cyrilzakka/clinical-trials huggingface dataset:
Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML

This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Patients with Philadelphia-Positive (Ph+) (or BCR/ABL+) accelerated phase chronic myeloid leukemia, Ph+ (or BCR/ABL+) blast phase chronic myeloid leukemia, or Ph+ (or BCR/ABL+) acute lymphoblastic leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate
* Men and women, 18 years of age or older
* Adequate hepatic function
* Adequate renal function
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
* Uncontrolled or significant cardiovascular disease
* Medications that increase bleeding risk
* Medications that change heart rhythms
* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
* History of significant bleeding disorder unrelated to CML
* Concurrent incurable malignancy other than CML
* Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
* Prior therapy with BMS-35425
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Genetic Study in Young Onset Parkinson's Disease

Parkinson's disease (PD) is the second most frequent neurodegenerative disorder after Alzheimer's disease. It causes motor dysfunctions, such as bradykinesia, resting tremor, rigidity and postural instability. Although PD appears to be sporadic in most cases, several causative genes and susceptibility factors have been identified that cause familial forms of the disease with Mendelian inheritance with autosomal dominant or autosomal recessive inheritance.

Approximately 5\~10% of patients with the clinical picture of PD carry a mutation in one of the known genes that cause monogenic forms of the disorder. The average age at onset is between 60 and 80 years and the average age of diagnosis is 60 years. Onset of primary parkinsonism before 50 years is known as early onset parkinsonism(EOP). Onset between 20 and 50 years is known as young-onset PD. Onset at younger than 20 years is known as juvenile parkinsonism (JP). At least, 13 loci and 9 genes are reported. The investigators study is aimed to screen the clinical diagnosed familial EOP for the common mutation site by PCR/DNA sequencing. The gene for screen are Parkin (pattern: PARK2), PINK1 (pattern: PARK6) and ATP13A2 (pattern: PARK9).


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease (according to UK Parkinson's Disease Society Brain Bank clinical diagnosis criteria)
* Onset before 50-year-old or positive family history

Exclusion Criteria:

* Secondary parkinsonism
Evaluation of Pain Location, Pain Quality and Pain Patterns in Subjects With Chronic Pain

In earlier work, the Sponsor developed a computer image processing system for analysis of pain diagrams from patients with chronic pain. This system was then tested in a study in over 500 chronic pain patients seen by both primary care practitioners and pain specialists. The hypothesis was that pain location would correlate with the pain type and the underlying cause of the pain. In the study, the computer analysis demonstrated clear correlations between pain diagram data and diagnosis/pain type. The present study extends these observations in a web-based setting, with a focus on the value of computer analysis of pain diagrams as diagnostic predictors.

Earlier work performed by the Sponsor (TMT) included development of a MatLab/ImageJ computer image processing system for generation of composite images from pain diagrams drawn by patients with pain, and for calculation of related quantitative variables. The system was tested in a pharmaceutical company-sponsored US study in over 500 chronic pain patients seen by primary care practitioners, and then seen by pain specialists. The hypothesis was that pain location would correlate with the pain type and the underlying cause of the pain. TMT's analysis established correlations between the pain diagram information and the underlying diagnosis and pain type (e.g., nociceptive or neuropathic) reported by the pain specialists. The present study extends these observations in a web-based setting, with particular emphasis on automated computer-generated visual pain patterns as diagnostic predictors.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects at least 18 years of age and of legal age of consent for the state in which they live.
* Able to respond to a questionnaire written in English.
* Report chronic pain (constant or recurring pain lasting more than 30 days and causing significant discomfort or limitation of activity).
* Provide informed consent to participate in the study.

Exclusion Criteria:

* Currently participating in another clinical trial.
* Institutionalized person such as a prisoner or nursing home resident.
* Questionnaire response suggests a medical or psychological condition that, in the opinion of the investigator, would compromise participation in the study, or suggests any other condition which, in the investigator's judgment, might increase the risk to the subject or decrease the chance of obtaining valid data.
* Pain has resulted in a workman's compensation case.
* Pain has resulted in litigation.
Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes

Contrast-induced acute kidney injury (CIAKI) is a major complication with adverse outcomes after contrast media injection. Although the risk of developing CIAKI is low in patients with normal renal function, it is dramatically higher in patients with conditions such as diabetes mellitus (DM) or chronic kidney disease (CKD). More recently, our data showed that contrast agents can induce endothelial dysfunction partially via free radicals in diabetes. Therefore, strategies to prevent CIAKI and endothelial dysfunction in DM patients with CKD are urgently needed. Alpha-lipoic acid and its reduced form, dihydrolipoate, are potent antioxidants. We hypothesized that alpha lipoic acid can prevent the contrast-induced acute kidney injury and endothelial dysfunction in type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* nephropathy (stage 3 and 4)

Exclusion Criteria:

* recive alpha lipoic acid
* type 1 diabetes
* nephropathy (stagte 1, 2 and 5)
* hypersensitivity to contrast media
* IV heart failure
* lactic acidosis
Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

Spinal anesthesia is widely used for lower extremity surgery, and sedation is often required during surgery. For sedation, propofol, midazolam and dexmedetomidine are frequently used. Dexmedetomidine is a highly selective alpha 2 receptor agonist, and has sedating and analgesic effect. Compared with propofol and midazolam, it has little or no respiratory inhibition and hemodynamically stable. It also has the effect of reducing delirium in the elderly. Dexmedetomidine has also been reported to prolong the duration of sensory and motor blockade effects of spinal anesthesia. However, several studies have reported that administration of dexmedetomidine in spinal anesthesia increases the incidence of bradycardia.

In a study of healthy young adults, concurrent administration of atropine with dexmedetomidine in spinal anesthesia significantly reduced the frequency of bradycardia requiring treatment. However, in elderly patients, it is often reported that there is little response to atropine in bradycardia, and ephedrine is more effective in treating bradycardia than atropine in the elderly.

The investigators therefore compared ephedrine and atropine as pretreatment to reduce the incidence of bradycardia when using dexmedetomidine as a sedative in elderly patients undergoing spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* Undergoing orthopedic surgery under spinal anesthesia

Exclusion Criteria:

* Contraindication for spinal anesthesia
* Atrial fibrillation, atrial flutter
* Cardiac valve disease
* Neurologic disease
* initial systolic blood pressure in operating room \> 160mmHg
Cardiac Diseases With Pregnancy in Benisuef Localities

The aim of this work is to demonstrate the variation of cardiac diseases among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes


Eligibility Criteria:
Inclusion criteria

* All pregnant ladies with Cardiac diseases, valvular heart disease, congenital heart disease, ischemic heart disease, cardiomyopathy, arrhythmias , big and pulmonary hypertension, presenting with pregnancy regardless age, any concomitant diseases and type of heart disease will be enrolled.
* A similar number of pregnant females free from previous mentioned cardiac diseases will be studied as controls.

Exclusion Criteria:
Ridge Augmentation in Posterior Mandible Using Tunneling Technique With Amix of Autogenous Bone and Xenograft With and Without Collagen Membrane

aim Evaluation of the amount of bone gain following Ridge augmentation using tunneling technique in atrophic posterior mandibular ridges using anorganic bovine bone derived mineral mixed with particulated autogenous bone chips with collagen membrane

Bone grafting before implant placement has become a routine procedure over the last 20 years. A 5-year survival rate of up to98.3% for implants placed in grafted bone has been reported.

Autologous bone grafts are considered the gold standard.However, the success rate of the grafting procedure may beinfluenced by various risk factors.

A particular challenge isposed by an extensive graft of the alveolar ridge, with relativelyhigh complication rates of up to 20% being reported, mostcommonly dehiscence. More serious complications such asdehiscence or mobilization of the graft were observed in one third of smokers compared to a complication rate of only 7.7%for non-smokers. Complications such as flap necroses, dehiscenceand resorption are frequently soft-tissue complications.

A tension-free wound closure is a key factor in the successof bone grafts. Periosteal incisions are a common techniquefor flap extension. However, too many relief incisions in the periosteum may also result in an excessively thin or stretched wound flap.

This type of soft-tissue management may result in perforation or flap necrosis above the bone graft.

In 1987 Härle reported on a tunneling access in connectionwith a technique for preprosthetic jaw ridge grafting in the mandibular side-tooth region with bone replacement materials.

In the clinical experience of the authors the use of a tunneling technique for preparation without a crestal incision can present an alternative with autologous bone grafts to conventional surgical procedures with a trapezoid flap design.

Eligibility Criteria:
Inclusion Criteria:

* medically free,age 22:50 years, atrophic posterior mandibleClinical diagnosis of Alzheimer's Disease Must be able to swallow tablets

Exclusion Criteria:

smoking Insulin dependent diabetes Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets
Fabry Patient's Experience Of PegunigaLsidasE Alfa Monthly Infusion

Pegunigalsidase alfa (PRX-102) is a long-term enzyme replacement therapy design for the treatment of patients with Fabry disease. Although in the clinical development program patient-reported outcomes and clinician-reported outcomes have been included, this may not allow for a sufficiently accurate assessment of the quality of life in patients with Fabry Disease treated with pegunigalsidase alfa.

This study will collect the patient experience on the pegunigalsidase alfa treatment administered intravenously every 4 weeks in the BRIGHT-F51 clinical study (NCT03614234).

