cyrilzakka/clinical-trials huggingface dataset:
Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot

THE PURPOSE OF THE STUDY is to optimize the therapy of patients with primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) by including monoclonal bispecific antibodies in post-induction treatment with simultaneous reduction of chemotherapy.

QUESTIONS AND OBJECTIVES OF THE STUDY:

* to determine the efficacy and feasibility of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL;
* to determine the safety and toxicity of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL;
* to determine the possibility of chemotherapy reducing when immunotherapy is included in the treatment regimen without loss of effectiveness;
* to determine the possibility of reducing the maintenance therapy duration to 1 year when immunotherapy is included in the treatment regimen without loss of effectiveness.


Eligibility Criteria:
Inclusion Criteria:

This study included patients with B-cell precursor ALL (BCP-ALL) diagnosed or confirmed in one of the clinics participating in the study. Also following criteria should be considered at the diagnosis for each case:

1. Age at diagnosis at 1 to 18 years.
2. The start of induction therapy within a time interval of study recruitment phase.
3. The diagnosis of BCP-ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow in the reference laboratories of Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology (D. Rogachev NMRCPHOI).
4. CD19 expression on tumor cells.
5. Informed consent of the patient parents (guardians)

Exclusion Criteria:

1. Any non-compliance with the inclusion criteria.
2. ALL is a second malignancy.
3. There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
4. The patient was treated before for a long time with cytotoxic drugs.
5. Initial CNS (central nervous system) involvement (status CNSII or CNSIII).
6. Initial leukocyte count ≥100×109/L (except for patients with significant translocations).
7. Patients not achieved cytological remission after induction
Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS)

The aim of our study is to determine the most efficient radiologic examination to assess the ankle sprain seriousness and so improve the therapeutic care.

The lateral ankle sprain is the most frequent purpose of consultation in emergency traumatology of the locomotive system.

If the ankle sprain is neglected or badly cared, it can induce a recurrence or several complications particularly functional ones. So a gravity diagnosis is necessary in order to choose the most accurate treatment.

Considering the difficulty of the clinical estimation, additional examinations aim to support the positive diagnosis, to clarify the gravity and to dismiss differential diagnosis.

Thus we suggest to evaluate three strategies in order to get a gravity diagnosis, make a better choice of treatment and so decrease the long-term functional complications : instability and recurrence.

The patients are randomly separated into three groups of 130 people. All the patients have a radiography and then, according to their group, they have either an ultrasonography or an ultrasonography and a stress radiography or only a stress radiography. The patients are followed up during two years by sending two questionnaires (CAIT and LEFS) at one and two years. The functional scores of these questionnaires assess and compare the functional complications for each group. Thus the radiologic examinations can be assessed in term of prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Lateral ankle sprain.
* Sprain occurred for less than 48 hours.
* Age between 18 and 55.
* Person affiliated at the Social Security.

Exclusion Criteria:

* Recurrent lateral ankle sprain occurred for less than 2 years and diagnosed by a doctor.
* Bilateral sprain, medio-tarsal sprain, syndesmosis sprain, subtalar sprain.
* Tendinous luxation (fibular, posterior tibial).
* Homolateral ankle fracture occurred for less than 2 years.
* Cuboid fracture, external tubercle of astragalus fracture, calcaneum fracture, fracture of the talus extremity, base of the fifth metatarsal bone fracture.
* Tearing of internal malleolus, tearing of astragalus posterior tubercle.
* Osteochondral lesions of the astragalus dome.
* Probable difficulty to follow up the patient.
* Patient taking anticoagulant.
* Pregnant woman, parturient, breast-feeding mother.
* Person deprived of freedom after a judicial or an administrative decision, person with legal protection measure.
Group Education Curriculum for Older Teens With Type 1 Diabetes

SMART T1D is a research study that offers interactive diabetes education for teens with type 1 diabetes in peer groups led by diabetes nurse educators. Participants in the study will be randomly assigned to either receive three of the group sessions in addition to their routine clinic care or to receive their usual diabetes clinic care.

The objective of this 12-month pilot randomized controlled trial is to evaluate the impact of a 3-session group educational curriculum, compared to standard care, on self-care adherence and transition readiness in adolescents with type 1 diabetes in the Boston Children's Hospital (BCH) Diabetes Program. Adolescents (15-18 years) with T1D will be randomized to receive a 3-session group curriculum ("SMART T1D" - Self-Management, Adherence and Readiness for Transition in T1D) in addition to usual care (intervention group) or to receive usual care with individual diabetes visits (control group) and electronic newsletters to match for attention.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the pediatric diabetes clinic at Boston Children's Hospital
* Age 15-18 years at enrollment
* Diabetes duration \>1 year
* Ability to speak/read English
* Visits to any BCH Diabetes Program site ≥1 times over the past 6 months
* Hemoglobin A1c at clinic visit prior to enrollment 7.5%-11%

Exclusion Criteria:

* Major medical or psychiatric comorbidities
* Established patients of one of the diabetes nurse educators delivering the intervention
Effect of Educatıon Gıven To Patıents Wıth Ureteral Stent (Dj) Insertıon On Postoperatıve Symptom Management And Qualıty of Lıfe

The data of the randomized controlled experimental study were collected at the Urology Clinics of Atatürk University Health Practice and Research Hospital between April and November 2022. The study sample consisted of 162 patients (82 in the training group, 80 in the control group) who were selected by simple random sampling method and met the inclusion criteria for the study.

Ureteral stents have been widely used in many urological procedures since their use was published by Zimskind in 1967 and Finley's use of the modern double J (DJ) stent in 1978. Ureterorenoscopy (URS) is a popular method used frequently in the diagnosis and treatment of ureteral diseases today. Apart from being performed for diagnostic purposes, URS is most commonly used to treat ureteral stones. The vast majority of ureteral stones are treated endoscopically. A Double-J (DJ) stent is often placed after ureterorenoscopy. The purpose of the stent is to prevent obstruction, renal colic, and deterioration of renal function. The fact that the DJ stent will remain in the patient for a certain period of time (approximately 3-4 weeks) causes anxiety in the patient. However, urinary system symptoms that impair the quality of life are observed in approximately 80% of patients who have a DJ stent. These symptoms include frequent urination (50-60%), urgency (57-60%), pain during urination (40%), incomplete voiding (76%), flank pain (19-32%), suprapubic pain (30%), incontinence and hematuria (25%). In addition, 32% of patients with DJ stents develop sexual dysfunction. 2,3,4 Patients who have DJ stents inserted after ureteroscopy surgery need more information, support, explanation and help to cope with the effects of these symptoms in the clinic and at home. 5 In this context, it is important to provide individualized and comprehensive education that includes the home care process before and after URS. It has been determined in the literature that education given before surgical intervention reduces anxiety, pain level, complication rate and depression rate in the postoperative period and increases patient satisfaction. 6,7,8 However, it is reported that individuals should be discharged with sufficient theory and practice to meet their post-discharge care needs. Although all healthcare personnel are responsible for the discharge education of individuals and their relatives, the most important responsibility belongs to nurses.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Volunteering to participate in the study
* Having URS surgery for the first time due to stones and temporary DJ stent placement

Exclusion Criteria:

* Having URS surgery for reasons other than stones
* Having a permanent stent
* Having major hearing and vision impairment
* Using antidepressants or anxiolytics
Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care

A multi-center, randomized, parallel, interventional, open label trial to compare Hemoglobin A1C-lowering effect of conventional treatment and Smart Care Service in patients with type 2 diabetes.

1. Objectives : To evaluate superiority in the Hemoglobin A1C -lowering effect of Smart Care Service compared to the conventional treatment in patients with type 2 diabetes.
2. Test and control group

   * Control group : The subject group who is receiving any conventional treatment (hospital visit).
   * Test groups

     * Conventional treatment + remote monitoring group: The subject group who is receiving the health care services using conventional treatment (hospital visit) and remote monitoring.
     * Remote visit + remote monitoring group: The subject group who is receiving remote visit and remote monitoring using videotelephony
3. Target Subject: Type II diabetes patients

Eligibility Criteria:
Inclusion Criteria:

1. More than 20 years of age and under 60 years of age
2. Patients who are able to receive outpatient treatment with type II diabetes mellitus.
3. If the patients require using insulin, patients who are using basal insulin or premixed insulin less than 2 times a day are eligible.
4. Patients with HbA1c above 7% and less than 11% (7%≤HbA1c≤11%).
5. Patients who are able to understand the purpose of this trial and to read and write.
6. Patients who are able to use the Smart Care PC for this study.
7. Patients who have wired/wireless internet access at home.
8. Patients who participate voluntarily and sign the informed consent.

