cyrilzakka/clinical-trials huggingface dataset:
A Real-world Study of Effectiveness and Safety in HR+/HER2- Breast Cancer Patients Treated With Ribociclib or Alpelisib

This study was a multinational and multicenter cohort study of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer (aBC/mBC) treated with ribociclib or alpelisib between the period of 01 January 2018 and 30 September 2021. Patients who were receiving active treatment for malignancies other than BC or participating in a clinical trial were excluded. This study was conducted retrospectively with secondary use of data.


Eligibility Criteria:
Inclusion criteria:

* Confirmed diagnosis of locally advanced/metastatic not amenable to surgery HR+/HER2- BC (progressed following prior therapy or de novo) for whom the treating physician took the decision to initiate treatment with ribociclib or alpelisib.
* Patients with at least one prescription for ribociclib or alpelisib during the index period (01 January 2018 to 30 September 2021).

Exclusion criteria:

* Patients who were participating in any interventional clinical trial that included investigational or marketed products at the time of index (ribociclib, alpelisib, and other); patients who were participating in other investigator-initiated research or non-interventional study (NIS) could be included as long as their standard of care was not altered by the study.
* Patients on active treatment for malignancies other than HR+/HER2- aBC/mBC at the time of index.
* IPO-Porto cohort only:

  * Patients who had participated or were participating in any interventional clinical trial that included investigational or marketed products at the time of index (ribociclib, alpelisib, and others).
  * Patients who underwent part of the treatment for locally advanced/metastatic not amenable to surgery HR+/HER2- BC outside the center.
Ocular Tissue Levels of 1.5% Levofloxacin Ophthalmic Solution Compared to an Active Comparator

Compare ocular tissue levels following topical ocular instillation of 1.5% levofloxacin ophthalmic solution or an active comparator in subjects undergoing cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Capable of instilling eye drop
* Scheduled for cataract surgery with intraocular lens (IOL) implantation
* Be medically cleared for surgery
* Women must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry, and must agree to continue to use the same method of contraception throughout the study
* Women of childbearing potential must have a negative urine pregnancy test at screening.
* Willing to adhere to the prohibitions and restrictions specified in this protocol.
* Subjects (or his/her legally acceptable representative) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

* Known allergy or other contraindication to the test article(s) or their components.
* Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
* History of or presence of any corneal pathology or disease
* Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
* History of severe dry eye syndrome.
* History or evidence of previous ocular surgery in the operative eye.
* History of any significant illness that could be expected to interfere with the study parameters.
* Use of disallowed therapies (systemic or topical):

  * Fluoroquinolone anti-infective agents (systemic or topical) within 2 weeks of Visit 1 or anytime after Visit 1 for the duration of the study;
  * Topical ophthalmic preparations (including tear substitutes and rewetting drops), within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study (other than the study medication as restricted above), with the exception of non-steroidal topical ophthalmic drops
* Use of contact lenses in the 2 weeks prior to the study and for the duration of the study.
* Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
* Pregnant or breast-feeding.
* Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
* Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Molecular Basis of PCOS in Oocytes and Surrounding Cells

Polycystic ovary syndrome (PCOS) is a common disorder in women of reproductive age that is characterized by elevated androgen levels, ovulatory dysfunction and polycystic ovarian morphology (PCOM). Moreover, has been associated to insulin resistance, obesity, type 2 diabetes and infertility.

Women with PCOS are a heterogeneous group, and specific PCOS phenotype could have a substantial impact on oocyte quality and molecular profile. Regarding the Rotterdam criteria for PCOS, four different phenotypes of the syndrome are defined (A, B, C, D). Phenotypic group A is the most frequent and severe subtype of PCOS. It is described that patients with so-called phenotype A exhibit a significantly increased risk of pregnancy complications compared to women with more favorable PCOS phenotypes. Specifically, this clinical-laboratory study will focus on the molecular characterization of PCOS phenotype A.

Epigenetic are external modifications to DNA that affect how cells "read" genes. These external modifications have garnered attention in the pathogenesis of PCOS since epigenetics changes have been reported in various organs in women with the condition. However, remains unknown whether these alterations are also found in the egg and in its surrounding cells.

Further research is needed to understand the PCOS disorder and to design treatments that can ameliorate the symptoms of the disease. In particular, this project aims to generate the molecular profiles of PCOS phenotype A eggs and surrounding cells and compare them with the ones obtained from and healthy controls. This approach involves the aspiration of immature eggs without hormonal stimulation or with stimulation of only a few days.


Eligibility Criteria:
Inclusion Criteria:

* women between the ages of 18 and 37
* biochemical hyperandrogenism
* ovulatory dysfunction
* polycystic ovaries)
* BMI \> 25.
* normal andro-gen levels
* normal ovarian function
* normal ovarian morphology
* BMI \< 29.

Exclusion Criteria:

* congenital adrenal hyperplasia
* Cushing's syndrome
* androgenic-secreting tumor
* high (\>grade 2) grade endometriosis
* major uterine or ovarian abnormalities
* pregnant women
* volunteers with metabolic syndrome
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis

The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.


Eligibility Criteria:
Inclusion criteria:

* Written Informed Consent must be obtained before any assessment is performed,
* Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
* Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.

A partial response is defined as having achieved ≥ PASI 50 but \< 75 response.

Exclusion criteria

* Pregnant women or lactating women
* Forms of psoriasis other than chronic plaque -type
* Ongoing use of prohibited psoriasis treatments
* Ongoing use of other non-psoriasis prohibited treatments
* Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
* Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
* UV therapy or excessive exposure to sunlight
Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy

The creation of an intracorporeal anastomosis during right hemicolectomy is regarded as superior than the extracorporeal anastomosis in terms of recovery of peristalsis, aesthetic results, analgesia requirements and length of hospital stay. The objective of this study is to compare the postoperative results of intracorporeal versus extracorporeal anastomosis in patients undergoing laparoscopic right hemicolectomy.

Laparoscopic surgery has entailed a great technical revolution in colorectal surgery, providing a better and quicker return to normal functions of the patients, associating a lower morbidity and better aesthetic results compared with traditional open surgery. This study wants to find the difference between intracorporeal and extracorporeal anastomosis.

The creation of an intracorporeal anastomosis in right hemicolectomy seems superior to extracorporeal anastomosis in terms of recovery of the normal bowel function, wound size, aesthetic results and analgesia requirements. This will entail a shorter hospital stay. Several studies have demonstrated this but all of them are retrospective non randomised.

In terms of postoperative pain, the most accepted theory is that it depends on the traction of the porto-mesenteric axis. When the intracorporeal anastomosis is performed there is no traction of this mesenteric axis while in the extracorporeal anastomosis this traction is more important in obese patients.

This traction of the mesentery, as well as being one of the main factors related with postoperative pain, is responsible of the postoperative adynamic ileus, that should have a higher incidence when the manipulation is higher.

In the patients undergoing an intracorporeal anastomosis, the assistance incision will be a suprapubic Pfannenstiel. In the patients undergoing an extracorporeal anastomosis the assistance incision will be a transverse in the right upper quadrant. It is well known that the Pfannenstiel incision has a lower incidence of superficial surgical wound infection, a lower rate of incisional hernia, a lower need of analgesics, and better aesthetic results, when compared with the incision in the right upper quadrant.

All this factors should entail a lower hospital stay in patients undergoing an intracorporeal anastomosis.

Eligibility Criteria:
Inclusion Criteria:

* Surgical procedure with curative purpose.
* American Society of Anaesthesiologists Physical Status (ASA) I, II and III.
* Elective surgery.
* Informed consent.

Exclusion Criteria:

* Denial of informed consent.
* Advanced neoplasia.
* Urgent surgery.
* ASA IV.
Lipid Encapsulation for Ileal Brake Activation

This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two treatments (active, and placebo) on two different days, following a randomized cross-over design.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25-30 kg/m2
* Voluntary participation

Exclusion Criteria:

* Milk (-protein or lactose)- allergy/intolerance
* History of serious GI complaints/surgeries
* Pregnancy, lactation
* Excessive alcohol consumption (\>20 per week)
* Abnormal eating behaviour
* Intention to stop smoking
* Reported unexplained weight loss or gain in the month prior to screening
* Self-admitted HIV-positive state
Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy

Patients and methods: 100 patients were included in this study. They divided into two groups, group (A) with drain and group (B) without drain. The investigators recorded the effect of drainage on, postoperative pain (Po-P) using visual analogue scale VAS at 6, 24, 48 hours and 1 week postoperative nausea/vomiting at 6, 24, 48 hours postoperative, abdominal collection, hospital stay, chest complication, and postoperative body temperature.

The patients were randomized into two groups using enclosed envelope. Group (A) with drain included 50 patients, and group (B) without drain included 50 patients.

Under general anesthesia, and same antibiotics (3rd generation cephalosporin) Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitonum at pressure 12 mmHg. In group A nelton catheter (no 20) was inserted at the end of operation.

The Intraoperative parameter observed included duration of the operation, amount of CO2 used in the operation, bile escape, saline irrigation during operation and volume of blood loss were recorded.

The patients started oral feeding 8 hours (h) postoperatively; abdominal ultrasound was done for all patients in both groups on day of discharge to show any collection or free fluid in the abdomen. The patients were usually discharged after removal of drain, and when the patient surgically free.

Postoperative pain was evaluated at 6 h, 24 h, 48, 1 week after operation using a visual analog scale (VAS) with which each patients noted the severity of pain at each evaluated time using a linear between zero (no pain) and 10 (severe pain). Postoperative analgesia in the form of non steroidal anti-inflammatory drug (NSAID) was administered intramuscularly when required. If the patients still complained of pain and required strong analgesic, (1 mg/kg pethidine intramuscularly) was administered. The total dose of these medications were recorded.

Postoperative maximum body temperatures were recorded at (6 h, 24 h, and 48 h) for all patients.

PONV were assessed postoperative after 6 h, 24 h and after 48 h. Metocloprpamide was given if the patients required reduction of nausea and the total dose of this medication was recorded. The frequency of vomiting was recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients with gallbladder stones and laparoscopic cholecystectomy

Exclusion Criteria:

* patients above 80 years old
* patients with acute cholecystitis
* patients with history of upper laparotomy
* patients with a hemorrhagic tendency due to cirrhosis
* patients refused to give informed consent and patients who were converted to open cholecystectomy
Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis

68 De Quervain tenosynovitis(MPS) diagnosed patients will be randomly divided into 2 groups. To groups; splinting+exercise+high-intensity laser therapy (HILT) and splinting+exercise+sham HILT will be applied. Visual anolog scale (VAS) scores, quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire and Hand grip strength measurements of the patients before-after treatment will be recorded and will be evaluated statistically.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with unilateral De Quervain tenosynovitis 18-65 years old

Exclusion Criteria:

* pain history of less than four weeks,
* upper extremity entrapment neuropathy,
* major psychiatric disease,
* upper extremity surgical treatment history,
* malignancy history,
* chronic rheumatic disease,
* cervical radiculopathy,
* cervical myelopathy,
* local corticosteroid injection prior to De Quervain tenosynovitis and receiving physical therapy.
Effects of Cranberry Juice on Cardiovascular Risk Factors

The purpose of this study is to evaluate the effects of cranberry juice on central and peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein concentrations and size characteristics, and HDL function. The investigators hypothesize that the bioactive compounds in cranberry juice may elicit beneficial effects on blood pressure and arterial health, as well as LDL-C and HDL function.

The investigators propose to conduct a 2-period randomized, crossover, placebo-controlled study to evaluate the effect of cranberry juice on central and peripheral blood pressure, indices of arterial stiffness, lipid and lipoprotein concentrations and size characteristics, and HDL function. Eligibility requires non-smoking men and women to be 30 to 65 years of age with BMI greater than or equal to 18 and less than or equal to 39, total cholesterol below 273 mg/dL for men and below 284 mg/dL for women, triglycerides below 350 mg/dL, and have systolic blood pressure of 120 to 159 mmHg and/or diastolic blood pressure of 80 to 99 mmHg. Subjects will undergo randomized treatments including 500 mL/d cranberry juice beverage and 500 mL/d of a color and taste matched placebo beverage. The two 8 to 12 week treatment periods will be separated by an 8 week washout.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women 30-65 years of age
2. BMI ≥ 18 and ≤ 39 kg/m\^2
3. Total cholesterol below 273 mg/dL for men and below 284 mg/dL for women
4. Triglycerides below 350 mg/dL
5. Non-smokers
6. At least one of the following:

   1. Systolic blood pressure 120-159 mmHg
   2. Diastolic blood pressure 80-99 mmHg

Exclusion Criteria:

1. History of acute or chronic inflammatory conditions or heart disease, kidney disease, liver disease, autoimmune disorders, or thyroid disease (unless controlled by medication and blood results within previous 6 months are provided)
2. History of diabetes mellitus (and/or a fasting glucose \>126 mg/dL at screening)
3. Stage II hypertension (blood pressure ≥ 160/100 mmHg)
4. Lactation, pregnancy, or desire to become pregnant during the study
5. Unwillingness to discontinue nutritional supplements, herbs, or vitamins unless approved by investigator
6. Use of medications/supplements for elevated lipids, blood pressure, or glucose
7. Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication
8. Conditions requiring the use of steroids
9. Unwillingness to refrain from blood donation prior to and during the study
10. Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
11. Allergy or sensitivity to cranberry juice or any ingredient in the study beverages
Blood Samples to Identify Biomarkers in Patients Treated With Cyclophosphamide After Donor Stem Cell Transplant

This trial uses blood samples to understand how patients' bodies process and respond to a drug called cyclophosphamide given after a donor stem cell transplant. Identifying biomarkers (molecules that can indicate normal or abnormal processes) may help researchers develop a blood test that can be used to predict how well patients will process and respond to cyclophosphamide.

"Ancillary-Correlative" study type

PRIMARY OBJECTIVES:

I. To determine whether endogenous metabolomics compounds obtained before cyclophosphamide administration can predict the ratio of 4hydroxycyclophosphamide to cyclophosphamide area under the curve (4HCY/CY AUC).

II. To evaluate mathematic models of CY and mycophenolic acid (MPA) pharmacokinetics and develop mathematic models including these pharmacokinetics, -omics data and clinical outcomes.

SECONDARY OBJECTIVES:

I. To assess if recipients' metabolomics and pharmacokinetics (e.g., CY and its metabolites AUCs) are associated with acute graft versus host disease (GVHD) and other clinical outcomes.

II. To assess the association of the intestinal microbiome with the plasma metabolome, acute GVHD and other clinical outcomes.

III. To obtain donor blood samples at one time pre-transplant and assess if donors' metabolomics are associated with acute GVHD and other clinical outcomes.

EXPLORATORY OBJECTIVE:

I. Donor and recipient germline deoxyribonucleic acid (DNA) isolation and genomic analysis.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I (PATIENTS RECEIVING A HAPLOIDENTICAL TRANSPLANT): Patients undergo collection of blood prior to transplant, on day 0, days 3-7, day 14, and day 21. Patients also undergo collection of saliva prior to transplant and collection of stool prior to and post-transplant. Donors undergo collection of blood and saliva within 8 weeks prior to donation.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo allogeneic hematopoietic cell transplant (HCT) with a haploidentical donor.
* Allogeneic HCT scheduled to treat any underlying disease. Patients with nonmalignant diseases or cancer are eligible
* Scheduled to receive post-transplant cyclophosphamide (any dose, any number of doses, any dosing frequency) as part of their post-graft immunosuppression or GVHD prophylaxis. Patients enrolled on treatment protocols that include post transplant cyclophosphamide (PTCy) but do not include mycophenolate mofetil (MMF) or tacrolimus can participate
* Willingness to:

  * Provide blood
  * Permit medical record review
Flavonols and Endothelial Injury

With increasing age, arterial endothelial cell function is impaired, which is associated with decreased regeneration response and increased intimal hyperplasia after endothelial injury. Dietary flavanols can reduce endothelial dysfunction acutely and chronically, but the exact mechanism is unknown. Recent studies suggest that flavanols may affect important endothelial regeneration response processes and possibly mediate long-term positive vascular effects. The aim of this study is to investigate age-dependent mechanisms of impaired endothelial regeneration and the influence of dietary flavanols on them. For this purpose, younger and old male patients, who are clinically indicated for elective transradial catheterization, will get periinterventional a test drink , which is rich on flavonols (800 mg flavanols daily), or control drink. Administration of drinks is randomized and double-blind. The test drinks should be given one week before the elective catheter examination until 1 week later. The endothelial regeneration is to be investigated as endothelium-dependent vasodilation non-invasively in the area of the puncture site on the forearm and by means of biomarkers in the blood. The endothelial function of the Arteria radialis will be measured with Flow Mediated Dilation (FMD) before and 24 h after catheterization. One month after catheterization patients undergo ultrasound examination of arteria radialis, to include structural vessel wall changes as intimal media thickness.


Eligibility Criteria:
Inclusion Criteria:

* planed catheterization, that has be done via Arteria radialis

Exclusion Criteria:

* acute infection (CRP\>0.5 mg/dl)
* malignant diseases
* heart failure (NYHA III-IV)
* renal failure (GFR\<60 ml/min)
* profoundly atrial fibrilation
* hypotension (≤100/60 mmHg)
* intolerance of nitroglycerin