cyrilzakka/clinical-trials huggingface dataset:
Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers

Metformin is drug that is normally used to treat people with diabetes. New research has discovered that metformin may also kill cancer stem cells. These cancer stem cells make up only a small portion of a cancer, but may be responsible for resistance to chemotherapy or for causing recurrence of the cancer. The purpose of this study is to determine the effect of metformin on colorectal cancer tumors. The study is designed to develop the methods to test tumors for cancer stem cells and then to determine the difference between treating with metformin and not treating with metformin with regard to the cancer stem cells. This research is investigational because the effect of metformin on cancer stem cells is not known in humans. Also, in patients who are not diabetic, metformin would normally not be given prior to surgery.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented colorectal cancer
* Intent to undergo disease resection or biopsy at least 7days from the treatment start date (allowing for a minimum of 5 days of treatment plus 2 days break)
* Medically fit for resection of their primary tumor or for biopsy
* Age 18-79 years
* Adequate renal function (serum creatinine levels \<1.5 mg/dL \[males\], \<1.4 mg/dL \[females\] or estimated creatinine clearance \>= 60 ml/min)
* Adequate hepatic parameters, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, and alkaline phosphatase levels ≤ 2.5 x ULN
* Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Intent to administer neoadjuvant chemotherapy or radiation therapy prior to the surgery or biopsy;
* Intent to perform surgery or biopsy within 7 days of study treatment start;
* Any situation where participation in this trial would alter, or cause significant risk of altering the ability or timing of a subject to undergo resection of their tumor
* Current use of metformin (within the past month);
* Blood glucose using point of care test \< 70mg/dl;
* Renal disease or renal dysfunction not meeting inclusion criteria;
* Significant medical conditions such as cardiovascular collapse (shock), acute myocardial infarction, septicemia, acute or chronic metabolic acidosis
* History of, or states associated with, lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), conditions associated with hypoxemia and pancreatitis
* Severe dehydration
* Clinical or laboratory evidence of hepatic disease
* Congestive heart failure requiring pharmacologic treatment, or unstable or acute congestive heart failure
* Known hypersensitivity to metformin hydrochloride
* Pregnant or lactating women
* Psychiatric illness or social situation that would limit compliance with study requirements and/or obscure results
Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection

The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD).

The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD)

Previously the CSGS was used in a clinical study in stroke patients (The Clot Out Study) to direct a catheter through blood vessels and to measure electrophysiological parameters in the blood vessels during procedures.

In the current study however, a commercially available CE marked guidewire will be used to direct a catheter through blood vessels while the Clotild® Smart Guidewire System will only be used to perform electrophysiological measurements in the blood vessels during peripheral endovascular procedures. It is thus designed for use as an adjunct to conventional angiographic procedures.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Subjects with acute and chronic occlusions in the arteries of the lower limbs
* Patients eligible for endovascular interventional procedures
* Written Informed Consent to participate in the study.

Exclusion Criteria:

* Target Vessel Aneurysm
* Target vessel diameter \<2mm
* Lesions starting at the Common Iliac Artery
* Any subject that is, according to the discretion of the investigator, not eligible for study participation
* Known lactating or confirmation of positive pregnancy test according to site specific standard of care
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Ulcerative colitis (UC) confirmed on endoscopy
* Moderately to severely active UC (Mayo score 6-12)

Exclusion Criteria:

* Current use of anti-TNF agents
Organisational Culture and Nutritional Care

The study explores the impact of organisational culture on multidisciplinary teams in the provision of nutritional care for older hospitalised acute in-patients by collaborating with patients and/or their relatives and healthcare practitioners to influence change.

This study adopts an action research (AR) approach given that sustained change is more likely if it incorporates authentic staff engagement. The key choice made in formulating the research design is to adopt an approach that is collaborative and participatory in a process of action and learning.

Here, eligible health practitioners involved in any aspect of the patients' food and nutritional care or helping to feed patients during mealtimes would be represented in one central team, engaging as co-researchers in the study.

Patients and/or relatives will participate in a focus group or interview session. The AR team participants will be involved in the iterative action research cycle, reflecting on current nutritional care practices, collectively evaluate patients' stories and consider ways to improve eating and drinking on the wards. The AR team will meet throughout the course of 12 months.

The study will provide insight into the impact of organisational culture ('the way the investigators do things') in the delivery of good nutritional care and elucidate the roles and responsibilities of nurses and other staff groups involved in the provision of nutritional care.

This research will provide data on the organisational culture of interdisciplinary teams working at both micro and macro levels while providing insight into the potential for AR to be used in a wider arena within the hospital to improve practice.

Eligibility Criteria:
Inclusion Criteria:

* Recently discharged patients aged 65 or over
* Recently discharged patients at the time of data collection
* Who at the time of admission received oral nutrition and hydration

Exclusion Criteria:

* Patients aged under 65
* Current in-patients
* Patients who have had no oral nutrition. e.g patients who had Percutaneous Endoscopic Gastrostomy (PEG) feeds whilst admitted
* Patients who are feeling too unwell to participate
* Patients lacking the mental capacity to give verbal or written consent
Correlation of Spinopelvic Movement With Lateral Radiographs

The purpose of this research is to compare a novel pelvic MetaWear sensor that looks at spine and pelvic movements when taking lateral sit-to-stand radiographs.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent.
* Hip pathology: 20 presenting for total hip arthroplasty, 20 presenting for joint preservation procedures.

Exclusion Criteria:

- Patients with lumbosacral hardware, contralateral THA, or DJD in the contralateral hip.
Comparative Efficacy of Sciatic and Femoral Blocks in Ankle Surgery

Comparison of Anesthetic and Postoperative Analgesic Efficacy of Femoral and Popliteal Sciatic Block vs Femoral and Anterior Sciatic Block in Ankle Surgery

The sciatic nerve, which arises from the sacral plexus, is the largest nerve in the body. It originates in the posterior region of the thigh in the lumbosacral area and is formed from the anterior branches of spinal nerves from L4 to S3 within the pelvis. It exits the pelvis through the greater sciatic foramen directly below the piriformis and then progresses towards the posterior compartment of the thigh, where it usually divides into the common peroneal nerve and the tibial nerve at the upper corner of the popliteal fossa. Sciatic nerve blocks provide both analgesia and anesthesia in surgeries below the knee, knee surgeries involving the posterior compartment, and foot and ankle surgeries. They can be used alone or in combination with an ipsilateral lumbar plexus block or femoral nerve block to provide surgical anesthesia or analgesia for the entire lower extremity.

Various approaches have been described to perform sciatic nerve block, including anterior and popliteal approaches. The anterior approach to the sciatic nerve can be performed as easily and successfully under ultrasound guidance as the popliteal approach. The anterior approach is advantageous when combined with a femoral nerve block, as it is performed with the patient in the supine position. Due to ease of application and high success rates, peripheral blocks have begun to be incorporated into anesthesia and postoperative analgesia strategies in ankle surgeries. The use of ultrasonography plays a crucial role in increasing the success rate of the block and reducing potential complications.

Eligibility Criteria:
* Inclusion Criteria:
* 18-65 years of age
* American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria:

* Pregnant
* Neuromuscular disease
* Peripheral neuropathy
* Coagulation disorders
* Allergy to local anesthetics
* Infection at the site where the nerve block will be applied
Cochlear Implantation in the Elderly

The goal of this study is to demonstrate that cochlear implantation is an effective, reasonable, and viable long-term option within a very elderly population


Eligibility Criteria:
* Inclusion Criteria :

  * 80 years or more
  * Primo-implantation
* Exclusion Criteria :

  * Under 80 years
  * Bilateralisation
  * Explantation or re-implantation
Effectiveness of ABRYSVO® Maternal Respiratory Syncytial Virus (RSV) Vaccine Against RSV in Infants in Western Pennsylvania

Globally, respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract disease (LRTD) in infants. Pfizer has developed ABRYSVO-a bivalent RSV prefusion F protein-based vaccine (RSVpreF) composed of two prefusion F proteins to protect against both RSV-A and RSV-B. In the United States, ABRYSVO has been approved and recommended for active immunization of pregnant individuals from 32 0/7 to 36 6/7 weeks' gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age. To generate critical evidence to support vaccine policy and implementation, Pfizer will collaborate with University of Pittsburgh to study vaccine effectiveness (VE) of ABRYSVO vaccination during pregnancy against RSV-associated outcomes in infants. The study will take place in a real-world population in Western Pennsylvania over multiple seasons, beginning in the 2023-2024 season, and will use a test negative design (TND approach). There will be no active enrollment of study participants, no direct contact with study participants, and no collection of any primary data outside of the Standard of Care (SOC). This study will use a TND to evaluate real-world VE of maternal ABRYSVO against RSV-associated outcomes in infants. Additionally, we will describe RSV-associated medically-attended visits for infants exposed to ABRYSVO and Beyfortus (monoclonal antibody (MAB) administered to babies up to 24 months for protection against RSV).


Eligibility Criteria:
Population included in ABYRSVO VE analyses:

1. Infants ≤ 6 months (≤ 180 days) of age on the index date.
2. Index date within the time period for data collection (approximately 01 October to 15 April in the 2023-2024 and 2024-2025 RSV seasons).
3. Infants born at ≥32 weeks of gestation.
4. Infants born to individuals who were expected (based on estimated date of delivery) to reach the indicated ABRYSVO vaccination window (320/7 to 366/7 weeks' gestation) during the local vaccination season.
5. Infant's electronic health record links to the maternal electronic health record.
6. Hospitalized at a UPMC facility during the RSV season (according to local hospital epidemiology ) with acute respiratory tract illness symptoms meeting the protocol-defined clinical case, and for whom RSV testing results from a specimen collected 10 days prior to hospital admission through 3 days after hospital admission are known.
7. Ability to document maternal ABRYSVO receipt or not.

Population excluded from ABYRSVO VE analyses:

1. Infants who received any licensed or investigational RSV preventive product (e.g., palivizumab, Beyfortus, active RSV vaccine (including investigational products or due to medication error) since birth.
2. Born to birth parent for whom ABRYSVO vaccination status cannot be verified in the maternal electronic health record or Pennsylvania Immunization Electronic Registry System (PIERS) system.
3. Infants who were born to an individual vaccinated with any other licensed or investigational RSV vaccine during pregnancy.
Potassium Titanyl Phosphate Laser Versus Pulsed Dye Laser for Rosacea - a Prospective Study

To compare the efficacy and safety of 532 nm KTP and 585 nm PDL for treating rosacea.

Rosacea is a common, chronic inflammatory skin disease that usually affects the cheeks, nose, forehead, and chin \[1\]. Clinically, it presents initially with transient erythema (flushing) and telangiectasia. As it progresses, persistent erythema and papules and pustules appear. Phymatous changes result from hypertrophy of the sebaceous glands, and usually manifest as rhinophyma, gnatophyma, and metophyma \[2\]. Depending on the literature, rosacea has a prevalence of 1% to 22% \[3\]. Time of manifestation of the disease is usually between 30 and 50 years \[4\]. Women are more frequently affected \[4\].

For laser treatment of rosacea, the pulsed dye laser (PDL) with a wavelength of 595nm is frequently used. The treatment includes at least three sessions at intervals of about 4 weeks and leads to lightening and reduction of the lesions as well as reduction of papules and pustules. Various clinical studies have already demonstrated the high efficacy of PDL \[5-7\]. The treatment is painless, and local or general anesthesia is not necessary.

The KTP laser is also an option in the treatment of rosacea. Due to the more stable technology of the frequency-doubled Nd:YAG (KTP) and associated lower maintenance problems, this laser system appears to be a safer and more reliable treatment option for rosacea patients.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years and older
* Good general health, no relevant previous diseases
* Presence of rosacea
* Cognitive ability and willingness to give consent (Informed Consent)

Exclusion Criteria:

* Age \< 18 years
* Pregnant and breastfeeding women
* Significant open wounds or lesions of the region to be treated
* Metallic implants in the region to be treated
* Missing consent and/or data protection declarations
Effect of Buffered Numbing Solution on Patients With Toothaches

The purpose of this study is to determine the effect of buffered lidocaine (a numbing solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing) solutions have shown promise in some medical and dental research. Patients presenting with toothaches will be given either a buffered numbing solution or a nonbuffered numbing solution. Neither the patient nor the operator will know which solution they will receive. Root canal treatment will be performed on the tooth and the ability of the buffered versus non-buffered numbing solutions will be compared.


Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of irreversible pulpitis (toothache) in a mandibular posterior tooth (back/bottom tooth) with moderate to severe pain
* ages 18 -65 years of age
* in good health (ASA I or II)
* able to grant informed consent.

Exclusion Criteria:

* allergy to lidocaine (numbing solution
* significant medical problem (ASA III or IV)
* have taken CNS depressants or analgesic medications within the last 24 hours
* pregnancy or lactating
* non-English speaking
* inability to give informed consent
AttraX® Putty vs. Autograft in XLIF®

The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.

This is a single-center, prospective, randomized study. Subjects will be recruited from patients already under the Investigator's care who are indicated for XLIF with iliac crest bone graft (ICBG) autograft or AttraX Putty. To minimize bias, all consecutive patients at a given investigational site who meet eligibility requirements will be asked to consent to participate in the study whereby the biologic (ICBG autograft or AttraX Putty) will be randomly assigned. All subjects will be followed for 24 months following surgery to quantify the clinical and radiographic improvements of each biologic compared to baseline and in comparison with each other.

