cyrilzakka/clinical-trials huggingface dataset:
Sex Differences in Postoperative Sleep Quality and Inflammation

Video-Assisted Thoracoscopic Surgery(VATS) is among the most common and disabling persistent pain and inflammation conditions, with increasing prevalence in the developed world, and affects women to a greater degree than men. And sleep disruption also remains a challenging problem in surgical settings. Postoperative sleep disturbances (POSD) are defined as changes in the sleep structure and quality of patients during the early stages after surgery, which are manifested as significantly shortened rapid eye movement (REM) sleep, prolonged awake time, and sleep fragmentation. Long-term POSD may increase the risk of postoperative delirium or cognitive dysfunction and delay recovery, thereby worsening the patient's physical condition. The aim of the study was to investigate the effect of sex differences on postoperative pain, inflammation and sleep quality among patients who have undergone video-assisted thoracoscopic surgery under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* ASA I-III
* under general anesthesia

Exclusion Criteria:

* patients with central nervous system and mental diseases;
* patients with preoperative sleep disturbances;
* patients with a history of sedative, analgesic, or antidepression drug use;
* patients with sleep apnea or moderate and severe obstructive sleep apnea-hypopnea syndrome;
Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer

This study aims to investigate the safety and efficacy of sintilimab combined with platinum-based chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer.

This study was designed as an open-lable, single-arm, exploratory clinical study. Sintilimab in combination with liposomal paclitaxel, cisplatin and S-1 will be given every 3 weeks to our patients for 2 cycles as neoadjuvant therapy. A radical dissection is scheduled within 6 weeks after last neoadjuvant treatment. This study will be devided for 3 phases: safety run-in, efficacy pilot and efficacy confirmation.

Eligibility Criteria:
Inclusion Criteria:

Histologically or cytologically confirmed esophageal squamous cell carcinoma.

The tumor is located in the middle or lower third of the esophagus ( more than 18cm below incisor), potentially resectable and requiring neoadjuvant therapy (T1b-3, Nany, M0 or T4a, N0-1, M0).

No prior treatment for this disease.

Eastern cooperative oncology group (ECOG) performance status of 0 to 1.

Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol.

Understand and voluntarily sign the informed consent(s).

Patients who are able to complete the treatment and follow-up according to the study plan.

Patients who have sufficient tissue samples and agree to provide their tissue samples and blood samples for detailed analysis.

Female patients in child bearing period must have evidence of negative pregnancy test and agree to take effective contraceptive measures during the study.

Exclusion Criteria:

Patients who may develop tracheoesophageal fistula or aortoesophageal fistula.

Patients suffering from severe malnutrition or needing tube feeding.

Uncured patients with other malignancies within 2 years.

Patients who have active autoimmune diseases or patients who are undergoing treatment of autoimmune diseases.

Patients who need systemic glucocorticosteroid treatment (more than 10mg prednisone daily or other equivalent drugs) within 7 days before the neoadjuvant therapy or other immunosuppressive drugs.

Patients who have immune deficiency.

Patients with active viral or bacterial infection who need systemic treatment within 7 days before the neoadjuvant therapy.

Patients with uncontrolled diabetes mellitus.

Patients with interstitial pulmonary disease, noninfectious pneumonia, or pulmonary fibrosis.

Patients with preexisting symptoms of sensory or motor nerve damage (greater than Grade 1, WHO) .

Patients who have received allogeneic organ or stem cell transplants.

Patients who are allergic to drugs or related ingredients in this study.

Patients who take part in clinical trials of other drugs or biological therapy at present.

Patients with any serious or unstable medical condition or mental illness.

Patients who are dependent on or addicted to alcohol or drugs.
Effect of Low-level Laser Therapy on Type II Controlled Diabetic Patients After Dental Implant Insertion

This study aimed therefore to evaluate bone density (BD) and OPG levels in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients. 40 T2DM patients were included in this study. Implants were randomly inserted in 20 non-lased T2DM patients (Control) and 20 lased T2DM patients (Intervention). BD and OPG levels in the PICF were assessed in both groups at the follow up points.

Background and objectives: Use of low-level laser therapy (LLLT) with dental implants has been suggested to improve bone quality during osseointegration. However, there is a lack of evidence about its influence on dental implants in diabetic patients. Osteoprotegrin (OPG) levels was reported as a biomarker for bone turnover to distinguish implant prognosis. This study aimed therefore to evaluate bone density (BD) and OPG levels in the peri-implant crevicular fluid (PICF) in lased controlled type II Diabetes Mellitus (T2DM) patients versus non-lased T2DM patients. Methods: 40 T2DM patients were included in this study. Implants were randomly inserted in 20 non-lased T2DM patients (Control) and 20 lased T2DM patients (Intervention). BD and OPG levels in the PICF were assessed in both groups at the follow up points.

Eligibility Criteria:
Inclusion Criteria:

* None of the participants had other major illnesses or severe diabetic complications.
* A detailed medical history of each subject was obtained according to the detailed questionnaire of the modified Cornell Medical Index \[22\].
* Diabetic control was measured by glycosylated hemoglobin A1c (HbA1c) of blood samples, patients had relatively stable glycemic control, as demonstrated by a difference not exceeding 1% in at least two HbA1c assays over the previous 6 months.
* Participants with partial edentulous posterior mandibular region with bone density ranging between D2 and D3, also having adjacent tooth with healthy periodontium were selected.

Exclusion Criteria:

* Any uncontrolled systemic diseases that prevent surgery for dental implant placement; (b) Need for guided bone regeneration or sinus lift for implant placement, and (c) History of radiation therapy in head and neck.
* Pregnant women, smokers and patients with para-functional habits, psychological problems or in-cooperated patients were also excluded.
Correlation Among Standing-sitting Sagittal Spinal Alignment, Paravertebral Muscle and Postoperative Clinical Outcomes in Patients With Adult Degenerative Scoliosis

This is a prospective single-center study. Patients with adult degenerative scoliosis are prospectively enrolled and followed. All patients will take standard standing and sitting posteroanterior and lateral whole spine X-ray and lumbar MRI examination before and after surgery. Functional evaluation and radiographs were assessed preoperatively and postoperatively.This study will focus on the correlation among standing-sitting sagittal spinal alignment, paravertebral muscle and postoperative clinical outcomes in patients with adult degenerative scoliosis.

The sagittal alignment of the spine, or sagittal balance, describe the ideal and normal sagittal spinal curvature distribution. With the deepening of the research on spinal morphology, function and pathology, more and more researchers pay attention to the role of sagittal alignment in the diagnosis and treatment of spinal deformity diseases. Some studies have shown that the restoration of patients with appropriate sagittal alignment can significantly improve their quality of life. Besides, paravertebral muscle can also influence the retaining of sagittal alignment. However, how to define the ideal sagittal alignment is still controversial for different patients with adult degenerative scoliosis(ADS) .

It was proved that the differences in sagittal parameters of the standing and sitting positions positions were influenced by age, gender and pelvic incidence(PI). In addition, patients with high PI are more prone to sagittal decompensation after long segment fixation (fixation of three or more segments) .Therefore, We speculate that the sagittal curvature of patients with large PI changes greatly from standing position to sitting position. So after long segment fixation, the spine in the state of standing position is more difficult to adapt to the changes of curvature and stress in sitting position, which is the possible reason that patients with high PI are more prone to sagittal decompensation. At present, how to design the proper corrective goals for patients according to both sagittal alignment and paravertebral muscle needs further research.

Thus, this study is aim to explore these three points about ADS patients: the characteristics of the sagittal spinal alignment changes from standing to sitting ; the adaption of the spine curvature in the standing and sitting position after long segment fixation surgery and the relationship among standing-sitting sagittal spinal alignment, paravertebral muscle and postoperative clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of adult degenerative scoliosis
* Cobb angle ≥10°

Exclusion Criteria:

* Neuromuscular diseases
* Arthritis
* Tumor
* A previous history of lumbar fusion surgery
Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker's diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung's Disease, and Gastrointestinal neoplasia.

The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria.

A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who will undergo submucosal endoscopy
2. Age \>18 years

Exclusion Criteria:

1. Age \<18 years
2. Pregnancy
3. Coagulopathy (platelets less than 50, INR more than 1.8)
Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration

We have developed a new minimally invasive system for endometrial dating, that allows the physician to monitor, capture, project and analyze the actual morphology and maturity of the endometrial surface, at any given time. A time series of such indications provides an assessment regarding the pace of development by which the endometrium is maturing during a relevant cycle.

FERTIGO®'s method for endometrial dating has been validated in swine and ex-vivo human samples, where image analysis of tissues has been compared with traditional endometrial dating techniques. The comparison yielded calibration means and correlation between FERTIGO®'s dating and the traditional dating methods.

