cyrilzakka/clinical-trials huggingface dataset:
Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.

Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for the achievement of \>6 x10\^6 CD34+ cells/kg. The patients that fail to mobilize \>6 x10\^6 CD34+ cells/kg will not be randomized and will subsequently be followed for disease progression and overall survival.. Patients with \>6 x10\^6 CD34+ cells/kg cryopreserved on study will be admitted to the hospital for planned ASCT. Patients will be randomly infused with either 3-4 x 10\^6 CD34+ stem cells/kg or 6-8 x10\^6 CD34+ stem cells/kg on d0 per study randomization. The cell dose ranges within the two groups allows variability within aliquots of cells at the time of cryopreservation. Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Diagnosed with relapsed or refractory de novo DLBCL or follicular lymphoma transformed to DLBCL to one previous line of anthracycline-containing chemotherapy
* KPS ≥ 70
* Complete or partial response by IWG Working Group or ICML Criteria to maximum of one salvage line of chemotherapy without pre-HDT/ASCT salvage radiotherapy.
* Eligible for high-dose therapy and autologous stem-cell rescue

  * Serum creatinine ≤ 1.5 mg/dL, or if creatinine \>1.5 mg/dL, calculated creatinine clearance of ≥50 mL/min by 24 hour creatinine clearance or CKD-EPI.
  * Last cycle of most recent salvage therapy within 8 weeks of enrollment
* Total bilirubin \< 2.0 mg/dL

  o If Gilbert"s disease is suspected and total bilirubin \> 2.0 mg/dL, direct bilirubin must be \< 2.0 mg/dL
* Females of childbearing potential and males must agree to use an acceptable form of contraception per institutional practices.

Exclusion Criteria:

* Disease progression by IWG Working Group or ICML Criteria since last therapy
* Prior autologous or allogeneic stem cell transplantation
* HIV infection
* Comorbid condition(s) which, in the opinion of the attending physician and/or MSKCC Principal Investigator, will preclude stem cell mobilization and/or high-dose therapy with autologous stem cell rescue
* Treatment plan that includes post-transplant maintenance therapy
* Salvage therapy that includes involved field radiotherapy
Nerve Burial for Preventing Neuralgia After Total Knee Arthroplasty

This is a randomized study investigating whether identification, ligation, and burial of superficial branches of the saphenous nerve crossing the surgical field during total knee arthroplasty reduces the rate of post-operative anterior knee pain and neuralgia compared to standard total knee arthroplasty.

Anterior knee pain is common after total knee arthroplasty. The incision necessarily travels through the path of a cutaneous nerve - branches of the saphenous nerve. Historically, no effort has been made to separate these branches and bury them away from the surgical scar. It has been noted that some patients develop a painful neuroma, that once resected results in a pain free knee. Investigators are trying to study if identification, ligation, and proper burial of the nerve can prevent the development of neuralgia compared to the typical surgical approach which ignores the nerve branches completely.

Eligibility Criteria:
Inclusion Criteria:

* Must have symptomatic knee osteoarthritis under consideration for total knee arthroplasty
* Must be willing to undergo randomization

Exclusion Criteria:

* Age \<18 or \>80 years
* Known pre-operative diagnosis of neuralgia, complex regional pain syndrome, or neuropathy, about the operative lower extremity
* Known pre-operative psychiatric disorder requiring medication
* Previous surgery about the operative knee
* BMI \> 40 kg/m2 (potential increased risk of soft tissue dissection through adipose)
* Ongoing pre-operative narcotic use in excess of 20 mg morphine equivalents per day for at least one month or pre-operative intravenous drug use (increased potential for complex regional pain syndrome and neuralgia, increased likelihood to require greater post-operative analgesia)
* Ongoing pre-operative use of neuropathic pain medications (gabapentin, pregabalin, amitriptyline, etc.)
* Medical comorbidities (American Society of Anesthesiologists grade \> 3 or deemed unfit by consulting internist) precluding elective TKA
* Significant language barrier (reading comprehension less than 8th grade reading level) or mental condition precluding accurate self-assessment of knee pain or function.
* Severe medication allergies to permissible post-operative analgesics (acetaminophen, tramadol, oxycodone, oxycontin, dilaudid)
Diacutaneous Fibrolysis, Effects on Tension Type Headache

Tension Type Headache (TTH) is a frecuent type of headache disorder (about 1 person in 5 worldwide). Individuals with TTH typically present pericraneal tenderness and an increased cervical muscle tone.

The most common treatment in primary care consists mainly on analgesic medication. However, different techniques of manual therapy have been shown to be effective in the treatment of these patients. Diacutaneous fibrolysis shows clinical benefits in relieving symptoms of tension type headache, but there is no scientific evidence that analyzes this effects.

The hypothesis of this study was that adding treatment with diacutaneous fibrolysis to the usual conservative treatment has beneficial effects on different variables of the headache.

The aim of the study was to assess the effect of diacutaneous fibrolisis on intensity, frequency, duration of headache and cervical function in patients with tension type headache.

A randomized controlled clinical trial has been designed to evaluate the effectiveness of diacutaneous fibrolysis technique compared to usual general practicioner care in patientes with tension type headache.

The study protocol has been approved by the Clinical Research Ethics Committee from the Aragon Community and all patients provided written consent.

Eighty-two people with clinical diagnosis of TTH were randomized into a intervention group or a control group. Intervention group received three sessions of Diacutaneous Fibrolysis, while control group was advised to maintain their usual pharmacologic treatment. Pain intensity (VAS), frecuency, location, cervical range of motion, head forward position and pressure pain thresholds (PPTs) were measured at baseline, postintervention, and 1 month follow-up after treatment. The Spanish version of the HIT-6 Questionnaire was used to measure disability/function at baseline and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Tension-Type Headache according to the criteria of ICDH-III.

Exclusion Criteria:

* Currently undergoing physiotherapy treatment for headache
* Modification of pharmacological treatment in the last month
* Presence of red flags
Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures

The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.

Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients who have not responded to medical treatment.Although several case series and non-randomized studies have shown the effectiveness of vertebroplasty in alleviating pain secondary to osteoporotic vertebral fractures, the long-term effect of this treatment has not been compared to standard medical treatment in a randomized study.

In our study we have analyzed the long-term effect of vertebroplasty in terms of quality of life in patients with painful osteoporotic vertebral fractures, randomizing them into two arms: percutaneous vertebroplasty or conventional medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5
* Fragility; i.e. fracture not in relation with significant trauma
* Recent fracture, pain beginning not earlier than 1 year before inclusion

Exclusion Criteria:

* No vertebral edema on STIR MR images
* Uncorrectable bleeding diatheses
* Active infection
* Substantial retropulsion of bony fragments
* Non-osteoporotic fracture
* Concomitant neoplasm
Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients

Objectives: The outcomes of heart transplantation are very favorable but inflammation still plays a critical role in deterioration of chronic transplants. Periodontal diseases are not only limited to supporting structures of the teeth, they also cause systemic inflammation. Based on the importance of inflammation in heart transplant recipients and the association between periodontal disease and systemic inflammation, this study explored whether periodontitis may be a modifier of serum high-sensitivity C-reactive protein (HsCRP) in heart transplant patients.


Eligibility Criteria:
Inclusion Criteria:

be clinically stable be at least 1 year post-transplant; no history of antibiotic use during the preceding 4 months have had no periodontal treatment within the previous year.

Exclusion Criteria:

having other systemic infections
The Use of Acupuncture for the Treatment of Vulvar Vestibulitis

Randomized controlled trial designed to determine whether acupuncture is an effective treatment for vestibulitis.

Patients were randomized to five acupuncture sessions designed to treat pain in the vulvar area (study group), or five acupuncture sessions designed for tranquility (controls). Participants and evaluating gynecologists were blinded to randomization. Participants were examined clinically before treatment and one month after completion of assigned treatment; at both visits they completed the Female Sexual Function Index (FSFI) questionnaire.

FSFI scores for pain during intercourse and total score were used to evaluate change. The examining gynecologist evaluated the degree of sensitivity to touch and the degree of local erythema. Response to treatment was evaluated for each group before and after treatment, and for study group compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of vestibulodynia

Exclusion Criteria:

* Pregnancy
* Patient who received other treatment for vestibulodynia in the month preceding.
Autologous Cord Blood Cells for Prevention of BPD in Preterm

To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates

We did a randomized, double-blind, placebo-controlled trial to assess effect of one intravenous dose of cord blood MNCs compared with placebo in reducing incidence of BPD in very preterm neonates.We enrolled preterm neonates less than 32 weeks of GA at neonatal intensive care units (NICUs) in Guangdong Women and Children Hospital within the first 24 postnatal hours. Patients were randomly assigned by 1:1 to receive either (5×107cells/kg ACBMNC or normal saline intravenously within 24 hours after birth according to a computer-generated schedule. The primary endpoint was efficacy at 36 GA or discharge home and all analyses were done by intention to prevent.MNCs viability was also tested before transfusion

Eligibility Criteria:
Inclusion Criteria:

* born in the study hospital;
* singleton birth;
* less than 32 weeks GA
* Without congenital malformations or known chromosomal aberrations;
* Without clinical chorioamnionitis;
* the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus;
* consents were obtained from their parents or guardians;
* the umbilical cord blood cells after processing were available.

