cyrilzakka/clinical-trials huggingface dataset:
Epstein-Barr Virus (EBV)-Specific T Cells as Therapy for Relapsed/Refractory EBV-positive Lymphomas

This trial will use a new method of treating lymphoma using a therapy derived from a person's Killer T cells. These Killer T cells are taken from a person's blood and grown in a test tube to increase the number of these cells that are specifically active against the lymphoma cells. The cells are then given to the patient by intravenous infusion with the aim of killing the lymphoma cells. Potentially this treatment will help to kill the residual/recurrent tumour that is present after other lymphoma treatment and reduce the chance of the tumour recurring.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent.
* EBV-positive lymphoma as determined by in situ hybridization or equivalent (excluding Burkitts Lymphoma).
* Age 18 years or older.
* ECOG performance status 1, 2 or 3
* Life expectancy of at least 6 months.
* Measurable disease: either relapsing, partially responsive, refractory or progressive disease, includes disease detected either by clinical examination, radiographic evaluation (including CT scans, and at physician's discretion by functional imaging), or a persistently detectable plasma EBV viral load.
* No chemotherapy / radiotherapy and/or antibody therapy for at least 2 weeks prior to anticipated date of first infusion.

Exclusion Criteria:

* EBV negative tumour
* Presence of detectable malignant cells in the peripheral circulation by flow cytometry or morphology
* Serious infection within the past 28 days that has not adequately responded to therapy
* Pregnancy, or unwilling to use adequate contraception
* Serology (taken within 3 months of CTL release date) indicating active HBV or HCV infection, positive serology for HIV I\&II, HTLV1 or syphilis
* Negative serology for EBV
* Psychiatric, addictive or any condition which may compromise the ability to participate in this trial
Supervised Versus Non-supervised Exercise on Adherence and Functional Outcomes in Colorectal Patients

Investigation into prehabilitation by increasing the supervision of exercise in patients undergoing colorectal resection for cancer and comparing with patients involved in a rehabilitation group receiving exercise after surgery.

The aims of this research project are the following:

To determine to what extent a structured multimodal prehabilitation regimen, which includes aerobic and resistance exercise, nutritional supplementation and psychological coping strategies, initiated before surgery, and continued while in hospital and after surgery, optimizes the recovery of functional walking capacity following colorectal resection for cancer.

To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* referred electively for resection of malignant, non metastasized, colorectal lesions.
* French or English speaking

Exclusion Criteria:

* ASA class 4-5
* co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
* cardiac abnormalities
* severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV), COPD, renal failure (creatinine \> 1.5mg/dl, and hepatic failure ALT and AST \> 50% over the normal range)
* Sepsis
* Morbid obesity (BMI \> 40)
* Anemia (hematocrit \< 30%, haemoglobin \< 10g/dl, albumin \< 25mg/dl).
Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin Hypersensitivity Treatment

This study aims to evaluate the longevity and efficacy of two products potassium oxalate-basedin two concentrations, 10% and 5%, by triple randomized blind clinical trial (split-mouth) . The desensitization approach (single agent) and the long-term effectiveness (baseline, 1 week, 2 weeks, 3 weeks). Data will be collected, tabulated and submitted to statistical analysis.

Dentin hypersensitivity (DH) is characterized as a short, intense and sudden pain caused by thermal, chemical and evaporative stimuli. There are several types of desensitizing agents, used to aid in the control of this pathology, but they are not very effective and have short longevity. The agents based on potassium oxalate have been used by dental surgeons because they have mixed action, both neural and obliterating. Therefore, the aim of this study is through a triple blind randomized clinical trial (split-mouth), evaluate the longevity and efficacy of two products potassium oxalate-based in two concentrations, 10% and 5%. Thirty-two with DH at least 2 teeth and adequate oral hygiene will be randomly divided into two different groups according to the desensitization approach (10% and 5%) The dentin hypersensitivity level will be evaluated immediately after desensitization and after 1, 2 and 3. Data will be collected, tabulated and submitted to statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Both genres, interested in the treatment of Dentin Hypersensitivity
* Patients with all teeth in their mouth
* Patients who have at least three teeth with Dentin hypersensitivity in different quadrants
* Good oral hygiene

Exclusion Criteria:

* Caries or unsatisfactory restorations
* Presence of periodontal disease and or parafunctional habits
* Cracks or enamel fractures
* Extensive or unsatisfactory restorations
* Recent restorations involving the labial surface
* Pulpitis
* Dentures
* Orthodontics
* Smokers
* Pregnant women
* Gastroesophageal disease presence
* Uncontrolled systemic disease
* Severe bruxism
* Constant use of analgesic
* Allergic response to dental products
Feasibility and Acceptability of Home-based Stretching Exercises in Fibromyalgia

The study aims to gather knowledge about the patient's acceptance of the intervention and testing procedures, assess the adherence to the intervention, estimate the recruitment rate, and inform the sample size calculation for a subsequent randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients are included if they are aged 18 to 55 years and diagnosed with fibromyalgia in accordance with the American College of Rheumatology (ACR) criteria

Exclusion Criteria:

* Non-controlled systemic disorders
* Impaired alertness or comprehension
* relevant joint disorders (e.g., severe arthritis, arthroplasty of the hip or knee, and rheumatoid arthritis)
* recent changes in therapy
* neurological and musculoskeletal conditions that could compromise assessments
Three-dimensional Printed Hand Orthoses

In persons with chronic hand conditions, orthoses are often prescribed to improve daily-life functioning. In most cases, orthoses are custom manufactured based on a plaster hand model, which is a time-consuming and labor-intensive process. It has been demonstrated that the production time to custom manufacture hand orthoses can be greatly reduced by using three-dimensional (3D) scanning and printing, offering a promising cost-effective alternative to conventional costum manufactured hand orthoses. However, before setting up a cost-effectiveness study in persons with chronic hand conditions, insight into the effectiveness of 3D-printed orthoses on performance of activities of daily living (ADL) is needed, as well as insight into potential cost reductions. To date, this information is largely unknown. The aims of this feasibility study are 1) to collect data on the preliminary effectiveness of 3D-printed orthoses on performance of ADL, satisfaction with the orthosis and quality of life compared to conventional orthoses in persons with chronic hand conditions, and 2) to compare the production time and costs of 3D-printed orthoses with conventional orthoses.


Eligibility Criteria:
Inclusion Criteria:

1. Having a chronic hand-wrist condition due to an injury, or a musculoskeletal disorder, neuromuscular disorder, or neurological disorder;
2. Minimum age of 18 years;
3. Currently wearing a conventional custom manufactured hand orthosis (including a wrist-orthosis, wrist/thumb orthosis or thumb orthosis) for permanent use;
4. Indicated for a new hand orthosis.

Exclusion Criteria:

1. Already wearing a 3D-printed orthosis
2. Wearing a silver wrist-orthosis, wrist/thumb orthosis or thumb orthosis
3. Wearing an orthosis prescribed for a dysfunctional hand;
4. Wearing a broken orthosis;
5. Wearing the orthosis only at night;
6. Worsening of disease;
7. Insufficient mastery of the Dutch language.
V2 Receptor Effects on Fluid Regulation and Performance

This primary aim of this study was to critically assess whether or not sweat water content and sodium concentration were acutely regulated by dynamic changes in antidiuretic hormone (arginine vasopressin or AVP) acting on the Vasopressin 2 receptor (V2R) during exercise. Secondary aims were to evaluate running performance and core temperature to further characterize the role of AVP in the coordinated balance of fluid and temperature homeostasis during exercise. The primary hypothesis was that activation of the V2R in sweat glands would result in water reabsorption and fluid conservation during endurance exercise.

Ten healthy habitual runners (\> 50km running per week) between 18-60 years of age participated in this double blind randomized control trial. Each subject presented to the exercise lab on four separate occasions. Trial 1 was a familiarization trial to determine each subject's maximal aerobic capacity and peak treadmill running speak (VO2 Peak test). Trials 2, 3 and 4 utilized the same exact protocol, differing only in pharmacological intervention. In a randomized, double-blind order (both participant and investigator blinded to the intervention), either a placebo pill, the V2 receptor antagonist tolvaptan (Samsca™, 30mg tablet), or the V2 receptor agonist desmopressin (DDAVP™, 0.2mg tablet) was ingested along with the CorTemp™ Core Temperature Sensor two hours before commencement of the Exercise Trial with 240mL of bottled water. The exercise protocol consisted of 60 minutes of treadmill running at 60% of peak speed (steady-state) followed by a performance test (the VO2 Peak test). Blood, saliva and urine, were collected before the exercise trial (baseline) and again after both the steady-state run and performance runs. Sweat was obtained from sweat patches after both the steady-state and performance runs. Core temperature, fluid intake, performance time, body weight, thirst and sodium palatability ratings were also assessed. Free access to water was allowed during the trial and all urine produced during the trial was measured and collected. The main outcome measure was sweat sodium concentration.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (no acute or chronic medical conditions or regular prescription medication use), habitual (\>50km/week)
* Distance runners between the ages of 18-60 years.

Exclusion Criteria:

* Individuals with chronic medical problems which require regular prescription medication
* Runners with pre-existing kidney problems
* Unable to sense thirst
* Difficulty swallowing
* Gastrointestinal disorders
* History of fainting associated with blood draw.
The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis

This research project is a study to immunology changes in critically ill patients with severe sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion.


Eligibility Criteria:
Inclusion Criteria:

* SIRS Criteria \> or = 2 meets definition
* Source of infection \> or = 1 meet definition
* Evidence of organ dysfunction \> or = 1 meet definition

Exclusion Criteria:

* WBC \< 5,000 /ul
* Platelet \< 30,000 / ul
* Pregnancy woman
* Advance stage cancer patients (terminally ill) who is refuse to be resuscitated
* Received blood transfusion \> 5 units in 24 hrs
* Allergy to Polymyxin-B
* High risk and uncontrolled bleeding
* Organ transplant patients
* On immunosuppressive agents within 2 weeks before study
* HIV infection
Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus

The purpose of this study is to confirm the mechanism of reduced response to DPP-4 inhibitor in some patients with type 2 diabetes and evaluate appropriate patients to treat with DPP-4 inhibitor

Sitagliptin, a DPP-4 inhibitor was used as an incretin enhancer in clinical practice first. In clinical trials, sitagliptin showed effective control of blood glucose level in type 2 diabetes and 100 mg once daily with metformin was similar to sulfonylurea (glipizide) with metformin in lowering HbA1c. Mostly in practice, stable blood glucose levels were maintained after change of sulfonylurea to sitagliptin in type 2 diabetes treatment. However, in some cases, there were abrupt severe hyperglycemia and uncontrolled blood glucose level after drug change to sitagliptin.

Several mechanism could be considered for reduced response to DPP-4 inhibitor in some type 2 diabetes patients. Firstly, significantly reduced secretion of glucagon-like peptide 1 (GLP-1) more than expected in diabetes or functional defect of GLP-1 activity could be the mechanism of loss of GLP-1 effect irrespective of DPP-4. Secondly, mutation or functional defect of DPP-4 enzyme could not be inhibited by DPP-4 inhibitor. Thirdly, GLP-1 receptor mutation or other defect in β-cell responsiveness to GLP-1 leads to reduction of response to DPP-4 inhibitor.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients with less than 15 yrs of disease duration
* BMI between 22-27 kg/m2
* HbA1c ≤ 9% at recruitment

  1. Study group

After change sulfonylurea to sitagliptin in case of metformin and sulfonylurea therapy

1. Increase of fasting blood glucose over 20 mg/dL or postprandial glucose over 30 mg/dL within several days or
2. Increase of HbA1c over 1% within 2-3 months without abrupt increase of blood glucose levels within several days

   * Sulfonylurea dose : less than glimepiride 4mg or gliclazide 120mg or glibenclamide 10mg
   * Metformin dose : 500\~2000mg
3. Reduced response to sitagliptin should be made a decision by investigators after understanding the condition of patients surely.

2. Control group

* Age, sex, BMI matched patients with same condition of study patients
* After change sulfonylurea to sitagliptin in case of metformin plus sulfonylurea therapy, no change of blood glucose levels like above or stable HbA1c change within 1% within 2-3 months

Exclusion Criteria:

* Other causes of increase of blood glucose levels except drug change
* Patients with history of insulin treatment
* Patients taking thiazolidinediones, alpha-glucosidase inhibitors, GLP-1 analogue or DPP-4 inhibitors
* Patients with renal, hepatic dysfunction
* Patients with diabetic complications such as coronary heart disease, cerebrovascular disease, proliferative diabetic retinopathy or diabetic gastroparesis
* Patients taking medications affecting glucose level
Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4

An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.

After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.

Eligibility Criteria:
Inclusion Criteria:

* Individual is on maximally tolerated stable medication regimen including 3 or more anti-hypertensive medications of different classes, one of which must be a thiazide or thiazide-like diuretic
* Individual has office SBP greater than or equal to 140mmHg and less than 160mmHg
* Individual has ABPM average SBP greater than or equal to 135 mmHg

Exclusion Criteria:

* Individual lacks appropriate renal artery anatomy
* Individual has eGFR of less than 30
* Individual has Type I diabetes mellitus
* Individual has had one or more episodes of orthostatic hypotension
* Individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea
* Individual has primary pulmonary hypertension
* Individual has other concomitant conditions that may adversely affect the patient or the study outcomes
* Individual is pregnant, nursing or planning to be pregnant
* Individual has had a previous organ transplant
Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

The purpose of this study is to look at pain management with opioids versus non-opioids after knee arthroscopy. This study will determine 1) whether the most commonly used non-narcotic medications provide pain relief comparable with the most commonly prescribed narcotic medications in patients undergoing arthroscopic knee surgery, and 2) whether patients' characteristics (gender, pre-operative knee symptoms, workers compensation status and employment status) affect pain level following surgery or medication usage.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 18 years of age through ≤ 80 years of age
2. Subjects undergoing elective arthroscopic knee surgery, to include partial meniscectomy, chondroplasty, or loose body removal.

Exclusion Criteria:

1. Previously enrolled in this study (enrolled for contralateral knee in this study)
2. Knee arthroscopy patients scheduled for knee ligament reconstructions
3. Bilateral knee arthroscopy
4. History of chronic opioid use or long-term analgesic therapy
5. Documented or suspected substance abuse
6. Documented or suspected chronic pain syndrome
7. Any known allergy or adverse reaction or contraindication to the components of hydrocodone, acetaminophen, or ibuprofen
8. History or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease)
9. With active peptic ulcer disease (history of severe heartburn)
10. Symptoms of infection with initial enrollment
11. Pregnant or nursing
12. Diagnosis of cognitive impairment
13. Unable or unwilling to provide informed consent for surgery or enrollment in this clinical study
14. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by Institutional Review Board) and agree to abide by the study restrictions.
15. Patient refusal
16. Currently taking Coumadin, Plavix, anticoagulation medications, or medications that increase bleeding, with the exception of ASA 81mg.
17. Patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits.
18. Alcoholism
Prostate Biomarkers in Men Consuming Tomato Products

Prostate Biomarkers in Men Consuming Tomato Products

Participants completed a minimum week-long washout period without consumption of tomato products prior to randomization to one of four dietary interventions. Men were randomized to one of the following dietary interventions: a controlled low lycopene diet (≤ 5 mg/d from foods), daily Prego® spaghetti sauce, daily V8® vegetable juice, or daily Campbell's® Tomato Soup. Each of the tomato products provided between 25 and 35 mg lycopene per day. In order to provide this dietary intervention in typical serving sizes in the context of a usual diet but devoid of other tomato sources, participants kept daily logs documenting compliance with the intervention product and a tomato-restricted diet from enrollment to the day of surgery (\~3 weeks). Study participants were asked to complete an abbreviated dietary history questionnaire (to establish typical consumption patterns of various tomato products) and two separate 3-day diet food records, once during the washout and once during the intervention period. Blood and 24-hour urine samples were obtained at two time points, after the one-week washout phase and at the end of the dietary intervention period. Fresh prostate samples were obtained at time of surgery.

Eligibility Criteria:
Inclusion Criteria: To be included in this study, men must:

* Have biopsy-proven, clinically localized adenocarcinoma of the prostate based on standard presurgical staging studies
* Have chosen to undergo a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options
* Have kidney and liver enzymes, CBC, and PT/PTT/INR within normal limits
* Agree to sign consent form prior to enrollment in the study

Exclusion Criteria: Men may not participate in this if they:

* Are currently taking lycopene or "alternative" dietary supplements
* Have a history of digestive or malabsorptive disorders, metabolic enzyme deficiencies, or other disorders requiring special dietary modifications (controlled type II diabetes mellitus was allowed)
A Study of Patient Management in HIV-1 Infected Patients Found to Have the Genetic Marker HLA-B*5701

This is a retrospective observational study which follows on from CNA106030 (a study evaluating whether prospective genetic screening for HLA-B\*5701 can reduce the incidence of hypersensitivity reactions to abacavir). This study aims to collect data on approximately 35 subjects who withdrew from CNA106030 when found to be HLA-B\*5701 positive. HIV disease management and adverse event data in these subjects, where the risk/benefit ratio of treatment with abacavir may alter subsequent prescribing, will be collected


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have received notification not to receive abacavir in the CNA106030 study because of a positive HLA-B\*5701 screen result, and were subsequently withdrawn from protocol CNA106030.
* Subjects willing and able to understand and provide written informed consent prior to participation in this study.
* French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion criteria:

* Subjects who were not enrolled in the CNA106030 study
* Subjects who are not HLA-B\*5701 positive
* Subjects who do not consent to being told their HLA-B\*5701 status