cyrilzakka/clinical-trials huggingface dataset:
Aging Mammary Stem Cells and Breast Cancer Prevention

To examine whether rapamycin can reduce malignant markers and aberrant mammary stem/progenitor cells (MaSCs) number in surgical specimens

A non-randomized, open-label, phase II, window of opportunity trial will be carried out to see if a 5-7 day rapamycin treatment can reduce malignant markers and aberrant MaSC number

Eligibility Criteria:
Inclusion Criteria:

* Women with confirmed menopausal status. All patients who have NOT had a prior bilateral oophorectomy and/or are younger than age 60, will require menopausal status verified by FSH and estradiol local labs.
* Women diagnosed with DCIS/LCIS, Atypical lobular hyperplasia (ALH) or ADH lesions detected by pathology
* Women scheduled for mastectomy or lumpectomy after DCIS/LCIS, ALH or ADH diagnosis
* Women consented to the UT Health Cancer Center MD Anderson Cancer Center tissue biorepository (HSC20070684H)
* Women of child-bearing potential willing to practice 2 forms of contraception, one of which must be a barrier method until at least 30 days after the last dose of rapamycin.
* Women of child-bearing potential must have a negative serum pregnancy test at time of enrollment.
* Patients must be able to swallow and retain oral medication.
* All patients must have given signed informed consent prior to registration on study.
* Patients must have normal organ and marrow function as defined below:

  1. Leukocytes ≥ 3,000/uL
  2. Absolute neutrophil count ≥ 1,500/uL
  3. Platelets ≥ 100,000/uL
  4. AST ≤ 2.5 X ULN
  5. ALT ≤ 2.5 X ULN
  6. Total bili ≤ 1.5 X ULN or Direct bili ≤ 1 X ULN

Exclusion Criteria:

* Women who are pregnant.
* Women who are receiving any other concomitant treatment for their DCIS/LCIS, ALH or ADH
* Women who are taking rapamycin for another diagnosis.
* Women with an allergy to rapamycin or its derivatives.
* Active infection requiring systemic therapy.
* Patients who are taking any pills containing herbal (alternative) medicines are NOT eligible for participation. Patients must be off any such medications by the time of registration.
* Immunocompromised subjects, including patients with human immunodeficiency virus
* Women currently taking strong CYP3A4 inducers or inhibitors. Drugs that cannot be coadministered with rapamycin include but are not limited to: Calcium channel blockers: nicardipine, Antifungal agents: clotrimazole, fluconazole, Antibiotics: troleandomycin, Gastrointestinal prokinetic agents: cisapride, metoclopramide, Other drugs: bromocriptine, cimetidine, danazol, HIV-protease inhibitors (e.g., ritonavir, indinavir), Anticonvulsants: carbamazepine, phenobarbital, phenytoin, Antibiotics: rifapentine. The research team can provide a full list of these medications.
* Patients with any of the following conditions or complications are NOT eligible for participation:

  1. GI tract disease resulting in an inability to take oral medication
  2. Malabsorption syndrome
  3. Require IV alimentation
  4. History of prior surgical procedures affecting absorption
  5. Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fed Conditions

Objective:

subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days.

Study Design:

Randomized, Two-Way Crossover, Single-Dose, and Open-Label


Eligibility Criteria:
Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

* Sex: male.
* Age: 18 - 45 years.
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines,Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
The Effects of Cannabidiol on the Driving Ability of Healthy Adults

A randomized, parallel-group, double-blind, exploratory two-arm trial to assess the effects of CBD on driving ability along with changes in psychological status (i.e. mood, drowsiness, sedation) and cognitive function. Forty healthy West Virginia University (WVU) students will be allocated and randomized to receive: (1) 300 mg of pure CBD oil or (N=20) (2) placebo matched in appearance and taste (N=20). After consuming the study drug, each individual will participate in a 25-35-minute driving simulation and their driving performance measured. To assess changes in psychological status (i.e. mood, drowsiness, sedation) and drug impairment-related cognitive function, the Visual Analog Mood Scale, Stanford Sleepiness Scale , Digital Symbol Substitution Test, Trail Making Test Part A and B, Psychomotor Vigilance Test, and Simple Reaction Time test will also be administered to participants at baseline (prior to study drug consumption) and following completion of the driving simulation test. The entire protocol will be completed in one day and should take 4-4.5 hours to complete for each participant.


