cyrilzakka/clinical-trials huggingface dataset:
A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) Treatment in Patients With Rheumatoid Arthritis

This multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the local label will be followed for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
* Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

Exclusion Criteria:

* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
* Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
* Patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Study to Identify the Impact of Denosumab on the Immune System in Patients With HER2 Negative Breast Cancer

The aim of this prospective, randomized, multicenter, open-label, explorative phase II study is to identify the impact of (neo)adjuvant denosumab on the systemic immunity and local immunologic microenvironment in postmenopausal patients with HER2 negative non-metastatic primary breast cancer.

In this study, postmenopausal patients with stage T1c + grade 3, stage II or III, HER2-negative breast cancer, which are planned to undergo surgery followed by adjuvant AC-T chemotherapy, are randomized between no denosumab, denosumab low dosing and denosumab high dosing. Denosumab administration will start one week before surgery and continue until the last chemotherapy cycle.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal, defined as 1 year without menstrual activity, previous bilateral oophorectomy, age older than 60 years or baseline FSH \>20 U/l and estradiol \<110 pmol/l.
* Clinical stage T1c + grade 3, stage II or III breast cancer amenable to adjuvant AC-T combination chemotherapy.
* Measurable disease (breast and/or lymph nodes).
* Histological proven HER2-negative breast cancer in the core biopsy material.
* WHO 0-2.
* Adequate bone marrow function (within 4 weeks prior to randomization): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l.
* Adequate liver function (within 4 weeks prior to randomization): bilirubin ≤1.5 X upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL.
* Adequate renal function (within 4 weeks prior to randomization): the calculated creatinine clearance should be ≥50 ml/min.
* Albumin-adjusted serum calcium \> 2.0 mmol/L (8.0mg/dL)
* Accessible for treatment and follow-up.
* Written informed consent.

Exclusion Criteria:

* Evidence of distant metastases (M1).
* History of breast cancer.
* Prior chemotherapy or radiation therapy.
* Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
* Prior or current bisphosphonate or denosumab usage.
* Serious other diseases as recent (last 6 months) myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias.
* Current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible), non-healed dental or oral surgery, a current or prior diagnosis of osteonecrosis of the jaw or planned invasive dental procedures for the course of the study.
* Known hypersensitivity reaction to any of the components of the treatment.
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

The main purpose of this study is to evaluate how safe and effective the study drug known as abemaciclib is in participants with lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) according to the American Joint Committee on Cancer Staging Handbook.
* Determined to have detectable mutations in codons 12 or 13 of the kirsten rat sarcoma (KRAS) oncogene by an investigational assay at the study central laboratory. A KRAS positive mutation result in codons 12 or 13 of the KRAS oncogene from tumor tissue per local laboratory will be permitted in no more than 10% of randomized participants.
* Have progressed after platinum-based chemotherapy (with or without maintenance therapy) AND have received one additional therapy which may include an immune checkpoint inhibitor or other anti-cancer therapy for advanced and/or metastatic disease OR is judged by the physician as ineligible for further standard second-line chemotherapy. Participants who have progressed after platinum-based chemotherapy and an immune checkpoint inhibitor (immunotherapy) e.g. pembrolizumab or nivolumab alone or in combination with other agents are eligible.
* Have measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug.

Exclusion Criteria:

* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
* Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
* Have the presence of unstable central nervous system (CNS) metastasis. History of CNS metastasis or stable CNS metastases is allowed (no longer requiring active therapy such as steroid medications). Participants with a history of CNS metastases must have a brain scan (for example, magnetic resonance imaging \[MRI\]) within 28 days of randomization to document stability, even if there have been no changes in symptoms.
* Have previously completed or withdrawn from this study or any other study investigating a cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6) inhibitors, or have received treatment with a prior CDK4 and CDK6 inhibitors.
Children Immune Functions(2)

To investigate the effect of milk-based formulas on infections and immune functions in healthy children.

Particular attention was paid to the role played by nutrition in supporting the gut ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial effects of probiotics were demonstrated for different infectious diseases, GII and URI.

The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly documented.

Eligibility Criteria:
Inclusion Criteria:

* Parents written and signed informed consent for participation in the study.
* Healthy children aged 1 to 3 years that are no more breastfed.
* Go to a selected nursery and / or pediatrician.
* Parents must have a phone at home or a cellular phone to call the paediatrician.
* No consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period.
* Parents are able to give their children, twice daily, 2 milk servings on a 5 months period.
* Children not being intensive consumers of regular yoghurts

Exclusion Criteria:

* Rotavirus and flu vaccines administration within the last 3 months prior to V1 (baseline visit).
* Used antibiotics within the last 30 days prior to V1 (baseline visit).
* Congenital or chronic disease.
* Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance.
* Significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection

Postoperative pain is a good indicator to confirm the advantages of the surgical methods in the era of minimally invasive surgery. Lateral neck dissection requires extensive dissection which may leads to postoperative numbness and pain. Robotic thyroid surgery has the advantage of precise and careful dissection and avoid the L-shape incision in the open approach. The study aims to explore the pain intensity and severity of lateral neck dissection on operation day, postoperative month 1 and postoperative month 3 among the robotic, endoscopic and open approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent lateral neck dissection via robotic, endoscopic or open approach
* Clinical diagnosis of differentiated thyroid cancer
* Clinical diagnosis of metastatic lateral lymph nodes

Exclusion Criteria:

* Participants with distant metastasis
* Participants with history of neck surgery or radiation
* Participants with vocal fold fixation by preoperative fibrolaryngoscope
Robotic vs. Laparoscopic Distal Pancreatectomy for Pancreatic Cancer

The present randomized controlled trial evaluates the incidence of R1 resections in patients undergoing robotic distal pancreatectomy compared to the laparoscopic technique.

Surgical resection the only potentially curative therapeutic approach in patients with pancreatic cancer. Among the clinicopathologic factors that are associated with long-term survival, a complete (i.e. R0) tumor resection is of utmost significance. Numerous reports have already demonstrated detection of tumor cells at the resection margin on microscopic examination (i.e. R1 resection) is associated with poor long-term survival. However, studies using a standardized pathological work-up of operative specimen from patients with pancreatic cancer revealed that most pancreatic resections are R1 resections. Innovative surgical techniques that reduce the incidence of R1 resections may provide a promising approach to improve the outcome of patients with pancreatic cancer.

For patients requiring a distal pancreatectomy, a laparoscopic pancreatic resection is increasingly performed, as it may enhance postoperative recovery without compromising oncological safety compared to the open approach. However, laparoscopic technique does not affect the proportion of patients with complete (R0) resections. Furthermore, the inability to control major vasculature frequently results in conversion to the open approach. The vast majority of R1 margins are located at the retroperitoneal dissection surface. Due to technical limitations, the open and the laparoscopic technique may not further reduce the incidence of positive resection margins at this location.

The 3D visualization provided by the robotic approach together with improved dexterity of the surgeon are likely to enable a meticulous dissection at the posterior dissection margin. This may result in a significant reduction of patients with positive resection margins. However, to date there has been no randomized controlled trial that compared the robotic to the laparoscopic technique. As health-care interventions need to prove efficacy and safety in well-designed randomized controlled trials, the present randomized controlled trial was designed to test, if robotic distal pancreatectomy increases the incidence of patients with complete (R0) tumor resection for pancreatic cancer. Secondary endpoints include oncological parameters such as the number of harvested lymph nodes and factors of perioperative outcome such as perioperative complications (Clavien-Dindo classification), pancreatic fistula, in-hospital mortality, blood loss and conversion rates.

Eligibility Criteria:
Inclusion Criteria:

* Suspected malignant disease of the pancreas scheduled for distal pancreatectomy
* Patient eligible for laparoscopic resection
* ≥ 18 years of age
* Written informed consent

Exclusion Criteria:

* Planned multi-visceral and/or vascular resection
* Evidence of distant metastases
* Expected lack of compliance
Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

The aim of this study is to determine the effectiveness of rifabutin triple therapy for the treatment of H. pylori infection in the Israeli population. Patients with or without a prior history of H. pylori eradication failure will be randomized to receive one of three possible treatments:

Group 1-amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd Group 2- amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd Group 3- standard of care

Patients who present to the outpatient gastroenterology clinic at our institution with a positive diagnostic test for H pylori will be screened. Included patients will undergo randomisation into 3 groups. Randomization will be performed by a random sequence generator to create equal sized groups in boxes of 12.

Group 1-amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd Group 2- amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd Group 3- standard of care Standard of care in previously untreated patients will consist of concomitant treatment (amoxicillin 1000mg, clarithromycin 500 mg, tinidazole 500 mg and esomeprazole all given twice daily for 14 days). In previously treated patients standard of care will consist of bismuth quadruple therapy, quinolone based therapy, or other susceptibility guided treatment where available.

Treatment duration will be 14 days in all groups. Patients who are randomised to Group 3 and fail treatment will be offered open label rescue treatment with amoxicillin 1000mg bd, rifabutin 150 mg bd and esomeprazole 40 mg bd (14 days).

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to outpatient clinic with evidence of H. pylori infection

Exclusion Criteria:

* allergy to any of the study drugs
* prior exposure to rifamycin drugs
* inability to provide informed consent
* pregnancy or lactation
* liver disease
* haematological disease
* renal failure
* active malignancy
* immune suppression
* patients not expected to benefit from Helicobacter pylori eradication
Encouraging Physical Activity: Action Or Direction?

Children's physical activity level is decreasing globally. Habits acquired in childhood and adolescence tend to continue in adulthood. Therefore, to obtain individuals who do physical activity or sports, this habit should be gained in childhood.

It is necessary to understand the factors affecting children's lives to increase the physical activity level of the children and make the active lifestyle a habit. These factors can be divided into the environment and family. It is the place where the family socialization process begins first and social norms and cultural values are learned. Parents can be more effective than the environment because they are the main decision-makers on the child. Parents configure the child's time, duties, provide the sports equipment to their child, transfer them for activity. They can support an active lifestyle by taking role models by children. Role modeling is defined as the child's behaviors of observation and social learning and their parents' behavior. In a review, it has been reported that physically active parents encourage their children to have more activities and may have active children. Small-group studies using an objective method are limited in terms of generalizability. While determining the activity level of the child and the family, the fact that the families can respond biased for their children and that the mother or father can take a role model according to the gender of the child reduces the quality of the studies. It remains unclear how and to what extent parents affect children's activity levels.

The aim of this study is to compare the physical activity level of children between 9-14 years of age, who have similar physical activity awareness, athletes and physiotherapist parents


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 9-14
* Being literate in Turkish
* Not having any physical disability preventing them from doing physical activities
* Attending physical education class regularly

Exclusion Criteria:

* Having a serious cognitive impairment
* Going to school on foot
* Physiotherapists to be selected for the physiotherapist group to work in the field of sports
UCB Cimzia Pregnancy Follow-up Study

The purpose of this observational follow-up study is to collect data systematically on pregnancies and offspring of women who become pregnant while participating in a Certolizumab Pegol (CZP) study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy is identified while the patient is participating in an interventional or noninterventional Certolizumab Pegol (CZP) study conducted by UCB, or a development partner, regardless of phase or treatment arm (ie, commercial or investigational, placebo or comparator treatment), or whose pregnancies were spontaneously reported to UCB due to potential CZP exposure during pregnancy
* Sufficient information to classify the pregnancy as prospective or retrospective is available
* Full initial reporter (ie, woman or healthcare provider (HCP)) contact information reported to allow for follow-up (name, address, telephone number/email address) and contact information for at least 1 applicable HCP if initial contact is the woman
* Consent to participate is provided

Exclusion Criteria:

* Pregnancies in which the resulting infant is over 1 year of age at the time of informed consent will not be eligible to participate in the study
Anti-Mullerian Hormone Levels Before and After an Open Myomectomy

Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. It is well known that ovarian surgery for endometriosis lowers Anti-Mullerian hormone, but little is known for other surgeries. We seek to investigate the hormone variations before and after an open myomectomy.

Hypothesis: Anti-Mullerian hormone levels drop following surgery but return to normal levels in a few months


Eligibility Criteria:
Inclusion Criteria:

* 18 to 42 years old
* Requiring open myomectomy for any indication

Exclusion Criteria:

* Incapable of informed consent
* Use of hormonal contraception or Gonadotropin-releasing hormone agonists in the past 3 months
* Woman over 42 years old
* Post-menopause women
* Positive B-human chorionic gonadotropin the day of surgery
* Ovarian surgery (at the same time)
* Pre-operative AMH below 0.3 ng/mL
BIOlogical Response to Exercise : A Metabolomic Study in Peripheral Artery Disease (BIOR)

The measurement of the transcutaneous oxygen pressure during walking allows to estimate the importance of ischemia, bilaterally and segment of limb by segment of limb. The determination of the metabolic compounds concentration, with metabolomic approach, is emerging in physiology and exercise.

This pilot study focuses on the feasibility of the metabolomics analysis with micro method , by capillary drawing from earlobe sampling, for patients with peripheral artery disease (PAD)

Ankle brachial index is measured at rest for alml subjects. Blood sample (180-360 microliter) will be collected at rest transcutaneous oxygen pressure is measured at the chest, calves and buttocks and results will be expressed as the minimal value of the DROP index (Limb changes minus chest changes) Patients walk on treadmill (2MPH 10% slope) until exertional limb pain. Blood sample (180 microliter) will be collected again, at minute 3 of recovery from walking Correlation of each metobolite increase to the sum of DROP values wil be studied.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patient able to walk on a treadmill
* Patient agrees to be involve in the protocol and sign the consent form

Exclusion Criteria:

* Patient not covered by the French health insurance
* Patient has a wash-out period for another clinical trial
* Patient with comorbidity as bleeding disorder or with a anticoagulant therapy
Risk Factors for Chronic Postoperative Pain After Elective Nephrectomy

Chronic postoperative pain (CPP) is typically defined as pain persisting for 3 months or more after surgery\[1\]. CPP is a common and increasingly prevalent morbidity, leading to long-term psychological issues, reduced quality of life, and impaired functionality\[2\]. To reduce the incidence of CPP, high-risk patients are identified, and various surgical techniques, pharmacological agents, and regional anesthesia techniques are employed\[3\].

The primary aim of our study is to scale chronic pain at 1 hour, 3 months, and 1 year post-nephrectomy using the Numeric Rating Scale (NRS), ranging from 0 to 10. The secondary aim is to evaluate the effects of factors influencing chronic postoperative pain on the NRS scores.

Patients gender, age, height(m), weight(kg), body mass index(kg/m2), diagnosis, smoking and alcohol history, comorbidities, surgical technique and duration, complications, lymph node dissection, thrombectomy, adrenalectomy, amount of bleeding(cc), need for blood transfusion, need for intensive care, analgesia technique used, amount of opioids and non-opioid analgesics used perioperatively, amount of vasopressors used, heart rate(bpm) and mean arterial pressure(mmHg) at induction, post-intubation, post-extubation, and 1 hour postoperatively, presence of postoperative pain, chronic analgesic use history(more than 3 uses per week), presence of fibromyalgia, frequent urinary tract infections, diagnosed with central sensitization disorders, bruxism, depression-panic attacks, allergic asthma, irritable bowel syndrome, and migraines will be recorded. The effects of these factors on NRS scores at 1 hour, 3 months, and 1 year postoperatively will be examined.

Eligibility Criteria:
Inclusion Criteria: -Patients aged 18-90 years,

* ASA I-IV,
* undergoing elective nephrectomy under general anesthesia will be included in the study.

Exclusion Criteria:

* Patients who cannot be reached by phone and hose who die within the 1-year postoperative period will be excluded from the study.