cyrilzakka/clinical-trials huggingface dataset:
Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced Anemia

The purpose of this study is to compare hemoglobin (Hgb) response rates between epoetin alfa (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other week) in anemic cancer patients receiving chemotherapy.

Chemotherapy related anemia occurs in a majority of cancer patients and can cause impaired treatment outcomes, increased treatment-related complications and altered quality of life. Epoetin alfa administered on a weekly dosing schedule of 40,000 Units subcutaneously (\[SC\], under the skin) with dose adjustments based on hematologic response produces significant improvement in hemoglobin levels, decreased transfusion frequency and improved quality of life. It is unknown if the recently developed agent, darbepoetin alfa, administered on an every other week fixed dose will produce similar improvements in hematologic and quality of life outcomes. Thus, further randomization studies are warranted utilizing once weekly dosing (QW) of Epoetin alfa compared to once every other week (Q2W) darbepoetin alfa. Patients will receive study medications for up to 16 weeks.Safety \& efficacy evaluations will be performed at specified intervals throughout the study.The study hypothesis is that the Week 5 hemoglobin response rate in the Epoetin alfa group is better than that in the Darbepoetin alfa group. The starting dose for study drug is either Epoetin alfa (PROCRIT) 40,000 Units SC QW or Darbepoetin alfa (ARANESP) 200 mcg SC Q2W. Doses may be adjusted depending on the patient's hemoglobin levels up a maximum of 60,000 IU SC QW Epoetin alfa or 300 mcg SC Q2W Darbepoetin alfa.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy
* Baseline hemoglobin value of \<11 g/dL
* Scheduled to receive cyclic chemotherapy for a minimum of 12 weeks
* \< 2 prior chemotherapy regimens in a metastatic setting
* Adequate hematologic \& renal function and platelet count \>100,000/mm3
* Estimated life expectancy of \> 6 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2

Exclusion Criteria:

* History of stem cell or bone marrow transplant
* Anemia due to factors other than cancer/chemotherapy
* Prior treatment with epoetin alfa or darbepoetin alfa or any investigational forms of erythropoietin within the previous 3 months
* Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy
* Uncontrolled hypertension or recent history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis
* new onset of seizures
* history of second active malignancy
* Major infection requiring hospitalization and antibiotics within 14 days of randomization
* Transfusion of white blood cells or packed red blood cells within 28 days of randomization.
Bone Changes Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Cast One

comparing bony changes around implants that will be joined by ametal framework either with electric weiling or with the conventional casting metal

joining multiple implants together in the edentulous arches is considered agood solution, using the conventional casting technique has many disadvantages due to lab errors and time and cost consuming on ,the other hand the study aims to owercome these disadvantages using electric welding metal framework.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 30 to 65 years old.
* Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.
* The patients must be completely edentulous.
* The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.
* Patients with good oral hygiene.
* Complete denture wearer.
* Adequate inter arch space for screw retained prosthesis.
* Absence of any intra-oral pathological condition.

Exclusion Criteria:

Patients with recent extraction(less than three months).

* Patients with inflamed ridge or candida infection.
* Patients with flappyridge.
* Parafunctional habits.
Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization

The primary objective is to evaluate the impact of an AKI Follow-up Clinic on major adverse kidney events (MAKE) in comparison to hospitalized patients surviving an episode of AKI who are not exposed to the AKI Follow-up Clinic intervention.

Survivors of acute kidney injury (AKI) are at increased risk of chronic kidney disease (CKD) and death, but have inconsistent follow-up care. Our team has developed and tested a model to deliver structured follow-up kidney care (the AKI Follow-up Clinic) that is feasible and sustainable, with standardized assessments based upon clinical practice guidelines that are transferable to any setting. This study will randomize patients with Kidney Disease Improving Global Outcomes (KDIGO) stage 2-3 AKI to the AKI Follow-up Clinic or usual care (control group). The usual care group will have a letter outlining their AKI diagnosis mailed to their family physician; the usual care group may still be referred to a nephrologist by their healthcare provider if desired, but these participants will not have access to the AKI Follow-up Clinic pathways. The primary outcome is development of a major adverse kidney event (MAKE), a composite of death, chronic dialysis, and estimated glomerular filtration rate (eGFR) decline. Outcomes will be ascertained after one year of follow-up, which is when AKI Follow-up Clinic patients are transitioned back to their family doctor or general nephrologist based upon pre-specified graduation criteria. Participants will also be followed using local hospital electronic resources and the Institute for Clinical Evaluative Sciences (ICES) administrative databases in order to assess the long-term impact of early nephrologist follow-up on AKI outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 yrs
* Kidney Disease Improving Global Outcomes (KDIGO) stage 2 AKI and above (including need for dialysis)

