cyrilzakka/clinical-trials huggingface dataset:
Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib

The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years and older.
* Chronic myeloid leukemia (CML)
* Previous treatment with imatinib at a dose of \>600 mg/day AND the development of progressive disease while receiving imatinib at that dose, OR
* CML with resistance to imatinib at a dose less than or equal to 600 mg/day with genetic mutation in the BCR-ABL gene that is associated with a high level of resistance to imatinib, OR
* Intolerance to imatinib at any dose
* Adequate organ function
* Women who are able to bear children must have a negative serum or urine pregnancy test. Adequate methods of contraception must be used throughout the study to avoid pregnancy for the entire interval of at least 1 month before and 3 months after completion of the study medication.

Exclusion Criteria:

* Woman who are pregnant or breastfeeding
* Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above
* Previous diagnosis of accelerated phase or blast crisis CML.
* Participants who are eligible and willing to undergo transplantation during the screening period
* Uncontrolled or significant cardiovascular disease
* Use of imatinib within 7 days.
* Use of interferon or cytarabine within 14 days
* Use of a targeted small-molecule anticancer agent within 14 days
* Use of certain medication that carry a known side effect risk of Torsade de Pointes - Certain medications that irreversibly inhibit platelet function or anticoagulants
* Prior therapy with dasatinib.
A Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC

The goal of this prospective, observational study is to explore the value of dynamic monitoring of minimal residual lesions in driver mutated stage III NSCLC for disease recurrence and prognosis assessment. The main question it aims to answer is:

1) Whether MRD(Minimal residual disease) status can predict recurrence events in stage III driven-mutant NSCLC in advance

Non-small cell lung cancer in stage III (IIIa, IIIIb, IIIc) has a low survival rate, and the 5-year survival rate of stage III patients is less than 30%. In clinical studies of non-small cell lung cancer operable stage III driver gene mutations, postoperative targeted adjuvant therapy improves patient survival relative to postoperative chemotherapy.

The tumor patients still have residual malignant tumor cells in vivo during or after treatment, and minimal residual foci are released during cell necrosis or apoptosis. Early the domestic large lung cancer MRD((Minimal residual disease)) prospective research results, for the first time through the dynamic monitoring of MRD high negative predictive value defined the potential cure population, found that postoperative MRD negative population could not benefit from adjuvant therapy, clarify the existence of preoperative Non-shedding tumor does not affect postoperative MRD monitoring, and exploring the stage II / III MRD turn high risk of postoperative lung cancer. Therefore, for nearly 70% of patients with driver gene-positive non-small-cell lung cancer, detecting clear driver gene mutations in the peripheral blood is expected to stratify the risk of recurrence/progression.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy
2. Age≥ 18
3. ECOG PS:0-1
4. Tumor molecular testing by EBUS or biopsy confirmed positive for one or more of the following driver genes:EGFR\\ALK\\ROS1\\RET\\KRAS\\PIK3CA\\BRAF\\HER2\\MET
5. Patients who met and agreed to surgery or radical chemoradiotherapy, and the remaining samples after cutting tissue sections did not affect the possible further clinical treatment of the subject
6. Provide 20 mL peripheral blood samples periodically
7. The subjects volunteered to join the study, and signed the informed consent form, with good compliance, and actively cooperated with the hospital for routine clinical diagnosis and treatment follow-up

Exclusion Criteria:

1. Patients with other malignancies within 5 years
2. According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival
3. The subject had other factors that may lead to the termination of the study, such as other serious diseases (including mental illness), serious laboratory abnormalities, and family or social factors that affected the safety of the subject, or the collection of data and samples
Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

Cohort 1: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN).

Cohort 2: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN) and to test a certain type of experimental neuromodulation (stimulation of the brain) with a device called a closed-loop brain-computer interface (clBCI) to see if can help to prevent pain due to CIPN.

Primary Objectives:

Objective 1 (Primary Objective): to examine preliminary baseline and serial electrophysiological markers associated with the onset and development of CIPN by tracking brain activity and CIPN symptoms throughout chemotherapy treatment.

Secondary Objectives:

Objective 2 (Secondary Objective): To preliminarily evaluate whether a clBCI program can regulate changes in EEG that are associated with CIPN while participants are undergoing chemotherapy.

Exploratory Objective: Explore whether there are associations between change in brain function and subjective report of CIPN.

Eligibility Criteria:
Inclusion criteria:

Objective 1 Inclusion criteria

1. Participants must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
2. ECOG Performance Status of 0-2;
3. Willing to come to MD Anderson for the imaging sessions.
4. Are 18 years of age or above.
5. Have a diagnosis of breast cancer and who are scheduled to begin chemotherapy.
6. will receive chemotherapy including doxorubicin, cyclophosphamide, docetaxel, or paclitaxel; 7) participants scheduled to receive six months of chemotherapy.

Objective 2 Inclusion criteria:

1) Inclusion criteria: Identical to Objective 1 and are willing to participate in the therapy sessions at their homes.

Exclusion Criteria

Objective 1 Exclusion criteria:

1. Participants who are taking any antipsychotic medications.
2. With active CNS disease, such as clinically evident metastases or leptomeningeal disease, dementia, or encephalopathy.
3. Have ever been diagnosed with bipolar disorder or schizophrenia.
4. Known, previously diagnosed peripheral neuropathy from causes other than chemotherapy; and
5. A history of head injury or who have known seizure activity, or with a prior history of chemotherapy.
6. Patients who will be administered ddAC-\>T.

Objective 2 Exclusion criteria

1) Same exclusion criteria as in Objective1. Medication usage will be tracked for patients in all groups. Once prescribed, participants must remain on a stable course of medications throughout the course of chemotherapy.
Comaprison of 68Ga-FAP-2286 and 18F-FDG PET/CT in Patients With Various Types of Cancer

To evaluate the potential usefulness of 68Ga-FAP-2286 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, and compared with 18F-FDG PET/CT.

Subjects with various types of cancer underwent contemporaneous 68Ga-FAP-2286 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 68Ga-FAP-2286 PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 68Ga-FAP-2286, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (aged 18 years or order);
* patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
* patients who had scheduled both 18F-FDG and 68Ga-FAP-2286 PET/CT scans;
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* patients with non-malignant lesions;
* patients with pregnancy;
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent;
Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

OBJECTIVES: I. Determine the effect of antiparasitic treatment with albendazole on the severity and duration of epilepsy due to neurocysticercosis.

II. Determine the effect of a short course of albendazole on Taenia solium cysts present in the brain.

III. Determine the natural regression of cerebral T. solium cysts in patients given placebo and their response to treatment at the end of the study.

PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to receive either albendazole and dexamethasone or placebo.

Patients receive phenytoin daily starting on day 1 and continuing until seizure free for 1 year. Albendazole and dexamethasone or placebo only is administered orally once daily on days 5-15.

Patients are asked to maintain a diary. Patients are followed on day 15 and 30, then every 3 months for 3 years.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Presence of Taenia solium infection as demonstrated by serology and head CT Head CT showing no more than 20 cysts
* At least 2 spontaneous seizures within the last 6 months excluding: Absence seizures Rolandic seizures Bilateral spike wave patterns compatible with genetic epilepsy

--Prior/Concurrent Therapy--

* No prior therapy for cysticercosis

--Patient Characteristics--

* Age: 16 to 65
* Performance status: Not specified
* Hematopoietic: Not specified
* Hepatic: Not specified
* Renal: Not specified
* Neurologic: No focal deficits No motor deficits No cranial nerve lesions History of epilepsy of less than 5 years in duration No head CT evidence of the following: Arteriovenous malformations Trauma Cerebral infarcts or hemorrhages No other focal disease not attributable to cysticercosis No moderate or severe intracranial hypertension No status epilepticus
* Other: No unstable condition due to systemic disease or cysticercosis Not pregnant
Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

Characterize the demographic and clinical features, as well as the main treatment results, among patients with advanced breast cancer treated with fulvestrant in Brazil.


Eligibility Criteria:
Inclusion Criteria:

* Positive HR or ER by immunohistochemistry
* Postmenopausal status at the time of treatment with fulvestrant
* Failure of at least one previous endocrine therapy before treatment with fulvestrant.

Exclusion Criteria:

* Patients who are still undergoing treatment with fulvestrant will not be eligible to participate in the study
Efficacy and Safety of Extract of Gelidium Elegans

Extract of Gelidium elegans inhibits lipid differentiation, accumulation, and synthesis in vitro and in vivo. It has also anti-obesity effect by inhibiting weight gain and decreasing body fat. In a preliminary study of obese adults aged 20 years or older, the extracts of Gelidium elegans showed a tendency to decrease in body fat and visceral fat, and to increase lean body mass. Based on these results, we tried to confirm the effect of body weight and body fat reduction of Gelidium elegans extract in overweight and obese people.


