bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Hand Exoskeleton Controlled by BCI in Post Stroke Patients
Condition: Poststroke/CVA Paresis
MeSH terms: Muscle Weakness; Paresis
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of non-invasive BCI-exoskeleton
      technology based on EEG patterns recognition matching to motor imagery in post-stroke
      patients with hand paresis.
    

Detailed description: 
      The BCI training is based on EEG activity patterns recording during hand motor imagery. A
      subject sit comfortably 1m from a computer screen which presents visual instructions during
      the session. The robotic exoskeleton is fixed to the paretic hand. Subject visually fixate on
      a circle presented in the center of the screen and receive instructions from three
      surrounding rhomboidal arrows. Subject is given three commands instructing them to relax or
      imagine slow hand opening movement with the right or left hand. The "Relax" command means
      that the subject have to sit still and look at the center of the screen. Commands are
      presented randomly, each of 10 sec duration.

      A visual cue provides the subject with feedback regarding the mental task recognition: the
      central circle turned green if the classifier recognizes the task in agreement with the given
      command, or remains white if the signal is not recognized. In addition to visual feedback the
      subject is provided with kinesthetic feedback: the exoskeleton is opening the hand when the
      classifier recognizes the imagery of paretic hand movement.

      The EEG is registered with 30 electrodes distributed over the head in accordance with the
      standard international 10-20 system. EEG signals are filtered from 5-30Hz. A Bayesian
      approach for EEG pattern classifying is used in the system. The activity sources most
      relevant for BCI functioning will be identified using an independent component analysis
      (ICA). Classification accuracy will by measured with Cohen's kappa (Kohavi and Provost,
      1998). The procedure may consist from up to three sessions, the duration of 1 session is 10
      min, there are 5 min time brake between session and total duration of procedure is up to 45
      min. The number of procedures - at least 10. The maximal interval between procedures is 3
      days.
    

Intervention name(s): hand exoskeleton, brain-computer interface (BCI),; hand exoskeleton, sham BCI
Intervention type(s): Device; Device
Intervention description(s): Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes; Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)
Other intervention name(s): mind-machine interface
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Post stroke hand paresis brain injury
Litramine in Weight Maintenance
Condition: Weight Maintenance; Overweight; Obese
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of Litramine on weight loss has previously been studied during a 12-week
      intervention period with promising results. The present study looks into the effect of weight
      maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.
    


Intervention name(s): Litramine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal); Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight maintenance; Overweight; Obese; Weight management
Efficacy of Temporary Positive Expiratory Pressure (TPEP) in Chronic Hypersecretion
Condition: Chronic Hypersecretions
Study type: Interventional
Phase: Phase 4

Summary: 
      Mechanical devices to increase the individual's bronchial hygiene are commonly used in
      patients with chronic retention of secretions and abnormal cough reflex. In this clinical
      context a new technology (namely TPEP® - Temporary Positive Expiratory Pressure) has been
      recently developed with the aim to improve the respiratory condition in patients suffering
      from chronic respiratory diseases. This trial has the aim to assess the clinical efficacy of
      TPEP in patients with chronic hypersecretion and airways obstruction, but with a normal
      competence of the cough reflex
    

Detailed description: 
      This is a single-blind multicentre controlled randomized trial with consecutive recruitment.
      Randomization list by blocks will be available. Group comparison will be made between active
      therapies including TPEP added to conventional MABT (Intervention) or MABT alone (Control).
      Active therapy will last 10 consecutive daily sessions in both groups.

      Primary outcome

      Efficacy comparison on change in:

      a.arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)

      Secondary outcomes

      Efficacy comparison on change in:

        1. Sputum characteristics

        2. Daily sputum volume

        3. Perceived sensation

        4. Lung functions (as assessed by spirometry and RM strength)
    

Intervention name(s): TPEP device (UNIKO); MABT (Manually assisted breathing techniques)
Intervention type(s): Device; Procedure
Intervention description(s): This technique is mainly based on a continuous low-pressure insufflation in the airways, which is likely to reduce (or even avoid) the potential pressure-related damages of other commonly used devices. This device should be used only in those individuals who are showing a normal competence of their cough reflex, thus it should be considered as a means which may help those techniques normally adopted for the individual's bronchial hygiene.; Conventionally manually assisted breathing techniques
Other intervention name(s): UNIKO; MABT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic bronchitis; COPD; Bronchiectasis
The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional

Summary: 
      This study evaluates the effects of subconjunctivally injected bevacizumab in patients with
      diffuse diabetic macular edema.
    

Detailed description: 
      At baseline, the macular thicknesses of both eyes of the patients with persistant diabetic
      macular edema were measured by optical coherence tomography. After 3.75mg bevacizumab was
      injected into subconjunctival space of the eyes with diabetic macular edema. The measurements
      of the macular thicknesses were repeated by optical coherence tomography in 15th, 30th, 60th
      day after injections. The macular thickness measurements before and after injection were
      compared.
    

Intervention name(s): Subconjunctival bevacizumab (Altuzan)
Intervention type(s): Drug
Intervention description(s): Subconjunctival injections of Altuzan 3.75mg were applied in order to eliminate the macular edema.
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does Intravitreal Injection of Triamcinolone Acetonide Impairs the Adrenal Function
Condition: Secondary Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Observational

Summary: 
      The use of intravitreal corticosteroids in the management ocular inflammatory diseases has
      recently gained widespread acceptance. The purpose of this study is to determine if the use
      of intravitreal triamcinolone is associated with suppression of endogenous cortisol
      production, as generally admitted for patients treated with oral or parenteral corticosteroid
      therapy.
    

Detailed description: 
      The normalcy of hypothalamic- pituitary- adrenal axis (HPA axis) of enrolled subjects will
      will be assessed before intravitreal injection of 4mg of triamcinolone and again after one
      day, one week and two weeks. Patients with abnormal HPA axis will be re-tested after four
      weeks and later until the HPA axis function return to normal. The HPA axis will be assessed
      with low dose (1mcg) intravenous corticotropin(ACTH) stimulation test, in which cortisol
      levels will be sampled before , 30 minutes and 60 minutes after 1mcg ACTH IV injection.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        hospital-based ophtalmologic clinic
Effects of Tribulus Terrestris in Women With Hypoactive Sexual Desire Disorder
Condition: Hypoactive Sexual Desire Disfunction
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypoactive Sexual Desire Disorder (HSDD) is the most prevalent female sexual dysfunction in
      society and is strongly linked to the quality of life of women. The androgen hormones decline
      over age in the premenopausal period, which occurs around 20 years. Tribulus terrestris is a
      plant native to India, recommended in the treatment of infertility, low libido and impotence.
      Its main active ingredient is the protodioscin, which has been attributed to an increase in
      testosterone levels and improved sexual function. The aim of this study is to evaluate the
      effects of Tribulus Terrestris in premenopausal women with HSDD.
    


Intervention name(s): tribulus terrestris; Placebo
Intervention type(s): Drug; Other
Intervention description(s): patients will use 750mg/day of tribulus terrestris; patients will take one pill a day (the same shape of the drug)
Other intervention name(s): tribulus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sexual function; hypoactive; desire; androgens
Combination Therapy in Indian Visceral Leishmaniasis
Condition: Leishmaniasis, Visceral
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 3

Summary: 
      Rationale

      The overall objective of this trial is to identify a safe and effective combination,
      (co-administration) short course treatment for the treatment of VL which could be easily
      deployed in a control programme. The hypothesis is that the combination treatment is as
      effective or better than the 5 mg/kg single dose of AmBisome and will reduce the risk of
      parasite resistance occurring. Safety and tolerability should be such that the combination
      can be easily deployed.

      Objective

      The specific primary and secondary objectives are as follows:

      Primary objective:

      To identify a short course combination treatment regimen which is at least as effective as a
      single dose of AmBisome 5mg/kg

      Secondary objective:

      To compare safety and tolerability of the various treatments measured by vital signs, blood
      biochemistry, (renal and liver function tests) haematology, spontaneous and elicited adverse
      event reporting

      Primary Endpoint:

      The primary efficacy endpoint variable is parasitological clearance 2 weeks after start of
      treatment with no relapse during follow up and no clinical signs or symptoms of VL at 6
      months post treatment.

      Parasitology is only carried out at any time during follow-up or at six months post treatment
      if there are signs or symptoms of VL infection.
    


Intervention name(s): amphotericin B deoxycholate; Liposomal Amphotericin B with Miltefosine; Liposomal Amphotericin B and Paromomycin Sulfate; miltefosine + Paromomycin sulfate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Amphotericin B deoxycholate 1 mg/kg on alternate days for 15 infusions; Liposomal Amphotericin B 5 mg Miltefosine 50 mg twice daily if patient weighs equal to or > 25 kg Miltefosine 50 mg once daily if patient weighs <25 mg; AmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11; oral miltefosine 50mg once daily (< 25 kg body weight) or twice daily ( > 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days
Intervention MeSH terms: Amphotericin B; Paromomycin; Liposomal amphotericin B; Miltefosine; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kala-azar; miltefosine; liposomal amphotericin B
Assessment of the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and Comparison of the Folate Metabolites During the 24 Weeks of Treatment (Yasmin + Metafolin Versus Yasmin + Folic Acid) Followed by a 20 Week Elimination Phase of Folate
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine and compare the uptake of levomefolate calcium
      (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of
      treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking
      contraception. Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) was
      co-administered over the entire period of 44 weeks.
    


Intervention name(s): EE 0.03 mg/DRSP 3 mg/Metafolin + folic acid placebo; EE 0.03 mg/DRSP 3 mg (Yasmin) + folic acid
Intervention type(s): Drug; Drug
Intervention description(s): Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.; Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Drospirenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
Condition: Leg Ulcer; Varicose Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg
      ulcers and to give preliminary information about the efficacy of two different Celaderm(TM)
      dosing regimens.
    

Detailed description: 
      Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R)
      compression vs. Profore(R) compression alone.
    

Intervention name(s): Celaderm (Frozen Cultured Epidermal Allograft); Celaderm (Frozen Cultured Epidermal Allograft); Control (compression bandaging)
Intervention type(s): Device; Device; Device
Intervention description(s): Four biweekly applications of Celaderm plus compression therapy; Four weekly applications of Celaderm plus compression therapy; Multi-layer compression bandaging
Other intervention name(s): Frozen Cultured Epidermal Allograft (CEA); Cultured Keratinocytes; Frozen Cultured Epidermal Allograft (CEA); Cultured Keratinocytes; Profore
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wound; leg; venous; chronic; wound healing
Multi Center Site , Controlled Trial Comparing a Bioengineered Skin Substitute to a Human Skin Allograft
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Observational

Summary: 
      Despite the widespread use of advanced biologics for the treatment of diabetic foot ulcers,
      data comparing one type of modality to another are scarce. This investigation is a
      prospective randomized study comparing a bioengineered skin substitute to a human skin
      allograft.
    

Detailed description: 
      The primary goal in treating a DFU is to obtain wound closure. Healing can be a lengthy and
      painful process for ulcers of diabetic etiology. Healing is often further complicated in
      subjects with diabetes by vascular compromise and peripheral ischemia, renal insufficiency
      and diminution of inflammatory responses

      The two products to be compared in this study are both commonly used for the treatment of
      diabetic foot ulcers. DermaGraft is considered a medical device by the FDA, and was cleared
      for the treatment of diabetic foot ulcers in 1997. It is a staple for the treatment of
      diabetic foot ulcers, and is widely used throughout the United States. It is composed of an
      absorbable substrate that has been seeded with living human fibroblasts. Once formed, the
      graft is cryopreserved until it reaches the clinic, where it is defrosted and applied to the
      wound surface.

      TheraSkin is composed of a split thickness skin graft harvested within 24 hours post-mortem,
      from an organ donor who has cleared the standard safety screenings. It is classified by the
      FDA as a donated tissue. Once harvested, the graft is sanitized according to FDA
      specifications, and cryopreserved, until it is delivered to the clinic for application to the
      foot ulcer. It is also a widely used treatment for diabetic foot ulcers.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population includes Diabetic patients with type 1 or type 2 Diabetes with foot ulcers
Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients
Condition: Acute Lymphocytic Leukemia
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Observational

Summary: 
      Determine P-glycoprotein expression in blood samples of Acute Lymphocytic leukemia (ALL)
      pediatric patients receiving MTX treatment and trace its ontogeny and compare it with its
      expression in pediatric healthy subjects. In addition, to determine the correlation of
      P-glycoprotein expression and Methotrexate concentration at steady state.
    

Detailed description: 
      The 20 leukemic patients will be classified into three age groups according to the ages that
      will be available at the time of sample collection.

        -  All patients will be recruited from Tanta Oncology Center, Tanta University.

        -  The study will be approved by the Research Ethics Committee of Tanta University and
           college of Pharmacy ethical committee.

        -  An informed consent will be obtained from parents of all patients in this research
           before enrollment.

        -  All patients' data will be private and confidential. Any unexpected risks that may
           appear during the course of the research will be reported to patients and the ethical
           committee on time.

      Blood Samples will be obtained from healthy pediatric subjects of the same ages of the
      diseased group subjects (Samples will be obtained from subjects from a primary care center
      during their routine blood analysis excluding patients of chronic diseases, patients
      receiving any medications, and patients of impaired kidney or liver functions).

      P-glycoprotein expression will be estimated in all samples using Permeability glycoprotein
      (P-gp), ELISA Kit, and its expression will be traced with development from the youngest till
      the oldest age available, this will also be compared with normal healthy pediatric subjects.
    

Intervention name(s): MTX, (but the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression)
Intervention type(s): Other
Intervention description(s): the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric Acute Lymphocytic Leukemia Patients aged < 18 years old who are already taking
        the ALL MTX protocol.
The Multi-disciplinary Treatment of Functional Gut Disorders Study
Condition: Irritable Bowel Syndrome; Functional Dyspepsia; Constipation - Functional; Faecal Incontinence; Functional Abdominal Pain Syndrome; Other Rome IV Functional Gastrointestinal Disorders
MeSH terms: Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Fecal Incontinence; Syndrome; Constipation; Dyspepsia; Abdominal Pain
Study type: Interventional

Summary: 
      Randomised controlled trial comparing standard outpatient clinic treatment with
      multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will
      be followed up to end of clinic treatment and 12 months beyond the end of treatment.
      Symptoms, quality of life, costs to the healthcare system and psychological outcomes will be
      assessed.
    


Intervention name(s): Multi-disciplinary clinic model; Standard outpatient care
Intervention type(s): Other; Other
Intervention description(s): Clinic model incorporating multiple disciplines for the treatment of functional gut disorders. Disciplines include: gastroenterologists, psychiatrists, psychologists, hypnotherapists, behavioural therapists and dieticians. End of clinic case conference involving clinical disciplines will also occur to coordinate care.; Standard care provided in outpatient clinics staffed by GI doctors only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Irritable bowel syndrome; Constipation; Functional dyspepsia; Multi-disciplinary treatment