This is an additional qualitative concept elicitation interview-based study to further understand the patients' experience with Fabry disease and with the pegunigalsidase alfa administered intravenously every 4 weeks. Patients will be asked a set of open-ended questions with probes to describe their experiences with Fabry disease on treatment with pegunigalsidase alfa. Qualitative research methods will be used to obtain a deeper understanding of the patient experience by generating in-depth information about the experiences, perspectives, and feelings of patients and others, in their own words (FDA Patient-Focused Drug Development Guidance 2).

The study will be offered to the 29 patients participating in the BRIGHT-F51 clinical trial (NCT03614234).

Eligibility Criteria:
Inclusion Criteria:

* The patient is participating in study PB-102-F51
* The patient is willing and able to participate in a 60-minute recorded interview
* The patient is able to read, understand, and speak sufficiently to participate in the interviews
* The patient signs informed consent to participate in the study

Exclusion Criteria:

* At investigators discretion, patient is considered to be unable to participate in a 60- minute telephone interview.
* Patient has any clinically relevant medical or psychiatric condition that, in the opinion of the investigator would interfere with the completion of the study activities. This includes but is not limited to language, speech, hearing or cognitive disorders that could impact a patient's ability to participate in an interview-based discussion.
Correlation of Eicosanoid and Proresolving Lipid Mediator Temporal Profiles and Resolution of Pain After Thoracic Surgery

The aim of the current pilot study is to investigate whether perioperative dysregulated systemic lipid mediator pathways (more specifically increased pro-inflammatory and decreased anti-inflammatory pathways) are associated with slower resolution of pain after surgery and increased risk for development of persistent postsurgical pain (PPSP). In addition, we will look for correlations between the pro-resolving lipid mediator profile and Quality of Recovery (QoR-15), duration of hospital stay, and frequency of complications, e.g. wound infections.

This is a prospective, observational pilot study that will assess whether 1) a peri-operative dysregulated metabolo-lipidomics or SPM profile is associated with slower resolution of pain after surgery and an increased risk for development of persistent postsurgical pain (PPSP), and 2) whether a peri-operative dysregulated metabolo-lipidomics profile correlates with low Quality of Recovery (QoR-15) scores, duration of hospital stay and frequency of complications, e.g. wound infection.

The study will address the following Specific Aims:

Specific Aim 1: To determine the correlation between the perioperative eicosanoid and pro-resolving lipid mediator temporal profile and day-to-day resolution of pain after thoracic surgery.

We hypothesize that patients who have slower resolution of pain after thoracic surgery have dysregulated systemic lipid mediator pathways when compared to those patients who have faster resolution of pain.

Specific Aim 2: To determine the effectiveness of perioperative SPM signature as a novel predictive marker for the development of persistent pain after surgery (PPSP).

We hypothesize that patients with dysregulated systemic lipid mediator pathways, more specifically up-regulated pro-inflammatory lipid mediator pathways and down-regulated pro-resolving lipid mediator pathways, are more likely to develop PPSP.

Specific Aim 3: To determine the correlation between the perioperative eicosanoid and pro-resolving lipid mediator temporal profile and quality of recovery after surgery, duration of hospital stay and complications.

We hypothesize that dysregulated lipid mediator profiles are associated with a decreased Quality of Recovery Score (QoR-15), prolonged hospital stay and increased rates of complications, such as problems with wound healing and infection.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85
* Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital

Exclusion Criteria:

* Pre-existing chronic pain or opioid use
* Current treatment with corticosteroids
* Evidence of active infection
* Chronic liver disease, end-stage renal disease (CKD-5), or chronic inflammatory disorders
* Recent major surgery or illness within 30 days
* Use of immunosuppressive medication
* History of organ transplantation.
Health-related Quality of Life in General Slovenian Population

The purpose of the study is to obtain reference data on health-related quality of life for the functional and symptom scales and single items of the European Organisation for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ C30) in a representative sample of Slovenian general population.

A sample of at least 600 people from the Slovenian population, randomly selected, age 18 years and more, representing geografic diversity, will take part in this postal survey. The EORTC QLQ C30 and a questionnaire about demografic data will be send by mail. This is the first study to obtain reference data from the EORTC QLQ C30 in a sample from the general Slovenian population. The results will serve as guidelines for interpreting health-related quality-of-life of different groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* age 18 y and more

Exclusion Criteria:

* serious comorbidity
* previously treated for cancer
Evaluation of the Interest of a Postural and Functional Analysis for the Follow-up of the Adapted Motor Activity of Patients Treated for Breast Cancer

The goal of this clinical trial is to evaluate the acceptability by patients treated for breast cancer of an adapted motor activity program over a period of 15 months controlled by a postural and functional analysis..

