cyrilzakka/clinical-trials huggingface dataset:
Effect of Prophylactic TKI Therapy Post-transplants on Ph+ ALL Undergoing Allo-HSCT With MRD Positive Pre-transplants

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) in early first complete remission improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Relapse remains a major cause of treatment failure even after allo-HSCT. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Our previous clinical trial (ID: NCT01883219) demonstrated that pre-emptive tyrosine kinase inhibitor (TKIs) administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ ALL. Moreover, our result suggested that Ph+ ALL with MRD positive pre-transplants had the higher rate of molecular biology relapse. In this study, we will evaluate the safety and efficacy of prophylactic TKI therapy post-transplants on Ph+ ALL undergoing allo-HSCT with MRD positive pre-transplants.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) in early first complete remission improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Relapse remains a major cause of treatment failure even after allo-HSCT. Overall, patients experiencing relapse have a dismal prognosis despite salvage treatment with TKIs. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Strategies to prevent relapse include tyrosine kinase inhibitor (TKIs) use, donor lymphocyte infusions (DLI), CAR-T and so on. At present, the utility of TKIs administration post-transplants is controversial. Our previous clinical trial (ID: NCT01883219) demonstrated that pre-emptive TKI administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ ALL. Moreover, we found that 58% Ph+ ALL with MRD positive pre-transplants would MRD positive post-transplants, whereas only 11.4% Ph+ ALL with MRD negative pre-transplants would MRD positive post-transplants, suggesting that Ph+ ALL with MRD positive pre-transplants had the higher rate of molecular biology relapse. In this study, we will evaluate the safety and efficacy of prophylactic TKI therapy post-transplants on Ph+ ALL undergoing allo-HSCT with MRD positive pre-transplants.

Eligibility Criteria:
Inclusion Criteria:

* Patient age of 14-65 years
* Ph+ ALL undergoing allo-HSCT with MRD positive pre-transplants
* Survival \> 30 days post-transplants
* MRD negative on day +30 post-transplants

Exclusion Criteria:

* Ph+ ALL undergoing allo-HSCT with MRD negative pre-transplants
* Survival \<30 days post-transplants
* MRD positive on day +30 post-transplants
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest

In sudden cardiac arrest patients with return of spontaneous circulation, brain damage is one of the main determinants of short-term mortality and poor prognosis (CPC 3-5). It is important to properly select group of patients in whom treatment is futile. According to current guidelines, multimodal approach is recommended. Optic nerve sheath diameter measured by ultrasound is non-invasive, fast, low-cost and readily available bed-side method, but evidence for its use as neuroprognostication modality is limited to only few small studies. The aim of this study is to evaluate validity of ONSD as neuroprognostication method at larger cohort of patients, compare it with other established methods and compare ultrasound and CT measurement of ONSD.

Additional relevant MeSH terms:

cardiac arrest, cardiovascular diseases, optic nerve sheath diameter.

Eligibility Criteria:
Inclusion Criteria:

* age of 18 years or older
* out of hospital cardiac arrest of non-traumatic cause with CPR and subsequent ROSC
* Glasgow coma scale (GCS) ≤ 7 or sedation 30 minutes after ROSC achievment

Exclusion Criteria:

* unavailable first measurment of the optic nerve sheath diameter (ONSD) measured by transorbital ultrasonography 24±6 hours after ROSC achievement
* refractory cardiac arrest
* craniocerebral injury
* intracranial tumor
* active intracranial bleeding
* haemorrhagic stroke and/or subarachnoid haemorrhage in the last 3 months
* facial trauma affecting the eye area
* active neuroendocrine tumor, small cell lung cancer, non-small cell lung
* CPC 3-5 before cardiac arrest
* sclerosis multiplex and/or optic neuritis of other etiology
Kids + Adolescents Research Learning On Tablet Teaching Aachen

The aim of this study plan is to implement a tablet quiz in the German-speaking area, in order to test the specific knowledge about chronic inflammatory intestinal diseases (CED) concerning pediatric patients in the context of an age-appropriated and interesting digital playing environment, and to process knowledge gaps at the subsequent doctor's contact. The quiz should be combined with a game and can be performed by the patients, while they wait in the ambulance for their doctor's appointment. The investigator's goals are to grasp playfully gaps in the CED knowledge regarding the patients and to use these in the following consulting hour for clarification and advice in line with a better understanding of the disease. With this, the specific knowledge, the understanding of the disease, the therapeutic adherence, and the self-efficacy should improve the self-responsible handling of the disease. In particular, the willingness of the group of older teenagers to transit into the adult medicine can be collected and processed. The investigators want to check the efficacy in a randomized, controlled study with two groups of 15 pediatric CED patients. The hypothesis is that the additional play of the tablet-CED-quiz and the individualized advice have a positive impact on the CED knowledge, the disease activity, the CED-related life quality and the willingness of teenagers for transition.


