cyrilzakka/clinical-trials huggingface dataset:
Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia

Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment option for acute leukemia. The haplo-hematopoietic stem cell transplantation(haplo-HSCT) and "GIAC" protocol have crossed HLA barrier and helped more patients find donors. However, the engraftment failure and incidence of graft-versus-host disease(GVHD) limit the prognosis of patients who receive the haplo-HSCT. It is believed that Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation improved hematopoietic reconstitution and reduced the incidence of GVHD, there is still no consensus about the efficacy and safety of this kind of therapy. This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation

This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation. Investigators will recruit 116 patients with acute leukemia, with 58 of them entering the haplo-HSCT group and receiving haploidentical hematopoietic stem cell transplantation, while the other 58 entering the combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group and receiving haploidentical and umbilical cord blood allogeneic stem cell transplantation at the same day. Then primary outcomes including overall survival and disease free survival, as well secondary outcomes such as cumulative relapse incidence and cumulative incidence of engraftment will be measured during 12 months after the intervention being finished.

Eligibility Criteria:
Inclusion Criteria:

* Ages 16-65 years inclusive.
* Diagnosed as acute leukemia, planning to receive haplo-HSCT
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* Presence of an available haploidentical donor
* Signing written informed consent and agreeing with taking designated umbilical cord blood

Exclusion Criteria:

* Uncontrolled infections less than 4 weeks prior to enrollment
* Secondary malignancy
* Psychiatric illness that would limit compliance with study requirements
* Impairment of heart, hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
* Allergic to blood products
* Other causes which are not suitable for the trial in investigator's consideration
Effects of L-Carnitine Supplementation on Respiratory Distress Syndrome

The aim of the present study was to investigate the efficacy of L-carnitine therapy on the occurrence and prognosis of respiratory distress syndrome


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 30-37 weeks
* singleton pregnancy

Exclusion Criteria:

* congenital malformed fetus
* Extreme premature
Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients

The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is quality of life.

The hypothesis of this study is that autosuggestion will increase geriatric patient's quality of life based on its impact to psycho-neuro-endocrine-immune pathways.

Geriatric patients diagnosed with multipathology after getting information and signing informed consent will be included in this trial. Autosuggestion was created by patients according to their preferences, modified by researcher to accomplish autosuggestion principles, recorded in a tape to be heard by walkman daily for 30 days. Intervention and control groups received usual standard medical therapy.

Baseline data were collected within one week after admission. Then the subject will be followed up for 30 days. Primary outcome was quality of life measured by COOP chart, analyze using on treatment analysis. Secondary outcomes were serum cortisol, interleukin-2, interleukin-6, IFN-ϒ (Interferon gamma), and N Acetyl Aspartat/ creatine ratio in limbic and paralimbic system by Magnetic Resonance Spectroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 60 years old with multipathology, inpatients
* Not in steroid therapy
* Could communicate (Karnofsky score: 40% or Zubrod/WHO score: 3)
* Cooperative
* Willing to go through all of the research steps.

Exclusion Criteria:

* Stroke
* Multiple Sclerosis
* Brain Tumour
* Using Pace maker
Different Hydration Strategies Associated With Aerobic Exercise In Coronary

The need to restore water losses resulting from physical activity has become established and diffused into international consensus for healthy individuals or high-performance athletes. However, the influence of fluid replacement when administered during and after exercise on cardiac autonomic modulation with autonomic alterations known as the coronary arteries remain poorly understood. The aim of the study was to evaluate and compare whether different hydration strategies are able to promote acceleration of the recovery of autonomic modulation in individuals with coronary artery disease undergoing aerobic exercise. This study is a cross-over clinical trial, which will be developed based on an experimental procedure performed in four stages. A total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation (CR) sessions. The participants will perform CR with mineral water intake in phase three and four. In phase three, the consumption will be done a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the second session. In phase four, hydration will be carried out in an uncontrolled manner, according to the desire to drink water during the protocol.


Eligibility Criteria:
Inclusion Criteria:

* Men with coronary heart disease ischemia, over 45 years
* At least three months of cardiovascular rehabilitation

Exclusion Criteria:

* Smokers, alcoholics
* Uncontrolled metabolic disease (eg, uncontrolled diabetes and thyroid diseases)
* Abnormal hemodynamic responses during exercise such as disproportionate increase / fall of heart rate and / or blood pressure to low / high levels of load
* Myocardial ischemia and / or severe ventricular arrhythmias during the exercise test
Evaluation of the Rotational Stability

To evaluate rotational stability of the investigational device implanted after cataract surgery.

The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 18 years or older
* Subject who diagnosed unilateral or bilateral age-related cataract.
* Potential postoperative BCVA of 0.2 log MAR (0.63) or better.
* Calculated IOL power in within the range of investigational IOL.
* Subject is able to understand, agree and sign the informed consent statement.
* Subject is able and willing to comply with the postoperative follow-up examination schedule.

Exclusion Criteria:

* Uncontrolled systemic or ocular disease.
* Extremely shallow anterior chamber.
* Previous intraocular and corneal surgery.
* Traumatic cataract.
* Pregnancy or lactation.
* Concurrent participation in another drug and device clinical investigation.
ALDH2 Mutation in Taiwanese Head and Neck Cancer

The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation associating dermatitis or mucositis in head and neck cancer patients who accept chemoradiation therapy

* One-site audit. The enrolled subject is confirmed by PIs

  ◦◦Source data is compared to external data sources medical records, either paper or electronic case report forms.
* NCI CTCAE v5.0 for AE records
* Patient recruitment according to inclusion criteria: 1. Newly diagnosed locally head and neck squamous cell carcinoma; 2. Apply for primary chemoradiation or adjuvant chemoradiation; 3. Signed informed consent
* Sample size assessment: 60 subjects will be included in one year for total 120 subjects
* Missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
* Fisher's exact test is for category comparison. Kaplan-Meier analysis is for survival analysis. AE grades will be analyzed according to NCI guideline. Two-side p \< 0.05 is suggested significant.

Eligibility Criteria:
Inclusion Criteria:

* Age \>20, \<70
* Newly diagnosed head and neck squamous cell carcinoma
* Tissue proved
* Signed informed consent
* Suitable for chemoradiation

Exclusion Criteria:

* Uncontrolled underlying diseases
* Allergy to chemotherapy
* Uncontrolled skin diseases or mucosa diseases
* Previously radiation therapy over head and neck
* Combined with other cancer currently
Assessment of Right Ventricular Function in Advanced Heart Failure

We examined the feasibility and reliability of a combined echocardiographic and right heart catheterization (RHC) approach for right ventriculo/arterial (R-V/A) coupling assessment in HF patients with dilated cardiomyopathy (D-CMP).

This is a single center, retrospective cross-sectional study. In 2016-17, for 6 months, we evaluated for eligibility 81 consecutive D-CMP patients afferent to "Niguarda Great Metropolitan Hospital" for RHC and echocardiography. All participants underwent the exams in the context of heart-transplant or advanced HF evaluation. Inclusion criteria were: 18 years old, given informed consent, D-CMP, New York Heart Association (NYHA) functional class II or III and reduced EF (≤ 35%). On the contrary, exclusion criteria were: missing the inclusion criteria and refused informed consent. The final sample consisted of 68 study participants (mean age 64±7 years, 82 % male).

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* Given informed consent
* D-CMP
* New York Heart Association (NYHA) functional class II or III
* Reduced EF (≤ 35%)

Exclusion Criteria:

* Missing the inclusion criteria
* Refused informed consent
Evaluation of Effectiveness of Two Different Doses of Mivacurium in Rapid Sequence Intubation

Mivacurium can be considered as an optimal choice for muscle relaxation in short duration surgeries, as butyrylcholinesterase can rapidly and reliably degrade this benzylisoquinoline muscle relaxant in vivo. However the histamine release related to a rapid high-dose injection, unsatisfactory intubation conditions and unexpected delay in recovery in patients may be encountered with butyrylcholinesterase deficiency

Intubation in emergency and full stomach patients stands as a challenge in anaesthesia. Rapid sequence induction (RSI) is the key player technique in avoiding gastric contents aspiration risk. Non-depolarizing neuromuscular blocking agents as mivacurium are of clinical significance in the anesthetic management of patient. Mivacurium has been has been preferred in situations who necessitating hemodynamic solidity all over the surgery, as only transient tachycardia and hypotension were recorded

Aim of work Using high doses of mivacurium can provide accepted condition of emergency intubation within favorable time - monitoring hemodynamics changes during and after intubation, time of recovery from high doses of muscle relaxant

Eligibility Criteria:
Inclusion Criteria:

* 20-60 year old patients.
* American society of anaesthesia (ASA) 1 and 2.
* Emergency surgery.

Exclusion Criteria:

* Refusal.
* allergy.
* neuromuscular disease.
* Suspected desaturation.
* Severe cardiac disease.
* Severe pulmonary disease.
Handled Echocardiography and Chronic Heart Failure

The aim of the study is to compare two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations, the other one using also periodical handled echocardiographic examinations.

Randomized, blinded, controlled, monocentric study comparing two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations every three months, the other one using also periodical handheld echocardiographic examinations at the 6th, 12th and 18th month.