Exclusion Criteria:

* Kidney transplant recipients
* Outpatient baseline eGFR under 30mL/min/1.73m2 (by CKD-EPI equation); ignore if baseline serum creatinine is unavailable
* Patients discharged from hospital with a persistent requirement for renal replacement therapy
* Clinical diagnosis or suspicion of: glomerulonephritis, vasculitis with kidney involvement, hemolytic-uremic syndrome, polycystic kidney disease, myeloma cast nephropathy
* Pregnancy
* Residence at a nursing home facility (rehabilitation and retirement home patients should not be excluded)
* Palliation as primary goal of care (defined as life expectancy ≤ six months or followed by a palliative care physician)
* Patients with previously established and ongoing nephrology follow-up (defined as ≥ one outpatient appointment with a nephrologist in the previous 12 months)
Drug Concentration Monitoring of Pembrolizumab in Non-Small Cell Lung Cancer Patients

This observational study explores associations between drug trough-levels and clinical outcomes in Non Small Cell Lung Cancer (NSCLC) patients treated with immunotherapy (pembrolizumab) either alone or combined with chemotherapy. Through-levels of pembrolizumab will be examined in blood samples collected during the first-line treatment period. In addition T-cell responses in peripheral blood and anti-drug antibodies will be monitored. Results of drug trough-levels and T-cell responses will be linked to clinical outcome. 250 patients with NSCLC will be enrolled in this trial.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be \> 18 years and must voluntary sign an informed consent
* Treatment-naïve patients with advanced NSCLC receiving immunotherapy alone (pembrolizumab) or combined with chemotherapy

Exclusion Criteria:

* Any anti-cancer therapy \< 6 months prior to inclusion
FAM-CAM Translation and Validation Into German

Validation and Translation of the Family Confusion Assessment Method (FAM-CAM) into German according to Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes of the International Society for Pharmaoeconomics and Outcome Research and comparison to CAM-ICU.


Eligibility Criteria:
Inclusion Criteria:

* Intensive Care Stay ≥ 48 hours
* Expected RASS ≥ 3
* Communication possible in German (minimum of C1 level of Common European Framework of Reference for Languages)

Exclusion Criteria:

* preexisting psychosis, dementia or depression
Evaluation of Intestinal Vascolarization With Indocianine Green Angiography During Rectal Resection or Left Colectomy

A randomized controlled multicenter trial on the usefulness of intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients who undergo laparoscopic rectal resection or left colectomy.

Anastomotic leakage after colorectal surgery is a severe complication. One possible cause of anastomotic leakage is insufficient vascular supply. The aim of this study is to evaluate the usefulness of intraoperative assessment of vascular anastomotic perfusion in laparoscopic colorectal surgery using indocyanine green (ICG)-enhanced fluorescence, in order to assess if the information of the ICG angiography could lead to change the site of resection and improving the anastomotic leak rate. Two-hundred and eight patients, undergoing rectal resection or left colectomy, for benign or malignant disease, with high vessels ligation, will be randomized intro 2 arms: ICH angiography (colonic perfusion is intraoperatively assed with ICG angiography and level of resection is selected based on the fluorescence) and Control (resection is performed with subjective judgment). The rate of postoperative leak in the two groups will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* adult patiens
* laparoscopic rectal resection or left colectomy

Exclusion Criteria:

* rectal amputation
* no anastomosis
* allergy to iodine or indocyanine green
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico

The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery.

The current study will use a randomized controlled trial to examine telehealth delivery of Trauma Focused-Cognitive Behavioral Therapy (TF-CBT) for youth with trauma symptoms receiving care in community based clinics in Puerto Rico. First, the effectiveness of Tele-TF-CBT in improving trauma symptoms will be examined compared with clinic-based TF-CBT. Next, the feasibility, acceptability, and engagement outcomes of Tele-TF-CBT will be examined in this population. Lastly, implementation factors will be explored.

Eligibility Criteria:
Inclusion Criteria:

* 7-18 years old
* experienced at least one traumatic event
* present with clinically significant levels of post-traumatic stress symptoms

Exclusion Criteria:

* significant suicidal ideation
* substance use disorder
* active psychotic symptoms
* pervasive developmental delays,
* currently living with or in close contact with the perpetrator of their abuse
Effect of Long-term Exercise on Haemostasis and Inflammation in Patients With Coronary Artery Disease

Introduction: Regular exercise training improves prognosis in patients with coronary artery disease (CAD). This study investigates whether the beneficial effects of exercise can be partly explained by favourable changes in haemostasis and inflammation.

Methods: 150 CAD patients are randomised to a supervised long-term exercise program (3 months) or usual care. Blood samples are obtained at baseline, 1.5 months, and 3 months after randomisation.

Results: The investigators will evaluate platelet turnover and aggregation, coagulation, fibrinolysis, and inflammatory markers before and after short- and long-term exercise, and the two randomised groups will be compared.

Perspectives: The present study will increase our knowledge of the beneficial mechanisms underlying the effect of exercise in CAD patients, potentially paving the way for improved exercise recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Angiographically verified coronary artery disease with stenosis of at least 50% or previous percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG) surgery.
* Diagnosis or revascularisation have been made at least 12 months prior to inclusion.

Exclusion Criteria:

* Inability to perform strenuous exercise
* Anticoagulant treatment
* Heart failure (ejection fraction \<30% or NYHA \>2)
* Implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT)
* Serious arrhythmia requiring hospitalisation within the last 6 months
* Severe valvular heart disease
* Chronic obstructive pulmonary disease GOLD IV
Effects of Botulinum Toxin Injection on Sensation and Postural Control in Children With Hemiplegic Cerebral Palsy

In this study, the investigators aimed to investigate the effects of botulinum neurotoxin type A (BoNT-A) injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic cerebral palsy who are ambulatory without an assistive device in daily life.

Cerebral palsy (CP) refers to a group of movement and posture disorders that limit activity and participation, that are attributed to non-progressive disturbances in the developing fetus or infant brain. One of the main clinical findings of CP is postural control disorder. Many concomitant impairments such as joint range of motion limitations, spasticity, contractures, sensory deficits and loss of selective motor control contribute to postural control disorder.

One of the most common causes of motor dysfunction in children with CP is the presence of spasticity. Spasticity in the ankle plantar flexor muscles and weakness in the dorsiflexor muscles are the main factors that cause gait disturbance. Thus, impairments in gait function cause limitation of postural stability. Although there are many methods in spasticity management, BoNT-A injections have been used effectively and safely for many years, especially in reducing ankle plantar flexor spasticity. There are limited number of studies in the literature investigating the effect of BoNT-A injection on postural control in children with spastic CP, and only one study included children with spastic hemiplegic (unilateral) CP and it was clearly highlighted that new studies are needed in this area.

The reclassification of CP acknowledges the contribution of impaired sensation in motor performance. Although it has been shown that somatosensory deficits in the lower extremities of children with spastic CP can negatively affect gait and balance, the effect of spasticity in the ankle has not been evaluated.

In this study, the investigators aimed to investigate the effects of BoNT injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic CP who are ambulatory without an assistive device in daily life.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemiplegic cerebral palsy
* Age between 5-13 years
* MAS ≥ 2 spasticity in the affected ankle
* Gross Motor Function Classification System (GMFCS) level I-II
* Able to understand given commands
* Sufficient cooperation to understand instructions and participate evaluations
* Giving an informed consent
* Botulinum toxin A injection decision made by an experienced Physiatrist

Exclusion Criteria:

* Visual, vestibular and cognitive deficits
* Botulinum toxin A treatment within 6 months or having undergone an orthopaedic surgery 1 year prior to inclusion in the study
* Presence of fixed contracture or joint instability in the affected ankle
* Severe scoliosis (Cobb angle \>40°)
* Uncontrolled epilepsy
* Having undergone selective dorsal rhizotomy
Ultrasound Guided Esophageal Pressure

