cyrilzakka/clinical-trials huggingface dataset:
PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced solid tumors or lymphoma that have not responded to previous treatment.

OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of PS-341 in patients with advanced solid tumors or lymphoma. II. Evaluate the pharmacodynamics of this drug by measuring 20S proteasome inhibition in these patients. III. Assess changes in P53 or P27, and possibly E2F-1 and cyclin E, in patients with lymphoma in response to this drug. IV. Evaluate objective tumor response to this drug in these patients. V. Evaluate the relationship between toxicity and 20S proteasome inhibition in blood and in accessible tumor tissue in these patients. VI. Evaluate response to treatment with this drug in patients with measurable or evaluable disease.

OUTLINE: This is a dose-escalation, multicenter study. Patients receive PS-341 IV on days 1 and 4. Treatment repeats every 14 days for at least 2 courses in the absence of unacceptable toxicity or disease progression. Patients with stable or responding disease may receive additional courses at the discretion of the treating physician. Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor or lymphoma that has failed standard therapy and no standard options available No leukemia or myeloma CNS lesions allowed if adequately treated by surgery and/or radiotherapy and symptomatically stable on maintenance glucocorticoids and not requiring anticonvulsants for at least 3 months

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 2.5 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No acute ischemia or significant conduction abnormality (i.e., bifascicular block or 2nd or 3rd degree AV blocks) Other: No other serious medical or psychiatric illness Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation with high-dose chemotherapy or radiolabeled monoclonal antibody therapy for lymphoma patients Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 2 weeks since prior major surgery Other: See Disease Characteristics No concurrent antiretroviral therapy
Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails

Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith\& Nephew's Trigen META intramedullary nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee flexion) and Group B=with the semi-extended surgical technique. (2\*100 patients)

Research Objectives:

The primary research objectives are to evaluate:

i) anterior knee pain and ii) the nail position and overall fracture alignment

Outcome Measures:

1. Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.
2. Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires
3. Knee-related adverse events
4. Overall fracture alignment

After surgery with standard intramedullary nailing technique in tibia fractures, 40-80% of the patients still complain of anterior knee pain postoperative. The expected advantages of the semi-extended nailing technique is less anterior knee pain and less malunion of the fracture.

Using the semi-extended nailing technique also might give the advantage of better position of the nail by a more concentric reaming of the tibia, due to less tension on the patella tendon during reaming process.

Eligibility Criteria:
Inclusion Criteria:

* Patient has sustained a closed (Tscherne Classification) or open tibial fracture (Gustillo-Anderson Classification) that is amendable for operative fixation with an intramedullary nail.
* Patient has an isolated tibia and fibula fracture
* Skeletally mature
* Patients aged between/including 18 to 70 years
* Patient has given formal consent to be involved in the trial and has completed the study consent form
* Patient is likely to comply with study follow-up requirements

Exclusion Criteria:

* Pathologic fractures
* Other fractures involving the same lower extremity
* Soft tissue injuries/problems that would prevent the surgeon from using both of the surgical techniques to insert an intramedullary nail
* Patient having pre-existing knee joint disease causing anterior knee pain
* Patient likely to have problems with follow-up
* Patient unwilling to give informed consent to be included in the trial
AED Log Analysis of 19 Cases in Out-of-hospital Environment

The study performed to demonstrate a reasonable assurance of safety and effectiveness of the Heart Guardian HR-501 when used in an out-of-hospital environment.

The defibrillation study was conducted by analyzing the logs of Heart Guardian HR-501 with Radian ECG Viewer. The product analysis was studied whether the device was operated normally in ECG analysis and electric shocks.

Eligibility Criteria:
Inclusion Criteria:

* out-of-hospital cardiac arrest
* \> 12 months

Exclusion Criteria:

* age under 12 months
COVID-19 Project ECHO in Nursing Homes

Nursing homes are ground zero for the COVID-19 pandemic. Nursing homes are ill-equipped for the pandemic; though facilities are required to have infection control staff, only 3% have taken a basic infection control course. Significant research has focused on infection control in the acute care setting. However, little is known about the implementation of practices and effective interventions in long-term care facilities.The investigators propose an intervention utilizing Project ECHO, an evidence-based telehealth model, to connect Penn State University experts with remote nursing home staff and administrators to proactively support evidence-based infection control guideline implementation. Our study seeks to answer the critical research question of how evidence-based infection control guidelines can be implemented effectively in nursing homes

The investigators will recruit 200 nursing homes with approximately 24,560 residents from across the United States through collaborations with our stakeholders. Nursing homes will be randomized to one of two arms: 1) AHRQ-funded COVID-19 ECHO that includes 16 weekly telehealth sessions addressing COVID-19 guidelines and best practices or 2) AHRQ-funded COVID-19 ECHO plus an additional 9 sessions with a focus on CDC infection control training. Randomization will be stratified by characteristics of nursing homes to ensure balance among the two trial groups, including size (number of beds),geographic location, and current COVID-19 infection rate. Patient-centered outcomes (nursing home residents with COVID-19 infections, hospitalizations, deaths, and QOL) will be assessed at baseline, 4, 6, 12, and 18 months. Our study is guided by the RE-AIM framework to critically evaluate both effectiveness and implementation outcomes of the proposed intervention. The RE-AIM framework is frequently utilized to improve sustainable adoption and implementation of effective, generalizable, evidence-based interventions like Project ECHO.

Eligibility Criteria:
Inclusion Criteria for Facilities Skilled Nursing Facility in United States Access to computer or electronic device

Exclusion Criteria for Facilities Previously participated in Project ECHO COVID-19 series either through Penn State or another institution
A Trial to Evaluate the Impact of Lung-protective Intervention in Patients Undergoing Esophageal Cancer Surgery

The purpose of this trial is to determine whether low tidal volume during intraoperative one-lung ventilation could decrease the incidence rate of postoperative acute lung injury compared to "normal" tidal volume.

Large tidal volume are known risk factor of acute lung injury.Mechanical ventilation with low tidal volume has been shown to attenuate lung injuries in critically ill patients.Esophagectomy surgery need a relatively long time of one-lung ventilation. A normal tidal volume of two-lung ventilation should be a large one when exerted to one lung. We hypothesized that low tidal volume ventilation during one-lung ventilation could decrease incidence rate of postoperative acute lung injury and mortality.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of esophageal carcinoma and planned for esophagectomy
* indication for one-lung ventilation
* informed consent
* ASA I\~II

Exclusion Criteria:

* NYHA III\~IV
* severe COPD
* pulmonary fibrosis
* any new pulmonary infiltrate on chest radiograph
* preoperative acute infection suspected
* altered liver function( Child-Pugh class B or moe)
* acute or chronic renal failure
* preoperative corticosteroid treatment during month before inclusion
Distraction Using VR for Children During IV in an Emergency Department

Exploring the use of virtual reality as a distracting intervention strategy for school-age children to receive intravenous placement in emergency department, and further understand the effectiveness of reducing pain and fear during the invasive procedure.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 7-12
* Children who were clearly conscious
* Children who agreed and were required to receive intravenous injections after physicians' diagnoses
* Children and their primary caregivers who could communicate in Mandarin or Taiwanese
* Children and their primary caregivers who could read Chinese that agreed to participate in this study and sign written consent forms

Exclusion Criteria:

* Children with developmental delay, epilepsy, or heart diseases
* Children undergoing chemotherapy; children who were visually or hearing impaired
* Children who were nearsighted with more than 8.0 diopters or farsighted with 5.0 diopters
* Children who had sustained head trauma in the past month
* Children who were confirmed to be obese according to the recommended body mass index values for children and adolescents
* Children who required blood transfusions and blood preparation to be performed according to physician diagnoses
* Children who received two or more intravenous injections and had their blood drawn only one time
A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.


Eligibility Criteria:
Inclusion Criteria:

W8M-MC-LAA2

* Have a Body Mass Index (BMI) of ≥27 kilograms per square meter (kg/m²)
* Have Type 2 Diabetes
* Have a HbA1c ≥7.0 % (53 millimoles/mole (mmol/mol)) to ≤10.5% (91 mmol/mol) and treated with diet and exercise alone or with a stable dose of metformin (and not more than the locally approved dose) with or without a sodium-glucose cotransporter 2 (SGLT2) inhibitor for at least 3 months prior to screening

W8M-MC-CWMM:

* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)

Exclusion Criteria:

W8M-MC-LAA2

* Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
* Have an on-going or history of bradyarrhythmia and/or sinus bradycardia
* Have an elevated resting pulse rate (mean \>100 beats per minute (bpm)) or reduced resting pulse rate (mean \<60 bpm) at screening
* Have any of the following cardiovascular conditions within 6 months prior to screening:

  * acute myocardial infarction
  * cerebrovascular accident (stroke)
  * unstable angina, or
  * hospitalization due to congestive heart failure
* Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<45 milliliters per minute (mL/min)/1.73 m2
* Have a history of acute or chronic pancreatitis
* Have fasting triglycerides \>500 milligrams per deciliter (mg/dL) (5.7 mmol/L) at screening
* All concomitant medications should be at a stable dose for at least 3 months prior to screening

W8M-MC-CWMM

* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening.
* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
* Have poorly controlled hypertension.
* Have a history of symptomatic gallbladder disease within the past 2 years
* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
* Have a lifetime history of suicide attempts.
Construction of a Database for TMA

Information about patients was collected by reviewing the Hitech case system and telephone and outpatient follow-up, and the case database was constructed by Epidata software. The sample size is expected to be 200 cases, the participating hospital is the First Affiliated Hospital of Soochow University, and the study time frame is from Dec 1, 2022, to Nov 31, 2027. The observation indexes of the study include the basic information of patients' age and gender and the clinical-related data of thrombotic microangiopathy.


Eligibility Criteria:
Inclusion Criteria:

* The patient has elevated lactate dehydrogenase to more than twice the baseline value, platelets less than 20 or decreased by more than 50% within 24 hours, and more than 2% of schistocytes visible on a peripheral blood smear. Alternatively, pathological sections show extensive micro thrombosis.

Exclusion Criteria:

* The investigator considers the subject unable or unwilling to cooperate with the study procedures.
Detection of Acid Sphingomyelinase/Ceramide Pathway Activation in Radiotherapy Patients Using Intravoxel Incoherent Motion (IVIM) Diffusion-weighted Magnetic Resonance Imaging and Serum Biomarkers

The purpose of this study is to find out if special blood tests and imaging scans can help evaluate the effects of the radiation the patient receives as part of standard treatment. The patient will undergo either stereotactic or conventional radiation treatment as determined by the treating doctor. Previous evidence suggests that blood flow to tumors is affected by the amount (dose) of radiation that it receives. This effect may be seen as soon as 1-2 hours after the radiation is given. This study will evaluate if these changes can be seen and measured by performing a special type of scan called Intravoxel Incoherent Motion (IVIM) diffusion-weighted Magnetic Resonance Imaging (MRI) and a blood test. IVIM MRI is a research exam which is similar to a standard MRI exam, with only a slight difference in the technical parameters used to acquire the images.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven cancer
* Patients deemed clinically appropriate for radiation treatment as part of the standard care provided by their treating physician, and will receive either 24 Gy (one fraction) or 3 Gy x 10 fractions.
* Life expectancy \> 6 months
* KPS\>60%
* Age ≥ 18 years old.

Exclusion Criteria:

* Pregnant patients
* Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc
* Prior radiotherapy to the site of intended treatment
* Patients with tumor involving brain or spinal cord
* Platelet count \<75,000/μl, HgB level \<9 g/dl, WBC \<3500/μl
* Presence of metastases in the upper thoracic spine (in order to avoid DW- MRI parameter measurement variability due to cardiac motion)
* Lesions \<1.5 cm (to assure robust measurements)
* Non-English speaking patients
Comparison Between Diode Laser and Bleomycin in Treatment of Hemangioma

Assessment of the Effectiveness of Bleomycin Intralesional Injection and Diode Laser on Management of Infantile Hemangioma., with regard to :

* Clinically based on Change in the Size and Color of Hemangioma.
* Ultrasonography considering Vascularity ,Echogenicity , Height , and Morphology .
* Comparison of Complications associated with Bleomycin and Diode Laser.


Eligibility Criteria:
Inclusion Criteria:

* Age between 3 Months and 1 Year old.
* Non Complicated Infantile Hemangioma

Exclusion Criteria:

* Younger than 3 Months or older than 1 Year.
* Complicated Infantile Hemangioma
Botulinum Toxin Injection to Treat Diffuse Esophageal Spasm

This study evaluates the effect of botulinum toxin 100 U or saline, injected endoscopically in the distal esophagus, on symptoms and manometry pattern in patients with diffuse esophageal spasm.

Patients are selected on the basis of a clinical diagnosis of diffuse esophageal spasm, based on endoscopy and manometry.

This is a sham-controlled cross-over study of injection of botulinum toxin or saline, in randomized order, in the distal esophagus.

All patients have undergone esophageal manometry which shows diffuse esophageal spasm, and a 24h pH monitoring/manometry to quantify acid reflux. All drugs prescribed to affect esophageal motility (nitrates, calcium antagonists) are stopped during the study. After randomisation, the patient will undergo standard esophageal manometry to assess baseline esophageal motility. On the same day the patient will be asked to fill out a set of symptom questionnaires including a dysphagia questionnaire. At endoscopy, the active treatment group receives 8 x 12.5 units, each in 0.5 ml, of botulinum toxin A which will be injected in the four quadrants of the esophagus at 2 and 5 cm above the lower esophageal sphincter. In the Sham group 8 \* 0.5 ml of physiologic serum will be injected. The randomisation will be performed at the endoscopy unit by a nurse otherwise not involved in the protocol.

After 1 month a stationary manometry and a new esophageal pH/manometry monitoring will be performed, followed by a second endoscopy with injection of saline or botulinum toxin in a cross-over mode. At the time of the second endoscopy each patient will fill out a dysphagia questionnaire. One month later, the dysphagia questionnaire is repeated.

Subsequently, follow-up will occur at the outpatient clinic after 6 and 12 months, with follow-up dysphagia questionnaires but no additional manometries or endoscopies, unless the clinical status deteriorates.

Eligibility Criteria:
Inclusion Criteria:

* Spastic motor disorder in the upper GI tract

Exclusion Criteria:

-
The Manchester Short Splint in the Rehabilitation of Zone II Flexor Tendon Repairs

The project sets out to compare two different splints in the outcome of zone II flexor tendon injury hand therapy rehabilitation programme. Traditional hand therapy is based on using a long forearm-based splint for 6 weeks in zone II flexor tendon injuries. Manchester University NHS Foundation Trust have devised a new shorter splint to use as an alternative to the traditional longer splint as there are cogent reasons for believing that permitting more wrist movement during rehabilitation will improve the range of finger movement ultimately (tendonesis effects).

Patients will be randomised to receive either the traditional long splint, or the short splint. Patients will be followed up and data will be collected at routine hand therapy appointments.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients 16 years and over, undergoing surgical repair of zone II flexor tendon injury in a single digit

Exclusion Criteria:

* Adult patients lacking capacity or motivation to participate in the planned physiotherapy
* Adult patients with special needs and vulnerable groups
* Adult patients who undergo surgical repair of their flexor tendon more than 4 days after the initial injury
* Patients unable to understand English adequately
* Adult patients unable to attend the hospital facility for the requisite number of planned physiotherapy sessions (social reasons)
* Adult patients with multiple level injuries
* Injuries with soft tissue loss requiring coverage
* Adult patients with two nerve injuries on the same finger
* Adult patients with multiple digit flexor tendon injury
* Adult patients with concomitant bony injury to the hand
* Children under 16 years age
Effect of Red Furu Consumption on Serum Vitamin B12 and Homocysteine Concentration In Healthy Young Volunteers

The aim of the present study is to investigate the effect of red furu (Chinese fermented soybean product) consumption on serum vitamin B12, Homocysteine concentration and other cardio-metabolic risk factors in healthy young volunteers.

The study will apply the parallel study method and participants will be randomized into two groups. In the randomized controlled clinical trial, twenty-three healthy young volunteers (11 females and 12 males, aged 19-39 years) were recruited from Zhejiang University, China. They were randomly assigned to two groups of either red furu (n=11, 5 females and 6 males) or tofu (n=12, 6 females and 6 males). Volunteers consumed a provided meal, either 50 g of red furu or tofu with two slices of bread for 1 day breakfast meal. Volunteers also recorded their normal dietary intake during the 3 days trial period using provided self-report food diary. Fasting blood sample was drawn at 0h, 24h and 72h. Serum VB12, Hcy and other cardio-metabolic risk factors were measured by standard methods.

Test Meals:

Red Furu Group: 50 g of red furu with 2 slices of bread. Tofu Group: 50 g of plain tofu eaten with 2 slices of bread. Volunteers will refrain from consumption of fermented products 1 week prior to the study. Thereafter subject feed on control diet and intervention diet for 1 day. Volunteers' normal diets and test meals will be recorded on a self-administered questionnaire, followed by testing serum vitamin B12, Homocysteine and other biochemical parameters.

5-10 mL blood will be collected per session. Blood will be collected: 3 times (0h-24h-72h).Participants will be asked to fast for 10-12 hours prior to the blood draw.

Eligibility Criteria:
Inclusion Criteria:

* 20-39 Years
* All Races

Exclusion Criteria:

* Taking antibiotics or vitamin B12 supplements within 1 month prior to enrollment