The events occurring during the 18 month follow up and the results of the final echocardiography performed in all the patients will be transmitted to and evaluated by an independent observer, unaware of the features of the follow up. At the end of the trial, the randomization code will be opened and the events will be ascribed to the two groups. The primary end point is rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events during the 18 months follow up. Secondary end points include home treated vascular events, cardiovascular death and the composite end point death + rehospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Heart Failure in functional class NYHA III
* At least once hospitalization during the last year for worsening of clinical symptoms or for the appearance of acute cardiovascular events
* Patients who cannot easily reach the pertaining Sanitary District for different reasons (i.e. the presence of architectural barriers, the absence of a lift, a too great distance between home and Sanitary District without someone helping)
* age ≥ 70 years
* written informed consent

Exclusion Criteria:

* Patients who were waiting for cardiac surgery or patients who had undergone a cardiac operation within three months
Comparative Quantification of MTX and Its Metabolites Post Glucarpidase

Acidification (i.e., addition of hydrochloric acid) of plasma samples from patients who have received Glucarpidase post high-dose MTX treatment is regarded as a necessary preanalytic step to avoid further in vitro enzymatic cleavage of MTX. However, it is unclear whether this acidification step is essential. A comparative study, which evaluates concentrations of MTX and its metabolites in paired (acidified versus non-acidified) plasma samples, has not yet been performed. Processing plasma samples without acidification would facilitate quantification of MTX, including plasma samples from patients treated at centers without adequate laboratory facilities.

Stored plasma samples (paired - acidified and non-acidified) from the specimens collection ('Tumorbiobank') of the Charité Comprehensive Cancer Center will be analysed by HPLC/MS.

A total of 136 samples from patients post Voraxaze across 3 levels of MTX concentrations:

30 without additive, 10 with 0.9% NaCl, 30 with HCl (stored at -80C) 9 without additive, 9 with HCl (stored at +4C and analysed after 3-5 days) 9 without additive, 9 with HCl (stored at -20C and analysed after 3-5 days) 30 with HCl (stored at +4C versus ambient temperature)

Eligibility Criteria:
Inclusion Criteria:

* Treatment with Glucarpidase

Exclusion Criteria:

* Lacking patient consent
Secondary Cancer Risk After Radiation Therapy for Rectal Cancer

Retrospective study comparing dose distribution of 3D conformal radiotherapy (3DCRT) and volumetric-modulated arc therapy (VMAT) to estimate secondary cancer risk for patients having had radiation therapy for rectal cancer. Twenty-five patients are included in this study. Planning CT scans are used for comparison of dose distribution and calculation of second cancer risk.

A model-based Analysis calculating the organ-specific excess lifetime attributable risk using the planning CT data sets of 25 patients to estimate second cancer risk for patients after radiotherapy for rectal cancer comparing conventional 3DCRT with VAMT techniques.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female \> 18 years of age
* pre or postoperative radiation therapy for rectal cancer
* Planning CT

Exclusion Criteria:

* Planning CT not available
Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers

The purpose of this study is to find out whether ubiquinol is well tolerated, can affect the symptoms of Parkinson's Disease and change the energy levels in the brain. Subjects will be randomized to taking ubiquinol or placebo and will have a neurological evaluation, magnetic resonance spectroscopy (MRS) and blood test for biological markers taken during the study.

Multiple lines of evidence have implicated abnormal energy metabolism and deficient mitochondrial function in Parkinson's disease, presenting a unique target for therapy. A pilot study of ubiquinol in PD was therefore undertaken to determine its effects upon physiologic measures of mitochondrial metabolic function. The incorporation of a neuroimaging biomarker is particularly important, since changes would demonstrate our ability to achieve Central Nervous System (CNS) access from this an formulation, accompanied by a meaningful neurophysiologic effect. Hydrogen Proton Magnetic Resonance Spectroscopy Imaging (1H MRSI) is a technique that provides insight into the metabolism of several endogenous brain compounds, most notably N-acetyl-L-aspartate (NAA), choline-containing compounds (Cho), and creatine and phosphocreatine (Cr). A number of studies of mitochondrial function have now firmly established the utility of 1H MRSI in probing potential mitochondrial energy metabolism dysfunction, in primary mitochondrial disorders, but also in PD. This pilot study is therefore designed to test whether oral ubiquinol affects cerebral indices of mitochondrial dysfunction, as measured by 1H MRSI in patients with Parkinson's disease, and to gather preliminary information on the safety and tolerability of ubiquinol in individuals with PD.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PD according to the Untied Kingdom (UK) Brain Bank Criteria, and confirmed by a Movement Disorders neurologist;
* age 40-75 years; diagnosis within 5 years of study participation;
* PD medications able to remain at stable doses in the opinion of the enrolling investigator;
* able to undergo MRI;
* absence of significant medical, psychiatric, and other neurological disease;
* absence of dementia and Mini-Mental State Examination (MMSE) \> 26.

