cyrilzakka/clinical-trials huggingface dataset:
Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention

To investigate the predictive value of the contrast media volume to creatinine clearance (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI

contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after unselective PCI. Receiver-operator characteristic (ROC) curves were used to identify the optimal sensitivity for the observed range of V/CrCl. The predictive value of V/CrCl for the risk of CIN was assessed using multivariate logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* patients who agreed to stay in the hospital for 2-3 days after percutaneous coronary intervention
* provided written informed consent
* Creatinine Clearance:15-60ml/min

Exclusion Criteria:

* pregnancy
* lactation
* intravascular administration of an contrast medium within the previous seven days
* treatment with metformin
* aminoglycosides
* N-acetylcysteine (NAC)
* nonsteroidal anti-inflammatory drugs within the previous 48 h
* intake of nephrotoxic drugs within the previous seven days
* history of serious reactions to contrast mediums
* severe concomitant disease
* renal transplantation , or end-stage renal disease necessitating dialysis patients who died during percutaneous coronary intervention
Day of Embryo Transfer for Patients Undergoing In Vitro Fertilization

We are examining whether pregnancy rates differ based on day of embryo transfer in patients who replace all available embryos after an In vitro Fertilization (IVF) cycle. Patients must be undergoing IVF treatment at Stanford University and patients will not receive compensation for their participation (no medical costs covered or patient payment for participation).

The decision on the number of embryos to transfer after an IVF cycle is based on the number of available embryos, the quality of the embryos, the patient's age, and the goal of limiting multiple gestations. Stanford Fertility Center and most IVF centers examine the embryos on the third day after oocyte (egg) retrieval to select for the best quality embryos to transfer, and depending on quality, the remaining embryos are frozen to be used in the future. Patients with a limited number of embryos, those that plan to replace all available embryos after an IVF cycle, do not need to wait until the third day after oocyte retrieval to select embryos, and may replace the embryos on the second day after the oocyte retrieval. We are examining whether pregnancy rates differ among these patients based on the day of embryo transfer (Day 2 vs. Day3). Patients must be undergoing IVF treatment at Stanford University and patients will not receive compensation for their participation (no medical costs covered or patient payment for participation).

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing fresh IVF cycle at Stanford Fertility Center who plan on replacing all available embryos.

Exclusion Criteria:

Patients that do not meet above criteria.
Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude

The now widely used reference interval for pulse oxygen saturation of the neonate after 24 hours of birth has been developed relying on data from low altitude.It is not suitable for neonates at high altitude. At present, no reference interval has been established at high altitude, and the existing studies have many limitations. So this study was designed.

Knowledge of the reference interval of pulse oxygen saturation (SpO2) in neonates is crucial for accurate identification of neonatal hypoxemia. The now widely used standard was derived from low altitude data, which is not suitable neonates at high altitude. At present, many scholars have paid attention to this problem. But, previous studies still have some limitations. For example, they often only focus on a specific altitude. However, with the increase of altitude, the pulse oxygen saturation decreases in a curve, so their study results are only suitable for this specific altitude and can not be widely used.

Eligibility Criteria:
Inclusion Criteria:

* Healthy singleton term infants with no clinical signs and symptoms (e.g., cyanosis, respiratory distress, heart murmur, etc.).

Exclusion Criteria:

* 1. Low birth weight (\< 2500 g). 2. Need for oxygen. 3.1 or 5 minute Apgar score \< 7. 4. Referred to the neonatal intensive care unit or neonatology department for various reasons. 5. Neonates discharged within 24 hours of birth. 6. Neonates diagnosed with congenital diseases in utero. 7. Refusal of consent.
A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer

Gastric cancer is the most common malignancy in Korea. The prognosis of unresectable gastric cancer has been improved by cytotoxic chemotherapy, but median survival rarely exceeds 1 year. New agents such as taxane, irinotecan and oxaliplatin combined with old agents such as 5-FU with or without leucovorin, doxorubicin, cisplatin showed higher response rates in phase II studies. Docetaxel as a single agents showed response rates of 17-24%, and the combination of docetaxel and cisplatin has shown a response rate of 37-56% and overall survival of 9-10.4 months. Oxaliplatin in combination with 5-FU and leucovorin(FOLFOX-6) showed an objective response rate of 50%, which included a 4% complete response. The preclinical studies, oxaliplatin has shown additive or synergistic cytotoxic properties with fluoropyrimidines, thymidylate synthase inhibitors, topoisomerase I inhibitors, microtubule inhibitors and DNA modifying/alkylating agents. The combination of docetaxel and oxaliplatin has been studied previously in the phase I setting in patients with metastatic breast and non-small cell lung cancer. The combination of docetaxel and oxaliplatin is a feasible and well tolerated regimen. Recommended doses were 75mg/m2 for docetaxel on day 1 and 70mg/m2 for oxaliplatin on day 2 without G-CSF support. The aim of this trial is to determine the dose limiting toxicities, maximum tolerated dose(MTD) and efficacy of oxaliplatin and docetaxel as combination chemotherapy in patients with advanced gastric cancer.

Primary objectives :

To define the dose-limiting toxicity and maximum tolerated dose in phase I study To evaluate the overall response rate in phase II study

Secondary objectives :

1. To evaluate the safety and tolerability of the treatment combination.
2. To estimate overall survival.
3. To estimate the time to progression and the duration of overall response.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction
* 18 ≤ age ≤ 70
* ECOG performance status of 0 - 2
* At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥ 2 cm in physical examination
* Previously untreated metastatic gastric cancer patients or relapsed gastric cancer patients (patients with recurrence at least 6 months from the date of last administration of adjuvant chemotherapy and/or radiation therapy with 5-FU and/or leucovorin containing regimen will be included in the study)
* Written informed consent
* Minimum life expectancy of 12 weeks
* Adequate liver, renal, bone marrow functions as evidence by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; ASAT and/or ALAT \< 3 UNL; serum creatinine ≤ 1.5 ULN

Exclusion Criteria:

* Any other malignancies within the past 5 years except skin basal cell cancer or CIS of cervix
* Serious comorbid diseases
* Pregnancy or lactation
* Previous history of drug allergy to one of the drugs in the study regimen
FAST: Clinical Feasibility

This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST).

The investigators will recruit 10 patients at Sunnybrook Health Sciences Centre that are scheduled to receive femoral antegrade intramedullary nailing to treat a femur fracture. This study evaluates the clinical ease of use of the Femoral Antegrade Starting Tool (FAST) device, and the surgical workflow during entry point selection and guidewire alignment for intramedullary nailing of femoral fractures. It is hypothesized that the usage of the tool will reduce surgery time and number of images required.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a femoral shaft fracture
* Undergoing anterograde intramedullary nailing procedure

Exclusion Criteria:

* Femoral head or neck fractures
Technology Dependency and Health-Related Quality of Life

This study will explore how people with an implanted cardioverter defibrillator (ICD) feel that dependence on this life-saving technology affects their health-related quality of life. ICD therapy is an important treatment option for patients with serious recurrent abnormal heart rhythms. Overall survival is significantly improved in high risk patients who receive this therapy. This study will explore patients' perceptions of the impact of this device on their health status and well being, and their physical, psychological and social functioning.

Patients 18 years of age or older who have an implanted cardioverter defibrillator may be eligible for this study.

Participants will fill out a questionnaire booklet containing 170 questions about how they feel about their health, including their concerns and stresses, feelings about dependency on life-saving technology, and illness perception. There are also questions on demography, such as age, marital status, employment, etc. The booklet may take up to 30 minutes to complete.

Information obtained from this study may lead to a better understanding of how people feel about their health after receiving an ICD and help patients and families adapt to living with the device.

With the efficacy of implantable cardioverter defibrillator (ICD ) therapy well established, the survival time of recipients of this technology must be interpreted more broadly. It is important to better understand how ICD recipients perceive their dependence on this life saving technology and how these perceptions influence their Health Related Quality of Life (HRQL). The purpose of this cross sectional, predictive study is to test a causal model that may explain the link between attitudes towards dependency on technology and HRQL in a sample of adult ICD recipients. The hypothesized model consists of seven variables: attitudes towards technology dependency; age; gender; illness history; illness representation; symptom distress; and HRQL. Adult subjects (greater than 18 years) who have received an ICD will be asked to participate. Subjects will complete a self-administered, mailed questionnaire that includes five instruments: 1) The Medical Outcomes Short Form 36 Survey Version 1.0; 2) The Important Concerns and Distress Questionnaire; 3) The Illness Perception Questionnaire; 4) The Dependency on Technology Scales; 5) Demographic Questionnaire. The model will be tested statistically by use of Structural Equation Modeling techniques. The definitive goal of this study is to develop a theoretically meaningful and statistically well-fitting model that specifies how dependence on technology influences HRQL. The hypothesis for this study is that the full structural equation model fits data from the sample of adult ICD recipients.

Eligibility Criteria:
INCLUSION CRITERIA:

Male or female adults (18 years of age or older).

Implantable cardioverter defibrillator.

EXCLUSION CRITERIA:

Unable to read written English.
One Week Clinical Study in Subjects With Menopausal Symptoms

The goal of this clinical trial is to Examine the Benefits of an Oral Product in Subjects With Menopausal Symptoms. The main questions it aims to answer are:

1. To assess the efficacy for improvement of menopausal vasomotor symptoms within 24 hours compared to placebo through Daily Diary and Mobile Application
2. To assess the efficacy for improvement of menopausal vasomotor symptoms hours compared to placebo through days 2-6 Daily Diary and Mobile Application
3. To assess the efficacy of the investigation product on stress/anxiety, mood swings, headaches compared to placebo through days 1-6 and with use of Daily Diary, Mobile Application and validated questionnaires (GCS, MENQOL).
4. To assess the efficacy of the investigation product on mood, stress and sleep at 7 days post treatment using validated questionnaires (PSQI, PSS, POMS)


Eligibility Criteria:
Inclusion Criteria:

* Healthy Females aged 40 to 65 years,
* Self-reporting menopausal symptoms (\> 5 hot flushes per day) and have been present for a minimum of previous 60 days prior to baseline visit.
* Reporting a variable cycle length of \> 7 days different from normal
* BMI 20-40 kg/m2
* Able to read, understand, and complete the study questionnaire and records.
* Able to understand the study procedures.
* Able to comply with all study requirements.
* Written informed consent to participate in the study.
* Willingness to actively participate in the study and to come to the scheduled visits.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Immune insufficiency
* Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
* History of hysterectomy
* Women on hormone replacement therapy
* Use of systemic corticosteroids or immunosuppressant drugs.
* Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
* Employees of the institute or the brand owner or the manufactures of the product
* Cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol,
* Alcohol or drug abuse
* Use of hormonal contraceptives within the last 3 months
* Use of other menopause supplements
* BP ≥160/110 mmHg
* Oophorectomy or amenorrhea \> two years. Note- Habitual medicine and supplement intake will be registered prior to inclusion in the study.
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* One of the following histologically or cytologically confirmed, advanced (unresectable or metastatic) solid tumors:

  * Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
  * Endometrial cancer
  * Head and neck squamous cell carcinoma (HNSCC)
  * Unresectable biliary adenocarcinoma (gallbladder or biliary tree \[intrahepatic or extrahepatic\] cholangiocarcinoma)
  * Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).
  * Triple-negative breast cancer (TNBC)
  * Hepatocellular carcinoma (HCC)
  * Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
  * Ovarian cancer
  * Gastric cancer
* Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.
* Adequately controlled blood pressure (BP) with or without antihypertensive medications.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
* Male participants must agree to follow contraceptive guidance.
* Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance.
* Adequate organ function.

Exclusion Criteria:

* History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
* Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent.
* Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
* Active autoimmune disease that has required systemic treatment in past 2 years.
* Active infection requiring systemic therapy.
* Concurrent active hepatitis B and hepatitis C virus infection.
* History of allogenic tissue/solid organ transplant.
* Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm).
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
Comparison H-FIRE and Laparoscopic RP in Treating Men With Localized Prostate Cancer

This trial is comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy.

Two hundred and sixteen patients with localized prostate cancer will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-frequency irreversible electroporation; group 2, laparoscopic radical prostatectomy. The primary outcome is the urinary function and sexual function.

Eligibility Criteria:
Inclusion Criteria:

1. Age less than 80 years old.
2. PSA\<20ng/ml.
3. Clinical stage ≤T2c.
4. Biopsy Gleason score ≤4+4.
5. No evidence of metastasis.
6. Fully understand the clinical trial protocol and sign the informed consent

Exclusion Criteria:

1. Any previous treatment to PCa.
2. Any previous surgery within 3 months.
3. Contraindications to MRI, bone scan, or PSMA-PET (eg, metal implant, contrast agent allergy).
4. History of any other malignant tumour.
5. Any other conditions that make the investigator judge that participants are not suitable for this trial.
Evaluation of the Efficacy and Safety of MV140

The purpose of the study is to evaluate the efficacy and safety of a biological vaccine (MV140) in women with Recurrent Urinary Tract Infections (RUTI) compared with a placebo group.

Double blind parallel placebo controlled study. The subjects will receive medication during three or six months and will be followed up during another twelve months.

Eligibility Criteria:
Inclusion Criteria:

* Women who gave their informed consent.
* Age between 18 and 75 years.
* Must be able to meet the dosage regimen.
* Subjects who had had at least 5 episodes of cystitis in the last 12 months.
* Subjects who had not responded to hygienic-sanitary measures and / or suppressive treatment and / or postcoital prophylaxis.
* Subjects who were free of urinary tract infections at the time of inclusion in the study.

Exclusion Criteria:

* Had not given their informed consent.
* Age was not within the established age range.
* Could not offer cooperation and/or had severe psychiatric disorders.
* Presented a pathologic post-micturition residue.
* Presented moderate to severe incontinence.
* Presented genital tumours.
* Presented Urinary tract tumours.
* Presented lithiasis.
* Presented alterations in the immune system.
* Presented complicated UTIs.
Efficacy and Safety of Colorectal Anastomotic Leak Testing

To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. The primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with colorectal cancer by pathology and scheduled for surgical treatment who meet the surgical indications.
2. Aged between 18 and 85 years.
3. American Society of Anesthesiologists (ASA) physical status classification is I - III.
4. The patient or his/her legal representative can understand and sign the informed consent form and is willing to cooperate throughout the study process.

Exclusion Criteria:

1. Patients with preoperatively diagnosed anastomotic leak or other severe abdominal infections.
2. Patients with severe cardiovascular and cerebrovascular diseases (such as recent myocardial infarction, unstable angina pectoris, severe heart failure, acute cerebral infarction, etc.) who cannot tolerate surgery and related tests.
3. Patients with severely impaired liver and kidney function (liver function Child - Pugh classification C or above, creatinine clearance rate \< 30 ml/min).
4. Patients with coagulation disorders (such as platelet count \< 50×10⁹/L, international normalized ratio (INR) \> 1.5, etc.) that cannot be corrected or are receiving anticoagulant therapy that cannot be adjusted.
5. Patients with a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures.
6. Patients with other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy.
7. Patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.
Carpal Tunnel Syndrome Treated With 830nm Diode Laser

The purpose of this study is to determine that 830nm diode laser directly above the transverse carpal ligament (between the pisiform and navicular bone) on subjects' wrists, and test this therapeutic effect.

The low level laser instrument (Painless Light PL-830, Advanced Chips \& Products Crop., USA) emitted two light beams with a distance of 2.5cm between them by two laser diodes.

Eligibility Criteria:
Inclusion Criteria:

* no operation of the wrist
* first onset of CTS more than 1 year ago with repeated episodes
* never having laser treatment before.

Exclusion Criteria:

* patients with any rheumatoid arthritis
* history of metabolic disease or paralyzed limbs caused by stroke
* taking any anti-inflammatory drug
* with other treatments, such as acupuncture, physical therapy and wearing orthosis
Laryngeal Masks for Bariatric Surgery

Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices.

The study will investigate two types of LMA devices endowed of different constructive features. The two devices share common features as far as providing access to the stomach and reducing morbidity of the upper airway. The two device differ in regard to ease of insertion and sealing of the airway and these features are particularly important in the obese patient.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I-III
* candidates to bariatric surgery

Exclusion Criteria:

* uncontrolled psychiatric symptomatology
* known or presumed pregnancy
* history of surgery on the airway or esophagus
* gastroesophageal reflux
Gastroprotective Agent Utilization and Compliance in Elderly Patients Taking Non-steroidal Anti-inflammatory Drug (NSAID) in France

The purpose of this study is to assess in general population NSAID and gastroprotective agent utilization and compliance in elderly people.


Eligibility Criteria:
Inclusion Criteria:

* French people \> 65 years old, part of Kantar Health Access Santé panel