cyrilzakka/clinical-trials huggingface dataset:
Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programe

In Spain, palbociclib was launched last November 1st, 2017. However, since February 2015 the on-going compassionate use programme of palbociclib has enabled drug access to patients with RH+/HER2- breast cancer previously treated with at least 4 treatment lines for advanced disease. During this period, approximately 400 patients have received treatment within this programme. Since this population of patients more pre-treated was not included in the studies for regulatory submission, the collection of efficacy and toxicity data in the clinical practice setting is of clinical interest.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with RH+ y HER2- metastatic breast cancer having progressed to at least 4 previous standard treatment lines in the metastatic setting, and are not eligible to receive palbociclib in a clinical trial
2. Absolute neutrophil count ≥1,500/mm3 (1.5 x 109/L)
3. Platelet count ≥100,000/mm3 (100 x 109/L)
4. Haemoglobin ≥9 g/dL
5. Creatinine ≤1.5 x ULN or creatinine clearance ≥ 60 mL/min
6. Total bilirubin ≤1.5 x ULN (≤3.0 x ULN in case of Gilbert's disease)
7. AST and/or ALT ≤3 x ULN (≤5.0 x ULN in case of hepatic metastases)
8. Alkaline phosphatase ≤2.5 x ULN (≤5.0 x ULN in case of hepatic or bone metastases)

Exclusion Criteria:

1. Major surgery, chemotherapy, radiotherapy, treatment with an investigational drug or any other active anticancer therapy within two weeks of treatment initiation
2. Previous radiotherapy in ≥25% of bone marrow
3. QTc \>480 msec, personal or family past history of short or long QT syndrome, Brugada's syndrome, or past history of QT interval prolongation, or tachycardia with Torsade de Pointes (TdP)
4. History of any of the following conditions within 6 months of treatment initiation: myocardial infarction, unstable angina, grade ≥2 arrhythmia (CTCAE version 4.0), atrial fibrillation, coronary or peripheral artery by-pass, symptomatic congestive heart failure, stroke, or pulmonary thromboembolism
5. Known hypersensitivity to palbociclib
6. Current or recent suicidal ideation or behaviour
Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles

Fiber reinforced composite resin space maintainer

Evaluation of the antimicrobial fiber reinforced composite resin space maintainer modified by silver nano particles.

Eligibility Criteria:
Inclusion Criteria:

* Premature loss of primary molar.
* Presence of teeth on the mesial and distal sides of the extraction space.
* Normal primary molar relation.
* No root resorption of abutment teeth.
* Presence of a succedaneous tooth bud.
* Absence of pathology on the eruption track of the succedaneous tooth.
* The age will be ranged from 4 to 9 years.

Exclusion Criteria:

* Carious buccal and lingual surface of abutment teeth.
* Absence of teeth on the mesial and distal sides of the extraction.
Radiographic Evaluation of Bone Height Gain With Dental Implant Placed Simultaneously With Closed Sinus Lifting Using Hydraulic Lift Technique Versus Summers' Osteotome Technique in Posterior Edentulous Maxilla (RCT)

Radiographic evaluation of bone height gain with dental implant placed simultaneously with closed sinus lifting using hydraulic lift technique versus summers' osteotome technique in posterior edentulous maxilla (RCT)

Evaluation will be done on the amount of bone height gain radiographically (using both panorama and CBCT) after placement of the dental implant simultaneously with closed sinus lifting using hydraulic lift technique versus summers' osteotome technique in patients with posterior edentulous maxilla (Randomized Clinical Trial)

Eligibility Criteria:
Inclusion Criteria:

* Edentulous patients in the maxillary posterior region .
* Patients in need to fixed restorations in posterior region .
* Patients with a healthy systemic conditions.(Apparently medically free)
* Patients with adequate inter-arch space for placement of the prosthetic part of the implant .
* Patients who had approximately 5-8 mm of available bone height between crest of bone and floor of sinus
* Both sexes.
* Patients with Good oral hygiene
* Patients more than 20 years old
* Cooperative and motivated patients

Exclusion Criteria:

* Patients with local pathological defects related to posterior maxilla .
* Heavy smokers.
* Abnormal habits that may alter results such as alcoholism or parafuctional habits .
* Patients with systemic diseases that may affect normal healing.
* Patients with psychiatric problem
* Patients with history of recent radiation therapy to the head and neck area .
* Patients with aggressive periodontitis .
Assessment of Lung Transplant Recipients Within The Scope of International Classification of Functioning, Disability and Health

This study was aimed to evaluate the patients undergoing lung transplantation under the International Classification of Functionality, Disability and Health (ICF) and to examine the relationships between the age at which lung transplant recipients were transplanted and recipients' comorbidity levels and body structure and functions, activity and participation level.

After lung transplantation, many complications related to various reasons are observed in patients in the long term. In this study, the severity of fatigue, limitation of daily living activities, kinesophobia, impaired sleep quality, anxiety and depression level, fragility level, balance and functional capacity in lung transplant recipients; investigators aimed to examine the relationship between the age at which the patient was transplanted and the level of comorbidity. Although there are studies on comorbidities, quality of life, daily living activities and participation level, anxiety and depression level, sleep quality, balance and physical fitness level in lung transplant recipients, kinesiophobia upper extremity functional performance in patients who have undergone lung transplantation surgery, COVID-19 infection There are no studies evaluating the anxiety associated with the disease. No study evaluating body structure functions, activity and participation level based on ICF in lung transplantation has been encountered. In our study, patients with at least 3 months past lung transplantation and without orthopedic and mental problems will be evaluated. It will be made as a single evaluation. The last pulmonary function test results of the patients, comorbidity conditions, fatigue, respiratory quality of life, coronavirus anxiety status, sleep quality, kinesophobia will be evaluated by questionnaires. Lower extremity dynamic balance and mobility will be evaluated with 1 minute sit-to-stand test, timed up and go test. Upper extremity functionality will be evaluated with a 6-minute pegboard and ring test.

Eligibility Criteria:
Inclusion Criteria:

* At least three months have passed since the lung transplantation, without any complications at the last doctor's control
* Clinically stable and, if any, accompanying comorbidities are under control
* Volunteering to participate in research
* Patients who do not have neurological and orthopedic problems that may prevent them from performing functional tests.

Exclusion Criteria:

* Single lung transplant recipient
* Have orthopedic problems
* Patients who cannot cooperate and adapt.
MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction

Prospective, non-randomized, single arm, multicenter observational study. The objective is to evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary intervention (PCI) due to acute ST elevation myocardial infarction (STEMI) in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is \>18 years of age.
2. Subject is experiencing clinical symptoms consistent with ST elevation acute myocardial infarction (STEMI) of \>30 minutes and \<24 hours.
3. Based on coronary anatomy, primary PCI is indicated for the culprit lesion with anticipated use of stenting.
4. Subject agrees to all required follow-up procedures and visits and has provided informed consent where required.
5. The target lesion is a de novo lesion in a native coronary artery.
6. The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment.

Exclusion Criteria:

1. Subject undergoing cardiopulmonary resuscitation.
2. Cardiogenic shock (SBP \<80 mmHg for \>30 minutes, or requiring IV pressors or intra-aortic balloon bump (IABP) or other hemodynamic support device for hypotension).
3. Co-morbid condition(s) or others that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
4. Target lesion involves a bifurcation with a side branch \>/=2.0 mm in diameter.
5. In the Investigator's opinion the lesion/vessel is unsuitable for treatment with the MGuard™ Prime Embolic Protection Stent System for any reason.
Adrenocorticotropic Axis and Neuropathic Pain

Chronic pain is often associated with a chronic stress and HHSG axis plays a pivotal role in maintaining homeostasis. The literature reports that pain in patients treated with opioids, significant changes are taking place in this axis with a collapse in hormone concentrations that are correlated with the decline on tests of quality of life and psychological testing. The investigators hypothesis is that this "endocrinopathy" could also be present in patients treated for neuropathic pain with other drug classes as opiates (antidepressants, antiepileptics), and may explain, at least in part, the impairement of the quality of life of these patients.

Day of inclusion: Blood sample for analysis of several hormones (cortisol, ACTH, SHBG, total testostérone et S-DHEA, βœstradiol et progestérone for women, LH, FSH).

Day +1: salivary samples (at wake-up, 30 minutes after wake-up, at lunch, at 06:00 pm and before sleep).

Day +2: salivary samples (at wake-up, 30 minutes after wake-up).

Eligibility Criteria:
Inclusion Criteria:

* Group of patients
* Patients older than 18 years,
* Male or Female with BMI between 18 and 35,
* Patients with chronic neuropathic pain for more than six months, except to diabetes or central neuropathic pain
* Patients receiving systemic therapy for treating chronic neuropathic pain such as antidepressants, anticonvulsants or opiates for at least 6 months.

Group of healthy volunteers

* non-painful healthy volunteers matched by age, sex, BMI and menopausal status for women,
* Free of analgesics within 8 days before the test,
* Aged over 18 years,
* Male or Female,

Exclusion Criteria:

* Subjects with a medical history and / or surgical judged by the investigator or his representative as being incompatible with the test
* Patients treated only by topical treatment (lidocaine patch only for example)
* Pateints receiving corticosteroid treatment at the time of enrollment, or who received such treatment during the last 6 months (regardless of the dosage form and dosage),
* Inflammatory and evolutive pathology requiring long term treatment,
* Type 2 diabetes,
* Postmenopausal women with replacement therapy,
* Weight change of more than 5% within 3 months before the study,
* BMI \<18 or\> 35,
Preventing Obstetric Complications With Dietary Intervention

The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are:

* Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns?
* Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups.

Participants in the standard of care will be asked to:

* Complete surveys
* Biometric screenings

Participants in the intervention group will be asked to:

* Complete surveys
* Biometric screenings
* Participate in weekly personal health coaching
* Receive and consume provided weekly meals.

Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth.


Eligibility Criteria:
Inclusion criteria:

1. Age at enrollment ≥ 18 years of age
2. Receiving prenatal care at Froedtert
3. ≤ 16 weeks and 6 days of gestation
4. At risk of preeclampsia, defined as being eligible for low dose aspirin treatment AND/OR at risk for gestational diabetes defined as having a history of gestational diabetes, OR previously given birth to an infant weighing ≥ 4000 g, OR has a diagnosis of PCOS
5. Pre-pregnancy Body Mass Index ≥ 25 kg/m\^2
6. Resides in Milwaukee County at time of consent
7. Low socio-economic status (\<200% of FPL defined as receiving Medicaid)
8. Able to read and communicate in English
9. Has access to a smart device/computer with reliable internet connection
10. Has access to a working refrigerator
11. Viable singleton pregnancy

Exclusion criteria:

1. Diagnosed with Type I or Type II Diabetes or Hemoglobin A1C ≥ 6.5%
2. Diagnosed with End Stage Renal Disease
3. Use of weight-increasing psychotropic agents
4. Active inflammatory bowel disease, or history of bowel resection or malabsorptive syndrome, or history of bariatric surgery
5. Significant food allergies, preferences or dietary requirements that would interfere with diet adherence
6. Multifetal gestation
7. Active substance use that would preclude program adherence
8. Chronic use of oral corticosteroids
9. Unable to provide informed consent
Retrospective Study of Glucose Monitoring for Glycemic Control in Patients With GSDIa

The primary objective of this study is to assess the percentage of time patients were in normal glucose control.

Retrospective Dexcom G6 iCGM data stored in the Clarity cloud from eligible patients will be accessed and downloaded, stripped of patient-identifying information and provided to the contract research organization (CRO) to review prior to sending to the Sponsor for analysis of glycemic control. The CRO will ensure data shared with the Sponsor is de-identified and transferred over a secure file transfer platform. Further, Remote Site Specialists (RSSs) from the CRO will work with the healthcare providers (HCPs) from participating sites to obtain additional patient data including medical history, prescribed diet, cornstarch/Glycosade use and demographic data directly, if available, from the medical charts and will enter this information into an electronic data capture (EDC) system.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GSDIa confirmed by either liver biopsy or molecular testing.
* Currently using the Dexcom G6 iCGM for glycemic control and with approximately one (1) month of CGM data available on the Dexcom Clarity cloud and have authorized sharing of data with thereferral center through the Dexcom Clarity app.

Exclusion Criteria:

* Presence or history of any disease, condition or chronic medication that, in the Investigator's opinion, would significantly affect interpretation of study results.
* Use of any investigational product or investigational medical device within 30 calendar days preceding screening or before completion of all scheduled study assessments during study enrollment.
Analyzing the Composition of Tears to Identify Cancer

This study will further evaluate the use of protein identification or protein pattern (signature) found in tears. We hypothesize that differences exist between the protein profile in tear fluid from patients with versus without cancer.

Specifically, this study will compare the protein profile in tear fluid from patients with breast, ovarian or colon cancer versus "normal male and female patients" for differences that show promise as a diagnostic indicator. If such differences can be found, then their diagnostic potential will be assessed and developed further in a subsequent study. The long-term goal of this project will be to develop a screening tool for the detection of breast and/or other cancers.

Eligibility Criteria:
Inclusion Criteria:

* Female or male, 18-100 years old
* Patients who present for a routine check-up
* Patients who present for the evaluation of an abnormal exam or test (mammogram, ultrasound, MRI, PET, etc.)
* May or may not have a mass present
* Patients who present for the evaluation of a palpable lump or mass
* Patients may be pre or post biopsy for a mass, as long as there is a portion of the mass remaining

Exclusion Criteria:

* Patient \< 18 y/o or \> 100 y/o
* Concurrent eye infection or trauma
* Active conjunctivitis
* Abnormal production of tears (too much or too little)
Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment

The objective of this study will be to evaluate a new protocol for the surgical treatment of periodontal disease with two novelties: to make a single incision in the midline of the interproximal area to respect the vascular supply and preserve the granulation tissue with regenerative potential.

The investigators will carry out a controlled and randomized clinical trial with a control group (n=25; modified Kirkland flap) and a test group (n=25; experimental surgical protocol: incision in the mid-interproximal area of the papilla and preservation of the granulation tissue).

Clinical parameters will be taken at the time of surgery and 12 months follow-up: bleeding on probing (BoP), clinical attachment level (CAL), residual probing depth (rPD),Probing pocket depth reduction (PPDr), recession (REC), interproximal gingival recession (iGR), width of keratinized gingiva (KT), gain of supra-alveolar clinical attachment (SUPRA-AG), early wound healing index (EHI).


Eligibility Criteria:
Inclusion Criteria:

* Stage III or IV periodontitis, including all grades.
* Unresolved deep pockets (probing pocket depth \[PPD\] \>5 mm + BoP) 4 to 6 weeks after non-surgical treatment.
* Interproximal plaque index \<35% maintained during periodontal treatment and maintenance.
* Adherence to periodontal maintenance appointments.

Exclusion Criteria:

* Systemic disease contraindicating periodontal surgery.
* Teeth with incorrect endodontic treatment or restoration.
* Stage I or II periodontitis.
Efficacy of Zinc Supplementation in Maintaining Sustained Remission in Children With Steroid-sensitive Nephrotic Syndrome

This study aims to fill the gaps by determining the efficacy of zinc supplementation in maintaining sustained remission in children with steroid sensitive nephrotic syndrome (SSNS).

There is a need to ascertain the efficacy of zinc supplementation in maintaining sustained remission in children with SSNS, thereby lowering the number of relapses and disease morbidity. The findings of this study could pave the way for reasonable evidence about the role of zinc supplementation is sustained remission in children with SSNS.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Aged 2-12 years
* With steroid-sensitive nephrotic syndrome, with frequent relapses

Exclusion Criteria:

* Children with steroid-resistant nephrotic syndrome
* With a history of chronic systemic illness (cardiac, metabolic, malignancy, pulmonary, neurologic, or rheumatologic)
* With a history of kidney disease like polycystic kidney disease
SURPASS Impella 5.5 Study

A multi-center, prospective \& retrospective, observational single-arm study of the clinical outcomes up to one year collected from electronic health records of patients which have undergone standard of care implantation of Impella 5.5, regardless of clinical situation or indication. All patients will be enrolled via an IRB-approved Waiver of Informed Consent and HIPAA Authorization.

All patients who were supported retrospectively (prior to site IRB approval) with Impella 5.5 at the investigative site will be entered into the SURPASS registry and specified as the retrospective cohort.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Subject has previously undergone an Impella 5.5 implant at a study site

Exclusion Criteria:

* Patients not receiving Impella 5.5
Prone Flexed Position in Percutanous Nephrolithotomy

prone flexed position in percutanous nephrolithotomy in comparsion with standard prone position. A randomized controlled trial.

Patients meeting the inclusion criteria will be randomly allocated to 2 groups:

1. 1st group will undergo prone-flexed PCNL.
2. 2nd group will undergo prone PCNL.

III. Recruitment of participants Patients appointed for an outpatient diagnostic cystoscopy will be reviewed for the inclusion and exclusion criteria. Legible patients will be asked to participate in the study and to sign the informed consent form.

IV. Randomisation Randomization will be performed using computer generated random tables using stratified blocked randomization in 1:1 ratio.

V. Study procedure Preoperative evaluations included

1. Detailed medical history
2. Physical examination
3. Routine blood examination
4. Urinalysis \& urine cytology
5. Renal and liver function tests
6. Coagulation profile

8. Computed tomography of the abdomen and pelvis

Operative Technique

Prone-flexed positioning i. Retrograde access will be obtained ii. The patient is repositioned prone with adequate padding under the pressure points of the head, chest, knees, and feet.

iii. The table is flexed 30 degrees at the level of the patient's mid lumbar region to open the space between the 12th rib and the posterior iliac crest dropping the gluteal muscles from the working plane.

Ancillary intervention

Patients will receive a 20-mL infiltration of 0.25% bupivacaine. Under fluoroscopic guidance, the local analgesic was infiltrated with a 22-gauge spinal needle (10-cm length) along the nephrostomy tract at the 3, 6, 9, and 12 o'clock positions (5 mL in each tract), including the muscles, subcutaneous tissue, and skin.

Patients will receive 1 g tranexamic acid at induction followed by three further doses of 500 mg over the next 24 h.

Eligibility Criteria:
Inclusion Criteria:

* Large renal or upper ureteral calculi or both,

Exclusion Criteria:

* (1) Age \<18 years or Pregnancy (2) Ureter pelvic junction obstruction (3) Bilateral simultaneous PCNL (4) Need for 3 percutaneous tracts intraoperative (5) Morbid obesity (BMI \>40) (6) Non opaque renal stones. (7)Refuse to complete study requirements (8)Untreated UTI (9)Atypical bowel interposition by CT (10)Tumour in the presumptive access tract area or Potential malignant kidney tumour