cyrilzakka/clinical-trials huggingface dataset:
Brief Title : Optimized Endoscopic Submucosal Dissection With Snaring for Colorectal Neoplasm

This study is aimed to analyze the outcomes after conventional endoscopic submucosal dissection (ESD) and optimized ESD with snaring (oESD-S) for colorectal neoplasm that is more than 20 mm in diameter of laterllay spreading tumor or flat elevated lesion without stalk.

Optimized ESD with snaring means submucosal dissection followed by snaring when narrowed circumference of the remained submucosal tissue beneath the lesion is less than 5 mm in diameter with snaring, then resected by using an electric current.

The investigators expect optimized ESD with snaring can provide more time-saving procedure with comparable en-bloc resection rate and perforation rate, when compared with the conventional ESD method.


Eligibility Criteria:
Inclusion Criteria:

* colorectal laterally spreading tumor that is more than 20 mm in diameter
* other elevated or flat colorectal neoplasm without stalk, that is more than 20 mm in diameter

Exclusion Criteria:

* colorectal neoplasms that are proven or suspected to be invaded more than submucosal invasion
* colorectal neoplasms that have severe fibrosis beneath the target lesion
* patient's refusal to participate this study
* less than 18 years old
* subjects who cannot consent voluntarily due to the communication difficulty
Diabetes, Insulin Resistance and Body Composition

The goal of this retrospective study is to learn about the correlation between diabetes, insulin resistance and body compositions.

The main question\[s\] it aims to answer are:

* \[The difference of body composition between the individuals of insulin resistance and diabetes\]
* \[The effect of diabetes on body composition\]


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 years and older.
2. Diagnosed with type 2 diabetes mellitus according to recognized diagnostic criteria.
3. Availability of complete body composition data (e.g., DXA measurements).
4. Documented HbA1c levels and other glycemic control data.
5. Continuous medical records available during the study period

Exclusion Criteria:

1. Presence of other severe metabolic diseases, such as liver failure or kidney failure.
2. Use of medications affecting muscle mass (e.g., glucocorticoids) for more than three months.
3. History of malignancy or ongoing treatment for cancer.
4. Missing critical research data (e.g., diabetes duration or HbA1c levels).
5. History of surgeries causing significant body composition changes (e.g., bariatric surgery).
New Robotic Assistance System for Spinal Fusion Surgery

The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery

Based on the literature review of similar devices and on the pre-clinical tests performed with the AQrate System on bench and cadavers, the study is build around the following hypothesis:

1. The design and principle of operation of the AQrate System permits a correct integration in the surgical procedure flow thus enabling the surgeon to benefit from its advantages while not generating any additional operational difficulties
2. The stability and ease of use of the device will permit the surgeon to achieve any planned spinal fusion without requiring additional assistance from the medical staff compared to a conventional spinal fusion surgery.
3. A spinal fusion surgery procedure that is performed with the use of the AQrate System is similar to conventional spinal fusion surgery. If correctly used, no additional adverse event should be observed.
4. The exposure to x-ray should decrease as the need of intraoperative recheck of pedicle screws placed should be reduced
5. The precision of placement of pedicle screw should not be adversely affected by the use of the system compared to conventional spinal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age from 18 years to 85 years) scheduled for spinal fusion surgery,
* Primary spinal surgery (It is the first surgery on this patient's spine)
* Patient is capable of complying with study requirements, and
* Patient is willing to provide a signed informed consent.

Exclusion Criteria:

* Pregnancy and lactation
* Simultaneous participation in other clinical studies
* Infection or malignancy
* Previous spondylodesis
* Previous spinal surgical procedures
* Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, neurofibroma)
* Spinal cord abnormalities with any neurologic symptoms or signs
* Paraplegia
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
* Patient cannot follow study protocol, for any reason
* Patient cannot or will not sign informed consent
* Patients in emergency situation, are not legally competent, cannot understand the situation,
* Pediatric patients
Up-positioning of the Testes as Supportive Therapy in Patients With Acute Orchitis

This is a single-blinded RCT evaluating the value of up-positioning of the testes as supportive therapy in patients receiving antimicrobial treatment due to acute bacterial orchitis.


Eligibility Criteria:
Inclusion Criteria:

* acute orchitis confirmed clinically and in scrotal ultrasound
* age \>=18 yrs

Exclusion Criteria:

* previous treatment of orchitis,
* need for exploration of the scrotum,
* need for hospitalization,
* physical and mental status not allowing for up-positioning of the testes during treatment
Study of Lonafarnib Versus Placebo in Subjects With Either Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) (Study P02978AM3)(TERMINATED)

The purpose of this study is to assess the benefit of lonafarnib (versus placebo) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML). Benefit will be measured by achievement of platelet transfusion independence for at least 8-consecutive weeks, and without simultaneous worsening of hemoglobin and/or need for red blood cell (RBC) transfusion. Additional endpoints will be hematologic response (which includes complete remission, partial remission, hematologic improvement), number of RBC transfusions, bleeding events, infections and safety.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed MDS (RA, RARS, RAEB, RAEB-T) or CMML according to FAB classification.
* Platelet transfusion dependence (requiring 1 to 8 platelet transfusion events every 4 week period (Day 84 to Day 57, Day 56 to Day 29, and Day 28 to Day 1) over an 8-week retrospective and 4-week prospective screening period).
* The individual number of platelet transfusion events during the three 4-weekly periods (Day 84 to Day -57; Day -56 to Day 29; Day -28 to Day -1) must not differ by greater more than 2 from the average number of platelet transfusion events during the 12 week screening period.
* If the subject is RBC transfusion dependent, the number of RBC transfusion events during the three 4-weekly periods (Days -84 to -57; Day -56 to Day 29 and Day -28 to Day -1) must not differ by more than 2 from the average number of RBC transfusion events during this 12 week screening period.

ECOG PS 0-2.

Exclusion Criteria:

* Subjects with chemotherapy/radiotherapy-associated secondary MDS.
* \<12 Weeks (prior to Day-1 Randomization) from any investigational drug use, any chemotherapy, radiotherapy, immunotherapy and any other treatment or MDS/CMML other than best supportive care.
* Hx of bone-marrow or peripheral stem-cell transplantation or treatment with donor lymphocyte infusion.
* Hx of AML.
* Known hx of immune thrombocytopenic purpura.
* Marked baseline prolongation of QTc interval, CTCAE Grade \>=1.
* Use of ketokonazole within 72 hours prior to study drug administration.
Retrospective Study of Patients With Severe Aplastic Anemia Who Relapsed After Immunosuppressive Therapy

Background:

Severe aplastic anemia (SAA) is a form of bone marrow failure. It usually results from a

cytotoxic T cell attack on the marrow stem cell. Two treatments can be used for most people with SAA. One is allogeneic hematopoietic stem cell transplant (HSCT). The other is immunosuppressive treatment (IST). For people who are treated with IST, relapse can occur. If this happens, they can have HSCT or be re-treated with IST. The two most common IST regimes used for relapsed SAA are rabbit ATG (rATG) and alemtuzumab. Both rATG and alemtuzumab have similar response rates and survival rates. There is not much long-term data on people who need repeat IST treatment due to relapse. Researchers want to look at data from past studies to learn more.

Objective:

To compare the data of relapsed SAA patients between those who received alemtuzumab versus rATG for repeat IST treatment.

Eligibility:

Adults and children with SAA who were enrolled on NHLBI protocol 12-H-0150, 06-H-0034, 05-H-0242, 03-H-0249, 03-H-0193, 00-H-0032, or 90-H-0146

Design:

This study uses data from past studies. The participants in those studies have allowed their data to be used in future research.

Researchers will review participants medical records. They will collect clinical data, such as notes, test results, and imaging scans. They will also collect the research data gathered as part of the original study.

Researchers will enter the data into an in-house database. It is password protected. All data will be kept in secure network drives or in secure sites.

Other studies may be added in the future....

Severe aplastic anemia (SAA) is a form of bone marrow failure and in most cases is the result of a cytotoxic T cell attack on the marrow stem cell. It is effectively treated in most patients with either immunosuppressive treatment (IST) or upfront allogeneic hematopoietic stem cell transplant (HSCT). However, in patients who are treated with IST, relapse remains an issue with a rate of 30-40%. Once relapsed, patients can be either re-treated with IST or undergo HSCT. The two most common IST regimes used for relapsed SAA are rabbit ATG (rATG) and alemtuzumab. Both rATG and alemtuzumab have been shown to have a response rate of approximately 60% in relapsed patients with similar overall survival rates of 83-85%. Previous predictors of relapse include time from diagnosis to IST, and early response to IST. Few long-term data exist on patients requiring repeat IST treatment due to relapse.

Eligibility Criteria:
* This is a retrospective chart review. The investigators will review the medical records of adults and children with severe aplastic anemia (SAA) enrolled on immunosuppressive therapy (IST) treatment protocols in the NHLBI.

