cyrilzakka/clinical-trials huggingface dataset:
Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies

Background:

- Gene therapy is a way to treat or prevent disease using genes. It is monitored very closely by regulators because there can be long-term, unexpected side effects. NIH is required to try to contact people who have been treated with gene therapy at least annually for up to 15 years. This is to see if they have had any bad side effects. This trial does not include any therapy and is only for patients previously treated on gene-therapy trials at the NCI Surgery Branch who are no longer enrolled on their original gene therapy clinical trial.

Objective:

- To collect of long-term follow-up data on people who have been in gene transfer studies. This follow-up is required by regulators.

Eligibility:

- People age 18 and older who have been in a previous NCI Surgery Branch gene therapy research study.

Design:

* After they get the genetically modified cells, participants will:
* Have blood drawn 3, 6, and 12 months later.
* Have an annual clinic visit for the next 4 years. They will have a physical exam. They will answer questions about any signs of neurological, autoimmune, or blood disorders, or any new cancers. Blood may be drawn.
* Be called or emailed annually for the next 10 years. They will answer health questions. Blood samples may need to be taken.
* Participants will be asked for their current address and phone number. They will also be asked for the address and phone number of 1 or 2 people who will know their whereabouts. One of these should be a family member if possible,
* At the time of the participant s death, researchers will request permission from their family for an autopsy.

Background:

-The National Cancer Institute Surgery Branch (NCI-SB) Branch investigator conducts clinical trials utilizing gene transfer. The current U.S. Food and Drug Administration (FDA) requirements for long term follow up may be up to fifteen years for some products. As this time period is frequently longer than studies are expected to be open, a long-term follow-up protocol is necessary to ensure the follow up of these subjects

Objectives:

-To facilitate collection of long term, follow up information on subjects who have participated in gene transfer studies as required by the U.S. Food and Drug Administration and other regulatory groups

Eligibility:

-Enrollment on a CAR T-cell treatment protocol for gene therapy.

Design:

-Patients will undergo physical exams; laboratory evaluation or phone follow up as required by the treatment protocol and/or as clinically indicated.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Subjects who have received treatment on a CAR T-cell gene therapy protocol. Age \>= 18 years as children are generally excluded from CAR T-cell gene therapy studies.
The Effects of Ozone Therapy on Wound Healing

the aim of present study was to evaluate effects of ozone therapy on wound healing after gingivectomy and gingivoplasty operations as a model of secondary wound healing.. Twenty three systemically healthy individuals participated in this study. Ozone was applied immediately after surgery, at 1st day and 3rd day after gingivectomy surgery. In the photographs of the wounds, the difference in color were evaluated and measurements were performed at the baseline, 3rd, 7th, 14th days after surgery.

Although ozone therapy has often been tried in medical science and has become more popular due to its antimicrobial, biocompatibility and healing properties, the effects of ozone therapy on surgeries that heals with secondary intention were not studied. In the lights of these informations, the aim of present study was to evaluate effects of ozone therapy on wound healing after gingivectomy and gingivoplasty operations as a model of secondary wound healing. Twenty three systemically healthy individuals participated in this study. All periodontal examinations were performed by one experienced examiner and non-surgical periodontal treatment of the patients were performed within two weeks after initial examination by the same clinician.Gingivectomy and gingivoplasty operations were performed by another examiner who was unaware of the study protocol.After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients. Ozone therapy was also performed by an experienced periodontist. As placebo application, left quadrants received regular air from the ozone generator.Postoperative pain was assessed at 3rd, 7th, 14th days after surgery with a visual analog scale At baseline and 3rd, 7th, 14th days after surgery, surgical area was disclosed by a plaque disclosing solution to visualize the epithelization degree of the surgical areas. Solution provided a clear vision to distinguish normal gingiva from the areas in which the gingival epithelium is absent, abraded or lacking sufficient keratinization. In order to evaluate epithelization degree of the wounds, standardized photographs were taken from each patient.In the photographs of the wounds, the difference in color were evaluated and darkly stained areas were considered as lack of enough epithelization. These measurements were performed at the baseline, 3rd, 7th, 14th days after surgery. The determinations were done by a calibrated examiner who was blind to test and control sites

Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 years of age
* systemically healthy
* non-smokers
* no medications taken for 6 months
* no pregnancy and lactation
* no contraindications for periodontal surgery
* no gingivectomy or mucogingival surgical history in the lower incisor region.

Exclusion Criteria:

* \<18 and \> 35 years of age
* systemical disease
* smoking and alcohol consumption
* medications taken for 6 months
* pregnancy and lactation
* contraindications for periodontal surgery
* gingivectomy or mucogingival surgical history in the lower incisor region.
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC); tissue (slides or blocks) available for HER2 confirmation.
* History of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer.
* At least 1, and no more than 3, chemotherapy regimens for MBC.
* Granulocyte count ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL.
* Serum bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5x the upper limit of normal (ULN).
* Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

* Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological therapy for the treatment of breast cancer within 2 weeks of the first study treatment.
* Prior cumulative doxorubicin dose \> 360 mg/m\^2 or the equivalent.
* History of significant cardiac disease, unstable angina, congestive heart failure (CHF), myocardial infarction, or ventricular arrythmia requiring medication.
Measuring Protein Requirement Using Amino Acid Oxidation in Strength and Endurance Athletes

Our objective is to determine the dietary requirement of protein for strength and endurance exercise trained (more than 4 months training experience) individuals between 18 - 30 years of age using the indicator amino acid oxidation (IAO) method. This study will be the first to determine the required quantity of protein need per day in strength- and endurance trained young adults using the IAO method.

The adequacy of the protein dietary requirement for strength (ST) and endurance (ET) exercise trained individuals has been a subject of considerable debate for many years and, at present, there is a discrepancy between those who establish dietary protein requirements for healthy adults and those issuing guidelines for athletes. Despite past nitrogen balance studies suggesting a greater protein requirement in ST and ET athletes, the Institute of Medicine (2005) recommends "no additional dietary protein for healthy adults undertaking resistance or endurance exercise". Current protein and amino acid (AA) requirement estimates for adults are based on nitrogen balance data which are considered to be flawed due to several methodological problems including the use of single linear regression for analyzing nonlinear data and an over/underestimation of nitrogen intake and excretion, respectively. To overcome these problems, the indicator amino acid oxidation technique (IAO) was developed for determination of dietary AA or protein requirements. The IAO method is based on the concept that when dietary protein is inadequate, all AA, including the indicator AA, will be oxidized. With increasing total protein intake, oxidation of the indicator AA will decrease. Once the requirement is met, there is no further change in the oxidation of the indicator AA and the inflection or 'breakpoint' is the estimated requirement. A mixed-effects change-point regression analysis to F13CO2 (label tracer oxidation in 13CO2 breath) in response to graded amounts of protein will be utilized to over come the limitations of linear regression previously used with nitrogen balance. These protein requirement measures using the IAO has not been carried out on ST or ET individuals previously so this will be the first study to do so. The results of this study will help determine the optimal protein requirement in ST and ET athletes which is important not only for athletes but also for older individuals whose loss of muscle mass has been linked to a variety of health concerns.

Eligibility Criteria:
Inclusion Criteria:

Healthy strength-trained and endurance-trained (more than 3 months training experience, at least 3x week) individuals (18-30 years old).

Exclusion Criteria:

* Unhealthy,
* sedentary individuals,
* those who are taking medication,
* those outside the age range, or
* those who have milk allergies
Remote Presence Timely Discharge Management

The purpose of this study is to integrate Remote Presence technology in order to increase the number of timely patient discharges before 11 am from the medical center.

Reduction in beds coupled with the increased need for health care services has led to a supply and demand struggle or capacity management challenge for health care facilities. This is now recognized as a major public health issue. The impact is readily seen as overcrowding in emergency departments. At present 76% of hospitals' emergency departments (ETDs) are at or over capacity with 33% reporting ambulance diversions, the most common sign of overcapacity within a health care facility. Compounding the physical capacity problem is the "human capacity strain" as admitted patients remain in the ETD for prolonged periods waiting for beds. Delayed admission to patient care units significantly strains the financial resources, impedes "patient flow" ultimately impacting the quality of care, patient satisfaction and the "bottom line." Discharge before 11 am optimizes the availability of hospital beds to meet admission demands thereby avoiding a surge over capacity or "patient back log", ambulance diversions in ETD; the post anesthesia recovery unit, admissions office and critical care units. Conversely competing needs for the attending physician's physical presence off of the hospital premises; off of the unit (private practice and meetings) often delays patient discharge from before 11 am to the afternoon and evening.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Primary care physicians in internal medicine
* Primary care physicians/practice group with established discharge pattern after 11 am
* Primary care physicians/practice group with fast access digital subscriber line (DSL) 300 kilobytes per second
* Primary care physicians/practice group who have Hackensack Medical Center (HUMC) intranet access from pre-determined location

Exclusion Criteria:

* Non-English speaking patients
* Patients requiring acute level of care on the day of discharge
A Study to Evaluate the Safety and Effectiveness of the 217z Laser With Zyoptix for Lasik

A Study to demonstrate the safety and efficacy of wavefront laser refractive surgery treatments for myopia and astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* Myopia with or without astigmatism.

Exclusion Criteria:

* Contraindications to LASIK.
STING MARK Universal Fiducial Marker System

Currently available fiducial marker and fiducial insertion strategies are rudimentary, imprecise, not compatible with multiple insertion catheters/needles and are overall unreliable. STING-MARK device is the first universal, fully detachable and non-premounted radiopaque fiducial device system. Allowing biopsy prior to insertion, STING-MARK is easily and reliably delivered through-the-needle to the tumor, in order to accurately pinpoint its location for image-guided therapies. This study aims at establishing proof of concept for STING-MARK, by demonstrating its usability, reproducibility, radio-opacity and retention in a variety of clinically-relevant ex vivo organ samples.

Patients undergoing surgical resection of solid organs at the CHUM or recipients of solid organ transplantation will be approached for consent into the study protocol. Human solid organs that are being removed for either elective surgery or transplantation will be removed in the standard manner and sent to the pathology laboratory as in the typical situation following removal. After the pathology team finishes with the organ, excess organ will be given to the research team for experimentation. In cases of recipient organs being removed for transplantation, they will be preserved in a plastic bag and then placed in the refrigerator. All experimentation will take place in the CRCHUM TID lab or Room 13 of the CHUM operating room.

Device insertion will occur with the designated needles and through the appropriate organ-specific route and imaging guidance. Multiple STING-MARK fiducials will be inserted. Plain film x-rays in 3 planes of the organs with the marker inserted will be taken and recorded.

Following experimentation, the organs will be appropriately labelled and returned to the pathology laboratory at the CHUM.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgical resection of solid organs
* Recipients of solid organ transplantation

Exclusion Criteria:

* None
Pulse Oximeter and Respiratory Rate Test

Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia Assessment of Spry Health's Respiratory rate accuracy in normal conditions and profound hypoxia


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult willing to participate

Exclusion Criteria:

* Wrist size outside the indicated use
* Low perfusion
* Smoking
Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost

The purpose of this study is to compare the safety and IOP-lowering efficacy of various low dose travoprost formulations in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Age related
* Other protocol-defined exclusion criteria may apply
Systematized Quality Exercise Alternatives for Stress Incontinence

This randomized controlled study evaluates the effect of home biofeedback compared to pelvic floor physical therapy for the treatment of stress urinary incontinence. Half of the participants will use a home biofeedback device for 3 months and the other half will attend pelvic floor physical therapy appointments for 3 months.

Biofeedback has been shown to be highly effective the treatment of stress urinary incontinence when used in conjunction with pelvic floor physical therapy under the instruction of a healthcare provider. Home biofeedback has not been well studied, even though several FDA cleared devices are on the market and available for patients to purchase. It is unclear if the biofeedback improves women's urinary incontinence, or if the increased contact with a healthcare provider causes the improvement.

Using a home biofeedback device, a woman places the device in her vagina and contracts the muscles of her pelvic floor to improve the strength, which can improve or cure incontinence when performed over time. Typically it takes 3 months for benefit to be seen.

Eligibility Criteria:
Inclusion Criteria:

* Female Subjects \>18 years of age
* SUI or Mixed UI with stress predominant symptoms and more bother by the SUI
* English speaking/reading
* Own a smartphone that can support phone application and Bluetooth for the biofeedback device
* Willing to come for 4 PFPT visits over 3 months if randomized

Exclusion Criteria:

* Prior anti-incontinence surgery
* Had prior pelvic floor physical therapy for SUI
* Prolapse of any compartment noted below the hymen
* Inability to speak/understand English
* Pregnant
* Decline or unable to return for frequent PT visits during study period
* Unable to be contacted for follow up by telephone
* Neurologic disorders known to cause neurogenic bladder
Exploratory Study on Dosage of Qizhi Weitong Granules in the Treatment of Irritable Bowel Syndrome （IBS)

The purpose of this study are as follows: 1) To evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of diarrhea-type irritable bowel syndrome (IBS-D);2) To explore the dosage of Qizhi Weitong Granulesin treatment of IBS-D.


Eligibility Criteria:
Inclusion Criteria:

* In line with the diagnostic criteria of WESTERN medicine IBS-D;
* Aged 18-65 (including 18 and 65 years old) years;
* The mean weekly NRS score for abdominal pain (the most severe in the past 24 hours) was between 3.0 and 7.0 within the last week, and there were at least 2 days per week when fecal traits were classified as type 6 or 7;
* Informed consent, voluntary test.

Exclusion Criteria:

* Stool number of type 7 according to Bristol Stool Chart, more than 3 times per day;
* TCM syndrome was diagnosed as deficiency of spleen and kidney Yang syndrome；
* Patients who took emergency medication (Piveronium bromide tablets) more than the standard during admission period (more than 2 days per week on average)；
* Patients who have been diagnosed with organic diseases of digestive system, such as inflammatory bowel disease, intestinal tuberculosis, intestinal tumor, etc., or are still complicated with peptic ulcer and infectious diarrhea；
* Patients with similar symptoms of IBS, such as eosinophilic enteritis, collagenous enteritis, lactose intolerance, etc.
* Patients with intestinal diseases of digestive system, such as tuberculous peritonitis, cirrhosis, chronic pancreatitis, etc.
* Patients with systemic diseases affecting digestive tract function, such as hyperthyroidism or hypothyroidism, endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, etc.
* Previous gastrointestinal surgery (except for appendicitis);
* Patients with serious cardiovascular diseases, serious liver and kidney diseases, hematopoietic system diseases, tumor, neurological or psychiatric system diseases;
* Major anxiety (SAS score ≥70) or major depression (SDS Score ≥73);
* Concomitant drugs affecting gastrointestinal motility and function (prokinetic drugs, anticholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrhea agents, antacids, antidepressants, antianxiety drugs, intestinal microbiota regulators, antibiotics, etc.) should not be discontinued in the test;
* Pregnant or lactating women who had a birth plan from enrollment to 3 months after the end of the trial.
* Allergic to the test drug emergency drug and its ingredients;
* Suspected or confirmed history of alcohol or drug abuse;
* Patients who participated in other clinical trials within 1 month prior to enrollment;
* Other subjects considered unsuitable for clinical trials by the researchers.
UK-Czech E-cigarette Study

Currently available smoking cessation treatments help only about 15% of smokers to quit long-term. These treatments do not typically address the behaviours and sensations associated with the act of smoking (e.g. handling a cigarette, inhaling, taste and feel of smoke on the throat). There is evidence that these elements influence smoking behaviour and cessation. Electronic cigarettes (EC) are a new product with a strong potential to be a realistic behavioural replacement for smoking.

Whilst EC deliver nicotine, their use does not involve tobacco combustion, which is the primary source of the many thousands of dangerous chemicals to which smokers of conventional cigarettes are exposed. Studies on EC products and users indicate there is little doubt that they are substantially safer than conventional cigarettes.

The investigators plan to conduct a study one of the very first studies to test the effects of adding EC to standard care on long-term validated outcomes. Before launching such a large and demanding trial however, data are needed on what proportion of smokers would be interested in using EC and what compliance with EC use can be expected, and no data exist to inform how large a sample is needed. This pilot study would provide such data.

A total of 200 smokers would be recruited at smoking cessation clinics in London and Prague. Half the smokers would be randomised to receive standard smoking cessation behavioural support and medication (standard care; SC), and half to receive SC plus EC. The EC group would receive a four week supply of EC. The outcome measures for the study would be smoking status at 4 and 24 weeks after the target quit date, EC use, acceptability, and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Smokers who want help with quitting
* Aged 18 or over

Exclusion Criteria:

* Pregnancy, breastfeeding, planning to conceive in the next 6 months
* Enrolled in other research
* Currently using electronic cigarettes
Left Atrial Volume and Function in Children Assessed by Echo 3DRT: Reference Values for Normal Children

The investigators study is trying to find the normal value to left atrial volume and left atrial function in healthy children by tridimensional real time echocardiography avaluation.


Eligibility Criteria:
Inclusion Criteria:

* research murmur

Exclusion Criteria:

* any congenital heart disease
* any systemic disease