cyrilzakka/clinical-trials huggingface dataset:
Conditioning Regimen in Elderly AML Patients Receiving Haplo-HSCT.

Elderly AML patients receiving conventional chemotherapy have poor prognosis. Allo-HSCT offers better long-term survival than chemotherapy, while high TRM limits its use. Current research focuses more on improving conditioning regimens to reduce TRM. Studies suggest Bu/Flu/Cy/ATG are safer and more effective for elderly AML haplo-HSCT, lowering TRM. However, prospective randomized trials are lacking. This study aims to compare Bu/Flu/Cy/ATG vs. Bu/Cy/ATG to determine if TRM can be reduced in elderly AML undergoing haplo-HSCT.

The prognosis of elderly patients with acute myeloid leukemia (AML) undergoing conventional chemotherapy is poor. Compared with chemotherapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) can improve long-term survival in elderly patients. However, the high transplantion-related mortality (TRM) limited its application. Currently, the top priority in transplantation for elderly AML patients is to reduce TRM through methods such as optimizing conditioning regimens, reducing graft-versus-host disease (GVHD), and preventing infections. Present research primarily focuses on optimizing conditioning regimens. Both domestic and international studies, as well as our team's preliminary research, suggest that replacing cyclophosphamide (Cy) with fludarabine (Flu) can reduce toxicity. Earlier prospective single-arm clinical study in our team confirmed that the Bu/Flu/Cy/ATG regimen is a safe and effective conditioning protocol for haploidentical hematopoietic stem cell transplantation (haplo-HSCT) in elderly AML patients. This study aims to use a prospective randomized controlled trial to verify whether the Bu/Flu/Cy/ATG conditioning regimen can reduce TRM compared with the Bu/Cy/ATG regimen in elderly AML patients undergoing haplo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

- (a)Diagnosed with AML in first complete remission (CR1). (b)Age ≥55 years. (c)Availability of an haploidentical donor, first transplant, no matched sibling or unrelated donor.

(d)Willingness to provide written informed consent.

Exclusion Criteria:

* (a) Uncontrolled active infection. (b) Secondary AML. (c)Refusal to provide informed consent.
The Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.

To determine whether administration of Alendronate early is more effective than late in the prevention of osteoporosis following a hip fracture


Eligibility Criteria:
Inclusion Criteria:

Male and Female aged \> 55 Low trauma hip fracture up to 90 days Be willing to submit to periodic bone mineral density radiographic studies of the spine \& 24 hr urine collection Written informed consent

-

Exclusion Criteria:

* Disorders known to affect bone metabolism Not taking bisphosphonates within last 6 months Drugs known to interfere with calcium metabolism within the lats 6 months prior to hip fracture serum calcium\> 2.65 mmol/L Treatment with any investigational drug within the last 30 days
Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Localised Renal Tumors (SABINA Trial)

Study evaluating the activity and efficacy of Stereotactic Body Radiotherapy for the treatment of medically inoperable localized renal cancer

Stereotactic Body Radiotherapy (SBRT) is a non-invasive alternative to surgery to control localized primary renal cell cancer (RCC) in medically inoperable patients. The kidney tumor has classically been considered radioresistant. Multiple retrospective series and few Phase II trial have studied the role of SBRT in localized renal tumors with favorable outcomes. Although large prospective studies are lacking, we evaluate the safety and effectiveness of SBRT for the treatment of renal cancer.

Participants will be allocated to recieve either single 26Gy fraction or Multifraction 3 - 5 fraction-squeme.

Assesment at regular intervals will estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR.

Follow-up visits occur at 1month and every 3 months in the first year after SBRT, then every 6 months in the second year and then yearly until study closure.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of Renal tumor and/or highly suspected malignant neoplasm by CT, MRI or PET.
* Tumor Diameter \>1cm - \<7cm
* Tumor visible on CT planning
* Medically inoperable disease (or rejection of surgery)
* Karnofsky Index \>70%
* \>18 y.o.
* Informed Consent signature

Exclusion criteria:

* Non-oncological renal disease or autoinmunological disorder that does not recommend the treatment with radiotherapy.
* Previous local/regional RT
* Life expectancy \<6 months
* Concomitance with other antineoplastic drugs
Neural Account of Social Placebo Effect

The current study aimed to reveal the neural mechanism of social placebo belief formation and belief representation, and also investigated how the brain pattern predict the social behavior performance under placebo manipulation.

Participants were randomly assigned to spray+ group (sprayed with saline but told as "oxytocin") and control group (sprayed with saline but told as "saline"). After 10 min, participants were invited to the resting-state, text viewing task in fMRI scanner.

In resting state session, participants with their eyes open and were instructed to attend to a black fixation cross centrally presented on a grey projection screen for 8 min (240TR).

