cyrilzakka/clinical-trials huggingface dataset:
Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures

Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone. There is for now no universally accepted approach to evaluate the progression of fracture healing. Typically, a fracture is considered as a delayed-union when the bone has not united within a period of time that would be considered adequate for bone healing. Delayed-union suggests that union is slow but will eventually occur without additional surgical or non-surgical intervention, whereas non-union is defined as the cessation of all reparative process of healing.

The incidence of impaired healing is estimated to range from 5 to 10% of all long bone fractures, depending on the fracture site, the type and degree of injury, among other factors. Currently the treatment of choice remains bone allograft or autograft. This procedure shows in general good results but requires an invasive surgery of several hours under general anesthesia, followed by a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients.

The present Phase 1/2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in the treatment of delayed-union fractures of long bones. In this study, delayed-union is defined at the time of screening as an absence of healing of minimum 3 months and maximum 7 months (+/- 2 weeks) after the onset of the fracture.


Eligibility Criteria:
Inclusion Criteria:

* Patient (or patient's legally acceptable representative) capable to provide a written, dated, and signed informed consent prior to any study related procedure
* Non-infected delayed-union fracture of a long bone of minimum 3 months and maximum 7 months (+/- 2 weeks)

Exclusion Criteria:

* Fracture interline larger than 2.5 cm
* Insufficient fracture stability
* Multifocal fracture
* Positive serology for hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV)
* Current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator
* Severe renal or hepatic impairment
Effects of Regional Nerve Block on Cancer Recurrence

It has been reported local anesthetics could inhibit tumor cell proliferation, metastasis and invasion ability，but it is still lack of clinical evidence. Our study aims to explore the effects of regional nerve block on cancer recurrence and the mechanism.

1. To study the effects of TAP block under ultrasound guide on the recurrence of gastric carcinoma, colon cancer, rectal carcinoma and liver cancer and the underlying mechanisms.
2. To clarify the effects of Lateral thoracic nerve block under ultrasound guide on the recurrence of lung cancer and the underlying mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary cancer undergoing elective surgery under general anesthesia

Exclusion Criteria:

* Disagree to participate，drop out,lose track, infectious abdominal wall，abnormal puncture point，coagulation dysfunction，allergy of local anesthetic ，immune disease,cancer metastasis,mental disease, acute and chronic infectious disease or other severe disease.
TAP Block With Liposomal Bupivacaine Versus Pre-incisional Wound Infiltration With Bupivacaine for Postoperative Pain

In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in patients undergoing Total laparoscopic or robotic assisted laparoscopic hysterectomy.

Patients undergoing laparoscopic or robotic assisted total hysterectomy at Erlanger Hospital will be randomized into one of two groups to receive either laparoscopic assisted TAP block with liposomal bupivacaine and bupivacaine (Group A) or pre-incisional bupivacaine (Group B). The remaining aspects of the perioperative care, including the general anesthesia care and postoperative care will be similar for all patients. Ideally, patients will be informed and consented for the study in the preoperative clinic setting. They will be randomized in the pre-anesthesia care unit.

Patients in Group A will receive laparoscopic-assisted bilateral TAP blocks using 10cc liposomal bupivacaine, 10cc Bupivacaine 0.25% and 10cc Normal Saline one each side. Patients in Group B will receive a total of 20cc pre-incisional Bupivacaine divided between each of the trocar sites. All patients will receive Ketorolac 30 mg, IV at the conclusion of surgery. All patients will be offered either oral pain medications or patient controlled anesthesia (PCA) opiate pain medication as indicated. Morphine equivalents will be calculated.

Postoperative pain control will be assessed using Visual Analog Pain Score (VAS). This will be done by recovery room personnel who will be blinded as to whether the patients received TAP block or pre-incisional anesthetic. VAS will be assessed at rest at 1 hour and 2 hours after arrival to PACU. Patients will be assessed with Overall Benefit of Anesthesia Score (OBAS) questionnaires at postoperative days 1, 2 and 7. OBAS questionnaires will be done by personnel blinded to anesthesia technique. Patients will also be blinded as to which group they were in. Total morphine equivalents of intraoperative and postoperative pain medications will be calculated through postoperative day 7.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-3,
* Scheduled for laparoscopic or robotic assisted laparoscopic hysterectomy,
* Able to participate personally or by legal representation in informed consent

Exclusion Criteria:

