cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder

The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.

This is a randomized, double-blind, placebo-controlled study to evaluate the effectiveness of two dose levels of topiramate (400 and 600 milligrams/day) compared with placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder. The trial consists of 3 phases: a screening period; double-blind treatment for 12 weeks; and an optional open-label period of at least 6 months. Assessment of effectiveness include change from baseline to Day 21 for the Young Mania Rating Scale (YMRS) total score. Also included during the 12 week study are the Global Assessment Scale (GAS), Montgomery-Åsberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS), Clinical Global Impressions (CGI), and health-related quality of life measures at specified time intervals. Safety assessments include evaluation of adverse events, rate of withdrawal from the study due to adverse events, and vital signs (blood pressure and pulse) throughout the study, as well as changes in clinical laboratory tests (hematology, biochemistry, urinalysis), electrocardiograms (ECGs), and physical examinations at specified times. The study hypothesis is that the change from baseline in Young Mania Rating Scale (YMSR) total score at Day 21 will be significantly better for the topiramate groups than for the placebo group. Topiramate tablets (50 or 100 milligrams) or placebo, beginning at 50mg daily and increasing over the first week to a maximum of 400mg/day or 600mg/day, depending on study group. Maximum dosage continues up to 12 weeks. Dosage can be decreased or increased at investigator's discretion.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV), and currently experiencing a manic or mixed episode by DSM-IV and Structured Clinical Interview criteria
* experienced at least one previous manic or mixed episode
* Young Mania Rating Scale (YMSR) score \>=20
* physically healthy
* females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test.

Exclusion Criteria:

* Diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence) by DSM-IV criteria
* DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder
* experienced a manic episode while taking an antidepressant or psychostimulant drug
* no significant and untreated or unstable medical illness of the liver, kidney, heart, lungs, or endocrine system
* no hypersensitivity to topiramate or have previously participated in a topiramate study.
The Impact of COVID-19 Pandemic on Hip and Knee Replacement

During the COVID-19 pandemic, the care of patients undergoing hip or knee replacement for osteoarthritis remains a clinical priority. To date, there is limited empirical knowledge about the impact of pandemic on the care of patients surgically treated for orthopaedic diseases, affected or not by COVID-19.

The aim of the present study is to describe and investigate the effects of the COVID-19 pandemic on the nursing-sensitive and rehabilitation outcomes of patients undergoing hip and knee replacement.

From hospital electronic registry of patients will be possible to screen the patients eligible for the study.

From each electronic patients record, health professional researchers will be responsable to collect data.

Variables about nursing and physiotherapy care, the staffing activities and the outcome achieved by the patients will be collected.

To investigate the impact of COVID-19 pandemic, data of the pandemic period (june-december 2020), will be compared with the data of the same year pre-pandemic (january-march 2020). During the period from april to may 2020, only orthopaedic surgery for emergency trauma or disease was allowed.

Eligibility Criteria:
Inclusion Criteria:

Patients undergone hip or knee replacement for osteoarthritis

Exclusion Criteria:

Patients undergone hip or knee replacement for fracture, trauma or oncological diseases
Association of Perioperative Electroencephalography Spectral Analysis With Postoperative Complications

Using data from electroencephalogram (EEG) obtained through intraoperative depth of anesthesia monitoring devices, combined with clinical symptoms such as postoperative pain and delirium, investigate their correlation and verify whether intraoperative EEG spectral analysis can predict the occurrence of postoperative pain, nausea and vomiting, restlessness, or delirium in patients undergoing surgery.

Due to the complexity of the original EEG waveforms, previous anesthesia depth monitoring systems only calculated a single index, such as Bispectral index (BIS) or patient state index (PSI), to determine the state under anesthesia. However, a single numerical change may not reflect the true state under anesthesia. By analyzing the original EEG waveforms, more information can be obtained, such as density spectral array (DSA) and power spectral density, which can quantify the energy distribution at various brain wave frequencies. This allows anesthesiologists to determine the effects of medication on brain waves and the effects of surgical stimulation on brain waves during surgery.

After obtaining the signed informed consent form, before inducing general anesthesia in the patient entering the operating room, an anesthesia depth monitoring patch is attached to the forehead, and EEG data during anesthesia is collected using the currently used anesthesia depth monitoring device. The monitoring process starts from the beginning of general anesthesia until the end of the surgery, and the EEG recording is stopped only when the patient wakes up from general anesthesia and leaves the operating room.

By using the original EEG during anesthesia depth monitoring to conduct spectral analysis and combining it with common post-anesthesia adverse symptoms such as pain, nausea and vomiting, delirium, and restlessness, a correlation analysis is conducted between the quantified EEG values and postoperative symptoms. This verifies whether intraoperative EEG spectral analysis can predict the occurrence of postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 20 years or older.
2. Patients who received general anesthesia within the our hospital system.

Exclusion Criteria:

1. Individuals with suspected infections, such as a fever higher than 38.3℃
2. Individuals with renal dysfunction, such as those with creatinine levels higher than 1.5 or those who require long-term dialysis
3. Individuals with cardiac dysfunction, such as those with NYHA class III or higher heart failure or coronary heart disease Individuals with neurological diseases, such as those with brain tumors, dementia, stroke, or epilepsy
4. Vulnerable populations, such as minors (under 20 years of age), pregnant women and fetuses, prisoners, adults who cannot give informed consent, individuals with disabilities, individuals with mental illness, residents of nursing homes or long-term care facilities, or those who may be subject to coercion or unable to make decisions freely.
Carbohydrate Mouth Rinsing and Softball Batting Performance

Participants rinsed their mouths for 20 seconds with 25 ml of either 6.4% maltodextrin (CMR) or placebo (PLA). After rinsing, the grip force, counter-movement jump (CMJ) and batting tests were performed in sequence.

The purpose of this study was to investigate the effect of CMR on softball batting performance. Fourteen trained collegiate female softball players completed two trials in a randomization crossover trail, in which they rinsed their mouths for 20 seconds with 25 ml of either 6.4% maltodextrin (CMR) or placebo (PLA). After rinsing, the grip force, counter-movement jump (CMJ) and batting tests were performed in sequence. The tanner tee was utilised to perform five sets of five balls at a time, with a minimum of 3 minutes rest between sets. The batting test recorded average exit velocity, maximum exit velocity and batting accuracy. The standardized standard deviation (SD) for launch angle represents standardized variability.

Eligibility Criteria:
Inclusion Criteria:

* more than 6 years of professional fast-pitch softball training
* more than 6 months of continuous training
* from at least the top four teams in the country

Exclusion Criteria:

* non-professionally fast-pitch softball training
* lack of regular training in the past 6 months
* in the event that the applicant has sustained a sports injury or is currently experiencing epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, or a brain injury, and has yet to undergo a period of recuperation exceeding three months
Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis

Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and efficacy of R115866 will be evaluated during the treatment period and the 8-week post treatment follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Plaque Psoriasis with PASI greater than or equal to 10
* Male or a female who was NOT of childbearing potential (i.e., post- menopausal for greater than 12 months or had a complete hysterectomy);

Exclusion Criteria:

* Spontaneously improving or rapidly deteriorating plaque psoriasis
* Guttate, pustular, erythrodermic, or other non-plaque form of psoriasis
* Subject was under treatment for a heart disorder or had a history of cardiovascular disease (excluding effectively controlled hypertension)
* Any acute psychiatric condition, including an increased risk for suicide attempt, based on medical and psychiatric history
* Previous use of a psoriasis vaccine or had participated in an investigational study of a psoriasis vaccine
* Previous use of systemic immunomodulatory therapy known to affect psoriasis and to typically decrease immune cell populations
* Previous use of any systemic immunomodulatory therapy known to affect psoriasis and NOT typically to decrease immune cell populations
* Previous use of any photo-therapy (including laser), photo-chemotherapy, or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or cyclosporine) within the previous four weeks
* Pregnant or a nursing mother
* Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, cancer (except non-melanoma skin cancer), a positive test for human immunodeficiency virus (HIV), a history indicating adrenal cortex dysfunction
Capsimax Effect on Metabolic Rate, Satiety and Food Intake

Comparison of Capsimax™ 2mg and 4mg of capsicum extract vs. placebo on metabolic rate and satiety.

Capsimax™ is a capsicum extract in a bead technology to avoid oral and gastric burning. Capsimax™ 2mg, Capsimax™ 4 mg and placebo was initially given as a single dose on an empty stomach with measures of metabolic rate, and satiety before and after and food intake at 1 hour after Capsimax™.

Eligibility Criteria:
Inclusion Criteria:

1. BMI between 25 and 40 kg/m2 inclusive
2. Healthy
3. If of child-bearing potential, use of effective contraception

Exclusion Criteria:

Subjects excluded will:

1. Have received an investigational product in another trial within 30 days of enrollment.
2. Have lost 10 or more pounds in the 3 months prior to randomization and maintained the weight loss.
3. Use tobacco products
4. Use a nicotine patch or gum.
5. Take regular medication other than oral contraceptives or estrogen replacement therapy.
6. Take products containing ephedra or medications known to increase metabolic rate like stimulants taken for attention deficit disorder.
7. Not eat at regular mealtimes.
8. Have a history of alcohol or drug abuse in the past year.
9. Nurse a baby or be a member of a vulnerable population including adults unable to consent, pregnant women, prisoners or minors.
10. Have a clinically significant history of diabetes, high blood pressure (\>140/90), thyroid disease, heart disease, kidney disease or liver disease.
11. Have a known allergy to capsaicin caffeine, piperine or niacin.
12. Have clinically significant laboratory findings in the opinion of the investigator.
13. Score greater than 13 on the restraint scale of the 3-factor eating questionnaire.
Effects of Hypolipemic Treatment on Adipokines

The study is planned to show whether monotherapies or combined hypolipemic therapy influence the fasting plasma glucose, serum adipokines (leptin, adiponectin, resistin) and proinflammatory cytokines (interleukin-6, TNF alpha) during 30 and 90 day course.


Eligibility Criteria:
Inclusion Criteria:

* Age (35-64yr)
* Primary hyperlipidemia (Total cholesterol \>200mg/dl, Triglycerides \>150mg/dl)
* Impaired fasting glycemia (glycemia 100-125mg/dl)
* For women:
* Menopause (\>12 months)
* Post hysterectomy
* Mechanical contraception
* Obtained informed consent

Exclusion Criteria:

* Secondary hyperlipidemia
* Morbid obesity (BMI\>40kg/m2)
* Alcohol or drug abuse
* Acute or chronic inflammation
* Congestive Heart Failure (NYHA III or IV)
* Unstable Ischaemic Heart Disease
* Moderate or severe hypertension
* Cancer in less than 5 years
* Chronic kidney disease (stage III-V)
* Liver failure
* Diabetes
* Oral contraception
* Not compliant patient
* Laboratory results:
* alanine transferase (\>3xULN)
* creatine kinase (\>5xULN)
* haemoglobin (\<10/dl)
* PLT (\<100G/l)
* WBC (\<3,5G/l or \>10G/l)
A Modified Rabbit Training Model for Establishing an Emergency Front of Neck Airway in Children

A "cannot intubate, cannot oxygenate" (CICO) situation is rare in paediatric anaesthesia, but can always occur in children under certain emergency situations. There is a paucity of literature on specific procedures for securing an emergency invasive airway in children under the age of 6 years. A modified emergency Front Of Neck Access (eFONA) technique using a rabbit cadaver model was developed to teach invasive airway protection in a CICO situation in children.

After watching an instructional video of our eFONA technique (tracheotomy, initial intubation with Frova catheter over which an endotracheal tube is inserted), 29 anaesthesiologists will perform two separate attempts on rabbit cadavers. The primary outcome is the success rate and the performance time overall and in subgroups of trained and untrained participants.


Eligibility Criteria:
Inclusion Criteria:

* Anesthesiologists working at the department of Anesthesia at University Children's Hospital Zurich

Exclusion Criteria:

* n.a.
Response to Supplement and Placebo in GERD

The purpose of this study is to investigate the effects of a widely available over the counter supplement marketed for heartburn symptoms on symptoms and health-related quality of life in patients with gastroesophageal reflux disease (GERD). This study is designed as a pilot trial to assess safety and feasibility and to provide preliminary estimates of effect sizes.


Eligibility Criteria:
Inclusion Criteria:

* Adult humans age 18-80.
* Fluency in written and spoken English.
* Heartburn symptoms 3 or more days per week for the past month.

Exclusion Criteria:

* Individuals taking a proton pump inhibitor (PPI) or H2 receptor blocker with a dose change within 2 weeks of the initial study visit.
* Individuals with Crohns disease, systemic sclerosis, known active ulcer disease, gastric cancer, Barrett's esophagitis
* Significant pain or difficulty with swallowing
* Heavy alcohol use (defined by \> 6 drinks/week for women and \> 13 drinks/week for men)
* Concurrent pregnancy
* Dementia
* Uncontrolled psychiatric disease
* Individuals unable to complete a paper symptom diary for 6 of 7 days prior to their baseline visit
* Subjects whose symptoms are predominantly dyspeptic more than heartburn or reflux
* Subjects who have used homeopathy for GI symptoms or have received constitutional homeopathic treatment within the past 2 weeks
* Subjects taking herbal products or other supplements for GERD or dyspepsia related symptoms (includes peppermint oil)
* Subjects who have taken \> 12 doses of NSAIDS within the prior 30 days (aspirin ≤ 325 mg daily is allowed)
* Subjects with lactose intolerance
Combined Bio- and Neuro- Feedback vs. Varenicline Use for Smoking Cessation

This study will develop and experimentally test the efficiency of a neurofeedback training protocol vs. varenicline use for smoking cessation.

This study will develop and experimentally test the efficiency of a neurofeedback(NF) training protocol for smoking cessation. As non-pharmacological, non-invasive and painless brainwave technique, NF contributes to teach individuals how they can take the control of their mind through operant conditioning. NF regulates brain function in natural way. Studies have reported an 80% rate of reducing or eliminating the need for traditional medication14. Therefore, other nicotine substitutes (such as varenicline) which may carry their own toxicity risk factor may become redundant. The protocol will include 5 bio- and 25 Neuro-feedback sessions, lasting approximately 36 months.

The electrophysiological evaluation of the efficacy of the intervention will include EEG resting state and a multifeature Mismatch Negativity (MMN) evoked response measurements before and after the participation of human volunteers. These data will be analyzed in terms of cortical activation patterns and cortical connectivity. Questionnaires will be used to collect behavioral and psychometric data regarding smoking related behaviors. Additionally, a clinical evaluation including spirometry, exhaled carbon monoxide, total antioxidant capacity, vitamine E, and cotinine will be conducted. The data will be collected prior, during, after the completion of the study and after a one-year follow up.

The Neurofeedback intervention will be compared to a different group of participants that will follow an intervention based on varenicline use for approximately 3 months. The electrophysiological evaluation of the efficacy of the intervention will include EEG resting state and a sleep polysomnography measurement. Questionnaires and clinical evaluation include the same measurements as the neurofeedback intervention but only in 3 time points: prior, during, after the completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Being continuous tobacco smokers (\>10 cigarettes per day) for at least 6 months
* Being unemployed for at least 3 months
* Being diagnosed with Asthma
* Being diagnosed with C.O.P.D.
* Age \< 35, for the group of Young Unemployed
* Age \>35 years, for the groups of Asthma and C.O.P.D. patients

Exclusion Criteria:

* Diagnosed neurological, mental or psychiatric illness
* Drug-resistance epilepsy
Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants

This Post-Market Clinical Follow-Up study aims to document the success and survival of the Axiom® BL X3 Implants up to 3 years after loading.

The total study duration for each patient should be 3 years after loading. .

The investigational devices are CE-(Conformité Européenne, meaning European Conformity) marked product.

14 centers will participate in France

Implants used are Axiom® BL X3 with lengths ranging from 6.5 to 18 mm and diameters ranging from 3.4 to 6.4 mm.

The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155, 21CFR 820 for FDA requirement and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.

Eligibility Criteria:
Inclusion Criteria:

* Patients must provide their informed consent for study participation and must be willing and able to attend control visit (in the standard of care)
* Patients must be males or females who are a minimum of 18 years of age
* Patients seeking an implant supported restoration
* Patient Affiliated to (or beneficiary of) the French Social Security
* Patients who do not present any contraindication for implant restoration, in accordance to IFU

Exclusion Criteria:

* Patients who have no follow-up visit planned with the investigator or co-investigators
* Patients with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance with study visit or unreliability
* A woman who is pregnant or planning to become pregnant at any point during the study duration
* Patients currently participating in another clinical research
* Patients who present contraindication for implant restoration, in accordance to IFU
* Adults under guardianship
A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients

RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer. RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.

RADICAL PC describes two prospective studies, one of which is embedded in the other. RADICAL PC1 is a prospective cohort study of men within one year of their first diagnosis of prostate cancer, or treated with Androgen Deprivation Therapy for the first time within 6 months prior to enrollment visit, or to be treated with Androgen Deprivation Therapy for the first time within one month after the enrollment visit. Its goal will be to identify factors associated with the development of cardiovascular disease among men with prostate cancer, with a particular focus on Androgen Deprivation Therapy. RADICAL PC2 is a randomized, controlled trial embedded in RADICAL PC1. RADICAL PC2 will test a systematic approach to modifying cardiovascular and lifestyle risk factors in men within one year of their first diagnosis of prostate cancer, or treated with Androgen Deprivation Therapy for the first time within 6 months prior to enrollment visit, or to be treated with Androgen Deprivation Therapy for the first time within one month after the enrollment visit.

Eligibility Criteria:
Inclusion Criteria:

1. A man with a diagnosis of prostate cancer that is either:

* new (i.e. the diagnosis was made within 1 year of the enrolment visit) or
* treated with Androgen Deprivation Therapy for the first time within 6 months prior to the enrolment visit, or
* to be treated with Androgen Deprivation Therapy for the first time within 1 month after the enrolment visit

Exclusion Criteria:

1. Patients will be excluded if they fulfill any of the following:

   1. are unwilling to provide consent or
   2. are \<45 years of age, or
   3. prostate cancer was found incidentally following cystectomy for bladder cancer
2. Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they:

   1. see a cardiologist every year, or
   2. both take a statin and have systolic blood pressure ≤130mmHg