cyrilzakka/clinical-trials huggingface dataset:
A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer

This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm has been established from dose escalation, additional patients with each combination will be enrolled in Stage 2.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* For paclitaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease
* For docetaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease or histologically documented advanced (Stage IV) or recurrent NSCLC
* For participants with breast cancer: HER2-negative disease as defined by local clinical guidelines
* Participants with NSCLC to be treated with docetaxel need to have received at least one prior anti-cancer treatment regimen in an advanced setting and to have docetaxel be considered appropriate treatment
* Evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) v.1.1
* Life expectancy \>=12 weeks
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1 at screening
* Adequate hematologic and end organ function
* Use of highly effective form of contraception

Exclusion Criteria:

* Prior anti-cancer therapy
* Prior treatment with phosphoinositide 3-kinase (PI3K) inhibitor
* Known significant hypersensitivity to any components of study treatment
* Grade \>=2 peripheral neuropathy
* Type 1 or Type 2 diabetes
* Grade \>=2 hypercholesterolemia or hypertriglyceridemia
* Congenital long QT syndrome
* Active congestive heart failure or ventricular arrhythmia
Sleeping Quality and Chronic Ocular Diseases

To assess the impact of sleep quality on chronic eyes diseases

In this study 3 questionnaires will be distributed to outpatients attending the routine examinations : the Pittsburgh, the Berlin and the Epworth tests These questionnaires, once completed, will then be collected to be then transformed into digital files for the appropriate statistical evaluations and the drafting of the results and conclusions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with macular degeneration or glaucoma or
* Healthy volunteers

Exclusion Criteria:

- Patients with other ocular disorders
Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause

The study is conducted in women at the menopause with a clinical diagnosis of Genitourinary Syndrome, which presents symptoms in of vulvovaginal atrophy and tract urinary and were treated with radiofrequency non ablative technique for capacitive transfer in intra-vaginal. All participants were evaluated by a physical therapist and did the exam of PH vaginal, cell maturation index and questionnaires. The participants made five sessions of Radio Frequency (RF) with an interval of seven days between them. The application of RF was performed by physical therapist trained in the technique of radio frequency through the Capenergie brand device with capacitive transfer method using non-ablative handle with active electrode intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 minutes more in the posterior wall of vagina.


Eligibility Criteria:
Inclusion Criteria:

* will be women in menopause until 65 years of age with clinical complaints of Genitourinary Syndrome of Menopause and who agree to voluntarily participate in the research.

Exclusion Criteria:

* will be excluded from the study participants with limited understanding, with neurological degenerative chronic diseases, sensory deficit in the genital region, users of pacemaker and intrauterine device of cooper and women under hormone therapy under six months
The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase two trail is to evaluate the immunogenicity of LAVI (non freeze- dried). The secondary objective is to evaluate the safety of LAVI (non freeze- dried).

Totally 2520 health people aged 3-59 years old will be divided into two age group, containing 1260 in 18-59 years old and 1260 in 3-19 years old. All subjects will receive vaccination either LAVI(non freeze- dried), LAVI(freeze- dried) or placebo in a ratio of 2:2:1.

All subjects will be collected any adverse events within 30 days and any serious adverse events within 6 months for safety evaluation. All subjects will be collected blood sample and nasopharyngeal swab for immunogenicity evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged in 3-59 years old
* Had not received vaccination of Influenza vaccine in the past one year
* Had not infected with Influenza virus
* This trail has been agreed by volunteers or his/her legal guardian
* Volunteers or his/her legal guardian will fellow this trail protocol

Exclusion Criteria:

* People with fever before vaccination, temperature higher than 37.0 #
* Females in suckling period, pregnancy (pregnancy test positive) or prepared to be pregnant
* People given whole blood, plasma or immunoglobulin therapy within 3 months before vaccination
* According to judgement of researchers, the subjects have any other factors that are not appropriate for this clinical trials
* Acute infectious disease or acute attack of chronic disease before inoculation
* People get any vaccine within 14 days before the trial
* People in immune deficiency or diagnosed with congenital or acquired immunodeficiency, people with immunosuppressive therapy in the past six months
* People with epilepsy or a history of mental illness
Systemic Uptake of Diclofenac Sodium in Combination With Miconazole as Antifungal Nail Gel When Applied Daily With Monitoring of Hepatic and Renal Enzymes, and Serum Levels of Diclofenac 12 Hours After Application, and at 3 and 6 Months Study

Study evaluates these take of diclofenac sodium when used in conjunction with miconazole and urea as a topical antifungal nail gel treatment for onychomycosis. All of the patient's will be treated with the active formula and blood levels of diclofenac sodium tested for as well as monitoring of hepatic and renal functions

Tinea Unguium/onychomycosis is a ubiquitous health problem affecting \~3% of the adult population. It is associated with higher risk for other disease processes. Effective treatment for this disease has been lacking. Oral antifungal agents are associated with high incidence of recurrence of disease, hepatotoxicity, cytochrome P450 Pathway interference, non-compliance, side effects and cost. No effective long-term topical applications have been verified. Debridement of the damaged nail in combination with a broad-spectrum topical antifungal agent and an anti-inflammatory agent is a safe, inexpensive and easily formulated alternative to previous ineffective treatments. The rationale for debridement is simple in that the effectiveness of the topical antifungal is present only when it is in contact with the fungal agent, nail bed and involved diseased tissue. The associated inflammatory response associated with fungal infections is well-established. The only topical NSAID available in the United States is diclofenac sodium. The combination of miconazole, diclofenac sodium and urea has proven effective in this researcher's self-treatment of tinea unguium. Miconazole and diclofenac sodium are well studied and well-established pharmaceutical

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 21 years of age at Visit 1.
2. Not pregnant.
3. Stage 3 or lower Chronic Renal Failure.
4. PT/INR \< 1.3 and not on anti-thrombotic; AST, ALT, Total Bilirubin WNL.
5. Documentation of a diagnosis of tinea unguium as evidenced by one or more clinical features consistent with the onychomycosis and one or more of the following criteria: KOH prep of the nail scrapings or positive culture of the nail scrapings; culture of nail with growth of any of the following Dermatophytes, non-dermatophytes or yeast.
6. TABLE 1 Epidermophyton floccosum Trichophyton mentagrophytes Trichophyton rubrum Acremonium Alternaria species Aspergillus species Botryodiplodia theobromae Fusarium species Onycochola canadensis Pyrenochaeta unguis-hominis Scytalidium dimidiatum scopulariopsis species Scytalidium hyalimum Candida albicans

Exclusion Criteria:

1. Chronic renal failure, chronic liver disease, alcoholism, pregnant, breastfeeding, or unwilling to practice birth control during participation in the study if of childbearing age..
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
3. Concomitant use of any prescribed medication that may be adversely affected by diclofenac sodium.
Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS)

the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.

the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.

Eligibility Criteria:
Inclusion Criteria:

renal diseases with indication to surgery adrenal masses

Exclusion Criteria:

open surgery in principle
Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery

The aim of the study is to determine whether there is a correlation between the microcirculation measured preoperatively in patients undergoing major vascular surgery and the postoperative mortality during hospitalization period. The microcirculation will be measured sublingually with the Cytocam-IDF imaging technique.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years

  * Males and females
  * ASA III classification
  * Written informed consent obtained by the patient
  * Elective hospital admission for major vascular surgery, both open and endovascular

Exclusion Criteria:

* Emergency surgery

  * Minor vascular procedures (e.g. varicose vein stripping; thromboembolectomy; vascular access formation)
  * Pregnancy
  * Refusal or inability to provide written informed consent (language barrier, mental retardation)
Optimys Femoral Stem for Total Hip Replacement

This retrospective observational study analyses the surgical performance, clinical and radiologic outcome as well as the rate of infections with a main focus on revision surgeries after primary implantation of the Optimys short stem femoral prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with an Optimys femoral component at the University Hospital Basel between 29.10.2013 and 29.10.2018

Exclusion Criteria:

* Clinical follow up at another Institution
* Documented dissent in study participation
This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus

This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are receiving study medication at Month 12 of the one-year study (CRAD001A2306) and sign a new Informed Consent to extend the treatment and observation period beyond Month 12.
* Females patients must agree to continue using an approved method of birth control throughout the study and for 3 months following the last dose of study medication.
* Another Informed Consent was required for the extension amendment. This Informed Consent allowed for separate consent to the amendment study itself, and the retrospective collection of biopsies and/or the yearly protocol biopsies
* Inclusion and exclusion criteria were not changed, except that patients who completed the core study in follow-up became eligible to participate in the amended extension.

Exclusion Criteria:

* Patients who are receiving study medication and do not sign a new Informed Consent to extend the treatment and observation period beyond Month 12 RAD001A2306)
Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study

Mechanical respiration during general anesthesia causes cold and dry gases to reach the lower airway, reduce the function of the airway mucosa, and cause accumulation of secretions. Inhaled dry gas is one of the causes of hypothermia during general anesthesia. To overcome this, the warm-humidifying breathing circuit uses warm, moisture-preserving gas to promote mucus mobility of the airway mucosal ciliate cells and prevents cold gases from evaporating from the mucosal surfaces which results lowering body temperature. We aimed to investigate the effect of newly developed Sohum warm humidifying respiration circuit (SH501) on the prevention of core body temperature reduction during surgery and systemic inflammation reaction.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 19
2. scheduled for brain surgery

Exclusion Criteria:

1. age \< 19
2. patients with severe obstructive lung disease and/or restrictive lung disease patients
3. patients with infectious disease
4. surgery with prone position or lateral position
5. arrhythmia
Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer

This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone (WBI group).

