cyrilzakka/clinical-trials huggingface dataset:
Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO

To determine whether short-term pre-operative nivolumab either as monotherapy or in combination with low dose doxorubicin or novel IO combinations can induce immune activation in early BC.

The investigators aim to test the activity of nivolumab monotherapy in primary breast tumors in a pre-operative window of opportunity trial. As the data of the investigators generated in the TONIC trial (metastatic TNBC) indicate that low dose doxorubicin may 'prime' the tumor microenvironment (TME) resulting in higher response rates on nivolumab, in addition, cohorts for treatment with nivolumab plus low dose doxorubicin will be opened. Given the emerging data on other immunomodulatory strategies, this platform study allows opening additional cohorts for promising novel immune-oncology (IO) drugs for which a strong efficacy signal has been seen without drug safety issues. The investigators will study the TME and systemic host factors with specific emphasis on immunosuppressive processes that can potentially be targeted by novel IO agents to further optimize BC immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* 18 years or older at moment of inclusion;
* Female gender;
* WHO performance status 0 or 1;
* Resectable primary breast cancer stage I-III. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.
* The tumors must be:

  * at least 10 mm (minimum cT1c) as determined by MRI
  * TNBC defined as ER\<10%, HER2-negative OR luminal B defined as ER≥10%, HER2-negative with either Ki67≥20% or PR =\<20% OR grade 3. HER2 negative is defined as an IHC score of \<2 or 2+ with a negative ISH.
  * For TNBC patients: TIL≥5%
  * For LumB breast cancer patients: TIL≥1%
  * For cohort 3B: N0 status, TN and TIL ≥50%
  * For cohort 4B: N0 status, TNBC and TIL 30-49%
  * For cohort 5B: N0 status, TNBC and TIL ≥50% ● Patients with multifocal/multicentric breast cancer are eligible if triple negative breast cancer histology as well as sufficient TIL percentages (30-49% in cohort 4B, ≥50% in cohort 5B) have been confirmed in all tumor lesions.

Exclusion Criteria:

* evidence or suspicion of metastatic disease. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures;
* evidence of a concurrent contralateral or ipsilateral second primary infiltrating breast cancer. Evaluation of the presence of a concurrent second primary breast cancer may include mammography, breast ultrasound and/or MRI breast;
* other malignancy except carcinoma in situ and basal-cell and squamous carcinoma of the skin, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiotherapy
* previous radiation therapy or chemotherapy;
* prior treatment with checkpoint inhibitors (including anti- PD1, -PD-L1, -CTLA-4);
* concurrent anti-cancer treatment, neoadjuvant therapy or another investigational drug;
Exploratory Study Providing Telepsychiatry in the Home With a Clinician Present

Telemedicine can expand access to behavioral health services for people who have difficulty traveling to clinics. Travel can be especially challenging for older adults with mobility issues or access to reliable transportation. Assessment in the home can uncover factors impacting patient's physical and behavioral health. The goals of this project to document benefits and barriers to expanding reimbursement for telemedicine to older patient's home as the originating site.

The goal of this project is to document the benefits and barriers to expanding reimbursement for telemedicine to older patient's home as the originating site. The objectives are:

* Develop training module for midlevel clinicians to be ready for dissemination
* Improved patient outcomes measures on satisfaction with care; functioning and symptoms (anxiety, depression, traumatic stress, sleep apnea, alcohol use and problems)
* Reductions in emergency healthcare utilization and medications prescribed as obtained from electronic health record (EHR) at the Federally Qualified Health Center (FQHC) and self-reports
* Summarize activities and barriers, including communication with primary care provider, identification and improvement of home environmental risks, and assistance to support system

This is an observational study of team-based telepsychiatry in the home for one group and team-based psychiatry in the clinic for the comparison group. The initial assessment will include information and informed consent for treatment, biopsychosocial assessment, summary for the psychiatrist, psychiatric evaluation and recommendations (all standard of care). To that the investigators are adding informed consent for program evaluation with 6 month follow-up with information for re-contacting (3 sources, addresses, email-telephone numbers), and brief administration of selected instruments before informed consent for treatment. If an eligible patient does not want to participate in the research study, the patient would still receive services.

Additional telemedicine sessions and/or therapy sessions will be conducted as medically needed in accordance with quality care. At six months (with one month window on either side) the evaluation packet will be re-administered by the clinician if convenient or by the research assistant either in person or by phone.

