cyrilzakka/clinical-trials huggingface dataset:
A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain.

Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. The maximum dose will be 600mg/day. Subjects may participate in this trial until October 2007. This time may be extended to allow them to participate until lacosamide is commercially available.

If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication, s/he enters a Titration Phase to determine the personal optimal dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Painful diabetic neuropathy

Exclusion Criteria:

* no clinically relevant liver enzyme abnormalities and impaired renal function, no cardiac abnormalities, no pregnant or nursing females

Exclusion Criteria:
Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases

The weaning of mechanical ventilation is difficult period. This period is particularly difficult for patient with obstructive chronic respiratory disease and a long mechanical ventilation is associated with an increased risk of infectious complication, cardiac dysfunction, muscular weakness or barotromatism. No guideline is available on the ventilator mode to use during the night. In weaning period, some studies have demonstrated that nocturnal control ventilation during the weaning period improved the quality and the quantity of sleep. The hypothesis is that use of nocturnal controlled mechanical ventilation could decrease the weaning period duration and the ventilation weaning failure because of a sleep improvement.

The main objective is to compare mechanical ventilation weaning period duration according to the nocturnal ventilator mode (pressure controlled ventilation versus pressure support ventilation) in patients with an obstructive respiratory disease. A secondary objective is to evaluate the rate of weaning failure after the first extubation according to the nocturnal ventilator mode and to evaluate the sleep during the weaning period according to the nocturnal ventilator mode.

All patients with weaning criteria, spontaneous breathing test will be done. If patient is able to have spontaneous ventilation with maximum of 16 cm of H2O of pressure support, he could be included in the study. The nocturnal ventilation mode will be randomised between pressure controlled ventilation and pressure support ventilation with the same pressure support than during the day. We will follow the quality and quantity of sleep with continue polysomnography. Indeed, patients in ICU could sleep during the night but too during the day. We will compare the duration of the weaning period between the two arms.

Eligibility Criteria:
Inclusion criteria :

* Patient with invasive mechanical ventilation (with B840 ventilator)
* Patient with ventilation weaning criteria
* Patient able to support during the day pressure support ventilation with pressure support lower than 19 cm of H2O.
* Patient with all mechanical ventilation weaning criteria for the first trial of spontaneous ventilation.
* Age \> 18 years

Exclusion criteria :

* Patient with central apnoea syndrome
* Patient with narcolepsy
* Patient with metabolic encephalopathy.
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP\~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.

Immunogenicity

* To assess pre- and post-primary series
* To assess pre- and post-booster series.


Eligibility Criteria:
Inclusion Criteria:

* Two-month old infants of either gender on the day of inclusion
* Born at full term of pregnancy (\>=37 weeks) with a birth weight \>=2.5 kg
* Informed consent form signed by the parent(s) or other legal representative(s) and an institution official other than an investigator
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received since birth
* Any vaccination (except BCG) in the 4 weeks preceding the first trial vaccination
* Vaccination planned in the 4 weeks following trial vaccination
* History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
* Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity
* Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s)
* Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of seizures
* Febrile (axillary temperature 37.4°C \[rectal equivalent temperature \>=38.0°C\]) or acute illness on the day of inclusion.
Peri-implant Mucosal Changes Over Time Following Implant Provisional Removal in the Esthetic Zone

The study will examine the temporary volumetric change that happens in the gums around an implant crown when the crown is removed. The main question of the study is "how much time has to pass to see a significant change, especially when there could be a need to make a mold of the surrounding gum to make a new crown?"

The area of the implant crown will be scanned with an intra-oral scanner over a period of 15 minutes.

When an implant crown is removed, the gum in the area, usually supported by the crown, might go through temporary changes once that support is gone. While the change itself may be temporary, some ways to make a final crown that would be esthetically pleasing might require making a copy of the temporary crown or a mold of the gum around the crown.

This study will involve the removal of an implant crown at a site where a failing tooth was removed, and a dental implant and a crown was placed into the extraction socket. Once the subject enrolls in the study, the area of the implant crown will be scanned right after the removal of the implant crown, and 1, 2, 3, 5, 7, 10, and 15 minutes after the removal of the crown. In order to record the exact location of the implant, a tag will be placed onto the implant and the tag will be scanned as well. The subject's crown will be also scanned so that all the data can be overlaid on top of each other to assess the actual change that occurs. After, the crown will be re-inserted in the patient's mouth so that the gum can rebound back to its original shape.

If the patient is able to return in the near future for a new crown, the patient will be asked to make one final scan of the mouth to see if there is any changes in the gums between that of the old and the new crown. This will show if the shape of the crown under the gums might have an effect on how the gums might look.

