cyrilzakka/clinical-trials huggingface dataset:
Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section

The aim of this study is to evaluate the effectiveness of low dose scheme with dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical conditions, best post-operative pain free experience, and more stable hemodynamic.


Eligibility Criteria:
Inclusion Criteria:

* Full-term pregnant women
* Singleton gestation
* American Society of Anaesthesiologists (ASA) physical status classes II and I

Exclusion Criteria:

* Preterm pregnancy (\<37 wks. gestation)
* Multiple gestation
* Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medications
* Asthma and allergy to non-steroidal anti-inflammatory drugs
* Conditions that prevent spinal anaesthesia
* Failed spinal block and conversion to general anaesthesia
* A history of established chronic pain
* Drug addiction
* A psychiatric disorder
* Inability to communicate effectively
Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds

This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients. Patients will be randomized to either the octenisept® group or to the placebo group.

Randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients. Patients will be randomized to either the octenisept® group or to the placebo group.

Primary Objectives: Antimicrobial efficacy of octenisept® compared to placebo. Secondary Objectives: Subjective tolerance of octenisept®, evaluation of wound parameters.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients of at least 18 years at the time of consent
* Patients with a venous leg ulcer (Ulcus cruris)
* Patients with a chronic leg ulcer
* Females of childbearing potential who are willing to comply with any applicable contraceptive requirements of the protocol
* Negative pregnancy test
* Satisfactory medical assessment
* Ability to provide written informed consent
* Signed declaration of consent
* Willingness to co-operate

Exclusion Criteria:

* Pregnant or lactating women and women not using contraception
* Known history of alcohol or drug abuse
* Use of any antibiotic medication within the last 7 days prior to the first dose
* Patients with serious concomitant disease
* Patients with a coagulation disorder
* Known history of allergic reactions attributed to octenisept® or one of its compounds
* Participation in another clinical trial within the last 30 days before randomization
* Concomitant treatment with other preparations that interfere with the trial preparation or the disease
* Absence of declaration of consent
* Doubt about willingness to co-operate
* Non-fulfilment of the inclusion criteria
Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery

The aim of this prospective randomized controlled study was to compare the prophylactic effects of intravenous single dose of ondansetron, ramosetron, and palonosetron on PCA-related nausea and vomiting after urologic laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* Patients aged (20-65 yr) Undergoing Laparoscopic Nephrectomy
* Patients who want a patient-controlled IV analgesia (IV-PCA)

Exclusion Criteria:

* History of allergy or hypersensitivity to 5-HT3 antagonist
* History of severe postoperative nausea/vomiting
* Prolonged QT interval on preoperative EKG
* Hypokalemia, Hypomagnesemia
* Intestinal obstruction
* Pregnant female or breast feeding mother
A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a Phase II, multicenter, open-label study designed to evaluate the safety and efficacy of SHR-1210 with BP102 in subjects who are chemotherapy naive and have Stage IIIB\~IV non-squamous NSCLC. The primary end points are ORR and PFS.

In this study, subjects will receive SHR-1210 combined with BP102 until progression or unacceptable toxicity (SHR-1210 or BP102 for a maximum of 2 years).


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
* Subjects who are chemotherapy naive and have Stage IIIB-IV non-squamous NSCLC;
* Gene diagnostic tests must show that subjects are with wild type of EGFR, ALK and ROS1;
* Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening;
* No prior systemic treatment;
* Adequate hematologic and end organ function;
* Female participants of childbearing potential must have a negative serum pregnancy test within -7 days of randomization and must be willing to use very efficient barrier methods of contraception or a barrier method plus a hormonal method starting with the screening visit through 6 months after the last dose Male participants with a female partner(s) of child-bearing potential must be willing to use very efficient barrier methods of contraception from screening through 6 months after the last dose.

Exclusion Criteria:

* Significant cardiovascular disease;
* Prior treatment with immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies;
* History of autoimmune disease;
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome;
* Severe infection within 4 weeks prior to randomization;
* Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study;
* Major surgical procedure within 4 weeks prior to randomization;
* History of hemoptysis within 12 weeks prior to randomization;
* Inadequately controlled hypertension;
* Evidence of bleeding diathesis or coagulopathy;
* Prior allogeneic bone marrow transplantation or solid organ transplant;
* Positive test for HIV, and patients with active hepatitis B or hepatitis C.
Comparison of the Efficacy of Pharmacology and Non-pharmacological Treatment in Women With Primary Dysmenorrhea.

Primary dysmenorrhea is a common problem in women. Women use many treatment methods to deal with primary dysmenorrhea. Therefore, this study aims to find the most effective treatment by determining the effectiveness of conservative and non-conservative treatment in women with primary dysmenorrhea. Another aim of the study is to generalize the use of conservative treatment methods in the treatment of primary dysmenorrhea.On the other hand, it aims to spread the telerehabilitation method, which allows the global Covid 19 outbreak to be maintained remotely online, in the world and in our country.

