cyrilzakka/clinical-trials huggingface dataset:
Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves During Thoracoscopic Esophagectomy

The clinical value of intraoperative nerve monitoring (IONM) in thoracoscopic esophagectomy remains uncertain. The aim of this randomized clinical trial was to compare the impact of RLN visualization versus IONM on their morbidity following thoracoscopic esophagectomy.

Recurrent laryngeal nerves (RLN) lymph nodes are the most common metastatic areas in esophageal squamous carcinoma. It is a clinical challenge to reduce high incidence of RLN injury rate result from routine dissection of RLN lymph nodes. Thoracoscopic approach may provide a clear operative field and potentially less invasive surgery. But there are still high RLN injury rate only depending on visualization of thoracoscopy. The use of intraoperative nerve monitoring (IONM) was shown very helpful to identify the RLN and associated with a reduction of RLN injury rate in thyroidectomy. However, there is no solid clinical evidence about the effectiveness of utility of IONM in thoracoscopic esophagectomy. Thus, the aim of this randomized clinical trial was to compare the impact of RLN visualization versus IONM on their morbidity following thoracoscopic esophagectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven primary intrathoracic middle and lower esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN lymph ndoe dissection.
2. No superclavicular lymph node metastasis after preoperative examination.
3. No contraindication for esophagectomy.
4. Expected surgical R0 resection.

Exclusion Criteria:

1. Pre-existed vocal cord dysfunction.
2. Thorax pleural adhesion rendering minimal invasive approach unfeasible.
3. Gastric tube cannot be used for reconstruction.
4. Combined with hemorrhagic disease.
5. Psychiatric patients.
6. Inability to undergo curative resection and/or follow-up.
Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity

The researchers will investigate if brain insulin action influences peripheral insulin sensitivity in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* BMI \< 28 kg/m2
* normal HbA1c
* healthy volunteers

Exclusion Criteria:

* Heparin induced thrombocytopenia (HIT)
* metal implants
* cardial diseases
* anemia
* patients taking any kind of drugs
Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects

This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Has stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes Quality Initiative (K/DOQI) with proteinuria, including any of the following aetiologies: immunoglobulin (IgA) nephropathy, polycystic kidney disease (PCKD), congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis, minimal change nephropathy, and membranous nephropathy.

Exclusion Criteria:

* Required peritoneal dialysis or haemodialysis.
* Has kidney disease due to diabetes mellitus, vasculitis, systemic lupus erythematosus, or known renovascular disease; antiglomerular basement membrane disease; or is on immunosuppressive medication.
Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

The purpose of this study is to investigate risk factors for mediastinal lymph node metastasis in potentially operable non-small cell lung cancer in order to find indications for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal staging. CT and PET/CT findings, histologic types and other risk factors will be analyzed. The investigators develop the prediction method for mediastinal metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
* Potentially operable

Exclusion Criteria:

* M1 disease
* Inoperable T4 disease
* Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT
* Confirmed supraclavicular lymph node metastasis
* Pancoast tumours
* T1 ground glass opacity nodule (with solid part 1\<cm)
* Solid T1 (1\<cm)N0 M0 by CT \& PET/CT
* Inoperable patients (after evaluating medical and surgical operability)
* Patients who refused surgical treatment
* Contraindications for bronchoscopy
* Drug reaction to lidocaine, midazolam, fentanyl
* Pregnancy
Goal-Directed Therapist-Guided Play-Based Intervention in Children With Cerebral Palsy

Abstract Objective: This study planned to examine the effect of Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI) on occupational performance, occupational satisfaction and functional performance in children with diplegic cerebral palsy (DCP).

Materials and Methods: This study was designed as a randomized controlled trial. 34 children with DCP (14 boys; 20 girls) who received routine therapy included to the study. All children were classified according to the Gross Motor Function Classification System (GMFCS) and the Manual Abilities Classification System (MACS). Participants were randomly divided into two groups: the GD-TG-PBI group (number =17; mean age: 7.70±2.25 years) and the control group (number =17; mean age: 7.41±2.06 years). Both groups received routine therapy twice a week for 45 minutes per session during 8 weeks; while the GD-TG-PBI group received GD-TG-PBI additional to routine therapy twice a week for 45 minutes per session during 8 weeks. Occupational performance and satisfaction were determined with the Canadian Occupational Performance Measure (COPM), and functional performance was evaluated with the Pediatric Evaluation of Disability Inventory (PEDI). The COPM and PEDI were performed before and after the intervention for both groups. Dİfferences between COPM and PEDI values before and after the intervention calculated, additionally the effect size of each parameter calculated.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria of the study were a spastic DCP diagnosis, being aged 4-12 years, Gross Motor Function Classification System (GMFCS) level I, II or III, and Manual Ability Classification System (MACS) level I or II, and ability to follow verbal instructions.

Exclusion Criteria:

* The exclusion criteria were mental retardation diagnosis, additional treatment other than neurodevelopmental treatment (NDT), surgical intervention or Botulinum Toxin injection in the last six months, diagnosis of psychiatric disorder accompanying CP, vision and/or hearing problems affecting participation.
Ultrasonographic Evaluation of Drug Spread in Epidural Space During Caudal Block in Children

Caudal block is the world-widely used technique for an effective postoperative analgesia in children undergoing OPD-based infra-umbilical surgery. Because the caudal block is usually performed with a single-shot, proper dosage is required to achieve sufficient analgesic levels. Several clinical researches have been performed to assess the drug spread levels using mathematical equation, X-ray evaluation, and ultrasonography during caudal block in children. In our previous study using fluoroscopy, we obtained the results that the established weight-based doses provided adequate block levels for each type of surgery.

Ultrasonography is precise tool to evaluate the spinal structures and can provide estimated information in real time during caudal or epidural block in children.

The aim of this study is to evaluate the drug spread level with a weight-based doses using ultrasonography during caudal block in children and assess the reliability of the real time ultrasonography to determine the drug spread levels. After general anesthesia, the patient will be placed in lateral decubitus position for caudal block. Total 1.5 ml/kg of 0.15% ropivacaine will be injected into the caudal space. The spread level will be step-wise evaluated using ultrasonography at the injected drug dose of 0.5 ml/kg, 1.0 ml/kg, 1.25 ml/kg, and 1.5 ml/kg.


Eligibility Criteria:
Inclusion Criteria:

* children who needed caudal block for postoperative analgesia (age 3 months \~ 5 years old)
* Consent from one of parents 3. ASA physical status I or II

Exclusion Criteria:

* bleeding tendency
* spinal anomaly
* infection focus on back
* allergic reaction to local anesthetics
* foreigner of illiteracy who cannot read consent form
STUDY The Effect of HNF-4A G60D Variant on the In VIVO CYP2D6 Activity By Tolterodine Pharmacokinetic Study

This study was to investigate the pharmacokinetics of tolterodine, substrate of CYP2D6 in healthy subject in relation to the presence of HNF-4A G60D variant.

After a single oral administration of 2 mg tolterodine in 31 healthy subjects (6 with the heterozygous mutation of HNF-4A G60D vs 25 subjects with wild type of that whose CYP2D6 genotype and gender were matched with variant group), blood were collected for 24hrs. Assay of tolterodine and the metabolite, 5-hyroxymethyl tolterodine was conducted using LC/MS/MS.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject whose HNF4a and CYP2D6 genotype ware determined

Exclusion Criteria:

* Subject whose HNF4a and CYP2D6 genotype ware not determined
Electro-acupuncture for Long Covid Neuropsychiatric Symptoms

In this study, a 16-week randomized, sham-controlled, double-blinded clinical trial will be conducted to to investigate the efficacy and safety of electro-acupuncture compared to sham acupuncture for treatment of long covid neuropsychiatric symptoms.

This is a prospective, randomized, sham-controlled, double-blinded and multiple center trial on electro-acupuncture for treating neuropsychiatric symptoms in long covid patients. A total of 150 participants will be randomly assigned to the electro-acupuncture and the sham-control group with 1:1 ratio. Both groups will receive 32 sessions of interventions during 16-week treatment duration (2 session per week), and will be followed up for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* adults over 18 years of age to 80;
* history of SARS-CoV-2 PCR+ at least 4 weeks prior to study entry; SARS-CoV-2 negative (PCR) at study entry;
* at least one persistent neurological symptom (impaired concentration, headache, sensory disturbances, or depression, or "brain fog") that began around the time of the acute COVID-19;
* willing and able to consent, complete all assessment and study procedures.

Exclusion Criteria:

* any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy, tumor);
* intellectual disability pre-existing to the Covid-19 episode;cardiovascular diseases such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers,
* acute brain injury or acute encephalopathy from another aetiology than covid (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity);
* documented pre-existing history of psychiatric illness, including substance abuse;
* open-heart cardiac surgery or cardiac arrest during the last 6 months;
* current hospitalization;
* pregnant women.
A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.