Eligibility Criteria:
Inclusion Criteria:

1) the participant must be currently enrolled as a WVU student, 2) be 18-30 years of age at time of study, 3) have a current drivers' license issued from any state in the United States, 4) has driven at least once in the past 30 days 5) is able to speak and read English, 6) is willing to be randomized and comply with study requirements including a urine drug test on the day they consent to participate in the experiment and complete a test drive to ensure the absence of simulation sickness, 7) not currently taking any daily prescription medications other than birth control, 8) have not been diagnosed with any serious chronic disease by a licensed healthcare provider (including but not limited to Alzheimer's and related dementias, Parkinson's disease or other neurodegenerative disorder, major depressive or anxiety disorder, schizophrenia or other serious mental illness, arrhythmias, cataracts, glaucoma, chronic obstructive pulmonary disease, diabetes, epilepsy, sleep apnea, and fibromyalgia), and 9) has an individual able to drive them home after testing or is willing to be driven home by study staff after testing completion.

Exclusion Criteria:

Participants will be excluded if they 1) currently smoke or use tobacco products, 2) have used illegal drugs (including cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, lysergic acid, mushrooms, or marijuana) in the past 30 days, 3) has consumed CBD in the past 7 days, or 4) is currently pregnant or lactating
Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer

de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.

Patients with de Novo metastatic prostate cancer with limited disease spread has been shown to gain benefit from local radiotherapy to the prostate. The internationally accepted fractionation schedule is 3 Gy (Gray) x 19-20 over a course of 4 weeks.

There is continous evidence for even more hypo-fractionated radiotherapy with higher fractionation doses. We will test if the schedule of 6.1Gy x 6 compares to standard of 3 Gy x 19 with regard to patient reported side-effects.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Histological confirmed prostate cancer
3. Indication for early palliative radiation therapy of low burden metastatic prostate cancer. Low burden as defined by modified CHAARTED trial criteria to maximum 4 skeletal mets at any site and/or any number of lymph nodes
4. baseline E-PROM

Exclusion Criteria:

1. High burden metastatic prostate cancer including all with visceral mets.
2. Unable to comply with study procedures.
3. Other diseases or medication that will put the patient at risk for more toxicity from radiotherapy
4. Radiation treatment start later than nine months after the prostate cancer diagnosis.
5. Severe micturition problems, IPSS \> 20 ( International Prostate Symptom Score)
Evaluation of the Impact of Adaptive Goal Setting on Engagement Levels of Government Staff With a Gamified mHealth Tool

Background: Although the health benefits of physical activity are well established, it remains challenging for people to adopt a more active lifestyle. Mobile health (mHealth) interventions can be effective tools to promote physical activity and reduce sedentary behavior. Promising results have been obtained by using gamification techniques as behavior change strategies, especially when they were tailored toward an individual's preferences and goals; yet, it remains unclear how goals could be personalized to effectively promote health behaviors.

Objective: In this study, the investigators aim to evaluate the impact of personalized goal setting in the context of gamified mHealth interventions. The investigators hypothesize that interventions suggesting health goals that are tailored based on end users' (self-reported) current and desired capabilities will be more engaging than interventions with generic goals.

Methods: The study was designed as a 2-arm randomized intervention trial. Participants were recruited among staff members of Noorderkempen governmental organization. They participated in an 8-week digital health promotion campaign that was especially designed to promote walks, bike rides, and sports sessions. Using an mHealth app, participants could track their performance on two social leaderboards: a leaderboard displaying the individual scores of participants and a leaderboard displaying the average scores per organizational department. The mHealth app also provided a news feed that showed when other participants had scored points. Points could be collected by performing any of the 6 assigned tasks (eg, walk for at least 2000 m). The level of complexity of 3 of these 6 tasks was updated every 2 weeks by changing either the suggested task intensity or the suggested frequency of the task. The 2 intervention arms-with participants randomly assigned-consisted of a personalized treatment that tailored the complexity parameters based on participants' self-reported capabilities and goals and a control treatment where the complexity parameters were set generically based on national guidelines. Measures were collected from the mHealth app as well as from intake and posttest surveys and analyzed using hierarchical linear models.

Note: Eindhoven University of Technology is not an official GCP sponsor. Hence, this study is not a medical clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Employee of Noorderkempen governmental organization

Exclusion Criteria:

* None
Virtual Cycling Environments for Persons With Parkinson Disease

This study asks three questions about Persons with Parkinson Disease that use a bicycle for exercise. 1. Does the use of virtual reality increase the intensity and and enjoyment of the experience compared to bicycling without virtual reality? 2. Does the way in which the bicycling (interval compared to continous) is performed affect the experience? 3. How does the way the virtual reality is delivered (with goggles or projected on a screen) affect the experience?

Participants attend two sessions. They complete movement assessments and questionnaires about physical activity. During the first session they bicycle in a semi-immersive (projected on a screen) and an immersive (with googles) virtual environment. After each bout they completed a questionnaire about the experience. In the second session they bicycle four times with and without a virtual environment using both a continous and interval mode. Their oxygen consumption is measured during cycling. They complete questionnaires after each exercise bout.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Parkinson's disease
2. Hoehn and Yahr stages II-III,
3. 45-75 years old
4. able to ride a stationary upright bicycle
5. able to sign informed consent.

Exclusion Criteria:

1. Have a recent history of severe heart disease, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than Parkinson Disease.
2. Are unable to follow directions or sign a consent form
3. Do not have adequate vision or hearing ability to see or hear a television
4. Have unstable medical condition or musculoskeletal disorder such as severe arthritis, recent knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to ride the bicycle
5. Have any other medical condition that prevents bicycling
6. Have moderate depression
Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients

The purpose of this study is the evaluation of a bioimpedance method for determination of dry weight in dialysis patients. Additionally normal tissue hydration in non-Dialysis patients is investigated in healthy subjects and patients with chronic kidney disease in stages K/DIGO I-IV


Eligibility Criteria:
Inclusion Criteria:

* clinically stable on dialysis within the last three months
* signed written informed consent

Exclusion Criteria:

* acute myocardial infarction or stroke within the last six months
* heart failure stage NYHA IV
* concommitant participation in other interventional trials
* psychiatric conditions that prevent subject from following the study procedures / protocol
* pregnancy or lactation
* limb amputation
* cardiac pacemaker
* joint implants
* implantable pumps and other metallic implants

For healthy subjects and CKD patients in stages K/DIGO I-IV the above mentioned criteria other than the first mentioned are applicable respectively.
Laparoscopic Surgery for T4 Tumor of the Colon Cancer (LST4C Trial)

The purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for T4 colon cancer

The investigators previous study indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy can be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. However, the clinical value of laparoscopic surgery for T4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. The aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for T4 colon cancer as well as the mortality and the morbidity. The number of patients needed to get a 80% power is 1960. The average number of patients/surgical center is approximately 200 in each of 10 surgical centers. The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center. The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed equestionnaire.

Systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy VS conventional open surgery).

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent

  * Histologically confirmed diagnosis of colon carcinoma
  * CT or MRI verified as T4 colon cancer without involvement of other organs
  * Without multiple lesion other than carcinoma in situ
  * Tumor size \< 8 cm
  * No bowel obstruction
  * Sufficient organ function
  * No history of gastrointestinal surgery
  * 18 years of age or older
  * Performance Status (ECOG) 0, 1 or 2 and life expectancy \> 12 weeks
  * Operable patients

Exclusion Criteria:

* • Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding

  * Unstable or uncompensated respiratory or cardiac disease
  * Serious active infections
  * Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
  * Stomatitis, ulceration in the mouth or gastrointestinal tract
  * Severe diarrhea
  * Peripheral sensory neuropathy with functional impairment
A Study of Gene Polymorphisms and Normal Tissue Radiation Injury in Patients Treated for Breast, Prostate, Brain, Lung, and Head and Neck Cancers

This study will examine, for the first time, the independent contribution of a patient's own genetic makeup to the development of post-radiation complications, permitting the future development of predictive tests to avoid radiation injury. To do this, the investigators will examine gene markers in a series of breast, prostate, brain and lung cancer survivors who have received conformal radiotherapy between 1996 and 2003 at the Cross Cancer Institute and Tom Baker Cancer Centre.

Major innovations in radiotherapy (RT) delivery (3D conformal RT, intensity modulated RT) now permit RT dose escalation to be tested as a means of improving disease control in many tumour sites. With delivery innovations, life-threatening toxicity occurs rarely, but significant clinical toxicity is common. In previous work the investigators have studied a cohort of 98 prostate patients who received dose-escalated 3D-CRT and have obtained evidence of genetic and dosimetric factors underlying rectal/bladder toxicity. They posit that the late radiation toxicity disease state has significant genetic determinants in other malignancies. These determinants are neither understood nor accounted for in selection of treatment, and the investigators propose to study additional well-characterized cohorts, who are clinically well from a disease control perspective, given that comprehensive dosimetric and outcome information is available on all.

For a thorough understanding of the molecular processes underlying tissue responses to radiation damage, the investigators propose a genomic analysis. Their working hypothesis is that normal organ toxicity will be associated with patient genetics as measured by single nucleotide polymorphisms (SNPs) in a select group of genes. The criteria for selecting SNPs will be based on a candidate gene approach, choosing genes implicated or demonstrated in DNA repair pathways and radiation-induced tissue damage/tissue homeostasis. Analysis of these data will use both statistically based bioinformatics approaches.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer
* Prostate cancer
* Squamous cell carcinoma (SCC) of the head and neck
* Non-small-cell-lung carcinoma (NSCLC)
* Glioma treated by radiotherapy

Exclusion Criteria:

* Follow-up less than 18 months
Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans

This is a study to learn more about traumatic brain injury (TBI) and suicidal behaviors. The purpose of this research is to find out more about the issues related to these conditions. This study seeks to explore the relationship between executive dysfunction and suicidal behavior in an outpatient population.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of traumatic brain injury, history of suicidal behavior.
2. Age 18-74.
3. Currently receiving care through the Eastern Colorado Health Care System (ECHCS) Denver VA TBI Interdisciplinary Team.

Exclusion Criteria:

1. History of other significant neurological disease.
2. Diagnosis of Schizophrenia.
3. Test of Memory Malingering (TOMM) performance lower than 50%.
4. Behavior which could be described as Substance Abuse in the 7 days prior to participation.
5. Current guardianship or mention of recommendation for guardianship in medical chart within the past six months.
6. Inability to read the informed consent document.
7. Inability to adequately respond to questions regarding the informed consent procedure.
8. Significant hearing impairment.
Phasix Mesh Use in Complex Open Ventral Hernias Study

The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or older) with a complex ventral hernia scheduled for repair

Exclusion Criteria:

* Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement)
* Unlikely to follow-up (live out of state, unable to be reached by phone or email)
* Non-English and non-Spanish speakers
* Pregnant or breast-feeding patients
* Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate
Added Value of OCT for Diagnosing Recurrent BCC After Non-invasive Treatment

Superficial basal cell carcinoma (sBCC) can be treated non-invasively, but follow-up is necessary because lesions can reoccur. This study aims to evaluate the additional value of optical coherence tomography (OCT) for the detection of recurrent BCC lesions, that may remain unrecognized by clinical and dermoscopic examination (CDE). This study compared the diagnostic accuracy of CDE and CDE combined with OCT for detection of recurrent basal cell carcinoma (BCC) after non-invasive treatment of sBCC.


Eligibility Criteria:
Inclusion Criteria:

* Non-invasively treated sBCC patients
* 18+ years of age

Exclusion Criteria:

* Unable to sign informed consent