The Text viewing task employed a mixed block and even-related fMRI design. Participants were asked to judge whether they could understand the stimuli or not by a button press (1=understand; 2=not understand). Three kinds of stimuli were presented in separate block including "oxytocin-function", "oxytocin-knowledge", "robot" related stimuli, each category contained 20 sentences. In each block, the sentence (within one category) was presented pseudo-randomized from 5s to 9s (with mean duration of 7s), then followed by a jittered time interval (interval time = sentence duration - response time; if participants made response within 5s, the sentence would not disappear until its duration reached 5s). There were two sessions with six blocks per session, and there were 5 sentences (trials) per block. The order of blocks and sentences were designed to present in pseudo-random order and were applied to all participants.

Eligibility Criteria:
Inclusion Criteria:

* All participants had normal or corrected-to-normal vision, and mental healthy.

Exclusion Criteria:

* Participants who reported no history of neurological, endocrine or psychiatric disorders, who majored in psychology in college or recently participated in any other drug study were not recruited.
Low-flow Extracorporeal Carbon Dioxide Removal in COVID-19-associated Acute Respiratory Distress Syndrome

The study aims to investigate the efficacy of extracorporeal CO2 removal for correction of hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distress syndrome

The prevalence of acute respiratory distress syndrome (ARDS) caused by COVID-19 is approximately 8%. Lung-protective ventilation is the current standard of care for ARDS. It limits lung and distal organ impairment, but is associated with hypercapnia in approximately 14% of patients with mild to moderate ARDS and almost all patients with severe ARDS. In this setting, early implementing of an extracorporeal CO2 removal (ECCO2R) therapy may prevent further escalation of invasiveness of therapy (eg, need for extracorporeal membrane oxygenation (ECMO)). A number of low-flow ECCO2R devices are now available and some of those can be integrated into a renal replacement therapy (RRT) platform. This study aims to investigate the efficacy of an original ECCO2R system used in conjunction with a RRT platform in hypercapnic patients with COVID-19-associated mild-to-moderate ARDS with or without acute kidney injury (AKI) necessitating RRT.

Eligibility Criteria:
Inclusion Criteria:

* mild-to-moderate ARDS according to the Berlin definition
* lung-protective ventilation with positive end-expiratory pressure (PEEP) \> 5 cm of water on mechanical ventilation expected to last \> 24 h
* hypercapnia \<80 mmHg
* bilateral opacities on chest imaging

Exclusion Criteria:

* age \< 18 years
* pregnancy
* patients with decompensated heart failure or acute coronary syndrome
* respiratory acidosis with persistent partial pressure of blood carbon dioxide (PCO2) levels \>80 mmHg
* acute brain injury
* severe liver insufficiency (Child-Pugh scores \> 7) or fulminant hepatic failure
* decision to limit therapeutic interventions
* catheter access to femoral vein or jugular vein impossible
* pneumothorax
Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)

Obsessive-compulsive disorder is a disabling and frequent disorder. In some patients, the medical treatment is ineffective. The pathophysiology of this disease is still unknown. Some data suggest that basal ganglia dysfunction could participate in the occurrence of OCD. The aim of this study is to evaluate the efficacy of subthalamic nucleus high-frequency stimulation in patients with severe OCD.


Eligibility Criteria:
Inclusion Criteria:

* Severe obsessive-compulsive disorder

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI)
* Severe cognitive or behavioral disorders
Cerebral Blood Circulation in Patients With Posterior Fossa Brain Tumor

The normal cerebral blood flow is guided by factors such as cerebral autoregulation (CA) and carbon dioxide reactivity (CO2R). Authors have demonstrated that CA and CO2R may be impaired in presence of intracranial tumors.Most studies pertaining to assessment of CA and CO2R in patients with brain tumors is limited to supratentorial tumors. Due to their anatomic location, posterior fossa tumors result in obstruction of ventricular outflow, produce hydrocephalus and features of raise intracranial pressure (ICP). It is possible that lesions in the posterior fossa may affect CA and CO2R. It should also be noted that posterior fossa surgeries are carried out in positions such as prone, lateral and sitting. Altered surgical positions themselves affect systemic hemodynamics which may influence cerebral blood flow; with presence of anesthetics further compromising the blood flow to the brain. Understanding the homeostatic mechanisms of CA and CO2R may help in deciding proper positioning of patients and maintenance of intraoperative hemodynamic.

The aim of this observational study was to evaluate CA and CO2R in patients with posterior fossa tumor prior to surgical decompression of the lesion.


Eligibility Criteria:
Inclusion Criteria:

* All patients with posterior fossa tumor
* Scheduled for elective surgery
* History of recent ventriculoperitoneal shunt (within 24 hours)

Exclusion Criteria:

* previous craniotomy
* patients on ventilatory support
* history of cerebrovascular accident
* syncope or carotid artery disease
* anemia
* polycythemia
* patients on vasoactive medications
* those suffering from medical conditions such as diabetes mellitus and hypertension.
TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant

This study is a comparison of the analgesic efficacy of transversus abdominis plane (TAP) blocks with ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine.

This study is a comparison of the analgesic efficacy of TAP blocks provided by ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine.

In the Liposomal Bupivacaine group, TAP block will be performed using ultrasound guidance. 12ml of 0,25% plain bupivacaine will be used for skin infiltration and to open up the TAP. Liposomal Bupivacaine 266 mg (1.3% in 20 ml) will be diluted to 40 ml volume with 20 ml of preservative free normal saline. 20 ml (133mg) of liposomal bupivicaine will then be injected into the TAP.

For those randomized to the TAP catheter group, ultrasound guidance will be used for TAP block and 5 mls 1% lidocaine will be used for skin infiltration. A peripheral nerve catheter will be placed approximately 3-5 cm into the TAP space after injection of ropivacaine. A bolus dose of 2.5 mg/kg of ropivacaine will be administered in a volume of 30 ml up to a maximum of 150 mg. An infusion with a programmable pump will be initiated at a rate of 8 ml/hr of 0.2% ropivacaine on the inpatient floor.

Eligibility Criteria:
Inclusion Criteria:

* Patients ages 18 years or older
* Renal Transplant Recipients

Exclusion Criteria:

* Patients less than 18 years of age
* Pregnant Women
* Prisoners
* Opioid Tolerant Patients taking more than 30 mg/day of oral morphine equivalent analgesia
* Patients on Systemic anti coagulation
* Patients unable to provide consent
* Hypersensitivity to amide-type local anesthetic or any component of the drug formula
Effects of Repeated Botulinum Toxin Injections in Children With Cerebral Palsy

One of the disorders observed in children with cerebral palsy (CP) is abnormal muscle tone, and the most common tone problem is spasticity. Botulinum toxin A (BoNT-A) injections are frequently used to reduce spasticity in CP rehabilitation. BoNT-A injections can be administered as a single dose, and some patients require repeated injections. The aim of this study was to examine the effects of repeated BoNT-A applications applied to the gastrocnemius muscle of children with CP on muscle morphology and functionality.

The study will be planned to include 50 children with CP. The children will be divided into two groups.Children who had been injected once or twice before were included in one group; children who received 3 or more injections were included in the other group.Gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle) was evaluated by ultrasonography, muscle stiffness was evaluated by shear wave ultrasound elastography, and muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist. Functionality of children with CP was evaluated with gross motor function measure (GMFM), time up go test, squat test and vertical jumping tests by an experienced pediatric physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Children with unilateral and bilateral, ambulatory, spastic CP, aged 5-18 years
* Children who had previously been injected with BoNT-A into the gastrocnemius muscle

Exclusion Criteria:

* Children with dyskinetic, ataxic, and hypotonic type CP
* Children with a history of any surgical operation or botulinum toxin injection treatment in the previous 6 months
Ventilation Distribution During Spontaneous Breathing in Healthy Newborn Infants

Electrical impedance tomography (EIT) is an evolving monitoring tool for respiratory support in neonatal and pediatric intensive care. In this observational study basic EIT parameters will be measured on 20 healthy newborn infants during spontaneous breathing and assess the effect of position changes in ventilation distribution.

NEO SensorBelts will be used to observe ventilation distribution in healthy newborn infants during quiet spontaneous breathing. Child's position will be changed 5 times every 10 minutes in a random order. Positions observed will be: left lateral, right lateral, supine, prone face to left, prone face to right and supine with the bed tilted 30 degrees. Total duration for the recording will be 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from a parent or legal guardian
* Gestational age 37+0 - 42+0 weeks
* Uneventful follow-up in maternity ward

Exclusion Criteria:

* Respiratory distress
* Admission to NICU
* Thorax skin lesions
* Prior participation in this study
Neo-Synalar Modified 48 Hour Patch Test

A 48 hour patch test performed in healthy volunteers to determine the presensitization (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base), fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium Lauryl Sulfate) and a negative control (Saline).

The primary objective of this study is to determine if any subjects exhibit an allergic reaction which may be indicative of a pre-existing sensitization.

Following approximately 48 hours of continuous skin contact, the patch units and test material are removed at the testing facility. The test sites are evaluated for a significant reaction according to the ESS (Erythemal Scoring Scale).

The test sites are also re-evaluated at 96 and 168 hours post-application (for late reaction) using the ESS.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 to 79 years inclusive.
* Subjects must be able to understand and execute informed consent.
* Female subjects must produce a negative pregnancy test.
* Subjects must be capable of following directions.
* Subjects must be considered reliable .