The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.


Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent form;
2. Subjects with generalized myasthenia gravis;
3. Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
4. MG-ADL ≥5 at screening and baseline;
5. Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
6. Subjects agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. Female subjects considered fertile by the investigator must have negative serum pregnancy tests before the first dose.

Exclusion Criteria:

1. Subjects with MGFA I and V type;
2. Subjects usingprescribed drugs;
3. Subjects with a prescribed disease or history of disease;
4. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
5. Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;
6. Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;
7. Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening;
8. Pregnant and lactating women;
9. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.
10. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male subjects who plan to donate sperm during the trial or within 1 year after the last dose;
11. A history of alcohol or drug abuse within the past 12 months;
12. Other conditions deemed unsuitable for participation in this study by the researchers.
Using Covered Stent of Diameter of 7mm in TIPS

This study evaluates the incidence of hepatic encephalopathy between covered stent of diameter of 7mm and 8mm in TIPS(transjugular intrahepatic portosystemic stent shunt ).Half of the participants will receive stent of diameter of 7mm ,while the other half will receive stent of diameter of 8mm.

TIPS is effective in the treatment of hemorrhage of digestive tract and intractable ascites,which are the complications of cirrhosis. At present, the high incidence of hepatic encephalopathy has been a major problem after TIPS. The high incidence rate of hepatic encephalopathy was closly associated with the diameter of the stent. We often use the stent of diameter 8mm in TIPS.In this study, we try to use the stent of smaller diameter of 7mm in TIPS,and compare the incidence of hepatic encephalopathy between the stent of diameter of 7mm and 8mm .

Eligibility Criteria:
Inclusion Criteria:

1. there is a clear TIPS treatment indications of liver cirrhosis portal hypertension patients of gastrointestinal bleeding.
2. undergoing elective TIPS to treat patients.
3. aged 18-70 years old

Exclusion Criteria:

1. preoperative patients with hepatic encephalopathy.
2. with portal vein thrombosis patients.
3. combined liver malignant tumor or other parts of the patients with malignant tumor.
4. In combination of peptic ulcer bleeding.
Effect of Muscle Relaxation Reversal on the Success Rate of Motor Evoked Potential Recording

Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during surgery without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation.The feasibility of TcMEP interpretation was assessed during partial NMB in adult neurosurgical patients. However, partial NMB may interfere record of TcMEP monitoring. Sugammadex is the first highly selective antagonist that can reverse NMB. This study aims to evaluate the success rate of intraoperative muscle relax reversal by sugammadex on intraoperative TceMEP recording.


Eligibility Criteria:
Inclusion Criteria:

* Age range from 18 to 65 years old
* American Society of Anesthesiologists (ASA) physical status I to II

Exclusion Criteria:

* BMI ≥35 kg/m-2
* History of epilepsy or use of antiepileptic drugs
* Personal history or family history of malignant hyperthermia
* Allergies to sugammadex; NMBs or other medication(s) used during general anesthesia
* Hemoglobin \<110 g/L
* TceMEP stimulation or recorded site infection
* Preoperative neurological dysfunction in both upper extremities
* Cardiac pacemaker
* Pregnancy and lactation
RCT to Examine the Effects of Scanning

The purpose of the study is to implement a randomized control trial testing effects of information scanning on cancer prevention and screening behaviors in a population sample of 50-70 year olds. Participants will receive one of five versions of an e-newsletter once/month for 12 months and will be asked to complete baseline, mid-point, and end-of-project surveys.


Eligibility Criteria:
Inclusion Criteria:

* US adults, male or female, between 50 and 70 years of age.

Exclusion Criteria:

* Potential subjects will be excluded if they are not between the ages of 50 and 70
To Assess the Efficacy and Safety of Vildagliptin as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea
* Patients on diet and exercise who have not reached target blood glucose levels
* Outpatients

Exclusion Criteria:

* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
* Significant cardiovascular complications as defined by the protocol
* Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply.
Effects of Anti-HIV Therapy on Nervous System Function

The purpose of this study is to observe the way two different anti-HIV treatment strategies affect nerve and brain function in adults with HIV.

AIDS dementia complex (ADC) is a condition characterized by cognitive impairment, psychomotor slowing, and behavioral change. A milder form of ADC, called HIV minor cognitive/motor disorder (MCMD), is characterized by similar symptoms but has less of an impact on daily functioning. The neurocognitive impairment that results from ADC and MCMD carries an increased risk of poor drug adherence, morbidity, and mortality. It is unclear if highly active antiretroviral therapy (HAART) is effective in preserving neurocognitive function or in preventing or treating neurocognitive impairment. Distal symmetric sensory polyneuropathy (DSPN) and nucleoside-related neuropathy are two other serious conditions that HIV patients are at high risk for. DSPN is thought to be caused by active HIV infection; nucleoside-related neuropathy is thought to be caused by mitochondrial toxicity related to the use of certain antiretrovirals. These 2 conditions may lead to severe pain and discomfort in the feet. It is unknown what connection, if any, there is between DSPN and nucleoside-related neuropathy and the use of HAART. More data are needed on the natural history of these conditions.

This trial is a substudy of a study of management of antiretroviral therapy (SMART). In the SMART study, patients will participate in one of two strategies: a drug conservation (DC) strategy and a viral suppression (VS) strategy. Participants in the DC group will stop or defer HAART, then receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of at least 250 cells/mm3. Participants in the VS group will receive HAART to maintain a viral load as low as possible, regardless of CD4 count. The purpose of this study is to compare changes in neurocognitive functioning and peripheral neuropathy symptoms between the 2 strategies of the SMART study.

Patients will participate in this substudy and the main SMART study at the same time. Within 45 days prior to randomization into the main SMART study, participants will have baseline data collected for this substudy. This data will include peripheral neuropathy assessments, treatments for symptoms of peripheral neuropathy. At selected study sites, additional measures will assess neurocognitive function, depression, alcohol and drug use, and education. At 6 months, 12 months, and every 12 months thereafter, peripheral neuropathy symptoms and treatment for the symptoms will be assessed; a pain questionnaire will also be completed. Participants will be followed until the SMART study ends.

Eligibility Criteria:
Inclusion Criteria:

* Coenrollment in the SMART study

Exclusion Criteria:

* Unable to comply with all study requirements
Effect of PECS II, Parasternal and Serratus Plane Blocks on Postoperative Pain in MIDCAB Surgery

AIM: It was aimed to evaluate the effectiveness of pectoral nerve block (PECS II), parasternal and serratus plane blocks in postoperative analgesia in minimally invasive cardiac surgery (MIDCAB).

INTRODUCTION: The frequency of minimally invasive cardiac surgery has increased in recent years. With this method, Coronary artery bypass graft (CABG) operations can be performed without sternotomy. It is a beneficial method for early postoperative mobilization, early recovery and better aesthetic appearance. Since there is a surgical intervention between the ribs, pain control is important in these patients.

METHOD: In the preoperative evaluation of patients planned for CABG, PECS II, parasternal and serratus plane blocks are routinely recommended for postoperative pain control. Consent for the procedure is obtained from patients who accept this procedure. After induction and before the surgical incision, these block applications are performed under sterile conditions under the guidance of ultrasonography. Standard intravenous analgesic agents are applied to our patients who do not accept block applications. The hospital core system files of our patients who underwent cardiac surgery with minimally invasive intervention in our hospital between January 1, 2021 and December 31, 2021 will be scanned retrospectively. Patients with and without block application will be divided into two groups. From our patients' files; Demographic data, extubation time, drain site and incision site pain at the 1st, 2nd, 4th, 12th, 24th, 48th and 72nd hours after extubation will be noted. In addition, it will be noted whether there is a need for additional rescue analgesia in cases where block is performed. The data obtained will be evaluated statistically and the results will be published in national or international scientific journals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 and over
* Patients who underwent MIDCAB surgery

Exclusion Criteria:

* Patients under 18 years of age
* Patients who did not undergo MIDCAB surgery
A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers

This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at least 7 days between dosing.


Eligibility Criteria:
Inclusion Criteria:

* Male healthy volunteers, 18-45 years of age inclusive
* Healthy as determined by screening assessments
* Body mass index (BMI) between 18-30 kg/m2

Exclusion Criteria:

* Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue disease or diseases
* History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
* Any history of alcohol and/or drug of abuse addiction during the past 5 years
* Smoking more than 5 cigarettes a day or the equivalent amount of tobacco
* Any clinically relevant abnormal test results prior to first dosing
* Positive for hepatitis B, hepatitis C or HIV infection
* Participation in an investigational drug or device study within 3 months prior to Day -1 of Period 1