The study will look into whether an immediate change might happen, and how much change actually takes place over the 15 minutes, in whichever direction it might happen.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have a maxillary anterior immediate implant and provisionalization treatment completed.
* The adjacent tooth next to the implant should be a natural tooth
* The temporary crown must have been in place for a minimum of 4 months
* The patient needs to be of general good health, with no significant medical history or social habits that might directly affect the hard and soft tissue
* Patient must have generally good oral hygiene without any history of gum disease or gum recession of other teeth around the region of interest

Exclusion Criteria:

* Patient with an implant crown that has no teeth next to the implant crown
* Patients who have an active gum disease
Social Media and Eating Disorder Fear

The goal of this observational study is to learn about the relationship between social media use and fear of eating disorders in university students. The main question it aims to answer is:

Is there a relationship between social media use and eating disorder fears in university students?

University students will answer a questionnaire face to face, including questions about their social media usage habits, the impact of social media on eating behavior scale, and the fears of eating disorders scale.


Eligibility Criteria:
Inclusion Criteria:

* Using social media

Exclusion Criteria:

* Pregnant or lactating individuals
Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor

Purpose:

To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.

Methods:

The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.


Eligibility Criteria:
Inclusion Criteria:

* Singleton uncomplicated pregnancy
* Nulliparity
* Live fetus
* 286 days of gestational age or above
* Abscence of contraindication for vaginal delivery
* Bishop score lower than 6

Exclusion Criteria:

* Multiple pregnancy
* Multiparity
* Stillbirth
* Oligohydramnios
* Suspected fetal distress
* Severe asthma
* Intolerance/allergy to prostaglandins
* Contraindication for vaginal birth
Tea Consumption and Cognitive Performance in the Very Old

Studies have found a beneficial effect of tea consumption on the reduction of risk of cognitive impairment and dementia in older aged populations. However, there is a paucity of data on these associations in the very old defined as individuals aged 85 years and over. Therefore, we hypothesized that higher tea consumption was associated with better global and domain-specific cognitive function. We investigated the relationship between tea consumption in the very old and measures of global cognitive function, memory, attention and psychomotor speed.

The Newcastle 85+ Study was a longitudinal (5-years), population-based cohort study of individuals aged 85+ years in North East England, United Kingdom. The final sample included 676 community-dwelling and institutionalized men and women recruited through general medical practices.

Baseline tea consumption was assessed through a 2x24-hr multiple pass recall and longitudinal measures of global and domain specific (memory, speed and attention) cognitive function through the standardized mini-mental state examination and the cognitive drug research system. Linear mixed models, controlling for demographic (e.g. age, sex and education) and health variables were used to determine whether tea consumption was protective against cognitive decline.


Eligibility Criteria:
Inclusion Criteria:

* Born in 1921
* Permanently registered with a participating general practice in Newcastle upon Tyne or North Tyneside primary care trusts in the UK

Exclusion Criteria:

* End-stage illness
* Individuals who might pose a safety risk to a nurse visiting alone, with dementia
* Clinical diagnosis of dementia at baseline
An Open-label, Single Dose, Parallel Design, Phase 1 Clinical Study of LCB01-0371

To investigate pharmacokinetics, safety and tolerability of LCB01-0371, LCB01-0371-B after a single oral dose in healthy male subjects.

To investigate safety, tolerability of LCB01-0371 after a single oral dose in healthy male subjects.

An Open-label, Single dose, Parallel design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral dosage form of LCB01-0371 in Healthy Male Volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male between 20 and 40 years of age at the time of screening
2. Agree to continue to use a medically reliable dual contraception and not to donate sperm in this protocol for the duration of the study and for 28 days after last dose of investigational product
3. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria:

1. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
2. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics
3. History of clinically significant disease such as allergic or anaphylactic reaction to drug, cardiovascular, peripheral vascular system, skin, mucous membrane, eye, otorhinolaryngologic system, respiratory, musculoskeletal, infection disease, Gastrointestinal system , liver, biliary system, endocrine, kidney, urogenital system, nervous system, psychiatric system, blood dyscrasia, tumor, fracture, problem(s)
4. blood donation and transfusion within 60 days prior to screening visit
5. Treatment with an other investigational product or Participation in other bioequivalence test within 90 days prior to screening visit
6. Use medication which expected to influence in this study within 30 days prior to screening visit
7. smokers over 10 cigarettes per day within 30 days prior to screening visit or unable to stop smoking in this protocol for the duration of the study from first dose of investigational product
8. drinkers over 3 glasses alcohol drink per week within 30 days prior to screening visit or unable to stop drinking in this protocol for the duration of the study from first dose of investigational product
9. positive result at urine drug screening test or urine nicotine test at screening visit
10. positive result at serum test(hepatitis B, hepatitis C, HIV, syphilis) at screening visit
11. corrected QT interval \>450 msec or significant abnormalities on screening ECG
12. other: Patients considered unable perform for the study by the investigator concerning
Effects of Horse Riding Simulator With or Without Visual Feedback on Balance and Postural Control

Spastic cerebral palsy is a neurological condition that causes muscle spasticity and motor impairments, greatly impacting a child's ability to maintain balance and control their posture. The horse riding simulator (HRS), inspired by hippo therapy, has emerged as a potential therapeutic intervention for enhancing motor function in individuals with cerebral palsy. This study explored the additional effects of mirror visual feedback when used in conjunction with the HRS. Strategically placed mirrors allow participants to observe their own body movements and positions in real-time. The simulator's rhythmic, multidimensional movements deliver sensory input and challenge the motor system, promoting postural adjustments and improved balance. Furthermore, the integration of mirror visual feedback appears to enhance the therapeutic benefits. Real-time visual information enables children to actively observe and correct their body positioning, leading to improved body awareness and more efficient motor responses.

Cerebral palsy (CP), one of the most common physical disabilities in childhood, is a disorder of movement and posture caused by non-progressive lesions in the developing brain. Children with CP, to varying degrees, have muscle weakness, tone abnormality, and motor-control impairment, causing abnormal posture and poor balance control.In high-income countries, the current birth prevalence of cerebral palsy has decreased to 1.6 per 1000 live births. However, in low- and middle-income countries, the birth prevalence is significantly higher. Children diagnosed with CP exhibit a range of muscle weakness, tone abnormalities, and impaired motor control. These factors contribute to abnormal posture and compromised control over balance

Eligibility Criteria:
Inclusion Criteria:

* Spastic cerebral palsy with level I and II according to Gross Motor Function Classification System (GMFCS)
* Age between 8 and 12 years
* Ability to sit and stand independently
* Both genders are included (female and male)

Exclusion Criteria:

* Having received an injection of botulinum toxin within 3 months
* Having undergone orthopedic surgery or selective dorsal rhizotomy in the previous 1 year
* Having undergone HRS training within 6 months;
* Having severe pain, joint dislocation, contracture, or spinal deformity
* Having experienced uncontrolled epileptic seizure
* Having poor visual or hearing acuity.
Comparison of Cosmesis, Patient Satisfaction and Quality of Life in Patients Undergoing Laparoscopic Surgery

To compare robot assisted versus conventional laparoscopic surgery performed for bening gynecologic disorders regarding cosmesis, patient satisfaction and quality of life

30 patients undergoing robot assisted laparoscopic surgery for bening gynecologic disorders and 30 patients undergoing conventional laparoscopic surgery for bening gynecologic disorders will be included in the study. All surgeries will be performed in the same hospital by the same surgeon. 6 months after the surgery the patients will be called and will be informed about the trial. After confirming that the questionnaires can be sent to them by e-mail, 4 questionnaires will be sent to the patients via e-mail. To evaluate cosmesis, patient satisfaction and quality of life VAS (visual analogue scale), SF-12 (short form-12) health survey, BIQ (body image questionnaire) and POSAS (the patient and observer scar assessment scale) will be sent to the patients 6 months after the surgery. Patients who have not completed the questionnaires will be called for reminders after 1 week. Patients will be expected to complete the questionnaire completely and accurately.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of being gynecologic disorders
* Patients undergoing conventional laparoscopic surgery
* Patients undergoing robot assisted laparoscopic surgery
* Patients undergoing surgery in our hospital by the same surgeon
* Patients willing to participate in the study

Exclusion Criteria:

* Malignancy
* Requirement of emergency procedure
* Pregnancy
* Visible previous abdominal scars or keloid
* Inability of patient to tolerate Trendelenburg position or pneumoperitoneum
* Patients undergoing surgery by another surgeon or in an another hospital
* Mental impairment that would preclude giving informed consent
Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment

* The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
* The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.


Eligibility Criteria:
Inclusion Criteria:

* Patients after first clinical event suggestive of multiple Sclerosis (MS) (according to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis.

Exclusion Criteria:

* Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)
Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to \< 11 years old.

Intermittent exotropia (IXT) is the most common form of childhood-onset exotropia with an incidence of 32.1 per 100,000 in children. Before surgery, many cases of IXT are treated using non-surgical interventions, such as part-time alternate occlusion. However, the "alternating" occlusion with traditional patches is usually out of control. The investigators are uncertain about the amount of "alternating" in patching treatment.

Here, the investigators introduce controlled intermittent alternating occlusion (CIAO) therapy, which is provided by a new electronic device, -liquid crystal glasses. This study is to determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to \< 11 years old. Children with IXT will be randomized into either an observation group or a CIAO therapy group.

Eligibility Criteria:
Inclusion Criteria:

* Intermittent exotropia (manifest deviation) meeting all of the following criteria:

  * Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near
  * Exodeviation at least 15PD at distance OR near measured by prism and alternate cover test (PACT)
  * Exodeviation at least 10PD at distance measured by PACT
* No previous surgical or non-surgical treatment for IXT (other than refractive correction)
* Visual acuity in the worse eye 0.3 logMAR or better (20/40 on ATS HOTV or 70 letters on E-ETDRS) for children ≥ 3 years of age
* No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS) for children ≥ 7 years of age
* Investigator not planning to initiate amblyopia treatment
* No hyperopia greater than +3.50 D spherical equivalent in either eye
* No myopia greater than -6.00 D spherical equivalent in either eye
* No prior strabismus, intraocular, or refractive surgery
* No abnormality of the cornea, lens, or central retina
* Investigator willing to observe the IXT untreated for 3 years unless specific criteria for deterioration are met.

Exclusion Criteria:

* N/A