cyrilzakka/clinical-trials huggingface dataset:
Multicentre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Three Standard of Care Regimens for The Treatment of Triple-Negative Breast Cancer in the Neoadjuvant/Adjuvant Setting (REaCT-TNBC)

Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2.

TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. Clinically, patients with TNBC have a poorer prognosis compared to patients diagnosed with other breast cancer subtypes. Because of the aggressive phenotype and due to observations that systemic chemotherapy offers significantly higher benefit in ER negative disease, current treatment guidelines from provincial and other organizations recommend that patients receive adjuvant systemic chemotherapy for any TNBC greater than 0.5 cm in greatest diameter or node positive independent of primary tumor size.

Currently, there is no world-wide standard recommended chemotherapy regimen for the management of TNBC in the neoadjuvant/adjuvant setting, with treatments varying from region and institution.

As physicians do not know what the "best" treatment for patients is, genuine uncertainty ("clinical equipoise") exists. Physicians will choose between different "standards" in their personal practice, using idiosyncratic decision making processes, without the physician or the patient knowing the optimal option. This is not good for patients, physicians and society as a whole. Determining the optimal treatment remains an important medical issue for patients, physicians and society. This study will survey opinions on a novel method to allow comparisons of established standard of care prophylactic treatment using the "integrated consent model" as part of a pragmatic clinical trial and attempt to compare head to head standard chemotherapy regimens in patients with TNBC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary TNBC breast cancer
* Planned for chemotherapy
* ≥18 years of age
* Able to provide verbal consent
* Willing to complete a survey

Exclusion Criteria:

* Metastatic disease
* Contraindication to one or more of the chemotherapy agents being evaluated in the study
Shortwave Diathermy and Pilates Exercises in Patients With Chronic Non-specific Low Back

The aim of this study is to verify the effectiveness of the association of Shortwave Diathermy and Pilates exercises in patients with chronic non-specific low back pain, on the reduction of pain, functional disability and improvement of the quality of life.

The drawing of the study will be a prospective, randomized controlled trial and double-blind with quantitative approach. Study participants 36 subjects diagnosed with non-specific chronic low back pain, which will be divided in two groups with 18 subjects in each: experimental group, which will be submitted to placebo + exercise shortwave diathermy and the control group to do active + exercise shortwave diathermy. There will be 12 one-hour sessions twice a week. The subjects will apply Shortwave Diathermy for 20 minutes, followed by Pilates mat.

Eligibility Criteria:
Inclusion Criteria:

* individuals diagnosed with chronic non-specific low back pain for a period of more than 3 months, without irradiation for lower limbs;
* who present pain intensity greater than 3 points in the Numerical Pain Scale;
* to sign the Free and Informed Consent Form.

Exclusion Criteria:

* BMI\> 30;
* previous surgeries in the spine;
* severe spinal affection (tumors, infection, unconsolidated or vicious consolidation fractures, inflammatory diseases);
* rheumatic disease;
* contraindication to performing the exercises according to the American College of Sports Medicine Guidelines;
* degenerative or inflammatory joint and other body segments;
* patients who are in labor litigation;
* pregnancy;
* patients who are undergoing other type of physiotherapeutic or drug treatment.
Study Medication Adherence and Its Determinants in Chronic Disease Through the Example of Methotrexate in Chronic Inflammatory Rheumatism

The aim of this study is

1) To describe the level and determinants of methotrexate adherence in patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) in the department of rheumatology in the Nîmes University Hospital


Eligibility Criteria:
Inclusion Criteria:

* treated by methotrexate
* patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis)

Exclusion Criteria:

* methotrexate for other diseases
Percutaneous Nephroscopic Treatment of Parapelvic Cysts

Background of the project: The surgical treatment of parapelvic cysts is currently less researched and there is no gold standard for surgery. Previously, in percutaneous nephrolithotomy, we found that fenestration and fenestration drainage in the simultaneous treatment of pararenal pelvis cysts under nephroscopic nephroscopic surgery has clear curative effect, less trauma, and quicker recovery.

Objective: To clarify the safety, efficacy and long-term efficacy of percutaneous nephroscopy in the treatment of parapelvic cysts.

Nature: Retrospective case cohort study. Basic research process: Retrospective collection of cases in our hospital who underwent percutaneous nephroscopy for the treatment of parapelvic cysts, and comparison of preoperative and postoperative cyst size changes and long-term efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Has undergone percutaneous nephroscopic surgery for parapelvic cysts
* Ability to receive study follow-up

Exclusion Criteria:

* Patient refuses or is unable to give consent
Preoperative Versus Postoperative Start With Thromboprophylaxis in THA (Total Hip Arthroplasty)

The purpose of this study is to determine if there are differences in clinical events, i.e bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight Heparin) is initiated before or after surgery.


