cyrilzakka/clinical-trials huggingface dataset:
Transversus Abdominis Plan Block Versus Rectus Sheath Block

The investigator aims to compare the analgesic efficacy of Transversus Abdominis Plan Block and Rectus Sheath Block which are used to prevent intraoperative and postoperative pain and reduce the use of opioid in abdominoplasty operations.

Abdominoplasty is a frequently performed surgical procedure in aesthetic and plastic surgery. It is performed to solve the pain caused by the large abdomen, respiratory distress and aesthetic problems. Since large tissue excision is made and a large area is worked on, providing perioperative pain control is also important to prevent both postoperative respiratory distress and postoperative chronic pain formation.

In order to prevent both intraoperative and postoperative pain and to reduce opioid use, peripheral nerve blocks that provide analgesia on the abdominal wall can be applied to patients before the surgical incision. The most well-known of these blocks is the Transversus Abdominis Plane block. Another block that has been proven effective in abdominal surgery is the Rectus Sheath block. In the Transversus Abdominis Plane block (TAP), local anesthetic is injected into the fascia between the internal oblique and transversus abdominis muscles, aiming for analgesia. It provides multidermatomal sensory block by spreading the local anesthetic agent in the fascial area. The Rectus Sheath (RK) block is also a preferred plan block in abdominoplasty surgery. In this block, local anesthetic agent is injected between the rectus muscle and the posterior rectus sheath to achieve analgesia.

Although the effectiveness of both blocks has been shown mostly in abdominoplasty operations, there is no publication in the literature showing and comparing their effectiveness in abdominoplasty operations. With this study, The investigator aimed to compare the analgesic effectiveness of the two blocks in patients who will undergo abdominoplasty operations.

Eligibility Criteria:
Inclusion Criteria:

Patients who will undergo elective abdominoplasty

* Patients between the ages of 18-65
* ASA (American Society of Anesthesiologists) I-II-III patients
* Patients with a body weight between 50-80 kg

Exclusion Criteria:

* - ASA IV patient group
* Patients under 18 years of age
* Patients without cooperation
* Patients with chronic alcohol use
* Patients in whom peripheral plane block application is contraindicated (infection at the application site, coagulopathy, local anesthetic allergy)
* Patients who do not want to participate in the study
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine

We are examining how morphine (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in our research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.

Pain management on the battlefield is critical for the wellbeing of the soldier. Given that a hemorrhagic injury on the battlefield is virtually always associated with pain, it is paramount that the selected pain medication does not disrupt appropriate physiological mechanisms that are beneficial towards the maintenance of blood pressure and vital organ blood flow during that hemorrhagic insult. Current guidelines for the selection of pain medications of a hemorrhaging soldier are based upon limited scientific evidence, with the vast majority of supporting studies being conducted on anesthetized animals. Thus, the interaction between hemorrhagic shock and pain medications commonly employed on the battlefield is yet to be determined in the conscious humans.

With this background, we will test the hypothesis that morphine will impair the capacity for a conscious human to tolerate a hemorrhagic insult.

The obtained data will provide the necessary scientific evidence in humans to support the Committee on Tactical Combat Casualty Care (CoTCCC) guidelines on the analgesic of choice for moderate to severe injuries where the casualty is in hemorrhagic shock. Notably, such data will identify the analgesic that least compromises a human's ability to tolerate a hemorrhagic insult, ultimately providing critical information to the combat medic on which analgesic should be employed for such an injury.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-obese (body mass index less than 30 kg/m2)
* Body mass greater than or equal to 65 kg

Exclusion Criteria:

* Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
* Any known history of renal or hepatic insufficiency/disease
* Pregnancy or breast feeding
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* Positive urine drug screen
* Currently taking pain modifying medication(s)
Preload, Weight Management, Risk of Cardiovascular Disease

Investigators presumed that preload consumers will have more weight reduction and lower risk of cardiovascular disease

To our knowledge, all previous studies evaluated the energy intake in a dietary meal after consuming a low-energy-dense preload while none assessed the sustainability of lower amount of energy intake and body weight changes in a long-term. On the other hand, the sustainability of lower energy intake in a long term might be affected by higher dietary diversity score due to considering preload in diets. Notably, increased diet variety is associated with higher overall dietary energy intake and weight gain.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25,
* older than 18 years

Exclusion Criteria:

* poor dietary compliance
Symptom-Targeted Rehabilitation for Concussion

The investigators are comparing two methods for helping improve everyday cognitive functioning in Canadian Armed Forces (CAF) veterans who have sustained a mild traumatic brain injury (mTBI). The two methods are 1) providing educational materials (Education Group) and 2) individual cognitive rehabilitation delivered by a trained Occupational Therapist or Speech-Language Pathologist (Therapy Group). The study is a pilot randomized controlled clinical trial (RCT), and will serve as pilot data for a future RCT.

The investigators are comparing two different methods for helping Canadian Armed Forces veterans with mild traumatic brain injury (mTBI) manage everyday cognitive difficulties. Cognitive rehabilitation is a type of therapy that helps people with brain injury who have challenges in everyday thinking. The investigators have developed a streamlined version of this type of cognitive rehabilitation therapy that can be done in person or virtually and takes place over a 3-week period. The investigators will provide education materials only to one group and individual cognitive rehabilitation delivered by a trained Speech Language Pathologist or Occupational Therapist to the other group. The investigators want to find out whether the individual therapy is better than providing the usual educational material. The therapy sessions are audio-recorded. At McMaster, the investigators job is to listen to the recordings and making sure the therapists are following the study manual. That includes making notes of what the therapists say or do. What the investigators learn in this study may help veterans with mTBI and cognitive issues affect their abilities to do everyday activities.

Eligibility Criteria:
Inclusion Criteria:

* Is a community-dwelling Canadian Armed Forces veteran.
* Is age 18 years or older.
* Self-identifies as a fluent English speaker.
* Has no previous history of neurological disorder affecting cognition, by self-report.
* Is able to participate in rehabilitation for 4 weeks: 3 weeks of treatment + baseline + outcome assessment, with potential rescheduling for missed sessions.
* Is not actively participating in cognitive rehabilitation directed by a registered health professional (e.g., speech-language pathologist or occupational therapist).
* Has access to an electronic device with Zoom video platform capacity and internet access.

Exclusion Criteria:

* A score of less than 20 on the Montreal Cognitive Assessment (MoCA), which indicates a risk for dementia.
* Cannot identify at least 3 problems on the Common Cognitive Complaints after Concussion Questionnaire (C4), as there would be insufficient areas for intervention.
Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement.

The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer.

Study visits:

* Screening
* Spacer placement
* Treatment planning simulation
* End of the radiation treatment
* 1,3,and 6-months FU visits.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with prostate cancer ≥ 18 years of age.
2. Patients are in one of the following risk groups:

   * T1-T3 prostate cancer with no posterior extra capsular extension
   * Gleason score ≤ 7
3. Planned for radiation treatment with rectal spacer.
4. Ability to understand and the willingness to sign a written informed consent form.

Exclusion Criteria:

1. Metastatic disease.
2. Previously treated localized adenocarcinoma of the prostate.
3. Active Inflammatory bowel disease requiring treatment with steroids.
4. Prior total prostatectomy.
5. Current urinary tract infection.
6. Acute or chronic prostatitis.
Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts

The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.

A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and females, 18 to 55 years of age
* Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females)

Exclusion Criteria:

* History or presence of significant disease
* History of substance abuse or dependence (except caffeine), or treatment for substance use disorder(s) within the year prior to screening or within 6 months for nicotine including e-cigarettes
* Use of any tobacco-containing or nicotine-containing products within 6 months prior to the first dose
* Use of any prescription or the over-the-counter medications within 14 days
Comparison of Two Different Treatment Effects on Individuals With Chronic Lateral Epicondylitis

The aim of this study is to compare the effects of Radial Extracorporeal Shockwave Therapy (rESWT) treatment and Deep Friction Massage (DFM) treatment on pain, functionality, grip strength (GS), edema, range of motion (ROM) of the elbow and quality of life in individuals with chronic lateral epicondylitis (CLE).

36 individuals diagnosed with CLE will be randomly divided into two equal groups. rESWT treatment will be applied to Group 1 and DFM treatment to Group 2. Visual analogue scale will be used to assess pain severity, functionality with Patient-Rated Elbow Evaluation Turkish version (PRTEE-T), GS with digital dynamometer, ROM of the elbow joint with goniometer, edema with environmental measurement, and quality of life with Short Form 36 (SF-36).


Eligibility Criteria:
Inclusion Criteria:

* Individuals with pain on the lateral epicondyle or proximal musculotendinous area of the forearm extensor muscles for at least 3 months,
* Individuals with a positive Thomsen Test ,

  - Individuals who have not received physical therapy for lateral epicondylitis,
* Individuals with a positive Maudsley Test will be included.

Exclusion Criteria:

* Individuals who have received any physical therapy,
* Individuals with reflected pain due to cervical and shoulder pathologies,
* Individuals with elbow osteoarthritis,
* Individuals with previous elbow fractures or elbow joint operations,
* Individuals with a history of systemic inflammatory disease,
* Individuals with osteoporosis,
* Individuals with cardiovascular problems will not be included in the study.
Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction

The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle modification program on symptoms and signs of heart failure as well as laboratory and echocardiographic measures of cardiac structure and function. This will be a 6 month trial in 50 patients with a clinical diagnosis of heart failure with preserved ejection fraction (HFpEF). Patients will be enrolled in the Medical University of South Carolina weight management 15 week lifestyle change program which will involve weekly visits that rotate among the clinical specialities (dietary, exercise and behavioral) and scheduled visits with the research Registered Nurse. Each patients baseline data will be used as the control and compared with the same measurements at the 6 month end point.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30
* Able to perform 6 minute hall walk test
* Left Ventricular ejection fraction \>45%
* Diagnosis of heart failure with preserved ejection fraction (HFpEF) ; confirmation of HFpEF based on 1 major or 3 minor criteria listed below.

Major:

1. Elevated BNP \>200
2. cardiogenic pulmonary edema
3. Pulmonary capillary wedge pressure at rest \>15 mmhg or with exercise \>25 mmhg using invasive right heart pressure measurement

Minor:

1. Left atrial enlargement (volume \>68 ml)
2. increased left ventricular wall thickness (\>1.1cm) by echocardiography
3. E/e' \>15
4. intermediate level of BNP, 60-199

Exclusion Criteria:

* uncontrolled blood pressure
* severe chronic obstructive pulmonary disease (oxygen or steroid dependent)
* recurrent major depression. presence or history of suicide behavior, and current substantial depressive symptoms. Antidepressant drugs are allowed if the dose has been stable for 3 months
* other major psychiatric illness (schizophrenia, bipolar, dementia)
* significant hepatic dysfunction
* untreated hypothyroidism or hyperthyroidism
* history of drug or alcohol abuse or dependency within the past 12 months
* acute coronary syndrome without revascularization in the past 12 months
* acute coronary syndrome with revascularization in the past 6 months
* Cerebrovascular accident or transient ischemic attack in the past 6 months
* cancer or terminal illness with life expectancy \< 3 years
* history of medical noncompliance
* significant anemia (hgb \<9)
* life threatening or uncontrolled arrhythmia
* hemodynamically relevant valvular heart disease
* infiltrative heart disease including cardiac amyloidosis, sarcoidosis, Fabry's disease
* genetic hypertrophic cardiomyopathy
* significant pericardial disease
* clinically relevant neuromuscular disease
* pregnant or may become pregnant in the next 6 months
* prior major organ transplant or intent to transplant ( on the transplant list)
* pacemaker dependant
* clinically significant congenital heart disease that may be cause of symptoms
A Study to Evaluate the Efficacy and Safety of AK127 in Patients With Advanced Solid Tumors

This study is to characterize the safety, tolerability and anti-tumor activity of AK127 as a single agent in adult subjects with advanced solid tumor malignancies.

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK127 as a single agent in adult subjects with advanced solid tumor malignancies. The study, as a dose escalation phase is to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK127 as a single agent, and describe Dose Limiting Toxicity (DLT).

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
2. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
4. Life expectancy ≥3 months.
5. Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy.
6. Adequate organ function.
7. Patients of childbearing potential must agree to use effective contraceptive measures.

Exclusion Criteria:

1. The patient has received prior immunotherapy against TIGIT target.
2. Not currently enrolled in any other clinical study.
3. Receipt of any anticancer therapy within 4 weeks or within 5 half-lives of the drug prior to the first dose of AK127.
4. Symptomatic central nervous system metastases.
5. Active malignancies within the past 1 years, with the exception of tumors in this study and cured local tumors.
6. Active autoimmune disease requiring systemic treatment prior to the start of study treatment.
7. There is a history of major diseases 1 year prior to the first dose.
8. Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose.
9. Received chest radiation therapy prior to the first dose.
10. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
11. Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
12. Receipt of live or attenuated vaccination within 4 weeks prior to the first dose of AK127.
13. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
14. Known history of active tuberculosis.
15. History of organ transplant or hematopoietic stem cell.
16. History of primary immunodeficiency.
17. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
18. Other cases deemed inappropriate by the investigator.
Dermal Fillers Patient Satisfaction

The face is arguably the most critical aesthetic unit of the body. As humans begin to age, numerous changes occur to the face. Changes include the formation of wrinkles, soft-tissue atrophy, gravitational descent resulting in sagging skin, loss of skin and muscle tone, and changes in bony architecture. These changes are potentiated in our population secondary to sun exposure and smoking. To combat the effects of aging on the face, a multitude of products and procedures exist to attempt to reverse the effects of sun damage and aging to achieve a youthful and rejuvenated appearance. There has been a shift from invasive procedures such as a facelift to noninvasive means using filling agents to restore lost contour deformities.

The investigators hypothesis is that the use of dermal filling agents effectively delays the need for invasive procedures such as facelifts, and that patient satisfaction has increased with the evolution of recent dermal filling agents.

The first part of this study will involve a retrospective review of patients who have had a dermal filler injection between 01/01/1998 through 12/31/2008 and then following up with one (1) patient satisfaction survey. The first part of the study, which is retrospective, may involve approximately 500 subjects. The data collected from the retrospective review will be the subject's name, medical record number, and address for contact information. Any other data collected will come from the answers on the questionnaire.

The second part of this study will be a prospective study involving 100 subjects who are scheduled to have a dermal filler injection. These subjects will be asked to complete one (1) patient satisfaction survey two weeks after injection. Facial photos will be taken before the injection and then two weeks after injection at the follow up visit. This will complete the subject's participation in this study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects from 21 - 80 years of age who are scheduled to have a dermal filler injection.

Exclusion Criteria:

* Subjects under 21 years of age or older than 80 years of age will be excluded from this study.
Multimodal Analgesia Methods in Patients Undergoing IPACK Block in Knee Arthroplasty

A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) - in patients undergoing total knee arthroplasty. dexketoprofen and paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).

Postoperative pain after total knee arthroplasty is serious and difficult to management. Multimodal analgesia recommended for the pain management. For these reasons, we planned a study involving two multimodal analgesia regimens. Patients who will undergo total knee arthroplasty will receive preemptive oral analgesic (dexketofrofen) 1 hour before the operation. Surgery will be initiated after spinal anesthesia is applied to the patients. Two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ IPACK- will be applied at the end of the surgery. dexketoprofenand paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).

Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon
* Age 18 to 80 years
* Planned use of regional anesthesia
* Ability to follow study protocol
* Patients of participating surgeons

Exclusion Criteria:

* Hepatic or renal insufficiency
* Younger than 18 years old and older than 80
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* BMI \> 40
* Diabetes
* ASA of IV
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5mg/day for one month)