Eligibility Criteria:
Inclusion Criteria:

1. Persistent back and/or leg pain unresponsive to conservative treatment for at least 6 months, unless surgical treatment is clinically indicated sooner
2. Indicated for a single-level XLIF between L1 and L5 with bilateral percutaneous pedicle screws
3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
4. 18-80 years of age at the date of written informed consent
5. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
6. Expected to survive at least 2 years beyond surgery
7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
8. Signed and dated informed consent form

Exclusion Criteria:

1. Mental or physical condition that would limit the ability to comply with study requirements
2. Spine abnormality requiring treatment at more than one level
3. Previous failed fusion at any spinal level
4. Prior fusion procedure at operative level (i.e., no revision of operative level)
5. Prior adjacent level fusion (note: prior decompression is not an exclusion)
6. Systemic or local infection; active or latent
7. Diseases that significantly inhibit bone healing (e.g., prior diagnosis of osteoporosis, metabolic bone disease)
8. Treatment with pharmaceuticals interfering with calcium metabolism
9. Undergoing chemotherapy or radiation treatment
10. Chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
11. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
12. Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
13. Immunocompromised or is being treated with immunosuppressive agents
14. Pregnant, or plans to become pregnant during the study
15. Subject is a prisoner
16. Participating in another clinical study that would confound study data
17. At risk to be non-compliant (e.g. (recently treated for) substance abuse, detainee, likely to immigrate)
Clinical Trial of Quantitative Detection Kit for Hsp90α in Breast Cancer

Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients

Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients, validate accuracy, specificity and sensitivity of Hsp90α kit.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients, healthy volunteers, benign breast diseases patients

Exclusion Criteria:

* Patients who previously received radiotherapy
Knowledge and Habits of Pregnant Teens

This study examines the link between health literacy, gestational weight gain, and infant birthweight in pregnant teenagers. A randomized trial of 50 participants will be conducted at the University of Mississippi Medical Center. Consent will be obtained from all participants. Both control and intervention groups will complete a 20 questions health literacy assessment at baseline and after eight weeks, along with the ASA24 dietary recall tool twice weekly. The intervention group will join a private social media group created solely for study purposes. This will be a private account, accessible only to participants who are added or invited by the study team.

This research study is to see if someone's ability to understand and use health information (health literacy) is linked to gaining a healthy amount of weight during pregnancy and having a baby with a healthy birth weight. The main question aims to answer if there is a positive correlation between increased health literacy, gestational weight gain, and adequate infant birth weight. We are conducting a prospective randomized trial involving 50 pregnant teenagers and their baby at a single institution. We will obtain study consent for 18 and 19 years old, and parental permission and assent for 13 -17 years old.

Control Group will complete the 20 questions health literacy during the first visit and after 8 weeks. Also, will complete the online called ASA 24 a 24-hour food recall tool. The ASA24 will be completed 2x /week for 8 weeks.

Intervention Group will complete the 20 questions health literacy during the first visit and after 8 weeks. Also, will complete the online called ASA 24 a 24-hour food recall tool. The ASA24 will be completed 2x /week for 8 weeks. In addition, participants assigned to the intervention group will be invited to participate in a private social media group. Participants will create a new account specifically for the study, or the study team can create an account on their behalf if they prefer. This will enable the study team to track participation without affecting any personal accounts. Education content will consist of published dietary recommendations during pregnancy, healthy craving hacks, healthy snacks, ways to get exercise in during the school day, etc. Participants will also be encouraged to ask questions and post any eating struggles.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age 13 - 19 yrs at enrollment
* \< 19.6 gestational weeks
* Ability to understand English
* Access to a smartphone or internet
* Willingness to follow study procedures
* Plan to deliver at UMMC
* Singleton pregnancy

Exclusion Criteria:

* Does not meet the inclusion criteria
* History of diabetes
* Current record of substance abuse
* Mental impairment
* Eating disorder
Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions

To evaluate the effect of Connective Tissue Graft and Pediculated-Connective Tissue Graft for extraction socket closure on soft tissue landmarks and ridge dimensions.

45 subjects were randomized into two groups Experimental: Main treatment group P-CTG group Active Comparator: Control group CTG group.

Eligibility Criteria:
Inclusion Criteria:

* Based on the Extraction Defect Sounding(EDS) Classification given by Caplanis et al,

  1. Systemically healthy subjects within the age group of 20-50years
  2. with extraction defect type 2 and type 3 were included in this study

Exclusion Criteria:

1. Medically compromised patients
2. Subjects who underwent radiotherapy or chemotherapy and
3. Smokers