cyrilzakka/clinical-trials huggingface dataset:
Nimotuzumab Plus Paclitaxel and Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer

Nimotuzumab, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in some studies with head-neck cancers. Advanced esophageal carcinoma have poor prognosis and majority of patients resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded before,the combination of paclitaxel with cisplatin showed good tolerance and efficacy to esophageal carcinoma. The investigators then initiated a prospective phase II clinical trial with Nimotuzumabplus paclitaxel/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.


Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age 18 to 75 years old
* Histologically confirmed esophageal squamous carcinoma, Unresectable recurrent or metastatic disease,no prior palliative chemotherapy; No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months,recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of paclitaxel as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
* Sex is not limited
* Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
* Karnofsky performance status ≥80
* Life expectancy of ≥ 3 month
* WBC \> 4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet \> 100,000/mm3, Hb \> 10g/dl(within 14 days before enrollment),ALT and AST \< 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level \< 1.0 times ULN,Serum AKP \< 2.5 times ULN,Serum creatinine \< 1.0 times ULN
* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever \> 38℃；
* Normal ECG and heart function
* Fertile patients must use effective contraception
* Good compliance

Exclusion Criteria:

* Previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy
* Known hypersensitivity to Nimotuzumab,Paclitaxel,Cisplatin
* Only with Brain or bone metastasis
* Tumor with length ≥ 10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
* No measurable lesions, eg. pleural fluid and ascites
* Suffer from severe heart disease or disease with other important organs
* Chronic diarrhea or renal dysfunction
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Chronic diarrhea
* Mentally abnormal or disable cognition,including CNS metastasis
The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL)

Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).

Prospective, Open-Label, Multicenter, Single Arm Study of the Aerin Medical Vivaer ARC Stylus to treat Septal Swell Bodies (SSB) to improve symptoms in adults diagnosed with nasal obstruction attributed to SSB.

Eligibility Criteria:
Inclusion Criteria:

1. Age 22 to 85 years (inclusively).
2. Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
3. Baseline NOSE score ≥ 55.
4. Presence of SSB hypertrophy limiting visualization of the middle turbinate (MT) by more than 50%.
5. Reduction in size of the SSB after application of topical decongestant on a cotton plug directly to the SSB region.
6. Improvement in the symptoms of nasal obstruction after SSB decongestion suggesting that the SSB may play a role in nasal obstruction.
7. Willing and able to withhold anticoagulant medications during the perioperative period (3-day window on either side).
8. Willing and able to provide informed consent.
9. Willing and able to comply with the participant-specific requirements outlined in the study protocol.

Exclusion Criteria:

1. Rhinoplasty, septoplasty, inferior turbinate (IT) reduction, or other surgical nasal procedures within the preceding 6 months.
2. Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the participant's nasal obstruction symptoms and warranting surgical intervention.
3. Any adjunctive surgical nasal procedure planned on the same day or within 3 months after the Vivaer procedure.
4. Known or suspected allergies or contraindications for any general or local anesthetic agents.
5. Known or suspected to be pregnant or is lactating.
6. Participating in another clinical research study.
7. Other medical conditions which in the opinion of the investigator would predispose the participant to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.
8. Known or suspected regular use of oxymetazoline (Afrin) nasal decongestant or oral steroids.
9. For sites participating in the CT substudy only: Active sinus condition (eg, significant sinus diseases, infection or polyp formation) identified by CT.
Chronic Sleep Deprivation and Changes in Cortical and Hippocampal Volume

Sleep is a physiological state that is essential for human performance, including academic, occupational, interpersonal, and psychological aspects. Sleep disruption or deprivation leads to a loss of psychomotor skills and an increased association with various diseases. Therefore, it is critical to assess how chronic sleep deprivation affects medical residents who work long shifts, including those assigned during their training.

Objective: To determine if there is an association between chronic sleep deprivation and changes in cortical and hippocampal volume, assessed by nuclear magnetic resonance, in first-year medical residents assigned to the High Specialty Medical Unit, Specialty Hospital No. 1, National Medical Center of Bajío, during a period of 2 months after their admission.

Materials and Methods: This is a retrospective cohort study of first-year residents at UMAE T1, with a calculated sample size of 37 patients. Results are presented using descriptive statistics with mean and standard deviation or median with confidence intervals, depending on the type of variable. The relationship between MRI values and sleep deprivation will be assessed using Pearson's correlation coefficient or its non-parametric equivalent.