Patients who opted out of future use of data on their prior studies will be excluded from this study.
Acceptability of Mobile Applications (Apps) to Enhance Smoking Cessation in a Clinical Tobacco Treatment Program - A Pilot Study

We will conduct a small-scale randomized controlled trial (RCT) with 24 adult smokers enrolled in the TTP. Participants will receive either the Free4Good mobile app for positive psychology skills training or a breathing relaxation mobile app control (Breathe2Relax). All participants will be receiving tobacco cessation treatment in the Tobacco Treatment Program at MD Anderson as standard of care.

The aims of this pilot protocol are to test the adherence, acceptability, user satisfaction, and preliminary efficacy of a smartphone mobile health app, Free4Good, which incorporates skills training in positive psychology vs. a relaxation app, Breathe2Relax (control condition), in a small randomized controlled trial of smokers (N = 24). Adherence will be measured directly through app usage data. Acceptability and user satisfaction will be measured via specific items included on a User Satisfaction Questionnaire. Efficacy outcomes include evidence of increased engagement in positive psychology-related quitting strategies (measured by the Quitting Strategies Questionnaire) and smoking abstinence.

Exploratory analyses including covariates such as nicotine dependence, mood, and depressive symptoms may be examined as appropriate, as these measures have been shown to predict abstinence outcomes in a variety of studies.1-4 Changes in mood and/or depressive symptoms may also be characterized

Eligibility Criteria:
Inclusion criteria:

* MD Anderson patient between the ages of 18 to 65
* current smoker (i.e., at least 1 cigarette or e-cig per day)
* smoking for at least one year,
* willing to set a quit date in the next 30 days,
* not engaged in smoking cessation treatment other than the MDACC Tobacco Treatment Program
* English speaking and ability to read and comprehend English, and 7) currently own an iOS mobile phone (iPhone) using iOS 9.0 or later and reports regular use (at least weekly) of at least 1 iOS app.

Exclusion Criteria

* endorsing current suicidal ideation or intent,
* meeting criteria for a current Major Depressive Episode measured by the PHQ-9,
* any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Collaborator,
* subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of the study.
* Pregnant women will not be excluded from participating in the study and any decisions about potential pharmacotherapy will be done as standard of care in the Tobacco Treatment Program, including a consultation with the medical team and a joint decision-making process with the patient to determine the best course of treatment given all co-morbid medical conditions.
Exercise Interventions of Eye Muscles Post Strabismus Surgery

It will be hypothesized that:

* Eye exercises have a positive effect on correction of remaining ocular deviation post strabismus surgery.
* Eye exercises have a positive effect on improving amplyobia.

This study applied to determine the effect of physiotherapy exercises on correction the remaining ocular deviation which still present following the strabismus surgery and also its effect on amplyobia.

Different type of physiotherapy exercises was applied to experimental group for 12 weeks beside the medical treatment applied post-surgery while the control group received traditional treatment only.

The near and far angles of ocular deviation were measured before and after the treatment for evaluation of strabismus and measuring visual acuity for evaluation of amplyobia.

Eligibility Criteria:
Inclusion Criteria:

* Patients received strabismus operation
* All types of strabismus surgery will be included
* They selected from Outpatient Clinic
* Patients begin the training program after 2 weeks of operation or more than this
* The patient still suffering from amblyopia post strabismus surgery

Exclusion Criteria:

* Muscular disorders that will impair performance during training.
* Neurological disorders.
* Malignant conditions.
* Psychiatric illness, severe behavior or cognitive disorders. Children who can't understand the therapist's instructions and orders.
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men

This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in preventing cancer in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate may prevent cancer.

PRIMARY OBJECTIVES:

I. Determine the toxic effects of Bowman-Birk inhibitor concentrate, administered as an orange juice suspension, in healthy male participants.

II. Determine a safe dose range of this drug in these participants. III. Determine a recommended phase II dose of this drug in these participants.

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics of this drug in these participants.

OUTLINE: This is a randomized, placebo-controlled, double-blind, dose-escalation study.

Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each dose level cohort is randomized to receive placebo. Participants receive 1 of 4 escalating doses of oral Bowman-Birk inhibitor concentrate or placebo, as an orange juice suspension, on day 1.

