cyrilzakka/clinical-trials huggingface dataset:
SMAD2, SMAD3 AND TGF-β GENE EXPRESSION IN URGE URINARY INCONTINENCE

Urge urinary incontinence (UUI) is a common health problem. Changes in collagen metabolism in pelvic support organs, such as uterosacral ligaments (USLs), might be responsible for the complex pathophysiology of UUI. The TGF-β pathway is involved in collagen synthesis and degradation. The Transforming Growth Family- β (TGF-β) superfamily has essential intracellular signaling components, such as newly identified SMAD family members. We evaluated the changes in the levels of TGF-β and SMAD gene and protein expression in the USL of patients with concomitant pelvic organ prolapse (POP) and UUI.

This study included 10 patients who had been diagnosed with POP and UUI in the study group and 14 asymptomatic women without complaints of POP and UUI in the control group. Biopsy samples were collected from bilateral USL tissues during vaginal or abdominal hysterectomy. Total RNA was extracted from USL tissue and analyzed by qPCR. The protein expression levels were also analyzed with ELISA.

Eligibility Criteria:
Inclusion Criteria:

* patients who had been diagnosed with POP and UUI
* asymptomatic women without complaints of POP and UUI

Exclusion Criteria:

* Women who have SUI,
* a history of gynecologic malignancy,
* endometriosis,
* connective tissue disorders,
* asthma,
* previous pelvic inflammatory disease,
* pelvic radiation anamnesis,
* smoking,
* previous surgery for POP or UI,
* those on steroid therapy and hormone replacement therapy
Effects of Esketamine on the Incidence of Postoperative Delirium and Postoperative Sleep Disturbance in Elderly Patients After Major Non-cardiac Surgery

Postoperative delirium (POD) is a common surgical complication.It is associated with a range of negative outcomes such as delayed postoperative recovery,prolonged hospitalization,additional medical expenditures and higher mortality.

Meanwhile,sleep disorders are not only an important predisposing factor for delirium,but also one of the main symptoms of delirium.Systemic inflammatory responses caused by sleep disorders may be an important mechanism for POD.

Many studies have shown that esketamie may inhibit inflammatory factors and enhance neuroplasticity.

In summary,we felt the need to further explore the therapeutic potential of esketamine in the area of POD as well as postoperative sleep disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≧ 65 years;
2. ASA Ⅰ-Ⅲ;
3. Elective major non-cardiac surgery;
4. Voluntary signed informed consent.

Exclusion Criteria:

1. People with mental illness;
2. Suffering from serious central nervous system disorders such as arkinson's disease, Alzheimer's disease, etc;
3. Elevated intracranial pressure;
4. Emergency or trauma surgery;
5. Prior history of postoperative delirium or postoperative cognitive decline;
6. The patient has impaired hearing or impaired vision;
7. Suffering from severe systemic underlying diseases (e.g. cardiac insufficiency, malignant arrhythmia, malignant hypertension, hepatic failure, renal failure, etc.);
8. The patient is in chronic pain;
9. The patient is severely malnourished;
10. Patients with stage 3 or 4 malignant tumors, pancreatic cancer, allbladder cancer, cholangiocarcinoma and other tumors with high malignancy and poor prognosis.
11. history of allergy to or contraindication to esketamine;
12. inability or unwillingness to complete questionnaires or clinical testing;
13. Unable or unwilling to use a postoperative intravenous analgesic pump.
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.

The object of the study will be children and adolescents from 6 to 15 years old, living in the city of Tashkent and in the Tashkent region. We will study patients with various clinical forms of chronic gastroduodenal pathology (CGDP). The effect of enteral oxygen therapy in the recovery of patients with CGDP due to the positive effect of the active form of oxygen on the hematological system and on the regenerative processes in the gastrointestinal tract will be studied. At the same time, the effect of enteral oxygen therapy on enhancing the effectiveness of eradication therapy during the treatment of carrier Helicobacter pylori due to the neutralization of the products of urea hydrolysis around bacteria under the action of reactive oxygen species will be studied.

In recent years, among the non-infectious diseases of children and adolescents, there has been an increase in many nosological forms of pathology of the gastrointestinal tract. Scientific works of recent years show that all over the world much attention is paid to the problem of timely prevention and improvement of chronic diseases of the gastroduodenal zone in children. This is mainly due to the fact that the incidence of diseases of the digestive system among schoolchildren is steadily increasing. In the clinical practice of gastroenterologists, it is often necessary to influence the regeneration processes in the gastroduodenal zone. The object of the study will be children and adolescents from 6 to 15 years old, living in the city of Tashkent and in the Tashkent region. We will study patients with various clinical forms of chronic gastroduodenal pathology (CGDP). The effect of enteral oxygen therapy in the recovery of patients with CGDP due to the positive effect of the active form of oxygen on the hematological system and on the regenerative processes in the gastrointestinal tract will be studied. At the same time, the effect of enteral oxygen therapy on enhancing the effectiveness of eradication therapy during the treatment of carrier Helicobacter pylori due to the neutralization of the products of urea hydrolysis around bacteria under the action of reactive oxygen species will be studied.

Eligibility Criteria:
Inclusion Criteria:

* children and adolescents aged 6 to 15 years;
* children with chronic gastroduodenal pathology: chronic gastritis, chronic gastroduodenitis, chronic duodenitis, gastric and intestinal ulcers of both sexes;
* children who have the opportunity to visit the clinic.

Exclusion Criteria:

* children under 6 years old and adolescents over 15 years old;
* children with chronic diseases of internal organs, except for the gastrointestinal tract;
* children with psychosomatic and neurological disorders;
* children in hospital;
* children with endocrine diseases;
* children who are allergic to eggs;
* children with blood diseases;
* children with cancer.
Radiofrequency Ablation Versus Hemithyroidectomy of Small Thyroid Cancers

This is a multicenter randomized controlled trial including patients with small (\<2 cm) suspected or confirmed thyroid cancers. Patients are included after informed consent and randomized to one of two treatments. One treatment is a standard henithyroidectomy and the second treatment is radiofrequency ablation (RFA) of the specific tumor. The investigators will evaluate initial outcome of the allocated treatment, thyroid hormonal function, oncologic safety, quality of life, and treatment costs in a follow-up period of five years after treatment.

The overall aim of the study is to improve patient's health by reducing the number of operations on small thyroid cancers. In patients with these small tumors, the long-term adverse outcome may be higher than possible benefits from the operation. For participants undergoing surgical treatment with HT, the investigators will measure final histology and both beneficial and adverse outcome from the operation. For participants undergoing RFA, the investigators expect to reduce the need for thyroid hormonal substitutions, reduce the surgical adverse outcomes, reduce treatment costs and increase QoL without a reduction in oncologic safety and outcome.


Eligibility Criteria:
Inclusion Criteria:

* Single tumor in the thyroid gland with a FNAB suspecious of cancer or diagnostic of cancer (category V or VI in the Bethesda system)
* tumor size of less than 2 cm in all dimensions.

Exclusion Criteria:

* suspicion of disseminated disease because of PET-positive lymph nodes ; suspect lymph-nodes by ultrasonography (US); or signs of capsular invasion of the tumor OR
* tumor not eligible for RFA treatment because of high-risk location; previous thyroid surgery; concomitant hyperparathyroidism (ionized calcium \> 1.32 mmol/L and PTH \> 6 pmol//L ) OR
* if the patient is pregnant OR
* If the patient is unable to give informed consent.
Functional Imaging of Psychic Pain

Suicidal behaviour (SB) represents a major public health problem, costing life in more that one million people every year worldwide. Even if SB is considered as a consequence of social adversity and depression, these stress factors are often necessary but not sufficient to explain the occurrence of a suicidal act. A preliminary study suggests that an increased perception of psychic pain during a major depressive disorder increases the risk of suicide behaviour. The investigators aimed to investigate the relationship between social exclusion (a classic trigger of psychic pain) and SB and improve our knowledge about the physiopathology of this domain.

Suicide behaviour (SB) represents a major public health problem. In order to improve prevention strategies, a better understanding of the physiopathology of SB is needed. According to a "stress vulnerability" model, people who make a suicide attempt when they are subject to a stress factor (environmental stress, interpersonal difficulties, depression, tobacco, substance abuse...) are those who have a specific vulnerability. Vulnerability factors to SB may be considered in clinical terms (propensity to hopelessness, aggressive impulsivity traits), neurobiological terms (serotoninergic system disorder, especially in the ventral prefrontal cortex-vPFC) and cognitive terms (decision making, cognitive functions mediated by the vPFC and the serotoninergic system). Finally, genetic factors seem also involved in suicide vulnerability. The investigators have conducted a preliminary study which suggests that increased perception of psychic pain during a major depressive disorder increases suicidal ideation and suicidal act. Study about anatomic basis of psychic pain and its triggers represents a relevant theme to understand the suicidal process. Among the classical factors triggering psychic pain and suicidal act, events of social exclusion appears to be crucial. Finally, many data suggests the close relationship between physic and psychic pain.

Eligibility Criteria:
Non specific criteria, for all the participants:

* Woman- 18-50 years old
* Non menopausal
* Right-handed
* Caucasian from western Europe (exception of Basque and Sardinian), for genetic purposes
* Subject who signed informed consent
* Able to understand the nature, the aim, and the methodology of the study and agree to cooperate during clinical and radiological evaluation

Specific criteria:For depressed suicide attempters :

* DSM IV criteria for major depressive disorder
* Personal history of suicide attempt
* No psychotropic treatment currently

For depressed affective controls :

* DSM IV criteria for major depressive disorder
* No personal history of suicide attempt
* No psychotropic treatment currently

For non depressed suicide attempters :

* Personal history of unipolar or bipolar mood disorder, according to DSM IV criteria
* Normothymic currently (HAMD\<7)
* Personal history of suicide attempt
* Minimum treatment Healthy controls :
* No personal history of axis I psychiatric disorders according to the MINI and the DSM IV criteria
Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer

The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to Patients with Advanced Pancreatic Cancer.

Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity.

Recent studies have suggested that local destruction of tumor tissue by oncolytic virus induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. PD-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. Combination of PD-1 blocking antibody plus oncolytic virus may increase anti-tumor efficacy in pancreatic cancer.

The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to patients with advanced pancreatic cancer who are refractory to standard chemotherapy. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every three weeks.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document.
* Age ≥ 18 years and ≤ 80 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
* Patients who have received at least two lines of anti-tumor chemotherapy, or patients who have been unsuitable or unwilling to standard therapy.
* Locally advanced, or metastatic pancreatic cancer.
* Presence of at least of one measurable lesion in agreement to RECIST criteria.
* The expected survival ≥ 3 months.
* Adequate organ performance based on laboratory blood tests.
* Patients who are willing or able to comply with study procedures.

Exclusion Criteria:

* Pregnant or nursing women.
* Primary pancreatic cancer, or prior treatment with oncolytic virus and PD-1 inhibitor.
* The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
* Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
* Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
* Allergic to study drugs.
* Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Self Medication With Oral Morphine After Total Knee Arthroplasty.

The study aims to compare two post operative pain management strategy's, traditional nurse dispensed pain control versus patient self medication. The investigators aim to establish if patients who self medicate have differing pain levels than those who take nurse dispensed oral morphine.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring total knee replacement surgery willing to provide written, informed consent.

Exclusion Criteria:

* Unable to safely self medicate.

Allergy to morphine.

Unable to provide consent.

Contraindication to the standardised anaesthetic or standard postoperative care.

Not consenting to an element of the standardised anaesthetic.

Pre-operative use of strong opiates e.g. Oramorph, MST, Oxynorm.
Margin Status After Pancreaticoduodenectomy for Cancer

This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology Protocol (LEEPP) with other "conventional" pathological protocol of PD specimen for periampullary cancer. Our aims were to evaluate the impact of the protocol and of the clearance on R1 rate and its prognostic value.


Eligibility Criteria:
Inclusion Criteria:

* pancreaticoduodenectomy for periampullary cancer

Exclusion Criteria:

* diagnosis of neuroendocrine neoplasm;
* previous pancreatic surgery;
* frozen section of each transection margins not performed or presence of positive transection margins without further resection (R1 intraoperative resection);
* presence of macroscopic residual tumor (R2 resection).
Efficacy and Safety of Berlim 25/10 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia

The purpose of this study is to evaluate the efficacy and safety of Berlim 25/10 association in the treatment of type 2 diabetes mellitus and dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;
* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;
* HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose \> 100 mg/dL at the screening visit;
* Participants with low or intermediary cardiovascular risk according to the Brazilian guideline on the prevention of cardiovascular diseases in patients with diabetes (2017), which have not reached the goal of LDL-c ≤ 100 mg/dL with lifestyle changes, who are or aren't using low-potency statins;
* BMI (body mass index) \> 19 Kg/m2 and ≤ 45 Kg/m2.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to the formula components used during the clinical trial;
* Type 1 diabetes mellitus;
* Fasting blood glucose \> 300 mg/dL;
* Risk factors for volume depletion;
* Participants with total cholesterol \> 500 mg/dL or triglycerides \> 500 mg/dL;
* Impaired renal function and end-stage renal disease;
* Participants with known heart failure, class III to IV (New York Heart Association);
* Impaired hepatic function;
* Medical history of pancreatic diseases that may suggest insulin deficiency;
* Bariatric surgery in the last two years and/ or other gastrointestinal surgeries that can cause chronic malabsorption syndrome;
* Condition that, in the investigator's judgment, may favor clinically significant changes in CPK levels;
* Current medical history of cancer and/ or cancer treatment in the last 5 years;
* Participants with known uncontrolled hypothyroidism or TSH levels \> 5 mIU/L;
* History of known muscle disease or prior statin intolerance;
* Participants using SGLT2 inhibitors, sulfonylureas and/or insulin therapy or PCSK9 inhibitors;
* Participants who used other medications with prominent action in the control of serum triglyceride and cholesterol levels in the last 4 weeks or who are using low-intensity statins that cannot be replaced by rosuvastatin 10 mg;
* Participants using medications that may interfere with triglyceride and cholesterol metabolism started less than 4 weeks ago or with dose adjustment in the last 4 weeks prior to the screening visit;
* Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months.
Anaerobic Exercise and Mental Acuity