Participant population/health conditions: patients with newly operated breast cancer who are candidates for an adapted physical activity program

This is a prospective, longitudinal, single-center, open-label study of a population of newly operated breast cancer patients who were candidates for an adapted motor activity program.

All included patients will be followed for a period of 15 months. Participating physicians will have the opportunity to recruit their patients during the 24 months following the study's initiation. The study will be completed once the last included patient has a final evaluation. The total duration of the study is 39 months (24 months of recruitment and 15 months of follow-up).

Each patient will be assessed four times: at inclusion before initiation of cancer treatment, and at M3, M9 and M15. At each patient visit with the investigating physician, an assessment will be completed on the electronic CRF by the physician or by the site CRA under the responsibility of the investigating physician.

Eligibility Criteria:
Inclusion Criteria:

* Adult woman, having given her consent to participate in the study,
* Patient with non-metastatic breast cancer,
* Cancer to be treated by surgery with or without adjuvant treatment (radiotherapy and/or chemotherapy).

Exclusion Criteria:

* Contraindication to the practice of a physical activity,
* Mental deficiency or any other reason that could hinder the understanding or the strict application of the protocol,
* Patient not affiliated to the French social security system,
* Patient under legal protection, guardianship or curatorship,
* Patient already included in another therapeutic study protocol aimed at evaluating the benefits of adapted physical activity.
The Preemptive Analgesic Efficacy of Nefopam

Nefopam is administered as a preemptive analgesic drug to the patient undergoing breast cancer surgery. It will be evaluated whether postoperative acute and chronic pain can be reduced.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with breast cancer
* Lumpectomy with axillary lymph node dissection or Lumpectomy with sentinel lymph node biopsy
* American Society of Anesthesiologists physical status I or II

Exclusion Criteria:

* Refusal
* Seizure
* Cardiac disease
* Monoamine oxidase inhibitor user
* Urologic disease
* Glucoma
* Preoperative analgesic drug medication
* Pregnancy
* Recurred breast cancer patient
Decitabine for Poor Graft Function Post Allo-HSCT

This randomized trial aims at validating the efficacy and safety of low-dose decitabine for PGF post allo-HSCT.

Poor graft function (PGF), defined by the presence of multilineage cytopenias in the presence of 100% donor chimerism, is a serious complication of allogeneic stem cell transplant (allo-HSCT). Emerging evidence demonstrates that the inadequate stem cells infusion, bone marrow microenvironment and immune dysregulation play a crucial role in maintaining and regulating hematopoiesis. Current therapies remain debatable, including selected CD34+ cells infusion, mesenchymal stromal cells infusion, prophylactic N-acetyl cysteine administration, etc. Thereafter, the investigators conduct a randomized trial aiming at validating the efficacy and safety of low-dose decitabine in PGF post allo-HSCT patients.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as PGF at day 28 post-HSCT or later. PGF was defined as two or three cytopenias, absolute neutrophil count ≤ 1.5 × 109/L, platelet count ≤ 30 × 109/L, hemoglobin ≤ 85g/L, lasting for more than 2 consecutive weeks;
2. Full donor chimerism;
3. Primary disease in remission;
4. No severe GVHD and relapse;
5. ECOG: 0-2;
6. Expected survival longer than 1 month

Exclusion Criteria:

1. Allergic to decitabine;
2. Active infections;
3. Uncontrolled GVHD;
4. Severe organ dysfunction;
5. Relapse of underlying malignancies;
6. Graft failure;
7. Received decitabine or participated in other clinical trials within one month before screening.
Infant Chest Compression

our aim was to quantitatively compare the quality of chest-compression of the new two thumb chest compression (nTTT) versus the current standard techniques: two finger technique (TFT), two thumb technique (TTHT) as defined by systolic-, diastolic-, mean arterial- and pulse-pressures. Our hypothesis is that nTTT generates higher arterial blood pressures compared to the established TFT and TTHT in an infant manikin model.

To simulate the scenario of infant CPR, an ALS Baby trainer manikin (Laerdal Medical, Stavanger, Norway) simulating a 3-month-old infant. The manikin was connected with a fixed-volume arterial system attached to a monitor (Draeger Infinity® Delta; Draegerwerk AG \& Co. KGaA, Luebeck, Germany) via an arterial pressure transducer (Edward Lifesciences: TruWave Disposable Pressure Transducer; Irvine, CA, USA). The arterial circuit composed of a 50-mL bag of normal saline solution (air removed) attached to the manikin chest plate and connected to the transducer with a 20-gauge intravenous catheter and tubing. The manikin was placed on a high adjustable hospital stretcher. The bed was leveled to the iliac crest of each rescuer for standardization. The manikin was previously intubated and ventilation was performed using a resuscitator bag.

Eligibility Criteria:
Inclusion Criteria:

* nurses
* give voluntary consent to participate in the study

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases