cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Precut-EMR for Resecting of Colonic Polyp

This study was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR for resecting of 10 \~ 20 mm colon polyp through prospective, randomized controlled trial.

In general, a potential risk of advanced colorectal neoplasia is proportional with size. However, recent study report that occurence rate of advanced neoplasia in small polyp is 9 \~ 10 %. And, incidence of interval cancer after screening colonoscopy was reported as 10 \~ 27%. So We can suspect that complete resection of small polyp is important. Previous study recommended that endoscopic submucosal dissection (ESD) is a safe and effective procedure for treating colon polyp larger than 20 mm because of high complete resection rate and low recurrence rate. In contrast, endoscopic mucosal resection (EMR) is more recommended for resecting colon polyp smaller than 20 mm because of technical ease and low rate of complication.

However, Complete resection rate of conventional EMR is 60 \~ 70%. In case of incomplete resection, local recurrence rate is higher than complete resection. And In case of adenocarcinoma, specimen of piecemeal resection cannot be evaluated a depth of invasion and resection margin, and physician cannot decide a therapeutic plan.

In precut-EMR, mucosal resection is performed after pre-incision around a polyp. When precut EMR of polyp \> 20 mm was performed in previous study, complete resection rate and en-bloc resection rate were higher and local recurrence rate was lower than conventional EMR. But, there is no study of comparsion precut EMR and conventional EMR for resecting colon polyp \< 20 mm. This study was attempted to determine the efficacy and complication of precut EMR comparing with convetional EMR through prospective, randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* All patients older than 20 years old who had 10\~20 mm colon polyp and agreed to participate a research

Exclusion Criteria:

* Medication history of antiplatelet agent within a week of procedure.
* Medical history of coagulopathy
* More than American Society of Anesthesiology class III
* Medical history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel disease, severe inflammatory disease.
* pedunculated polyp and polyp with malignant potential.
Assessing the Experience of Patients Undergoing Follicular Lymphoma Clinical Research

Historically, participation in medical studies is highly skewed towards particular demographic groups of people.

This research will invite several participants to gather a wide range of information on clinical trial experiences for follicular lymphoma patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of follicular lymphoma.

The data collected from this study will help improve future outcomes for all follicular lymphoma patients as well as those in under-represented demographic groups.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18 years of age or older
* Patient has been diagnosed with follicular lymphoma
* Patient has access to a home internet connection in order to provide regular updates through the course of the study

Exclusion Criteria:

* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Inability to provide written informed consent
* Patients receiving any other investigational agents
Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

Study is prospective and multi-center. Study will include 100 to 200 patients across up to 20 sites.The study sites will be located in the United States.The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis.

The iUni G2 Unicompartmental Resurfacing Device (iUni) is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The study subjects will be followed for 10 years post implant. The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis. The iUni is a patient-specific unicompartmental resurfacing device designed from the patient's unique anatomy using proprietary software which interprets data from the patient's CT scan. The patient matched implant design is then coupled with unique patient-matched disposable instrumentation designed using the same CT data and software. The follow-up visit schedule will include visits at 6 weeks, 6 months (optional), 1 year, 2 years, 5 years and 10 years post implant.The remaining follow-up data collected at years 3, 4, 6, 7, 8, and 9 may be collected via phone call/email and does not require a subject visit to the site.The study sites will be located in the United States.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical condition included in the approved Indications For Use
2. Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
3. Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits
4. \> 18 years of age

Exclusion Criteria:

1. Simultaneous bilateral procedure required
2. BMI \> 35
3. Treatment for cancer within the past 5 years, with the exception of skin cancer
4. Poorly controlled diabetes
5. Neuromuscular conditions which prevent patient from participating in study activities
6. Active local or systemic infection
7. Immunocompromised
8. Fibromyalgia or other general body pain related condition
9. Advanced tricompartmental osteoarthritis
10. Symptomatic patellofemoral disease
11. Rheumatoid arthritis or other forms of inflammatory joint disease
12. Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified
13. Advanced loss of osteochondral structure on the affected femoral condyle
14. Compromised ACL, PCL or collateral ligament
15. Severe (\>15º) fixed valgus or varus deformity
16. Extension deficit \> 15 º
17. Prior history of failed implant surgery of the joint to be treated
18. Unwilling or unable to comply with study requirements
19. Participation in another clinical study which would confound results
Lowering Stress Levels of Women in Lebanon

The goal of this clinical trial is to compare the experiences of women who learn the TM technique to those who do not. The main questions it aims to answer are:

1. Do women in rural Lebanon who practice the TM technique experience lower stress levels compared to those who do not.
2. Do women in rural Lebanon who practice the TM technique experience increased happiness, self-efficacy, and resilience levels compared to those who do not.