This is a randomized controlled trial to examine the effect of anaerobic activity (e.g., weight training) on gut microbiome metabolism and neurological health in healthy sedentary men.

The human gut microbiome, which houses over 2,000 distinct bacterial species, has recently been characterized as a highly influential force on the health and longevity of its host. By way of several distinct pathways comprising the "microbiome-gut-brain axis", this diverse population is known to communicate with the human brain in a bidirectional manner and is implicated in the pathophysiology of several metabolic and psychological disease states. The ability to support a healthy, diverse microbiome through modifiable behavioral interventions - such as diet and exercise - is a topic of growing interest. Most of the evidence pertaining to the relationship between physical activity and the gut-brain axis at this time, however, investigates the influence of aerobic exercise providing limited insight to how other modalities of physical activity may differ. Specifically, this study will examine the impact of an 8-week weight training protocol on gut microbiome metabolism and neurological health in healthy sedentary men. Participants will be randomly assigned to the intervention group or the waitlist control group.

Eligibility Criteria:
Inclusion Criteria:

* free of any existing medical diagnoses
* willing and able to participate in moderate to vigorous exercise as determined by the ACSM Health/Fitness Facility Preparticipation Screening Questionnaire
* sedentary (defined as a score \<14 on the Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ))
* equipped with access to a complete gym

Exclusion Criteria:

* antibiotic use within the past six months
* prebiotic, probiotic, or high-dose antioxidant supplementation within the past 6 months
* smoker (cigarettes and/or marijuana)
* regular laxative use
* blood pressure \>129/80 at baseline
Randomized Control Trial to Assess Postoperative Pain After Sling Placement

There are many ways to perform a suprapubic approach pubovaginal sling. Some surgeons inject local pain medical into the retropubic space before placing the sling, others do not. This study is to determine if injection of local pain medication into the retropubic space before placing a mid-urethral sling for urinary stress incontinence results in lower postoperative pain scores, lower use of postoperative narcotic medication and lower rates of urinary retention.

To evaluate if an injection in the retropubic space with a local acting anesthetic, Marcaine, (bupivacaine) at the time of mid-urethral sling placement will improve patients' reported post operative pain and decrease the use of narcotic pain medication. This study will include all female patients age 18 and older who will undergo a mid-urethral sling with or without anterior repair for the treatment of urinary stress incontinence by a member of the Division of Urogynecology and Reconstructive Pelvic Surgery who consent to be in the study.

Once patients have consented to participate in the study they will be randomized into two groups. One group will have the mid-urethral sling placed in the usual fashion with no injection of local anesthetic. The other group will have the mid-urethral sling placed after the retropubic space has been infiltrated with local anesthetic as previously described in the literature. Pain will be assessed with the use of a Visual Analog Scale during the hospitalization and the use of narcotic pain medication will be assessed during recovery and overnight in the hospital. Patients will be asked to record how often and what type of pain medication they use. Patients will also be asked to keep a log of their urination if they are discharged home with self catheterization. They will be asked to mail in their pain medication log and voiding diary (if needed) at a two-week post-operative. Outcomes will then be compared.

Eligibility Criteria:
Inclusion Criteria:

* Any female patient, age 18 or older, who elects to have a mid-urethral sling with or without an anterior or posterior repair at the University of North Carolina Hospitals by a member of the Division of Urogynecology.

Exclusion Criteria:

* Any patient with a chronic pain syndrome, a contraindication to nonsteroidal anti-inflammatory drugs (NSAIDs) such as liver disease, abnormal coagulation, esophageal disorders or peptic ulcers or where pain evaluation is unreliable because of neurological disease and those on treatment with steroids/NSAIDs/opioids prior to surgery.
* Also excluded will be any patient who is having any other reconstructive pelvic surgery concomitantly or would require the placement of a suprapubic catheter.
* Patients electing to have their surgery with regional anesthesia, such as an epidural or spinal will be excluded.
* All minors, decisional impaired people, nursing mothers and non-English speaking people will be excluded.