrana® is a stimulant medication that has been approved by the
      Food and Drug Administration for the treatment of ADHD in children over the age of 6 years
      old.
    

Detailed description: 
      Methylphenidate and amphetamines are considered to be the first line of treatment for ADHD in
      children (Biederman et al, 1997). Although treating children and adolescents with stimulants
      does not appear to increase the risk of substance use disorders (Wilens et al, 2003), little
      is known about the abuse of prescription stimulants in adults with ADHD. A review of the
      literature on the abuse potential of methylphenidate in animals and humans found that
      methylphenidate produced reinforcing, discriminative-stimulus, and subjective effects similar
      to amphetamines or cocaine (Kollins et al, 2001). Although the abuse rates of methylphenidate
      and other stimulant medications used for the treatment of ADHD have not been empirically
      established, significant concern exists so that regulatory mandates are enforced to control
      distribution, and some physicians may be reluctant to use stimulants in patients with drug
      abuse histories. The introduction of a methylphenidate patch is an important advancement, as
      the patch formulation should increase compliance while minimizing abuse potential, making it
      an attractive treatment option in the large population of individuals who have a history of
      previous drug misuse. The primary aim of this study is to assess the efficacy of the
      methylphenidate patch in adult individuals with ADHD who have abused stimulants in the past.
      It is hypothesized that the methylphenidate patch will be efficacious in reducing ADHD
      symptoms in this population.
    

Intervention name(s): Daytrana (methylphenidate patch)
Intervention type(s): Drug
Intervention description(s): Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.
Other intervention name(s): Daytrana Patch, Methylphenidate Patch
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity ADHD
Symptoms and Physical Activity in COPD Patients in Europe
Condition: COPD
Study type: Observational

Summary: 
      An observational, multinational, cross sectional study to describe 24-hs symptoms, physical
      activity and their relationship in stable COPD patients in Europe
    

Detailed description: 
      The study is a multi-centre, multi country, observational prospective cross sectional study
      to determine the prevalence and severity of early morning, day and night-time symptoms and
      physical activity patterns and to evaluate their correlation between each other and with
      disease severity, adherence to respiratory medications, direct costs and PROs in patients
      with stable COPD in Europe.

      Approximately 2000 patients will be enrolled in convenient sites in several (9-12) selected
      countries.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male and female ambulatory patients aged over 40 years diagnosed with stable COPD according
        2013 GOLD criteria
A Four Month Home Based tDCS Study on Patients With Alzheimer's Disease.
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The study is an open label study on patients with Alzheimer's dementia using home based
      transcranial direct current (tDCS) stimulation. Aims of the study is to investigate
      applicability and effect of treatment.
    

Detailed description: 
      Active tDCS of 2mA is applied via surface based electrodes daily for 30 minutes over a 4
      month period. Anodal electrode is placed over the left temporal lobe. Participants is
      followed up by home visit and phone calls.

      Cognitive tests are performed prior to the treatment period, right after finishing 4 months
      of treatment and 4 months after treatment is terminated.
    

Intervention name(s): transcranial direct current stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): Apply 30min low dose (2mA) transcranial current stimulation on the scalp every day for four months.
Other intervention name(s): tDCS
Intervention model: Single Group Assignment
Intervention model description: Treatment study, open label
Masking: None (Open Label)
Primary purpose: Treatment
B40 Non-Invasive Blood Pressure Equivalency Study
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient
      Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
    

Detailed description: 
      Automated non-invasive blood pressure devices have a long history. These devices first made
      their appearance in the mid-1970's. Since that time, there have been many improvements in the
      performance of these devices. Specifically, when making changes to the algorithms that
      control these devices, the goals are: to improve accuracy and precision in the blood pressure
      (BP) estimates, to reduce the time needed to determine the BP estimates, to increase comfort
      for the patient, and to work through artifacts and arrhythmias that are often present in the
      clinical environment.

      The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient
      Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
    

Intervention name(s): Blood Pressure Readings on B40 Patient Monitor
Intervention type(s): Device
Intervention description(s): Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: The focus of this study is to demonstrate that DINAMAP® SuperSTATTM NIBP algorithm has been implemented correctly without performance losses to the B40 monitor
AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia
Condition: Higher Risk Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia
MeSH terms: Leukemia; Preleukemia; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective is to assess the safety, tolerability, and efficacy of AMG 176 as
      monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of
      Higher-Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia (HR-MDS/CMML).
    

Detailed description: 
      This study is a Phase 1 clinical trial designed to assess the safety, tolerability, and
      efficacy of AMG 176 as monotherapy and in combination with the 7-day regimen of azacitidine
      for the treatment of HR-MDS/CMML. Participants will be treated with intravenous (IV) AMG 176
      and IV or subcutaneous (SC) azacitidine.
    

Intervention name(s): AMG 176; Azacitidine
Intervention type(s): Drug; Drug
Intervention description(s): Administered as an intravenous (IV) infusion.; Administered as an IV infusion or subcutaneous (SC) injection.
Intervention MeSH terms: Azacitidine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Higher Risk Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia; Myelodysplastic Syndrome; Myelomonocytic Leukemia
Post-Market Evaluation of the EVO ICL
Condition: Myopia; Myopic Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The objective of this study is to assess the rate of early intraocular pressure (IOP)
      increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).
    