The sample size was selected to provide robust indicators of barriers to home based assessments. The comparison group was included to provide a context for the findings. It is anticipated that the home group will have greater problems at baseline than the clinic based comparison group but both will show improvements.

Eligibility Criteria:
Inclusion Criteria:

* patient at FQHC
* referred for psychiatric services
* 50 or older

Exclusion Criteria:

* does not speak English
Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population

To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek interest in participating in future studies.

This is a Registry where there will be no intervention to the standard of care.Participants will be required to attend a single visit that will involve having a multi-parametric MRI at no cost to them. In addition, the invesigators will collect contact information of participants including their email address, phone number and house address so that they can be contacted to discuss possible participation in future studies which may be sponsored by Perspectum or third parties, such as pharmaceutical companies, the participants personal information shall never be shared with these third-parties. Additionally, the contact information of the participants medical providers shall be collected so that, if requested, their LMS reports can be used in their diagnostic pathway.

Imaging will be performed at two Touchstone Imaging locations, one in downtown Dallas and the other in Southlake.

A total of 100 participants will be enrolled over a period of 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers aged 18 years and over•
* Participant willing and able to give informed consent for participation in the registry.

Exclusion Criteria:

* The participant may not enter the Registry if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria at the imaging center including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
CivaDerm(TM) Surface Therapy Pilot Study

This is a pilot study to determine the usefulness of new brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit basal cell and squamous cell carcinoma patients by providing conformal radiation therapy to the surface of the skin.


Eligibility Criteria:
Inclusion Criteria:

* subject signed informed consent
* Confirmed superficial or nodular basal cell or squamous cell carcinoma
* Biopsy proven on chest, stomach, back, arms, legs, feet (trunk and extremities)
* \>5 mm of residual tumor
* tumors \< 3 cm
* Capable of complying with Patient Release Instructions

Exclusion Criteria:

* Is unable or unwilling to comply with the protocol requirements
* Pregnant or breast feeding
* Metastases
Intraoperative Dialysis in Liver Transplantation

Patient with liver failure waiting for liver transplantation are often hospitalized and commonly supported in an intensive care unit prior to surgery. These patients are sick, and in addition to the complications of a failing liver, other organs such as the kidneys often fail as well. As a consequence, these patients are at an increased risk for complications related to their kidney failure during their liver transplantation procedure. One potential method to diminish the risk of these complications is to provide dialysis support to these patients during their liver transplantation in the operating theater in the form of continuous renal replacement therapy (CRRT). While this is increasingly being performed and is theoretically appealing, there is very little information to support this practice. In addition, the use of CRRT during surgery is not entirely without risk. The investigators have performed two preliminary studies on the use of CRRT during liver transplantation and our data would strongly support the need to conduct further higher-quality studies to better evaluate its feasibility, safety and usefulness. Our proposed study is for a randomized trial comparing the use of CRRT during surgery with standard supportive care in sick patients with liver failure scheduled to receive a liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Consent
* Adult (age \> 18 years on the day of assessment of eligibility)
* Planned cadaveric orthotopic liver transplantation
* Pre-operative unadjusted (natural) Modification of End-Stage Liver Disease (MELD) score \> 25.
* Pre-operative AKI, defined by a minimum RIFLE-RISK, AND/OR pre-operative estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2, calculated by the Modification of Diet in Renal Disease (MDRD) equation.

Exclusion Criteria:

* Planned living-related donor liver transplantation
* Pre-operative potassium \[K\] \> 4.5 mmol/L AND urine output \< 100 mL in the 6 hrs preceding assessment of eligibility
* Pre-operative pH \< 7.3
Protocol for Women at Increased Risk of Developing Breast Cancer

To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.

A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.

Eligibility Criteria:
Inclusion Criteria:

* women who have a high risk of breast cancer
* older than 18 years

Exclusion Criteria:

* anticoagulants
* marked breast tenderness
* pregnant or within twelve months of breast feeding/childbirth
Relation Between Muscle Mass, Total Body Fat, Visceral Fat, Waist Hip Ratio and Sleeping Hours in Patient With Nonspecific Back Pain

Objective: To find out if there are a relation between muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours in patient with nonspecific back pain.

Design: Cross sectional study. Subjects: 30 male and female patients with age ranged from 25 to 40 years old diagnosed as nonspecific low back pain will participate in this study.

Main measures: the Outcome measures will be including the assessment of muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours.

Results: The results will be analyzed via co relation test.

Objective: To find out if there are a relation between muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours in patient with nonspecific back pain.

methods:

* tatinia bioelectric impedance device used for measurement of muscle mass total body fat and visceral fat
* waist hip ratio measured by tape measurement The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement (W⁄H).

participants 30 male and female patient will participate in this study

Eligibility Criteria:
Inclusion Criteria:

* •adulthood with low back pain

  * Their ages will range from 20-40 years old.
  * All of them suffer from mild to moderate degree of low back pain.
  * The subjects complain from low back pain for 1 month ago

Exclusion criteria:

Exclusion criteria were a history of any of the following condition:

* inflammatory diseases or any rheumatic disorders,
* a history of vertebral fractures
* surgical spinal fixation.
* •any neurological disorders like MS
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF10073 After Single and Multiple Doses in Healthy Volunteers

The objective of this study is to assess the safety and tolerability of single ascending doses of inhaled CHF10073 (Part 1 of the study) and multiple ascending doses of CHF10073 (Part 2 of the study). The study will also evaluate the PK profile of study drug in plasma and urine after single and repeated administrations of CHF10073.

In addition, this study will also investigate the metabolites profile of CHF10073 in plasma, urine and faeces (Part 2 of the study) and the PK profile of CHF10073 in the lungs after bronchoalveolar lavage (BAL) (Part 3 of the study).


Eligibility Criteria:
Inclusion Criteria:

* Subject's written informed consent;
* Healthy males aged 18-55 years;
* Understanding of the study procedures and the correct use of the inhalers;
* BMI between 18.5 and 30.0 kg/m2;
* Non- or ex-smokers (\<5 pack-years and stopped smoking \>1 year prior to screening);
* Good physical and mental status;
* Vital signs within normal limits; body temperature \<37.5°C;
* 12-lead digitised ECG in triplicate considered as normal;
* Lung function measurements within normal limits;
* Males with pregnant or non-pregnant WOCBP partners must be willing to use contraception

Exclusion Criteria:

* Recent participation in another clinical trial;
* Clinically significant abnormal 24h Holter ECG (Part 1 and 2);
* Clinically relevant and uncontrolled medical disorders ;
* Subjects with history of respiratory diseases ;
* Presence of any current or recent infection;
* Clinically relevant abnormal laboratory values;
* Abnormal liver enzymes;
* Positive results from the Hepatitis serology results;
* Positive HIV-1 or HIV-2 serology results ;
* Recent blood donation or blood loss (≥450 mL) ;
* Heavy caffeine drinker ;
* Recent use of any kind of electronic smoking devices;
* Documented history of alcohol abuse within 12 months prior to screening ;
* Documented history of drug abuse within 12 months prior to screening ;
* Intake of non-permitted concomitant medications ;
* Known intolerance and/or hypersensitivity to any of the study excipients ;
* Unsuitable veins for repeated venipuncture;
* Part 3 only: contraindication to the BAL procedure;
* Part 3 only: recent lower respiratory tract infections
Complications of High Frequency Jet Ventilation

High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. However, complications occuring during the use of HFJV are poorly known. In this retrospective cohort study, the charts of all patients who had a bronchoscopy with the use of HFJV between 2019 and 2023 in our hospital will be analyzed. Primary outcome will the description of all complications during HFJV. Complications are defined as:

* Hypoxia: SpO2 \< 90% for 1 min
* Severe hypoxia: SpO2 \< 85% for 1 min
* Hemodynamic instability, defined as Arterial pressure \< 90/60
* Cardiac arrhythmia
* Laryngospasm or bronchospasm
* Barotrauma or volutrauma
* Need for ICU admission

A model predicting the risk for developing any complication will be developped using 2 mathematical methods:

* a multivariate analysis
* a data mining approach

For both approaches, the following variables will be included in the model:

* Age
* Gender
* Weight
* Height
* BMI
* Smoking
* Alcohol consumption
* Consumption of Other drugs
* ASA class
* Obstructive pulmonary disease
* Restrictive lung disease
* COPD status (1, 2, 3, 4)
* Interstitial lung disease
* Lung tumor

  * Trachea location
  * Carina location
  * Bronchial location
* Pulmonary or tracheal stenosis
* Presence of stridor
* Severe stenosis (\< 6 mm)
* Baseline SpO2 (pre-intervention)
* Pre-intervention oxygen requirement Procedure
* Duration (min)
* Stent placement
* Dilation
* Laser treatment
* Length of hospital stay Lung function tests
* FEV1 (forced expiratory volume)
* VC (Vital Capacity)
* FEV1/VC (Tiffeneau ratio)
* CPT (total lung capacity)
* DLCO (carbon monoxide diffusion)


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent a bronchoscopy with the use of high frequency jet ventilation between January 1st, 2019 and December 31st, 2023 at Erasme University Hospital, Brussels

Exclusion Criteria:

* Incomplete medical chart
* Patient who expressed their opposition to the use of their medical data
Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata

This is a single center, randomized, investigator-masked study to determine the efficacy and safety of latanoprost and bimatoprost ophthalmic solutions in promoting eyelash growth in patients who have lost their eyelashes due to alopecia areata. These medications are FDA-approved as eyedrops for patients with glaucoma who have been noted to grow longer, darker, and thicker eyelashes with their use. In this study, patients will be asked to apply these solutions to the affected eyelid margins of one eye with a sterile cotton-tipped applicator once a day.

This is a pilot, single-center, randomized, investigator-masked study to evaluate the efficacy and safety of latanoprost (Xalatan) ophthalmic solution compared to bimatoprost (Lumigan) ophthalmic solution in patients with eyelash loss due to alopecia areata. This is a collaborative study between the Departments of Dermatology and Ophthalmology at UCSF. Patients will be randomized to receive either latanoprost or bimatoprost. Patients will be instructed to apply latanoprost or bimatoprost to the affected eyelid margins of one eye using a sterile cotton-tipped applicator once a day (similar to the application of eyeliner). The untreated eye will serve as a control. When substantial eyelash growth is noted in the treated eye, patients will be instructed to decrease application to once a week. Patients will be seen every four weeks in the Department of Dermatology. In addition, eyelash growth will be assessed in the Beckman Vision Center where eyelash length will be measured, and photographs will be taken at baseline, 2 months, and 4 months. Intraocular pressure will be documented at baseline and at each visit to the Beckman Vision Center. The study will be conducted over four months.

Eligibility Criteria:
Inclusion Criteria:

* Males and females in good general health, ages 18-70.
* Patients with alopecia areata who have had 50% or more eyelash loss for 6 months or longer.

Exclusion Criteria:

* Any pre-existing eye disorder that would preclude use of a topical agent around the eyes (e.g. infection, inflammation, recent surgery.)
* Subjects with limited close vision who cannot see their eyelid margin clearly.
* Immunosuppressed state.
* Women who are pregnant or who are trying to become pregnant, or are breast-feeding.
* Patients with known allergy to latanoprost or bimatoprost, other prostaglandin F-2a or related drugs, or to benzalkonium.
* Unable to read or follow instructions.
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes

This trial is conducted in the United States of America (USA). The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects older than 35 years old will be considered
* Gestational diabetes mellitus
A Prospective Study of the Disease Characteristics of Adult Patients With Long Chain Fatty Acid Oxidation Disorders

The purpose of the study is to collect information on disease characteristics from adult patients diagnosed with fatty acid oxidation disorders (FAOD).

In this study there will be no drug intervention. The study will include a Baseline visit and a follow up visit scheduled at Month 4. At these visits medical history, safety assessments, concomitant medications, exercise tests and quality of life questionnaire data will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. A genetically confirmed diagnosis of one of the following:

   1. Carnitine palmitoyltransferase 2 deficiency
   2. Very long-chain Acyl-CoA dehydrogenase deficiency
   3. Long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency
   4. Trifunctional protein deficiency
2. A stable treatment regimen for at least 30 days
3. Ambulatory and able to perform the study exercise test, using walking aids if necessary
4. Willing and able to personally sign and date an informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

1. Unstable or poorly controlled disease as determined by one or more of the following:

   1. Presence of symptoms of acute rhabdomyolysis with clinically significant elevations in serum CK
   2. Evidence of acute crisis from their underlying disease
2. Currently taking a PPAR agonist
3. Have motor abnormalities other than those related to the fatty acid oxidation disorder that could interfere with the study procedures, as determine by the investigator
4. Evidence of significant concomitant medical or psychiatric disease that in the opinion of the Investigator may interfere with the conduct or safety of this study
5. Pregnant or nursing females