bioihbjkbjnl/mcl2 huggingface dataset:
Weightbearing After High Tibial Osteotomy
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      In this project we want investigate the clinical results after different rehabilitation
      regimens(Limited or unlimited weightbearing after surgery) in Open-wedge High Tibial
      Osteotomies.

      The hypothesis is that unlimited weightbearing is beneficial for the healing and
      rehabilitation.
    

Detailed description: 
      In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high
      tibial osteotomy is a good choice of treatment for the young and active patient.

      However it leaves an open gap which has to be filled with a bone substitute and requires
      stable fixation.

      Different rehabilitation-regimens are described, many advocating a period of partial
      weight-bearing for a period after surgery.

      Results from biomechanical studies suggest that immediate full weight-bearing is safe,
      enabling earlier mobilisation without compromising safe solid healing.

      The aim of the present study is to evaluate whether there is any difference in clinical
      outcome, correction, stability and healing in open-wedge osteotomies (osteosynthesis with the
      Dynafix® system (EBI)) after 2 different rehabilitation regimens: Limited weight-bearing (20
      kg) for 6 weeks, and unrestricted weight-bearing.

      The investigation is performed as a randomised prospective clinical trial including 20
      patients with a planned 2 years follow-up period.

      Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and
      Lysholm score.

      Routine standing x-rays is performed. Stability of the osteotomy is assessed with Roentgen
      Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional
      measuring of eventual loss of correction.
    

Intervention name(s): Unlimited postoperative weightbearing
Intervention type(s): Procedure
Intervention description(s): Unlimited postoperative weightbearing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee; Osteotomy; Healing; Rehabilitation; Roentgen Stereometric Analysis
Phase IIA Study in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the effects of AZD 2624 in patients with schizophrenia
    


Intervention name(s): AZD2624; Olanzapine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Suspension; PO BID
Other intervention name(s): Zyprexa
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia
Effectiveness of Bethanechol Chloride and Early Bladder Training for Prevention of Bladder Dysfunction After Radical Hysterectomy in Cervical Cancer Stage IB - IIA
Condition: Bladder Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Compare the effectiveness of bethanechol chloride and early bladder training for prevention
      of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA.
    

Detailed description: 
      Cervical cancer is the third most common cancer in women worldwide, after breast and
      colorectal cancer. Molecular biology has firmly established a causal relationship between
      persistent infection with high risk human papilloma virus (HPV) genotypes and cervical
      cancer.

      Cervical cancer stage IB1 and selected IIA 1 lesions without extensive vaginal involvement
      can be treated with either RH and pelvic lymph node dissection (PLD) or primary
      chemoradiation.

      Bladder dysfunction is the most common complication after radical hysterectomy. The incidence
      is approximate 10-80 %. Management of bladder dysfunction is continuous urethral
      catheterization or clean intermittent self-catheterization. Prolonged urethral
      catheterization may increase the risk of urinary tract infection.

      Early postoperative bladder training that consist of a scheduled clamping trans-urethral
      catheter every 3 h and unclamping trans-urethral catheter 15 min during the entire day.

      Bethanechol chloride is a cholinergic drug and may enhance the detrusor muscle contraction,
      resulting in higher maximum flow rate, and lower postvoid residual urine.

      This study was conducted to compare the effectiveness of bethanechol chloride and early
      bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical
      cancer stage IB - IIA.
    

Intervention name(s): bethanechol chloride; early bladder training; early bladder training and bethanechol chloride; no early bladder training and no bethanechol chloride
Intervention type(s): Drug; Device; Other; Other
Intervention description(s): bethanechol chloride(10) 2 tablets oral tid, ac. Start on3rd - 5th postoperative day; early bladder training start on 3rd - 5thpostoperative day; bethanechol chloride 2 tablets oral tid, ac and early bladder training start on 3rd - 5th postoperative day; no bethanechol chloride and no early bladder training
Intervention MeSH terms: Bethanechol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Interferon Gamma-1b in Friedreich Ataxia (FRDA)
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      Friedreich ataxia (FRDA) is a progressive neurodegenerative disease of children and adults
      for which there is presently no therapy. Recently, a study reported that interferon gamma
      (IFN-g) could raise frataxin protein levels in both cell lines derived from patients with
      Friedreich ataxia and in a mouse model with Friedreich ataxia. The present study will test
      whether IFN-g is safe, tolerated and potentially efficacious in a heterogeneous cohort of
      children with FRDA.
    