Exclusion Criteria:

* Subjects who are ill of health or taking medication that could influence the purpose, integrity, or outcome of the trial.
* Female subjects who are pregnant.
* Subjects with a history of adverse reactions to cosmetics, OTC (over the counter) drugs or other personal care products.
* Subjects who have used topical or systemic steroids or antihistamines within 7 days prior to trial initiation or plan to use either during the duration of the trial.
* Subjects with known allergy to neomycin, bacitracin, gentamicin, paromomycin, spectinomycin, streptomycin or tobramycin.
* Subjects with known allergy to corticosteroid.
* Subjects with a history of auto-immune disease (e.g. lupus, psoriatic arthritis, rheumatoid arthritis).
Optimal Site for Rapid Urease Test in the Stomach

The accurate diagnosis of H. pylori infection is an important step for establishing the strategy for gastric cancer prevention. During endoscopy, rapid urease test (RUT) is the first of biopsy-based H. pylori tests. Despite indirect test for H. pylori detection, RUT shows rapid result with good sensitivity and specificity. Several study reported that H. pylori density was related to positive reaction time of RUT. However, there was no study comparing the positive reaction times of RUT according to biopsy site, degree of gastric atrophy, and intestinal metaplasia.

The aims of this study were to: (1) assess the positive reaction times of RUT in the body and antrum, (2) investigate the association between the difference of RUT results (body and antrum) and gastric atrophy, and intestinal metaplasia, and (3) evaluate the optimal biopsy site for RUT according to degree of gastric atrophy in Korean population.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who underwent upper endoscopy and rapid urease test

Exclusion Criteria:

* : age \< 20 or \> 70 years; anemia (serum hemoglobin level \< 10 g/dL); severe systemic disease or advanced chronic liver disease; use of certain medications, including proton pump inhibitors, H2-receptor antagonists, or antibiotics; a history of H. pylori eradication; a history of gastric surgery; a recent history of upper gastrointestinal bleeding.
Clinical and Laboratory Characteristics of Sickle Cell Anemia Patients Admitted With Fever

This study will summarized the clinical and laboratory data and the outcome of all the patients suffering from Sickle Cell Anemia (Including Sickle cell thalassemia) admitted to the pediatric ward.

The actual protocol for SCA patients admitted with fever is to obtain blood cultures and start empiric antibiotic treatment.

The study cohort included 60 SCA patients actually treated in the Pediatric Hematology Unit.

Eligibility Criteria:
Inclusion Criteria: All patients admitted with fever as the only presenting symptom.

Exclusion Criteria: Patients admitted with another causes related or unrelated to sickle cell disease and have also fever.
Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer

The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion
* Performance status ≤2 on the ECOG scale
* Serum bilirubin must be ≤1.5 upper limit of normal (ULN)
* ALAT ≤2 x ULN
* Able to comply with study and follow-up procedures
* Patients with reproductive potential must use effective contraception
* Written (signed) informed consent to participate in the study

Exclusion Criteria:

* Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
* Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
* Inability to take oral medication, or requirement of intravenous alimentation
* Nursing mothers
Evaluate Patients With Chronic Hepatitis by Three-dimensional Force-controlled Ultrasound Measurement

Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness. However, pressing the transducer onto the skin with too much force will significantly reduce the subcutaneous adipose tissue thickness. In this study, a force controlled system combined with US transducer was used for 3D subcutaneous fat imaging and reconstruction.

The diagnosis of fatty liver (steatosis) is made when fat in the liver exceeds 5-10% by weight. Fatty liver (FL) is commonly associated with alcohol or metabolic syndrome (diabetes, hypertension, obesity, and dyslipidemia), but can also be due to any one of many causes. Most people were detected from serum lipid abnormalities in the physical examination, and confirmed as the fatty liver disease by ultrasound imaging. In some previous studies, ultrasound was reported to provide an accurate and reliable measurement tool for the thickness measurements of subcutaneous adipose tissue. This method can overcome some limitations of the skinfold thickness measurements. Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness. However, pressing the transducer onto the skin with too much force will significantly reduce the subcutaneous adipose tissue thickness. In this study, a force controlled system combined with US transducer was used for 3D subcutaneous fat imaging and reconstruction. Finally, the correlations between body fat percentage and subcutaneous fat in steatosis patients have been investigated. The body fat percentage was determined by dual energy X-ray absorptiometry (DEXA, GE Lunar iDXA canner) and bioelectrical impedance analysis (BIA, Omron，HBF-370), and then, the correlation between body fat percentage and subcutaneous adipose tissue in normal and steatosis patients have been evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 20-65 adults who are confirmed have fatty liver by echo

Exclusion Criteria:

* none