cyrilzakka/clinical-trials huggingface dataset:
Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia

This is an observational study of HIV-1 infected children starting antiretroviral therapy to measure the magnitude and quality of general immune reconstitution and pathogen-specific immune reconstitution to measles virus.

This is a prospective, observational cohort study of 230 HIV-1-infected children initiating ART at public clinics in Lusaka, Zambia to measure the magnitude and quality of general immune reconstitution and pathogen-specific immune reconstitution to measles virus. Non-specific immune reconstitution will be assessed by serial measurements of the number and percentages of CD4+ and CD8+ T-lymphocytes, number and percentages of activated CD4+ and CD8+ T-lymphocytes (using cell surface staining for HLA-DR and CD38), changes in the proportions of naïve and memory CD4+ and CD8+ T-lymphocyte subsets (using cell surface staining for CD45RA and CCR7), and changes in thymic output as determined by TREC levels. Virologic responses to ART will be assessed by serial measurements of plasma HIV-1 RNA levels.

Within the observational study, there is a nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers to assess the proportion of revaccinated children who develop protective immunity and the duration of protective immunity. Anti-measles virus IgG antibodies will be measured 9 months after initiation of ART. The results will be available at the 12-month follow-up visit and measles revaccination will be recommended to those children lacking protective antibody levels to measles virus.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls 9 months to 10 years of age residing in Lusaka, Zambia are eligible for enrolment.
* initiating ART
* history of measles vaccination confirmed by examination of the Immunization Card.
Specific Use-Result of Spiriva Respimat® in Asthmatics

The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use

The study is Post-Marketing Surveillance on the Long-Term Use of Spiriva Respimat in Japanese patients with mild to moderate persistent asthma. The patient population who receive Spiriva Respimat and the safety profile is not expected to change. This study can investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mild to moderate persistent bronchial asthma
* Patient aged ≥ 15 years
* Patients who are naive to Spiriva Respimat and receive Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least ICS treatment.

Exclusion Criteria:

* Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat
* Patients who have been enrolled in this study before.
Safety and Efficacy of Firmagon® (Degarelix) for Injection

The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for injection under the conditions of general clinical practice in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible for the treatment of Firmagon® (degarelix) for injection according to the approved product label, and Firmagon® (degarelix) treatment decided before study enrolment. Moreover, patient should have not previously received Firmagon® (degarelix) for injection before the study commencement date at each site. - Indication: treatment of advanced, hormone-dependent prostate cancer.

Exclusion Criteria:

* Patients with previous or concurrent known hypersensitivity to any component of the drug.
Median Study for Biochemical Serum Markers in First Trimester of Pregnancy

The purpose of this study is to get initial values (normal medians) for certain biochemical serum markers for pregnancy weeks 10-13. Also initial values for mean arterial blood pressure measurement and certain ultrasound measurement may be established.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* maternal age 18 - 45 years
* gestational age 10 -13 (+6 days)verified by ultrasound

Exclusion Criteria:

* mental retardation or other mental disorders that impose doubts regarding the true subject's willingness to participate in the study
* lack of needed demographic data
Longitudinal Assessment of Post-concussion Driving in Young Adults

Upwards of 3.8 million concussions occur annually in the United States. Driving is a highly complicated activity that requires visual, motor, and cognitive skills, which are commonly impaired after concussion. Yet, the time course of post-concussion driving impairment has not been characterized. There is a critical need to 1) determine when concussed individuals should return to driving and 2) identify the key concussion assessment predictors of readiness to return to driving. In the absence of formal recommendations, impaired concussed drivers are at risk to themselves and others on the road.

The first specific aim is to compare simulated driving between concussed individuals and non-concussed yoked matched controls across five longitudinal timepoints (pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance) and daily naturalistic driving from day 2 to day 9.

Driving recommendations must be appropriate and necessitated by concussion impairments, since excessively strict recommendations wrongfully strip concussed patients of their independence and may dissuade individuals from seeking medical care. The second specific aim is to identify widely used concussion assessment outcomes that predict simulated driving performance among concussed individuals throughout concussion recovery.

To address these aims, 100 concussed and 100 yoked matched control young adult college athletes will complete a simulated driving assessment and a robust concussion assessment battery at pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance. Naturalistic driving (measured with in-car global positioning systems) will be captured from day 2 to day 9 (7 days total).

This study will determine the acute and subacute time course of post-concussion driving impairment and determine key predictors of post-concussion driving performance. Results from this innovative approach will have a broad and positive impact that will improve the safety of both concussed individuals and the general population, guide the practices of health professionals, inform the future work of researchers, and substantiate the work of policy-makers by providing evidence-based recommendations for managing post-concussion driving.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Possesses a valid driver's license
* 1 year or more of driving experience
* Normal or corrected-to-normal vision
* Rostered on an organized athletic team at the college level
* (Concussion Group Only) Diagnosed with concussion by a physician and meet inclusion criteria above.

Exclusion Criteria:

* Four or more previous concussions
* A concussion within the past 6 months
* History of any major neurological disorders or injuries
* Current use of any medications that evoke drowsiness (prescription or over the counter)
* Current orthopedic condition that interferes with driving (e.g. a walking boot, shoulder immobilizer)
* Heavy use of alcohol (binge drinking 5+ days in the past 30 days)
* Any illegal drug use (any illegal substance use)
Combination of Conditioned Medium and Umbilical Cord-Mesenchymal Stem Cells Therapy for Acute Stroke Infarct

The purpose of this study was to determine the effectiveness of a combination of intranasal conditioned medium (CM) with intraparenchymal umbilical cord mesenchymal stem cells (UC-MSCs) transplantation in acute stroke patients to induce neurogenesis.

This study has 3 arms namely CM and UC-MSCs treatment, UC-MSCs treatment only, and control. The investigator hypothesized that group of CM and UC-MSCs combination is the optimal treatment to induce neurogenesis in stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 25-60 years diagnosed with ischemic stroke acute phase
* The patient has had a CT scan/MRI of the brain to assess ischemic territory
* The patient must have an NIH Stroke score of 8-20
* The patient or legal assistant has obtained detailed informed consent regarding the study protocol and agreeing to participate in the study
* Patients with The Glasgow Coma Scale (GCS) score \> 8
* Patients with Pt-APTT values within normal limits

Exclusion Criteria:

* Patients with recurrent stroke in the 6 months preceding the episode current stroke
* CT or MRI images show midline shift and bleeding transformation
* Participate in similar studies using CM and/or UC-MSC
* Patients who are immunocompromised and/or who are receiving therapy immunosuppressive
* Patients who cannot have a CT or MRI examination due to their condition
* Patients with impaired renal and hepatic function after the onset of ischemic stroke: Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) \> 5x the upper limit of normal values and a significant increase in urea-creatinine values
* Patients with a history of malignant tumors or other severe neurologic conditions.
TMS of Visual Working Memory

The purpose of this study is to understand how the brain allows individuals to keep information "in mind" over brief intervals. During the experiment, participants will be asked to maintain fixation while they attend to and remember different visual stimuli (e.g., the location of a dot on the screen, the color of a circle, the orientation of a line, the speed of a group of moving dots) on a computer monitor. Participants will make decisions about these visual stimuli and indicate their decisions by pressing buttons or making eye movements. Through the use of Transcranial Magnetic Stimulation (TMS) investigators hope to understand the contributions of different anatomical areas while subjects perform this task.

This study will use a within subject design in which each participant will perform a working memory task combined with Transcranial Magnetic Stimulation. TMS will be applied in three possible procedures, 1) Online TMS, 2) Offline TMS and 3) Sham TMS. All subjects will be given two trials within their one session, one of which will be sham TMS for all subjects and another of which will be randomly assigned to either Online or Offline TMS. Trials order will be randomly counterbalanced across subjects, who will be blind to the treatment of frontal vs. sham TMS (independent variable). Participants will be randomized into either the online or offline groups by computer generated lists to ensure equal numbers of participants in each condition. Half of the subjects will receive online TMS (online group) and half will receive offline TMS (offline group). Subjects will be randomly assigned to one of the two groups. The dependent variables will be performance accuracy and reaction time on the working memory task. By utilizing online and offline TMS, investigators will be able to explore whether frontal cortex is involved transiently in visual working memory or persistently throughout the task.

Eligibility Criteria:
Inclusion Criteria:

* Neurologically healthy individuals will be recruited.

Exclusion Criteria:

* Individuals with neurological issues (e.g., history of seizures, neurosurgery, brain trauma) will be excluded.
* Women of childbearing potential will be told that although there are no known risks of the procedure to the unborn fetus, they should not take part in the study if they are or might be pregnant.
* Minors and the elderly will be excluded.
* Individuals who are on medications that heighten the risk of TMS adverse events will be excluded.
Eosinophilic Cystitis Mimicking Urothelial Neoplasia

We explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. Surgical procedure and clinical outcome also evaluated. T

A pooled 22 patients diagnosed with eosinophilic cystitis on microscopic examination in our hospital during four years were retrospectively studied.We explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. Surgical procedure and clinical outcome also evaluated. Transurethral resection of the lesions were performed and pathologically examined, we re-examined the studied cases and made a clinical correlation.

Eligibility Criteria:
Inclusion Criteria:

* Clinically suspected urothelial neoplasia

Exclusion Criteria:

* Patients who did not complete the follow up period
Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring

Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate.

Currently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days).

This pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Mitral valve prolapse diagnosed on previous echocardiography or cardiac MRI
* New York Heart association classification ≥3
* Willing and able to provide signed written informed consent
* No contra-indication for long-term monitoring (known allergy to adhesives)

Exclusion Criteria:

* Prior cardiac surgery, including previous mitral valve intervention
* Prior endovascular mitral valve repair (MitraClip)
* Previous catheter ablation of ventricular arrhythmias
* Patients not in sinus rhythm
* Patients on anti-arrhythmic drugs but betablockers
* Known alternative arrhythmic substrate, for example previous myocardial infarction
* Known allergy to adhesives
Effect of Backward Walking Training vs Forward Walking Training to Improve Balance and Mobility in Children With CP

Children with cerebral palsy frequently experience balance issues and gait impairments; gait training is a crucial component of their rehabilitation because it greatly enhances the children's socialisation and quality of life.

Since there is no known cure for cerebral palsy, the focus of treatment is shifting to enhancing activities like walking and self-care. Enabling the child with cerebral palsy is the ultimate goal of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Only CP patients will be included.
* Patient will be included from Bahawalpur only.
* Patient will be included having minimum age of 10 year.

Exclusion Criteria:

* Other cities patient will not be included.
* Patient less than 10 years age.
* Patient suffering from other neurological conditions.
Endoscopic Stenting for Chronic Abdominal Pain

The prospective sham randomized study will evaluate the role of endoscopic stenting inpatients with chronic pancreatitis and chronic abdominal pain.

Endoscopic stenting is increasingly used for the treatment of a variety of pancreatic disorders. Although a number of studies suggest that pancreatic stenting relieves abdominal pain in approximately 70% of patients, there has been no randomized study. Since any intervention may improve pain, the effectiveness of endoscopy cannot be ascertained without a true placebo arm or sham therapy group.

The study will aim to determine the effectiveness of pancreatic stents in relieving chronic pain in the setting of chronic pancreatitis. Since these procedures do carry risk, a placebo controlled fashion is used for this study

Eligibility Criteria:
Inclusion Criteria:

* All patients referred to the principal investigator for chronic pancreatitis will be enrolled.

Exclusion Criteria:

* There are no gender nor racial exclusion.
Subcostal Transversus Abdominus , Erector Spinae and Paravertebral Blocks Effects on Laparoscopic Cholecystectomy Cases

Sixty patients with ASA (American Society of Anesthesiologist) I-II physical status between the ages of 20-60 were randomized into three groups: TAP block group (Group T), ESP block group (Group E) and PVB group (Group P). Bilateral 20cc (total 40cc for each patient) 0.25% bupivacaine was applied by ultrasound (US) guidance. Intraoperative vital signs (heart rate, blood pressure, and saturation), Train-of-four (TOF) values, additional dose of opioid and muscle relaxant needs, complications were recorded. Postoperative side effects (nausea, vomiting, itching, tremor), the need for additional postoperative analgesia, Visual Analog Scale (VAS) scores were noted.

Cases; under the age of 20 - over 60, emerge and bleeding, outside the ASAI-II functional status, undergo surgery other than laparoscopic cholecystectomy, refused to participate in the study, allergic to local anesthetic agents, with a body mass index (BMI) \>30, have contraindications for regional anesthesia (sepsis, local infection, coagulopathy, heart disease, hypovolemia, cases that do not want regional anesthesia), pregnant were not included in the study.Twenty patients in each group and a total of 60 patients were included the study by power analysis. According to the randomized, single-blind, closed-envelope method, patients were randomly divided into three groups.

Group T (Subcostal TAP Block): 40 cc (20cc+20cc) 0.25 % Bupivacaine for bilateral application Group E (ESP Block): 40 cc (20cc+20cc) 0.25% Bupivacaine for bilateral application Group P (PVB): 40 cc (20cc+20cc) 0.25% Bupivacaine for bilateral application were prepared.

Eligibility Criteria:
Inclusion Criteria:

* 20-60 years,
* ASA I-II ,
* scheduled for elective laparoscopic cholecystectomy
* under general anesthesia,
* agreed to participate in the study,

Exclusion Criteria:

* under the age of 20 - over 60,
* emerge and bleeding,
* outside the ASAI-II functional status,
* undergo surgery other than laparoscopic cholecystectomy,
* refused to participate in the study, allergic to local anesthetic agents,
* body mass index (BMI) \>30,
* have contraindications for regional anesthesia (sepsis, local infection, coagulopathy, heart disease, hypovolemia, cases that do not want regional anesthesia),
* pregnant
Lamotrigine for Symptoms of Geriatric Bipolar Depression

This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 Years or older
* BP Disorder-I or II: Depressive episode (DSM -IV-TR; SCID-I/P)
* HAM-D score \> 18 (GRID-HAM-D 24-item version)
* Availability of an Informant is encouraged but not required for study participation

Exclusion Criteria:

* Chronic psychotic conditions, ie. schizophrenia, schizoaffective disorder, delusional disorder
* Contraindication to lamotrigine (Physician interview, medical assessment)
* Documented history of intolerance to lamotrigine
* Patients who have previously failed to respond to at least 12 weeks of treatment with lamotrigine
* Active substance dependence (SCID-I/P) or substance-related safety issues or PI concerns
* Mood Disorder Due to a General Medical Condition or Treatment (Physician interview)
* Rapid cycling (Physician interview): As defined in DSM-IV: At least 4 episodes of mood disturbance in the previous 12 months that meet criteria for a Major Depressive, Manic, Mixed or Hypomanic Episode. Episodes are distinguished either by partial or full remission for at least 2 months or by a switch to an episode of opposite polarity
* Dementia (by DSM-IV or brain degenerative diseases; Physician interview);
* Inability to communicate in English (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in English)
* Clinically significant sensory impairment (i.e., cannot see well enough to read consent or visually-presented material; cannot hear well enough to cooperate with interview; Physician interview)
* Recent history of cardiovascular, peripheral vascular events or stroke
* High risk for suicide (e.g., active SI or current intent or plan)
* Inpatient status
Cardiac Computed Tomography: Characteristics of Isolated Left Ventricular Non-compaction

The diagnostic criteria for isolated left ventricular non-compaction cardiomyopathy (IVNC) have been well established for echocardiography and cardiac magnetic resonance, such validation is lacking for computed tomography (CT). Such criteria are of great clinical relevance as a growing number of patients undergo a cardiac CT scan in daily clinical routine.

The investigators aim to test the diagnostic accuracy of cardiac CT in distinguishing IVNC from lesser degrees of trabecular layering seen in potential differential diagnoses such as cardiomyopathies and left ventricular hypertrophy or dilation.

The investigators hypothesize that echocardiographic diagnosed pathological trabeculation can be distinguished by determining the ratio of non-compacted to compacted myocardium on cardiac CT.


Eligibility Criteria:
Inclusion criteria:

* Established diagnosis of IVNC or differential diagnosis
* Age: Men \> 30 years, women \> 50 years without menstruation for at least 2 month.
* Written informed consent to participate

Exclusion criteria: Contraindication for cardiac CT

* Renal insufficiency (GFR \< 60ml/min)
* Known allergy to iodinated contrast agent
* Known Hyperthyroidism
* Non-sinus rhythm
* Known premature ventricular or supraventricular beats
* Hypotension (systolic blood pressure \< 100mmHg)

Contraindication for CMR

* Implanted cardiac pacemaker or defibrillator
* Other implanted medical devices (e.g. implantable cardioverter-defibrillator)
* Claustrophobia
* Known premature ventricular or supraventricular beats
* Pregnancy
* Claustrophobia
Lips and Tongue of Mouth Breathing Children

Purpose: to characterize the posture, tone and mobility of lips and tongue of mouth breathing children.

Methods: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in São Paulo, SP, Brazil . It was used the MBGR protocol to evaluate the posture, tone and mobility of lips and tongue of mouth breathing children.


Eligibility Criteria:
Inclusion Criteria:

* Mouth breathing children diagnosed by doctor.

Exclusion Criteria:

* Children with mental, neurological or hearing diseases, or with cold or flu at the examination day.