cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of KUC 7483 CL Tablets in Healthy Male Volunteers

Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

   1.1 No finding deviating from normal and of clinical relevance

   1.2 No evidence of a clinically relevant concomitant disease
2. Age ≥ 30 and Age ≤ 60 years
3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance

The clinical relevance of study parameters will be assessed by the investigator or his deputy
Role of the Autonomic Nervous System in HIV-Lipodystrophy

The study aims to characterise the influence of the autonomic nervous system activity on the development of the lipodystrophy syndrome in HIV-infected patients by measuring heart rate variability and various metabolic pathways in HIV patients receiving highly active antiretroviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infection
* Age above 18 years
* No AIDS defining event during last 6 months
* No infection during last 6 weeks
* No concommitant drug interfering with insulin sensitivity and ANS-activity
A Multimodal Predictive Recurrence Score for Patients With Clear Cell Renal Cell Carcinoma

The main goal of this observational study is to construct a predictive recurrence model for renal clear cell carcinoma through an artificial intelligence multimodal algorithm, which will improve the prognosis and survival time of ccRCC patients by helping clinicians to formulate individualised follow-up and to screen for appropriate adjuvant therapy candidates.


Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant renal tumours must have postoperative pathological confirmation of renal clear cell carcinoma with pathological TNM stage Ⅰ-Ⅲ;
* Have available preoperative imaging
* Have available post-operative pathological paraffin samples or HE-stained tissue sections
* Must agree to and be able to comply with the study's visit schedule and other requirements as specified in the protocol, including follow-up visits by telephone

Exclusion Criteria:

* The patient's tumour type cannot be determined on the basis of histopathological sections
* Simultaneous combination of primary tumours at other sites;
* No regular follow-up imaging data
* Cases in which other factors led the investigator to believe that enrolment was inappropriate
* Cases that met all the inclusion criteria of the appeal and did not meet all the exclusion criteria were selected for this study
Tracking Results of Ablations to Combat AF Registry Generation 2

The primary objective of the TRAC-AF Registry is to capture real-world safety and effectiveness data on AtriCure devices used to conduct concomitant open heart and/or hybrid ablation, and management of the Left Atrial Appendage concomitant to a cardiac ablation.

The TRAC-AF registry is a proactive measure for AtriCure to remain informed about the safety and effectiveness of their ablation devices and associated procedures under real-world use conditions. The analysis of the data from the registry may be used for product development efforts, regulatory submissions, and publications.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has been scheduled by physician(s) to undergo or has undergone cardiac ablation procedure(s) utilizing at least one AtriCure device.

   EXCEPTION: Participating registry sites that wish to compare AtriCure devices, and their associated procedures' safety and effectiveness, with other therapies for the management of cardiac diseases, can include patients who did not receive treatment with an AtriCure device, but were treated or will be treated for similar baseline disease state.
2. Patient is willing to provide written informed consent, (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry), or authorization per institution and geographical requirements.

Exclusion Criteria:

1. Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.
2. Patient with exclusion criteria required by local governance.
Immediate and Short-term Effects of Low-level Laser

Athletes experience an exhaustive routine of training, associated with the reduced time of rest, facilitates the appearance of muscle fatigue, which increases the risk of muscle injuries, especially during the execution of the jump. Low Level Lasertherapy is a technique that has been increasingly improved due to the physiological effects it provides in the muscle recovery process. However, there is still a lack of studies focused on the use of this technique in functional improvement, especially in jumping sports. Objectives: To evaluate the immediate and short-term effects of low-level laser on the functional performance of lower limbs of jumping athletes and to evaluate the short-term effects of low-level laser on the activation of the gluteus medius and quadriceps muscles. Methods: This is a brief, double-blind, randomized, placebo-controlled clinical trial. Will be recruited 24 handball and volleyball players aged between 18 to 35 years. The primary outcome of our study is functional performance (modified hop test and modified SEBT), and as a secondary outcome (level of electromyographic activity). After the baseline assessments, the athletes will be randomized and allocated into two groups: Intervention Group (IG, n=12) and Control Group (CG, n=12) and submitted to a fatigue protocol, followed by laser therapy or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Handball and volleyball athletes;
* Age between 18 and 35 years;
* Both sexes;
* Athletes who maintain a training routine for their sport, at least twice a week

Exclusion Criteria:

* History of acute injury to the lower limbs (LL) in the last 2 months;
* Occurrence of pain and injury during the study;
* Any change in physical activity routine during the week of assessments.
Lexapro®'s Efficacy After Dose Escalation in Remission Study

The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and 30 mg in patients with major depressive disorder.

In this study, the investigators are going to examine the efficacy of escitalopram after dose escalation and evaluate remission rate. This study design is the double-blinded 6-week prospective study. It would be useful for clinicians because there were few study of high-dose antidepressant treatment in lack of remission in major depressive disorder patients. To control of bias, the investigators included patients with lack of remission after 4-week escitalopram treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 \~ 65
* Patient with major depressive disorder according to DSM-IV criteria
* Patient have signed on the informed consent, and well understood the objective and procedure of this study.
* MADRS total score ≥ 18
* Competent patient who is manage to answer the questionnaires.
* In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.

Exclusion Criteria:

* In previous depressive episodes, no efficacy although more than one antidepressant treatment
* Allergy or hypersensitivity to escitalopram
* Diagnosed to schizophrenia or bipolar disorder or schizoaffective disorder (DSM-IV)
* MADRS 10 score ≥ 5, or patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion
* Pregnant or breast-feeding female patient
* Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion
* Significant severe medical condition
* Patients who take antipsychotics or mood stabilizer or other psychiatric drugs excluding benzodiazepines or beta blockers or hypnotics
* History of participating to other investigational drug trial within 1month prior to screening
* Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator
Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension

The aim of this study is to assess whether renal denervation (RD) added to usual care compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP monitoring (ABPM) after 6 months in subjects with an average day-time systolic BP of at least 135 mmHg as determined with use of ABPM, despite use of three or more BP lowering agents or with documented intolerance or contraindication for to 2 or more of the 4 major classes of antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics) obstructing use of 3 antihypertensives

Further aims are to assess the effect of renal denervation on the use of BP lowering agents, to explore the effect of renal denervation in strata of estimated glomerular filtration rate (eGFR) (eGFR 20-60 mL/min per 1.73m2 and eGFR\>60 mL/min per 1.73m2) and according to baseline office BP.

Randomization will be stratified by hospital and eGFR and will be at a 2:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

1. Individual has a mean day-time SBP ≥ 135 mmHg, as determined with the use of ABPM, while using 3 or more antihypertensive agents for at least 3 months prior to inclusion or with documented intolerance to 2 or more of the 4 major classes antihypertensive drugs ( ACE/ARB, Calcium channel blocker, Beta Blocker, Diuretic) and no possibility to take 3 anti-hypertensive drugs.
2. Individual is ≥18 years of age.

Exclusion Criteria:

1. Individual is unable or unwilling to sign informed consent.
2. Individual has a treatable secondary cause of hypertension.
3. Individual has an eGFR below 20 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) calculation.
4. Individual has renal artery anatomy that is ineligible for treatment
5. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
6. Individual is pregnant, nursing or planning to be pregnant.
7. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
8. Individual is currently enrolled in another investigational drug or device trial.
Ultrasound-guided Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block and Serratus Anterior Plane Block for Breast Surgery

The study will compare ultrasound-guided Pectoral nerve block, Erector Spinae Plane block, and Serratus anterior plane block for pain management following elective breast surgeries

Adequate acute postoperative pain control is important for patients undergoing breast surgery because the pain may be severe and longlasting. Surgical incision at the breast and axillary areas is associated with significant pain, with high incidence of acute pain progressing to chronic pain in 25% to 60% of patients. Post-mastectomy pain managed with opioids often lead to side effects of nausea and vomiting.

Regional anesthetic techniques are used in the current management of pain associated with breast surgeries .They attenuate surgical stress response , intraoperative consumption of opioid, prevent central sensitization and diminish postoperative pain.

The efficacy of fascial plane blocks like pectoral nerve block (PECS), serratus anterior plane block (SAP), and erector spinae plane block (ESP) has been proven in previous studies. These blocks require deposition of local anesthetic in an inter-fascial plane through which peripheral nerves travel.

The Pectoral nerve block relies upon the deposition the local anesthetic at the inter-fascial planes among the pectoralis major, minor, and serratus anterior muscles: it blocks the pectoral, the intercostobrachial, the intercostals III and VI, and the long thoracic nerves.

Erector Spinae Plane block is another interfacial plane block. It involves deposition of local anesthetic between erector spinae muscle and transverse process of T5 vertebrae and targets both dorsal and ventral rami of thoracic spinal nerves.

Serratus anterior plane block involves the injection of local anesthetic in 1 of the 2 fascial planes, superficial and deep to serratus anterior muscle at the level of the fifth rib in midaxillary line. The SAP block targets the lateral cutaneous branches of the thoracic intercostal nerves. The deep SAP block was found to have similar analgesic efficacy and technically easier and safer to perform as compared to the superficial SAP block.

Eligibility Criteria:
Inclusion Criteria:

• Age from 21 to 65 years old female, American Society of Anesthesiologists (ASA) physical status I or II, who will undergo breast surgeries under general anesthesia.

Exclusion Criteria:

* Patient refusal to participate in research.
* Body Mass Index (BMI) ≥35 kg/m2.
* Sensitivity to the intervention drugs.
* Coagulation abnormalities.
* Psychiatric disorder and communication difficulties.
* Chronic neurological disease.
* Any skin infection at the needle puncture site.
* Chest wall deformity
Safety and Efficacy of tPBM for Epileptiform Activity in Autism

For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.


Eligibility Criteria:
Inclusion Criteria:

* Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R).
* Between 4 and 12 years of age, at baseline.
* Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment.
* Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period.
* Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry
* Ability to tolerate procedures, as determined at the discretion of the investigator.
* At least one 24hr EEG with data in EDF format that is accessible to investigators.

Exclusion Criteria:

* Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior
* Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill)
* Severe prematurity (\<34 weeks gestation) as determined by medical history
* Current uncontrolled gastroesophageal reflux disease since GERD can cause movements that appear like seizures
* Genetic syndromes
* Congenital brain malformations
* Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.
* Failure to thrive or Body Mass Index \&lt; 5%ile or \&lt;5%ile for weight (male \&lt;11.2kg; female \&lt;10.8kg by CDC 2000 growth charts) at the time of the study.
* Concurrent treatment with drug that would significantly interact with treatment.

  * • Stimulants
  * • Anti-Psychotics
  * • Antihistamines
* Excessive Hair that the caregivers are unwilling or unable to shave or braid.
* Inability to tolerate the required dosage of tPBM treatment due to sensory issues.
Educational Intervention for Hypertension Management

An interventional study is designed and a structured educational session will be conducted regarding the management of Blood pressure for the general physicians of Karachi, Lahore, Peshawar, Islamabad, Multan and Quetta. The purpose of designing this study is to observe the effect of hypertension educational intervention for general physicians to improve patient outcomes indirectly. Results of this study may provide a basis for developing a hypertension educational program targeted at general physicians.

Study Procedure

1. Screening of General physicians as per inclusion criteria and recruitment of GPs by clinical research associate after obtaining informed consent form.
2. GPs will be asked to fill hypertension awareness questionnaire at baseline
3. Both group of GPs with the help of clinical research associate will recruit 5 patients from study site.
4. After obtaining informed consent, Patient will be asked to fill hypertension awareness questionnaire at baseline or recruitment day and share pictures of 12-hour blood pressure measurement (from digital BP apparatus) with clinical research associate.
5. Randomization of GPs will be than in to 2 Groups.
6. After randomization, Group 1 GPs will receive (1 day) face to face education and Group 2 GPs will receive print version of education material.
7. After GPs education intervention, patients will be invited for regular checkup at GPs clinic.
8. Patient will be again asked to fill hypertension awareness questionnaire after 3 months and share pictures of 12-hour blood pressure measurement (from digital BP apparatus) with clinical research associate. (1st, 2nd \& 3rd Month).
9. GPs will be asked to fill hypertension awareness questionnaire again after 3 months (Post intervention)

Eligibility Criteria:
Inclusion Criteria:

* GPs who have at least three years of practice experience in the broad disciplines of primary care using the Numerical Pain Rating (NPR) scale over the past week ≥ 2 on a 0-10 numerical pain scale.
* Patients between 18-60 years.
* Patients with uncontrolled blood pressure according to Pakistan hypertension league guidelines
* Patients with or without angiographically proven coronary, peripheral or cerebral vascular disease.
* Patients must be able to give informed consent and be able to read and comprehend in the Urdu (National Language)
* Patients must have a digital BP apparatus at home.
* Patients must have a phone with camera and internet.

Exclusion Criteria:

* GPs who had attended a planned Hypertension educational program during the last 6 months.
* Patients with a recognized psychiatric disorder as per the Diagnostic and Statistical Manual of Mental Disorders
Mindfulness-based Crisis Intervention for COVID-19 Frontline Healthcare Workers During COVID-19

The COVID-19 outbreak is having an impact on the well-being of healthcare workers. Previous reports on pandemics show that such an impact may last beyond the time of the outbreak. Mindfulness-based interventions help healthcare professionals to reduce stress and may foster resilience and recovery, although they have never been tested in a context such as the current one. This single-arm trial explores the acceptability, safety and usefulness of an on-site, brief Mindfulness-based intervention to reduce stress for front line health workers during a crisis.


Eligibility Criteria:
Inclusion Criteria:

* All frontline healthcare workers present in the ward at the time of intervention

Exclusion Criteria:

* Extreme adverse events
Vascular Adaptations to Single-Sprint Training

The long-term objective of this research line is to identify and implement an effective and feasible intervention capable of preventing and/or reducing the burden of cardiometabolic and obesity-related diseases that affect Mississippians and others. The pursuit of this long-term objective will begin with achieving the specific aims proposed in this pilot project, which are to determine the effect of single sprint training for improving (1) systemic macro-vascular function, (2) local and systemic micro-vascular function, and (3) cardiorespiratory fitness. These aims will be achieved using a randomized controlled trial whereby 40 males and females will be randomized into an intervention group (n=20) or time-matched negative control group (n=20). The intervention group will perform a single maximal effort sprint on a cycle ergometer for twenty seconds 3 days/week for 4 weeks and the control group will be asked to maintain pre-intervention habits/behavior over 4 weeks. All outcome measures are non-invasive, and will be assessed pre-, mid-, and post-intervention, with the exception of cardiorespiratory fitness, which will be measured pre- and post-. To achieve aim 1, brachial artery flow-mediated dilation via ultrasonography and systolic and diastolic blood pressure via automated oscillometry will be measured on the arm. To achieve aim 2, post-occlusive reactive hyperemia via near-infrared spectroscopy and reactive hyperemia via ultrasound will be measured in the arm and leg, respectively. To achieve aim 3, pulmonary gas exchange will be measured during a graded exercise test on a cycle ergometer. All outcomes will be compared across time between conditions and sex with a three-way Bayesian Repeated Measures ANOVA using pre-values as covariates and an uninformed prior. 95% credible intervals will also be calculated to power future investigations using this intervention. If the intervention is found effective, future studies will be conducted to determine the efficacy of the intervention in larger groups and more clinical populations, and to determine the mechanisms mediating the adaptations. If ineffective, the knowledge gained will be used to develop future interventions.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years
* Untrained (no regular exercise engagement for the previous 6 months)
* Healthy enough to begin exercise (assessed via Physical Activity Readiness Questionnaire)

Exclusion Criteria:

* Illness/injury preventing cycling exercise
* Prescribed medication to control heart rate
* Prescribed medication to control blood pressure
* Use of nicotine within the previous 6 months