Detailed description: 
      This study will be conducted at up to 10 sites in the US, by surgeons qualified by experience
      and training to implant the EVO/EVO+ lens.
    

Intervention name(s): EVO ICL
Intervention type(s): Device
Intervention description(s): The EVO ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Intervention model: Single Group Assignment
Intervention model description: All enrolled subjects will undergo phakic eye surgery to have the STAAR EVO Implantable Collamer Lens (ICL) implanted in one or both eligible eyes.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nearsightedness; phakic IOL; toric ICL; ICL; TICL; EVO; astigmatism
Correlation Between the 'Nine Holes Peg Test' Performance and the Triple Stimulation Technique Within a Group a Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The main goal of this study is to determine if the Triple Stimulation Technique (TST) can be
      correlated to performance in the manual dexterity 'nine holes peg' test, within a control
      group and a group of patients with multiple sclerosis.

      TST (Triple stimulation technique) combines two techniques used in neurologic diagnosis:
      magnetic stimulation and electroneuromyography. It is based on the principle of two
      collisions between the descending central stimulation (magnetic stimulation) and the
      ascending peripheric stimulation. TST allows to better quantify central nervous system
      diseases. The abnormal amplitude registered by TST is proportional to the intensity of
      conduction disorders. The evaluation of these disorders is more precise than with the
      magnetic stimulation technique alone.

      The Nine Hole Pegs technique is a simple manual dexterity test, commonly used in ergotherapy.
      The participant tries to place 9 pegs in a 9 holes perforated plate, and then tries to remove
      them as quickly as possible. The hand must stay in a depression within the plate, thereby
      insuring a constant distance between the hand and the pegs.

      The nine hole peg will be realized first, and the triple stimulation examination performed
      after. The acquired data will be analyzed in order to find a correlation between the
      impairment level given by these two tests.
    


Intervention name(s): Nine Hole Test; Triple Stimulation Technique
Intervention type(s): Other; Device
Intervention description(s): The Nine Hole Pegs technique is a simple manual dexterity test, commonly used in ergotherapy. The participant tries to place 9 pegs in a 9 holes perforated plate, and then tries to remove them as quickly as possible. The hand must stay in a depression within the plate, thereby insuring a constant distance between the hand and the pegs.; TST (Triple stimulation technique) combines two techniques used in neurologic diagnosis: magnetic stimulation and electroneuromyography. It is based on the principle of two collisions between the descending central stimulation (magnetic stimulation) and the ascending peripheric stimulation. TST allows to better quantify central nervous system diseases. The abnormal amplitude registered by TST is proportional to the intensity of conduction disorders. The evaluation of these disorders is more precise than with the magnetic stimulation technique alone.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: nine holes peg; triple stimulation; multiple sclerosis
Diabetes Mellitus and Pregnancy : Knowledge Assessment
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Diabetes, a chronic and frequent disease, is a risk factor of pregnancy complications such as
      preeclampsia, congenital malformations and macrosomia.

      Preconception care is all methods to assess the best prognostic for a diabetic pregnancy.
      Among these methods, contraception is very important to plan the pregnancy on a chosen
      moment.

      The content of the preconception care is well established. However, information of diabetic
      women concerning contraception and giabetic pregnancy has been little studied.
    

Detailed description: 
      The aim of the study is to describe the knowledge of the patients with diabetes concerning
      contraception and pregnancy planning.
    

Intervention name(s): Data record
Intervention type(s): Other
Intervention description(s): Data record
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women between 18 and 40 years old, consulting in diabetology department of Reims
        Universitary Hospital and Charleville Mézières General Hospital
      
Keywords: Diabetes mellitus; pregnancy; contraception
Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical Coherence Tomography Study
Condition: Effects of the External Testosteron Intake Over the Choroids of the Patients With Androgen Deficiency
Study type: Observational

Summary: 
      According to the results Ciloğlu et al., CSC is related to elevated total testosterone
      levels. Testosterone may play a role in predisposing males to CSC. Thus, we aimed to
      investigate the possible effect of external testosteron intake over choroidal parameters;
      such as choroidal thickness, choroidal vascularity index, choroidal stromal ve luminal
      areas,ect.
    

Detailed description: 
      In the study, we have two group: First group consists of patients with testosteron deficiency
      and there are sex and age-matched healthy control subjects in the second group. We will
      measure the parameters of both groups at baseline. And first month and 3rd month we will
      remeasure the values of the parameters by enhance depth optical coherence tomography. The
      results will be compared between the groups.
    

Intervention name(s): external testosteron
Intervention type(s): Drug
Intervention description(s): external testosteron
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        randomly selected subjects aged between 30 and 800
Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (US)
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind study designed to investigate the efficacy, safety and PK of a single
      dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for
      COVID-19 and are either asymptomatic or have mild symptoms.
    

