cyrilzakka/clinical-trials huggingface dataset:
PD-1 Knockout Engineered T Cells for Metastatic Renal Cell Carcinoma.

This study will evaluate the safety of PD-1 knockout engineered T cells in treating metastatic advanced renal cancer. Blood samples will also be collected for research purposes.

This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1 knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Biomarkers and immunological markers are collected and analyzed as well.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically verified stage IV Renal cancer with measurable lesions (On CT: longest diameter of tumoral lesion \>=10 mm, shorted diameter of lymph node \>=15 mm; measurable lesions should not have been irradiated)
* Progressed after all standard treatment
* Performance score: 0-1
* Expected life span: \>= 6 months
* Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy
* Major organs function normally
* Women at pregnant ages should be under contraception
* Willing and able to provide informed consent

Exclusion Criteria:

* Pathology is mixed type
* Emergent treatment of tumor emergency is needed
* Poor vasculature
* Coagulopathy, or ongoing thrombolytics and/or anticoagulation
* Blood-borne infectious disease, e.g. hepatitis B
* History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
* With other immune diseases, or chronic use of immunosuppressants or steroids
* Compliance cannot be expected
* Other conditions requiring exclusion deemed by physician
The Role of Imaging in the Diagnosis of Acute Appendicitis During the COVID-19 Pandemic

This is a retrospective observational study in the form of a cohort study evaluating the use of pre-operative imaging for the diagnosis of acute appendicitis in a tertiary centre during the first and second waves of the COVID-19 pandemic in the United Kingdom. The study group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2020 and February 2021, while the control group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2019 and February 2020. The final histology will be used as primary outcome, as the study hypothesis is that increasing the use of pre-operative imaging will reduce the negative appendicectomy rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages who underwent emergency appendicectomy (either laparoscopic or open) for suspected acute appendicitis
* Patients of all ages who underwent partial ileo-caecectomy or right hemicolectomy for suspected acute appendicitis

Exclusion Criteria:

* Patients who underwent elective interval appendicectomy for a previous appendiceal phlegmon
* Patients who underwent appendicectomy or right hemicolectomy for appendiceal tumours
* Patients who underwent diagnostic laparoscopy for suspected acute appendicitis, where the appendix was not removed
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease

This project is designed as a prospective, randomized, open, controlled clinical trial. For the first time, acupuncture was applied to the treatment of dry ocular neuropathic pain. Its mechanism was discussed by comparing the efficacy between acupuncture and artificial tears.


Eligibility Criteria:
Inclusion Criteria:

* According to the DEWS diagnostic criteria, the OSDI score ≥ 13, with positive signs of dry eye (SIt ≤ 10mm/5min or TBUT ≤ 10s) or CFS positive;
* VAS\>0;
* Signed informed consent.

Exclusion Criteria:

* Patients with dry eye who have had irritants directly irritating the ocular surface in the past 3 days;
* Eyeball infections, allergies, deformities, abnormal movements
* Any history of eye surgery
* Have had eye trauma or fundus laser treatment within 3 months
* Used drugs that affect tear production such as antihistamines, antidepressants, etc. within 30 days
* Suffer from systemic diseases that affect tear production, including Sjogren's syndrome, diabetes, mental illness, malignant tumors, etc.
Multimodal Investigation of Neural Plasticity

This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in cognitively intact older adults (healthy controls, HC) and in those with mild cognitive impairment (MCI).

The goal of this study is to learn important information about the effects of weak electrical stimulation (known as high-definition transcranial direct current stimulation or HD-tDCS) on brain functioning in those with mild cognitive impairment (MCI). The findings will help determine how stimulation affects brain's activity and metabolism (in particular, the neurotransmitter glutamate). Ultimately, this information may help develop new treatments for those with Alzheimer's disease. The study will use different forms of brain imaging to see whether stimulation changes how the brain responds during a memory task. Functional magnetic resonance spectroscopy (fMRS), functional magnetic resonance imaging (fMRI), and functional near-infrared spectroscopy (fNIRS) will be used. The study also uses cognitive tests and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Normal cognition for HC and diagnosis of Mild Cognitive Impairment (MCI) for MCI participants
* Right-handedness
* Magnetic resonance compatible, criteria that also apply for high definition transcranial direct current stimulation (HD-tDCS; e.g., absence of metallic or electronic implants in the upper body or head)

Exclusion Criteria:

* History of other contributing neurological or medical conditions known to affect cognitive functioning
* Significant mental illness
* Sensory impairments that limit ability to participate
* History of alcohol or drug abuse/dependence
Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis

Treatment with PPARgamma ligands have been shown to reduces intestinal inflammation in murine models of colitis. The aim of this study was to evaluate the effect of treatment with local PPARgamma ligand (rosiglitazone) in distal ulcerative colitis.The patients are treated with rosiglitazone enema, once a day, for fourteen days. Disease activity was assessed before and after treatment by endoscopical and clinical activity score.


