cyrilzakka/clinical-trials huggingface dataset:
A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic Anemia

Severe acquired aplastic anaemia (SAA) is a bone marrow failure disease characterized by pancytopenia and a hypocellular bone marrow. The corn pathophysiological mechanism is the destruction of hematopoietic stem/progenitor cells mediated by auto-reactive effector T cells. Immunosuppressive therapy with horse antithymocyte globulin (ATG) plus cyclosporine (CSA) is currently the standard of treatment in patients with aplastic anaemia who are not eligible for bone marrow transplantation and with response rates from 40% to 70%. Previous studies showed that horse ATG (hATG) is apparently more effective than rabbit ATG (rATG) as the latter has higher treatment related mortality (TRM). Unfortunately hATG is unavailable in China, so we conduct a optimized standard treatment (9 days protocol) of rATG plus CSA and Levamisole (LMS) Sequential maintaining (termed Optimized Standard Protocol, OSP) for severe aplastic anemia. This prospective study is designed to evaluate the efficacy and safety of Optimized Standard Protocol as first line therapy in newly diagnosed severe aplastic anemia patients.

During the treatment period, rATG is administered at a dose of 1.97 mg/kg/day for 9 days by slow intravenous infusion. CSA is administered orally at a dose of 3 mg/kg qod, and Levamisole was administered orally at a dose of 2.5 mg/kg qod. The CSA and Levamisole (LMS) is designed to alternately every other day.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed SAA (according to the standard criteria)

  1. Bone marrow cellularity less than 30% (excluding lymphocytes)
  2. At least two of the following: Absolute neutrophil count less than 500/ uL; Platelet count less than 20,000/ uL; Absolute reticulocyte count less than 20,000/ uL.
* Age greater than or equal to 6 years old

Exclusion Criteria:

* Serum creatinine greater than 2.5 mg/dL
* Underlying carcinoma (except local cervical, basal cell, squamous cell)
* Prior immunosuppressive therapy with ATG, antilymphocyte globulin (ALG), or high dose cyclophosphamide.
* Current pregnancy or lactation or unwillingness to take oral contraceptives or use an effective method of birth control.
* Diagnosis of Fanconi anemia or other congenital bone marrow failure syndromes
* Evidence of a clonal disorder on cytogenetics. Patients with super severe neutropenia (ANC less than 200/uL) will not be excluded if results of cytogenetics are not available or pending.
* Underlying immunodeficiency state including seropositivity for HIV
* Inability to understand the investigational nature of the study or give informed consent
* Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient s ability to tolerate protocol therapy, or that death within 7-10 days is likely.
Safety and Efficacy of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients

The investigators primary objective is to determine if acute normovolemic hemodilution (ANH) for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period as compared to usual care. This study will enroll 24 pediatric heart surgery patients, aged 6 months to 3 years old undergoing either ANH prior to initiating cardiopulmonary bypass or the standard of care procedures for the use of cardiopulmonary bypass.

Blood transfusion has been associated with worse outcomes in pediatric cardiac surgical patients. The major complications associated with it include increased blood loss during and after surgery, kidney disease requiring dialysis, abnormal coagulation profile, increased vasopressor use, and increased time spent on the ventilator and in the intensive care unit. One strategy to minimize blood product administration is acute normovolemic hemodilution (ANH). The investigators primary aim is to determine if ANH for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period, compared to usual care. The investigators designed a randomized, controlled, open label study that equally assigns 24 pediatric cardiac surgery patients aged 6 months to 3 years into two groups to receive either ANH prior to initiating cardiopulmonary bypass or usual standard of care. Participants in the ANH arm of the study will have 10 ml/kg of blood removed following anesthetic induction. In order to maintain normal circulating volume, the collected blood will be replaced with an equal volume of 5% albumin. All participants will be treated with a standardized protocol aimed at blood conservation including the use of retrograde arterial and antegrade venous perfusion, small circuit size, intraoperative red blood cell salvage, and low hemoglobin targets to trigger transfusion.

Eligibility Criteria:
Inclusion Criteria:

* Informed signed consent must be obtained by a legally authorized representative.
* Must be undergoing an elective surgical repair or palliation of a cardiac defect with the use of the cardiopulmonary bypass machine.
* Must be clinically stable at the time of evaluation for eligibility and on the day of randomization.

Exclusion Criteria:

* Patients who carry a diagnosis of a bleeding disorder.
* Patients who have an abnormal coagulation profile as evidenced by a preoperative coagulation screen.
* Patients who have received a blood transfusion in the preceding 120 days.
* Patients who have a diagnosis of a chromosomal abnormality.
* Patients whose participation in the study is deemed unsafe by their primary care team.
Pexelizumab in Conjunction With Angioplasty in Acute Myocardial Infarction (APEX-AMI)

In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body's own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac symptoms for at least 20 minutes within past 6 hours;
* Will undergo primary PCI;
* Has ECG evidence of acute high risk ST elevation myocardial infarction;
* Willing and able to be followed for at least 12 months.