Eligibility Criteria:
Inclusion Criteria:

-patients 50 years or older undergoing cemented total hip arthroplasty for primary osteoarthritis

Exclusion Criteria:

* allergy to Low-Molecular-Weight -Heparin
* bleeding disorders
* renal failure
* hepatic disease
* active treatment for malignancy
* history of deep venous thrombosis or pulmonary embolism
* major operations,trauma,stroke or cardiac infarction the last 3 months before surgery.
Post-Myocardial Infarction Patients in Santa Catarina, Brazil - Catarina Heart Study

Prospective cohort evaluating patients in the State of Santa Catarina (Brazil) with the diagnosis of the first acute myocardial infarction from July 2016 until December 2020.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years;
* Presence of precordial pain suggestive of acute myocardial infarction associated with electrocardiogram with new ST segment elevation in two contiguous leads with limits: ≥0.1 mv in all leads other than leads V2-V3 where the following limits apply : ≥0.2 mv in Men ≥40 years; ≥0.25 mV in men \<40 years, or ≥ 0.15 mV in women or presence of precordial pain suggestive of acute myocardial infarction associated with elevation of troponin I or CK-MB above the 99th percentile of the upper reference limit

Exclusion Criteria:

* Previous acute myocardial infarction;
* Disagreement with the Terms of Informed Consent.
Individual Differences in Drug Response

Females are increasingly using cannabis, yet remain underrepresented in preclinical and clinical cannabinoid research. This female-specific research plan will test the effects of two recreationally relevant doses of oral THC and placebo in healthy females at two phases of the menstrual cycle. Acute oral THC will be administered in a double-blind and counterbalanced design. Menstrual cycle phase will be determined using blood serum analyses of estradiol and progesterone and self-reported responses. The main hypothesis is circulating estradiol levels are associated with cardiac, neuroendocrine, and subjective THC response. The rationale for the presented work is to better understand the risks of cannabis use, in order to maximize possible medical potential and minimize public health risks. The expected outcome of this work is a deeper understanding of how circulating estradiol levels may associate with response to THC and how the physiological response is associated with the subjective response. Uncovering the individual differences in response to THC will allow for more preventive action against cannabis-induced anxiety, paranoia, and psychosis.


Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old, females (N=60)
* Body Mass Index 19-26
* High school education, fluent in English
* Occasional cannabis users ( \<11 times in past 30 days)

Exclusion Criteria:

* History of daily cannabis use
* Past or present severe substance use disorder
* Current or past diagnosis with drug treatment for psychosis/bipolar/schizophrenia
* Past year major depression
* Current or past Post Traumatic Stress Disorder
* Attention Deficit Hyperactivity Disorder
* Cardiovascular illness, high blood pressure, abnormal electrocardiagram
* Current medications (NO hormonal birth control or intrauterine device)
* Pregnant or planning to become pregnant
Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Post-Spinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries.

This prospective, randomized, controlled, double-blinded study is designed to evaluate the efficacy of nefopam compared to dexmedetomidine and meperidine for the prevention of postspinal anesthesia shivering while minimizing side effects.

Numerous clinical studies have demonstrated that nefopam effectively prevents and treats postoperative shivering after general anesthesia. For instance, a dose of 0.15 mg/kg nefopam is comparable in efficacy to 0.5 µg/kg dexmedetomidine for treating shivering after orthopedic or abdominal surgery. Additionally, 20 mg of nefopam is equally effective as 50 mg of meperidine in preventing shivering following certain neurosurgical procedures . Notably, patients administered nefopam experience less sedation and hypotension compared to those given dexmedetomidine. However, further research is needed to evaluate nefopam's effects on preventing shivering after neuraxial blockades.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 21-60 undergoing elective lower abdominal, urological, gynecological, lower limb, orthopedic, or plastic surgeries under spinal anesthesia.

  * ASA physical status I and II.

Exclusion Criteria:

* • Known hypersensitivity to nefopam, dexmedetomidine, or pethidine.

  * Thyroid disorders, psychiatric disorders, severe diabetes, or autonomic neuropathies
  * Known history of substance or alcohol abuse
  * A history of convulsive disorders or severe neurological diseases
  * Severe cardiac, pulmonary, renal, or hepatic disease
  * Obstetric procedures and procedures requiring transfusion of blood and blood products.
  * A contraindication to spinal anesthesia, e.g., coagulation disorders, local or general infection, increased intracranial tension, and progressive neurological disorders.
  * Failed or partial spinal block.
1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers

* Locally delivered Alendronate (ALN) have potent inhibitory effect on bone and increases new bone formation in chronic periodontitis patients
* Till date no study has reported the effect of local delivery of ALN in chronic periodontitis patients among smokers. Hence the aim of this study is to investigate the clinical and radiographic effects of locally delivered ALN as an adjunct to the non surgical treatment in smoker chronic periodontitis patients.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy subjects with probing depth (PD) ≥ 5 mm or periodontal attachment level (PAL) ≥ 4 to 6 mm and a radiographical vertical bone loss ≥ 3 mm
* No history of periodontal therapy in preceding last 6 months
* No use of antibiotics in the preceding 6 months

Exclusion Criteria:

* Subjects with known systemic disease
* Known or suspected allergy to the ALN/bisphosphonate group
* Those on systemic ALN/bisphosphonate therapy
* Subjects with aggressive periodontitis,
* Use of smokeless tobacco in any form,
* Alcoholics
* Immunocompromised subjects
* Pregnant or lactating females
START: Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism

The purpose of this research is to study the effects and safety of Sensipar approved by the Food and Drug Administration (FDA) in patients with kidney failure who are being treated with dialysis and have uncontrolled secondary hyperparathyroidism (HPT).

The purposes of this study are: - To assess the effectiveness of a treatment algorithm that includes Sensipar on bio-intact parathyroid hormone (biPTH), adjusted serum calcium (Ca), serum phosphorus (P), and calcium-phosphorus product (Ca x P) levels in the management of SHPT in CKD subjects on dialysis by determining achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Guideline targets. - To assess the use of vitamin D sterols and phosphate binders when Sensipar is incorporated in the treatment of SHPT. - To assess the safety and tolerability of Sensipar.

Eligibility Criteria:
Inclusion Criteria: - Subjects with chronic kidney disease who have received dialysis for at least one month before the first dose of study medication and are clinically stable. - Adults at least 18 years of age who have given written informed consent. - Out of target PTH values, defined as the most recent historical measurement of biPTH \> 160 pg/mL within 3 months prior to informed consent signature. - Serum calcium \>/= 8.4 mg/dL within one month prior to informed consent signature. Exclusion Criteria: - Unstable medical condition, defined as having been hospitalized within 30 days before Day 1, or otherwise unstable in the judgement of the investigator. Hospitalization solely for dialysis vascular access revision does not qualify as an unstable medical condition. - Parathyroidectomy in the 3 months before Day 1. - Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets. - Use of investigational drug or device or participation in trial of investigational drug or device (except experimental dialysis machines) within 30 days of enrollment into the study. Any investigational procedures. - Females of child-bearing potential who are pregnant (e.g., positive serum pregnancy test) or are breast feeding. Females of child bearing potential who refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study. - Hypersensitivity to Sensipar or any of its components. - Previously participated in this or any other Sensipar study, or received/is receiving Sensipar as a commercially available product. - Disorder that would compromise the ability of the subject to give written informed consent and/or to comply with study procedures.
Probiotics in the Treatment of Irritable Bowel Syndrome

Evidence have shown benefits of gut flora modulation in treatment of irritable bowel syndrome (IBS), but few reports are available on the effects of multistrain probiotics and there are few reports available in this regard from our society. Thus, we investigated if probiotics are effective in our patients as well. We hypothesize that the multistrain probiotic Balance containing seven bacteria species including Lactobacillus strains, Bifidobacterium strains, and Streptococcus thermophiles reduces the symptoms of irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65
* diagnosis of IBS based on the Rome III criteria
* willingness to participate

Exclusion Criteria:

* receiving other probiotics compound during the study
* receiving antibiotics during the study
Assessment Of Different Indices in Prediction of Noninvasive Ventilation Failure in Patients With Acute Respiratory Failure

This study will use different indices for prediction of NIV failure in ARF patients Evaluation of HACOR score and ROX index for early prediction of NIV failure in patients with ARF.

Study value of diaphragmatic dysfunction assessed by ultrasound as tool for prediction of success of NIV in ARF patients.

Compare clinical significance of these scoring systems between hypoxemic and hypercapnic RF

Noninvasive ventilation (NIV) is a useful and safe method to improve gas exchange in patients with acute respiratory failure (ARF) of different etiologies. NIV reduces the work of breathing, improves arterial oxygenation and alveolar ventilation. It is associated with improved survival in the acute care setting (Cabrini L 2015) when compared to conventional oxygen therapy. As NIV offers several major advantages over invasive ventilation (e.g., preserving the ability to swallow, cough, and communicate verbally), it is widely used to avoid intubation.

Although NIV nowadays is frequently used, its failure rate remains high (25-59%), indicating that not all patients benefit from this treatment. There is an association between the unsuccessful NIV and the poor outcome has been suggested. Among patients who experience NIV failure, either premature or delayed NIV discontinuation further increases mortality. Thus, identifying the predictors of NIV failure is crucial because of the strong link between failure and poor outcomes. So, researchers woke to make scoring systems that may predict NIV failure, as HACOR and ROX indices.

Recently, ultrasonography (US) of the diaphragm as a bedside method is used for evaluation of diaphragmatic function and predicting failure of NIV in acutely ill patients.

Up till now there is limited research to support significance of different indices for prediction of NIV failure and need for invasive mechanical ventilation (IMV).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute hypoxic respiratory failure who need Noninvasive ventilation.
2. Patients with acute hypercapnic respiratory failure who need Noninvasive ventilation.

Exclusion Criteria:

1. Age \< 18 years old.
2. Patients with unconsciousness, severe hemodynamic instability, unable to fit mask (Recent facial surgery, trauma, or deformity), inability to protect the airway or clear respiratory secretions or any other contraindication of NIV.
3. neuromuscular disease or chest wall deformities.
4. Pregnancy.
5. NIV intolerance.
6. severe obesity with Body Mass Index (BMI)≥35 kg/m2
Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Mitral Valve Surgery

A single-center prospective study. Patients undergoing minimally invasive mitral valve surgery between February 2016 and December 2018 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review and from the Swedish Web system for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) electronic data collection platform.


Eligibility Criteria:
Inclusion Criteria:

* Operated with minimally invasive mitral valve surgery between February 2016 and March 2019 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.

Exclusion Criteria:

* None.
Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers

46 eligible overweight women with hypovitaminosis D are assigned to either vitamin D or control group using block randomization method. Vitamin D3 pearl (Zahravi Pharma Co, Tabriz, Iran) containing 50000 IU cholecalciferol or placebo are administered weekly for 12 weeks. Participants in both groups are structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study.

For the randomized controlled clinical trial (RCT), the first fifty eligible women were assigned to either the vitamin D or placebo group using the block randomization method. Each Vitamin D3 pearl (Zahravi Pharma Co, Tabriz, Iran) contained 50000 IU cholecalciferol and was administered weekly for 12 weeks according to guidelines for treating vitamin D deficiency. Placebo pearls (Zahravi Pharma Co, Tabriz, Iran) had the identical appearance, taste, and smell as the vitamin D pearls and could only be identified by the package code. The placebo pearls were administered similarly. To keep the study double-blinded, an assistant who was not involved in assessments managed the randomization and supplement assignment procedure. Participants were structured to hold their sun exposure and physical activity habits and not take any vitamin supplements during the study. They were also asked to inform the researcher before taking any new medications. All participants were provided with a moderately reduced diet (a reduction of 300 kcal per day) based on their basal weight. The nutrigenetic study investigated 75 eligible women (including the vitamin D group and the last fifty women who entered the study). The nutrigenetic study protocol was the same as that mentioned above for the vitamin D group in the RCT. Compliance was ensured by weekly text messages and voice calls to remind the users of the supplement on the given day. In addition, the supplement and placebo pearls were presented in two visits; once at the baseline visit and then after six weeks. Pearls packs were collected from each subject (at week 6 and week 12) to check if all the pearls were consumed as recommended.

During the first and last visits, anthropometric and laboratory assessments were performed for all subjects. The primary outcomes are improving anthropometric, inflammatory, and metabolic markers of overweight women with hypovitaminosis D.

Eligibility Criteria:
Inclusion Criteria:

* low serum vitamin D level \<30ng/ml
* 25\<BMI\<30 kg/m2
* Age: 20-50
* Free of chronic diseased such as cancer, diabetes, cardiovascular disease, renal diseases, gastrointestinal diseases, no multivitamin supplement intake, no change in weight in the last 3 months

Exclusion Criteria:

* Getting pregnant during the study
* Suffering from thyroid disorders and other diseases mentioned during the study
* Not taking supplements weekly
Hydroxyethyl Starch and Renal Function After Radical Prostatectomy

The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.

Hydroxyethyl starch (HES) is widely used in hospitals to maintain circulation in critically ill patients. In recent years studies have raised suspicion that HES is nephrotoxic. So far acute kidney injury has been diagnosed based on creatinine measurements, but new technology allows for earlier diagnosis using measurements of biomarkers in urine.

The purpose of this project is to investigate HES's potential toxicity and effects on the circulation and kidneys using measurements of biomarkers specific for toxicity and for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of HES 130/0.4

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Males
* Indication for radical prostatectomy

Exclusion Criteria:

* Blood donation within the last month
* Lack of wish to participate
* eGFR\< 15ml/min