Detailed description: 
      Subjects will be randomized 1:1:1:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS
      20 mg, COVI-DROPS 40 mg, or placebo in a double-blind manner. Investigational product
      (COVI-DROPS or placebo) will be administered once on Study Day 1. Subjects will be followed
      to Day 60.
    

Intervention name(s): COVI-DROPS; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2; Diluent solution
Other intervention name(s): STI-2099
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: covid-19
Renal Impairment Study
Condition: Reflux; Renal Excretion
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and
      leaves the blood in people with normal kidney function or with different degrees of reduced
      kidney function.
    


Intervention name(s): AZD3355
Intervention type(s): Drug
Intervention description(s): capsule, oral, single dose
Other intervention name(s): Lesogaberan
Intervention MeSH terms: Lesogaberan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Safety; tolerability; exposure; healthy; renally impaired subjects
Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy
Condition: Gestational Edema
MeSH terms: Edema
Study type: Interventional

Summary: 
      Incidence of ankle edema is high during pregnancy, If left untreated, it may lead to
      difficulty walking; stiffness; stretched skin which can become itchy and uncomfortable.
      Acupressure promotes the condition of the circulatory and lymphatic system leading to the
      elimination of edema. The aim of this study is to investigate the efficacy of acupressure
      versus traditional physical therapy treatment on ankle edema during pregnancy.
    

Detailed description: 
      Sixty pregnant women aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will
      participate in this study. They will be assigned into three equal groups, Group A will
      receive only traditional physical therapy protocol in the form of advice including elevation,
      wearing supportive stocking, and avoiding standing in one position for extended periods, and
      Group B will receive the same traditional treatment as group A in addition to circulatory
      exercises, 3times per week for 4 weeks; while Group C will receive the same conventional
      physical therapy protocol in addition to foot acupressure 3times per week for 4 weeks.
    

Intervention name(s): advices; Traditional physical therapy; Acupressure
Intervention type(s): Other; Other; Other
Intervention description(s): each pregnant woman was advices how to elevate her legs and daily positions to elevate edema; each pregnant woman was advised about daily routine in addition to circulatory exercise; each pregnant woman was advised about daily routine in addition to acupressure therapy
Other intervention name(s): daily advices; circulatory exercise; acupressure therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sixty pregnant women aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into three equal groups, Group A will receive only traditional physical therapy protocol in the form of advice including elevation, wearing supportive stocking, and avoiding standing in one position for extended periods, and Group B will receive the same traditional treatment as group A in addition to circulatory exercises, 3times per week for 4 weeks; while Group C will receive the same conventional physical therapy protocol in addition to foot acupressure 3times per week for 4 weeks.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Edema Leg
Comparison of Stabilization Exercises Versus Thrust Manipulation Technique on Pelvic Girdle Pain.
Condition: Pelvic Girdle Pain
MeSH terms: Pelvic Girdle Pain
Study type: Interventional

Summary: 
      The objective of this research is to compare the efficacy of stabilization exercise versus
      pelvic girdle pain thrust manipulation technique in females with postpartum pain.
    

Detailed description: 
      Pelvic-girdle pain is a mechanical disorder growing rapidly as a consequence of changing
      delivery pattern and changing lifestyle. Medication with synthetic drugs not only has been
      unable to effectively curtail the spread of this disease conditions but also is most of the
      times linked with co-occurring side-effects. The exercise and manual therapy-based approach
      could lead in reducing the functional limitations and morbidity rate in females with the
      postpartum pain. This research could also help in spreading the awareness globally, to
      Prenatal and Postnatal Hospital Caregivers.
    

Intervention name(s): Routine physical therapy treatment with the Stabilization exercises; Routine physical therapy treatment + High-velocity thrust manipulation
Intervention type(s): Other; Other
Intervention description(s): The program was based on specific training of the transversely oriented abdominal muscles with coactivation of the lumbar multifidus at the lumbosacral region, training of the gluteus maximus, the latissimus dorsi, the oblique abdominal muscles, the erector spinae, the quadratus lumborum, and the hip adductors and abductors. Initially, we focused on the specific contraction of the transversely oriented abdominal muscles. After approximately 2 weeks, loading was progressively increased throughout the intervention period. The women were required to exercise for 30 to 60 minutes, 3 days a week, for 3-4 weeks.; : For high-velocity thrust technique, a modified Chicago technique was used. For this procedure, the lumbopelvic region was targeted. The side to be treated was chosen, based on the subject's report of her most symptomatic side. The physical therapist, performed passively side bend the subject toward the painful side, rotate the upper body in the direction opposite to the side bending, and then deliver a quick posterior and inferior thrust at a grade V including a small-amplitude/high-velocity therapeutic movement. A maximum of 2 attempts per side was permitted if no pop was heard following the first attempt. If the subject showed improvement of 50% or less after the first treatment, the intervention was categorized as a failure, the examination and intervention were repeated, and the subjects were asked to return 2 to 4 days later. If the subject showed greater than 50% improvement, the intervention was categorized as a success, and study participation was concluded.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment