cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Valproate in Peripheral Neuropathic Pain

The purpose of this study is to determine whether valproate is effective and well tolerated in the treatment of neuropathic peripheral pain. The drug is administered by intravenous route followed by oral route during 4 weeks.

Background. Neuropathic peripheral pain is often refractory to usual analgesics. Some anticonvulsant drugs may be effective, but often partially only, and not always well tolerated. Valproate is a well-known anticonvulsant drug, with moderate possible adverse events and for which an intravenous form is available.

Aim. The principal aim is to assess the efficacy and safety of sodium Valproate in peripheral neuropathic pain. Secondary aims are to asses the effect of IV and oral treatment on neurophysiologic measures.

Design. Randomized, double-blind vs. placebo, parallel groups, monocentric clinical trial.

Treatments. Experimental arm: Intravenous eight-hour sodium Valproate infusion, followed by a four-week oral route sodium Valproate treatment. Control arm: Intravenous eight-hour placebo infusion, followed by a four-week oral route placebo treatment. Rescue medications are allowed in both groups.

Eligibility criteria. Peripheral neuropathic pain with pain intensity of at least 40 mm on a visual analog scale.

Outcomes. Primary outcome is the intensity of pain on a visual analog scale after 4 weeks of treatment. Secondary outcomes: intensity of pain after IV treatment; neurophysiologic measures (thermal thresholds, RIII reflex); association of response to IV treatment with oral treatment efficacy.

Eligibility Criteria:
Inclusion Criteria:

* peripheral neuropathic pain
* signed written informed consent

Exclusion Criteria:

* central neuropathic pain
* current or past hepatic disease
Effectiveness of Board Game on Improving Elementary School Students' Infection Control

The goal of this clinical trial is to learn if board game can improve elementary school students' infection control intentions. The investigators use the theory of planned behavior (TPB), which includes three main factors: attitude, subjective norm, and perceived behavioral control. The main questions it aims to answer are:

1. Exploring the factors influencing children's behavioral intentions of infection control through theory of planned behavior?
2. The effectiveness of board game on improving children's knowledge and behavioral intentions of infection control?

Researchers will compare gamified instruction to conventional lesson lecture to see if the former has better results.

Students who participated in filled out the questionnaire three times, each time taking about 15 to 20 minutes: before the intervention, after the intervention, and after a one-month delay. The students' legal representatives filled out a basic demographic questionnaire before intervention, which took about 5 minutes.

After a one-month delay, two groups of students were asked to filled out the post-test questionnaire again. Then, students in the control group were invited to participate in a board game and asked which teaching method they preferred (gamified instruction or conventional lesson lecture).


Eligibility Criteria:
Inclusion Criteria:

* Students in fifth to sixth grade of the elementary school (10 to 13 years old) and their legal representatives must fill in the informed consent form.

Exclusion Criteria:

* N/A
A Study of LY2951742 in Healthy Japanese and Caucasian Participants

The main purpose of this study is to evaluate the safety of the study drug known as LY2951742 in healthy Japanese and Caucasians. The study will also investigate how the body processes the drug and how the drug affects the body. The study is expected to last about 5 to 7 months, depending on the arm.


Eligibility Criteria:
Inclusion Criteria:

* Participants are either Caucasian or first generation Japanese.
* Participants' body mass index (BMI) is between 18.0 and 35.0 kilogram per meter square (kg/ m\^2).

Exclusion Criteria:

* Participants are heavy caffeine drinkers defined by regular intake of more than 5 cups of coffee (or equivalent in xanthine containing beverages) per day, and/or are unable or unwilling to abide by caffeine restrictions as specified in the protocol.
* Participants are smoking within the previous 6 months.
* Participants have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing or have received a vaccination within 1 month.
* Participants have known allergies to LY2951742, related compounds or any components of the formulation, or history of significant atopy.
* Participants are allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone.
Comparison Between Natural Progesterone and Vaginal Pessary for the Prevention of Spontaneous Preterm Birth

The aim of this study is to compare the effectiveness between the cervical pessary and the natural progesterone in reduction of preterm birth rates in pregnant women with a uterine cervical length of 25 mm or less evaluated by transvaginal ultrasonography.

Preterm birth is the leading cause of perinatal morbidity and mortality. The rates of spontaneous premature labor have not changed much during the past 10 years. A significant decrease in mortality and morbidity of premature babies will only be possible if women at risk of spontaneous preterm birth are accurately identified and administered preventive therapies. Ultrasonographic measurement of the cervix between 20 and 24 weeks of gestation can improve the identification of both women with single pregnancies and those with twin pregnancies at risk. Asymptomatic women with a short uterine cervix (25 mm or less) are at increased risk of spontaneous premature labor.

The prophylactic use of progesterone during the early phase of pregnancy in women with a history of preterm birth and those with a short cervix can prevent preterm birth.

The cervical pessary is a device used also for the prevention of preterm birth. Vaginal infections are also important causes of preterm birth. There are not many studies about the vaginal microbiome in pregnant women.

Measurement of cervical length is used as a screening test because it is inexpensive, has a short learning curve, and is well tolerated by patients. In addition, placement and removal of the pessary is an easy, accessible, and noninvasive procedure. The results on the concentration of omega 3 and preterm birth are still conflicting.

The aim of this study is to compare the effectiveness of the cervical pessary and the natural progesterone in reduction of preterm birth rates in pregnant women with a uterine cervix measuring 25 mm or less in length as evaluated by transvaginal ultrasonography, assess whether there is a relationship between maternal plasma concentration of omega 3 and preterm birth, and compare the microbiome in these women.

Methods: A prospective randomized controlled trial including pregnant women at the time of morphological ultrasound between 20 and 23 weeks and 6 days of pregnancy. Pregnant women in this gestational age with cervical length of 25 mm or less will be randomized between the conduct and the inclusion of progesterone vaginal pessary. In patients of both groups vaginal discharge sample will be collected at the time of randomization.

Eligibility Criteria:
Inclusion Criteria:

* gestational age between 20 weeks and 23 weeks and 6 days
* singleton pregnancies

Exclusion Criteria:

* fetal death at randomization
* major structural or chromosomal abnormality
* cervical cerclage in the current pregnancy
* preterm rupture of membranes diagnosed before randomization
A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)

To evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg subcutaneous weekly injection when co-administered with MTX

this study is to evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg subcutaneous weekly injection when co-administered with MTX for additional 48 weeks (a total of 100 weeks including 52 weeks of the treatment period in Study LG-ECCL002) in the subjects who have completed the treatment period of phase III clinical study for LBEC0101 (Study No. LG-ECCL002).

Eligibility Criteria:
Inclusion Criteria:

* Patients who completed the treatment period of Study LG-ECCL002
* Patients requiring continuous treatment for rheumatoid arthritis upon the investigator's discretion
* For childbearing female patients or surgically non-sterile male patients, those who agreed to avoid pregnancy using proper contraceptive methods during the study.
* Patients who made a voluntary decision to participate in this clinical study and gave a voluntary written consent to comply with all the instructions with full understanding after being informed of the study

Exclusion Criteria:

* Patients deemed difficult to participate in this extension study due to the adverse events which occurred in Study LG-ECCL002, upon the investigator's discretion at screening
* Patients with at least 10 swollen joints (out of the total 66 assessing joints) or at least 12 tender joints (out of the total 68 assessing joints) at screening
* Women in pregnancy or lactation, or patients planning to be pregnant during the study period
* Patients ineligible for this clinical study upon the investigator's discretion
Korean Multicenter Registry of EPIC Stent for Iliac Artery Disease: (K-EPIC Registry)

* Prospective, single-arm, multi-center registry study
* A total of 150 subjects with iliac artery disease who meet all inclusion and exclusion criteria will be included.
* Patients will be followed clinically for 12 months after the procedure.
* Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months.
* Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months.
* Quality of life by standardized questionnaires (at baseline \& at 1 \& 12 months)


Eligibility Criteria:
Inclusion Criteria:

1. Age 19 years of older
2. Symptomatic peripheral artery disease:

   * Moderate or severe claudication (Rutherford category 2 or 3)
   * Critical limb ischemia (Rutherford category 4)
3. Iliac artery lesions with stenosis \> 50%
4. ABI \<0.9
5. Patients with signed informed consent

Exclusion Criteria:

1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 5 or 6)
3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
5. Bypass graft lesions
6. Age \> 85 years
7. Severe hepatic dysfunction (\> 3 times normal reference values)
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF \< 40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy \<1 year due to comorbidity
12. Untreated proximal inflow disease of aorta or the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty

This is a randomized, non-blinded, parallel assignment, clinical trial for the evaluation of safety and efficacy of ReHub, a telerehabilitation system made up of a cloud platform and an exercise kit with smart sensors, for performing rehabilitation exercises after a primary Total Knee Arthroplasty.

Primary TKA patients are allocated randomly to the control arm or the experimental arm with a 1:1 ratio. Both arms follow the usual rapid recovery protocol for TKA surgeries at Hospital Clínic de Barcelona, which includes discharge after 2-3 days from the surgery, the prescription of a daily plan of 5 exercises for autonomous rehabilitation and domiciliary visits by a physiotherapist starting approximately 2 weeks after the surgery. The experimental arm participants use ReHub to do their exercises instead of working independently and physiotherapists monitor their performance and adherence remotely.

Outcomes assessment is performed at hospital discharge (baseline), at stitch removal (2 weeks after baseline) and 2 weeks after stitch removal (4 weeks after baseline).


Eligibility Criteria:
Inclusion Criteria:

* Candidates to primary TKA
* Age from 18 to 75 years old
* Ability to understand and accept the clinical study procedure and to sign an informed consent form
* Good predisposition to the use of technology or cohabitation with someone that can give them technological support
* Availability to attend the Hospital for control visits
* Patient resides in the area of influence of Hospital Clínic de Barcelona

Exclusion Criteria:

* Reluctance or inability to use technology
* Any type of disability that could alter the homogeneity of the study
* Sensory and/or cognitive impairment
* Concomitant medical conditions that may influence the rehabilitation process
* Any local or systemic complications after TKA surgery (e.g. surgical wound infection, suspicious of deep vein thrombosis)
Cenobamate in the Intensive Care Unit

The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.

Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70.
* Undergoing EEG monitoring.
* Acute frequent seizures (\>1/hour) or status epilepticus (\>5 min of consecutive seizures, or seizure burden \>20% within past 1 hour).
* Adjunctive conventional antiseizure medication indicated.

Exclusion Criteria:

* History of medication-related rash.
* On medication or device affecting enteral absorption (e.g., phenobarbital, pentobarbital).
* Counterindication to cenobamate as described in the prescribing information.
Study of 24 Hour Blood Pressure and the Association to Complications to Type 1 Diabetes

The aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (BP) in patients with type 1 diabetes. The investigators wish to gain knowledge on the relation between central and peripheral 24 hour BP and a possible association to late complications in diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* more than 18 years of age

Exclusion Criteria:

* End Stage Renal Disease (ESRD)
* dialysis
* other kidney disease than diabetic nephropathy
Electromagnetic Field Effects of Mobile Communication (LTE) on Sleep in the Context of Genetic Variation

The effect of electromagnetic fields of the latest standard in mobile communication (long term evolution, LTE) on sleep is studied in healthy, young individuals.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-30 years
* German knowledge (reading and writing)
* Right-handedness
* Body mass index (BMI) 18.5-25.0 kg/m2
* Mobile communication (phone calls) less than 2 hours per week
* Moderate alcohol consumption (less than 5 alcoholic beverages per week)
* Moderate caffeine consumption (less than 5 caffeinated foods per day, e.g. coke, coffee, energy drinks, green or black tea, chocolate)
* Informed consent

Exclusion Criteria:

* Travels across more than 2 time zones in the last 30 days or during the study
* Nocturnal shift work
* Extreme chronotype or extreme sleep duration (less than 5 hours or more than 10 hours on average)
* Sleep disorders or problems
* Severe acute or chronic neurological, mental or general health disorders, which might impair the participant's safety or affect the study's outcome
* Use of medication (regular or during the study), which might affect the study's outcome
* Recreational drug use
* Smoking (or other tobacco products)
* Severe skin allergies
* Relevant findings in physical examination or during the screening night (e.g. sleep disorders)
* Participation in an other clinical trial in the last 30 days or during the study
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.

This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax ACWY phase at 24-30 months a dose of Mencevax ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered.

Eligibility Criteria:
Inclusion criteria:

* Healthy male or female between and including 15 and 24 months of age
* Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)

Exclusion criteria:

* Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).
* History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.
Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial

Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) refractory to optimal medical management, in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex. It is mainly limited by a high proportion of non-responders. Attempts have been made, in small studies, to increase the number of stimulation sites in order to optimize the resynchronization therapy. V3 is a planned multicenter, randomized trial whose objective is to evaluate the clinical benefit conferred by the addition of a second endocardial or epicardial LV lead in non-responders after at least 6 months of standard biventricular stimulation.

The V3 trial will examine the clinical benefit conferred by the addition of a second LV lead in non-responders compared to standard CRT.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Recipient of a CRT-P or CRT-D system for greater than 6 for standard indications, including LV ejection fraction greater than 35 percent and New York Heart Association (NYHA) functional class III or IV
* Optimized biventricular stimulation and medical therapy since implantation of the system
* Presence of sinus rhythm, or atrial fibrillation with spontaneous or induced complete atrio-ventricular block
* Greater than 93 percent LV stimulation since the last device interrogation, with a LV capture threshold less than 5.0 Volts/0.5 milliseconds
* Unchanged or worsened clinical status by CRT, according to the HF composite endpoint described by M. Packer, in absence of a reversible cause
* Signature of a written, informed consent to participate in the trial

Exclusion Criteria:

* LV lead location in the great cardiac vein
* Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
* Chronic renal dialysis
* Concomitant disorder which might interfere with the results of the V3 trial
* Blood systolic pressure greater than 180 millimeters of mercury (mmHg) or diastolic pressure greater than 95 mmHg despite optimal medical management
* History of stroke, myocardial infarction or unstable angina pectoris within the last 3 months
* Presence of correctible valvular disease
* Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, to comply with the trial's procedures, or to sign the informed consent
* Subject is pregnant
* Subject participates in another research project
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age and able to give informed consent
* Iron deficiency is the primary etiology of anemia
* Screening Visit central laboratory Hemoglobin (Hgb) ≤ 11g/dL
* Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL when TSAT was ≤ 30%

Exclusion Criteria:

* Previous participation in a FCM trial
* Known hypersensitivity reaction to FCM
* Requires dialysis for treatment of chronic kidney disease
* Current anemia not attributed to iron deficiency
* Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
* Anticipated need for surgery
* AST or ALT greater than 1.5 times the upper limit of normal
* Received an investigational drug within 30 days of screening
* Pregnant or sexually-active females who are not willing to use an effective form of birth control