Objective:

* Compare the effect of post-BCS WBI vs. WB+RNI on disease-free survival in pN1 breast cancer patients who received AT-based chemotherapy.
* Evaluate the impact of WBI or WB+RNI according to molecular subtype of tumor.
* Compare the treatment-related toxicities between the WBI and WB+RNI.
* Compare the patient's quality of life between the WBI and WB+RNI.

Outline: This is a a randomized, multi-center, phase III study. Patients are stratified according to molecular subtype of tumor (luminal A vs luminal vs luminal HER2 vs HER2-enriched vs basal-like), axillary lymph node management (sentinel lymph node biopsy \[SLN\] only vs axillary lymph node dissection+/- SLN) and participating institutions. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive WB+RNI.
* Arm II: Patients receive WBI alone.

Arm circumference and quality of life (EORTC QLQ-C30 \& EORTC QLQ-BR23) are assessed within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 months after completion of radiotherapy, and then annually thereafter for five years.

Patients are followed at 3 months after completion of radiotherapy and annually thereafter for seven years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven invasive carcinoma of the breast.
* One to three positive axillary lymph nodes (pN1) proven in pathologic specimen.
* Prior breast-conserving surgery and post-operative adjuvant chemotherapy including taxane.
* Administering adjuvant hormonal therapy in cases with hormone receptor-positive tumor.
* Administering anti-HER2 therapy in cases with HER2-positive tumor.

Exclusion Criteria:

* Metastases in supraclavicular or internal mammary lymph nodes.
* Metastases in distant organs.
* Neoadjuvant chemotherapy or hormone therapy before surgery.
* Not receiving adjuvant anthracycline and taxane.
* Bilateral breast cancer
* Previous history of radiotherapy of the ipsilateral breast or supraclavicular lymph nodes.
* Prior history of other types of cancer, except thyroid cancer, carcinoma in situ of the cervix, or skin cancer.
Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis

This study is a double-blind, placebo-controlled, randomized clinical trial to determine whether IVIG is effective in improving motor scores in patients with myasthenia gravis and worsening weakness.

Patients aged 18 years or older with a diagnosis of myasthenia gravis (MG) and worsening weakness were enrolled in the study after providing informed consent. Fifty-two patients were recruited to the study, but one withdrew consent prior to starting so that 51 patients were recruited. Baseline clinical assessments using the Quantitative MG Score for Disease Severity (QMGS) were repeated at 2 and 4 weeks after treatment with IVIG or saline infusion. The Post-Intervention Status was assessed at 2 and 4 weeks after treatment. The treatment was randomized and double-masked. Electrophysiological and immunological tests were done at baseline and after 2 weeks. Baseline characteristics were compared by the Student's t test for continuous variables or Chi-square test for categorical variables. An analysis of covariance was performed for the primary outcome measure, the change in QMGS.

Eligibility Criteria:
Inclusion Criteria:

* age \> or equal to 18 years old with a confirmed diagnosis of myasthenia gravis and worsening weakness

Exclusion Criteria:

* age \<18; severe myasthenia gravis requiring intensive care admission; change in immunosuppresive medication in previous 3 months; patients with severe bulbar weakness at risk for aspiration and respiratory failure; patients with other serious underlying medical conditions (renal failure, congestive heart failure); unwilling to provide informed consent.
A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery

The primary objective of the study is to demonstrate the non-inferiority or superiority of Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding with conventional surgical techniques is ineffective or impractical.


Eligibility Criteria:
Inclusion Criteria (pre-surgery):

1. Subject has signed an independent ethics committee (IEC)-approved informed consent document
2. Subject is undergoing hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, and/or other hepatic surgery, any of which may be combined with other surgical procedures involving the gall bladder or intestines
3. Subject age is \>18 years at time of consent
4. If female and of child-bearing potential, subject has negative pregnancy test during screening and is not breast-feeding
5. If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits

   Inclusion Criteria (during surgery):
6. Presence of mild to moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical
7. Absence of intra-operative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety
8. Approximate TBS surface area of ≤ 100 cm\^2

Exclusion Criteria:

1. Subject has known hypersensitivity to Fibrocaps or any of its components
2. Subject has known allergy to porcine gelatin
3. Subject has known hypersensitivity to Tachosil or any of the excipients included in Tachosil
4. Subject is unwilling to receive blood products
5. Subject is having hepatic surgery due to emergency-traumatic event
6. Subject requires extrahepatic bile duct resection (common bile duct resection or resection of the bile duct which leads to performing an anastomoses between the bile duct and small bowel) and biliary anastomosis, and/or pancreatic resections
7. Subject has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator, or baseline abnormalities of international normalized ratio (INR) \> 2.5 or activated partial thromboplastin time (aPTT) \> 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
8. Subject has a platelet count \< 100 x10\^9 PLT/L during screening
9. Subject has medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
10. Subject is currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery or is planning participation in another clinical trial within 6 weeks after surgery