Eligibility Criteria:
Inclusion Criteria:

* 1. Between the ages of 19 and 50
* 2. BMI is at or greater than 23 and less than 30 kg/m\^2

Exclusion Criteria:

* 1. uncontrolled hypertension
* 2. uncontrolled diabetes
* 3. current serious cerebrovascular and cardiovascular disease
Assessment of Endotracheal Tube Temperature Effects in Children Undergoing Adenotonsillectomy

Adenotonsillectomy is one of the most commonly performed surgical procedures in children worldwide. life-threatening complications such as laryngospasm and bronchospasm may develop in the postoperative period.

The aim of this study was to compare the effects of using endotracheal intubation tubes at different temperatures during intubation on respiratory complications in the postoperative period in children undergoing adenotonsillectomy.

Adenotonsillectomy (AT) is one of the most common surgical procedures performed in children. Its incidence has been increasing day by day and has almost doubled since the 1970s. In recent years, with the development of surgical techniques and anesthetic approaches, significant progress has been made in the recovery and postoperative management of these patients and morbidity has decreased significantly. The most feared complications of AT in children are respiratuar complications such as laryngospasm and bronchospasm. These complications can occur during AT or in the postoperative period, requiring rapid response by the anesthesia and surgical team and extensive postoperative monitoring. They may result in increased morbidity and prolonged hospitalization. Different methods including intravenous lidocaine, topical lidocaine, propofol, iv magnesium and the like have been proposed to reduce laryngospasm; different results have been obtained in studies. Thermal softening of endotracheal tubes (ETT) with normal warm saline before intubation has been shown to be significantly effective in reducing sore throat and hoarseness during recovery and postoperatively. The aim of this study was to compare the intraoperative and postoperative respiratory effects of using endotracheal intubation tubes at different temperatures during intubation in children undergoing adenotonsillectomy.

Eligibility Criteria:
Inclusion Criteria:

* Parents who agreed to participate in the study
* Children undergoing adenotonsillectomy
* ASA 1 and 2 class patients

Exclusion Criteria:

* Emergency surgery
* Children with a history of difficult airway
* Children who have had upper airway surgery
* Presence or suspicion of upper or lower respiratory tract infection
* History of cardiac and respiratory diseases
* Patients with craniofacial malformations
Digital Diabetes Remission Trial

This is a multicentre, open-label Randomised Controlled Trial run in the United Kingdom. The main aims are to assess whether the Habitual Remission Programme (digital therapeutics + 12-week 800kcal/day low-energy diet, delivered remotely) is more likely to lead to weight loss and remission in adults with type 2 diabetes, when compared to standard of care.

Participants will be randomly allocated to the Habitual Programme or standard care as delivered by the National Health Service (NHS). They will take a home blood test for HbA1c at baseline, 3 months and 6 months, and complete online fortnightly surveys to record their weight, waist circumference, blood pressure, side-effects and any changes in medication, for 6 months. These measurements will be taken at 6 months and 12 months after finishing the intervention for those allocated to the intervention.

Participants will be recruited from General Practitioner (GP) surgeries in England, managed by Lindus Health. Research Nurses at Lindus Health will complete screening and informed consent procedures.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give consent for the study prior to participation
* Be aged between 18-75 years, with type 2 Diabetes Mellitus of duration \<6years.
* Has access to a smartphone or computer
* Has a Body Mass Index (BMI) of ≥28 kg/m2
* HbA1C between 86 mmol/mol (10%) ≥ 48mmol/mol (6.5%), within the previous 12-months

Exclusion Criteria

* Is currently using Insulin
* Weight of change \>5% in the past 3-months
* Has a history of are known to be suffering with alcohol/substance abuse
* Has cancer or is knowingly under investigation for cancer
* Has had a myocardial infarction within the previous 6-months
* Has severe or unstable heart failure e.g., New York Heart Association (NYHA) grade IV
* Has porphyria
* Has learning difficulties
* Is currently on treatment with anti-obesity drugs
* Has had bariatric surgery
* Has been diagnosed with an eating disorder or purging
* Is pregnant or less than 4-months postpartum or considering pregnancy in the next 2-years
* Is currently breastfeeding
* Has required hospitalisation for depression or taking antipsychotic drug
* Has a history of illnesses that could interfere with the interpretation of the study (e.g. HIV, Cushing syndrome, chronic kidney disease, chronic liver disease, hyperthyroidism, hereditary fructose intolerance, depression or antipsychotic drug use within the past 2 years)
* Currently talking Glucagon-like peptide-1 receptor agonists (GLP-1 RAs)
* Has pancreatitis
* Currently taking part in a Clinical Trial of an Investigative Medicinal Product (CTIMP) trial for antidiabetic medication
* Abnormal diabetic foot review (QOF codes for diabetic foot at moderate risk, at high risk, at increased risk, ulcerated).
Effect of Repeated Doses of BI 1060469 and BI 1021958 on Glomerular Filtration Rate (GFR) in Healthy Volunteers

Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed by iohexol clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.

The secondary objective of this trial is to investigate the glomerular filtration rate (GFR) as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after oral administration of single and repeated doses of BI 1060469, and BI 1021958.


Eligibility Criteria:
Inclusion criteria:

* Healthy male subjects according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests, including negative test result on occult blood in stool (only for subjects assigned to Naproxen)
* Age 18 to 45 years (incl.)
* Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
* Repeated measurement of systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, or pulse rate outside the range of 50 to 90 mmHg
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Serum creatinine laboratory value out of the normal range
* GFR (Glomerular Filtration Rate) \< 90 mL/ min at screening
* Urinary toral protein/creatinine ratio \> 0,1 mg protein/ mg creatinine
* Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
* Further exclusion criteria may apply
High Diagnostic Performance of the Indicator Plaster Neuropad for the Detection of Diabetic Autonomic Neuropathy

Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.

Diabetic autonomic neuropathy (DAN) is a prevalent and severe complication of Diabetes Mellitus (DM). When the autonomic regulation of the cardiovascular system is affected, it is referred to as cardiovascular autonomic neuropathy (CAN), the most critical subtype of DAN. Early diagnosis of CAN is crucial, as it can identify patients at elevated risk for cardiovascular complications. This study aimed to assess the Neuropad test's effectiveness, specificity, sensitivity, and accuracy as a diagnostic tool for detecting DAN.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus

Exclusion Criteria:

* age\>75 years,
* estimated creatinine clearance rate (using the Cockcroft-Gault formula) \<30 ml/ min,
* history of limp amputation,
* causes of neuropathy other than diabetes,
* drugs that can affect perspiration, and
* skin disorders that could affect the result.
Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy

A prospective randomized study was performed including consecutive patients who underwent an elective laparoscopic cholecystectomy (LC) for symptomatic cholelithiasis during the 18 months period. This prospective randomized trial aims to compare two umbilical closure techniques for trocar site hernia (TSH) in laparoscopic cholecystectomy.

Laparoscopic cholecystectomy (LC) is currently the gold standard in the treatment for symptomatic cholelithiasis that offers a variety of advantages over conventional open surgery such as shorter recovery time, better cosmesis, less wound complication rates, and less pain (1,2). Despite these advantages, LC can result in unique complications. Among these complications, trocar site hernia (TSH) is one of the most important complications because laparoscopic cholecystectomy promises smaller abdominal incisions and better cosmetic outcomes. A second surgical intervention due to TSH may overshadow the gains of the previous laparoscopic surgery. In studies conducted to date, the rate of trocar hernia in laparoscopic cholecystectomy has been presented at very different rates. Many studies have shown that the most frequent site of TSH is the umbilical trocar site (3-6).

To avoid this important complication of laparoscopic cholecystectomy, many different techniques have been described to date for trocar port fascia repair (7-12). Most of these techniques require special devices. In addition, a few studies compare these techniques with standard fascial closure, which is mostly used by surgeons (11,12).

We hypothesized that the fascial closure of the umbilical trocar incision under the intra-abdominal vision with the laparoscopic camera could be reduced TSH. This prospective randomized controlled study aims to assess whether fascial closure of umbilical trocar site under direct laparoscopic vision in LC can reduce the incidence of TSH.

Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* symptomatic cholelithiasis

Exclusion Criteria:

* acute cholecystitis
* age under 18 years
* previous umbilical hernia repair
* pre-existing umbilical hernia