cyrilzakka/clinical-trials huggingface dataset:
Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

The Serpentine (Stratify cancER PatiENTs by ImmuNosupprEssion) project, represents the most consistent effort so far attempted to translate MDSC into clinical practise by producing an off-the-shelf compliant assay for quantifying these cells in peripheral blood.

The study will demonstrate that this assay helps personalizing cancer therapies by tailoring them to immune patient features. The project will also take advantage of innovative and high-throughput techniques to define additional MDSC related biomarkers and, most importantly, to identify novel drugs for Myeloid-derived Suppressor Cells (MDSC) blocking in predisposed patients. Finally,it will perform the first survey assessing the link between MDSC and "perceived social isolation", an emerging western social problem recently shown to cause myeloid cell dysfunction and immunosuppression though neuroendocrine circuits. Globally, the Serpentine proposal has the ambitious goal to translate into the clinical oncological practise the use of MDSC quantification as a tool for the systematic assessment of systemic immunosuppression, providing at the same time operational insights into the strategies to overcome this pillar mechanism of cancer progression.

Eligibility Criteria:
Inclusion Criteria

* Histologically documented diagnosis of metastatic/locally advanced melanoma, hormone-refractory breast cancer, RCC and UC, SCCHN, SCC or NSCLC, stage III resectable NSCLC will also be included
* Will and ability to comply with the protocol
* Willingness and ability to provide an adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample available for exploratory biomarker analysis
* Age from 18 to 90 years at the time of recruitment
* ECOG Performance Status \<= 2
* Understanding and signature of the informed consent
* Consenting to participate to the socio-economical-psychological survey

Exclusion Criteria

* Known history of HIV infection
* Serious neurological or psychiatric disorders
* Pregnancy or lactation
* Inability or unwillingness of participant to give written informed consent
* Inability or unwillingness to be regularly followed up at the same center
Tai Chi for Knee OA Pain Management: a Mechanistic Study

This study is to determine how 8-week Tai Chi intervention alters plasma endocannabinoid and its receptors in monocytes/marcrophages, plasma oxylipinds, plasma brain-derived neurotrophic factor, brain white matter connectivity/efficiency, and functional/clinical outcomes in women with knee OA.

Knee osteoarthritis (OA) is one of the five leading causes of disability. Previous studies have shown that a mind-body moderate-intensity Tai Chi (TC) exercise (8-24 weeks) reduced pain and improved physical function for knee OA, when compared to a waiting list, attention control, usual physical activity, or physical therapy. However, TC's mechanisms of action regarding improvement of one's clinical condition and its functional outcomes in individuals with knee OA are poorly understood. This study is to determine how 8-week TC intervention alters plasma endocannabinoid and its receptors in monocytes/marcrophages, plasma oxylipinds, plasma brain-derived neurotrophic factor, brain white matter connectivity/efficiency, and functional/clinical outcomes in women with knee OA.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women.
2. WOMAC pain score ≥ 50 on at least 1 of the 5 questions in pain subscale (range of 0 to 100, with higher scores indicating greater pain.
3. English literacy.
4. Able to undergo an MRI scan
5. Diagnosed Have the following symptoms associated with knee OA based on American College of Rheumatology clinical classification criteria for osteoarthritis (Peat 2006). Pain in the knee. Need to at least 3 of the following: over 50 years of age, less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement, or no palpable warmth of synovium.

Exclusion Criteria:

1. Prior experience with mind-body practice (e.g. TC, Qi Gong, yoga, or acupuncture) or physical therapy programs for knee OA within the past 3 months.
2. Severe medical limitations (i.e., dementia, symptomatic heart or vascular disease, or recent stroke) precluding full participation.
3. Medical/neurologic or other systemic diseases affecting the musculoskeletal systems (i.e. polio/Parkinson's/multiple sclerosis, etc. in addition to cerebral vascular accident or stroke) and diabetes with peripheral neuropathy affecting their sensory/balance.
4. Intra-articular steroid injection or reconstructive surgery on most severely affected knee in the past three months.
5. Intra-articular hyaluronic acid injections on most severely affected knee in the past six months.
6. Inability to walk without an assistive device.
Predictors of Scar Dehiscence in Patients With Previous Caesarean Section

In recent decades, the percentage of Cesarean section deliveries has dramatically increased in most countries. Concomitantly, the rates of vaginal birth after Cesarean have decreased steadily.

The pregnant women with previous Cesarean section face a difficult choice for their next delivery between a trial of labor after Cesarean or repeat caesarean section delivery.

The performance of multiple Cesarean section exposes women to greater risks of complications; furthermore, the risk of complications increases with each subsequent Cesarean section.

In fact, women with previous Cesarean section are more likely to experience short and long-term maternal complications in future pregnancies, or a trial of labor after Cesarean, with the risk of \[uterine dehiscence, uterine rupture, genitourinary tract damage, hemorrhage and hysterectomy, abnormal placentation (placenta previa and placenta accreta) and difficulties during surgery


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant full-term 37-42 weeks.
2. Previous one caesarean section

Exclusion Criteria:

1. Absolute indication of cesarean section in previous and in current pregnancy
2. Pregnant women with Hemoglobin \<9
3. Pregnant women with bleeding tendency
4. Pregnant women with collagen disease
5. Pregnant women with pre-eclampsia and eclampsia
6. Pregnant women with gestational diabetes
7. Multiple pregnancy
Body Composition and White Adipose Tissue Inflammation

The investigators want to find a better way to predict the risk of having fatty tissue inflammation by using a different approach to finding out body fat composition. In this study, the investigators want to estimate the body fat composition using a DEXA scan. DEXA stands for dual energy X-ray absorptiometry. It is the standard and established test to determine bone mineral density (how strong the bones are) to diagnose osteoporosis. This test can also be used to determine the body composition including percent body fat and lean mass. The investigators will compare the participants DEXA scan results for body fat composition to the inflammation found in the breast tissue from the mastectomy to see if there is a relationship. If successful, this may help us predict which patients may be at risk for breast cancer in the future. In addition, the investigators will compare the participants DEXA scan results for body fat composition and inflammation found in the fat tissue from the mastectomy or prostatectomy to the level of exercise activity as measured by a short questionnaire to see if there is a relationship. The investigators will also measure the participants waist to hip ratio.

Finally, at the time the participant has blood drawn for their standard presurgical testing, the investigators will also test the blood for prediabetes using a blood test called hemoglocin A1c. The investigators will also measure for the participants waist to hip ratio, and a Hgb A1c blood drawn will be take at the time of presurgical testing. If not feasible, Hgb A1c can be drawn at a separate visit prior to the DEXA scan. If successful, this may help us predict which patients may be at risk for breast cancer in the future.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Female
* All BMIs
* Patients undergoing mastectomy at MSKCC (i.e. Nipple-sparing mastectomy, skin-sparing mastectomy, simple mastectomy, modified radical mastectomy, radical mastectomy); mastectomy may be either prophylactic or therapeutic. OR
* Patients undergoing hysterectomy at MSKCC
* History of prior breast surgeries/procedures is acceptable

Exclusion Criteria:

* Pregnancy (confirmed or suspected);
* Inability to lay supine on equipment table and maintain the position for the necessary time;
* Weight superior to the maximum allowed by the DEXA machine (over 350 lbs or 158 kg);
* Greater than 10% baseline weight loss in the past year;
* Planned surgical procedure is not a Mastectomy (i.e. breast conservation surgery or other non-mastectomy procedure; such as lumpectomy) or hysterectomy
* Metastatic cancer
* History of Wasting Syndromes or Cachexia
* Use of daily NSAIDs, aspirin, or steroids (other than inhaled or topical) within 30 days of surgery
* Use of neoadjuvant systemic or radiation therapy.
Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia

Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - Pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anaemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with sickle cell anaemia.

Hypothesis : Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly chloroquine in reducing incidence of malaria in children with sickle cell anaemia.

Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces incidence of malaria among high risk group such as children with sickle cell anaemia.

We calculated a sample size of 110 patients in each group for a power of 95% assuming that the incidence of malaria in children receiving weekly chloroquine will be 0.36 and those receiving presumptive treatment with sulfadoxine - pyrimethamine the incidence would be 0.16 according to (schellenberg et al )

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 12 years attending sickle cell clinic in Mulago Hospital during the study period with a negative peripheral smear for parasites, adherence to appointment visits, consent by care takers to participate in the study.

Exclusion Criteria:

* Patients with known allergy to sulfonamides, Patients with severe illnesses requiring urgent admission, Patients with documented treatment for malaria in the past one month with Sulfadoxine- Pyrimethamine. Patients on cotrimoxazole prophylaxis
e-Motivación: Developing and Pilot Testing an App to Improve Latinos' Screening Colonoscopy Rates

Among Latinos, a fast growing and underserved population, Colorectal Cancer (CRC) is the third leading cause of cancer death in men and in women. Compared to non-Latino whites, Latinos are less likely to be diagnosed with localized CRC and more likely to be diagnosed with advanced stage disease. Of the recommended CRC screening tests, a colonoscopy allows for both the detection and removal of precancerous and cancerous polyps. Although screening colonoscopies can detect and prevent CRC, more than half of Latinos have not received a screening colonoscopy within the recommended time frame (one screening colonoscopy per ten years).

The purpose of this study is to develop and begin to test an electronically-delivered motivational interviewing progressive web application (e-MI app), called Motívate. The Motívate app will be offered in both English and Spanish to patients who self-identify as Latino/a/x, after they receive a referral for a screening colonoscopy.

A pilot study will be conducted to begin to examine the efficacy of the Motívate app for improving screening colonoscopy uptake among Latinos. Participants (N=80) will be randomly assigned, stratified for language, to one of two groups: Motívate app (N=40) or general health information video (N=40). The results of the pilot study will inform power calculations for a future randomized clinical trial that will formally test the efficacy of the app. If this program of research proves the Motívate app efficacious there is a strong argument to integrate the app into standard clinical care in order to reduce the overall burden of CRC in the growing and vulnerable Latino community.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified as Latino/a/x;
* English or Spanish-speaking;
* Received a physician referral for a screening colonoscopy;
* Has access to a tablet, smartphone, or computer with working Internet.

Exclusion Criteria:

* Hearing or vision impaired;
* Aim 1 or 2 participant.
Effect of 90% Effective Dose of Metaraminol in Supine and Left Tilt Positions on Cesarean Section

For hypotension after spinal anesthesia, metaraminol has different 90% effective doses in the supine position and the left-tilt position. We plan to conduct a non-inferiority trial to compare the effects of the two on the fetus and the mother.


Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy at term scheduled to be delivered via elective cesarean delivery;
2. height 150-180 cm;
3. American Society of Anesthesiologists (ASA) physical status II-III;
4. body mass index (BMI) \<35 kg/m2.

Exclusion Criteria:

1. transverse presentation, fetal macrosomia;
2. uterine abnormalities (eg, large fibroids, bicornuate uterus);
3. polyhydramnios;
4. ruptured membranes, oligohydramnios;
5. intrauterine growth restriction;
6. gestational or nongestational hypertension, diabetes, or eclampsia;
7. hypertensive disorders or any condition associated with autonomic neuropathy (such as diabetes mellitus for \>10 years) or renal failure;
8. contraindications for combined spinal-epidural anesthesia;
9. participants who declined to sign informed consent forms.
A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers

The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of 528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as the safety of vapendavir will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening;
* Capable of giving written informed consent;
* Subject is able to understand and comply with the protocol requirements, instructions and restrictions;
* Healthy on the basis of physical examination, medical history, medication usage, vital signs (VS), electrocardiograms (ECGs), and clinical laboratory tests;
* Female subjects who are not post-menopausal for at least 2 years or surgically sterile with complete hysterectomy or bilateral oophorectomy and male subjects who are not surgically sterile via vasectomy, must agree to use a double barrier method of birth control, such as a condom plus spermicidal agent (foam/gel/film/cream/suppository); and
* Female subjects must not be breastfeeding or pregnant.

Exclusion Criteria:

* Positive results for Hepatitis B, Hepatitis C, or HIV;
* Frequent use (defined as \> 5 times/day) of tobacco products, including cigarettes, cigars, chewing tobacco;
* A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event;
* Current or recent respiratory infection (defined as within 14 days of first study visit participation)
* Presence or history of significant allergy;
* Clinically significant abnormalities noted on ECG;
* Screening vital signs representing sustained elevated systolic blood pressure \<90 mmHg or \>140 mmHg, and/or diastolic blood pressure \<55 mmHg or \>90 mmHg.
* Presence of significant gastrointestinal abnormalities such as diarrhea or constipation;
* Safety laboratory abnormalities noted at screening which are clinically significant
* Current or defined history of abuse of alcohol or illicit drugs;
* A positive pregnancy test at screening;
* Poor vein access or fear of venipuncture or sight of blood; and
* Regular consumption of alcohol defined as either \> 2 units (glass or shot) of alcoholic beverages per day or \> 14 units per week.
Usage of Dapagliflozin in the Management of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients

This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB) and written informed consent of the patient.

This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. The study would enrol T2DM patients who are/were inadequately controlled (HbA1c \>7%) with existing anti-diabetic medications and who have been prescribed dapagliflozin 3 months prior to study initiation. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice and prescribed dapagliflozin 3 months before will be screened for enrolment in study. Dosage of dapagliflozin and other medications should be as per the routine clinical practice and prescribing information. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients with 18 years and above.
2. Patients who provide written informed consent.
3. Patients with previously diagnosed Type-2 diabetes mellitus
4. Patients with inadequately controlled diabetes (HbA1c \>7%) with existing anti-diabetic medications, prior to initiation of dapagliflozin treatment.
5. Patients who are taking dapagliflozin within last 3 months.

Exclusion Criteria:

1. Patients with Type-1 diabetes mellitus
2. Patients with any medical condition which in the opinion of the investigator would interfere with safe completion of the study
3. Pregnant or lactating women
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).

Subjects will be randomized to treatment in a 2:1 ratio (ferumoxytol: iron sucrose) and stratified by age group (2 to \<6 years; 6 to \<12 years; and 12 to \<18 years). Subjects will receive one of the following treatment regimens:

• Ferumoxytol: 7 mg Fe/kg IV (maximum 510 mg/dose) x 2 doses, the first dose administered on Day 1 and the second 2 to 8 days later.

OR

• Iron sucrose (Venofer®): 4 mg Fe/kg IV (maximum 200 mg/dose) x 5 doses, the first dose on Day 1 and subsequent doses administered at least once per week and up to 3 times/week. All subjects will be monitored at the study site through at least 1 hour after the completion of each infusion of study drug. Assessment of blood Hgb concentrations, adverse events, and other safety assessments will be performed through study Week 5.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 2 years to \<18 years of age at time of consent
2. Has IDA defined as:

   1. Hemoglobin (Hgb) \<11.0 g/dL AND
   2. Any one or more of the following:

      * Transferrin saturation (TSAT) \<20%
      * ferritin \<100 ng/mL
3. Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate

Exclusion Criteria:

1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
2. History of allergy to intravenous (IV) iron
3. History of ≥2 clinically significant drug allergies
4. Subjects with CKD (defined as eGFR of \<60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
5. Low systolic blood pressure (BP) (age 1 to 9 years \<70 + \[age in years x 2\] mmHg, age 10 to 17 years \<90 mmHg)
6. Hgb ≤7.0 g/dL
7. Serum ferritin level \>600 ng/mL
Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19

The objective of this study is to determine the safety, feasibility and efficacy of a bidirectional oxygenation Positive End Expiratory Pressure (PEEP) mouthpiece in coronavirus disease 2019 (COVID-19) patients requiring supplemental oxygen by non-rebreather mask.

Severe cases of COVID-19 often mimic the typical course of Adult Respiratory Distress Syndrome (ARDS) and its predictable sequelae. These patients often require intubation and ventilator support in order to sustain adequate oxygenation. Once a COVID-19 patient is intubated, Positive End Expiratory Pressure (PEEP) is a mainstay of treatment and is used in order to improve lung function, treat underlying atelectasis, improve oxygenation, and improve survival. In fact, early clinical data as well as reports from front line physicians treating COVID-19 suggest that PEEP has been the most effective treatment modality. In many cases, PEEP has resulted in improved oxygenation and improved survival.

PEEP decreases the propensity for the alveoli to collapse by increasing the air pressure in the lungs. This residual pressure in the lungs at the end of exhalation decreases shunting and allows for more complete gas exchange and improved oxygenation. In patients, PEEP is one of the safest ways to increase partial pressure of oxygen (PaO2) and is used on almost all modern ventilator settings.

The GO2 PEEP MOUTHPIECE is a simple, comfortable, and straightforward mouthpiece with a bidirectional valve that effectively delivers PEEP with every breath. Early application of the GO2 PEEP MOUTHPIECE in non-intubated COVID-19 patients may improve outcomes and save lives. Furthermore, this device may allow for less strain on limited resources, especially ventilators. This PEEP mouthpiece could be employed under an oxygen non-rebreather mask to improve oxygenation and avoid intubation.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 positive
* Oxygen saturation \<92%
* Able to provide informed consent
* Receiving oxygen by non-rebreather mask
* Not currently requiring intubation

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Cognitive impairment
* Rapidly decompensating status requiring urgent or emergent higher level of care