cyrilzakka/clinical-trials huggingface dataset:
Sensitivity of Organoids to Predict Treatment Outcome in Breast Cancer Metastases

The aim of the study is to generate patient-derived organoids (PDOs) from brain resection or biopsied extra-cranial metastases. The preliminary data collected will be used to assess the ability of PDOs to predict patients' treatment response and their radio-sensitivity and chemo-sensitivity can be correlated with their survival outcome.

The SOTO-BC trail is an observation study and the patients will continue their clinical visits and follow-up as per normal standard of care.

Patient cohorts:

1. Breast cancer patients with brain metastases undergoing surgical resection with or without further radiotherapy (SRS or whole brain radiotherapy)
2. Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy

Primary objective:

To assess the percentage of successful generated organoids from resected brain or resected/biopsied extra-cranial metastases of breast cancer patients

Secondary objectives:

1. To assess the sensitivity of radiotherapy in PDOs
2. To assess the sensitivity of the same systemic treatments that the patients previously had and will have in PDOs
3. To correlate the treatment sensitivities of PDOs above with the treatment outcome of patients
4. To correlate IC50 doses/dose response curves above with the objective response rates of patients undergoing same systemic treatment

Study Procedures:

Breast cancer patients with resectable brain or extra-cranial metastases or who will undergo a biopsy of the extra-cranial metastases will be asked to consent for this study and for their resected/biopsied samples to be used to generate PDOs. The investigators aim to recruit 20 patients in the pilot phase of the study.

When the PDOs contain sufficient cells, these cells will be treated with increasing doses of radiotherapy and/or relevant systemic treatments in order to determine the IC50 and to obtain dose-response curves of these PDOs to the treatments. The investigators will treat the PDOs with the same treatments that the patients had or will receive in order to correlate the responses to radiotherapy and/or systemic treatments including immunotherapy (co-cultured with immune cells).

The response of these PDOs will be compared to the treatment outcome and survivals in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients with brain metastases who are suitable for surgical resection or Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy
* Age \> 18 years old

Exclusion Criteria:

* Patients unable to give informed consent e.g., mental disability or vulnerable adults
Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects

The objective of this study is to determine the relative gentleness of a new medical tape.

The objective of this study is to determine the relative gentleness of a new medical tape. A three-prong multidimensional evaluation consisting of expert grader, subject discomfort assessment, and laboratory assessments was used. One pre-study visit took place up to 7 days prior to the start of the study. The study was conducted over two days with one tape sample applied and removed. Assessments were taken on the final day. This was to mimic a normal tape application in health care practice.

Eligibility Criteria:
Inclusion Criteria: Subjects will be infants or children of either gender who meet the following criteria:

1. Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema
2. Who are between the ages of 6 months - 4 years of age (48 months)
3. Who have a Fitzpatrick Skin Type of I, II or III
4. Whose parent or legal representative agrees to not use any products (i.e. topical medications, creams, powders or ointments) on the test sites for 24 hours prior to the study start date
5. Whose parent or legal representative agrees to sponge bathe their child during the study but agrees to not bathe their child 1 hour before each visit.
6. Whose parent or legal representative agrees to not soak the tape during a sponge bath. If the site gets wet, parent or legal representative agrees to pat their child's back dry (no rubbing).
7. Whose parent or legal representative is willing to sign the Informed Consent Form (with photo release) and HIPAA Authorization.

Exclusion Criteria:

1. Who are known to be developmentally delayed
2. Who have any known allergy or sensitivity to tapes
3. Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test site
4. Who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study
5. Who have had a strep infection within the 2 weeks prior to the start of the study
6. Who have a history of uncontrolled diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions
7. Has participated in any study in the last 2 weeks, or are currently participating in another study, or are scheduled to participate in another study during this study period.
8. Has any other skin disorders that, in the opinion of the investigator, will interfere with the study results or will increase undue risk for the child.
Prone Position During ECMO in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Hypoxaemic Patient

Introduction:

The main manifestation of COVID-19 pneumonia is acute respiratory distress syndrome (ARDS), which in some cases can be more severe than intubation, extracorporeal membrane venous oxygenation (VV-ECMO) to ensure hematosis. Despite support from VV-ECMO, some patients may remain hypoxemic. One possible therapeutic procedure for these patients is the application of the prone position.

Objective:

The main aim of this study was to investigate the modification of the PaO2/FiO2 ratio, the compliance of the respiratory system in VV-ECMO with refractory hypoxemia. The secondary objective was to evaluate the safety and feasibility of the inclined position for ECMO.

Methods:

the investigators reviewed the electronic records and lists of all 23 COVID-19 patients. were placed for the first time in PP with an average duration of 16 h . patient characteristics, pre-ECMO characteristics, ventilator/ECMO settings, and changes in ventilator/ECMO settings and blood gas analysis before and after PP.

The main objective of the current study was to investigate the change in PaO2/FiO2 ratio, the compliance of the respiratory system in VV-ECMO patients with persistent hypoxemia. Measurements were taken before PP, 1 h after the start of the PP, at the end of the PP cycle.

The secondary objective of this study was to assess the safety and feasibility of emergency positioning for patients with severe ARDS during ECMO treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SARS COV 2 infection complicated by ARDS, and needed a VV ECMO.
* patient who presented refractory hypoxemia during VV ECMO.

Exclusion Criteria:

* patient who has received ECMO V-A or ECMO VV for reasons other than ARDS.
Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

This study will assess if Sitagliptin addition to metformin or glitazone is better than current sulphonylurea based treatments during Ramadan. The rationale is that Sitagliptin offers metabolic advantages primarily with the low incidence of hypoglycemia over current sulphonylurea based treatments.

To define metabolic alterations during Ramadan:

1. Primary end point: Occurrence of hypoglycemia. The patients will record hypoglycaemic episodes in a self-monitoring diary together with blood glucose values.
2. Secondary endpoints: Body weight, fasting blood sugar (FBS), glycosylated haemoglobin (HbA1c)/Fructosamine, triglycerides (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C).
3. A subgroup will undergo CGMS assessment to define glycaemic excursions during and after fasting.

Eligibility Criteria:
Inclusion Criteria:

1. Muslim men and women with Type 2 diabetes.
2. Age 18-78 years
3. Intending to fast during the month of Ramadan
4. On oral antihyperglycemic agents (sulphonylurea based/combination therapy)

Exclusion Criteria:

1. Patient with hypersensitivity or contraindication to Sitagliptin treatment
2. Patient with CKD (creatinine clearance \<50 ml/min)
3. Patients who have participated in another intervention study in the last 2 months
4. Patients who do not give informed consent
5. Pregnant or breast feeding women.
6. Patients on insulin
7. Patients with severe liver disease
Genicular Nerve and Intra-articular Radiofrequency Versus Platelet Rich Plasma Injection for Knee Osteoarthritis

The social impact of degenerative diseases such as articular cartilage pathology and osteoarthritis (OA) is steadily increasing, because of the continued rise in the mean age of the active population. A variety of noninvasive solutions have been proposed for pain treatment, improvement in function and disability, and ultimately, modification of the course of severe cartilage lesions and OA, with variable success rates. Intra articular and genicular nerves radiofrequency (RF) is a minimally invasive technique that usually aims at the neuropathic pain. One important mechanism for the chronic pain mediated by OA is peripheral sensitization, which increases the transmission of pain signals. Through conduction block in pain-transmitting nerve fibers by thermal damage, RF could ease pain without destroying the antennal nerve. The role of growth factors (GFs) in chondral repair is now widely investigated in vitro and in vivo.

Platelet-rich plasma (PRP) is a simple, low cost, and minimally invasive method that allows one to obtain from the blood a natural concentrate of autologous GFs.

The aim of this study is to compare the efficacy of intra articular Platelet Rich Plasma (PRP) injection versus combined ultrasound guided intra articular and genicular nerve pulsed radiofrequency on chronic knee pain in patients with knee osteoarthritis.

The regeneration capacity of cartilage is limited because of its isolation from systemic regulation and its lack of vessels and nerve supply. Osteoarthritis (OA) has a major impact on functioning and independence and ranks among the top 10 causes of disability worldwide

Eligibility Criteria:
Inclusion Criteria:

* Patients experienced unilateral lesion with a history of chronic (≥4 months)
* Pain or swelling of the knee and imaging findings (radiography or magnetic resonance imaging \[MRI\]) of degenerative changes of the joint
* Patients shall to be clinically unresponsive to conservative treatment modalities

Exclusion Criteria:

* Diabetes
* Rheumatic diseases
* Coagulopathies
* Severe cardiovascular diseases
* Infections
* Immunosuppression
* Patients receiving anticoagulants
* Use of non-steroidal anti-inflammatory drugs in the 5 days before blood donation
* Hemoglobin concentration less than 10 g/dl
* Platelet count less than 150,000/cubic mm.
PET-MRI in Diagnosing Patients With Colon or Rectal Cancer

This pilot clinical trial studies positron emission tomography (PET)-magnetic resonance imaging (MRI) and PET-computed tomography (CT) as diagnostic imaging in patients with colon and/or rectal cancer. New diagnostic imaging procedures, such as PET-MRI, may help find and diagnose rectal cancer or recurrence of colorectal cancer

PRIMARY OBJECTIVES:

I. To test the diagnostic performance of PET- MRI in the staging of preoperative high-grade rectal cancer patients, defined by T3 stage or higher or N1 stage or higher or presence of metastasis, that are referred to PET-CT and MRI.

II. To test the diagnostic performance of PET-MRI the follow up of colorectal cancer patients that are referred to PET-CT with or without a diagnostic MRI request by their physicians.

SECONDARY OBJECTIVES:

I. To test different attenuation correction MR sequences and novel diagnostic MR sequences.

OUTLINE:

Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.

Eligibility Criteria:
Inclusion Criteria:

* Either having a T3 (the cancer has grown through the muscularis propria and into the outermost layers of the colon or rectum but not through them) or higher, node positivity or metastatic lesion in the context of rectal cancer or being studied for colorectal cancer follow up, independent of the renal function
* PET-CT should be requested by a referring physician; in the case of having an MR requested as well, it will be reported from the MRI images generated in the PET-MRI
* Stable physical medical conditions to undergo a MRI
* Informed consent must be given and signed prior to study enrollment

Exclusion Criteria:

* Refuse to give and/or sign the informed consent
* Subjects who do not meet the above mentioned inclusion criteria
* Subjects who have a pacemaker
* Subjects who have a metallic prostheses either in the pelvis or in the abdomen that will interfere with the MR imaging of that anatomical area
* Subjects who suffer from claustrophobia
* Pregnant women
* Cognitive impairment that affects the subject's ability to give consent
Scalp Cooling in Gynecologic Cancer Patients

In gynecologic cancers, many common chemotherapy agents can lead to chemotherapy-induced alopecia. Currently scalp cooling is the most well studied preventive measure. However, its acceptability and its impact on patients' QOL in Asian population is unclear.

Dynamic scalp cooling system prevents alopecia by inducing vasoconstriction leading to a reduction of scalp blood flow, thus reducing the delivery of cytotoxic drugs to the hair follicles and reducing follicular metabolic activities. One recent meta-analysis included 10 studies showed that the efficacy was 43% in general.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be at least 18 years old.
2. Patients with primary gynecologic cancers.
3. Patients who are going to receive at least four cycles of chemotherapy that are known to induce alopecia, such as carboplatin, paclitaxel, taxotere, topotecan, etoposide, vincristine and ifosfamide.
4. Patients who are fit to give informed consent.

Exclusion Criteria:

1. Patients who have pre-existing alopecia of CTCAE v5.0 grade 1 or above will be excluded.
2. Patients who have the following conditions will be excluded:

   1. migraine
   2. scalp or brain metastasis
   3. hypothyroidism
   4. uncontrolled diabetes
   5. liver and / or renal derangement (where liver enzymes and / or creatinine are 1.5x more than upper normal limit)
   6. severe untreated anaemia
   7. cold sensitivity
   8. cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
3. Patients who had brain irradiation.
4. Patients who have documented psychiatric disorders will be excluded.
5. Patients who are pregnant.
Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms

Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. This observational study is designed to collect patient-reported outcomes and serial serum samples in order to investigate potential etiologies of this bothersome toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Stage I-III breast cancer who are scheduled to receive endocrine therapy with an aromatase inhibitor
* All prior surgery, chemotherapy, and radiation therapy should be complete or should be completed by the time of AI treatment initiation (within 28 days of study enrollment)
* Age 21 and above and postmenopausal
Biological Rhythms and Vestibular System

The purpose of this study is to study the relationship between the vestibular system and chronobiology

The purpose of this study is to study the relationship between the vestibular system and chronobiology.

Two parts will be performed. In the first one patients with bilateral vestibular areflexia will be compared to control subjects.

In the second the effect of vestibular stimulation on circadian rhythms will be evaluated

Eligibility Criteria:
Inclusion Criteria:

* No treatment changing vigilance/wakefulness
* Moderate caffein uptake (2 to 3 cups a day)
* Moderate smoker (5 cigarettes a day)
* Regular sleeping habits

Exclusion Criteria:

* Sleeping duration \<6 hours or \>9 hours
* Night workers
* Pregnancy
* Sleep or wakefulness disorders
* Progressive neurodegenerative disorders
* Progressive psychiatric disorders
* Thyroid disease
* Type 1 diabetes
* Not able to practice physical activity
* Drug or alcohol addiction during the last 6 months
Colorectal Resection in Emergency General Surgery

Primary anastomosis is associated with higher rates of perioperative morbidity/mortality and that fecal diversion improves overall mortality, decreases length of stay, and lowers rates of surgical complications requiring unplanned operative intervention.

This is a prospective observational study. All patients undergoing colon resection in the urgent/emergent setting meeting our inclusion/exclusion criteria will be enrolled in the study. Data will be collected prospectively and the decision to perform proximal diversion or anastomosis is solely the responsibility of the managing acute care surgeon. No guidelines or protocols will be suggested so as to avoid any influence on practitioner decision-making. The plan is to complete the data collection and analysis by 03/01/2020

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing urgent/emergent colon resection (less than 24 hours after decision to operate) by an acute care surgeon

Exclusion Criteria:

* Elective operations performed by acute care surgeons within 24-hours of the decision to operate (e.g., scheduled resection of non-obstructed, non-perforated malignancy)
* Prisoners
* Pregnancy
* Wards of the state
* Patients less than 18-years of age
* Traumatic mechanisms of injury
* Death within 24-hours of index operation
Role of ARMA in Selective Subset of Refractory GERD Patients.

To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).

Patients coming with symptoms of Gastroesophageal reflux disease (GERD) - A digestive disease in which stomach acid or bile irritates the food pipe lining, will be screened for eligibility and informed written consent will be taken. At initial screening, score based on clinical symptoms i.e. Gastroesophageal Reflux Disease- Quality of Life score (GERD HRQL) \& Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease Questionnaire (FSSG) score will be completed. All patients will undergo esophagogastroscopy (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract). to look for reflux (the backward flow of stomach acid into the tube that connects your throat to your stomach (esophagus)) related changes in the esophagus.

Esophageal high-resolution Manometry (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done to measure the various parameters which help doctor understand your disease.

24-hr pH impedance (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done after stopping anti-secretory medicines (medicines for the long-term treatment of GERD) for atleast three days to assess for esophageal parameters.

All patients will be divided randomly into two arms, ARMA and sham. Those in the ARMA arm will receive ARMA procedure, while patients in the sham arm will receive only upper gastrointestinal endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Normal Upper Gastrointestinal endoscopy And
* 24 hour pH Impedance: AET \< 6%, More than 80 refluxes
* Patients who are willing to give consent for the procedure

Exclusion Criteria:

* Large Hiatal hernia \>3cm
* Lower esophageal sphincter (LES) pressure \>15 mm Hg
* Paraesophageal hernia
* GE flap valve grade IV (Hill's classification)
* Barretts esophagus
* Esophageal dysmotility
* ASA physical status \>II
* Previous esophageal or gastric surgery
* Pregnancy
Engaging Men From Blue-collar Industries in Weight Loss

Objectives\*: Primary Objective: Aim 1: Examine the acceptability of tailored behavioral weight loss program and a standard program in men working in blue-collar occupations.

Aim 2: Compare recruitment approaches that vary on trust-based messaging to recruit men with overweight/obesity who work in blue-collar occupations.

Secondary Objectives: Determine the feasibility of retaining participants to a randomized trial over six months.

Men working in blue-collar occupations have a high prevalence of overweight and obesity and have high rates of comorbidities associated with obesity. Unfortunately, these men are unlikely to participate in evidenced-based weight loss interventions. Further, few efficacious interventions have been developed that target this population for weight control. The purpose of this study is to test the feasibility and acceptability of tailored recruitment messages and a novel, tailored behavioral weight loss intervention in the context of a randomized trial.

Eligibility Criteria:
Inclusion criteria:

1. Age 18 years and older
2. Male
3. Body mass index (BMI) \> 25 kg/m2
4. Employed \>20 hours per week in an occupation classified as blue collar
5. Ability to communicate in English
6. Provision of signed and dated informed consent form

Exclusion criteria:

1. History of bariatric surgery
2. Diabetes managed with insulin
3. Diagnosis of a serious mental illness
4. Conditions contraindicated to exercise independently (determined using four questions of Physical Activity Readiness Questionnaire)
5. Report of potentially hazardous alcohol use (ASSIST \>27)
6. Weight loss in the prior six months of 10 pounds or greater
7. Body mass index ≥60 kg/m2, due to increased injury risk with exercise
8. Diagnosis of an eating disorder
9. Any major medical condition that could increase risk for injury or other contradictions for treatment, or high likelihood of attrition, as determined by the study team
Investigation of Clinical Feature and Brain Function in Narcoleptic Patients

This study evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD

Polysomnographic (PSG) work-up one night to record nocturnal sleep condition in narcolepsy with /without RBD and control subjects including sleep macrostructure, occurrence of sleep onset rapid eye movement period(SOREMP), sleep stages distribution, and sleep arousle and leg movement and apnea hyponea index would be calculated.

Functional magnetic resonance imaging (fMRI) has been used in human to nonivasiverlyn investigate the neural mechanisms. This technique also apply to measures the variations in brain perfusion, structure and morphology in narcolepsy patients by assessing the blood oxygen level-dependent (BOLD) signal diffusion tensor imaging (DTI and voxel-based morphometry(VBM)

This study compare the feature of PSG and fMRI between narcolepsy with RBD, narcolepsy without RBD, control subject to evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD.

Eligibility Criteria:
Inclusion Criteria:

* Narcolepsy meet to the international classification of sleep disorder,3rd edition (ICSD-3) , and RBD meet to the minimal diagnostic criteria according to the international Classification of Sleep, control subjects .

Exclusion Criteria:

History of heart disease History of central nervous system organic psychosis AHI\>15次/h History of alcohol dependence and drug abuse