cyrilzakka/clinical-trials huggingface dataset:
Senl-T7 CAR-T Cells for Treatment of Relapsed or Refractory CD7+ Lymphoma

This study is an open and prospective clinical study, taking patients with relapsed or refractory CD7+ lymphoma as the test subjects, in order to evaluate the safety and efficacy of Senl-T7 CAR-T for patients with CD7+ lymphoma.

Main research purposes:

To evaluate the safety and efficacy of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma

Secondary research purpose:

To investigate the cytokinetic characteristics of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosed as relapsed or refractory lymphoma; 2. Tumor cells express CD7 (express CD7 by flow cytometry or immunohistochemistry); 3. The expected survival period is greater than 12 weeks; 4. KPS or Lansky score ≥60; 11 5. Age 2-70 years old; 6. HGB≥70g/L (can be transfused); 7. Indoor blood oxygen saturation\> 90%; 8. Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value; 9. The subject or guardian understands and signs the informed consent form;

Exclusion Criteria:

* 1. One of the following cardiac criteria: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT synthesis Syndrome or secondary QT prolongation is at the discretion of the investigator. Echocardiography LVSF\<30% or LVEF\< 50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (the absence of this symptom confirmed by echocardiography within 12 months after treatment); 2. There is active GVHD; 3. Have a history of severe pulmonary dysfunction diseases; 4. Merge other malignant tumors in advanced stage; 5. Combined with severe infection or persistent infection and cannot be effectively controlled; 6. Combined with severe autoimmune disease or congenital immunodeficiency; 7. Active hepatitis (hepatitis B virus deoxyribonucleic acid \[HBVDNA\] or hepatitis C virus ribonucleic acid \[HCVRNA\] test positive); 8. Human immunodeficiency virus (HIV) infection or syphilis infection or HTLV infection; 9. There is a history of severe allergies to biological products (including antibiotics); 10. Clinically significant viral infection, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BKV, HHV(human herpesvirus)-6; 11. There are central nervous system disorders, such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, Cerebellar diseases, etc.; 12. Female patients are pregnant and lactating, or have a pregnancy plan within 12 months; 13. Circumstances that the researcher believes may increase the risk of the subject or interfere with the results of the test.
Pancreatic Neuroendocrine Tumor：Factor of Surgery Influencing Survival

Investigator determined the factor of surgery associated with the survival of pancreatic neuroendocrine tumor.

The variables including clinical characteristics, surgical data and pathological findings are examined by univariate and multivariate analyses.

Eligibility Criteria:
Inclusion Criteria:

* The patients with pancreatic neuroendocrine tumor underwent pancreatectomy

Exclusion Criteria:

* The patients with pancreatic neuroendocrine tumor did not undergo pancreatectomy
Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer

Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with resectable non-small cell lung cancer.

Vaccine production will be attempted on all patients who undergo surgery and meet all inclusion/exclusion criteria.

Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine (HSPPC-96) from the tumor tissue of patients with resectable non-small cell lung cancer.

All patients will undergo surgery to remove the tumor and will be followed for recurrence and overall survival.

The primary goal of this trial is to determine if HSPPC-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer.

The secondary goals are to further characterize the safety and efficacy profile, to evaluate disease recurrence in patients receiving, and to evaluate overall survival in patients receiving HSPPC-96.

HSPPC-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. A portion of the tumor tissue is sent to Antigenics' manufacturing facility where it will undergo processing to create a vaccine. This vaccine may help the patient's immune system attack cancerous cells while leaving healthy cells alone.

Eligibility Criteria:
This is a summary of criteria. Only the Principal Investigator can determine eligibility.

Inclusion Criteria:

* Suspected non-small cell lung cancer, Stage IB, Stage II, or Stage IIIA
* Tumor size \> 3x3 cm or equivalent to a 9 cm² lesion
* Scheduled surgery with curative intent
* At least 18 years of age
* Must not be pregnant or breast feeding
* Agree to not receive any other investigative agent at any time while enrolled in this study

Exclusion Criteria:

* Previous treatment for non-small cell lung cancer
* Clinical signs or symptoms of brain metastases
* History of immune suppression or autoimmune disorder
* Severe active infection or other serious medical illness, that in the opinion of the Principal Investigator, would prevent study completion
* Other malignancies in the past 5 years, except adequately treated in situ cervix carcinoma or non-melanoma skin cancer
Comparison Between Lingual and Labial Fixed Orthodontic Appliances in the Treatment of Crowding Cases

Patients who have moderate crowding that could be treated without extraction will be treated in this study using either lingual or labial fixed orthodontic appliances. All patients will receive a cone-beam computed tomography (CBCT) scan in two different times (T0: before treatment, T1: after treatment). The dentoalveolar changes will be assessed.