Exclusion Criteria:

* failure to meet diagnosis by above criteria;
* time since diagnosis \> 5 years before study participation;
* PD medications not predicted to remain at stable doses in the opinion of the enrolling investigator;
* unable to undergo MRI;
* unable to comply with informed consent process;
* presence of significant medical, psychiatric (including major depressive disorder) or other neurological (including epilepsy, brain tumor, stroke) disease;
* diagnosis of dementia and/or MMSE 26 or lower;
* possibility of pregnancy (negative test required in women of childbearing age);
* taking medications including antipsychotic agents and dopamine- blocking anti-emetic agents;
* taking Coenzyme Q10;
* participation in another clinical trial within the last 3 months.
The Efficacy of Regional Scalp Block in Craniotomy

The objective of this clinical trial is to evaluate the role of scalp nerve block in craniotomy. The primary questions it seeks to answer are: What are the efficacy and safety profiles of scalp nerve block in craniotomy? The anesthesia protocol and monitoring were standardized for all participants. Participants were divided into two groups: the scalp nerve block group and the general anesthesia group. General anesthesia was induced using fentanyl (1-2 mcg/kg), propofol (1-2 mg/kg), and rocuronium (0.6 mg/kg). In the scalp nerve block group, a nerve block was administered using 0.5% ropivacaine.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>18 years
* American Society of Anesthesiologists (ASA) classification I-III
* Glasgow Coma Scale (GCS) score ≥ 13
* Elective craniotomy

Exclusion Criteria:

- Patients with cardiovascular abnormalities, impaired renal and hepatic function, diabetes mellitus, systemic and/or scalp local infection, and those with a history of current dexamethasone administration
Telephone and Mail Intervention for Alcohol Use Disorders

Randomized controlled trial and benefit-cost study of a telephone and mail intervention for non-treatment-seeking primary care patients with alcohol abuse or dependence


Eligibility Criteria:
Inclusion Criteria:

* primary care patients with DSM-IV alcohol abuse or dependence

Exclusion Criteria:

* pregnancy
* suicidality
* alcohol treatment in prior 3 months
A Multi-component Program to Reduce Obesity in Children

In an attempt to challenge the increasing prevalence of childhood obesity, many programs have been executed in order to improve childrens' lifestyle. Programs involved either school, family or environmental measures. In most, success was only limited.

The purpose of this trial is to examine the ability of a low-cost multi-component program to improve behavioral, diet and activity habits in both school, family and afternoon settings. Ths ultimate goal is to construct and assess a lifestyle modification program that can be implemented in schools and kindergartens on a national level.

Participants will be \~2,500 children aged 5-12 from 22 kindergartens and elementary schools, divided into control and intervention centers.

Teachers and students will be provided with materials in order to perform activities on healthy food and drink choices and habits during the school day. Schools will offer increased physical activity opportunities to children, as will afternoon community centers. Children will be given personal exercise items. Parents will be offered lectures on topics of diet and activity. Diet and activity habits will be assessed by a questionnaire, and height, weight and body fat percentage will be measured before and after the program.


Eligibility Criteria:
Inclusion Criteria:

* schools with lunch served
* school principal agreement
* school has 2 weekly PE classes
* parent and children consent given

Exclusion Criteria:

* consent not given
Factors Influencing Occurrence of Bile Leaks in Surgery

The objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract.

The objective of our study is to identify the factors influencing the occurrence postoperative of biliary leaks, Sex, Age, BMI, Bilirubin level, Protein level, and surgical technique (And other factors)are analyzed to study their influence on occurrence of postoperative biliary leak.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has undergone a surgical bilioenteric anastomosis for any etiology.

Exclusion Criteria:

* Any patient who has undergone a nonsurgical (endoscopic / radiological) bilioenteric anastomosis.
* Subjects under the age of 18. Years.
* Subjects who refused to participate in this study.
* Cases of biliary and pancreatic anastomoses performed during the same surgery.
Correlation Analysis of Xpert Carba-R Detection of Non-colonized CRE in BALF and Rectal Swabs From Patients With LRTI

Assess the correlation between Xpert Carba-R detection of carbapenemase gene types in bronchoalveolar lavage samples and rectal swab samples from non-colonized CRKP patients with lower respiratory tract infections, and evaluate the relationship between first-time lower respiratory tract infections and intestinal colonization of CRKP.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and above
* CRKP is cultured from lower respiratory tract specimens in 15 days
* Lower respiratory tract infection based on at least two of the followings: abnormal temperature (body temperature greater than 38.5°C or less than 36.5°C), leucocyte count abnormality (leucocyte count greater than 10\*10\^9/L or less than 4\*10\^9/L), and the presence of purulent tracheal secretions.

Exclusion Criteria:

* There are other bacteria that can produce carbapenemases exist in lower respiratory tract specimens
* Infected with CRE before