cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Safety and Efficacy of CAR-T Cells in the Treatment of Refractory Myasthenia Gravis

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD19 CAR-T therapy for patients with refractory myasthenia gravis, and to evaluate the pharmacokinetics of CD19 CAR-T in patients.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 and gender unlimited；
* 2. Confirmed as refractory myasthenia gravis with AchR antibody positive and accord one of the following three conditions

  1. Repeated electrical stimulation suggests neuromuscular conduction deficits；
  2. Tensilon test and neostigmine test positive;
  3. The doctor judged that the symptoms of MG improved after treatment with oral cholinease inhibitors;
* 3. Consistent with the clinical classification of MGFA myasthenia gravis IIa-IVb (including IIa，IIb，IIIa， IIIb， IVa，IVb)
* 4. The baseline MG-ADL score ≥5 and the musculi oculi related score\< 50 ；
* 5. Baseline QMG score\>11;
* 6. Regular treatment with poor efficacy and/or lack of effective treatment means that there is still recurrence or exacerbation after treatment with conventional hormones, immunosuppressants (such as azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, etc.) or rituximab；
* 7. The estimated survival time is more than 12 weeks;
* 8. Women of childbearing age who have negative urine pregnancy test before medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up.

Exclusion Criteria:

* 1. Epilepsy history or other central nervous system disease;
* 2. During the screening visit, the patient's thymectomy was less than 12 months or thymectomy was necessary during the study period or thymic radiation therapy ;
* 3. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythm ia in the past;
* 4. Pregnant (or lactating) women;
* 5. Patients with severe active infections;
* 6. Active infection of hepatitis B virus or hepatitis C virus;
* 7. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
* 8. Those who have used any gene therapy products before;
* 9. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 10. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0 mg /dl;
* 11. Those who suffer from other uncontrolled diseases are not suitable to join the study;
* 12. HIV infection;
* 13. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Composition and Collection Feasibility of Gut Microbiota in Children With and Without Obesity

Adults with obesity have an imbalance of bacteria in their intestines which may contribute to weight gain and diseases related to obesity. Restoring the balance of these bacteria (the "microbiota") could help reduce weight and related diseases. However, little is known about this imbalance in children with obesity. This research study will map out the compositions of the gut microbiota of children and compare them with those of children who have healthy weights and different degrees of obesity. This project will also measure the amounts of fatty acids in the stools which are an indication of how efficiently the intestines absorb calories from food. If an imbalance is detected in children with obesity, then this information can help researchers test ways to restore the gut microbiota with hopes of reducing weight and some of its related health problems.


Eligibility Criteria:
Inclusion Criteria:

1) patients aged 5-12 years

Exclusion Criteria:

1. patient who have received either oral or parenteral antibiotics in the last 3 months
2. patients who have a diagnosed immunodeficiency
3. patients who are on medications that modulate the immune system including systemic prednisone and biologics
4. patients who have a gastrointestinal condition which is known to alter the gut flora such as inflammatory bowel disease, chronic diarrhea, celiac disease and eosinophilic gastroenteritis diseases
5. patients who have taken proton pump inhibitors in the last 3 months
6. patients who have taken probiotics in the last 6 months.
Clinical and Metabolic Characterization of Long-term Courses of Obesity Patients

The long-term courses after bariatric surgery are not sufficiently known. Furthermore there is a heterogeneity in postoperative responses.

The aim of this study is to investigate the glycemic course (prediabetes, development of diabetes) of patients with obesity (BMI\>=35 kg/m2) who had undergone bariatric surgery compared to patients with obesity who have not. A further aim is to investigate predictors of weight development, development of body composition and insulin sensitivity of patients who had undergone bariatric surgery compared to obesity patients who have not undergone bariatric surgery. The long-term courses after different surgical procedures (Roux-Y vs Sleeve) will be compared.

In this study 300 patients with obesity who had been metabolically characterized in a previous study will be recruited.

These patients are examined (medical history, physical examination including ECG, BIA, weight, height) and metabolically characterized.

Participants without diabetes undergo a glucose tolerance test and fasting blood sampling will be performed in participants with diabetes. All patients complete questionnaires to activity, nutrition, life quality, impulsiveness, depression and eating behavior.

Randomly selected participants will be offered an abdominal fat tissue biopsy. When consent is given, this will be performed at least two days after the glucose tolerance test.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the study " Das ADIP-Programm: Charakterisierung adipöser Probanden mittels genauer phänotypischer und genotypischer Klassifizierung"

Exclusion Criteria:

* BMI \< 35 kg/m2 at start of the previous study
* Women during pregnancy and lactation
* Patients who are unable to give their consent
* Patients who have undergone surgery within the last 3 months
* acute disease or infection within the last 4 months
* HIV- or hepatitis B/C-positive
* for biopsy of fat tissue: known coagulation disorder or PTT or INR out of reference range
Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent

A Randomized Comparison of a Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) With a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) for Percutaneous Coronary Intervention

Objectives: The purpose of this study is to compare the Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) with a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) in a non-inferiority trial.

Design: Prospective, multi-center, randomized, non-inferiority trial to be conducted at 3 Swiss interventional cardiology centers. Patients will be randomized in a single-blind fashion (1:1 randomization) to either the Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) or the Zotarolimus-Eluting Stent (EndeavorTm, Medtronic).

Study Population: Patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, unstable angina, and non-ST elevation myocardial infarction, who qualify for percutaneous coronary interventions

Antiplatelet Therapy: Aspirin 100 mg qd indefinitely; Clopidogrel 75 mg qd for 3 months

Enrollment: A total of 300 patients will be enrolled

All patients will undergo repeat angiography at 6-8 months.

All patients will be followed for up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

The following patients are eligible for inclusion

1. Age ≥18 years
2. Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, unstable angina, and non-ST elevation myocardial infarction
3. Presence of one or more coronary artery stenoses \>50% in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents;
4. No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria:

1. Pregnancy
2. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, titan, zotarolimus or contrast material
3. Inability to provide informed consent
4. Currently participating in another trial before reaching first endpoint
5. ST segment elevation myocardial infarction (STEMI)
Montelukast in Children With Wheezing

In this study children with recurrent wheezing (\>/= 2 episodes in the last 6 months)and aged less than 2 years will be enrolled as outpatients. They will undergo lung function evaluation by Rint and by assessment of the flow curves at baseline and after 4 weeks of treatment with Montelukast 4 mg/day. Symptom dairies will be filled by parents during the study period.

Patients aged less than 2 years with recurrent wheezing. At visit 1 patients with symptoms will be enrolled and the study explained. They will return home with bronchodilator therapy.

Within 1 week they will return for visit 2 to start a run-in period with bronchodilators prn and they will fill dairies with symptoms and drug use. Skin prick test will be evaluated at that time.

At visit 3 after 1 week of the run-in period they will start therapy with Montelukast 4 mg for 4 weeks, using bronchodilators prn and filling diaries.

The final visit will be after four weeks with re-evaluation of the lung function

Eligibility Criteria:
Inclusion Criteria:

* Age between 6-24 months
* Patients with recurrent wheezing (at least 2 episodes in the last 6 months)
* Patients with symptoms at enrollment

Exclusion Criteria:

* Chronic respiratory diseases (cystic fibrosis, chronic lung disease) symptoms at visit 1 that require hospital admission
Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block

Transversus Abdominis Plane Block (TAPB) is frequently used for the management of postoperative pain in patients undergoing cesarean section. Recently, Erector Spinae Plane Block (ESPB) has been defined and used in several clinical scenarios. However, data regarding the ESPB use in the aforementioned patient group is limited.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 45 years
* ASA2
* Undergoing cesarean section under spinal anesthesia

Exclusion Criteria:

* History of chronic pain
* Body mass index \> 35
* Urgent/emergent surgeries
* Major bleeding
* Any additional surgical procedure
* Contraindication for any drugs used in the protocol
* The presence of any instrumentation in the procedure sites
Diabetes Multicenter Observational Study (DIAMOND-1-)

The purpose of this study is to examine whether pump treatment combined with the use of continuous glucose monitoring system is a mena to normalize glycaemic control.

In this study, 100 subjects, users of Paradigm 522/722 Infusion Pump and Self- Monitoring Blood Glucose finger sticks for the control of their glucose levels for at least 3 months prior enrollment will participate. Moreover the subjects won't have achieved the best blood glucose control, with an average HbA1c above 7% and should meet all the inclusion and none of the exclusion criteria. The HbA1c value for screening purposes can be taken from the medical chart, while in the enrollment visit according to current medical practice of each investigational center, the sample taken for HbA1c measurement will be analyzed centrally by HPLC, in a lab in Germany. In all enrolled patients a continuous glucose monitoring system will be provided. Since this is an observational study, the provision of the glucose monitoring system will be based on medical justification and will not be done per protocol requirement. All subjects will be followed for 3 months according to the current medical practice of each investigational center. All other visits, e.g. patient comes into the hospital because of symptoms, will also be recorded as unscheduled visits. These visits are usually linked to Adverse Events.

Eligibility Criteria:
Inclusion Criteria:

* Subjects and/or their legal representative must sign the Patient Data Release Form (PDRF).
* Subjects must be aged between 12 and 45 years old.
* Subjects must be pump and Self- Monitoring Blood Glucose fingersticks users for at least 3 months and no more than 9 months.
* HbA1c \>7.0% with a measurement no older than three months prior to enrollment.
* Diagnosed T1D at least 1 year before study entry.
* Subjects must be able to understand how to use the Paradigm REAL-Time System and how to adjust and administer corrective treatment.
* Subjects should not have used the sensor in the past.

Exclusion Criteria:

* Hearing or vision impairment so that alarms can not be recognized.
* Alcohol or drug abuse other than nicotine.
* Subjects suffering from severe chronic disease or genetic disorder other than T1D. (i.e. Down syndrome etc.)
* Subjects suffering from allergy.
* Subjects in pregnancy or with desire to conceive during study.
* Subjects participating in other device or drug studies.
A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis

The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Men and women ≥ 40 years of age
* Patients with knee osteoarthritis at one or both knee by ACR

Exclusion Criteria:

* Patients with known or suspected secondary knee osteoarthritis
* Other exclusions applied
MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease

Diseases of dementia are chronic, untreatable, and cause a massive burden of morbidity. In this proposal, we seek to tackle the problem of better, earlier, and more efficient diagnosis using deuterium metabolic imaging (DMI). The study is divided in two sub-studies: 1) optimization and simplification of DMI protocols, and 2) a cross-sectional study of DMI in Alzheimer's patients and healthy controls.


Eligibility Criteria:
Inclusion criteria:

AD-patients:

* Aged 55-85 years.
* Male or female.
* AD diagnosis by the NIA-AA 2011 research criteria.8
* Able to give written informed consent.
* Mini-mental state examination (MMSE) equal to or above 18.9
* Brain FDG-PET performed at Aarhus University Hospital consistent with AD.

Healthy participants:

* Aged 18-85 years.
* Male or female.

Exclusion criteria:

All participants:

* Diabetes or any other metabolic disease.
* Other significant brain disease:

  * Strokes.
  * Tumors.
  * Chronic small vessel disease (clinically suspected, or Fazekas ≥ 2 if clinical MRI is available).
  * Epilepsy.
  * Other neurodegenerative or -inflammatory disease.
* Contraindications for MRI:

  * Pacemaker, neurostimulator or cochlear implant.
  * Metal foreign bodies such as fragments and irremovable piercings.
  * Unsafe medical implants (safety of heart valves, hips and the like must be confirmed).
  * Claustrophobia.
  * Largest circumference including arms \> 160 cm.
* Pregnant - women must be post-menopausal or confirmed non-pregnant by an onsite test.
A Randomised Controlled Trial of Hysteroscopic Resection of Mild Septum/Arcuate Uteri.

At least 82 cases of recurrent miscarriage women with a diagnosis of arcuate uterus, confirmed by three-dimensional intra-vaginal sonography (3D-TVS) and hysteroscopy, will be recruited. The subjects will be randomly divided into two groups, the experimental group will be given hysteroscopic treatment, the control group will receive no treatment. The pregnancy rates (\>12 weeks) of the two groups will befollowed and compared.

This study will be carried out at the Hysteroscopy center of the Fuxing Hospital, Beijing, China. At least 82 recurrent miscarriage women with a diagnosis of arcuate uterus who had unexplained recurrent spontaneous abortion (less than 12 weeks) before and have fertility requirement will be recruited. The patients will be explained the study and sign the informed consent. According to the random number table, the corresponding cases were divided into treatment group and control group. The experimental group will be given hysteroscopic treatment, the control group will receive no treatment. The follow up of the spontaneous abortion rate and the pregnancy rate of two groups will be screened within 1-2 years and the correlation between the arcuate uterus and recurrent miscarriage will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Women with arcuate/mild septum uteri
2. Women with unexplained recurrent miscarriage (less than 12 weeks)
3. Having a second time fertility requirement
4. Having Informed consent before entering this study, and be willing to receive hysteroscopic treatment

Exclusion Criteria:

1. 3D-TVS and hysteroscopy suggest uterine fibroids (submucosal and III type uterine fibroids, intramural fibroids,the diameter of whichis greater than 4cm), adenomyosis, endometrial polyps, intrauterine adhesions and other uterine factors that may lead to spontaneous abortion
2. Endometrial pathological diagnosis of chronic endometritis, endometrial hyperplasia and endometrial cancer
3. Ultrasound or HSG suggest hydrosalpinx
4. Chromosome abnormalities of the couples, positive findings of pre-thrombosis state and the detection of immunity, uterine malformation, uterine fibroids, adenomyosis and other uterine factors causing recurrent miscarriage
5. Semen abnormality in male
6. FSH \> 10
The Effect of the Duty Loading on the Stress Response of Physician

The investigators will study in the possibility of cardiovascular disease, caused by the duty loading, of physician of internal medicine. The investigators will also explore if there {dose response effect} between the duty loading and the stress response of physicians of internal medicine. Therefore, the investigators will compare the stress responses of physicians of internal medicine during with different duty loading ( non-duty day, one duty area with 3 wards, 2 duty areas with 6 wards) in a observational method. Those stress response will be measured by cardiovascular risk indicators, including blood pressure, heart rate variability, blood sampling and urine sampling.


