cyrilzakka/clinical-trials huggingface dataset:
Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Breast Cancer

The purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy method on the basis of autologous antigen-activated dendritic cells in the treatment of patients with breast cancer.

This technology is intended for complex treatment of patients with breast cancer and is aimed at preventing the occurrence and treatment of secondary foci. The need for this technology is justified by the widespread occurrence of breast cancer among women, a decrease in the average age at onset of the disease and a young age, and the chemoresistantness of locally advanced forms of cancer.

Currently, technologies are being developed to improve the clinical outcomes of patients with complex treatment of breast cancer. Many patients are immunosuppressed after surgical, radiation and chemotherapeutic treatment, which leads to dysfunction of T cells, resulting in tumor cells avoiding immune surveillance. Restoration of antitumor immunity during immunotherapy is one of the modern approaches in the treatment of breast cancer, which contributes to the formation of an effective specific immune response, the destruction of tumor cells while minimizing toxicity. Dendritic cells (DC) and the lymphocytes induced by them are one of the most effective methods for the destruction of residual cancer cells, which are the leading cause of relapse and metastasis.

Eligibility Criteria:
Inclusion Criteria:

1. For the first time established morphologically confirmed diagnosis of breast cancer
2. patients with II A, II B, IIIA, III B stages of breast cancer;
3. Patients with progressive or primary IV stage of breast cancer with cytologically confirmed and accessible soft tissue metastases;
4. Patients with HER-2 / neu 3 + positive and patients with triple negative breast cancer of the I-II stage (biologically unfavorable forms of breast cancer more prone to recurrence and metastasis).
5. Absence of severe somatic pathology in which medical intervention (at the stage of obtaining biological material or the stage of immunotherapy) will only worsen the patient's condition,
6. The patient's desire.

Exclusion Criteria:

1. Pregnancy at any time,
2. Impossibility of correction of therapy of concomitant diseases, if the taken preparations are proved to influence the immune status,
3. Rapid progression of the underlying disease, in which the use of immunotherapy is deontologically unjustified,
4. Individual intolerance to the components of the vaccine and / or the development of severe side effects on any of the components,
5. Refusal of the patient to participate in the study in oral or written form.
6. Patient involvement in any other clinical study (including those that the patient has not been informed by the direct oncologist who has been treated, but which has become known already after the beginning of any stage of the study).
Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

Impaired olfaction is one of the major complaints of patients with nasosinus polyposis, with nasal obstruction. In case of failure of medical treatment for patients with polyposis nasosinusal, they may use endoscopic surgery nasosinusal. Before surgery, 73% are hyposmic or anosmic, compared to 43% after surgery. Persistence of hyposmia or anosmia despite the removal of polyps can be explained by mechanisms inflammatory in the mucous membrane of the olfactory cleft. In addition, studies in mice have shown a degeneration of primary olfactory neurons at the level of the olfactory mucosa in connection with directly with TNF alpha, a pro-inflammatory molecule.


Eligibility Criteria:
Inclusion Criteria for patients :

* Patients with nasosinus polyposis requiring nasosinus surgery
* Patient affiliated or entitled to a social security
* signed consent

Inclusion Criteria for control group :

* Patients with an indication for septoplasty
* Patient affiliated or entitled to a social security
* signed consent

Exclusion Criteria for patients :

* Patients with nasosinus polyposis secondary to another disease
* Patients with hyposmia or anosmia prior to naso-sinus polyposis
* Patients with diagnosed neurodegenerative disease
* Patients who are mentally or physically unable to perform olfactory tests
* Patients on anti-TNF-alpha therapy, long-term oral corticosteroid therapy, or other immunomodulatory therapy.

Exclusion Criteria for control group :

* Patients with nasosinus polyposis
* Patients with chronic rhino-sinusitis
* Patients with hyposmia or anosmia
* Patients with diagnosed neurodegenerative disease
* Patients who are mentally or physically unable to perform olfactory tests
* Patients on anti-TNF-alpha therapy, long-term oral corticosteroid therapy, or other immunomodulatory therapy.
Storage Symptom After Laser Prostatectomy

Recent literature indicated that postoperative storage symptoms after Photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were often reported and generally more common than after transurethral prostatectomy (TURP). However, almost all literature focused on postoperative urgency or dysuria immediately after PVP or HoLEP. Thus, there has been a scarcity of data on serial changes of storage symptoms in the postoperative period after PVP or HoLEP and data on predicting factors that influence improvement in storage symptoms postoperatively. The aim of this study was to compare serial changes of postoperative storage symptoms between PVP and HoLEP, and to identify the predictors that influence improvement of storage symptoms postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of prostatic hyperplasia
* underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate
* 12-months follow-up data were available

Exclusion Criteria:

* previous diagnosis of urethral stricture, prostate carcinoma, and neurogenic bladder disease
pMDT in Thoracic Surgery--------For the Baseline Investigation and Technical Preparation Stage

The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary postoperative pain management strategy is the best way to control postoperative pain in thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the thoracic surgery department of Peking University People's Hospital, the investigators have summarized the experience in multidisciplinary pain management and promoted this study in multi-centers across the country, hoping that this study can improve the current situation of acute pain management in patients after thoracic surgery, and at the same time, the deficiencies of this clinical protocol can be found out and improved.

The postoperative acute pain refers to the acute pain (usually lasting less than 7 days) that occurs immediately after surgery, and its nature is traumatic pain. It may develop into a chronic pain, such as a neuropathic pain or a mixed pain, if it is not fully controlled at the initial state. It will seriously impact the physiology and psychology of a patient. According to the study, the postoperative acute pain is one of the risks for postoperative complications, and it may result in the death of a patient. However, the alleviation of a postoperative acute pain can shorten the duration of stay in hospital, and reduce the overall cost for treatment of a patient.

The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary postoperative pain management strategy is the best way to control postoperative pain in thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the thoracic surgery department of Peking University People's Hospital, the investigators have summarized the experience in multidisciplinary pain management and promoted this study in multi-centers across the country, hoping that this study can improve the current situation of acute pain management in patients after thoracic surgery, and at the same time, the deficiencies of this clinical protocol can be found out and improved.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75, ASA I-II;
* Patients undergoing thoracoscopic surgery;
* Patients who can understand and fill in the self-evaluation;
* Patients who signed the Informed Consent Form.

Exclusion Criteria:

* Pregnant women;
* Patients with preoperative chronic pain and long-term opioid use;
* Patients with advanced tumors who have received preoperative chemotherapy or who are expected to receive postoperative chemotherapy.
Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain

This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.

Subjects will go through screening, an open-label conversion and titration phase of up to 6 weeks followed by an open-label treatment phase for up to 48 weeks with a 2 week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosed moderate to severe chronic pain condition treated with around-the-clock opioids for at least the past 3 months or in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their pain
* Subjects must have been taking opioids at least 5 days/week for the past month at an average daily dose of at least 30 mg hydrocodone
* Subjects must be able to complete study procedures and attend clinic visits for 6 to 12 months
* Females subjects of childbearing potential must have a negative urine pregnancy test at the Screen Visit, and must consent to use a medically-acceptable method of contraception throughout the entire study period.
* Subjects must have had an adequate medical evaluation for the treatment of their underlying painful condition and appropriate primary medical/surgical therapies for the underlying condition
* Subjects must voluntarily provide written informed consent

Exclusion Criteria:

* Any clinically significant condition that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of pain or increase the risk of opioid-related adverse events (AEs)
* A medical condition that, in the opinion of the Investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete study drug
* A surgical procedure for pain within the last 3 months
* Uncontrolled blood pressure, i.e., a sitting systolic blood pressure \>180 mm Hg or \<90 mm Hg, and/or a sitting diastolic blood pressure \>120 mm Hg or \<50 mm Hg at Screening
* A body mass index (BMI) \> 45 kg/m2
* A hospital anxiety and depression scale (HADS) score of \>12 in either depression or anxiety subscales or an established history of any psychiatric disorder that is poorly controlled
* A clinically significant abnormality in clinical chemistry, hematology or urinalysis
Blood Sample Analysis in Predicting Overall Survival in Patients With Recurrent or Metastatic Head and Neck Cancer

RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood sample analysis in predicting overall survival in patients with recurrent or metastatic head and neck cancer.

OBJECTIVES:

* To validate the mass spectrometry profile that is predictive of survival benefit in patients with recurrent or metastatic head and neck squamous cell carcinoma treated with EGFR inhibitors.

OUTLINE: Plasma and serum samples are analyzed by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and classified according to prognosis ("good" vs "poor") using a previously developed predictive algorithm.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of recurrent or metastatic head and neck squamous cell carcinoma
* Meets 1 of the following criteria:

  * Enrolled on clinical trial ECOG-E3301 and previously treated with irinotecan hydrochloride and docetaxel
  * Enrolled on clinical trial VU-VICC-HN-0501 and previously treated with docetaxel and bortezomib
* Plasma and serum samples available for analysis

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias

The purpose of this research study is to measure the clinical effectiveness of two different polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length of hospital stay, perioperative complications, recurrence rate, pain score, comfort level and postoperative quality of life. A secondary goal of the study is to evaluate the ease of use and time it takes surgical residents to place the mesh and perform the surgery using these two different meshes.

Inguinal hernia repair is one of the most common operations performed by general surgeons in the world. There are two main ways to repair an inguinal hernia, open or laparoscopic. Open compared to laparoscopic, is more invasive and leads to more scarring and longer recovery periods. Laparoscopic repair is done by making a small cut in or just below the umbilicus and has become an accepted standard for inguinal hernia repair and has become the technique of choice for recurrent inguinal hernias.

During laparoscopic repair, the placement of a prosthetic mesh aids in reinforcing the abdominal wall and allowing for tension free repair. Meshes also helps to lower the recurrence rate. The most safe and effective type of mesh prosthesis currently being used in laparoscopic inguinal hernia repairs are polypropylene meshes. There is some emerging evidence that "lighter weight" forms of polypropylene meshes may improve quality of life outcomes following surgery for inguinal hernias. Further evaluation is needed to support this evidence.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing laparoscopic repair for the treatment of either single or bilateral inguinal hernias
* All surgical residents at New Hanover Regional Medical Center

Exclusion Criteria:

* Subjects requiring emergency surgery
* Pregnant subjects
* Subjects under the age of 18 years of age
Glulisine Pre- and Postmeal

To investigate in type 1 diabetic patients the glucodynamic response to HMR1964 insulin and RHI (HOE31HPR100) injected subcutaneously before and after a standard meal


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus

Exclusion Criteria:
A Graphene Far-infrared Intervention Study of Cognitive Status in Older Adults

This study is a 4-week group controlled trial to explore whether graphene far-infrared intervention can improve the cognitive status of older adults presenting with symptoms of Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), or Alzheimer's Disease (AD), and is dedicated to enhancing the cognitive status of older adults and improving their mental health. Participants were older adults who presented with cognitive problems. Participants were divided into SCD and MCI/AD groups based on their cognitive level, and each group was further divided into a graphene far-infrared intervention group and a placebo control group. We also measured the depression and anxiety levels of the older adults and incidentally observed whether the graphene far-infrared intervention could have a positive impact on their mental health outcomes, which was not the focus of our study.


Eligibility Criteria:
Inclusion Criteria:

* Age 55 years and above (age limit may be relaxed to not less than 45 years if there is a special desire to participate in the intervention)
* No barriers to daily communication
* Individuals participating voluntarily

Exclusion Criteria:

* Good cognitive functioning (SCD score of 0)
* Subjective desire to withdraw
* Individuals who reported discomfort opting out during the experimental procedure
Cardiac Arrhythmias at Extreme Altitude

Background: Exposure to high altitudes has been associated with an increased risk of cardiac arrhythmias in healthy subjects and an increased risk of sudden cardiac death.

Aim: The aim of the present study is to evaluate the risk and the incidence of cardiac arrhythmias at extreme altitude.

Methods: This is a prospective cohort study of healthy volunteers determined to climb Mount Everest. Subjects will be evaluated for eligibility by electrocardiography and echocardiography. All study participants will undergo ambulatory rhythm monitoring in their home environment within 12 weeks of the climb. Subsequently, ambulatory rhythm monitoring will be repeated during the ascent from basecamp to the summit of Mount Everest. The primary endpoint will be the composite of supraventricular and ventricular tachyarrhythmias, and bradyarrhythmias.

Background: Several physiological changes at high altitude give rise to a pro-arrhythmic milieu. A fall in atmospheric pressure at high altitude decreases the partial pressure of oxygen (PaO2) and causes arterial hypoxemia. Respiratory alkalosis secondary to hyperventilation causes hypokalemia and hypocalcemia. Both factors facilitate the occurrence of rhythm disturbances, and may be further exacerbated in an adrenergic state with increased epinephrin levels.

Objectives: The primary objective is to investigate the incidence of supraventricular and ventricular tachyarrhythmias, and the incidence of bradyarrhythmias in climbers during the ascent of Mount Everest. The secondary objective is to investigate clinical, electrocardiographic and echocardiographic predictors of cardiac arrhythmias at extreme altitude.

Methods: This is a prospective cohort study of healthy volunteers climbing Mount Everest. Subjects will be evaluated for eligibility by electrocardiography and echocardiography. All participants will undergo a stress test in order to rule out pre-existing rhythm disturbances during exercise. Study participants will undergo ambulatory rhythm monitoring in their home environment within 12 weeks of the climb. Subsequently, subjects will repeat ambulatory rhythm monitoring during the ascent from basecamp to the summit of Mount Everest. The subjects will act as their own controls.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Normal electrocardiogram
* Normal echocardiography
* Written informed consent

Exclusion Criteria:

* Known cardiac arrhythmia
* Evidence of AV-block, left bundle branch block, or repolarization disorders on electrocardiogram
* Evidence of structural heart disease (valve disease more than mild) or compromised left ventricular ejection fraction as assessed by echocardiography
* Symptoms or history of skin cancer, rash, skin disease, keloid or injury
* Cardiac pacemakers, cardiac defibrillators, implantable electrical devices
* Pregnancy, breastfeeding
Sinus Augmentation in the Posterior Maxillary Region: a Case Report of 0mm Bone Height.

Sinus floor elevation (SFA) and GBR have been applied in the placement of dental implants in longstanding edentate posterior maxilla region. However, the number of study on the efficacy of these procedure on areas with 0mm bone height is limited. This case study aims to compare two cases of 0mm bone height in the posterior maxillae region with different handling procedure. In this article, two female patients in their 40s underwent maxillary sinus augmentation (sinus lifting) due to longstanding missing posterior maxillary molars with the bone of which area had resorbed entirely, leaving 0mm bone height. One patient went through conventional sinus augmentation while the other had a two-stage - sinus - lift procedure. Researchers compared the bone - volume induced between the two procedures.


Eligibility Criteria:
Inclusion Criteria:

* 0mm bone height at posterior maxillae region

Exclusion Criteria:

* general contraindication to implant surgery
* subjected to irradiation in the head and neck area \<1 one year before implantation
* uncontrolled diabetes
* pregnant or nursing
* substance abuse
* heavy smoker
* psychiatric therapy or unrealistic expectations
* immunosuppressed or immunocompromised
* treated or under treatment with oral or intravenous aminobisphosphonates
* untreated periodontitis
* poor oral hygiene and motivation
Physical Activity in Chronic Obstructive Pulmonary Disease(COPD) Acute Exacerbation Patients

Patients who are suffering from Chronic Obstructive Pulmonary Disease (COPD) had a decreased level of physical activity which is consequentially related to another acute exacerbation event. In this study, we selected patients from those who were admitted for acute exacerbation of COPD, evaluated physical activity by accelerometer (wearable multisensory armband devices) to find out the correlation between physical activity in COPD acute exacerbation patients.


Eligibility Criteria:
Inclusion Criteria:

* COPD patient who have forced expiratory volume in one second/ forced vital capacity (FEV1/FVC) \< 70% by spirometry and those who have not been admitted for acute exacerbation in recent 3 months

Exclusion Criteria:

* Those who does not consent or those who have drug addiction, psycho-socially or medically not feasible to this study
Interactions Between Environmental Exposures and Gut Microbiota in Early Life

Recruit the mothers and their infants who bron in Peking University People's Hospital from 2023 to 2026, to evaluate the interaction between environmental exposure and gut microbiota.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant woman

   * aged 20-40 years old
   * natural conception
   * single pregnancy
   * gestational age ≥36 weeks
2. Newborn

   * normal Apgar score
   * no serious congenital diseases

Exclusion Criteria:

-