Exclusion Criteria:

* Isolated low risk inferior wall myocardial infarction;
* Received fibrinolytic therapy;
* History of complement deficiency;
* Suspected neisserial infection;
* Participating in other investigational study;
* Pregnancy;
* Previous enrollment.
Education and Counseling for Abstinence From Tobacco After Pregnancy

The purpose of this study is to develop and field test a maintenance of smoking abstinence program designed for a predominately low-income, high-risk population of women from a wide variety of ethnic and racial backgrounds who have quit smoking because of (or during) their pregnancy.

BACKGROUND:

Pregnancy is an ideal time to help underserved young women to stop smoking cigarettes and remain abstinent for life. The field has made great progress in assisting women to quit during this time. Unfortunately, maintenance of this highly significant behavior change is dismal. Up to 75% of those who quit for pregnancy end up returning to smoking after delivery of the newborn. For underserved women, pregnancy is one of the few times that they have an extended contact with the health care system. Therefore, there is an opportunity to help these women quit smoking for the health of their fetus in addition to their own health. To date, there has been insufficient research on how best to maintain abstinence during the critical postpartum period, during which a unique constellation of risk factors (including sleep deprivation, variations in negative mood, and increased stress) heighten the probability of relapse. The potential payoff is enormous. The literature, while not extensive, provides sufficient guidance and justification for the specific approach and intervention components the study has chosen.

DESIGN NARRATIVE:

This study will develop and field test a maintenance of smoking abstinence program to be designed for a predominately low-income, high-risk population of women from a wide variety of ethnic and racial backgrounds who have quit smoking because of (or during) their pregnancy. The study will compare biologically confirmed postpartum smoking relapse rates of women who receive an educational intervention during pregnancy combined with sustained telephone counseling after that intervention, with women who receive only an educational intervention. Participants will begin at 28 weeks prenatal and will be followed through 1, 3, 6, and 12 months postpartum.

The specific aims of the current maintenance study are: 1) to compare biochemically confirmed smoking abstinence rates of women who quit smoking during their pregnancy and who receive an intervention based on telephone counseling using motivational interviewing versus quitters who receive usual care, maintenance of abstinence will be assessed at 1, 3, 6, and 12 months postpartum; and 2) to collect both qualitative and quantitative data to better understand short term and long term maintenance mediators and moderators of abstinence postpartum for women of low socioeconomic status (SES) who quit smoking during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Smoked tobacco immediately before pregnancy

Exclusion Criteria:

* Smoked tobacco in the previous 7 days when contacted at 28 weeks gestation
* No telephone access
Evaluation of a Novel and Simplified Technique for Intrauterine Contraceptive Devices Insertion: a Prospective Cohort Study

The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years.

The fear and the pain associated with IUDs insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia.

The pain during IUDs insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and irritation of the endometrial lining by the IUDs.


Eligibility Criteria:
Inclusion Criteria:

* Women requesting intrauterine contraceptive device as a contraction
* Women accepted participation in the study

Exclusion Criteria:

* Uterine abnormalities
* Endometrial lesions as polyp
* Adenomyosis
* Fibroids distorting the cavity
* Intrauterine adhesions.
* Chronic pelvic pain
* Dysmenorrhea
* History of cervical surgery
Effectiveness of Transcranial Direct Current Stimulation (tDCS).

Reducing pain and recovery of strength and function are major challenges in physical therapy. Transcranial direct current stimulation (tDCS) is a novel intervention that has gained popularity in the rehabilitation of athletic injuries, pain management, and sports performance. Acute application of tDCS has been shown to modulate the perception of effort and fatigue, enhance motor learning, improve endurance performance, and improve muscular power and strength. tDCS has also been shown to reduce pain in patients with chronic pain conditions. Using a double-blind, randomized clinical trial design, we aim to evaluate the effectiveness of tDCS plus standard rehabilitation compared to rehabilitation alone on pain, balance and proprioception, functional performance, and strength following acute ankle inversion sprain. We hypothesize that the group using tDCS will demonstrate superior outcomes in all variables of interest.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-40
2. Within 2-weeks s/p acute grade 1 or 2 ankle inversion sprain

Exclusion Criteria:

1. Self-Reported Pregnancy
2. Being treated for and on medication for a mental health diagnosis
3. Concussion or non-lateral ankle sprain lower extremity injuries within the past 6 months
4. Open wound or dermatologic lesion on the head or region of application
5. Active implantable medical devices such as cochlear implants or cardiac pacemakers, or with metal implants in the head (excluding standard orthodontic braces, fillings, etc.).
6. Epilepsy or history of seizures
7. Participants who are not fluent in English
Optimization and Follow-up of the Consecutive Use of Two Intragastric Balloons in the Treatment of Obesity

This is a cohort study with the objective of describing during a 12-month follow-up, weight loss in obese patients submitted to treatment using two consecutively air-filled IGB (Heliosphere® 600 cc and Heliosphere 720 cc) without any interval between the removal of the first and the placement of the second.

Intragastric balloon (IGB) implantation is a widely used technique to treat overweight subjects and those with mild obesity. The effectiveness of the air filled balloon (Heliosphere BAG®) in improving weight loss, reduction of BMI, percentage of body weight loss, percentage of excess weight loss and complications six months after placement is notable. Several methods are available for IGB placement and new techniques are being developed to reduce discomfort during and after the procedure. Thus, the use of an IGB as an effective method to avoid bariatric surgery is proposed. However, the precise protocol to balance complications and discomfort while maximizing weight loss is still to be established.

Our secondary objectives will be:

* Describe the weight loss, changes in the BMI and excess weight loss between the implantation of the first IGB until its removal;
* Describe changes in the components of the metabolic syndrome;
* Describe changes in blood pressure;
* Estimate the rate of early explant;
* Describe the conditions of surgery;
* Describe operative complications;
* To describe safety in the perioperative period, in the immediate postoperative period and in the late postoperative period

Eligibility Criteria:
Inclusion Criteria:

* Class I obesity (30-34.9 kg/m2), Class II obesity (35-39.5 kg/m2) or overweight (25-29.9 kg/m2).

Exclusion Criteria:

* Morbid obesity (BMI\>40kg/m2), operative contraindications.
Professional Development in Emergency Medical Services

The ProDEms-trial focuses on nurses and ambulance drivers working in prehospital care, taking care on the one hand of patients suffering from time-sensitive critical conditions like STEMI, acute stroke or severe traumatic brain injury, and on the other hand of patients whose lives are not in immediate danger but suffer from acute exacerbation of chronic conditions or suffer from acute pain.

In the current study the investigators will use a multistage approach to test the hypothesis whether the use of a CDSS in prehospital emergency care will: 1. Improve protocol adherence, 2. Reduce emergency department length of stay, 3. Improves diagnostic accuracy; without impeding the workflow of the prehospital team or impairing patient safety.


Eligibility Criteria:
Inclusion Criteria:

* Patients who receive treatment from the Paramedic Intervention Team (PIT) in the prehospital Emergency Medical Services (EMS) area of the University Hospitals, Leuven.

Exclusion Criteria:

* Patient-related interventions not dispatched by the Emergency Medical Dispatch center (EMD)
* Patient related interventions during transport between two healthcare facilities or in mass casualty situations.
Predictive Role of Red Cell Distribution Width in Upper GI Bleeding Patients

Acute upper-gastrointestinal bleeding (UGIB) is a commonly encountered cause of admission in emergency department (ED). Early risk stratification allows appropriate therapy that may be helpful to advance the patient's morbidity and mortality. Investigators hypothesized that early RDW levels may have an independent, linear relationship with recurrent or massive bleeding in UGIB patients.

This is a retrospective clinical study including the UGI patients in ED. All data will be collected through the electrical medical records. The major endpoints are the high risk patients and 30-days mortality which defined cases of including any of one among the death, re-bleeding, and received the intervention (such as blood transfusion, endoscopic therapy and operation).

Investigators assessed the relationship between initial RDW level and high risk patients and 30-days mortality. In addition, investigators compare the dicrimination power for predicting outcomes between the UGIB scoring system and RDW level.

Univariate and multivariate logistic regression testing and a Cox hazard regression model were used to determine the factors associated with outcome variables. In addition, investigators constructed receiver operating characteristic curves, and the areas under the curves and confidence intervals were calculated to compare the discriminatory power for outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Diagnosis as Upper gastrointestinal bleeding
* Check RDW when patients visited at emergency department

Exclusion Criteria:

* Paediatrics
* Follow up loss
* Data could not be acquired
The Effectiveness of Two Different Types of Shoulder Slings in Stroke

The aim of this study is to investigate the effectiveness of shoulder slings on pain, motor function, daily life and balance in acute hemiplegic patients and to investigate whether different types of slings are superior to each other.

Thirty-two patients with hemiplegic shoulder subluxation due to acute stroke were divided into two groups: shoulder supported slings and forearm supported slings. Hemiplegia rehabilitation passive and active-assistive range of motion, stretching, and neurophysiologic exercises were performed for all patients per day for 8 weeks.Pain assessment was performed with Visual Analog Scale, sensorimotor evaluation was performed with Fugl Meyer Assessment of Motor Function,daily life activities were assessed with Barthel Index, and balance was evaluated with Berg Balance Scale.