After completion of study treatment, participants are followed periodically for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Male
* Performance status - ECOG 0-2
* RBC normal
* WBC ≥ 3,000/mm\^3
* Platelet count normal
* Hemoglobin normal
* Hematocrit normal
* ALT and AST normal
* Bilirubin normal
* Creatinine normal
* No history of heart disease
* EKG normal
* No history of pancreatitis or obstruction of pancreatic ducts
* No history of pancreatic cancer or pancreatic adenoma
* Amylase normal
* Lipase normal
* Cholesterol normal
* Triglycerides normal
* Serum glucose ± 10% of normal
* Within 15% of ideal body weight
* No history of chronic medical condition
* No history of excessive alcohol consumption (i.e., \> 2 alcoholic beverages per day on average)
* No history of amyloidosis
* Non-smoker

  * Former smokers are eligible provided they have not smoked within the past 3 months
* No history of medical condition that would influence gastrointestinal uptake of the study drug
* No history of diabetes mellitus
* No allergy or prior adverse reaction to soybeans
* Not a vegetarian
* No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer
* No evidence of other life-threatening disease
* No evidence of psychiatric problems
* More than 12 months since prior chemotherapy
* More than 1 month since prior experimental drugs
* More than 3 days since prior consumption of alcoholic beverages
* More than 2 weeks since prior and no concurrent regular use (i.e., \> 3 times/week) of nonsteroidal anti-inflammatory drugs
* More than 2 weeks since prior multivitamin tablets (or other vitamin supplements) of \> 2 per day
* No more than 2 multivitamin tablets (or other vitamin supplements) per day during study participation
* No more than 1 serving of tofu, soy milk, or other primarily soy-based food per day
Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome

The obstructive sleep apnea syndrome (OSAS) involves recurrent sleep-related upper airways (UA) collapse. UA mechanical properties and neural control are altered, imposing a mechanical load on inspiration. UA collapse does not occur during wakefulness, hence arousal-dependent compensation. Experimental inspiratory loading in normal subjects elicits respiratory-related cortical activity during wakefulness. The objective of this study is to test whether awake OSAS patients would exhibit a similar cortical activity. Whether or not such cortical compensatory mechanisms have cognitive consequences would be also analyze.


Eligibility Criteria:
Inclusion criteria :

1. OSAS patients

   * severe OSAS with an Apnea-Hypopnea Index (AHI) \> 30/h
   * without CPAP treatment
2. Non-OSAS patients

   * absence of OSAS (AHI \< 15/h and absence of excessive daytime sleepiness with Epworth score \<11)

Non-inclusion criteria :

* \< 18 years old
* \>75 years old
* left-handed
* BMI\> 40 kg/m²
* another sleep disorder
* central component of sleep apnea syndrome (central apnea index\> 5 / h)
* current or past neurological pathology
* respiratory pathology (obstructive ventilatory disorder, restrictive ventilatory disorder, hypercapnia)
* MRI contraindication (metallic foreign body, claustrophobia, pregnant woman, etc.)
* taking drugs that can modify the BOLD signal on MRI (psychotropic drugs, vasodilators, vasoconstrictors, etc.),
* uncorrected sensory impairment (vision or hearing)
* protected by law.

Exclusion criteria :

* pregnant woman according to the positive beta-hCG test result
* left-handed following the laterality questionnaire
* MINI results showing:

  * a current mood episode
  * a current disorder of the use of psychoactive substances or in the last 6 months (excluding tobacco)
  * an eating disorder
  * a diagnosis of bipolar disorder, current or past schizophrenia
Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma

The purpose of the study is to evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) in participants with androgen receptor (AR) positive, high-risk salivary duct carcinoma (SDC).

The procedures include screening, treatment and follow-up period. The treatment includes rezvilutamide plus Luteinizing Hormone Releasing Hormone agonist (LHRHa) for up to 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Histologically confirmed salivary duct carcinoma and stage III or IVa or IVb according to AJCC Cancer Staging Manual Eighth Edition
* Completed SDC surgery, and adjuvant radiotherapy is planned or ongoing or has completed
* Androgen receptor (AR) positive
* White blood cell (WBC) ≥ 3.0 x 10\^9/L, Neutrophil count≥ 1.5 x 10\^9/L, Platelet count (PLT) ≥ 75 x 10\^9/L, Haemoglobin (Hb) ≥ 90 g/L
* Serum creatinine (Cr) \< 1.5 x upper limit of normal(ULN) or creatinine clearance ≥ 50 ml/min.
* Total bilirubin (TBIL) \< 1.5 x ULN, AST\< 2.5 x ULN, and ALT\< 2.5 x ULN
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2, and ability to take oral medication
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 year after the end of study intervention administration
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:

* Received prior anti-AR pathway therapy
* Treatment with another investigational drug or chemotherapy within 6 months
* History of hypothalamus or pituitary dysfunction
* History of seizure
* Clinically uncontrolled diseases, such as septic shock, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) class III or IV heart disease, clinically unstable arrhythmia, myocardial infarction (in the past 6 months)
* Previous cancer except skin cancer rather than malignant melanoma or any cancer curatively treated \> 5 years prior to study entry
* Pregnancy or lactation