Eligibility Criteria:
Inclusion Criteria:

* Attending physicians of internal medicine of Taipei municipal hospital, certified by Taiwan society of internal medicine.

Exclusion Criteria:

* thyroid dysfunction
* pregnancy, diabetes mellitus
* history of cardiovascular disease (stroke, coronary arterial disease, or myocardial infraction)
* current smokers, or
* taking sleeping pills or B-blocker
Preoperative Nerve Block for Rhinoplasty/Septoplasty

Addiction is an inherent risk when prescribing opiates for pain relief, and methods to reduce its use or amount prescribed can help mitigate this risk for addiction. Patients undergoing rhinoplasty are often prescribed a short course of opiates during the acute post surgical phase. Studies have shown intraoperative sphenopalatine ganglion (SPG) nerve block in endoscopic sinus surgery can reduce post operative narcotic use. The purpose of this study is to determine if use of SPG block can be used to reduce narcotic use in the acute post operative phase of rhinoplasty/septoplasty.

With the current opioid epidemic, more than 40,000 deaths can be attributed to prescription and illicit opioid use per year. There is inherent risk for patients to develop addiction when prescribing opiates for pain relief, and methods to reduce its use or the amount prescribed can help mitigate this risk.

Surgery is one of the leading causes for prescribing narcotics to control pain. Patients undergoing rhinoplasty are often prescribed a short course of opiates during the acute post surgical phase. Intraoperative sphenopalatine ganglion (SPG) block has been successfully and safely used in endoscopic sinus surgery, and has been shown to decrease narcotic use and inpatient hospital stay time.

The investigators are interested in determining if use of SPG block may offer an improved strategy to reducing the use of narcotics for post rhinoplasty/septoplasty pain relief. The investigators hypothesize that SPG block will reduce the amount of post operative opiates required for pain control.

The study population will include patients undergoing rhinoplasty/septoplasty at Keck Medical Center of USC who are able to provide consent. The study will include two arms: SPG block (experimental) and placebo saline injection (control). Patients' post operative pain scale and narcotic use will be recorded until first follow-up visit (2 weeks). Patient demographics, surgical indication, and intraoperative analgesia will be recorded. T-tests will be conducted between patient groups. ANOVA will be used to analyze other factors that may be associated with decreased narcotic use.

Eligibility Criteria:
Inclusion Criteria:

1. Any patient requiring rhinoplasty/septoplasty and able to provide consent.
2. Must be willing to participate.
3. Must be able to complete consent in English or Spanish.

Exclusion Criteria:

1. History of opioid substance abuse disorder.
2. \<18 years old
3. Currently pregnant
Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC

Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Cervical lymph node metastasis is frequently encounted on the date of diagnosis. Surgical resection is one of the most important treatment methods for head and neck squamous cell carcinoma with or without lymph node metastasis. At present, for cN0 patients, prophylactic neck dissection is recommended for squamous cell carcinoma originating in suprglottic, hypopharyngeal and oropharyngeal areas et al. Related studies reported that less than 30% of patients with cN0 were confirmed to have lymph node metastasis in postoperative pathological examination, who underwent neck dissection. Unnecessary neck dissection may increase complication incidence, such as neurovascular injury, chylous leakage, sialosyrinx. Accurate preoperative assessment is helpful to reduce unnecessary neck dissection. Sentinel lymph node biopsy were proved to be effective in reducing prophylactic lymph node dissection in breast cancer, melanoma and other malignant tumors. Compared with γ probe detection and indolyanine green injection, microbubble and contrast-enhanced ultrasound has no radiation and disturbance to resection margins in sentinel lymph nodes detection. Furthermore, surgeons could conduct lymph node puncture biopsy simultaneously under ultrasound guidance, which can further minimize surgical trauma. At present, the role of microbubble and contrast-enhanced ultrasound in sentinel lymph node detection and biopsy is rarely reported in head and neck squamous cell carcinoma. This study aims to explore the accuracy of peritumoral microbubbles and contrast-enhanced ultrasound for sentinel lymph nodes biopsy in predicting cervical lymph node metastasis in head and neck squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70;
* Pathological biopsy indicated head and neck squamous cell carcinoma;
* MR/CT examination indicate no suspected cervical lymph node metastasis;
* The patient intent to perform primary focal resection and unilateral/bilateral neck dissection at our center;
* agree to participate in clinical trials and sign informed consent.

Exclusion Criteria:

* allergic to microbubbles contrast agents;
* patients who cannot tolerate surgery;
* enlarged cervical lymph node in palpation or suspected cervical lymph node metastasis indicated in MR/CT examination;
* distant metastasis.