Thus, M3T FERTIGO®'s system is designed to enable the determination of the actual physiological cycle date, in good correlation with the indirect (endometrial thickness and hormones level) and delayed known methods (histopathology). To this end, a high quality, low magnification (X2-X4) image of the endometrium surface should be acquired, stored and analyzed.

This trial will evaluate, on the one hand, the safety and usability of the FERTIGO® device and, on the other hand, calibrate it by evaluating image quality. Both safety and usability will be measured through questionnaires answered by the participants (adverse events and satisfaction) and by the physicians (satisfaction), respectively, considering the introduction of the device, its use, and its removal.


Eligibility Criteria:
Inclusion criteria:

1. Healthy women
2. Age: 18 - 40, both inclusive
3. Regular menstrual cycles

Exclusion criteria:

1. Simultaneous participation in another clinical study that, at researcher's criteria, could interfere with the results of this study
2. Current pregnancy
3. Women with known existing endometrial pathology
4. Women with known oligo-ovulation or un-ovulation.
5. Women who were diagnosed with Endometriosis or Adenomyosis
6. Women with medical history of malignant tumors in their reproductive system
7. Women with IUD in place
8. Women menstruating on the day of the procedure
9. Women who have signs and symptoms of PID
10. Women who currently use any hormonal medications.
Evaluation of Lovastatin in Severe Persistent Asthma

This study has two purposes:

1. to determine whether lovastatin, a commonly used medication to lower cholesterol in the blood, can produce beneficial changes in airway inflammation and in the airway smooth muscle
2. to examine whether lovastatin will have favorable changes in asthma symptoms of patients with moderate or severe asthma.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years to \<65 years
* Severe persistent asthma (per 2002 National Asthma Education and Prevention Program guidelines)
* Treatment with daily fluticasone (500 ug BID) and salmeterol (50 ug BID) during the past 4 or more weeks
* Pre-bronchodilator FEV1 \<80% predicted
* Post-bronchodilator improvement in FEV1 of at least 12% and 200 mL or a PC20 to methacholine of \<8 mg/mL
* Evidence of inadequate asthma control in the past 2 weeks: use of rescue inhaler \> 4 days and \>8 occasions in the past 2 weeks, daytime asthma symptoms \> 4 days in the past 2 weeks, or 1 or more nocturnal awakening in the past 2 weeks
* No evidence of alternate diagnosis (e.g., sarcoidosis, eosinophilic pneumonia) on bronchoscopy performed as part of routine care in the Refractory Obstructive Lung Disorders clinic.
* Completed research bronchoscopy while on current dose of daily fluticasone and salmeterol within 4 weeks of meeting other inclusion criteria. Note: many patients in the ROLD clinic require a bronchoscopy to confirm the diagnosis of asthma and exclude other diagnosis (e.g., sarcoidosis). These patients are asked to participate in a research protocol (separate from this proposal) that allows investigators to collect additional samples (endobronchial biopsies, bronchoalveolar lavage fluid, endobronchial brushings) at the end of the clinical portion of the bronchoscopy {IRB protocol # 15361A entitled, "Airway inflammation in refractory obstructive lung disease (ROLD): understanding markers of inflammation and remodeling"}. This protocol was recently submitted to the IRB in March 2007.

Exclusion Criteria:

* Pregnancy or lactation
* Severe metabolic disease
* Other respiratory or inflammatory disorders (sarcoidosis, emphysema)
* Hypokalemia, dehydration
* Uncontrolled seizure disorder ( 2 or more seizures in last year)
* Major surgery, trauma
* Pre-existing liver disease (AST or ALT \>10% above the upper limit of normal)
* Elevated CK (\>50% above the upper limit of normal)
* History of alcohol abuse
* Current smokers or ex-smokers with \> 10 pack-years of smoking
* Partial ileal bypass surgery
* Concurrent treatment with drugs known to be have potential interactions or associated with rhabdomyolysis (Cimetadine, danazole, delavaridine, diltiazem, fenofiibrate, nefazodone, niacin, protease inhibitors, quinipristoline/dalfopristin, ranolazine, rifampin, telbivudine, telithromycin)
* HIV patients taking protease inhibitors
* History of allergy or intolerance to statin
* Use of 1 or more doses of any cholesterol lowering medication in the previous 12 weeks
* Clinical indication for treatment with statins
Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis

The project will involve a within-subjects, repeated-measures research design. Participants will initially be screened for relevant inclusion/exclusion criteria for maximizing safety of participating in an exercise study. If a participant meets those inclusion/exclusion criteria, they will visit Kessler Foundation three times. The first visit will involve a baseline session where participants will complete several cognitive tests. This will be followed by a training session, where participants will be provided with a FitBit, and will be trained by research staff to walk at a rate of 100 steps per minute. Once participants demonstrate proficiency at walking at this rate using the FitBit, participants will complete several questionnaires, followed by a maximal, graded exercise test to determine cardiorespiratory fitness. One week later, participants will return to Kessler Foundation to complete 1 of 2 experimental sessions that will be delivered in a random order that further will be counterbalanced across participants (to minimize the potential effects of session order on brain function and blood flow, respectively). Both experimental sessions will follow the same structure. First, participants will undertake a 30-minute MRI scan at Kessler Foundation to measure brain function and brain blood flow. Immediately following the MRI scan, participants will engage in either 20 minutes of treadmill walking exercise or 20 minutes of overground walking exercise at a rate of 100 steps per minute. Immediately following the 20-minute exercise bouts, participants will undertake another MRI scan for measuring brain function and brain blood flow. Participants will return to Kessler Foundation a third time to complete the opposite experimental session that was not completed during the second visit (i.e., overground walking exercise if treadmill walking exercise was completed during the second visit). In total, each participant will undergo four MRI scans over the course of the study (i.e., pre-treadmill, post-treadmill, pre-overground, post-overground). .


Eligibility Criteria:
Inclusion Criteria:

* Clinically-definite MS diagnosis
* Relapse-free for at least 30 days
* Low risk for contraindications for exercise testing
* Low risk for contraindications for MRI
* Historically physically inactive prior to MS diagnosis
* Historically highly physically active prior to MS diagnosis

Exclusion Criteria:

* Diagnosis of uncontrolled major depressive disorder, schizophrenia, bipolar disorder I or II, or substance use disorders
* Taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines)
* Historically moderately physically active prior to MS diagnosis
The Modifying Eating and Lifestyles at School Study

The purpose of this study is to examine the impact of introducing healthier, chef-enhanced foods and/or environmental modifications (choice architecture) on selection and consumption of school foods among elementary and middle school students.

Project Modifying Eating and Lifestyles at School (MEALS) was a school-based study developed by the nonprofit organization Project Bread (www.ProjectBread.org) and the Harvard School of Public Health. Project Bread hired a professional chef to work with several schools in a low-income, urban school district in Massachusetts to enhance the palatability and nutrient profile of the school meals. Four schools were randomly assigned to receive the professional chef. Additionally, two schools in that district and four schools in a second school district were randomly assigned to receive a behavioral psychology intervention to influence the selection and consumption of the healthier foods offered. Selection and consumption were assessed at baseline, up to 3 months post-implementation (short-term implementation for chef-enhanced meals), up to 4 months post-implementation (long-term implementation for behavioral psychology) and/or up to 7 months post-implementation (long-term implementation for chef-enhanced meals).

Primary Aim 1: to examine the impact of introducing healthier, chef-enhanced foods with increased palatability on selection and consumption among elementary and middle school students. It is hypothesized that there will be an increase in the selection and consumption of entrees, fruits, and vegetables in schools where healthier, chef-enhanced foods are served.

Aim 2: to examine the impact of physical modifications to the placement and displays of foods in the cafeteria on selection/consumption among elementary and middle school students. It is hypothesized that there will be an increase in selection and consumption of entrees, milk, fruits, and vegetables when modifications are made.

Eligibility Criteria:
Inclusion Criteria:

* Students in grades 1-8 attending a participating school and receiving a school meal on a study day

Exclusion Criteria:

* Bringing a lunch from home on a study day or not eating lunch in the cafeteria on a study day
TNS for Major Depressive Disorder: a Phase II Randomized Controlled Trial

This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate the effect of the Trigeminal Nerve Stimulation (TNS) on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in patients with moderate / severe depressive episode.


Eligibility Criteria:
Inclusion Criteria:

1. patients between 18 and 69 years
2. patients with a diagnosis of depression according to the SCID
3. score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode)
4. agreement to participate in the study as recommended in the IC.

Exclusion Criteria:

1. patients with psychiatric indication for hospitalization
2. patients with psychiatric comorbidity
3. patients with a diagnosis of personality disorder
4. presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.