Participants will:

* complete baseline surveys
* be divided into experimental and active-control groups
* those in the experimental group will learn the TM technique, the control group will be offered an online didactic course on stress reduction
* both groups will complete post-test surveys at the end of 1 and 3 months

  * Researchers will compare experimental and control groups to see if the intervention effects stress levels.

Methods: We will measure the effects of TM on 62+ women of the Chouf region of Lebanon using the following measures: Perceived Stress Scale, Connor-Davidson Resiliency Scale, New General Self-Efficacy Scale, and the Arabic Scale of Happiness. This is a randomized controlled trial with an experimental group and an active wait-list control group.

Measurements will be taken at baseline (pre-test) and at 1 and 3 months post-test.

Eligibility Criteria:
Inclusion Criteria: Females living in the Chouf region of Lebanon between the ages of 18-95.

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Exclusion Criteria: Anyone: not female, under 18 or over 95, not in sound mental condition.

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The Impact of Inspiratory Muscle Strength Training

The study is a pre-post test with quasi experimental design. Forty-two intubated-adults who had been mechanically ventilated for more than 21 days were selected on the basis of inclusion criteria in respiratory care ward. These patients were classified equally into study group and control group. The experimental group received the intervention of respiratory muscles training 5 times/ a week for 6 weeks. The control group received normal care. The intervention was adjusted trigger sensitivity to 10% of the first recorded Maximal Inspiratory Pressure at the start of training, then increased the ventilator trigger sensitivity and training duration weekly. The largest of ventilator trigger sensitivity is not over 40% of the initial Maximal Inspiratory Pressure and the timing of training duration is no longer than 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Age \>20y/o
* Vital signs stable
* MIP \<20cmH2O
* Ventilator FiO2\<40%, PEEP \<8
* Ventilator mode:PSV or SIMV

Exclusion Criteria:

* Patient or family refuse
Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy

This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy.

This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy. Patients with a history of common extensor tendinopathy for greater than 3 months, refractory to conservative treatments, are randomized into one of two groups: injection with leukocyte rich platelet rich plasma or percutaneous tenotomy with the Tenex system. Both groups of patients are followed up in clinic at 1 week, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following the procedure to examine levels of pain or complications following both procedures.

Eligibility Criteria:
Inclusion Criteria:

* At least 3 months of lateral elbow pain
* Subjectively failed trial of physical therapy and counterbracing
* Identifiable pathology on ultrasound (one or more of the following: thickened or disorganized tendon origin, microtearing, edema, neovascularization

Exclusion Criteria:

* Steroid injection within the last 3 months
* Previous surgery for common extensor tendinopathy
* Current treatment with analgesics
* Pregnant, non-English speaking, or illiterate individuals
* History of anemia
* History of bleeding disorder
* Anticoagulant use
* History of cervical radiculopathy
* Hemoglobin less than 11 grams per deciliter
* Hematocrit less than 33%
* Platelet count outside of normal range of 150-400 x 1000 microliter
The Effects of TAP Block on Thiol/Disulfide Homeostasis and Pain in Laparoscopic Gynecological Surgery

In the study, it was aimed to compare patients who underwent laparoscopic gynecological surgery with and without TAP block in terms of postoperative pain levels and Thiol/Disulfide homeostasis. In addition, the relationship between postoperative pain levels and Thiol/Disulfide homeostasis will be investigated.

Thiols are organic sulphur derivatives containing Sulfhydryl Residues (-SH) in their active regions. Thiols easily react with oxygen containing free radicals to form disulfides. This is a defence mechanism against oxidative stress.7 An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).The role of dynamic thioldisulfide homeostasis has been increasingly shown in many diseases. There is a growing number of evidences that an abnormal thiol-disulfide homeostasis may play role in the pathogenesis of a variety of diseases such as cardiovascular disease, malignancies, rheumatoid arthritis, chronic kidney disease, and acquired immunodeficiency syndrome.

Laparoscopic gynecological surgery has several advantages when compared to open surgery, including faster postoperative recovery and lower pain scores. However, the possibility of significant postoperative pain remains. Trocar placement, tissue dissection, and pneumoperitoneum formation contribute to postoperative pain in laparoscopic surgery. If this pain is not treated adequately, it can cause an increase in pain levels, nausea and vomiting, and as a result, a decrease in patient comfort and a prolongation of hospitalization. Ultrasound-guided transversus abdominis plane (TAP) block is easy to perform and has recently become a popular technique for reducing postoperative pain after abdominal surgery. It has been reported that it provides effective postoperative analgesia with a decrease in opioid consumption in various open abdominal surgical procedures and contributes to faster patient recovery.

In the study, it was aimed to compare patients who underwent laparoscopic gynecological surgery with and without TAP block in terms of postoperative pain levels and Thiol/Disulfide homeostasis. In addition, the relationship between postoperative pain levels and Thiol/Disulfide homeostasis will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone laparoscopic gynecological surgery
* Patients who agreed to participate in the study

Exclusion Criteria:

* Patients who did not agree to participate in the study
* Patients with missing data
Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Dental Treatment

Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The purpose of this run is to use the association between this use during surgery and the attrition of post-operative pain and discomfort. In the research, laboratory and monitoring results will be obtained before, during and after the operation. Postoperative patient complaints will be evaluated at the postoperative service visit. This study is decided on a completely voluntary basis.


Eligibility Criteria:
Exclusion Criteria:

Inclusion Criteria:

Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included.

Exclusion Criteria:

developmental delay anxiety disorder Known history of allergy to alpha-2 agonistic agents use of antipsychotic medication beta blocker use of anticonvulsant drugs chronic pain syndrome with cardiac and craniofacial anomalies
Antimicrobial Revision in Persistent Febrile Neutropenia

Febrile neutropenia is often seen in patients with hematologic malignancies who receive cytotoxic chemotherapy. These patients are usually placed on posaconazole prophylaxis upon starting chemotherapy. If an episode of febrile neutropenia occurs, generally an anti-pseudomonal beta lactam, like cefepime or piperacillin-tazobactam, is initiated. In patients who continue to fever on these agents, the optimal method of antimicrobial revision has yet to be determined.

In this prospective, randomized, open-label, single-center trial, the primary objective is to compare the clinical efficacy of two approaches to antimicrobial revision among patients with persistent febrile neutropenia. Neutropenic patients on cefepime or piperacillin-tazobactam who continue to fever for greater than 96 hours will be randomized to receive either meropenem or micafungin dosed according to local guidelines. The primary outcome is a global success rate including a composite of defervescence within 72 hours of meropenem or micafungin initiation, absence of signs or symptoms of infection, and no modification to antimicrobial regimen after initiation of meropenem or micafungin. The secondary outcomes to be collected include in-hospital mortality or discharge to hospice, hospital length of stay, time to defervescence, days of therapy of meropenem or micafungin, rate of Clostridioides difficile infection on meropenem or micafungin, and cause of any proven breakthrough infection while on meropenem or micafungin.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Diagnosis of hematologic malignancy
* Receiving chemotherapy as treatment of hematologic malignancy
* Neutropenia defined as an absolute neutrophil count (ANC) ≤ 500 cells/mm3 or an ANC ≤ 1000 cells/mm3 with a predicted decline to \< 500 cells/mm3 within 48 hours
* Prescribed cefepime or piperacillin-tazobactam as initial treatment for febrile neutropenia
* Persistent fever for ≥ 96 hours since initiation of cefepime or piperacillin-tazobactam OR recurrent fever that occurs ≥ 96 hours since initiation of cefepime or piperacillin-tazobactam (fever defined as single temperature of ≥ 38.3°C (101°F) or a temperature of ≥ 38°C (100.4°F) on two consecutive measures separated by at least one hour)
* Receipt of posaconazole as neutropenia prophylaxis for at least 3 calendar days

Exclusion Criteria:

* Clinically or microbiologically confirmed infection at time of enrollment, For example, a positive culture or rapid diagnostic test, positive imaging (X-ray, CT, MRI) or biomarker, such as galactomannan, that is consistent with infection
* History of infection with organism known to be resistant to meropenem or micafungin
* Documented allergy to carbapenems or echinocandins
* Concomitant use of valproic acid
* Uncontrolled seizure disorder
* Pregnancy
* Previous enrollment in this study
Manipulating Tobacco Constituents in Female Menthol Smokers

This study examines the potential effect of reducing nicotine content or menthol or both in women of reproductive age, a vulnerable population identified by the FDA in need of further research.

