cyrilzakka/clinical-trials huggingface dataset:
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib

This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.

This was a multicenter, non-treatment based companion sample collection protocol conducted in the US only. This protocol sought to evaluate the aberrations of common pathways for newly diagnosed HR+/HER2- advanced breast cancer tumors and responses to ribociclib in diverse patient populations. This companion sample collection protocol was available for all US patients enrolled on CLEE011A2404 (CompLEEment-1) and did not alter the planned treatment. Tumor collection required for this study occurred at two time points: at baseline/screening and upon the development of progressive disease as shown in the protocol. Patients eligible for this companion study were required to sign an optional additional consent form at the time of enrolling into the core trial.

After eight patients had consented and samples had been taken, it was determined that the companion study protocol had not been properly initiated or monitored at the sites. This was determined to be a significant GCP violation and the clinical team made the decision to terminate the trial. In addition to the GCP issues, enrollment had been closed to the core study so enrolling additional patients was no longer possible. The limited number of samples would not provide any meaningful analysis. The samples were never analyzed. The study was not terminated due to safety or efficacy concerns. Samples collected were either destroyed or will be retained for up to 15 years based upon the decision of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent was to have been obtained prior to any baseline/screening procedures.
* Patients eligible for this companion sample collection protocol sample collection protocol must have met all inclusion in CLEE011A2404.

Exclusion Criteria:

* Patients eligible for this companion sample collection protocol must not have met any of the exclusion criteria in the CLEE011A2404 study, in addition to the following:
* Patients without either fresh or archival tumor tissue accessible.
Investigating the Role of the Polyol Pathway in the Central Nervous System

Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess cerebrospinal fluid levels of metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 DM with HbA1C treated with metformin, sulfonylurea, insulin, or combination OR age-matched, non-diabetic obese (BMI \> 30 kg/m\^2) OR age-matched lean, healthy control subjects (BMI \< 25 kg/m\^2)
* Age 18-55
* BMI 18-45 kg/m\^2

Exclusion Criteria:

* Creatinine \> 1.5 mg/dL
* Hgb \< 10 mg/dL
* ALT \> 2.5 x ULN
* Untreated thyroid disease
* Uncontrolled Hypertension
* Known Neurological Disorders
* Untreated Psychiatric Disorders
* Malignancy
* Bleeding Disorders
* Smoking
* Current or recent steroid use in last 3 months
* Illicit drug use
* Pregnancy, actively seeking pregnancy, or breastfeeding
* Inability to enter MRI/MRS
Clinical Research on a Novel Deep-learning Based System in Pancreatic Mass Diagnosis

In this study, a single-center, prospective, self-control, and blind design was adopted.

It is planned to enroll 100 patients with solid pancreatic masses who are to be diagnosed with contrast-enhanced harmonic endoscopy ultrasonography (CH-EUS) follow by EUS-guided fine-needle aspiration (EUS-FNA). First, all patients will be diagnosed both by the AI-assisted diagnosis system and the endoscopists under CH-EUS; Second, to compare the EUS-FNA under the guidance of the AI-assisted ultrasound diagnosis system and the EUS-FNA under manual identification, patients were randomly assigned to undergo EUS-FNA with or without the guidance of AI-assisted diagnosis system for the first two passes.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years old, \<90 years old 2.The patient is confirmed to be a solid pancreatic mass in imaging examinations (MRI, CT or ultrasound), and CH-EUS is required for auxiliary diagnosis 3. Agree to participate in this study and sign the CH-EUS informed consent form

Exclusion Criteria:

* Subjects who meet any of the following criteria cannot be selected for this trial:

First. The patient's physical condition does not meet the requirements of conventional ultrasound endoscopic puncture:

1. Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc.
2. Blood coagulation dysfunction (platelet count \<50×1012, international standardized ratio\> 1.5) or taking oral anticoagulants such as aspirin or warfarin within a week
3. Anesthesia assessment failed
4. Had acute pancreatitis within 2 weeks
5. Pregnancy or breastfeeding
6. Known history of allergy to sulfur hexafluoride or other components
7. Recent acute coronary syndrome or clinically unstable ischemic heart attack
8. Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure\> 90mmHg), patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.

Second. Disagree to participate in this study

Third. There are other problems that do not meet the requirements of this research or that affect the results of the research:

1. Pancreatic disease has undergone surgery or chemotherapy beforehand
2. The patient was diagnosed with pancreatic cystic disease or duodenal stenosis
3. Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up
Ultrasound Guided Hematoma Block in Distal Radius Fractures

This study will investigate the effectiveness of analgesia of ultrasound hematoma block compared to 'blind' hematoma block in patients with dislocated distal radius fracture.

Distal radius fractures represent one of the most common injuries in the Emergency Department (ED). Proper treatment especially for dislocated fractures can minimize the chance of residual injury. For closed reduction anesthesia is essential for safety, satisfaction and result. Different methods of regional anesthesia can be used but hematoma block (HB) is the technique most often used in EDs in the Netherlands and recommended by Dutch guidelines. In practice however a HB, does not always lead to adequate anesthesia, this might be because of poor infiltration into the fracture site. Ultrasound could additionally provide real-time guidance of injection into the fracture site, maximizing the analgesic effect of HB. In this study the effectiveness of analgesia of ultrasound HB will be compared to 'blind' HB in patients with a dislocated distal radius fracture.

Patients with a confirmed dislocated fracture of the distal radius requiring closed reduction will be randomized to either ultrasound guided hematoma block or normal 'blind' hematoma block. NRS-scores will be given before, during and after hematoma block and during and after reduction of the fracture. These scores will be the primary endpoint of this study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 16 years
* Confirmed fracture of the distal radius requiring closed reduction, defined as any off the following items(7):

  * \>10 degrees of dorsal angulation;
  * \>20 degrees of volar angulation;
  * \>2 mm step-off intra-articular;
  * \>3 mm radial shortening;
  * \>15 degrees radial inclination;
  * Translation and non-intact radio-carpal alignment in the lateral view
  * Significant translation in the posterior-anterior(PA)-view.

Exclusion Criteria:

* No informed consent can be given (cognitive impairment, severe dementia, no knowledge of Dutch language e.a.)
* Neurovascular compromise or open fractures requiring (immediate) surgery or reduction.
* First reduction already performed
* Multi-trauma patients requiring other urgent procedures/tests or with respiratory or hemodynamical compromise
* Pre-existent osteosynthesis material in situ in the affected arm
* Skin injury (with exception of minor abrasions), local infection or recent burns hindering or contra-indicating the use of ultrasound and ultrasound gel
* Allergy for local anesthetics
Prospective Randomized Trial Comparing THD Versus Stapler Operation for 3rd Degree Hemorrhoids

Haemorrhoids have, in literature, extremely high ranges of prevalence, 4,4% to 36% and there is a debate on the best treatment for III degree hemorrhoids. The Stapled Hemorrhoidopexy is indicated in grade III haemorrhoids due to its advantages vs. other techniques in pain reduction and time before resume of normal activity. The new technique of Doppler guided trans-anal arterial ligation (THD) appear to be another important therapeutic tool thanks to its scarce complications, the minimally invasive procedure and efficacy of the short term results. The rationale of the two surgical techniques is different: in fact, the Stapled Hemorrhoidopexy is based on the hypothesis that the mucosal and sub/mucosal resection and stapling can cure the prolapse, etiologic factor of haemorrhoids; on the other hand, the interruption of the arterial inflow of hemorrhoids by THD reduces hemorrhoidal tissue." Aim of this study is to compare 2 techniques: The doppler guided transanal haemorrhoidal dearterialisation with the THD device and the stapled Haemorrhoidopexy (according to Longo) for III degree (Goligher) haemorrhoid, not regarding the number of prolapsed piles

After informed consent 284 patients with III degree hemorrhoids from 10 colorectal units will be randomized into two groups: stapler vs doppler guided transanal hemorrhoidal dearterialisation with the THD device.The early and long term outcome, as well as other secondary outcomes (costs, return to work and degree of satisfaction) will be recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* III degree hemorrhoids
* both sex
* age between 18 and 70 years
* ability to understand the procedure
* written informed consent

Exclusion Criteria:

* previous surgery for hemorrhoids
* fecal incontinence
* obstructed defecation
* other active anorectic diseases
* irritable bowel syndrome
Initial Evaluation of the Cellie Coping Kit for Children With Injury

The purpose of this study is to assess the feasibility (fidelity, acceptability, implementation, cost) of the Cellie Coping Kit for Children with Injury as well as to determine the intervention's efficacy (mechanisms of action and health outcomes).

The goal of this study is to assess the Cellie Coping Kit for Injury intervention feasibility and initial efficacy.

Aim 1: Intervention Feasibility Assess intervention feasibility (implementation, cost, fidelity).

Aim 2: Intervention Efficacy (Mechanisms of Action and Health Outcomes): Conduct initial efficacy evaluation of the Cellie Intervention on mechanisms of action (adherence and coping behaviors) and health outcomes (physical recovery, HRQOL, emotional health).

Hypotheses: At 6-week follow-up (T2), compared to a Treatment as Usual (TAU) control group, parents in the intervention group will report greater adherence to medical discharge instructions (H2.1) and encourage their child to use a higher number of adaptive coping strategies (cognitive, active, support seeking; H2.2); children in the intervention group will generate a greater number of adaptive coping strategies (H2.3).

Hypotheses: At a 12-week follow-up (T3), compared to TAU, children in the intervention group will report better HRQOL and emotional health (H2.4); parents in the intervention group will report better child HRQOL and child emotional health (H2.5). Objective injury recovery scores will be higher for the intervention group (H2.6).

Method: 80 children with injury and one parent per child will participate in a pilot RCT with a wait-list control design. Participants will complete baseline assessments of targeted study variables prior to randomization (40 to the intervention; 40 to usual care) and then repeat measures 6 (T2), 12 (T3), and 18 weeks (T4) later. Those in the immediate intervention condition will initiate the intervention following the T1 assessment. Those in the wait-list condition will initiate the intervention following the T3 assessment.

Eligibility Criteria:
Inclusion Criteria:

* child has incurred an injury within the last month requiring medical attention
* one caregiver per child willing to participate
* sufficient English language skills to understand intervention and assessment materials
* access to internet or telephone for follow-up assessments

Exclusion Criteria:

* injury resulting from family violence
A Study to Evaluate the Effect of MK-8669 (Ridaforolimus) on QTc Interval in Participants With Advanced Cancer (MK-8669-037)

To assess the potential for ridaforolimus to prolong the QTc interval (an effect on the electrical activity of the heart) in participants with advanced cancer. This study will be done in 2 parts. Part 1 (Pt 1) will evaluate the effect of a single 100 mg dose of ridaforolimus on QT interval in participants with advanced cancer. Fridericias's correction (QTcF) will be used. In Part 2 (Pt 2), participants will receive ridaforolimus at the current therapeutic dose (40 mg x 5 days).


Eligibility Criteria:
Inclusion Criteria:

* Participant must have metastatic or locally advanced cancer which has failed to respond to standard therapy or no therapy exists.
* If the participant is a female, she must be postmenopausal or if she is of childbearing potential she must have blood pregnancy tests during the study and be willing to use 2 methods of contraception.
* If the participant is male and has female partners of child-bearing potential, he must agree to use a medically acceptable method of contraception during the study and for 30 days after the last dose of study drug.

Exclusion Criteria:

* Participant has had chemotherapy, radiotherapy or biological therapy within the past 4 weeks.
* Participant is currently receiving other anti-cancer therapy.
* Participant is currently participating or has participated in a study with an investigation drug or device within the last 30 days.
* Participant has a primary central nervous system tumor or active brain metastases.
* Participant has a psychiatric disorder.
* Participant uses illegal drugs.
* Participant is pregnant or breastfeeding.
* Participant is known to be human immunodeficiency virus (HIV) positive.
* Participant has a known history of Hepatitis B or C.
* Participant has newly diagnosed diabetes.
* Participant has an active infection.
* Participant is unable to swallow capsules.
* Participant has received a blood transfusion with one week of study entry.
* Participant has a history of cardiac problems including heart failure, myocardial infarction, unstable angina, congestive heart failure or cardiac arrhythmia.
* Participant has a known sensitivity to the components of the study drug.
* Participant has not adequately recovered from any prior surgical procedure.
* Participant does not agree to refrain from use of herbal remedies and consumption of grapefruit juice for 2 weeks prior to and during the study.
Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck

The primary aim of this study was to determine the Harris hip score as an evaluation of hip function, in mentally competent elderly patients (\>65 years old) treated with either THR or IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare the rate of reoperations and complications between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Acute displaced femoral neck fracture Garden III or IV,
* Age over 65 years,
* Admission from their own home,
* No concurrent joint disease or previous fracture in the lower extremities,
* Healthy or controlled medical conditions without significant systemic effects (ASA 1-2),
* Harris hip score of 100
* Acceptance from the patient to participate in the study.
Medications for Chronic HIV: Education and Collaboration

This study will examine whether a computerized, self-administered assessment of patient medication adherence and health behaviors, plus support for adherence, improves the ability of clinicians to identify adherence problems and leads to better adherence.

Antiretroviral medications are highly effective in controlling HIV, if patients adhere to the regimen. However, HIV medication adherence problems are very common, and evidence is clear that providers have great difficulty 'diagnosing' poor adherence accurately. If healthcare providers can identify patients with adherence problems, they can intervene to help patients overcome these problems and take their medications as prescribed, which can improve symptoms and quality and length of life. Both clinicians and HIV positive patients will be recruited to this study. Before each clinic visit, patients randomized to the intervention will be asked to answer questions about their medications, medication-taking behavior, and risk-factors for non-adherence on MedCHEC, a tablet touch-screen computer that generates provider and patient reports. We will give these reports to the provider and patient to assist with the clinical visit. Based on the MedCHEC-generated report, the patient may be referred to an Adherence Care Manager (ACM). The ACM will assist the patient in overcoming adherence barriers by telephone and in-clinic counseling. The study will evaluate the effects of this system on adherence and clinical care using both quantitative methods (randomized controlled trials of effects on adherence and providers' adherence estimates), and qualitative methods.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Confirmed HIV-positive
* On or newly starting antiretroviral medication for HIV
* Under treatment at one of the study sites
* Available by telephone

Exclusion Criteria:

* Clinically diagnosed by provider with significant cognitive impairment, or Mini-Mental Status Exam score less than or equal to 22
* Inability to read English
* Inability or refusal to use MedCHEC touch-screen computer
* Inability or refusal to use any form of electronic drug monitoring device (MEMS)
* Never available by telephone
Efficacy and Safety of Aspirin Therapy With CABG

evaluate the safety of preoperative aspirin therapy when performing bypass surgery in conditions of artificial blood circulation

The hypothesis of the study was that aspirin therapy started 24 hours before CABG is safe.

The effectiveness of this hypothesis will be assessed by the presence of a 30-day period after CABG myocardial infarction, ischemic stroke, repeat revascularizations

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patient able to give informed consent

Exclusion Criteria:

* Missing consent
* Urgent or emergent surgery
* Off-pump CABG
* Рatient has clear indication for anticoagulation (eg. mechanical heart valve, atrial fibrillation) or ADP receptor antagonist (eg. drug-eluting stent)
* History of bleeding diathesis, significant GI bleed, ICH, or liver failure
* Allergy to or intolerance of aspirin
Comparison of Two Types of Lingual Fixed Retainer Fabricated

This study includes patients who have had previous orthodontic treatments (without tooth extraction) and who have good alignment of their lower incisors. Investigators will compare two types of lingual retainers made with CAD-CAM

This study includes patients who have had previous orthodontic treatments (without tooth extraction) and who have good alignment of their lower incisors. Investigator will compare two types of lingual retainers made with CAD-CAM by comparing them with the traditional lingual retainers according to the following groups:

1. Patients will be apply to them a lingual retainer made of fibers manufactured using CAD-CAM technology
2. Patients will be apply to them a lingual retainer made of metal made using CAD-CAM technology
3. Patients will be apply to them a conventional lingual retainer made of braided stainless steel wire (control group)

Eligibility Criteria:
Inclusion Criteria:

* Patients with mixed dentition at age 14-24 years. They have a good alignment of the lower incisors.- Have good oral and periodontal health.-

Exclusion Criteria:

Patients who have a deep bite Patients who have previously used retainer Patients with poor oral care
Appetite Regulation in Older-Aged Obese Individuals

This study plans to learn more about how age and weight impact appetite and food intake. Specifically, this study is being done to see whether age and obesity impact appetite and the brain's response to food. In this study the investigators will be evaluating how participants brains respond to food images as well as your food-related behaviors and hormones. The investigators will be comparing older individuals aged 65 to 85 years who are normal weight compared to those who are obese. The Investigators will then compare older aged individuals to younger adults aged 21 to 45 years.

In a cross sectional design participants will be studied on one occasion after a 3-day diet run-in. On the study day they will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken and appetite measures performed. Participants will then undergo functional magnetic resonance imaging (fMRI). This will be followed by a breakfast meal. Blood and appetite measures will be performed every half hour for 3 hours. Repeat fMRI will be performed 30 minutes after the meal. After three hours participants will be offered a buffet style lunch and then will be done with the study visit.

Eligibility Criteria:
Inclusion Criteria:

* Older aged adults (O): 65-85
* Younger adults (Y): 21-45
* Obese (Ob): body mass index (BMI) 30-40
* Normal Weight (NW): BMI 18-25

Exclusion Criteria:

* Pregnancy;
* Advanced organ failure;
* Active cancer diagnosis;
* Uncontrolled hypertension or metabolic disorder;
* Cognitive impairment or psychiatric disease limiting ability to comply;
* Presently in an exercise or diet program;
* Recent weight loss of \>5 lbs in past 6 mo.;
* Bariatric surgery;
* Use of any weight loss drugs;
* Use of any medication known to significantly affect appetite (anti-depressants are allowable);
* Present tobacco use;
* Use/abuse of substances of abuse including any marijuana use by history;
* Any contraindication to MRI;
* Claustrophobia;
* Body weight \>300 lbs; and
* Inability to fit in MRI scanner.