Exclusion Criteria:

* birth-weight was less than the third percentile for gestational age according to Fenton curve,
* if they had severe perinatal asphyxia (defined as an Apgarscore of 0-3 for more than 5 minutes, a cord blood pH of less than 7.00, or both) and were expected to die shortly after birth.
A Novel Diet Approach to Combat Gestational Diabetes

There is an urgent need to implement novel diet approaches to combat the increasing rates of gestational diabetes mellitus (GDM). The primary aim of this study is to establish the feasibility of time-restricted eating in pregnancy, to prepare for future larger controlled trials in this research project to determine the efficacy of time-restricted eating in women at risk of GDM. Expectations:

1. Women who have an increased risk of GDM will be able to adhere to time reduced eating during pregnancy.
2. Time reduced eating will improve short-term glycemic control in pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* carrying one singleton live foetus
* in pregnancy week 12-30
* having at least one risk factor for gestational diabetes mellitus (GDM) according to Norwegian guidelines for GDM screening: pre-pregnancy BMI \> 25 kg/m2, GDM in previous pregnancy, primiparae aged \> 25 years, first degree relative with diabetes mellitus, Asian or African ethnicity, previous delivery of new-born \> 4.5 kg
* understand written and spoken Norwegian language

Exclusion Criteria:

* habitual eating window \< 12 hours
The Effects of Blood Pressure on Renal Function and Oxygenation in Septic Shock

The purpose of this study is to evaluate renal effects of 3 different levels of mean arterial pressure in early case of septic shock. In 8 patients diagnosed with early septic shock, we will adjust mean arterial pressure (MAP) to three different levels, using norepinephrine. At each level of MAP, central and renal hemodynamics and oxygenation states will be measured. Analysis will be made to describe the pathophysiology at MAP 75 mmHg, and then to evaluate at which MAP renal function and oxygenation is least affected negatively.

It is under debate what level of mean arterial pressure is the most appropriate for organ perfusion in septic shock. The kidneys are usually used for end-organ evaluation of appropriate perfusion and appropriate blood pressure level. What "adequate blood pressure" means is today unclear.

The purpose of this study is to chart the renal perfusion, oxygenation and function, and moreover to evaluate renal effects of 3 different levels of mean arterial pressure, in early phase of septic shock.

Patients will be included within the first 24 hrs after admission to the ICU diagnosed with septic shock. The patients will be sedated, mechanically ventilated and in need for norepinephrine for adequate blood pressure levels.

After 60 mins of steady state at MAP 75 mmHg, norepinephrine will be adjusted achieve MAP of 60 and 90 mmHg respectively, MAP being held at each level for 30 mins. At the end of each 30 mins period, central and renal hemodynamics will be measured, blood and urine samples will be collected.

Central hemodynamics will be measured by, and blood samples collected via a pulmonary catheter and an arterial line.

Renal hemodynamics will be measured using a renal vein catheter for retrograde thermodilution giving at hand renal blood flow (RBF), renal vein blood samples and urine collection provides extraction of Cr-EDTA for filtration fraction (FF) and glomerular filtration rate (GFR), renal oxygen consumption, and renal oxygen extraction as a measure of balance between renal oxygen delivery and consumption.

Via renal vein catheterisation and retrograde thermodilution, the study group have the unique possibility to actually evaluate renal blood flow, renal oxygenation and renal function in humans in vivo.

After finishing the data collection, analysis will be made to answer the question: which MAP is the most optimal concerning RBF, GFR and renal oxygenation in patients with septic shock?

Eligibility Criteria:
Inclusion Criteria:

* stable septic shock
* normovolemic
* norepinephrine
* intubated/ventilated
* normal s-creatinine according to local laboratory regards.
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (sex at birth).
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening.
* Stable daily dose(s) \>= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
* Metformin
* sodium-glucose co-transporter 2 inhibitor (SGLT2i)
* Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
* Body mass index (BMI) \>= 30 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
* Renal impairment with estimated Glomerular Filtration Rate less than \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
* Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Local Thrombolytics Before Thrombectomy in STEMI

Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of myocardial tissue.

Although the use of thrombus aspiration with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain.

Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective in patients with STEMI.

The study will select patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing manual thrombectomy followed by primary percutaneous coronary intervention (PCI).

Patients will be randomized to receive local bolus of 200,000 units urokinase or saline solution

Eligibility Criteria:
Inclusion Criteria:

* ST-elevation myocardial infarction
* angiographic evidence of massive thrombosis in the culprit artery
* Indication to manual thrombectomy followed by primary percutaneous coronary intervention (PCI)
* Able to understand and willing to sign the informed CF

Exclusion Criteria:

* Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation

In this study, the investigators aimed to apply their previously developed multi-locus blood-based assay targeting circulating tumor DNA methylation to monitor postoperative relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II (without high risk) colorectal cancer after radical resection.

This is a prospective, multicenter, observational, real-world study. Research objects: patients with surgically resectable colorectal cancer and ctDNA positive before surgery in stage I and stage II (without high risk). After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, postoperative week 3, postoperative 5 years ( every 3 months for the first 2 years, and every 6 months for the rest 3 years). Participants will be observed and examined during the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed stage I/II (without high risk) colorectal cancer.
* Male or female ≥ 18 years of age on the day of signing informed consent.
* Patients need to receive surgical resection, and with ctDNA positive prior to resection of colorectal cancer (CRC).
* Patients must have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.

Exclusion Criteria:

* Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer.
* Induction of neoadjuvant systemic therapy prior to resection of CRC.
* Patient is pregnant or lactating.
* Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.
* Inadequate tumor material (either quality and quantity) to support circulating tumor DNA (ctDNA) analysis.