Exclusion Criteria:

1. Patients with type I diabetes mellitus
2. Patients who are using Bolus insulin (short-acting insulin) or insulin pump.
3. Patients who take medicines which can significantly affect glycemic control.
4. Patients with acute illness, untreated other disease or diabetic complications required additional treatment.
5. Patients currently being hospitalized or planning to hospitalize during the study period.
6. Patients who have severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).
7. Pregnant or lactating women.
8. Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).
9. Patients with uncontrolled chronic lung disease.
10. Patients with known history of alcoholism, mental illness, or drug dependency.
11. Patients who have cognitive disorder or psychiatric problems
12. Patients who have participated in other clinical trial within 12 weeks prior to screening visit.
13. Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.
Methylene Blue for the Treatment of Septic Shock

The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock.

Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide.

A potential benefit of methylene blue in the treatment of septic shock has recently been described by Estrada. In patients with septic shock, methylene blue initiated within 24 h reduced time to vasopressor discontinuation and increased vasopressor-free days at 28 days. It also reduced length of stay in ICU and hospital without adverse effects.

In this randomized controlled trial, we aim to evaluate the efficacy and safety of methylene blue on septic shock.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 years old or older;
2. diagnosis of septic shock within 12 h.

Exclusion Criteria:

1. recent intake (4-weeks) of selective serotonin re-uptake inhibitors;
2. pregnant;
3. definitive pulmonary hypertension or chronic pulmonary heart disease;
4. known glucose-6 phosphate dehydrogenase (G-6PD) deficiency;
5. known allergy to methylene blue, phenothiazines, or food dyes;
6. anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);
7. refusal of the attending staff or patient family;
8. participated in other study.
Effect of CGM With Predictive Alarm on Hypoglycemia in Young Patients With T1D.

The use of continuous glucose monitoring (CGM) is becoming the new standard in glycometabolic control in patients with Type 1 Diabetes Mellitus (T1DM) even in subjects in multiple daily insulin injections (MDI). Compared to self-monitoring of blood glucose (SMBG), the CGM systems allow continuous monitoring of the glycemic trends contributing to modify the therapeutic habits of adult and pediatric patients with T1DM and allowing to better managing of critical situations such as hypoglycemia. Recently, the accuracy and reliability performance of the latest generation of CGMs using predictive alarm for hypoglycaemia and hyperglycemia has been compared to other commercially available CGM systems, showing good levels of concordance.

The use of this new technology, through the continuous monitoring of the pre-and post-prandial glucose levels and the evaluation of the glycemic trends, could influence the therapeutic habits of patients and could substantially contribute to modifying insulin therapy. Furthermore, the presence of the predictive alarm technology for hypoglycemia could lead to reduce the number of hypoglycemic episodes and to modify the way these hypoglycemic episodes are managed; moreover, the use of this technology could improve the time spent in the target glycemic range \[Time in Range (TIR), 70-180 mg/dl\] with possible improvement also in glycemic variability control.


Eligibility Criteria:
Inclusion Criteria:

* T1DM for at least 12 months \[assessed by positivity of at least one of the antibodies against islet cells (ICA), insulin (IAA), glutamate dehydroxylase (GADA), islet antigen 2 (IA2A), or Zinc Transporter 8 Antibodies (ZnT8)\];
* MDI therapy from at least 6 months with basal-bolus treatment (long acting insulin analog plus rapid acting insulin analogue);
* HbA1c \< 9.0%
* normal weight (BMI \<85th percentile for age and gender);
* no other chronic diseases (thyroiditis, celiac disease, etc) or eating behavior disorders (DCA);
* signed informed consent from parents or legal guardians and patients (\<18 y).