Lingual orthodontic appliances provide an ultimate esthetic solution for patients who do not want visible orthodontic appliances. Recently, lingual orthodontic treatment outcomes have become similar and comparable to those produced with labial orthodontic treatment. However, placement of orthodontic brackets on the lingual surfaces of teeth causes changes in their morphology, which results in articulation problems, chewing difficulties, tongue irritation and other impairments. In this respect, the main difference between the labial and lingual techniques is the distance between the point of application of the force that is transmitted through the bracket and the centre of resistance of the tooth. Consequently, the displacement and stress induced in bone by these two techniques will also differ, and these need to be evaluated so that useful comparisons can be made between these two techniques. Patients who have moderate crowding that could be treated without extraction will be treated in this study using either lingual or labial fixed orthodontic appliances. All patients will receive a cone-beam computed tomography (CBCT) scan in two different times (T0: before treatment, T1: after treatment). The dentoalveolar changes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Class I malocclusion.
* Moderate crowding in the dental arch (3 to 5-mm tooth-size arch-length discrepancy).

Exclusion Criteria:

* Inappropriate oral hygiene and periodontal diseases.
* Previous orthodontic treatment.
* Craniofacial syndromes, cleft lip and/or palate (soft and/or hard).
* Subject with systemic diseases.
Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia?

The investigators hypothesize that perioperative oral administration of pregabalin would reduce postoperative pain and produce reduction in postoperative opioid consumption after anterior cruciate ligament (ACL) reconstruction . Patients are randomly assign to 1 of 2 groups. The placebo group receive placebo capsules 1 hour before surgery and 12 hours after initial dose. The pregabalin group receive pregabalin 150 mg, respectively at the same points.


Eligibility Criteria:
Inclusion Criteria:

* age between 20-65 years
* physical condition type I or II in ASA (American Society of Anesthesiology)

Exclusion Criteria:

* patients of ASA classification 3 or more
* with a history of cardiovascular or respiratory disease
* dizziness or frequent headache
* active alcohol or drug usage,
* intake of any analgesics daily or 48 hours before surgery
* impaired renal and/or hepatic function
Clinical and Kinematic Assessment for Determination of Botox® Injection Parameters in Cervical Dystonia

This study investigates the use of a kinematic measurement device to quantify the abnormal head movements and postures in patients with cervical dystonia (CD) in order to individualize and optimize botulinum toxin type A (BoNT-A) injection therapy. A single sensor captures five degrees of freedom of the neck and head that distinguish which muscle(s) contribute to CD and the amount of BoNT-A to inject into these muscle(s). The efficacy, relief and improvements in social, occupation and function by injections will be investigated. The efficacy of BoNT-A therapy using either BoNT-A injection parameters from clinical-based assessments and kinematically-based assessments will be investigated in CD patients. Individuals clinically diagnosed with CD will be randomized for two treatment conditions: A) injection parameters from a kinematic assessment only, or B) injection parameters from a clinical assessment only.


Eligibility Criteria:
Inclusion Criteria:

* Consenting male and female individuals between the ages of 18 and 80
* Diagnosed with idiopathic spasmodic torticollis (also called cervical dystonia) by neurologist
* Botulinum neurotoxin type A injection(BoNT A; Botox®) naïve individuals will be randomized into either clinical-assessment arm or kinematic-assessment arm and the participants will be blinded to which arm they are a part of
* CD individuals who are receiving suboptimal BoNT-A effects will be recruited to receive kinematic-based injections. These participants will have to wait a minimum of 4 months before participating in this study
* Able to attend all study sessions
* Able to provide written consent

Exclusion Criteria:

* Pregnant individuals
* Women who are nursing
* Individuals with a known Botox® allergy
* Individuals with a known or suspected traumatic cause for the torticollis, a prior thalamotomy, or peripheral (nerve or muscle) operation
* Individuals with cervical contractures that limit passive range of motion
* Motor/nerve diseases such as myasthenia gravis, other diseases of the neuromuscular junction and/or Amyotrophic Lateral Sclerosis
* Myotomy or denervation surgery involving the neck or shoulder region
Evaluation of the Effectiveness of the Training Given to Mothers With 0-5 Age Group Children for Fire Management

The research was conducted in a randomized controlled design to evaluate the effectiveness of the fever management training given to mothers of children aged 0-5.

The research was conducted between January 2023 and April 2023 in the Pediatric Ward of Gebze Fatih State Hospital. The study included 120 mothers, with 60 in the intervention group and 60 in the control group, who had children aged 0-5 years old admitted to the hospital with a complaint of fever. The data was collected using the 'Mother and Child Information Form,' 'Parent's Fever Management Scale (PFMS),' 'Fever Management Knowledge Statements Form (FMKSF),' and 'Follow-up Form. The data were analyzed using appropriate statistical methods in the SPSS (Statistical Package for Social Sciences) for Windows 26.0 software package.

Eligibility Criteria:
Inclusion Criteria:

* Mothers with 0-5 age group children in fever
* Must be literate

Exclusion Criteria:

* Discharge before 3 days
Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients

In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. This favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq (100mCi) in case of significant risk of persistent disease. Few centers investigated the possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff.

Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic efficiency needs to be checked.

This is a multicentric, randomized, controlled, open-label phase III clinical trial involving 26 French centers. It aims at comparing four strategies of management of postoperative radioiodine ablation, each strategy combining a method of TSH stimulation (thyroid hormone withdrawal or rhTSH (Thyrogen®, Genzyme)) and an activity of 131I (low-dose (1GBq, 30 mCi) or high-dose (3,7GBq, 100 mCi)).

Eligibility Criteria:
Inclusion Criteria:

* 18 year or older
* Newly diagnosed differentiated papillary or follicular thyroid carcinoma who underwent total thyroidectomy between 30 and 60 days before randomization and treated by LT4 for at least one month.
* Patients are all staged pT1\<1cm N1 or pT1\>1cm N0 N1 Nx or pT2 N0
* The performance status is 0 or 1.
* All patients will provide written consent to participate.

Exclusion Criteria :

* partial thyroidectomy
* patients treated by LT4 less than one month
* time from thyroidectomy superior to 60 days at randomization
* patients with Hurtle cancer or aggressive histology
* Patients staged pT1\<1cm N0 or T2 N1 or T3 or T4 or M1
* patients for which the use of rhTSH is required for medical reasons
* patients with major concurrent medical disorder (cardiac, renal, liver, respiratory)
* patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission for at least 2 years)
* patients with recent history of drugs affecting thyroid function, including iodine containing medications or radiocontrast agents
* patients with recent history of 131I whole body scan
* pregant women or breast-feeding
Comparison of CSII and MDI in Pediatric Patients With Type 1 Diabetes

Prospective, randomized, open-label, two-sequence crossover study to investigate the effects of continuous subcutaneous insulin injection (CSII, using DIA:CONN G8 insulin pump) in pediatric patients with type 1 diabetes using multiple daily insulin (MDI) injection

This trial consists of two crossover periods of 5 weeks each (MDI to CSII or CSII to MDI), followed by an extended period of 12 weeks (MDI or CSII). Each intervention period has wash-out period (5 days) excluded from the outcome measurements.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is aged 2-17
2. The subject with one or more of the below at diagnosis

   * serum c-peptide \< 0.6 ng/mL
   * positive glutamic acid decarboxylase (GAD) antibody
   * positive Islet cell antibody
   * positive anti-Insulin antibody
   * positive anti-Islet Antigen-2 (IA-2) antibody
3. The subject was diagnosed with type 1 diabetes ≥ 1 year
4. The subject is treated with multiple daily insulin injection
5. The subject must have available continuous glucose monitoring (CGM) data with a percentage of active CGM time ≥ 70% in the past 4 weeks.

Exclusion Criteria:

1. Subjects who were treated with insulin pump therapy within 12 weeks prior to trial
2. Any systemic treatment with drugs known to interfere with glucose metabolism within 12 weeks prior to trial
3. Subjects with underlying hematologic disorders that can affect the HbA1c levels
4. Subjects with underlying medical disorders that can affect glucose metabolism
5. Subjects with a neuropsychiatric disorder such as depression or eating disorder
6. Subjects with underlying thyroid disorders and abnormal thyroid function
Acupuncture Treatment for Active Crohn's Disease

The purpose of this study is to observe the efficacy and safety of acupuncture and moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and peripheral immunity.

1. A randomized controlled trial.
2. Acupuncture and moxibustion treatment, placebo control.
3. To observe the efficacy and safety of acupuncture and moxibustion treatment versus placebo controlled for Crohn's disease.
4. To observe the effect on the regulation of intestinal microbiota in Crohn's disease.
5. To observe the effect on the regulation of peripheral immunity in Crohn's disease.
6. To observe the effect on the regulation of brain function and structure in Crohn's disease.

Eligibility Criteria:
Inclusion Criteria:

1. meet the diagnostic criteria of Crohn's disease;
2. age 16-70 years old;
3. patients with mild or moderate disease (150\<CDAI\<450) and evidence of active inflammation: serum C-reactive protein concentration ≥5 mg/L, fecal calprotectin concentration ≥250 μg/g, or obvious endoscopic evidence of ulcerations during the screening period of past 4 weeks;
4. patients who were not responsive, intolerant, dependent, or refused to use any one of the following medications: mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), and anti-TNF-α agents;
5. did not take or take one or more of the following drugs: prednisone \<15 mg/d for at least one month, azathioprine (\<1 mg/kg/d), methotrexate (\<15 mg/week), or mesalazine (\<4 g/d) for at least 3 months;
6. no history of use of anti-TNF-alpha or other biological agents within 3 months immediately preceding the enrolment in the study;
7. no previous history of receiving acupuncture;
8. provision of written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women, and those desirous of conceiving in the near future;
2. patients with severe organic diseases;
3. patients with mental illness;
4. patients receiving antibiotics, probiotics, prebiotics, traditional Chinese medicine, or other drugs;
5. patients with multiple comorbid conditions that require long-term therapy with drugs, which may affect the outcome measures;
6. patients with severe extraintestinal manifestations, such as severe skin diseases, eye diseases, or thromboembolic diseases;
7. severe intestinal fistula, abdominal abscess, intestinal stenosis and intestinal obstruction, perianal abscess, gastrointestinal bleeding, bowel perforation, or other complications;
8. patients with short bowel syndrome;
9. patients with a history of abdominal or gastrointestinal surgery in the past six months;
10. patients with skin diseases or defects at the sites of acupuncture that prevents the application of acupuncture.
Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan

The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or intolerance to Methotrexate or biologics


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a history of an inadequate therapeutic response or intolerance in the opinion of the examining physician to at least one biologics or Methotrexate (MTX).
* Diagnosis of Juvenile Idiopathic Arthritis (JIA) by International League of Associations for Rheumatology (ILAR) criteria as oligoarticular, polyarticular Rheumatoid Factor (RF+), polyarticular (RF-), or systemic with a polyarticular-course.
* Men and women, ages 4 to 17 years, inclusive at enrollment.
* Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease as defined by:

  1. ≥2 active joints (e.g. presence of swelling, or if no swelling is present, limitation of motion (LOM) accompanied by pain, tenderness, or both) at screening and at Week 0 (Day 1).
  2. ≥2 joints with LOM at screening and at Week 0 (Day 1).

Exclusion Criteria:

* Systemic onset JIA with any of the following manifestations within the last 6 months prior to enrollment: intermittent fever due to JIA, rheumatoid rash, hepatosplenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.
* Presence of any other rheumatic disease or major chronic infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, hypogammaglobulinemia, or systemic lupus erythematosus, etc.)
Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19

EC CORONACOLCHI is a multicenter, double-blind and randomized clinical trial with two branches. Patients who meet all the inclusion criteria and none of the exclusion criteria will be randomized 1: 1 to be included in one of the following groups:

* Experimental group: colchicine for 2 weeks orally at the doses described, added to the standard treatment of COVID-19.
* Control group: placebo for 2 weeks orally added to standard COVID-19 treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1 - Acute symptoms compatible with SARS-CoV-2 infection: fever, cough, myalgia, dysgeusia / ageusia, dyspnea, pulmonary infiltrates on X-ray / CT, or any sign / symptom attributable to said infection
* 2. Microbiologically confirmed infection by SARS-CoV-2 (PCR and / or CLIA or ELISA serology or with a valid microbiological diagnostic test with antigen test).
* 3.\> 18 years.
* 4. \<2 weeks from the onset of symptoms.
* 5. Admitted (with or without pneumonia) and ambulant (with pneumonia demonstrated by X-ray or CT)
* 6. Some analytical degree of moderate inflammation defined by PCR between 20 and 80 mg / L and / or ferritin between the high limit of normality (LAN) and 3 times said LAN
* 7. Signing of the Informed Consent, or acceptance of oral consent before witnesses.

Exclusion Criteria:

* 1. Drug allergy.
* 2. Intolerance to lactose and / or cow's milk proteins.
* 3. Renal failure with GFR \<30 ml / min.
* 4. Liver cirrhosis or severe liver failure
* 5. Pregnancy or breastfeeding.
* 6. Blood dyscrasias or cardiac disorders that in the opinion of the investigator contraindicate the use of colchicine.
* 7. Pre-existing degenerative neuromuscular disease.
* 8. Acute or chronic diarrhea or malabsorptive syndrome that in the judgment of the clinician contraindicates the use of colchicine.
* 9. CRP\> 80 mg / L or ferritin\> 3 times LAN
* 10. Shock or hemodynamic instability.
* 11. Respiratory distress measured by PaO2 / FIO2 \<300 or baseline O2 saturation ≤ 93%.
* 12. Patients undergoing mechanical ventilation.
* 13. Chronic treatment with any drug that, in the opinion of the investigator, interacts with colchicine and cannot be discontinued during the clinical trial, unacceptably increasing the risk of toxicity (digoxin, cyclosporine, etc.)
* 14. Have received any dose of colchicine, tocilizumab, any antiL6 or antiL1 drug.
* 15. Current treatment with corticosteroids (except chronic corticosteroid therapy without recent increase in dose).
* 16. Participation in any other clinical trial of patients with COVID-19.
* 17. Any other condition that, in the opinion of the investigator, contraindicates the use of colchicine or puts the subject at risk due to their participation in the study.