Study is designed to address the following questions that have been outlined by the FDA as particular areas of interest:

1. What are the factors, including menthol and other flavorings that influence the appeal of tobacco products to vulnerable populations: What is the impact of these factors on cessation, switching tobacco products and multiple use?
2. What is the potential impact of modifying nicotine levels on dependence, and smoking rate and cessation, as well as patterns of switching products and use of multiple tobacco products?
3. Beyond nicotine, what other constituents enhance addictive properties?

Eligibility Criteria:
Inclusion criteria are:

1. smoking at least 5 menthol cigarettes daily for the last year;
2. able to speak, read and understand English
3. female age 18 -45 years of age;
4. stable residence;
5. not intending to quit smoking within the next 6 weeks.

Exclusion criteria are:

1. unstable psychiatric disorder (Psychiatric symptoms reported by patient or identified in medical record that cause current significant impairment in functioning or judgment such that the person's ability to come consistently for study appointments or render a decision regarding informed consent is in question.);
2. substance use which exceeds any of the following: marijuana use 3x/week, consuming 21 drinks/week or illicit drug use 1x/week;
3. history of cardiovascular disease;
4. current blood clot in arms or legs;
5. blood pressure \>160/100;
6. unstable medical problems which may include but are not limited to immune system disorders, severe respiratory diseases, kidney or liver diseases, thyroid problems, substance abuse or dependence that would limit patients ability to follow experimental protocol (based on history and drug and alcohol questionaires) or other heart conditions. The study physician will determine whether a given medical condition is unstable and the appropriateness of study participation for a particular subject;
7. Serious quit attempts in the last 3 months (to ensure stability of smoking);
8. regular use (e.g., greater than weekly) of tobacco products other than cigarettes;
9. Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
10. Pregnant or breastfeeding those planning to become pregnant,and those who are of childbearing potential and are not using an "acceptable form" of birthcontrol such as Depo-provera, Norplant, tubal ligation and barrier methods such as condoms or diaphragm.
Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis

Leptomeningeal metastasis, characterized by tumor cells infiltrating and proliferating in the subarachnoid space, represents a distinct pattern of central nervous system involvement and is a fatal complication of malignant tumors. This study is a prospective, single-arm phase I/II clinical trial aimed at evaluating the safety and efficacy of intrathecal Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) bispecific antibodies combined with pemetrexed in treating leptomeningeal metastases from solid tumors, with the goal of identifying more effective treatment options.

Leptomeningeal metastasis is a severe form of tumor metastasis, primarily treated with intrathecal chemotherapy. Recently, immunotherapy has been applied to various solid tumors. Previous studies have demonstrated that combining PD-1 monoclonal antibody immunotherapy with intrathecal pemetrexed is both safe and effective. Currently, a clinical study in Switzerland is investigating the use of combined PD-1 and CTLA-4 dual immunotherapy with intrathecal administration for treating leptomeningeal metastasis. Cadonilimab, the world's first PD-1/CTLA-4 bispecific antibody, is widely used in clinical settings, showing good safety and efficacy. This prospective, single-arm Phase I/II clinical study aims to evaluate the safety and efficacy of intrathecal Cadonilimab (PD-1/CTLA-4) combined with pemetrexed in treating leptomeningeal metastasis from solid tumors, seeking more effective treatment options.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive.
2. Male or female aged between 18 and 75 years; Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.
3. No history of severe nervous system disease; No severe dyscrasia.

Exclusion Criteria:

1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.
4. The first month to treatment, as well as during induction and consolidation therapy, new drugs effective against meningeal metastases were used, excluding those previously administered. These primarily included small molecule targeted therapies, such as EGFR-TKI/ALK-TKI drugs like Osimertinib and Lorlatinib.
5. Patients with poor compliance or other reasons that were unsuitable for this study.