This study aims to determine the effects of different treatment approaches in women diagnosed with primary dysmenorrhea. Patients who are examined by a physician and diagnosed with primary dysmenorrhea using ultrasonography will be included in the study. The cases will be divided into 5 groups by randomization. In the first group, patients who are prescribed diosmin by the attending physician will be taken. The second group; Patients who are prescribed naproxen sodium by the attending physician will be taken. The third group; Pelvic floor exercises will be performed 2 days a week and 12 weeks a week using the motor imagination technique created by the women health physiotherapist. In the fourth group, acupressure technique applied by applying pressure to non-invasive acupuncture points will be applied daily for 12 weeks. The fifth group will be the control group. Online access will be synchronized with the phone or computer, and training sessions will not be recorded to protect the patient's personal information. Cases will be evaluated online at the beginning of the study and at the end of the 12-week program.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18 whose menstrual cycle continues,
* Primary dysmenorrhea was diagnosed by the obstetrician by ultrasonographic evaluation.
* Participants who agree to participate in the study will be included.
* Participants in the diosmin group who were prescribed diosmin by the physician
* Participants in the NSAI group who were prescribed an NSAI by the physician

Exclusion Criteria:

* Receiving hormone therapy
* Those receiving psychiatric treatment for stress disorder or anxiety
* Intrauterine contraceptive device
* Using birth control pills
* Women diagnosed with secondary dysmenorrhea
* With neurological deficits
* Patients who were not suitable for NSAI and Diosmin treatment by the physician were excluded by the physician and were not included in our study.
Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life

The primary objective of this open randomised controlled trial is to assess the add-on effect of EMD-U compared to CAU alone, in improving dermatology-specific quality of life in patients with atopic dermatitis or prurigo nodularis who suffer from severe scratching behaviour.

The main study parameter is the difference in treatment effect between EMD-U and CAU at T2, measured with the Skindex-29 symptoms scale. There are five measurement points: T0, T1 after 4 weeks, T2 after 8 weeks, T3 after 12 weeks, and T4 after 6 months.

Patients are randomly allocated to either the EMD-U or CAU condition.

Rationale: The EMD protocol for urge (EMD-U) is a recently developed treatment that combines elements of Eye Movement Desensitization and Reprocessing (EMDR) therapy, Cognitive Behaviour therapy, and hypnotherapy. EMD-U aims to reduce the urge for scratching behaviour through desensitization techniques, self-registration of behaviour, and homework assignments. The EMD-U treatment has shown promising results in reducing scratching behaviour in patients with atopic dermatitis and is currently being investigated in patients with prurigo nodularis. Yet, the added value of the brief EMD-U intervention in addition to the care as usual (CAU) in improving dermatology-specific quality of life is unknown.

Objective: The primary objective of the study is to assess the add-on effect of EMD-U compared to CAU alone, in improving dermatology-specific quality of life in patients with atopic dermatitis or prurigo nodularis who suffer from severe scratching behaviour.

Study design: An open randomised controlled trial, with two arms: 1) EMD-U, 2) CAU (control). There are five measurement points: T0, T1 after 4 weeks, T2 after 8 weeks, T3 after 12 weeks, and T4 after 6 months.

Study population: Patients with atopic dermatitis or prurigo nodularis who suffer from substantial scratching behaviour.

Intervention (if applicable): Patients are randomly allocated to either the EMD-U or CAU condition.

The EMD-U treatment lasts eight weeks, in which two EMD-U sessions and two phone calls take place in the first three weeks. After the first EMD-U session, patients are instructed to apply the learned technique at home until the end of the study. In the five following weeks, patients are phoned twice to ask for their experiences with the practicing at home.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 ≥
* A confirmed diagnosis of atopic dermatitis or prurigo nodularis
* Suffering from persistent and frequent scratching behaviour
* IGA-CPG activity score ≥ 3 OR Skindex-29 symptoms subscale score ≥ 42
* Stable course of treatment in the two weeks prior to the study (no medication change, etc.)
* Sufficiently motivated to take part in a new intervention aimed at behaviour change

Exclusion Criteria:

* Insufficient understanding of Dutch language
* Severe psychiatric disorders that require treatment first, such as delusional disorder or major depression
* If medication is changed during the course of the study, the participant will be considered a drop-out from the moment the medication has changed.
Participants Preferences to Disease Modifying Agents in Relapsing Remitting Multiple Sclerosis Condition

This multi-center non-interventional, observational, cross-sectional study in adult participants with relapsing remitting multiple sclerosis (RRMS) will evaluate the participants' preferences for disease modifying treatments (DMT) in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged greater than or equal to (\>/=) 18 years
* Participants who have a diagnosis of RRMS as documented in their medical records
* Participants who have been prescribed a DMT for at least 3 months
* Participants who have an expanded disability status scale (EDSS) score of 1-6 points

Exclusion Criteria:

- Participants with any personal or medical condition that in opinion of the investigator would interfere with or make impossible proper participation in the study
Different Doses of Colchicine on hsCRP

Colchicine reduced atherothrombotic cardiovascular events in the COLCOT and LoDoCo2 studies. US Food and Drug Administration approved colchicine as the first anti-inflammatory drug for cardiovascular diseases on June, 2023. However, there is a lack of evidence for colchicine in East Asian population with coronary heart disease, and its effectiveness and safety need further exploration. Therefore, this study aims to use different doses of colchicine to treat patients with coronary heart disease after percutaneous coronary intervention, explore the effects of different doses of colchicine on hsCRP levels, and find the optimal dose of colchicine for treating coronary heart disease in China.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate, understand and sign an informed consent form;
2. Age ≥ 18 years old, regardless of gender;
3. Patient diagnosed with coronary heart disease requiring percutaneous coronary intervention;
4. Complete all planned percutaneous coronary intervention during hospitalization;
5. Patient must be treated according to national guidelines for standard treatment of coronary heart disease.

Exclusion Criteria:

1. Known allergies to colchicine;
2. Colchicine was taken within 10 days before randomization;
3. Abnormal liver function test (alanine aminotransferase \>3 times the upper limit of normal value);
4. Abnormal renal function test (eGFR\<30mL/min);
5. Thrombocytopenia (platelet count \<100 g/L);
6. Uncontrolled infectious diseases;
7. Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, and malignant tumor, etc;
8. Pre-existing or plan for the administration of nonsteroidal anti-inflammatory drugs, hormones, immunomodulatory drugs, or chemotherapeutic drugs;
9. Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives;
10. Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.
What Influences Physicians' Decisions - Statistics or Stories?

The purpose of this study is to test whether physicians change their use of non-recommended tests, procedures, or medications more in response to evidence based-guidelines, price information, or an individual patient's story.

We will perform a randomized controlled trial (RCT) of information presented to physicians to test the hypothesis that an identifiable victim affects physician practice behavior more than a statistical victim.

Specifically, we will answer the following research questions: 1) do physicians order fewer non-recommended tests, procedures, or medications if they are told about a patient or a physician who had a bad outcome from that test, procedure, or medication than if they are simply told the guideline or the cost of the test, procedure or medication, 2) does the effect of learning about the identifiable victim last longer than the effect of learning about the guideline or the cost of a test, procedure, or medication, and 3) does the identifiable victim effect differ if the victim is a patient or a physician? We hypothesize that because of the propensity to respond more to the identifiable victim rather than the statistical victim that physicians will order fewer unnecessary tests when they are told about an individual patient case than if they are simply told about the guideline, that the effect of the identifiable victim will last longer than the effect of the statistical victim, and that a patient as the identifiable victim will have more effect than a physician as the identifiable victim.

The identifiable victim effect refers to the tendency to offer more aid to a specific, identifiable victim rather than a vaguely defined group of people with the same need. In the this study, the identifiable victim is a fictional patient who experience a negative consequence as a result of an unnecessary test. The identifiable victim effect is described and studied in the following articles:

Small D. Sympathy and callousness: The impact of deliberative thought on donations to identifiable and statistical victims. Organizational Behavior and Human Decision Processes 2007;102:143-53.

George Loewenstein, Deborah A. Small, and Jeff Strand. "Statistical, identifiable, and iconic victims" in Edward J. McCaffery, Joel Slemrod (2006). Behavioral public finance. Russell Sage Foundation; pp. 32-35.

Eligibility Criteria:
Inclusion Criteria:

* Primary care physicians in the Weill Cornell Physicians Organization

Exclusion Criteria:

* None
AGC Mode vs Minimal Flow in Breast Surgery

The aim of this study was to compare the AGC mode and manually controlled minimal-flow anesthesia for volatile anesthetic consumption, hemodynamic parameters, and recovery from anesthesia

Modern anesthesia machines use circular systems in which ventilated gas re-circulates to a certain degree and is therefore reused, preserving temperature, and humidity. The rebreathing fraction is increased by a reduction in fresh gas flow, which leads to a considerable decrease in consumption of fresh gas and volatile anesthetics, resulting in reductions in cost and atmospheric pollution. In a closed ventilation system, only the patient's requirements for oxygen and anesthetic agents are supplemented. A fresh gas flow-rate of 0.5 l/min is defined as the minimal-flow technique. The oxygen and anesthetic gas titration can be manually controlled by the anesthetist. To assure safe and appropriate anesthesia, manually controlled anesthesia requires constant monitoring and numerous adjustments to the gas dosage by the anesthetist, especially for low- and minimalflow anesthesia. Oxygen flow and volatile anesthetics can also be automatically controlled by anesthesia machines using end-tidal control (such as AGC mode of Maquet FLOW-i anesthesia machine), which ensures constant end-tidal concentration of oxygen and anesthetic gas via feedback and continuous automatic adjustment mechanisms. Anesthesiologists needing to make fewer interventions during a case may have clinical importance in terms of distraction, record keeping and patient safety. In addition to this advantage, we wanted to compare the AGC mode and manually controlled minimal-flow anesthesia for volatile anesthetic consumption, hemodynamic parameters, and recovery from anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* undergoing breast surgery
* ASA physical status I-II
* female
* operation lasting at least 1 hour
* those who agreed to volunteer for the study with an informed consent form

Exclusion Criteria:

* coronary artery disease, CHF
* pregnancy or breastfeeding women
* decompensated diabetes mellitus
* kidney or liver failure
* chronic obstructive pulmonary disease
* opioid sensitivity
* history of malignant hyperthermia
* history of smoking
* alcohol or drug addiction
* significant anemia
* sepsis
* BMI \>35
* patients with allergies to the drugs used in the study
Solifenacin, Levofloxacin or Lornoxicam, Which Is Ideal for Management of Intravesical Instillation BCG Side Effects?

Compare the different supposed clinical treatment of side effects associated with intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs lornoxicam (NSAID)

For urothelial carcinoma (UC), which accounts for over 90% of bladder cancers, more than 70% of bladder cancer patients present with non-muscle-invasive disease. Approximately 40-80% of these tumors will recur within the first year, of which 10-25% will progress to muscle-invasive disease.

Intravesical treatments with cytotoxic chemotherapy and immunotherapy have become the mainstay following transurethral resection (TUR). Increasing knowledge of BCG use allows for effective management of these once debilitating side effects. The majority of patients will still experience cystitis-like symptoms to some degree, including urinary frequency (71%), cystitis (67%), fever (25%), and hematuria (23%).

Oxybutynin increases in fever, flu-like symptoms, dry mouth and constipation. However, in this study oxybutynin started the night before treatment causing an element of incomplete bladder emptying and allowing an increased BCG dwell time. We think that these effect can be reversed by use anticholinergic 6 hours post BCG instillation Anti-inflammatory drugs significantly reduced BCG-induced granulocyte activation and did not impair BCG-induced lymphocyte cytotoxicity against bladder tumor cells in mice. The committee of International Bladder Cancer Group (IBCG) recommend use of anti-inflammatory agents (NSAIDs) for treatment of non-bacterial or chemical cystitis and other systemic BCG side effect.

Fluoroquinolone with tuberculostatic properties, has been shown to significantly prolong survival in mice with BCG systemic infection and did not affect the antitumor efficacy of BCG. ofloxacin significantly decreased by 18.5% the incidence of class II or higher moderate and severe adverse events of BCG.

Because of sparse published studies on BCG side effect management, the 2016 European Association of Urology (EAU) guidelines management options for side effects associated with intravesical BCG modify the IBCG committee clinical practice without any degree of recommendation. So, in this study the investigators will try to fill the gap in the literature.

Eligibility Criteria:
Inclusion Criteria:

• Patients classified as intermediate or high risk of the bladder tumour

Exclusion Criteria:

* Patient over 80 years (natural decline in immune system function)
* Refuse to complete study requirements
* Contraindication to BCG therapy
* High post-void residual (PVR) above 85 ml
* American Urological Association (AUA) Symptoms score above 20
* Sensitivity to previously mentioned 3 drugs
* High serum creatinine
Prognostic Indicators in Pituitary Adenoma Surgery: a Comprehensive Analysis of Surgical Outcomes and Complications.

Predicting the outcome of pituitary surgery, particularly the risk of complications, is a critical determinant in selecting the appropriate treatment modality for patients. To date, only a limited number of risk factors have been identified for complications following pituitary surgery, including tumor size, younger age, and previous surgical intervention. Furthermore, existing studies have demonstrated that prolactin levels can serve as a surrogate marker for assessing pituitary function, specifically revealing associations between elevated prolactin levels and anterior pituitary insufficiencies.

In a retrospective study on the "HYP'OP" cohort, the aim of the study is to identify predictive factors for both surgical outcomes and complications.


Eligibility Criteria:
Inclusion Criteria:

* Transsphenoidal pituitary surgery at Nancy University Hospital (France) between 2012 and 2022 for a pituitary adenoma.

Exclusion Criteria:

* No 4 month evaluation.