Eligibility Criteria:
Inclusion Criteria:

* Female and male children and young adults between 8-21 years
* Diagnosis Morbus Crohn, Colitis ulcerosa or Colitis indeterminate
* Clarification and signed Informed Consent Form
* Patients must know how to write and read in German
* Patients must be able to play independently on the tablet

Exclusion Criteria:

* Age \< 8 years or \> 21 years
* Illiteracy
* Mental or psychomotor disability
Cloud Platform Integration Model for Pregnant Women Exercise Consultation

To construct the platform for exercise counseling for pregnant women, and evaluate the effects of that telecare platform integration model for exercise consultation on exercise behaviors and prenatal health outcomes among pregnant women during pregnancy.

This study will develop and construct an exercise counseling model with using cloud platform for women during pregnancy. In addition, we will evaluate the effects of that telecare platform integration model for exercise consultation on exercise behaviors and prenatal health outcomes among pregnant women during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women who less than 17 gestation and able to understand basic technologies such as smartphone and computer

Exclusion Criteria:

* women who had a diagnosis of pregnancy related compliactions and absolute limited exercise, such as preterm contraction, ruputer of menbrance, evidence of intrauterus growth retardation, heart and lung disease, cervical incompetence and/or medical conditions that influence exercise.
Efficacy and Safety of D-chiro-inositol in Obese Patients

The study aims to evaluate the efficacy and tolerability of a food supplement based on D-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet

Scientific studies on overweight/obese non-diabetic subjects have shown that weight loss improves insulin sensitivity. In fact, in these subjects weight loss reduces the insulin response to the oral glucose load and lowers plasma concentration of triglycerides.

However, although the insulin value is reduced with diet, it does not reach the levels found in overweight/obese non-insulin resistant subjects.

It has been shown that the supplementation of D-chiro-inositol (DCI), a polyol with an insulin-sensitizing action, can positively affect insulin resistance, avoiding the typical side effects of classic insulin sensitizers. In fact, DCI improves glucose tolerance and increases insulin sensitivity, as demonstrated in hyperinsulinemic women with polycystic ovary syndrome.

Therefore, considering the role of DCI, we want to investigate the efficacy and tolerability of a DCI-based product in overweight / obese women with insulin resistance who are approaching a low-calorie diet.

Eligibility Criteria:
Inclusion Criteria:

* Women between 25 and 40 years old
* Diagnosis of insulin resistance (HOMA ≥2.5)
* 26≤ BMI ≤32

Exclusion Criteria:

* Subjects with no indication for treatment
* Pregnancy and breastfeeding
* Treatment with drugs or supplements that interfere with the mechanism of action of insulin
Timing of Orthodontic Therapy and Regenerative Periodontal Surgery in Advanced Periodontitis Patients With Pathologic Tooth Migration

Pathologic tooth migration (PTM) is a common complication of advanced periodontitis and often motivation for patients to seek orthodontic therapy. An interdisciplinary approach is required to control the periodontal infection, reconstruct the defects and realign the migrated teeth. The optimal timing of active orthodontics after regenerative therapy is a topic of ongoing debate.

There are no data available from RCTs that have compared the effect of the timing of orthodontic tooth movement (early vs. late) on the outcomes of regenerative periodontal surgery in these patients.

It is the aim of the present randomized clinical multicenter trial to compare 2 different treatment protocols of a combined perio-regenerative and orthodontic therapy in advanced periodontitis patients with intrabony defects and pathologic tooth migration in order to establish whether one treatment modality is superior to the other with regard to clinical outcomes. A total of 46 patients will be enrolled and randomized into 2 treatment groups that differ by the time point of initiation of orthodontic therapy (early: 4 weeks vs. late: 6 months following regenerative periodontal surgery).

Primary outcome measure will be the change in clinical attachment level (CAL gain) at 12 months after regenerative therapy. Secondary outcomes will include changes in probing depth BOP, gingival recession, radiographic bone height and patient-centered outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Advanced periodontitis
* Presence of intrabony defects at a minimum of 2 and a maximum of 7 adjacent teeth (positions 15-25 or 35-45) in either the maxilla or the mandible with PPD of ≥6 mm at a minimum on one site
* Pathologic tooth migration
* Full mouth plaque index (PI) \<25% at baseline (after initial non-surgical periodontal therapy)
* Full mouth bleeding on probing (FMBP) \<25% at baseline (i.e., following initial non-surgical periodontal therapy)
* Committed to the study and the required follow-up visits

Exclusion Criteria:

Any contraindications for oral surgical procedures

* Uncontrolled diabetes or other uncontrolled systemic diseases
* Disorders or treatments that compromise wound healing
* Medical conditions requiring chronic high dose steroid therapy
* Bone metabolic diseases
* Radiation or other immuno-suppressive therapy
* Infections or vascular impairment at the surgical site
* Presence of oral lesions (such as ulceration, malignancy) or mucosal diseases
* History of malignant disease in the oral cavity or previous radiotherapy to the head
* Inadequate oral hygiene or unmotivated for adequate home care
* Current smokers \> 6Cig
Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption

There are a number of popular, freely available online interventions targeting hazardous alcohol consumption. Unfortunately, most have limited or no published evidence regarding their efficacy. Of particular interest is the intervention, 'Hello Sunday Morning.' The current project proposes to evaluate its' efficacy employing a RCT, using The Check Your Drinking intervention as an active comparator in the trial.

Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 6 months time. Those who agree to be followed-up will be assigned by chance to be asked versus not asked to access one of the interventions and then recontacted 6 months later to ask about their drinking and their impressions of the online intervention. The primary hypothesis to be tested is that participants receiving access to any of the online interventions will report a greater level of reduction in number of drinks in a typical week between the baseline survey and six-month follow-up as compared to participants in the control condition.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
* Typically consumes 15 or more drinks per week,
* Willingness to complete a 6-month follow-up survey

Exclusion Criteria: None
Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial

Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have neuropsychological disorders and moderate appearance behavior disorder, but with a significant impact both family, school and social persisting into adulthood.

Executive functions (EF), in general, and working memory (MT), in particular, are frequently altered in older children preterm infants compared to controls born at term.

The identification process of loss in certain diseases, as well as improving knowledge of brain functioning, and development with the possibility of neuronal plasticity has led research teams to develop intervention programs focused on process cognitive qualified of "remediation" cognitive (RC). Schematically, the RC is defined as a rehabilitation or altered cognitive functions. MT can be improved by encouraging the operation of the spots mental stimulant. These programs are effective on MT but do not have the expected impact on other FE, language or nonverbal functions (visuospatial). The functional benefit of cognitive remediation remains controversial.

Improving mental functions untrained as nonverbal MT, attention and secondarily learning is possible but still unproven on wide population. Similarly, randomized trials are needed to test this type of cognitive remediation among preschoolers old very premature.


Eligibility Criteria:
Inclusion Criteria:

* Already included in the study EPIPAGE 2, born between 24 and 34 weeks' GA (gestational amenorrhea),
* Children aged 5 to 6 years,
* Children exhibiting a total intellectual quotient \>70 from the WPPSI IV (during the 5-year assessment in EPIPAGE 2),
* Children having a visuo-spatial Working Memory impairment defined by a working memory index \<85 from the WPPSI IV,
* Children with parents (or legal guardians) authorizing participation in the study and a signed informed consent form,
* Children affiliated with medical insurance.

Exclusion Criteria:

* Children with severe cerebral palsy, based on the Gross Motor Function (GMFCS score \>2) and Bimanual Fine Motor Function (BFMF \>2) classification system (Elvrum AG 2015, Marois P 2015),
* Children with blindness or amblyopia, defined by a visual acuity \<3 (during the 5-year assessment in EPIPAGE 2),
* Children with deafness, as defined by a prescribed hearing aid,
* Children with chromosomal disorder or autistic syndrome,
* Children included in the EPILANG study protocol (an ancillary project to EPIPAGE),
* Children who do not speak French
* Children with parents having no internet connection,
* Triplets.
Studies of Kidney Transplant Outcome

The purpose of this study is to improve outcome for kidney transplant recipients. There has not been commensurate improvement in medium and long-term outcomes. Ongoing clinical research is necessary to improve transplant outcomes.

This study is looking at information already collected of transplant outcomes (short, medium and long-term complications and quality of life). This will specifically look at:

1. 10 year follow-up of steroid-free maintenance immunosuppression
2. A cross-sectional study of infection after kidney transplantation (with emphasis on infection in steroid-free recipients
3. An evaluation of the Delayed Graft Function (DGF) nomogram in Thymoglobulin treated recipients at the University of Minnesota

Eligibility Criteria:
Inclusion Criteria:

* Kidney Transplant Recipient at the University of Minnesota
* Kidney Transplant Recipients on steroid-free maintenance immunosuppression

Exclusion Criteria:

* Non-kidney transplant patients at the University of Minnesota
EEG Studies of Ketamine General Anesthesia

We are doing this research study to find out how and where ketamine acts in the brain. Ketamine is an anesthetic (a drug or agent used to decrease or eliminate the feeling of pain by putting you in an unconscious state). We will look at the brain using a machine that records the brain's electrical activity, called an electroencephalogram (EEG). We will assess how it impacts patient's pain responses.

In this trial, participants will be given ketamine at a high enough dosage to induce general anesthesia. EEG recording will be conducted during this time. Cognitive assessments and pain monitoring will be administered at various points before and after ketamine induction.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 to 45
* Normal body weight and habitus, BMI less than or equal to 30
* Non-smoker
* American Society of Anesthesiologists (ASA) physical status classification P1

Exclusion Criteria:

* Cardiovascular: myocardial infarction, coronary artery disease, peripheral vascular disease, arrhythmia, congestive heart failure, valvular disease, hypertension
* Respiratory: bronchitis, chronic obstructive pulmonary disease, smoking, shortness of breath
* Hepatic: hepatitis, jaundice, ascites
* Neurologic: seizure, stroke, positive neurologic findings on neurologic examination, multiple sclerosis, Meniere's disease, Parkinson's disease, neuropathy, peripheral stenosis
* Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
* Endocrine: diabetes, thyroid disease
* Renal: acute or chronic severe renal insufficiency
* Hematologic: blood dyscrasias, anemia, coagulopathies, on anticoagulant therapy
* Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia
* Psychiatric: history or treatment for an active psychiatric problem, depression
* Reproductive: pregnancy, breast-feeding
* Medications: regular use of prescription and non-prescription medications expected to affect CNS function, St. John's Wort
* Allergies: labetalol, ondansetron, glycopyrrolate, ketamine, midazolam
Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke

The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers.

This trial is to examine whether (1) the immediate effects of treatment intensity in MT would occur on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in MT on functionality can persist for six months after treatment finished; and (3) the MT could result in cortical/movement reorganization as well as the changes in physiological markers.

Eligibility Criteria:
Inclusion Criteria:

* first episode of stroke in cortical regions
* time since stroke less than 3 months
* initial motor part of UE of FMA score ranging from 24 to 52
* no serious cognitive impairment

Exclusion Criteria:

* aphasia
* visual impairments
* major health problems or poor physical conditions
* currently participation in any other
Assessment of the Effect of Captopril Versus Combination of Captopril and Pentoxifylline on Reducing Proteinuria in Type 2 Diabetic Nephropathy

Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. Pentoxifylline as a TNFa blocker may hinder progression of diabetic nephropathy in combination of captopril.

Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. TNFa is a cytokine that is a target for medical therapy in diabetic nephropathy. In this study the effect of captopril on overt diabetic nephropathy compared to effect of combination of captopril and an antiTNFa drug ( pentoxifylline).

Eligibility Criteria:
Inclusion Criteria:

1. Absence of kidney or urinary tract disease
2. Absence of high blood pressure OR Controlled blood pressure (≤140/90) with medication other than ACE inhibitors and/or non dihydropyridine calcium channel blockers
3. A well controlled blood sugar level (HbA1c≤7.5%)
4. Adhering to the diet protocol for patients with renal disease

Exclusion Criteria:

1. NYHA functional class III, IV
2. Valvular heart disease
3. Unstable angina, myocardial infarction, cerebrovascular accidents
4. Psychiatric disease
5. Prior allograft kidney transplant
6. Acute illness
7. Infectious disease including urinary tract infection
8. Leukocytosis or any febrile illness at enrollment
9. Prior history or development of any form of malignancy
10. History of alcohol or drug abuse or smoking
11. Pregnancy
12. Need for surgery during the study
13. Allergy to derivatives of methyl xanthines
14. Current Pentoxyphilline use