Exclusion Criteria:

* T1DM for less than 12 months;
* CSII therapy
* Previous usage of CGM with predictive alarm for hypoglycemia or hyperglycemia
* MDI therapy from less than 6 months
* use of regular insulin instead of rapid acting insulin analogue;
* other chronic diseases (thyroiditis, celiac disease, etc.) or eating behavior disorders (DCA).
Bicentric Study on the Use of ECMO-VV or VA for Severe ARDS Associated With Covid-19

Describes the cohort of patients receiving ECMO-VV or ECMO-VA in the management of severe ARDS refractory to SARS-CoV-2 in the Strasbourg and Louvain centres


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18;
* Diagnostic COVID-19 by RT-PCR;
* Hospitalisation in resuscitation for the management of complications related to COVID-19
* Implanted ECMO-VV or VA during hospitalisation;
* Patient agreeing to participate in the study

Exclusion Criteria:

* Sujet who has expressed opposition to participating in the study.
* Sujet under guardianship or trusteeship
* Sujet under safeguard of justice
Hysteroscopy With Fundus Uterus Scratching Incision VS Office Hysteroscopy Before ET With Donor Eggs

A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients.

A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in women without intrauterine pathology which is likely to have an adverse effect on reproductive outcomes. The study populations will be constituted by oocyte recipients.

Study group: Hysteroscopy with fundus endometrial incision Control group: Office Hysteroscopy without any endometrial injury

Eligibility Criteria:
Inclusion Criteria:

* oocyte acceptors
* age 30-50
* embryo transfer with Hormone Replacement Therapy
* embryo transfer within 6 months of hysteroscopy

Exclusion Criteria:

* previous uterine pathology
* sperm sample \<1mil/ml
* leiomyoma
* septate uterus
Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors

The purpose of this study is to assess short and long term outcomes after radiofrequency ablation (RFA) combined with chemotherapy for pulmonary malignancies in patients who are not candidates for surgical resection. This study will evaluate the efficacy of RFA combined with chemotherapy for the treatment of lung tumors by assessing its impact on local tumor control, progression free survival, overall survival, dyspnea score and quality of life (QOL).

Percutaneous image-guided RFA is a minimally invasive technique used to treat solid tumours. Because of its ability to produce large volumes of coagulation necrosis in a controlled fashion, this technique has gained acceptance as a viable therapeutic option for unresectable liver malignancies. Recently, RFA has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RFA in the destruction of experimentally-induced pulmonary malignancies. Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response. We designed a prospective clinical trial aimed at assessing feasibility, safety and effectiveness of RFA combined with chemotherapy in the treatment of lung malignancies.

Eligibility Criteria:
Inclusion Criteria:

* adult (\> 18 years) male or female patient
* patient has biopsy-proven NSCLC or lung metastasis
* patient has been rejected for surgery and has been considered unfit for radiation therapy
* each 6 cm or smaller in greatest diameter of tumor, by CT scan
* tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart
* tumors are accessible by percutaneous route
* patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* patient has platelet count \> 100 x 109 /L and international normalized ratio ≤ 1.5
* patient has signed written informed consent prior to any study specific procedures.

Exclusion Criteria:

* patient is considered at high-risk for RF ablation due to major co-morbid medical conditions
* patient has more than 3 tumors / lung
* patient has at least one tumor \> 6 cm in greatest diameter
* tumor is associated with atelectasis or obstructive pneumonitis
* patient has renal failure requiring hemodialysis or peritoneal dialysis
* patient has active clinically serious infection
* patient has history of organ allograft
* patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results
* patient is pregnant or breast-feeding
* patient has ECOG performance status \> 2
* patient has platelet count ≤ 100 x 109 /L or international normalized ratio \> 1.5.
Postoperatively Treated Patients With Lower Limb Fracture With or Without an Anti-gravity Treadmill

The presented study is designed to prove efficacy of the anti-gravity treadmill (alter G®) compared to a standard rehabilitation protocol in patients with tibial plateau or ankle fractures with six weeks of partial weight bearing.


Eligibility Criteria:
Inclusion Criteria:

* patients with a postoperative partial weight bearing after tibial plateau or ankle fracture.
* man and woman of an age between 18 and 65

Exclusion Criteria:

* Body weight more than 100kg
* serious illness or poor general health as judged by physician that may influence the rehabilitation
* open fractures (\>1° according to Gustilo and Anderson)
* surgical site infection
* pregnancy
* neuromuscular disorders or preexisting muscle atrophy.