Ethical considerations: The study will be conducted with the informed consent of the patients in accordance with the General Health Law on Research and the Helsinki Declaration of 1975. The risk associated with this study is more than minimal.

Resources: Magnetic resonance studies will be performed at the High Specialty Medical Unit, Specialty Hospital No. 1, National Medical Center of Bajio, under the supervision of affiliated physicians specializing in the field of radiology and a fourth year resident in Diagnostic and Therapeutic Imaging.

Eligibility Criteria:
Inclusion Criteria:

* New resident physicians assigned to the High Specialty Medical Unit, Hospital de Especialidades No. 1 Centro Médico Nacional Del Bajío.

Exclusion Criteria:

* - Patients who have ingested caffeine, nicotine or alcohol in the last 24 hours.
* Patients with sleep disorders who present a score greater than 5 in the initial assessment of the Pittsburgh Sleep Quality Index.
* Patients with psychiatric treatment.
* Patients ingesting medications that intervene in the awake state.
* Patients with drug abuse (marijuana, cocaine, etc.).
* Patients with claustrophobia.
* Patients with metallic implants.
Symptoms and Quality of Life of Patients With Suspected Endometriosis

All patients undergoing surgery due to suspected endometriosis in a previously selected 3-month period within the study period (between 12/2022 and 12/24) (each participating center will define the particular 3 months in question) will be asked to participate in this study. Upon inclusion, patients will be asked to fill out questionnaires regarding endometriosis-associated symptoms as well as a detailed patient history. Furthermore, patients will be asked to fill out 2 standardized questionnaires, one regarding quality of life (Endometriosis-Health Profile-30) and one regarding sexual function (Female Sexual Function Index). Six and 12 months after surgery, patients will again be asked to fill out these two standardized questionnaires as well as a questionnaire regarding postsurgical therapy and endometriosis-associated symptoms. The surgeon will be asked to fill out a form regarding the surgical procedure and possible surgical complications.

The primary endpoints of this multicenter observational study are to prospectively examine:

1. if the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification
2. if the surgical intervention has an effect on the quality of life in relation to the individual #ENZIAN compartments.


Eligibility Criteria:
Inclusion Criteria:

* Planned surgery for suspected endometriosis
* Age between 18 and 50
* signed informed consent

Exclusion Criteria:

* menopause
* current malignant disease
Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers

The primary objective of this trial is to evaluate the subjective performance of two different daily disposable contact lenses in a population of daily disposable lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Currently wearing any spherical daily disposable lens in daily wear, daily disposable modality for at least 3 months prior to enrollment with the exception of the 2 study products
* Currently Wearing lenses at least 8 hrs/day and 5 days/week.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Prior history of corneal or refractive surgery.
* Requires monovision correction.
* Other protocol-defined exclusion criteria may apply.
Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy

To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy.

1. The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) .
2. Venous blood (4 ml) is collected from each subject and placed into tubes containing Ethylene Diamine Tetraacetic Acid(EDTA) before and after each treatment. Lymphocytes are sorted by Fluorescence Activated Cell Sorting(FACS) and stored at -80°C until processing.
3. The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。
4. Estimate Immunotherapy response, time to disease progression, survival rates and clinical benefit response on patients. Response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups: sensitive and non-sensitive to immunotherapy.
5. Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed with malignant tumor;
* Age: 18-80 years;
* an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* At least one measurable lesion according to the RECIST criteria;
* Adequate bone marrow, cardiac, liver, and renal function;
* Life expectancy ≥2 months;
* Not received other anti-tumor treatment
* Informed consent signed

Exclusion Criteria:

* previous history of other malignancies;
* Uncontrolled central nervous system metastases;
* Serious or uncontrolled concurrent medical illness.
The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery

This research add resistance training to patients who undergo cardiac rehabilitation program after coronary bypass surgery, comparing the level of PCSK9 level on that group to another group who receives conventional rehabilitation program (only aerobic exercise)

The PCSK9 level measured before and after cardiac rehabilitation program (around 3-4 weeks), and compared between two groups. ELISA method will be used to measure plasma PCSK9 level.

Resistance training will be given by professional trainer in gymnasium of National Cardiovascular Center Harapan Kita supervised by cardiologists, following rules from American College of Sports Medicine guideline regarding to exercise after cardiac event.

Eligibility Criteria:
Inclusion Criteria:

* post elective coronary artery bypass surgery
* \> 18 years old
* sign informed consent

Exclusion Criteria:

* contraindications of resistance training (unstable angina, uncontrolled blood pressure (systolic \> 160 mmHg diastolic \> 100 mmHg), acute heart failure, pulmonary diseases, arrhythmia malignant)
* musculoskeletal pain, visual analog scale \>3
* post congenital heart disease surgery
* post elective coronary artery bypass surgery with malfunction valves (operated or not)
Impact of Amantadine on Traumatic Brain Injury

The aim of this study is to evaluate whether the addition of amantadine to the management regimen of traumatic brain injury patients would have a favorable effect on recovery and neurological complications in association with prognosis biomarkers Interleukin-18 (IL-18), Neuron-specific enolase (NSE) and (Neurotensin).

Proposal Steps

1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
2. All participants agreed to take part in this clinical study and provide informed consent.
3. Patients will be enrolled if they present with clinical signs of trauma, from Emergency department at Tanta University Hospital
4. Complete physical, laboratory, radiological assessment will be done for all patients
5. Serum samples will be collected for measuring the biomarkers.
6. All enrolled 50 patients will be divided into two groups; Group I are patients who will receive amantadine as added on therapy. Group II are patients who will be managed with the standard regimen.
7. All patients will be followed up during 6 weeks period.
8. At the end of 6 weeks, prognosis biomarkers will be withdrawn.
9. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
10. Measuring outcome: The primary outcome is to compare the effect of adding amantadine on recovery rate and neurological complications in trauma patients.
11. Results, conclusion, discussion and recommendations will be given.

Methodology

* 50 Patients will be randomized equally to the assigned study groups
* Prognosis biomarkers (IL-18, NSE and Neurotensin) will be measured using ELISA
* Conventional routine tests (including renal function tests) will be assessed
* Patients will be evaluated clinically (such as Glasgow score...) for recovery rate for neurological complications.

Eligibility Criteria:
* Inclusion criteria

  •Adult patients will be enrolled if they present with clinical signs of trauma brain injury
* Exclusion criteria

  * Age lower than 18
  * Females with positive pregnancy test
  * Known congestive heart failure or ischemic heart disease
  * Any injury disturbs the examination (high cervical cord injury or locked-in syndrome, could be a source of bias)
  * Penetrating head trauma
  * Need for any operation (laparotomy or craniotomy)
  * Severe brain disease (For example CVA history or brain tumour)
  * Renal failure with GFR lower than 60 ml/min
  * Patients with unknown identity
Non-invasive CTS Device Clinical Trial

Sham-controlled, multi-center and remote patient-centered randomized controlled clinical trial to investigate the efficacy of a novel non-invasive, unobtrusive study device in reducing symptoms of carpal tunnel syndrome (CTS). Daily wear of the study device is expected to significantly reduce symptom severity (evaluated by the Boston Carpal Tunnel Questionnaire) in mild to severe CTS-diagnosed patients. Subjects are randomized into the active device group or sham group for 8 weeks, then followed for 12 weeks post-treatment.

It is hypothesized that daily wear of the study device will result in significant improvements in patient-reported symptom severity. It is also hypothesized that the effects from active study device treatment will be significantly greater than effects from sham treatment. In both cases, it is hypothesized that improvements will be sustained post-treatment.

This study is designed as a randomized, double-blind, sham-controlled, two-arm trial consisting of an eight-week treatment period (active study device or sham), followed by one required follow-up four weeks later (at week 12).

There are two study groups: the active device group receiving the active study device and the sham group receiving a non-active sham device. Subjects will be informed that they have a 50:50 chance of receiving treatment or a sham. They will also be informed that if they receive sham device, they will be offered the active device 4 weeks into the post-treatment period. However, all subjects will not know what treatment they are on until the conclusion of the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically diagnosed with mild to severe carpal tunnel syndrome (CTS)
2. CTS diagnosis confirmed by a nerve conduction study (NCS) performed within the past 24 months OR at enrollment/baseline visit

   1. CTS severity determined via AANEM criteria 13
   2. Bilateral CTS accepted (worse wrist via NCS and/or BCTQ is designated as the study wrist)
3. BCTQ SSS \> 2
4. Reliable access to and ability to use Internet, Wi-Fi, or mobile data through computers, mobile devices, laptops, and/or tablets
5. Willing to abstain from any other treatment or therapies for CTS throughout the study
6. Ability to read and write English, or has a reliable person to assist with reading and writing English

Exclusion Criteria:

1. Other upper extremity neuropathies (e.g., epicondylitis, radial nerve neuropathies, ulnar nerve neuropathies)
2. Double crush syndrome
3. Cervical stenosis
4. Brachial plexopathy
5. Wrist fractures or cysts
6. Prior wrist surgeries, especially carpal tunnel release surgery
7. Injection of corticosteroid/cortisone into the wrist or hand within the past 6 months
8. Thyroid disease
9. Rheumatoid arthritis
10. Diabetes
11. Systemic diseases
12. Connective tissue diseases
13. Fibromyalgia or chronic pain syndrome
14. Diabetic neuropathy
15. BMI \> 40
16. Participation in other research studies or clinical trials currently or within the past 2 weeks.

To assess eligibility, visit: carpaltunneltrial.com
Correlation Between Quality of Life and Severity of Parkinson's Disease

This study aim to evaluate the correlation between Quality of Life (QoL) and severity of Parkinson's Disease (PD) by assessing the presence of an optimal cut-off point on the Parkinson's disease questionnaire (PDQ-39) as related to the Hoehn \& Yahr (H\&Y) scale in a cohort of Italian adults with PD.

A multicenter, cross-sectional study was performed in central and northern Italy. This study was conducted on a cohort of consecutive individuals at three neurologic outpatient clinics. All participants were evaluated with the PDQ-39, and the severity of PD was recorded according to the H\&Y scale by a neurologist. Receiver operating characteristic (ROC) curves and coordinates of the curve, which were visually inspected, were used to find cut-off points with optimal sensitivity and specificity. These were in turn used to determine the optimal PDQ-39 cut-off score for identifying disease severity according to H\&Y stages.


Eligibility Criteria:
Inclusion Criteria:

* age \> 50 but \< 90 years,
* H\&Y stages I, II, III, and IV,
* a mini-mental state examination \> 22 points,
* a minimum level of five years of education.

Exclusion Criteria:

* Individuals with emotional or psychiatric problems (as determined by clinical screening)
Goal Directed Fluid Administration for Kidney Transplantation

The goal of the proposed study is to evaluate the efficacy of a goal-directed fluid administration algorithm on early graft function in patients undergoing kidney transplantation. Fluid administration has increasingly been scrutinized within anesthesia related literature as an area for improvement, and the imbalance present between estimated blood loss and total fluid administered for kidney transplants must be amongst the highest case categories. Considering the patients are anuric for the majority of the procedure, unguided administration of multiple liters of crystalloid appears antiquated.


Eligibility Criteria:
Inclusion Criteria:

* end stage renal disease requiring dialysis
* age \>18y
* normal cognitive function.

Exclusion Criteria:

* severe left ventricular dysfunction (EF\<50%)
* known cardiomyopathy
* symptomatic CAD known valvular disease
* severe anemia (Hgb\<7.0)
* patients with prior transplants o
* patients who suffered surgical complications as communicated by the surgical team.

We chose these exclusion criteria to prevent enrolling patients who would not tolerate aggressive hydration possible in the treatment group. The exclusion criteria may be excessively restrictive, however, given the current practice that frequently results in rapid large volume loading without a monitor of intravascular volume status.
Parent-child Communication and Health-risk Behavior

Engaging in health-risk behaviors such as tobacco and alcohol use put youth at risk for health problems that may compromise their futures and are extremely costly to society. Positive parent-child communication, characterized by openness, satisfaction with the family, caring, and effective problem-solving, has been found to be protective against a youth's involvement in health-risk behaviors. To promote positive adult-youth communication, in earlier work we developed, tested, and found efficacious an intervention, Mission Possible: Parents and Kids Who Listen (MP). This study is designed to test the following hypotheses: (a) Adults and youth who participate in MP will demonstrate more positive communication when compared with adults who did not participate; (b) Youth who participate in MP will have a lower incidence of health-risk behavior when compared with youth who did not participate; and (c) Positive adult-youth communication will mediate childhood health-risk behavior in the presence of risk processes that predict participation. The experimental design is a 2-group (intervention and comparison) pre-test repeated measures design with six waves of data collection over three years and two booster sessions of the intervention. Elementary school and community centers in Madison and Chicago served as recruitment sites for parent-child dyads.


Eligibility Criteria:
Inclusion Criteria:

* Adults and youth must be English speakers
* Youth must be 10 years old

Exclusion Criteria:

* Severe mental or physical illness that could preclude involvement in data collection procedures
* Family plans to move from the metropolitan areas prior to study completion