Detailed description: 
      Study Objectives:

      Primary:

      • To assess the effect of Interferon Gamma-1b (IFN-g) on increasing frataxin expression and
      protein in children with FRDA.

      Secondary:

        -  To assess the effect of IFN-g on neurological outcomes (FARS, performance measures, and
           hearing) in subjects with FRDA.

        -  To assess the effectiveness of IFN-g on quality of life in subjects with FRDA.

        -  To assess the safety and tolerability of IFN-g at the currently approved dose in the
           FRDA population.

      Study Phases:

      Screening - During screening, subjects will be assessed for inclusion and exclusion criteria.

      Intervention - Subjects will begin treatment at baseline visit and the dose of study
      medication will be increased to the maximum dose over four weeks. The subjects will be
      maintained at the maximum dose for 8 weeks. After 12 weeks, treatment will stop. Study
      medication will be administered via subcutaneous injections three times per week for 12
      weeks.

      Follow-up - Follow-up visits will occur at 7 and 28 days after the subject has completed the
      12 weeks of active treatment.
    

Intervention name(s): Interferon Gamma-1b
Intervention type(s): Drug
Intervention description(s): Subjects will begin by taking 10 mcg/m2 of IFN-g-1b for the first two weeks of the study. Dose will be escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study. Finally, the dose will be escalated to 50 mcg/m2 of IFN-g-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
All doses will be administered via subcutaneous injection.
Other intervention name(s): Actimmune™; IFN-g-1b
Intervention MeSH terms: Interferons; Interferon-gamma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Friedreich ataxia; Interferon gamma-1b; FRDA
Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary Generalization
Condition: Epilepsy; Partial Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether levetiracetam as adjunctive therapy is
      effective in the treatment of partial seizures, with or without secondary generalization,
      associated with refractory focal epilepsy.
    


Intervention name(s): Levetiracetam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution (Each mL contains 100mg of levetiracetam) or immediate-release tablets (Tablets containing 500mg or 1000mg of levetiracetam); Placebo, properly standardized to suit the characteristics of each dosage form (oral solution and tablets) of levetiracetam
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; Partial; Seizures; Adjunctive
Association Between Types of Pain and Motor Activities Physical Activity
Condition: Spinal Cord Injury; Chronic Pain
MeSH terms: Spinal Cord Injuries; Chronic Pain
Study type: Observational

Summary: 
      This study will investigate the relationships between: (1) physical activity (PA) and types
      of chronic pain (nociceptive and neuropathic), and (2) virtual reality (VR) and types of
      chronic pain (nociceptive and neuropathic).
    

Detailed description: 
      Chronic pain can be differentiated by its underlying mechanisms. However, this important
      distinction is not applied to most non-pharmacological treatment approaches. Studies that
      have shown modulation of chronic pain with physical activity (PA) or virtual reality (VR)
      have not evaluated differential effects on nociceptive and neuropathic pain. Therefore, it is
      unknown if neuropathic pain and nociceptive pain respond differently to PA and VR, and if
      treatment could be optimized through targeted interventions or a combination of
      interventions. Understanding the relationships between different types of pain and motor
      activity will provide new insight to inform future recommendations to alter PA levels for
      pain modulation.

      A prospective, cohort design will be employed for this study of individuals with SCI for a
      duration of one week in the community. This study will identify trends that are different
      between the responses of different types of pain and motor activities (i.e., PA and VR). The
      data obtained will also capture fluctuations in PA levels across participants and
      corresponding pain levels because PA levels will be collected through real-world data in the
      community.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals with chronic SCI who live in the Greater Philadelphia region and have
        experienced chronic pain are eligible to participate in the study. Recruitment efforts will
        be targeted equally towards men and women of all races and ethnicities, however because SCI
        is more prevalent in men, we anticipate higher recruitment of men than women.
      
Keywords: physical activity; virtual reality; nociceptive pain; neuropathic pain
The Big Breakfast Study
Condition: Obesity; Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This weight loss study will investigate the impact of diet composition and meal size (large
      breakfast meals and smaller evening meals) on body weight, energy balance and eating
      behaviour, by altering calorie (meal) distribution.
    

Detailed description: 
      The aim of this study is to further strengthen our understanding of the role of dietary
      components (in particular fibre and protein) in a healthy diet. The information gained from
      this research will lead to better policy advice, particularly in relation to healthy weight
      management, metabolic control, mental health and intestinal health. It will also lay the
      foundations to produce healthier primary products and aid the food industry in developing new
      and healthier products (e.g. products that aid hunger control and satiety). This will be
      addressed through four interlinked objectives:

      O1: Healthy weight management and improved metabolic and mental health O2: Identification of
      gut bacteria and compounds of relevance to vascular and gut health O3: Linking fibre
      consumption to intestinal microbial communities and health O4: Mathematical modelling of
      interactions between diet and gut microbial communities
    

Intervention name(s): High Fibre; High Protein
Intervention type(s): Other; Other
Intervention description(s): High fibre/carbohydrate (50% CHO, 35% fat and 15% Protein) with 45% calories at breakfast and 20% evening meal provided and buffet lunch. Total dietary fibre will be at least 30g/d for 2000kcal intake and provided as a mixed soluble and insoluble fibre sources to maintain palatability of the diet (e.g. wheat bran, fava bean, lentil, buckwheat).; • High protein diet (30% protein, 35% fat and 35% CHO) with 45% calories at breakfast and 20% evening meal provided and buffet lunch. Protein will be a mixed meat matrix to include poultry, fish, red meat, prawns, eggs, dairy. Total dietary fibre will be no more than 15g/d for 2000kcal intake.
Other intervention name(s): HF; HP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Validation of the TMD Pain Screener in a Specialized Headache Center
Condition: Temporomandibular Disorder; Headache Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Headache Disorders; Headache
Study type: Observational

Summary: 
      The purpose of the study is to investigate whether a questionnaire can be used to detect
      whether patients referred to the Danish Headache Center have a painful temporomandibular
      disorder (TMD).

      TMD is a major public health problem that affects up to 15% of the adult population and can
      cause headaches that can be immediately difficult to differentiate from other headache types
      such as tension headaches and migraines. By applying the so-called diagnostic criteria for
      TMD through a standardized study program, TMD diseases such as myalgia of the jaw muscles,
      arthralgia and discus displacements of the jaw joints and jaw arthritis can be diagnosed.
      However, this requires dental expertise and is time consuming. At the Danish Headache Center,
      the current screening question is used for TMD in order to identify who could benefit from
      further investigation in dentistry. But it is still unknown how accurate these questions are
      in selecting those patients who have TMD diseases in a patient group with a headache. The
      investigators would like to investigate this in order to improve the referral procedure of
      headache patients for relevant dental treatment or physiotherapy. This is believed to be of
      importance both in a specialized unit such as the Danish Headache Center and in neurological
      medical practice.

      Patients will be recruited who are referred to the Danish Headache Center, who have been
      given TMD screening questions and who have indicated in writing that they wish to be
      contacted for research projects.

      In the study, 25 subjects with TMD screening question score of ≥ 3 points will be included,
      which will be gender and age matched with 25 subjects who have TMD screening question score
      of <3 points. The patients will be interviewed to classify the patients headache 15 min and
      then have a jaw examination done and then the DC / TMD examination will be done and lasts
      approx. 30 min. The examination is performed by a skilled physiotherapist and it does not
      involve any side effects or risks.
    


Intervention name(s): TMD pain screener
Intervention type(s): Diagnostic Test
Intervention description(s): The danish TMD pain screener is given to all participants
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to the Danish Headache Center with any type of headache are included.
        Half the population has a high probability of having a painful TMD, the other half is
        matched on age and gender but has a low probability of having a painful TMD.
      
Keywords: orofacial pain; DC/TMD
The Influence of Storage Container and Defrost Process on Components in Breast Milk
Condition: Human Milk
Study type: Observational

Summary: 
      Breast milk is best food for neonates and preterm infants. However many handling would be
      done if direct breastfeeding is not feasible, and it may result in nutrients change in human
      milk. We investigate the influence of storage in different containers and different thawing
      or heating methods on human milk nutrients.
    


Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        healthy mothers lactating breast milk during first year of their babies
      
Biospecimen description: 
      breast milk
Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache
Condition: Oral Contraceptive; Headache; Pelvic Pain
MeSH terms: Headache; Pelvic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present study is to investigate whether women taking a new combined oral
      contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone
      withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle
      compared to a commonly used contraceptive pill (Microgynon).
    


Intervention name(s): EV/DNG (Qlaira, BAY86-5027); Encapsulated Microgynon + Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one capsule SH T00658ID for 28 days per cycle for 6 treatment cycles no pill-free interval; Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Combined Oral Contraceptives; Pelvic Pain; Headache
Transcranial Direct Current Stimulation (tDCS) Augmentation by D-Cycloserine as a Treatment for Depression
Condition: Major Depressive Disorder; Bipolar Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Among antidepressant treatments, Electroconvulsive therapy (ECT) stands as the most effective
      in treating acute depression. However, patient concerns with the cognitive side effects of
      ECT have encouraged the development of new and more focal forms of brain stimulation such as
      transcranial Direct Current Stimulation (tDCS). The investigators' current study of tDCS as a
      treatment for depression suggests that this technique has antidepressant effects and is safe,
      painless and well tolerated. However, not all patients may respond to this treatment and the
      concern of possible relapse in some patients who respond to tDCS has raised interest in
      finding treatments that may enhance and prolong the antidepressant effects of tDCS. This
      study will investigate whether D-Cycloserine, a medication shown to lengthen the effects of
      tDCS on brain activity, can also enhance/prolong the antidepressant effects of tDCS in people
      suffering from depression.
    


Intervention name(s): D-Cycloserine; tDCS (Eldith DC-Stimulator (CE certified))
Intervention type(s): Drug; Device
Intervention description(s): 100 mg D-cycloserine once every weekday taken 2 hours before tDCS session.; tDCS session lasting continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm, 35 cm2) covered by sponges soaked in saline will be used, held in place by a head band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
Other intervention name(s): Eldith DC-Stimulator (CE certified)
Intervention MeSH terms: Cycloserine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Treatment; Transcranial direct current stimulation; D-cycloserine
Transcutaneous Electrical Stimulation in Lower Limb Amputees
Condition: Lower Limb Amputation
Study type: Interventional

Summary: 
      Current lower limb prostheses support ambulation by absorbing and stabilizing positions
      during walking. Users of lower limb prostheses rely solely on sensory information provided by
      the contact between the socket and the residual limb. Restoring sensory feedback could
      potentially improve their quality of life and participation in daily activities. Despite a
      high incidence of lower limb amputations, there are few studies in the literature addressing
      the restoration of sensory feedback in lower limb amputees, particularly studies utilizing
      invasive techniques. In an effort to overcome these limitations, various non-invasive methods
      have been tested. Despite resulting benefits such as improved gait symmetry and stability,
      most non-invasive stimulation systems are non-somatotopic, failing to generate a sensation
      referred to the patient's missing limb. From the literature, Transcutaneous Electrical Nerve
      Stimulation (TENS) emerges as a very promising non-invasive and somatotopically-based sensory
      feedback approach, capable of inducing sensations referred to the amputees' phantom limb.

      Therefore, the proposed study will involve the use of TENS as a means to stimulate
      sensitivity and prevent perceptual disturbances associated with the interruption of
      peripheral nerve structures occurring in individuals undergoing amputation. These
      disturbances, besides influencing the development of symptoms characterized by neuropathic
      pain, can impact prosthesis management.
    


Intervention name(s): Transcutaneous Electrical Nerve Stimulation
Intervention type(s): Other
Intervention description(s): Phase 1: Participants undergo a comprehensive assessment in a single experimental session (mapping session) aimed at mapping the regions and sensations that can be electrically stimulated. This mapping protocol is conducted on both the intact and amputated limbs.
Phase 2: This phase comprises a 4-week experimental protocol, including:
four mapping sessions conducted at the onset of each week, where the protocol is randomly applied to the participant's intact and amputated limb.
three stimulation sessions held over three consecutive days in the initial week to assess the participant's ability to discern stimuli of varying intensities.
ten sessions utilizing an end-effector gait rehabilitation robot, aiming to train the participant in walking using the proposed sensory feedback restoration system based on TENS under controlled and repeatable experimental conditions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other