Eligibility Criteria:
Inclusion Criteria:

* Acute patients who were independent and ambulatory prior to stroke and had their first stroke attack (\<3 months)
* Mini-mental Status Test (MMST) score ≥ 24,
* Developing hemiplegia after stroke, standing independently for at least 2 minutes,
* Lower limb being in stage 4-5 according to the Brunnstrom Approach (for ambulation and standard balance)
* Upper limb being in stage 1-2 according to the Brunnstrom Approach
* Spasticity 0-1+ according to Modified Ashworth scale

Exclusion Criteria:

* Has a neurological history other than the diagnosis of hemiplegia (Parkinson's etc.)
* Having used shoulder slings and orthosis.
* Having a disease that can affect balance (cranial, etc.)
Pneumatic Sleeves and Congestive Heart Failure

Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and its influence on cardiac activity in healthy subjects, the investigators expect to improved cardiac function in patients suffering from congestive heart failure.


Eligibility Criteria:
Inclusion Criteria:

* CHF (as clinically evaluated and asessed by TTE)
* Gave informed consent
* NYHA Class II-III
* LVEF equal or less than 40%

Exclusion Criteria:

* Patients who could not sign informed consent
* NYHA Class IV
* Oxygen saturation less than 90% under room air
Correlation Between CYP2C19 Genotype, Level Of Clopidogrel Metabolite And Platelet Inhibition Status

The aim of this study is to check correlation between CYP2C19 genotype level of clopidogrel metabolite in plasma and platelet inhibition status.

THE FIRST PHASE OF THE RESEARCH WILL INVOLVE PATIENTS RECRUITMENT AND INFORMED CONSENT FOR GENETIC TESTING.THE MAJORITY OF PATIENTS WILL BE RECRUITED FROM EMERGENCY DEPARTMENT. EVERY PATIENT WILL BE ASKED ABOUT HIS AND HIS PARENT'S ETHNICITY (ASHKENASI OR SEPHARDY JEW) AND ADDITIONAL DRUGS HE TAKES. IF PATIENT AGREES TO PARTICIPATE IN THE STUDY , HIS BLOOD SAMPLE WILL BE COLLECTED FOR 3 KINDS OF TESTS:

1. GENETIC (FOR CYP450 2C19)
2. PLATELET MAPPING TEST ( BY THROMBOELASTOGRAPH ASSAY)
3. CLOPIDOGREL INACTIVE METABOLITE DETERMINATION BY CHROMATOGRAPHIC METHOD

Eligibility Criteria:
Inclusion Criteria:

* \> 18 OLD PATIENTS
* THAT TAKE CLOPIDOGREL MORE THAN 1 WEEK

Exclusion Criteria:

* PREGNANCY
* CHRONIC LIVER DISEASES
SLC13A5 Deficiency Natural History Study - United States Only

SLC13A5 deficiency (Citrate Transporter Disorder, EIEE 25) is a rare genetic disorder with neurodevelopmental delays and seizure onset in the first few days of life. This natural history study is designed to address the lack of understanding of disease progression. Additionally it will identify clinical and biomarker endpoints for use in future clinical trials.

This is a longitudinal observational study of the natural history of SLC13A5 deficiency for up to 2 years. This study does not involve any therapeutic intervention. The study includes in-person clinical assessments and laboratory analyses including standardized clinical evaluations, neurocognitive and quality of life scales, video movement rating scale, laboratory measurements of blood and urine, EEG capturing wake and sleep, EKG. Additionally, remote assessments in 1st year (every 3 months) and 2nd year (every 4 months) of enrollment will be made and caregiver will be asked to keep a seizure diary for the duration of the study. Personnel having expertise to comprehensively evaluate biological pathways that are perturbed by SLC13A5 deficiency will analyze the collected data. Improved understanding of disease pathogenesis will guide therapeutics and reveal clinical and biomarker endpoints for use in future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

1. Parent(s)/legal representative and/or patient must be willing and able to give informed consent/assent for participation in the study.
2. Males and females of any age are eligible for this study
3. Suspected or confirmed diagnosis of SLC135 deficiency with genetic variants in both SLC13A5 alleles and consistent clinical characteristics. Variants of uncertain significance in one or both alleles are acceptable if deemed good candidates by participant's primary geneticist or neurologist and study personnel.
4. Participant and caregiver must be willing to provide clinical data, participate in standardized assessments, and provide biological samples.
5. Willingness to travel to one of the three sites annually is favored, but not required.

Exclusion Criteria:

1. The presence of a second, confirmed disorder, genetic or otherwise, affecting neurodevelopment or with other overlapping symptoms of SLC13A5 deficiency.

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