Eligibility Criteria:
Inclusion Criteria:

* Distal ulcerative colitis (Mayo Clinical Score \> 7)
* Age \> 18 years
* Written consent

Exclusion Criteria:

* Age \< 18 years
* Severe ulcerative colitis
* Systemic treatment with steroids or azathioprin within the last 3 month
* Known liver or kidney disease
* Severe heart failure
* Pregnancy or breast feeding
Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells

Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed cGvHD
* Informed consent obtained from patient and donor.
* Any patient who has undergone allogeneic stem cell transplantation with c GvHD.
* Have not received additional agent for cGVHD within 3 months.
* Expected life is more than 90 days.
* Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
* Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.

Exclusion Criteria:

* Invasive fungal disease.
* Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease).
* Patient is with a history of hypersensitivity to bovine products.
* Relapsed malignancy.
Wound Healing In Diabetes (WHy) Study

This observational study aims to identify risk factors and molecular mechanisms of impaired wound healing, to guide better foot care in the diabetic population.

Diabetes is linked with vascular complications of the eye, kidney and foot. Barbadians suffer from an unusually high prevalence of diabetic foot complications, which can cause difficult-to-heal foot ulcers and even lead to amputations of the toes or feet.Studies from the CDRC have indicated alarmingly high rates of amputation and mortality due to diabetic foot in Barbados. The goal of this study is to improve early detection of persons at risk of the vascular complications of diabetes through non-invasive scanning and genetic susceptibility tests.

The general hypothesis to be tested in this study is that persons with diabetes (PWD) and non-healing foot ulcers are more likely to have a disturbed mechanism for wound-healing than PWD without this particular complication. If the hypothesis is proven correct, this will empower patients and physicians with the diagnostic tests to make early interventions towards avoiding the complications of diabetes.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of diabetes
* Barbadian national
* self reported ethnicity of Black/African descent
* clear knowledge of ulcer history

Exclusion Criteria:

* no clinical diagnosis of diabetes
* non-national of Barbados
* self reported ethnicity not Black/African Descent
* unclear knowledge of ulcer history
Peabody Developmental Motor Scaling In Children With Period Duchenne Muscular Dystrophy

To perform the reliability and validity study of the Peabody Developmental Motor Scale (Peabody Developmental Motor Scales-2) in children with Duchenne Muscular Dystrophy (DMD).


Eligibility Criteria:
Inclusion Criteria:

* for Group I:

  * No neurodevelopmental problems or diseases
  * 3-5 years old
  * Being able to cooperate with the instructions given by the physiotherapist.
  * Children who volunteered to participate in the study and whose families gave consent form will be included in the study.
* for Group II:

  * Being diagnosed with Duchenne Muscular Dystrophy by a pediatric neurologist
  * 3-5 years old
  * Children who volunteered to participate in the study and whose parents' consent was obtained will be included in the study.

Exclusion Criteria:

* Children with a behavioral condition and any disorder that interferes with testing (eg autism spectrum disorder)
* Failure to cooperate with the physiotherapist who made the evaluations.
* Lack of volunteers.
Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842.

A Phase 1, Open Label, Parallel-Cohort, Randomized, Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between PF-04965842 and Fkuvoxamine (cohort 1) or Fluconazole (Cohort 2) in healthy subjects.

A phase 1 study to evaluate the effect of fluvoxamine (a strong CYP2C19 and moderate CYP3A inhibitor) or fluconazole (a strong CYP2C19, moderate CYP2C9 and CYP3A inhibitor) on the pharmacokinetics, safety and tolerability of PF-04965842 in healthy subjects.

This study will be a Phase 1, open label, randomized, fixed-sequence, parallel-cohort study drug-drug interaction study. The study includes 2 periods:

In Period 1: all subjects will receive one single oral dose of 100 mg PF 04965842 tablet. (Treatment A). PK will be evaluated in the first 72 hours post adminstration of PF 04965842.

In Period 2:

* Cohort 1: subjects will receive fluvoxamine (immediate release tablet 50 mg) once daily for 9 consecutive days; on Day 8, subjects will receive a single oral dose of 100 mg PF 04965842 approximately 3 hours after fluvoxamine administration. (Treatment B). PK will be evaluated in the first 72 hours post administration of PF 04965842.
* Cohort 2: subjects will receive fluconazole capsule(s) once daily for 7 consecutive days (400 mg on Day 1 and 200 mg on Day 2-7 in Period 2); on Day 5, subjects will receive a single oral dose of 100 mg PF 04965842 approximately 1 hour after fluconazole administration. (Treatment C). PK will be evaluated in the first 72 hours post administration of PF 04965842.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
* Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
* History of hypersensitivity to or intolerance of fluvoxamine and/or fluconazole.
* Any condition possibly affecting drug absorption.
* A positive urine drug test.
* Screening supine systolic BP \<90 mm Hg or 140 mm Hg following at least 5 minutes of supine rest OR Screening supine diastolic BP \<50 mm Hg or 90 mm Hg following at least 5 minutes of supine rest.
* Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
TXA Study in Major Burn Surgery

Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid (TXA) is a medication that was first introduced in the 1960's as a treatment for heavy menstrual bleeding. Over the past 20 years, it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. Investigators believe tranexamic acid may possibly decrease bleeding related to major burn surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your stay.

In this study, prior to each surgical procedure to treat the participants burn injury, the participant will receive either the drug tranexamic acid or placebo. The placebo is a liquid that looks like the tranexamic acid medicine, but does not have any active ingredient in it. In this study, both the tranexamic acid and the placebo are considered research.

Neither the participant nor the study doctor will choose what treatment the participant gets. The participant will have an equal chance of being given the tranexamic acid or the placebo. Neither the participant nor the study doctor will know which treatment the participant is receiving.

The participant will receive one 1 gram dose of either tranexamic acid or placebo immediately before surgery. The dose of tranexamic acid or placebo will be given in the participants vein over a 10-minute period.

Information from the participants medical record related to their surgery and recovery time in the hospital will be collected by medical staff assisting with this study and recorded on study forms. These study forms will be labeled with the participants study number instead of their name.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing burn excision surgery for standard of care purposes (to include: greater than or equal to 350 cm2 of full thickness or deep partial thickness burns)
* Male or female \> 18 years of age
* Subject or subject's medical decision maker agrees to participate in this study and provides informed consent

Exclusion Criteria:

* Subjects with a history of hypercoagulopathy, deep vein thrombosis (DVT), pulmonary embolism
* Baseline creatinine level greater than 2.83 mg/dL
* Subjects with known hypersensitivity to tranexamic acid
* Patients with acquired defective color vision
* Patients with subarachnoid hemorrhage
* Children
* Pregnant women
* Prisoners
An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer

This study is intended to evaluate the safety, tolerability, and possible effectiveness of an investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related protein (PTHrP) when compared to zoledronic acid in patients with breast cancer metastatic to bone.

The study will also evaluate the possible effects of both study drugs on performance status, markers of bone metabolism, and skeletal events related to bone metastasis including elevated blood calcium levels, bone pain, metastatic lesions, complications and interventions. The levels of CAL in the blood will also be evaluated.


Eligibility Criteria:
Major Inclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you have/are:

* Must be a female at least 18 years of age and be using an effective form of birth control.
* A documented history of breast cancer and at least one bone metastasis that has not been previously treated by radiation or surgery, and is not anticipated to be treated within the next 24 weeks.
* A total body bone scan and other radiographic scan(s) performed on you within 4 weeks prior to or during the screening period sufficient to image all sites of bone metastases.
* You must be willing to perform a daily telephone diary and be willing to keep a paper diary and provide voluntary consent to participate in this study.

Major Exclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you do not have/are not:

* A change in analgesic (pain relief) type medication during the screening period (example, non-narcotic to narcotic).
* Received radiation therapy to any bone metastasis or started a new course of chemotherapy within 3 weeks prior to the screening visit or during the screening period.
* Used any bisphosphonate type drug during the 30 days prior to the anticipated first dose of study drug
* Vertebral spine or weight-bearing bone metastasis that would place you at imminent risk for fracture or surgical intervention.
* Evidence of active infection or immune deficiency, renal failure, abnormal liver function, or a serum calcium level \> 10.1 mg/dL.
* Use of any investigational drug within 30 days prior to screening.
Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections who have failed or are intolerant of rifampin.

Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or intolerant of rifampin.

Rifabutin dosage 150-300 mg daily( depending upon age, and clinical conditions) in NTM patients who fail treatment with rifampin.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 and older with positive acid-fast bacilli smears and cultures for drug-resistant mycobacteria

Exclusion Criteria:

* Children less than 18 years of age
* Pregnancy
* Low platelet count, except with very serious disease
DEI Education in Anesthesiology

To date, there has not been an assessment of ASA members to determine satisfaction with DEI and cultural humility/structural competency education within institutions and programs. We developed a 24-question survey that will be distributed via email to current members of the American Society of Anesthesiologists. Members include learners at all levels - medical students, residents and fellows - as well as attending anesthesiologists, CRNAs, research staff etc. The survey questions are aimed to assess the current state of diversity training in anesthesiology education. This survey serves as a needs assessment and will help gather information on the current state of DEI education within the specialty. The results of the survey will serve as an impetus for improvement in this domain by developing novel educational modules and workshops on these topics, at the institutional level and nationwide.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist Member

Exclusion Criteria:

* Not a member of the American Society of Anesthesiologists
Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men

This research trial studies the incidence of human papilloma virus (HPV) infection and HPV-associated disease in screening Indian men who have sex with human immunodeficiency virus (HIV)-positive men. Gathering health information over time from Indian men who have sex with men (MSM) may help doctors determine how many HIV -positive MSM develop new HPV infections and how many HIV-positive MSM have HPV related disease.

PRIMARY OBJECTIVES:

I. Determine the prevalence of HPV-associated premalignant lesions in the anus and penis in Indian HIV-seropositive men who have sex with men (MSM).

SECONDARY OBJECTIVES:

I. Describe risk factors for prevalent premalignant lesions in the anus and penis in Indian HIV-seropositive MSM.

II. Describe the prevalence and incidence of penile and anal HPV infection in Indian HIV-seropositive MSM.

OUTLINE:

Participants receive a questionnaire and undergo a targeted physical and anal clinical exam at months 0, 6, and 12. Participants also undergo a penile skin cell and anal swab at months 0, 6, and 12 for cytology, HPV deoxyribonucleic acid (DNA), and CD4+ T-cell count at months 0 and 6 and HIV viral load testing at months 0 and 12. Participants also undergo high-resolution anoscopy (HRA) and penile clinical exam at month 12.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive, as documented by any licensed HIV test according to the Indian National acquired immune deficiency syndrome (AIDS) Control Organization (NACO) guidelines
* Participants report any sex with a man in the past 6 months
* Participants must speak Hindi, Marathi, or English
* Participants should not have any plans to move out of the area in the next 12 months and commit to attending two additional visits one at 6 months and one at 12 months

Exclusion Criteria:

* Active drug or alcohol use or dependence, or other impairment that, in the opinion of the site investigator, would interfere with adherence to study requirements

  * Participants with impairments that, in the opinion of the site investigator, are temporary, will be asked to return another day for enrollment
* Inability to provide informed consent
* History of a sex change operation that would preclude collection of penile or scrotal specimens
Weight Change in PWS Over Six Months

This is a completely text-messaging based study and all data will be collected via surveys administered on a mobile phone. For this study, we will gather and analyze data on changes in body weight over a 6-month interval in individuals aged 12 and over. This will help us learn more about the normal variation in weight, over time, in the PWS population.

The incidence and natural history of several PWS symptoms are poorly defined. In this text-messaging based study we will gather and analyze data on changes in body weight over a 6-month interval, in individuals aged 12 and over. We would like to learn about the normal weight variation in the PWS population.

We anticipate that this study will inform future clinical trials for hyperphagia/obesity related therapies, and provide a basis for understanding how well potential therapies are working. For this study, there will be no intervention and the all data will be collected via texting.

Eligibility Criteria:
Inclusion Criteria:

Participants with PWS are eligible for this study. Eligible PWS participants must be 12 years and older. Participant/legal representative of participant must have a text messaging enabled mobile phone in order to participate in the study Participants must reside in the U.S. or Canada

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Exclusion Criteria: