cyrilzakka/clinical-trials huggingface dataset:
Characterizing Postoperative T and B Cell Dysfunction in Cancer Surgery Patients, Using COVID-19 as a Model Antigen

The Auer Lab research program studies how surgery affects the immune system and how this can lead to suppression in cancer patients which can lead to cancer reoccurrence. This has been well characterized in literature, with a clear demonstration that both surgery induced suppression of T cell and Natural Killer (NK) cell result in cancer recurrence..

The present study is the first in humans, to our knowledge, to demonstrate antigen specific dysfunction in T cells and B cells following cancer surgery. The study capitalized on the widespread vaccination of cancer patients against COVID before surgery, which allowed us to measure the response to the antigen S protein of SARS-CoV2. While the study is translational in methodology, we believe it will be of significant interest to all surgeons because it clearly establishes that surgery profoundly suppresses antigen-specific T and B cell responses, which have implications for postoperative infectious complications and cancer recurrence for those patients undergoing tumor resection


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of a primary abdominal malignancy consented to undergo major surgery with a planned length of stay of 3 or more days.
* Eligible patients must have signed a consent for surgical resection of the malignancy.
* Adequate hematological function defined as: platelet count ≥ 100 x 109/L, absolute neutrophil count ≥ 1 x 109/L, white blood count ≥ 2.5 x 109/L, hemoglobin count ≥ 90 g/L.
* Adequate organ functioning, including: total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST, ALT \< 2.5 x ULN; INR \<1.5 ; CrCl\>30mL/min.
* Ability to understand and provide a signed informed consent form (ICF) approved by the Institutional Review Board (IRB/IEC/REB).
* Ability to comply with protocol requirements.

Exclusion Criteria:

* Documented significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin A). Subjects may be on physiologic doses of replacement prednisone or equivalent doses of corticosteroid (\<7.5 mg daily).

  * History of autoimmune disease (even if controlled with medication) such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
  * Allergies or any contraindication to the use of tadalafil or any components of Cialis® or the influenza vaccine (including eggs), Agriflu®.
  * Serious intercurrent chronic or acute illness, or other illness considered by the investigator as an unwarranted high risk for an investigational product.
  * Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
  * Patients with resting hypotension (BP \<90/50 at rest) or hypertension (BP \>170/110 at rest).
  * Patients with cardiac failure or coronary artery disease causing unstable angina.
Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML

1. To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in in a second complete remission of acute myeloid leukemia (AML).
2. To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema) increases survival compared to a threshold derived from historical data
3. To evaluate whether SCT from haploidentical donors for children having no matched donor will result in better survival with acceptable toxicity.

Target variables:

* Treatment response
* Event Free Survival
* Leukemia Free Survival
* Graft Versus Host Disease
* Regimen related toxicity

Eligibility Criteria:
Inclusion Criteria:

* Aged between 0-21 years
* Patients suffering from either refractory de novo AML or relapsed AML or patients with very high risk AML in CR1
* In sexually active patients two reliable contraception methods are used. This includes every combination of a hormonal contraceptive (such as injection, transdermal patch, implant, cervical ring) or of an intrauterine device(IUD) with a barrier method (e.g. diaphragm, cervical cap, or condom) or with a spermicide.
* Written informed consent of patient, parents or legal guardians

Exclusion Criteria:

* Severe renal impairment (GFR \< 30% predicted for age)
* Pregnant or lactating females
* Current participation in another clinical trial
* Patients ≥ 12 years old for Group 1 ("BuCyMel") (patients younger that 12 years continue to be included)
Platelet Rich Plasma for Knee Osteoarthritis

This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis. Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also receive second look surgery and intraoperative biopsy.

Osteoarthritis is a chronic disease defined by progressive degradation of the joint as well as loss of cartilage on joint surfaces. The degeneration that occurs in the joint leads to changes in the catabolic and anabolic activity of chondrocytes. Osteoarthritis may induce pain, stiffness and limitation in range of motion of the joint and also may impact the quality of life. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. Although several studies have assessed the effects of PRP on knee osteoarthritis, a higher level of evidence has not been provided. This study aimed to analyze the effect of PRP on knee osteoarthritis. After performing arthroscopic knee surgery plus intraoperative PRP in eligible patients, a second look arthroscopic surgery with intraoperative biopsy will be arranged 6 months later. Pre- and post-operative imaging and clinical outcomes will also be compared.

Eligibility Criteria:
Inclusion Criteria:

* Age between 30 and 70 years
* With diagnosis of osteoarthritis, grade II\~grade IV, II-III medial compartment

Exclusion Criteria:

* Lateral compartment and patellofemoral joint osteoarthritis
* With prior history of knee surgery
* Severe varus deformity
* With current or prior history of traum or infection at the knee
* With current or prior history of cancer
* With current or prior history of hematological disease
* Pregnancy
* Patients who will not cooperate with one-year followup
Factor V Leiden Mutation and Implantation Failure

The purpose of this study is to determine whether inherited thrombophilias (tendency toward blood clotting) increase the risk of failure of the embryo to implant in IVF. The specific condition to be studied is the presence or absence of the Leiden mutation of the Factor V gene.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing in-vitro fertilization with successful ovarian hyperstimulation, oocyte retrieval, and fertilization
* Transfer of at least 2 fresh embryos of Grade 2 (preembryo with blastomeres of equal size and \<=10% cytoplasmic fragmentation) or better

Exclusion Criteria:

* Infertility due to uterine anatomic defect
* Current use of anticoagulant medication, such as heparin or aspirin
* Known presence of any other condition associated with increased risk of thrombosis
Cervical Device Contraception-2 (Nanopaz)

Measure blood progesterone by using cervical device contraception.

A very small cervical device that releases small amount of progesterone 20 mcgm/day.

The target of the research is to measure blood progesterone by using the cervical device.

This small device delivers progesterone by nanotechnology method.

Eligibility Criteria:
Inclusion Criteria:

* 10 healthy women are candidate for hysterectomy

Exclusion Criteria:

* Women with neoplastic malignancy disease or thrombophylia
The Effect of Enzyme-containing Mouth Spray on Oral Health Status and S.Mutans Levels in Paediatric Patients

An interventional study was done on evaluating the Effect of Enzyme-containing Mouth Spray on Oral Health Status and S.Mutans levels in Paediatric Patients attending Hospital Universiti Sains Malaysia ( HUSM ) , Kelantan. This study compared the gingivitis score , plaque score and saliva bacteria count between the patients receiving a standard preventive advice alongside with normal saline mouth spray and those receiving standard preventive advice alongside with an enzyme containing mouth spray .

General Objective

To evaluate the effect of enzyme-containing mouth sprays on children's oral health compared to those receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up.

Specific Objectives

1. To compare the mean plaque score in children using enzyme-containing mouth sprays with standard preventive advice compared to children receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up.
2. To compare the mean gingivitis score in children using enzyme-containing mouth sprays with standard preventive advice compared to children receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up.
3. To compare the mean saliva bacterial count in children using enzyme-containing mouth sprays with standard preventive advice compared to children receiving receiving normal saline mouth spray with standard preventive advice after a 4-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Children of age group 4-7

Exclusion Criteria:

* Children with medical problems
* Children with Special Needs
* Uncooperative Children ( Level of Cooperation would be measured using Frankl's behavior scale)

Reviewer's comment : To list down Frankl's Classification and how we define uncooperative

As per AAPD 2022 , The Frankl behavior rating scale is a frequently used behavior rating systems in both clinical dentistry and research. This scale indicates observed child's behaviors into four categories (1; Definitely negative, 2; Negative, 3; Positive, 4; Definitely positive)

1. _ _ Definitely negative. Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism.
2. _ Negative. Reluctance to accept treatment, uncooperative, some evidence of negative attitude but not pronounced (sullen, withdrawn).
3. + Positive. Acceptance of treatmen, cautious behavior at times, willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively.
4. ++ Definitely positive. Good rapport with the dentist, interest in the dental procedures, laughter and enjoyment
Efficacy Study Comparing Hand-assisted Laparoscopic and Mini-incision Muscle Splitting Incision Living Donor Nephrectomy

The purpose of this study is to compare the effects of hand-assisted laparoscopic and mini-incision muscle-splitting donornephrectomy on living kidney donors. The hypothesis is that the mini-incision is not inferior to the laparoscopic technique.

Living kidney donation has become an important source for kidney transplantation because of insufficient numbers of post mortem kidney donations. To reduce the surgical trauma of the donor operation and improve postoperative recovery minimal invasive techniques have developed. Especially the laparoscopic and the hand-assisted laparoscopic technique gained wide popularity. Minimal invasive open techniques have had less publicity. One of those open techniques is to perform the open donornephrectomy by means of an anterolateral approach. A transverse subcostal incision of 10 cm or less is made. The abdominal wall is opened by splitting the muscles and sparing the nerves. Staying in the retroperitoneal space the kidney is freed and taken out. Laparoscopic approaches have especially become more popular after the hand-assisted technique had developed. By means of an 8 cm transverse suprapubic skin incision and a vertical midline fascia incision the abdominal cavity is opened and a hand is inserted in the abdomen through an air tight sleeve. Three more trocarts are needed for the insufflation, the video camera and surgical instruments to perform a transperitoneal donornephrectomy. The hand in the abdomen assisting in the procedure has especially increased the sense of safety compared to the full laparoscopic technique without compromising the advantages of the laparoscopic technique.

So far no prospective or retrospective study has been done comparing the hand-assisted laparoscopic with the mini-incision muscle-splitting technique. Most studies that have been done comparing the (hand-assisted) laparoscopic technique with more invasive open techniques resulted in favour of the former technique.

Comparison(s): The study compares the effects of hand-assisted laparoscopic and mini-incision muscle-splitting donornephrectomy on living kidney donors.

Eligibility Criteria:
Inclusion Criteria:

* Accepted as living kidney donor by local protocol
* 18 years or older
* Excellent understanding of Dutch language
* Able to be operated on by both surgical techniques
* Having read patient information and signed informed consent

Exclusion Criteria:

* Previous surgery using subcostal incision(s)
* Not meeting the inclusion criteria
The TIOB - Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers.

The purpose of the Texas Immuno-Oncology Biorepository (TIOB) is to collect and store well-defined and well-annotated serial biospecimens of tissue, blood, urine and stool in a longitudinal manner from cancer patients who are receiving either standard of care surgical interventions and or FDA approved immunotherapeutics across the largest not-for-profit health system in Texas. Comprehensive clinical and radiological data from a diverse population of patients with different racial, social and ethnic backgrounds matched with serial biospecimens over a patients journey with cancer marks the TIOB as a unique research facility.

The goal of establishing the Texas Immuno-Oncology Biorepository (TIOB) is to create a research facility that purposely consents patients to collect, catalog, process, store, and analyze biospecimens with well-annotated clinical/radiological data from patients receiving surgical interventions or immunotherapeutics in our combined clinics throughout Texas. Potential types of studies that will be enabled by this resource will include but are not limited to (a) morphological studies including immunohistochemistry, (b) genomic and molecular analysis, including circulating, cell-free DNA, RNA, as well as extracellular vesicles and their cargo, (c) proteomic analysis involving protein isolation, (d) interrogation of circulating immune cells as well as the underlying tumor immune microenvironment, and (e) single-cell and spatial transcriptomics. Correlation of these studies with clinical, treatment outcome, and demographic information will be possible. Translation of multi-omics technologies will be a key feature of the TIOB and data integration strategies including genomics, epigenomics, transcriptomics, proteomics, radiomics, metabolomics and microbiomics will be possible and offer opportunities to improve our understanding of the complex biological interactions that define cancer.

Eligibility Criteria:
Inclusion Criteria:

* Understand and willingness to sign written informed consent method.
* Patients who are suspected by a physician of being at risk for developing cancer.
* Patients with confirmed or clinically suspected malignancy by a physician. This includes but is not limited to candidates for immunotherapy, surgical candidates, patients receiving Standard of Care drugs, immunotherapy drugs, participating on a clinical trial with immunotherapy drugs, patients who have received immunotherapy drugs in the past, patients with any other approved or investigational disease management.

Exclusion Criteria:

* Patients unwilling to donate blood
* Patients unwilling to provide informed consent for the collection of fresh or archived tumor tissue.
Milk as Treatment for Hypoglycemia

Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets without raising blood sugars too much the way that orange juice or glucose tablets sometimes do.

Subjects will wear a continuous glucose monitor prior to test to determine normal glucose levels. The morning of the test an IV will be inserted into the subject and insulin and saline drips will be started. Blood glucose levels will be checked every 10 minutes until the subject becomes hypoglycemic. IVs will be stopped at that time and subject will be given skim milk, orange juice or glucose tablets at that time. Blood will be drawn every 15 minutes until blood sugars stabilize. Blood draws will be analyzed to determine glucose, insulin, epinephrine, norepinephrine, glucagon, cortisol, growth hormone and GLP-1 levels. Procedure will be repeated two more times using other glucose methods (skim milk, orange juice or glucose tablets).

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes
* Able to be consented
* Able to wear continuous glucose monitor
Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.

The metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. Recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. Statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. Pitavastatin, a chemically synthesized statin, has potent LDL-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. However, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.

Eligibility Criteria:
Inclusion Criteria:

* Hypercholesterolemic patients

Exclusion Criteria:

* Patients receiving lipid-lowering agents
* Familial hypercholesterolemia
* Renal disease
* Diseases of liver, gallbladder and bile ducts
* Pregnant women
Three Techniques for Ultrasound Guided Axillary Brachial Plexus Block

The brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. The brachial plexus block through the axilla (BPVA) is one of the techniques most commonly used to obtain regional anesthesia of the upper limbs, being performed by anesthesia of the terminal branches of the brachial plexus, which would be the ulnar, median, radial and musculocutaneous nerves. With the aid of ultrasound , two techniques can be used to perform the BPVA . The first , known as multiple puncture technique , the local anesthetic is deposited around each nerve that want to block . This technique is most commonly used to perform the BPVA . The second technique , known as 2 injections , local anesthetic is deposited below the axillary artery and around the musculocutaneous nerve . This technique has been proposed to try to reduce the execution time of anesthesia . Studies actually show that the technique of 2 injections showed less time to perform the block, with the same success rate. However, the technique of 2 injections showed a longer latency and higher rate of vascular puncture . (14) In order to perform a procedure with shorter execution time , without changing the latency, success rate and ensuring patient safety , the investigators designed this protocol to evaluate three techniques for performing the ultrasound- guided axillary brachial plexus block.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed by the patient (IC)
* Indication for brachial plexus block for anesthesia and analgesia in candidates for hand surgical procedures
* ASA physical status I, II or III according to the American Association of Anesthesiology.

Exclusion Criteria:

* Cognitive impairment or psychiatric disease
* Active infection condition at the puncture site of the block
* Bleeding disorders
* History of allergy to bupivacaine.
Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients

A Pilot Randomized Controlled Trial (RCT) will be conducted where where mechanically ventilated patients will be randomized to optimal protein (Achieve 80% protein supplementation adequacy with daily titration) versus standard protein feeding. Both groups will receive standard usual early exercise therapy.

Specific aim 1: To determine if optimal protein supplementation improves functional outcome of patients as measured by Functional Status Score (FSS) on Day 7.

Specific aim 2: To determine if optimal protein supplementation reduces muscle loss of patients at Day 7 as measured by the Rectus Femoris thickness and cross-sectional area (RFCSA) using skeletal muscle ultrasound.

Specific aim 3: To determine difference in functional recovery between groups using quality of life (QOL) scores and 6-minute walk distance at 3 months after hospital discharge.

The hypothesis is protein inadequacy can be overcome with optimized protein supplementation to reduce muscle loss/sarcopenia and functional impairment in ICU survivors.

This study will be a prospective pilot randomized controlled trial. Collaboration will be between the National University Hospital (Medical, Surgical and Cardiothoracic ICUs), Centre for Healthy Aging, National University Health System (NUHS) and Physical Education \& Sports Science, National Institute of Education (NIE). Patients admitted into these ICUs will be screened and those meeting the inclusion criteria will be approached for consent. If the patient is unable to consent, his/her legally acceptable representatives will be approached. This approach is routinely done in ICU studies. As with other ICU studies, potential difficulties in consenting and recruiting patients will be expected. To overcome this, all adult ICU patients at NUH will be included in the current study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21 years and above.
2. Expected mechanical ventilation duration ≥ 48 hours.
3. Expected to stay in hospital for ≥ 4 days.

Exclusion Criteria:

1. Pregnant woman.
2. Amputation of either lower limbs.
3. Surgery of lower limb during the current admission.
4. 4. Any neurological/rheumatologic/orthopaedic/burn/trauma/physiological problem with feeding difficulties during 48h of intubation
5. Wheelchair-bound, walking aids and ADL-dependent.
6. Patient not able to feed by 48 hours AND not given parenteral feeding.
7. Patients on Continuous Renal Replacement Therapy.
8. Sepsis with poor prognosis.
9. Competing trial
10. Moribund within 48hours.
11. COVID-19 patients.
12. Declined to participate the study