* History of relevant allergy to the study drugs (Bupivacaine),
* Chronic opioid use or drug abuse history,
* Inability to understand the study protocol,
* Refusal to provide written consent,
* Soft tissue infection of the abdominal wall and skin
Shared Decision Making for Schizophrenia

The impact of a decision aid for inpatients with schizophrenia on perceived involvement and compliance is studied in comparison with routine care.

to follow

Eligibility Criteria:
Inclusion Criteria:

* schizophrenia (ICD10)
* age 18 - 65 years
* inpatients

Exclusion Criteria:

* mental retardation
* no informed consent
Comparison Between Standard Deep Anterior Lamellar Keratoplasty (S-DALK) and Intralase Enabled Deep Anterior Lamellar Keratoplaty (IE-DALK)

A prospective comparison between standard deep anterior lamellar keratoplasty (S-DALK) performed manually using a blade (trephine) and femtosecond laser-enabled deep anterior lamellar keratoplasty (IE DALK), where incisions are performed using the femtosecond laser.

Even though corneal transplants have been around for more than 100 years, and tools to improve their surgical technique keep getting perfected, both regular and irregular postoperative astigmatism continue to be major concerns in achieving predictable visual results. Femtosecond laser technology allows for the creation of more precise incisions with more reproducible patterns, which could lead us to believe that astigmatism management and visual results should be improved with this technology. This would be the first study to prospectively analyze standard versus femtosecond laser-enabled deep anterior lamellar keratoplasties in order to elucidate their relative advantages in the quest for a gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Either advanced keratoconus or corneal scarring requiring a deep anterior lamellar keratoplasty

Exclusion Criteria:

* Previous keratoplasty
* Advanced glaucoma
* Any other retinal or optic nerve pathology that could potentially affect visual outcome
* Strabismus or amblyopia
* Significant limbal stem cell deficiency (invlolving \> 3 limbal clock hours)
* Active autoimmune disease.
Effect of Surgery and Radiation Therapy on Tc-99M Sestamibi Uptake Patterns in Molecular Breast Imaging

The investigators hope to prove that radiation and surgical scarring does not result in changes that affect the MBI pattern 6-12 months after completion of treatment.

The study will allow us to evaluate whether surgery and radiation have persistent effects on the breast tissue with regards to whether and how such changes impact MBI images and to determine whether the inflammatory changes due to treatment resolve within 6-12 months of completing treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women who have planned surgical excision of a lesion or have had a baseline MBI study as part of another MBI research protocol who are within 6-12 months of completing breast surgery who are able and willing to return to Mayo Clinic for a follow up MBI study once the 6-12 month interval is complete.
* Women who plan BCT for a malignant lesion or who are within 6-12 months of completing breast conserving treatment and have had a baseline MBI study as part of another MBI research protocol and are able and willing to return to Mayo Clinic for a follow up MBI study.

Exclusion Criteria:

* Women who do not require surgical excision of a breast lesion or breast conserving treatment for breast cancer.
* Patients undergoing mastectomy.
* Women who are pregnant or lactating.
* Women who are taking hormonal contraception or hormone replacement therapy (vaginal estrogen is permitted), or have used these agents within the previous 3 months.
* Women who have received chemotherapy within the previous 6 months or receive chemotherapy as part of their cancer treatment.
* Men (due to the very low incidence of male breast cancer and the lack of any available data regarding the use of scintimammography or MBI in men).
* Women under the age of 18 years.
* Women unable to sit comfortably during image acquisition.
* Women who are unable to return to Mayo Clinic for a follow up MBI scan 6-12 months after surgical excision or 6-12 months after completing radiation therapy for breast conservation.
Safety Study of PLX4032 in Patients With Solid Tumors

The primary objective of this FIH study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic mutation.

Activating mutations of the BRAF gene have been observed in a variety of cancers, including 55-68% of malignant melanomas. In general, oncogenic mutations of BRAF correlate with a poor outcome. PLX4032 is a compound that selectively inhibits oncogenic B-Raf kinase.

Two extension cohorts of patients with confirmed V600E mutations will be recruited, consisting of advanced melanoma and metastatic colorectal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Solid tumors confirmed histologically whose tumors are refractory to standard therapy, or for whom standard or curative therapy does not exist
* Patients from whom paired melanoma biopsies are planned must have a V600E+ BRAF mutation confirmed prior to the administration of PLX4032
* Previous chemotherapy, immunotherapy, or radiation therapy must have been completed at least 2 weeks prior to starting PLX4032 therapy, and all associated toxicity must be resolved prior to administration of PLX4032
* Patients in the Extension cohorts (melanoma or adenocarcinoma of the colon or rectum) must have both a V600E+ BRAF mutation and measurable disease (by RECIST V 1.0 criteria) prior to the administration of PLX4032. All patients enrolled must provide archival or fresh melanoma tumor biopsy for confirmation of V600E+ BRAF mutation status by TaqMan assay
* ECOG performance status 0 or 1
* Life expectancy ≥ 3 months
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* Brain metastases that are progressing or have been documented to be stable for less than 3 months, or for which systemic corticosteroids are required
* Investigational drug use within 28 days of the first dose of PLX4032
* Uncontrolled intercurrent illness
* Refractory nausea and vomiting, malabsorption, or significant bowel resection that would preclude adequate absorption
BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study

The aim of the study is to further understand whether the use of non-invasive monitoring NIRS (Near Infrared Spectroscopy) is useful in reducing postoperative complications in high-risk patients undergoing elective surgery.

Background:

Perioperative complications lead to impaired quality of life as well as prolonged disability. In high risk patients, early hemodynamic optimization with the goal of achieving and maintaining tissue oxygenation in the perioperative period has resulted in an improvement of outcomes and a reduction in surgery-related complications. Maintenance of adequate oxygen delivery to tissue, is one of the fundamental aspects of anesthesia. Regional Oxygen Saturation of the brain tissue (rSO2) as measured by near-infrared spectroscopy (NIRS) is a promising tool in vascular surgery and cardiac surgery for the monitoring of global cerebral perfusion.

Objectives:

This study has the purpose to assess whether an rSO2-based hemodynamic optimization algorithm is able to reduce overall perioperative complications in high risk patients.

Design:

BRAIN-PROMISE is a monocentric, randomized controlled trial.

Population:

Hypertensive elderly or frail patients undergoing major surgery.

Experimental Intervention:

Cases will be managed using a NIRS-targeted goal directed therapy.

Control Intervention:

Controls will be managed according to standard care.

Outcomes:

The primary outcome are the incidence of perioperative complications at 30 days and the percentage of successful reversal of reduction in NIRS.

Trial size:

A total of 200 patients will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* hypertensive patients with American Society of Anesthesiologists (ASA) score≥ 2 with either Age ≥ 65 years or frailty score ≥5
* presence of an arterial catheter during anesthesia
* planned high-risk surgery (abdominal, vascular, urologic, thoracic one-lung ventilation (OLV) procedures), longer than 60 minutes, in general anesthesia
* ability to give informed consent according to International Conference on Harmonization ICH/ Good Clinical Practice (GCP), and national/local regulations

Exclusion Criteria:

* Unable to consent to study inclusion
* Language barrier
* Severe neurological or psychiatric disease
* End-stage dementia
* Total Intravenous anesthesia
* No use of hypertensive medication at home.
Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery

In France, during surgery, only 4% of parents are present at induction, most often for children with disabilities with iterative interventions. Some studies have shown that the presence of parents during induction decreases the anxiety of children, while others do not. Their conclusions all advocate preparing parents for this presence in the operating room in an accompanying course.


Eligibility Criteria:
Inclusion Criteria:

* 5 to 12 year olds requiring scheduled surgery
* scheduled outpatient or weekly hospitalization.
* Anesthesia envisaged by inhalation induction
* Agreement of parents (and child according to age).
* Even parent (s) present at pre-anesthesia and on the day of surgery

Exclusion Criteria:

* Child with previous surgery
* Parent (s) of a child who has already had surgery
* Parent (s) or child unable to follow the whole procedure (autism, blindness ...)
Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases

In this study the investigators are going to evaluate the efficacy pentoxifyline in HTLV-1 patients with neurological diseases: HAM/TSP or neurogenic bladder. In some laboratory experiments the investigators observed that this drug had the capacity to reduce the immune response in HTLV-1 infected cells. Since the exacerbated immune response is know to cause neurological disease in patients with HTLV-1 the investigators hope that pentoxifyline can alleviate symptoms and delay the progress of HAM/TSP in patients.

The human T-lymphotropic virus type 1 (HTLV-1) infects 20 million individuals worldwide and is the causative agent of HTLV associated myelopathy/ tropical spastic paraparesis (HAM/TSP). Although only 5% of HTLV-infected individuals will develop HAM/TSP, the investigatorts have observed that about 30% have neurological complaints and/or neurogenic bladder associated with HTLV-1. The immunopathogenesis of those diseases is related to the exaggerated immune response with high production of cytokines and induced neurological injury. So far there is not any effective drug against HTLV-1 and modulation of the immune response can help to alleviate the clinical manifestations of those patients and prevent the progression of symptoms. The preliminary data show that pentoxifylline has ability to decrease production of TNF-α and IFN-γ in patients with HTLV-1 infection and patients with HAM/TSP. The proposal entitled "Evaluation of the efficacy of pentoxifylline in attenuating the neurological disease associated with HTLV-1 and negatively modulate the immune pathological response" extends the previous studies in order to determine the ability of pentoxifylline in modulate the immune response and modify the course of the clinical manifestations in patients infected with HTLV-1. The influence on the immune response in the expression of disease will be determined in a therapeutic trial with two groups of patients: 1) patients with neurogenic bladder associated with HTLV-1, 2) patients with HAM/TSP. Primary end point is clinical and neurological exam and secondary end point are measure of proinflammatory cytokines (TNF-α, IFN-γ, IL-1 and IL-6) and chemokines that attract T cells to sites of inflammation (CXCL9 and CXCL10).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 80 years;
* Confirmed HTLV-1 infection with Western Blot analysis;
* HAM/TSP diagnosed patients according to the WHO
* Patients with HTLV-1 and neurogenic bladder diagnosed by clinical and urodynamic study
* Disease duration \< 5 years

Exclusion Criteria:

* Neurological diseases with functional limitations.
* Co-infection with Hepatitis B or C, Syphilis, Chagas Disease or HIV
* Use of immunossupressive drugs
* Immune disease
* Pregnancy
EMPOWER Weight Management

This research is to develop a virtual weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.

EMPOWER is a remote weight management program utilizing an online textbook platform, E-Text, and mobile web application. EMPOWER is a two-year program: 1-year intervention, 1-year follow up. Data is collected via FFQ (NIH DHQIII), daily weighing using a wifi-enabled scale, and 24-hour dietary records via the web application. EMPOWER consists of 19 online sessions (45 minutes/each) and 3 individual advising sessions with an RD.

EMPOWER aims to improve health parameters related to obesity, such as hyperlipidemia and hypertension. Health parameters will be monitored primarily by the subject's personal physician. Any test results will be sent to the EMPOWER research team for analysis via REDCap.

EMPOWER team consists of social workers in addition to nutrition experts. The social work team aims to monitor and improve lifestyle, stress management, and behavior.

Eligibility Criteria:
Inclusion Criteria:

* body mass index in the overweight or obese range (BMI) \>28 kg/m2 (if Asian, BMI \>25kg/m2);
* not currently pregnant or lactating;
* have Wi-Fi at home, a working email, and an iPhone or Android smartphone;
* self-reported obesity co-morbidities (such as diabetes type 2 or hyperlipidemia);
* be a Carle Foundation Hospital patient and have regular contact with a primary care physician;
* not using insulin injection;
* able to attend the 22 (1 hour) diet improvement sessions;
* willing and safe to lose 20 lb. or more for 6 months and maintain a healthy weight for one year;
* keep weighing their weight for two years;
* fluent in reading and writing English.

Exclusion Criteria:

* age \<18 or \>75 years;
* body mass index of \<28 kg/m2 (if Asian, BMI \<25kg/m2);
* currently pregnant;
* currently lactating;
* use insulin injection;
* not able to attend the 22 (1 hour) diet improvement sessions for 1 year;
* failed to set up a Wi-Fi scale;
* failed to submit a FFQ.
Structured Gym Activities and Aerobic Activities in People With Cardiac Conditions

To compare the effect of structured gym activities and traditional aerobic activities on cardiorespiratory endurance in people with cardiac conditions To compare the effect of structured gym activities and traditional aerobic activities on quality of life in people with cardiac conditions


Eligibility Criteria:
Inclusion Criteria:

* Individuals with cardiac conditions including post-first myocardial infarction, post valvular diseases, post-CABG patients.
* Individuals who can perform cardiorespiratory exercises with ease(who are able to complete 6 minute walk test).
* Individuals who have not performed regular physical activity in the past 6 months (PA-R)
* No regular exercise or gym activity since last 6 months

Exclusion Criteria:

* Individuals who are highly trained in gymnastic
* Already trained (any gym activity or regular exercise)
* Individuals with Diabetes, hypertension, and kidney diseases.
* Any neurological complication
* Any Musculoskeletal Disorder