cyrilzakka/clinical-trials huggingface dataset:
Urinary Markers for Unilateral Kidney Obstruction

Renal colic is usually caused from an obstructing stone along the ureter. Some of the patients present with a high level of creatinin in the blood, even though there is a normal functioning contralateral kidney. Furthermore creatinin is not an ideal marker for renal function during acute changes.

Several works have shown that modern urinary markers such as NGAL (neutrophil gelatinase-associated lipocalin), KIM-1 (Kidney Injury Molecule-1) and others rise earlier and are much more sensitive for kidney insult. There is a lack of research on their role in acute kidney obstruction

The study population will include 100 men and women that will be recruited during the upcoming year, with a follow up of up to 3 months.

The study population will be divided into 2 groups:

1. The stone group: about 80 patients, aged 18-65, with normal creatinine for the past year that presented in our ER because of renal colic, and their imaging shows a ureteral stone.
2. The non-stone group: about 20 patients that present in our department for elective surgery not related to stones or bladder outlet obstruction.

The stone group:

---------------- In the ER the patients will be examined, undergo blood and urine workup and imaging as usual. If they are applicable according to our inclusion and exclusion criteria and admitted and they will be included in our stone group. After signing an informed consent, either as patients with a ureteral stone and normal creatinine or as patients with a ureteral stone and an abnormal creatinine, Their urine sample will be sent for the urinary markers: NGAL, KIM-1, ENdothelin and Cystatin C.

At this point it will be decided to admit or discharge them according to their clinical imaging and laboratory findings, as acceptable. The admitted patients will be followed for 48 with additional blood and urine tests.

The admitted patients that will undergo renal drainage will be a specific subgroup in which a selective urine test will be taken from the drained kidney

The non stone group:

-------------------- These are our control group from which we will take a single blood and urine test before their elective surgery.

Eligibility Criteria:
Inclusion Criteria for stone group:

* no known kidney disease
* turned to the ER due to renal colic
* imaging demonstrates a partially or totally obstructing ureteral stone

Inclusion Criteria for non stone group:

* turned to the urology department for ambulatory surgery: hydrocelectomy, varicocelectomy, stress incontinence repair,circumcision,cystoscopy

Exclusion Criteria:

* patients with stones in the contralateral ureter
* patients who underwent renal surgery
* patients who took NSAID's (nonsteroidal antiinflammatory drugs) in the past week before presentation
* patients woth anatomical defects in the kidneys
Impact MRSA -PCR on Patient Management

Staphylococcus aureus represents one of the most met germs, with Escherichia coli, during bacteremia. Microbiologist distinguish at aureus S. two profiles of resistance in beta-lactamines: S. aureus sensitive to the methicillin ( SASM) and the S. aureus resistant to the methicillin ( SARM).

With the implementation of the MALDI-TOF, it is now possible to identify the origin responsible of the bacteremia the day of the positivity of the hemoculture ( J0) and to set up a treatment with adapted antibiotic, which, in the case of a sepsis to aureus S., is the vancomycine. Ye it was demonstrated, that the use of the vancomycine on the SASM increased the average duration of stay and a more important rate of relapse.

The PCR SARM was organized in the GHPSJ in 2014. It allows from the day of the positivity of the hemoculture ( J0), to determine the phenotype of resistance of S. aureus.


Eligibility Criteria:
Inclusion Criteria:

* Hemoculture positive to Staphylococcus Aureus Methicillin Sensitive

Exclusion Criteria:

* Positive test to Staphylococcus Aureus Methicillin Sensitive but not hospitalized.
Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer

The aim of the study is to determine the optimal dose of the combination of docetaxel and gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with respect to efficacy and toxicity in a phase II trial.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified adenocarcinoma of the prostate.
* Hormone refractory prostate cancer (HRPC) defined as progression during previous anti-hormone treatment. Patients must have been off previous anti-androgen therapy for more than 4 weeks.
* Stage IV disease (verified by imaging or clinical examination).
* PSA \> 10 microgram/l.
* PSA progression defined as a \> 25% increase between two independent measurements performed with a 1-month interval or more after discontinuation of anti-androgen treatment.
* Castrate level of testosterone (\< 50 ng).
* No previous oestrogen or steroid as metastatic prostate cancer treatment.
* Satisfactory hepatic function in the form of total bilirubin ≤ UNL (upper normal limit), ASAT/ALAT ≤ 2.5 x UNL, alkaline phosphatase ≤ 5 x UNL.
* Satisfactory renal function, defined as serum creatinine ≤ 1.5 x UNL.
* Satisfactory haematologic function defined as ANC \>1.5 x 10\^9/l, leucocytes \>3.0 x 10\^9/l, thrombocytes ≥ 100 x 10\^9/l, haemoglobin \> 7 mmol/l
* ECOG performance status ≤ 2.
* Life expectancy \> 3 months.
* Patient must be able to adhere to protocol requirements.
* Written informed consent.
* \> 18 years of age.

Exclusion Criteria:

* Previous prostate cancer treatment with oestrogens or steroid hormones.
* Previous chemotherapy.
* Previous treatment with systemic radioactive isotopes.
* Bisphosphonate treatment (concomitant).
* Radiation therapy covering more than 25% of the bone marrow producing area.
* Other serious coincidental and/or concomitant medical condition.
* Symptomatic cerebral metastases.
* Other previous or current malignant disease, excluding \*adequately treated and cured planocellular skin carcinoma; or \*other cancer assessed to carry minimal risk of recurrence.
* ECOG performance status \> 2.
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency

This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CTAP101 Capsules administered for 26 weeks to treat SHPT in subjects ≥18 years of age with stage 3 or 4 CKD and vitamin D insufficiency. The study will be conducted at approximately 40 sites within the United States (US). Approximately 550 subjects will be screened to randomize approximately 210 eligible subjects, stratified by CKD stage (approximately 105 subjects in each stage) in a 2:1 ratio to receive either CTAP101 Capsules or matching placebo. An Interactive Voice Response System (IVRS) will provide study treatment group assignments using the computer-generated randomization code provided by the IVRS vendor. Subjects will receive an initial daily dose of 1 capsule (CTAP101 Capsules, 30 µg, or matching placebo) for the first 12 weeks. After l2 weeks (visit 8) and per pre-defined criteria, the dose may be increased in a blinded fashion by the IVRS with oversight by an independent medical monitor.

Eligibility Criteria:
Inclusion Criteria:

1. Urinary albumin excretion ≤ 3000 mcg/mg of creatinine
2. Stage 3 or 4 CKD
3. Plasma iPTH: ≥ 85 pg/mL and \< 500 pg/mL
4. Serum Ca: ≥ 8.4 mg/dL and \< 9.8 mg/dL
5. Serum P: ≥ 2.0 mg/dL and \< 5.0 mg/dL
6. Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and \< 30 ng/mL.
7. Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2 months

Exclusion Criteria:

1. History of kidney transplant or parathyroidectomy
2. Spot urine calcium:creatinine ratio \> 0.2 (\>200 mg/g Cr)
3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
4. Currently on dialysis
5. Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per month) during the study
Abnormal Post-partum Glucose Metabolism After Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation

The main objective of the study is to estimate and compare the percentage of patients with abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed with gestational diabetes before or after 24 weeks of pregnancy. Abnormal glucose metabolism is defined as type 2 diabetes, glucose intolerance or impaired fasting glucose.

The secondary objectives of this study are to compare between the two groups:

A. the rate of type 2 diabetes only, glucose intolerance only, impaired fasting glucose only, and patients requiring insulin at 4-12 weeks postpartum

B. rates of maternal and obstetric complications

C. risk factors (age, body mass index, personal history of gestational diabetes or macrosomia, first degree family history of diabetes).

D. For fasting glucose done before 24SA, we will calculate the optimal threshold for predicting abnormal glucose metabolism in the immediate postpartum period among women with gestational diabetes.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 10 months of follow-up
* The patient is pregnant and consulting before 24 weeks of amenorrhea AND has at least one of the following risk factors: age \> 35 years; body mass index \> 25; family history of type 2 diabetes; history of gestational diabetes; history of macrosomia.
* The patient has a fasting blood glucose level \>= 0.92 g/l before 24 weeks of amenorrhea OR a fasting blood glucose level \< 0.92 g/l before 24 weeks of amenorrhea AND an abnormal oral glucose tolerance test (75 g of glucose) between 24 and 28 weeks of amenorrhea (normal values are set at T0 \< 0.92 g/l; T60 \< 1.80 g/l; T120 \< 1.53 g/l).

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study, with the exception of the following studies: Papillo PMA (RCB 2013-A00538-37), LXRs (RCB 2009-A00968-49), GrossPath (RCB 2014-A01120-47), BAKRI (RCB 2013-A00914-41), OASIS II (RCB 2013-A00773-42), ElastoMAP (RCB 2013-A01148-37), ElastoDéclench (RCB 2014-A00828-39) and UpSideDown (RCB 2014-A01921-46).
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient cannot read French
* The patient has a known history of type 2 diabetes
* The patient is diagnosed with type 2 diabetes during pregnancy (fasting blood glucose level \> 1.26 g/l)
* The patient has a contra-indication for a treatment necessary for this study
* The patient is taking chronic or intermittent oral or inhaled corticosteroids, or a β2 agonist treatment for a previous disease or a disease discovered during pregnancy within one week preceding the fasting glucose or oral glucose tolerance test.
A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers

A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of MEDI0382 in healthy volunteers.

This is a first-time-in-humans (FTIH), randomized, double-blind study designed to evaluate the safety, tolerability, and PK of MEDI0382 administered as single-ascending SC doses to healthy subjects (age 18-45). Eight subjects per cohort will be enrolled in a total of 8 cohorts. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee (DEC). Within each cohort, the subjects will be randomized to MEDI0382 or placebo (3:1). Following screening, the study duration for each subject will be approximately 29 days, consisting of an inpatient evaluation period, and an outpatient follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers, ages 18-45
* Must provide written informed consent
* BMI \>22 and \<30 kg/m2 and body weight \>70kg
* Venous access suitable for multiple cannulations
* Vital signs within normal specified ranges
* Females must be non-lactating and non-childbearing potential
* Males must practice 2 effective contraceptive measures if sexually active

Exclusion Criteria:

* Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
* History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* History of cancer, with the exception of non-melanoma skin cancer
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
* Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening.
* Concurrent or previous use of a GLP-1 receptor agonist
* Current or previous use of systemic corticosteroids within the past 28 days prior to screening
* Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
* Known or suspected history of alcohol or drug abuse within the past 3 years.
* Positive drug screen
* Current smoker
Comparison of Quality of Recovery Between Remimazolam and Propofol Anesthesia in Patients Undergoing Arthroscopic Meniscectomy

This study aims to compare quality of recovery after surgery and anesthesia between patients undergoing arthroscopic meniscectomy under general anesthesia with either propofol or remimazolam based total intravenous anesthesia. This study is a randomized trial with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 19 or older, ASA class I\~III,
* scheduled for arthroscopic meniscectomy under general anesthesia and eligible for LMA use.

Exclusion Criteria:

* Patient refusal,
* patients unable to read consent form, active URI or uncontrolled asthma,
* pneumonia,
* history of allergies to propofol or benzodiazepines,
* decreased liver or kidney function, heart failure of ejection fraction\<55%,
* pregnant or breastfeeding patients,
* history of substance abuse/addiction
A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants greater than or equal to (≥) 18 years of age
* B-cell CLL
* No previous treatment for leukemia

Exclusion Criteria:

* History of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer
* Comorbid condition requiring long-term (greater than \[\>\] 1 month) systemic corticosteroids during study treatment
* Known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV)
The Leipzig TAVI Registry

A single-center registry including all patients treated with TAVI at the Heart Center, Leipzig, Germany

A single-center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Leipzig, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan up to 10 years to assess valve durability.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated with TAVI

Exclusion Criteria:

* None
Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort

We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of catheter-related bladder discomfort.

The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. The adjuncts to reversal agents such as glycopyrrolate and atropine are known to block the muscarinic receptor in different ways.

We want to evaluate the efficacy of the glycopyrrolate and atropine for the prevention of catheter-related bladder discomfort.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for transurethral bladder excision under general anesthesia
* ASA I-III

Exclusion Criteria:

* Foley catheter less than 18 Fr.
* Patients with obstruction of urinary tract
* Patients with neurogenic bladder
* Patients with severe obesity
* Patients with neurologic disorder
* Patients with chronic pain
* Patients with allergic history to atropine or glycopyrrolate
Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer

This trial aimed to assess efficacy and safety of cetuximab when given in combination with chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of SCCHN
* Recurrent and/or metastatic SCCHN, not suitable for local-regional treatment
* Presence of at least 1 measurable lesion according to RECIST Version 1.1
* Signed written informed consent before any trial-related activities are carried out
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

* Prior systemic chemotherapy, except if given as part of multimodal treatment for locally advanced disease, that was completed within 6 months before randomization
* Surgery (excluding prior biopsy for diagnosis) or irradiation within 4 weeks before trial entry
* Previous treatment with monoclonal antibody or signal transduction inhibitors targeting epidermal growth factor receptor
* Nasopharyngeal carcinoma
* Known central nervous system metastasis and/or leptomeningeal disease
* Medical or psychological condition that would not permit the participant to complete the trial or sign informed consent
* Legal incapacity or limited legal capacity
* Other protocol-defined exclusion criteria could apply
The Supporting Patient Activation in Transition to Home Intervention

This study evaluates if motivational interviewing sessions aiming to motivate recently discharged patients with either chronic obstructive pulmonary disease or congestive heart failure to be active in post-discharge self-management can reduce re-hospitalization rates.

Included patients transition to home will be bridged through a telephone-call from a patient activation coach two days post-discharge. The patients will thereafter get motivational interviewing sessions by the same patient activation coach with the the goal that the patients are motivated to the knowledge, skills and confidence needed to manage the four main activity areas: 1) medication management; 2) adhere to care plan/ follow-up visits according to the discharge plan; 3) recognize indications (symptoms/signs) that the condition is worsening and how to respond; and 4) contact and manage relations/encounters with health care providers. Patients in control group will receive standard care, i.e. discharge and follow-up as in normal procedures. The investigators will use a randomization in permuted blocks of 10 intervention patients and 10 control patients included. To test the hypothesis that the re-hospitalizations rate is 15 % lower in the intervention group compared to the control group 242 patients (121 per group) are needed for power of 80% with the level of significance set to 5 % using two-sided chi-square.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older with chronic obstructive pulmonary disease or congestive heart failure admitted at a short-term medical ward and who are living in their private home.

Exclusion Criteria:

* Diagnoses of dementia or cognitive impairment, and need of interpreter to participate in conversations.

The exclusion criteria are related to the patients' possibilities to participate in the motivational interviewing sessions by phone.
Evaluation of Copeptin Levels in Elective Cesarean Section With Different Anesthetic Technique

In this study, investigators aimed to investigate the effects of general and spinal anesthesia techniques on copeptin levels during cesarean section and their relation with fetal distress.

During the delivery process, the mother and the baby generate some endocrine responses to this emotional and physical stressful action. Arginin-Vasopressin prohormone (copeptin), which is more stable and measurable in blood, is used as an endogenous stress indicator. Copeptin levels have been shown to be significantly increased in vaginally delivery when compared to cesarean section (c / s). In a caesarean section; it is a known fact that when the general anesthetic method and the used anesthetic substances are taken into consideration, it gives a significant stress to the mother and the baby. Spinal anesthesia with no impaired fetal oxygenation and without orotracheal intubation and neuromuscular blockers may reduce fetal distress. However, there was no study investigating the effect of the anesthesia techniques in elective cesarean section on the fetal stress and the level of copeptin, in the literature review. Therefore investigators aimed to compare spinal and general anesthesia technique in elective cesarean section, to evaluate level of copeptin and their relation with fetal distress.Investigators hope that this study will guide the anesthesia method that can be chosen primarily in caesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years of age
* ASA I-II
* 36-40 gestational weeks
* BMI ≤ 40
* Undergoing elective cesarean section

Exclusion Criteria:

* Coagulopathy
* Known central or peripheral nerve disease
* fetal anomalies
* birth weight less than 2000 grams and above 4500 grams,
* infants with a risk of meconium or amniotic fluid aspiration
* kidney failure, diabetes mellitus, hypertension, cardiac disease, antepartum hemorrhage, asthma bronchiole, Rh incompatibility, congenital malformations