cyrilzakka/clinical-trials huggingface dataset:
Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts

We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast Imaging (a new gamma-camera based breast imaging technology) in women with dense breast tissue who are at increased risk for breast cancer.

The sensitivity of conventional mammography (MMO) is poor in women with mammographically dense breast parenchyma. We have developed Molecular Breast Imaging (MBI) - a new technique which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography that has a high sensitivity (\~90%) for the detection of breast cancers independent of breast density.

The aim of this study is to demonstrate the utility of MBI as an adjunct screening modality for the detection of occult breast cancers in women with mammographically dense breast tissue. Initial recruitment will be from the pool of patients awaiting a screening mammogram in the Department of Radiology at Mayo Clinic Rochester. All patients will have a screening MMO and an MBI study. Patients with positive studies (MBI or MMO) will undergo additional diagnostic studies. At 15 months post-recruitment, all patients will be contacted by phone or mail to determine whether subsequent to their study, there has been any change in their breast status.

Eligibility Criteria:
Inclusion Criteria:

1. Past prior screening mammography (SM) interpreted as negative or benign (This screening must have been performed at Mayo Clinic Rochester, Minnesota).
2. Past prior SM interpreted as heterogeneously dense or extremely dense (This screening must have been performed at Mayo Clinic Rochester, Minnesota).
3. Women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts.
4. Subjects had to have at least one of the following risk factors:

   1. Known mutation in breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2)
   2. History of chest, mediastinal, or axillary irradiation
   3. Personal history of breast cancer
   4. History of prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or atypical papilloma
   5. Gail or Claus model lifetime risk greater than or equal to 20%
   6. Gail model 5 year risk greater or equal to 2.5%
   7. Gail model 5 year risk greater or equal to 1.6%
   8. One first-degree relative with history of breast cancer
   9. Two second-degree relatives with history of breast cancer

Exclusion Criteria:

1. They are unable to understand and sign the consent form
2. They are pregnant or lactating
3. They are physically unable to sit upright and still for 40 minutes.
4. They have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).
5. They have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.
6. They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.
Safety and Efficacy of Cariprazine in Patients With Schizophrenia

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided informed consent prior to any study specific procedures
* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
* Current psychotic episode (schizophrenia exacerbation) \< 2 weeks duration at Visit 1
* Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
* CGI-S score ≥ 4

Exclusion Criteria:

* Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
* Bipolar I and II disorder
* Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
* DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
* Women who are pregnant or breast feeding
A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia

This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia.

This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia. Approximately 150 subjects will be enrolled across 7 study centers in the United States. At Visit 2, subjects will be randomized 1:1:1 to one of three treatment arms: CSF-1, CSF-1 Component #1, or CSF-1 Component #2. All subjects will dose twice a day in both eyes with a single drop of their assigned treatment for approximately 1 week. At Visit 3, subjects randomized to CSF-1 will now receive a different concentration of CSF-1, subjects randomized to CSF-1 Component #1 will receive a different concentration of CSF-1 Component #1 and subjects randomized to CSF-1 Component #2 will continue dosing with the same concentration of CSF-1 Component #2. All subjects will continue dosing twice a day in both eyes for approximately 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must:

  1. Have presbyopia

Exclusion Criteria:

* Subjects must not:

  1. Have any contraindications to the study medications or diagnoses that would confound the study data
Bronchoscopy vs. Clinical Pulmonary Infection Score Guided Approach in Suspected Ventilator-Associated Pneumonia (VAP)

The reported incidence of ventilator associated pneumonia (VAP) is 10 to 15 per 1,000 ventilator days. VAP leads to an excess cost exceeding $40,000 per patient and is associated with a crude mortality rate as high as 76%. The clinical criteria for the diagnosis of VAP have low specificity and may lead to unnecessary antibiotic use. The Clinical Pulmonary Infection Score (CPIS) and bronchoscopic approaches lower unnecessary antimicrobial use, antimicrobial resistance, and superinfection compared to the traditional clinical criteria.

Based on the available evidence and local microbiology data, we have developed a VAP management protocol guided by CPIS or bronchoalveolar lavage (BAL) in adults with suspected VAP. These two approaches have not been compared against each other. Although the diagnostic studies in the CPIS guided approach are inexpensive and easily available, BAL has the potential to minimize the unnecessary use of antibiotics and reduce the development of drug resistant pathogens.

In this study, we propose to test the hypothesis that BAL leads to a reduction in antibiotic use compared to CPIS in patients with suspected VAP. The study design will be a randomized, clinical trial comparing CPIS versus BAL. The primary outcome measure will be antibiotic utilization. The secondary outcome measures will be mortality, morbidity, development of resistant pathogens and superinfection and infection related financial burden.

Completion of this trial will help us identify the best approach to avoid unnecessary antibiotic utilization and minimize the development of resistant pathogens (with their associated morbidity and mortality) in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Endotracheal intubation
* Suspected VAP with:
* New or progressive pulmonary infiltrates plus two of the following (In patients with pre-existing ALI or ARDS, physicians' suspicion of VAP with two of the listed criteria will be used.): Temperature \> 38 C or \< 36 C, WBC \> 12,000/mL or \< 4,000/mL, purulent endotracheal secretions.
* Patient or legally authorized representative is able to sign Informed Consent

Exclusion Criteria:

* Prison inmates
* Immunocompromised patients
* Participation in another trial conflicting with the design of the current trial
* Previous history of VAP during the same hospitalization
* Previous participation in the current study
* Concomitant non-pulmonary infection diagnosed within 3 days preceding the suspected VAP
* Patient's primary care provider does not want subject to be enrolled in the study
* Contraindications for bronchoscopy
Photochemical Tissue Bonding

The broad aim of this study is to evaluate the efficacy of photochemical tissue bonding (PTB) for the closure of skin excisions. We will test the hypothesis that full thickness skin excisions treated with PTB can heal with less scarring than those treated with the conventional suture closure method.

Hypertrophic scarring is a frequent endpoint after traditional surgical excision of skin cancers of the chest. These scars create significant long-term morbidity to the patient. There is a clinical need for an alternative treatment that would reduce factors associated with hypertrophic and possibly keloid scar formation by providing minimal tension, low infection risk and an absence of foreign body material. This would result in a normal appearing and healed scar without associated patient morbidity. Photochemical tissue bonding may provide this alternate treatment. PTB differs from sutures by continuously joining the tissue surfaces on a molecular level rather than only at discrete suture points. In addition, PTB does not incite foreign body reactions nor create tissue injury during passage of the needle and tying a knot, injuries that may initiate scarring.

Eligibility Criteria:
Inclusion Criteria:

* Histopathology confirmed basal cell carcinoma or well-differentiated squamous cell carcinoma without subcutaneous fat invasion on the chest, arm or abdomen or a diagnosis of atypical or dysplastic nevi on the chest, arm or abdomen.
* Able to follow involved post-operative care instructions
* Able to comply with study requirements
* Age 20-60 years

Exclusion Criteria:

History of underlying photosensitivity condition Skin phototypes V-VI Use of photosensitizing medication History of Accutane use within the past 12 months History of underlying bleeding disorder or use of anticoagulant (e.g. coumadin) Active smoker Known pregnancy or lactating mother Allergies or reactions to lidocaine or epinephrine Underlying immunodeficiency Inability to comply with study requirements Pacemaker or defibrillator in place
Comparison of Ultrasound-Guided Infraclavicular Block and Ultrasound-Guided Axillary Block

The purpose of this study is to compare the rate of complete sensory block at 30 minutes following ultrasound-guided single injection infraclavicular block and ultrasound-guided double injection axillary block. The investigators research hypothesis is that both blocks will show comparable rates of complete sensory block at 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* American Society of Anesthesiologists Class 1 to 3
* Undergoing a surgery at the elbow, forearm, wrist or hand under regional anesthesia

Exclusion Criteria:

* Age less than 18 years
* Body mass index more than 40 kg/m2
* Weight less than 45 kg
* Patient refusal
* Contraindication to regional anesthesia (coagulopathy, local infection at the puncture site, systemic infection)
* Previous neurological deficit in the operated arm
* Severe renal or hepatic failure
* Prior surgery in the axillary or infraclavicular area
* Pregnancy or breast-feeding
Healthy Children and Virtual Reality Mediation of Simulated Pain

The objective of this study is to develop central nervous system (CNS) biomarkers of pain experienced during medical procedures and pain relief induced by Virtual Reality Pain Alleviation Therapy (VR-PAT). The study team plans to use innovative functional near-infrared spectroscopy (fNIRS) to identify and quantify the targeted CNS biomarkers. The ultimate goal of this project is to optimize the CNS biomarkers for predicting and/or monitoring response to virtual reality (VR)-based pain reduction approaches for pain management in clinical trials.

20 healthy children will be recruited for a 1-hour research visit where they will wear a blood pressure cuff to simulate pain and an fNIRS neuroimaging device while playing an immersive/engaging VR game, a passive VR video, and an iPad game.

The objective of this study is to develop central nervous system (CNS) biomarkers of pain experienced during medical procedures and pain relief induced by Virtual Reality Pain Alleviation Therapy (VR-PAT). The study team plans to use innovative functional near-infrared spectroscopy (fNIRS) to identify and quantify the targeted CNS biomarkers. The ultimate goal of this project is to optimize the CNS biomarkers for predicting and/or monitoring response to VR-based pain reduction approaches for pain management in clinical trials.

Collaboration will occur through a team science model to address the following three specific aims:

Aim 1: To quantify the central nervous system (CNS) responses associated with self-reported pain intensity during a simulated pain condition.

Aim 2: To assess brain response patterns to virtual reality (VR)-based interventions for pain management.

Aim 3: To assess the degree to which objective brain measures and brain responses to VR intervention modulate objective brain markers of pain.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-17 years, inclusive
* Subjects and legal guardians can communicate (read and write) using English

Exclusion Criteria:

* Currently experiencing any pain (acute or chronic)
* Took any pain medication within the past 12 hours
* Vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
* History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
* Minors in foster care, incarcerated, or currently pregnant
Effect of Gastric Cancer Specialist Training Program in Laparoscopic Gastric Cancer Surgery（STP-LRG-1）

To prospectively evaluate the effect of the gastric cancer specialist training program of Fujian Medical University Union Hospital on laparoscopic gastric cancer surgery.

Laparoscopic gastric cancer surgery has the advantages of less trauma, quick postoperative recovery, less postoperative pain symptoms, less postoperative complications, and shorter average hospital stay. In addition, the surgical safety and oncological efficacy of laparoscopic radical gastrectomy for gastric cancer have been obtained. Confirmed by numerous clinical studies.

However, due to the difficult operation, complex anatomy and high technical requirements of laparoscopic gastric cancer surgery, the operator needs to have rich experience in laparotomy, skilled laparoscopic operation skills, and the ability to actively prevent and deal with complications after surgery. Therefore, at this stage, laparoscopic radical gastrectomy for gastric cancer is only suitable for large hospitals with certain conditions, and it should be gradually carried out on the basis of chief surgeons with rich clinical experience in radical gastrectomy and skilled laparoscopic technical experience.

The gastric cancer specialist training program (STP-LRG-1) of Fujian Medical University Affiliated Union Hospital (STP-LRG-1) has more than 9 years of trainee training experience. The effectiveness of STP-LRG-1 has not been prospectively evaluated, so this study aimed to prospectively evaluate whether STP-LRG-1 can improve the surgical skills of trainees and ultimately improve short-term outcomes for patients during and after surgery

Eligibility Criteria:
Inclusion Criteria:

1. The title of fellow physician or above, with experience in performing laparoscopic radical gastrectomy for gastric cancer independently or under supervision;
2. The hardware facilities and staffing of the operating room support the completion of laparoscopic gastric cancer surgery;
3. Surgical videos of laparoscopic radical gastrectomy before and after the training required for this study can be provided;
4. Clinicopathological data, intraoperative and postoperative short-term outcome data of the patients operated by the surgeon before and after training can be provided;
5. Informed consent

Exclusion Criteria:

1. Refuse to carry out laparoscopic gastric cancer surgery;
2. Due to the limitations of equipment or policies, the unit cannot routinely carry out laparoscopic gastric cancer surgery;
3. Those who have not performed laparoscopic gastric cancer surgery within 1 month before participating in the training and cannot provide video;
4. Those who are not expected to perform laparoscopic gastric cancer surgery within 1 month after participating in the training;
5. Participate in other clinical investigators during the same period.
Knee Functionality Recovery Indicators in Athletes Submitted to Ligamentoplasty of the Anterior Cruciate Ligament

Anterior cruciate ligament (ACL) injuries are recurrent, especially in sports. There is still no consensus on the characterization of functional indicators in this clinical condition, as well as their correlation with measuring instruments and clinical functional tests. It is intended to study the changes in functionality of users undergoing this surgery, aiming with functional assessment scales at different times of recovery. This will allow deciding on more adapted recovery strategies, which can meet the musculoskeletal requirements of the user.

It is proposed to carry by carrying out quasi-experimental, quantitative and analytical studies. The sample will consist of athletes who have started recovering from ACL surgery and who meet the previously established inclusion and exclusion criteria.

The study will use and compare functional tests (Star Excursion Balance Test, Lateral Step Down Test and Weight-Bearing Lunge Test) with measurement instruments: Knee and Osteoarthritis Outcome Score (KOOS), Lyshom Knee Scoring Scale, Lower Extremity Functional Score (LEFS), Return to Sport After Injury Scale (ACL-RSI) and IKDC Subjective Knee Evaluation Form.

The intervention will be performed on individual athletes who have had anterior cruciate ligament injury for the first time or recurrence of this ligament in the same knee or injury in the contralateral knee.

Eligibility Criteria:
Inclusion Criteria:

* Start of physiotherapy in the preoperative context and continuation of recovery up to 2 weeks after surgery; age equal to or greater than 18 years; With or without meniscal injury; Be able to correctly fill in the assessment instruments and complete the Informed Consent Form;

Exclusion Criteria:

* Concomitant bilateral injury/history of surgery or contralateral dysfunction; meniscal suture; cartilaginous injury; injury to the internal lateral ligament, external lateral ligament and posterior cruciate ligament; concomitant intra and extra-articular plastic surgery; individuals with recent heart disease, intermittent claudication, neuropathies and cognitive alterations.
Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty

This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief. The goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female between the ages of 18-65
* Patients willing and able to sign the informed consent
* Patients able to comply with follow-up requirements including self-evaluations
* Patients requiring a primary total knee replacement
* Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis

Exclusion Criteria:

* Revision total knee arthroplasty
* Bilateral total knee arthroplasty
* Patients with inflammatory arthritis
* Patients with a body mass index (BMI) \> 40
* Allergy to ropivacaine, bupivacaine, or other local anesthetic agents
* Current use of opioid drugs
* Patients with a history of total or unicompartmental reconstruction of the affected joint
* Patients that have had a high tibial osteotomy or femoral osteotomy
* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels
* Patients with a systemic or metabolic disorder leading to progressive bone deterioration
* Patients that are immunologically compromised, or receiving chronic steroids (\>30 days), excluding inhalers
* Patients' bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis
* Patients with knee fusion to the affected joint
* Patients with an active or suspected latent infection in or about the knee joint
* Patients that are prisoners
Oral Administration of DCI to Women With PCOS

To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood, and, if so, if that change is accompanied by i) an increase in DCI-IPG release in blood (as determined by bioactivity) during an oral glucose challenge and ii) an increase in whole-body insulin sensitivity.

A total of 46 women will be studied. We will study 23 obese and 23 non-obese women. There will be no BMI restriction. Twenty-three women will be randomly assigned to receive DCI (experimental group) and 23 women to receive placebo (control group). The women will be studied during the equivalent of the follicular phase of the cycle, as documented by a serum progesterone concentration of 2 ng/ml.

PCOS will be defined using criteria developed at the 1990 NICHD conference on PCOS3 - i.e., all women will have oligomenorrhea (eight or fewer menstrual periods annually) and hyperandrogenemia (elevated serum total or free testosterone concentration), and secondary causes of hyperandrogenism or ovulatory dysfunction will be excluded (see below: Entrance Criteria). All women will undergo a standard oral glucose tolerance test (OGTT) to screen for diabetes mellitus,16 but impaired glucose tolerance (IGT) will not be an exclusion criteria because of the high prevalence of IGT in this population.8,17-19 We intentionally will not screen the women for the presence of insulin resistance. Women with PCOS who have disorders associated with insulin resistance - such as hypertension21-23 or dyslipidemia21-23 - will not be excluded as long as they have been on a stable dose of medication for 6 months.

Eligibility Criteria:
Inclusion Criteria:-

(1) Non-obese and obese women with PCOS between 18-40 years of age. (2) oligomenorrhea ( 8 menstrual periods annually), (3) biochemical hyperandrogenemia (elevated total or free testosterone), (4) normal thyroid function tests and serum prolactin, and (5) exclusion of 21 -hydroxylase deficiency by a fasting 17 -hydroxyprogesterone \<200 ng/dl.41 (6) acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis). (7) Signed, witnessed informed consent. (8) Ability to comply with study requirements.

Exclusion Criteria: - (1) Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer). (2) Current use of oral contraceptives, DepoProvera or Norplant.. (3) Documented or suspected recent (within one year) history of drug abuse or alcoholism. (4) Ingestion of any investigational drug within two months prior to study onset.