The investigator aimed to evaluate the effect of ultrasound guided esophageal pressure on the incidence of gastric insufflation during anesthetic induction in infants and small children undergoing general anesthesia.

effect of ultrasound guided esophageal pressure on the incidence of gastric insufflation in children

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing general anesthesia with endotracheal intubation

Exclusion Criteria:

* patients with hypertrophic pyloric stenosis
* patients with delayed gastric emptying
* patients with esophageal stenosis
* patients with at risk of gastric aspiration
* patients with ileus, hepatomegaly, ascites (cannot visualize gastric antrum with ultrasound)
Multiple Dose Japanese Bridging Study

The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese and non-Japanese subjects
* Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry
* Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country
* BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects
* Men ages 20 to 45 years

Exclusion Criteria:

* Serum creatinine values above the normal range
* Urine protein or blood levels above the normal range
* Liver function tests above the normal range
* TSH, free T3, or free T4 outside the normal range
* Amylase or lipase levels above the normal range
* Positive Fecal Immunochemical Test (FIT™)
My Scrivener® - Measuring Effectiveness and Dose Response in Children

This study will assess whether a computer haptic peripheral device programmed to provide repetitive motion training is as effective as the same repetitive motion training provided by a human being.

This study builds on a large body of neurological research that uses robot-guided repetitive motion training to induce neuroplasticity and improvements in upper extremity motor skills in adults and children. This research study is looking at handwriting, a fine-motor task that is used daily.

In our study, we want to see if 3-dimensional robotic-assisted repetitive motion training can be a safe and effective intervention for school-age children with fine motor deficits arising from several different impairment origins. Our research construct is: Legible handwriting = function of (tactile feedback, visual feedback, duration, and fine-motor control).

Independent variables:

* Tactile feedback is a continuous variable of force-feedback measured in pounds of force.
* Duration is a continuous variable measured in seconds and number of repetitions.
* Visual feedback is the letter scribed on the paper.

Dependent variable:

* Legible handwriting will be measured by scoring on the Test of Handwriting Skills and the Print Tool™ evaluation.
* Fine motor deficit/control will be measured directly and objectively by quantifying the error between the desired scribing task and the actual scribing task.

The robotic device is an affordable (\<$200) computer haptic (the Falcon(R)) that currently is approved by the FCC for home and office. It is \*not\* approved for medical use. This is an investigational, nonsignificant risk device.

Eligibility Criteria:
Inclusion Criteria:

* Meet the following base prerequisites for writing: orientation to written language; eye-hand coordination, single handed utensil or tool manipulation (BAMF score \>= 6), recognize all letters of the alphabet (unless the child has dyslexia).
* Children have illegible printing for their grade, or legible printing but a speed less than the norms for their grade and sex.
* Be able to grasp a pen.
* Be able to speak and understand English.
* Be able to follow instructions.
* Be able to devote at least 20 minutes to the assigned tasks (short breaks will be allowed).
* Be enrolled in school at grade K or above.
* A score lower than 80% on the Print Tool™ or the Cursive Tool.

Exclusion Criteria:

* Unable to pass the informed assent screener.
* Unwilling to sign or mark the informed assent documents.
* Uncontrolled spasticity.
* A BAMF score lower than 6 (includes severe paralysis of the upper extremity).
* Cerebral palsy other than hemiplegia cerebral palsy
* Severe autism or intellectual disabilities that prevent productive interactions with the investigator
Clinical Assessment of Patients With High Bone Mass Due to Mutation in Lrp5

The aim of the study is to describe patients with a high bone mass phenotype due to a mutation in the low density lipoprotein l receptor 5 gene (LRP5) and compare them with age and sex matched controls. Moreover, bone density and microarchitecture as well as markers of bone metabolism are evaluated

Cases and controls are closely matched on age and sex and evaluated cross-sectionally.

Dual x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HR-pQCT) are used in order to evaluate bone density as well as microarchitecture. Bone turnover markers and body composition are also measured.

Eligibility Criteria:
Inclusion Criteria:

* Lrp5 mutation/ADOI

Exclusion Criteria:

* Pregnancy
A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects with clinically significant cardiovascular disease in the past 6 months.