cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18

This clinical study is a randomized, open label, multiple-dose, 2-way crossover, phase I (Bioequivalence) study to compare the safety and pharmacokinetics profile of WID-CLZ18 and Clozaril 100 mg tablet (Clozapine) after oral administration in schizophrenia patients.


Eligibility Criteria:
Main Inclusion Criteria:

1. Males and females adults aged 20 to 65 years
2. Diagnosed as schizophrenia prior to the screening visit
3. On treatment with a stable dose of clozapine 200 mg/day for at least 12 weeks before the screening visit and taken at 100 mg twice daily during the study period

Main Exclusion Criteria:

1. Subjects who have a medical history specified in protocol
2. Subjects with confirmed abnormal laboratory values specified in protocol
3. Subjects who have a medication history or safety risks specified in protocol
4. Subjects who can not comply with requirements of pharmacokinetic sampling as per protocol
5. Subjects who are expected to have the prohibited concomitant medication therapy during the study period
6. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy
7. Subjects who are not suitable for the clinical trial
The Implementation of PREP2 Algorithm Into Clinical Practice

Stroke is a worldwide major cause of disability with great social and economic burdens. The recovery of motor function is crucial for the patient to regain independence and quality of life. Identifying early predictors of motor recovery and outcomes is useful for planning personalized rehabilitation programs and increasing their efficiency. However, making predictions using a single clinical assessment is often difficult and a combination of multiple tools is required. In the last decades, were validated two predictive algorithms for upper limb function and independent walking that can be easily implemented into clinical practice with the aim of increasing knowledge on expected outcome after stroke in patients, families and rehabilitation teams. This will be the first single-site randomized control trial that will test the implementation of such tools in a rehabilitation setting in Italy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stroke;
* new upper and/or lower limb weakness.

Exclusion Criteria:

* cerebellar or bilateral stroke;
* contraindication to TMS;
* cognitive or communication impairment precluding informed consent;
* assisted walking prior to admission;
* severe medical conditions.
Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

Study objective: To investigate the potential anti-proteinuric efficacy of aliskiren, a novel direct renin inhibitor (DRI), in addition to angiotensin receptor blocker (ARB) in immunoglobulin A nephropathy (IgAN) patients at risk of developing progressive renal failure.

This will be an open-label pilot study in which IgAN patients with persistent proteinuria despite maximum dose of ARB treatment will be assigned to receive Aliskiren. There is the optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of \<130/80 mmHg.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 - 70 years of age
* Histologic diagnosis of IgA nephropathy
* Proteinuria \> 1 g/day or UPC \> 1 mg/mg or 113 mg/mmol at least twice
* Receiving treatment with the maximum dose of ARB for at least 3 months
* Patients who are willing to give written, informed consent

Exclusion Criteria:

* eGFR \< 15 ml/min/1.73 sq.m
* UPC \>5000 mg/g or 570 mg/mmol, or \<500 mg/g or 57 mg/mmol
* Serum K+ \> 5.2 mmol/L
* Presence of bilateral renal artery stenosis
* Presence of diabetes mellitus
* Renal histology showing pathologies other than IgAN
* Known allergy to ARB or DRI
* Patients on ARB/ACEi combination within 12 weeks of randomization
* Concurrent treatment with corticosteroids, Nsaid, or immunosuppressant
* Patients with connective tissue disease or obstructive uropathy
* Patients with malignancy or conditions severely limiting life expectancy
* Female who are pregnant or intending to conceive
* Female of child-bearing age unwilling to practice contraception
* Patients who are unable to give informed consent
* Patients simultaneously participating in another study
Assessing Speech Perception and Amplification Benefit During Infancy

The goal of this project is to compare aided and unaided speech discrimination among infants with hearing loss and a cohort of infants with typical hearing.

Working Hypothesis: Among this group of infants with hearing loss, performance will be significantly better when infants are tested while using amplification (i.e., aided condition) compared to when tested without amplification (i.e., unaided condition). Infants fit with optimally programmed amplification will perform similarly to the infants with typical hearing on speech discrimination tasks.


Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 6 months and 36 months (inclusive) at the time of enrollment.
* English is the primary spoken language in the home
* Demonstrated ability to complete a conditioned head turn via visual reinforcement audiometry (VRA)
* If normal hearing

  -Normal hearing sensitivity bilaterally
* If Hearing Loss

  * Children with diagnosis of bilateral sensorineural hearing ranging from mild to severe
  * Children currently using hearing aids
  * Children currently enrolled in intervention

Exclusion Criteria:

* Children born earlier than 35 weeks gestation
* Children with abnormal tympanometry on the day of testing
* Children with concerns of secondary disabilities
* Children with Auditory Neuropathy
* Concerns of hearing loss in normal hearing children
Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium: Comparison Between Sugammadex Versus Neostigmine

Cholinesterase inhibitors such as Neostigmine and Edrophonium have been used to reverse neuromuscular blockade after surgery. However, these drugs have a relatively slow onset and have adverse effects associated with stimulation of muscarinic receptors. In addition, neostigmine cannot be used to reverse profound blockade.

Anesthetics may exert their effects on various facets of cerebral function such as cerebral metabolic rate (CMRO2), cerebral blood flow (CBF), cerebral blood flow-metabolism coupling, intra cranial pressure (ICP), autoregulation, vascular response to CO2 and brain electrical activity. The net result of all these effects of the anaesthetic agents combined with their systemic effects may prove beneficial or detrimental to an already diseased brain.

In neurosurgical patients, clear and rapid recovery is required to early assess the neurological status and to maintain the cerebral oxygenation and metabolism within the normal physiological values which may be saved by sugammadex.

The aim of this study is to compare Sugammadex versus neostigmine as a reversal to the neuromuscular blockade of rocuronium in patients undergoing supratentorial tumors resection. Comparison will include hemodynamics, respiratory effort and degree of sedation.

Indicators of global cerebral oxygenation and haemodynamics will be calculated using jugular bulb and peripheral arterial blood sampling.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical class status I - III .
* Patients scheduled for elective supratentorial brain tumor resection

Exclusion Criteria:

* Severe uncompensated cardiac disease.
* Severe uncompensated respiratory disease.
* Severe uncompensated hepatic disease.
* Severe uncompensated renal disease.
* Morbidly obese patients.
* Documented hypersensitivity to one of the used drugs.
* Surgery in sitting position
* Surgery in prone position
* Patients with altered level of consciousness.
* Pregnancy.
Epstein-Barr Virus and Cancer Risks

The goal of this prospective cohort study is to investigate the associations between Epstein-Barr Virus (EBV) antibody levels and the risk of overall and site-specific cancer types in Southern China. The main questions it aims to answer are:

Question 1: In addition to the established EBV-associated cancer types, such as lymphomas, nasopharyngeal carcinoma, and stomach cancer, whether EBV is associated with other cancer types? Question 2: What's the cancer burden attributed to EBV in Southern China?

Growing molecular evidence suggests the involvement of EBV in various cancers, however, comprehensive epidemiological evidence is still lacking. In this study, researchers conducted a population-based prospective cohort study to investigate the associations between EBV antibodies and the risk of overall and site-specific cancer types in Southern China. All the participants underwent EBV antibody tests at enrollment and were subsequently followed up annually for cancer incidence, vital status, and immigration status. The primary objective of this study was to provide prospective evidence for the role of EBV in multiple cancers, shedding light on the etiology of a broad range of common EBV-associated cancers.

Eligibility Criteria:
Inclusion Criteria:

* Subject residents in Zhongshan or Wuzhou City;
* Subject has no medical record of prevalent cancer;
* Subject has psychical condition and well consciousness, and willingness to accept and cooperate with the study\&amp;#39;s follow-up procedures.

Exclusion Criteria:

* Subject has heavy cardiovascular, liver, or kidney disease;
* Subject has prevalent cancer.
Acceptability of Video Games to Promote Asthma Education and Self-management in Children

Asthma is a chronic lung disease affecting over 800,000 Canadian children. Knowing how to avoid asthma triggers, to take care of one's health, and to know when and why to do one's treatment can help prevent asthma crises, and have a better quality of life.

Games in health can make the management of asthma easier by helping the child better understand his condition, his triggers, and manage his asthma by himself. Games also offer a personalized experience, where players can receive feedback about their learning. However, few studies explored the use of games in childhood asthma.

This study will test 4 games for children with asthma. Through different characters and scenarios, the goals of the games are to help the child with asthma to better recognize and manage his asthma triggers and symptoms. The objectives of this study are:

* Evaluate the acceptability of these games in children with asthma
* Gather feedback on the games to guide future development


Eligibility Criteria:
Inclusion Criteria: Along with a parent, children

* aged 8-12 years inclusively
* with physician-diagnosed asthma
* who are on a daily controller medication
* who understand French or English.

Exclusion Criteria: children with

* chronic respiratory conditions other than asthma
* cardiovascular diseases
* neuromuscular disorders
* developmental delay.
Analysis of Postural Control in Children Suffering From Triceps Suralis Shortening.

The central nervous system (CNS) coordinates balance through the visual, vestibular, and somatoproprioceptive systems, which produce muscle activation for postural control. Among the important muscle activations for postural control are those produced in the ankle joint, which is crucial for maintaining postural control in sports settings, along with the gastrocnemius and soleus muscles. Studies show that children who practice sports improve their postural stability and accelerate sensory maturation, which can affect the development of the lower limb extremity, specifically the insertional musculature of the ankle and foot. The present study aims to analyze postural control in school-aged children with triceps suralis retraction and assess the effectiveness of treatment with stretching versus a heel pad for 3 and 6 months. Additionally, the study will analyze whether the physical activity the children engage in influences their stability

A randomized controlled trial will be conducted to evaluate the effectiveness of using a heel pad and a gastrocnemius and soleus stretching protocol. The outcomes of both interventions will be evaluated and compared, including pre-intervention and post-intervention assessments at 3 months and 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Children 8-12 years old
2. Regular sports practice
3. Decreased range of flexión

Exclusion Criteria:

1. Having neurological, vestibular, muscular, psychological or visual visual disease.
2. Traumatic pathology 12 months prior to the measurement (sprains, talalgias, etc.).
3. Diseases of balance or motor control.
4. Surgeries in the last 12 months.
5. Taking medications that may affect the neuromuscular system.
6. Sports practice in the last 48 hours.
Measurement of the Skin Sympathetic Nerve Activity

Sympathetic nerve activity can be measured transcutaneously in awake patients by computer-based filtering of raw signal obtained via skin leads attached on the chest. Electrocardiogram can be removed by applying a high-pass filter setting of 150 Hz. Electromyogram can be filtered by applying a high-pass filter setting of 500 Hz or a band-pass filter setting of 500-1000 Hz.

However, it is not known whether the skin sympathetic nerve activity (SKNA) can be measured in anesthetized and/or paralyzed patients. Therefore, we planned this pilot study to observe whether the SKNA can be obtained in these patients. If the SKNA ca be observed, it will be presented in milivolt (uV).


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo resection of breast cancer under general anesthesia after insertion of laryngeal mask airway

Exclusion Criteria:

* Autonomic nervous system disease
* Medication acting on the autonomic nervous system
* Refuse to participate
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects

This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females ≥ 50 years
* Body mass index equal to or greater than 18.5 kg/m2 and less than 35.0 kg/m2

Exclusion Criteria:

* Known or suspected allergy to tolterodine ER or darifenacin or their components
* Subjects with irregular day and night patterns such as night shift workers
* Significant medical problems know to affect heart rate (ie., hypertension, hypotension, history of heart failure, history of pulmonary disease, etc.)
* History of any malignancy within the past 5 years, with the exception of localized basal cell carcinoma of the skin
* Pregnant or nursing women
* Subjects with diseases such as urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, severe renal insufficiency, etc.

Other protocol-defined inclusion/exclusion criteria may apply
Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.


Eligibility Criteria:
Inclusion Criteria:

* Male \>/= 18 years of age
* Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy
* Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of:

  1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association \[AUA\]); or
  2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology \[ASTRO\]-Phoenix)
* Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1
* Life expectancy ≥6 months as determined by the investigator
* Able and willing to provide informed consent and comply with protocol requirements

Exclusion Criteria:

* Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
* Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer
* Treatment with ADT in the past 3 months of Day 1
* Receipt of investigational therapy for prostate cancer within 60 days of Day 1
* Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study
Kenya HIV Self-Testing in PrEP Delivery

In a three-arm, randomized trial, the investigators will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent PrEP adherence and HIV testing.

Guidelines recommend HIV-1 testing quarterly for individuals on PrEP. Clinic-based HIV testing every three months is costly for both clinics and participants. The investigators propose using HIV self-testing to replace quarterly clinic-based HIV testing for participants on PrEP, eliminating half of clinic visits and saving staffing and participant costs. The investigators want to understand the effect that reduced clinic contact frequency (resulting from HIV self-testing) has on PrEP adherence or completion of HIV-1 testing, overall and in subgroups.

The investigators will enroll roughly 495 eligible individuals on PrEP: 165 men and 165 women in HIV-1 serodiscordant couples and 165 women at risk of HIV-1 infection (priority populations for PrEP delivery in Kenya and more generally in Africa).

In this study, participants will be randomly assigned in a 2:1 fashion to either six-monthly clinic visits or quarterly clinic visits. Participants randomized to six-monthly clinic visits will receive a 6-month supply of PrEP and either two blood-based HIV self-tests (blood-based HIV self-testing arm) or two oral fluid HIV self-tests (oral fluid HIV self-testing arm). Participants randomized to quarterly clinic visits will receive a 3-month supply of PrEP and get tested for HIV by a healthcare professional at the clinic (standard of care arm)

Study outcomes, measured at Months 6 and 12, include PrEP adherence (defined as the detection of PrEP in dried blood spots as well as persistence in refilling PrEP), HIV-1 testing, and safety (including side effects and social harm).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years HIV-1 uninfected based on negative HIV-1 rapid testing
* Not currently enrolled in an HIV-1 prevention clinical trial
* Taking PrEP and planning to continue
* Willing to be randomized to either clinic based HIV-1 testing or HIV-1 self-testing
* Note: Women who are pregnant at screening/enrollment are still eligible

Exclusion Criteria:

* Unable to provide written informed consent
* Contraindication to use Tenofovir (TDF)+/- Emtricitabine (FTC)/ Lamivudine (3TC)

For the HIV-1 serodiscordant couples, HIV-1 infected members of the couple will be enrolled for a single visit at baseline, if:

* Age ≥18
* Able and willing to provide written informed consent
Incidence of Chronic Pain After Thoracotomy

Thoracotomy is frequently performed in thoracic surgery. It is widely accepted that thoracotomy causes severe acute pain. Many factors such as postoperative analgesia treatment plan, operation time, number of chest tubes, and duration of chest tube stay can affect acute pain. This acute pain prolongs the discharge time of the patients and increases the frequency of postoperative pulmonary complications and postoperative morbidity. Postoperative acute pain may cause chronic thoracotomy pain in the later period, and may adversely affect the quality of life of the patients.

This study aims to analyze the symptoms of chronic pain in the 3rd and 6th months postoperatively in patients who had undergone thoracotomy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index (BMI) between 18-35 kg/m2
* Patients undergoing elective thoracotomy

Exclusion Criteria:

* Advanced cancer
* History of chronic analgesic therapy
* Patients with previous thoracic surgery
* Patients who were operated under emergency conditions
A Study of the Pharmacokinetics And Pharmacodynamics of Intravenously Administered Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C And Previous Non-Response to Pegylated Interferon And Ribavirin Combination Therapy

In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis C genotype 1 who were non-responders to previous standard combination therapy with pegylated interferon and ribavirin. Patients will be randomized to receive either weekly or twice weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after a washout period of 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult caucasian patients, 18 - 70 years of age
* Hepatitis C, genotype 1
* Non-responder to previous anti-HCV therapy with peginterferon alfa and ribavirin
* Compensated liver disease (Child-Pugh class A) for \>/= 24 months before baseline
* Positive for anti-HCV for \> 6 months, with detectable serum HCV-RNA

Exclusion Criteria:

* Treatment-naïve or responder to previous therapy
* HCV infection other than genotype 1
* Positive for Hepatitis A, Hepatitis B or HIV infection at screening
* Chronic Hepatitis of other than HCV origin
* Decompensated liver disease (Child-Pugh class B or C)
* Therapy with systemic antiviral, antineoplastic or immunomodulatory agents in the 6 months prior to study
* Clinically relevant retina disorder
* Pregnant or lactating women and male partners of pregnant women
BUDI (Bariatric UroDynamic Improvement)

In the population of obese women, the prevalence of urinary incontinence (UI) is around 70%. It was shown in the literature that weight loss by bariatric surgery allowed a significant improvement in the symptoms and impact on the quality of life of the IU. However, no prognostic factor for recovery has yet been identified and the pathophysiological mechanisms underpinning this improvement are not fully elucidated.

The main objective of this study is to highlight the urodynamic changes associated with the improvement of the symptom and quality of life scores in a population of incontinent obese women before and after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

The research protocol will be proposed to all patients requiring bariatric surgery (gastric bypass or sleeve gastrectomy) and describing urinary incontinence according to the definition of the International Continence Society (ICS)

Exclusion Criteria:

* minors under the age of 18
* pregnant or lactating women
* women not speaking French (important to understand and respond to questionnaires)
* women who have not given their written consent
* neurological diseases,
* patients who have benefited from urinary incontinence surgery, prolapse treatment or pelvic surgery at risk of urodynamic modifications (extensive resection of deep endometriosis, pelvic wound surgery, pelvic radiation therapy).