cyrilzakka/clinical-trials huggingface dataset:
Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer

The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.

A Phase IIa Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination with Paclitaxel versus Paclitaxel alone in Patients with Metastatic, Gastric or Gastro-oesophageal Junction, Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status (SAGE)

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older (20 years or older in Japan)
* Patients must have radiologically confirmed progression following 1st line fluoropyrimidine and platinum based treatment for metastatic gastric cancer (the date of progression and start of first line treatment to be captured on the database)
* Suitable for paclitaxel therapy.
* At least one lesion, not previously irradiated and not chosen for a mandatory fresh tumour biopsy during the study screening period, that can be accurately measured at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeat assessment.
* Ineligible for trastuzumab treatment by local assessment. This should include IHC analysis to determine HER2 status with further testing by FISH/CISH when considered part of local practice. Eligible patients are defined as; HER2 IHC 0, HER2 IHC +1 and +2

Exclusion Criteria:

* Have received more than 1 prior chemotherapy regimen for metastatic gastric cancer. (chemotherapy as adjuvant treatment is permitted).
* Any prior taxane therapy (at any time from diagnosis of gastric cancer)
* Any prior therapy with an inhibitor of ErbB1 (EGFR) or ErbB2 (HER2) (eg, lapatinib)
* Resting ECG with measurable QTc(F) interval of greater than 480 msec at 2 or more time points within a 24 hour period (see section 6.4.9.1 )
* Unresolved toxicity grater than CTCAE grade 2 (except alopecia) from previous anti-cancer therapy
Doppler Ultrasound and CT Versus Laparoscopy in Assessment of Ovarian Malignancy

The aim of this study is to assess validation of ultrasound (± Doppler) parameters in the diagnosis of suspicious ovarian malignant tumors and laparoscopic assessment of these findings according to Fagotti score evaluation of suspicious malignant tumors

The aim of this study is to asses validation of ultrasound (± Doppler) parameters in the diagnosis of suspicious ovarian malignant tumors and laparoscopic assessment of these findings according to Fagotti score evaluation of suspicious malignant tumors

Eligibility Criteria:
Inclusion Criteria:

1. all patients with clinical or radiological suspicion of ovarian cancer.
2. at least one of clinical presentation of suspected or advanced ovarian cancer and performed ultrasound or CT or MRI that detect a pelvic mass and CA125 is more than 200 UL/ML.
3. patients with eastern Cooperative Oncology Group status from 0 to 3.

Exclusion Criteria:

1. the women outside the age group in our study.
2. any known malignancy at other sites.
3. uncompliant patients who have severed uncontrolled infection or any other medical problem.
4. any previous major surgery.
5. patients who refuse to give an informed consent to do laparoscopy.
6. pregnancy and its complications.
Study of Antenatal Model to Prevent Preterm Delivery

The purpose of this study is to determine whether antenatal model in vaginosis are effective in preventing vaginal infection and preterm delivery

The standard antenatal care nowadays can not answer for preterm delivery problems. Thus, comprehensive and proactive approach is needed for preventing preterm delivery. This antenatal model is consisted of midwife training, early detection of bacterial vaginosis, pregnant women campaign and self administered pH check

Eligibility Criteria:
Inclusion Criteria:

* 14- 18 week gestation pregnant women with or without any vaginal discharge
* singleton pregnancy, without any fetal or uterine anomaly

Exclusion Criteria:

* Any complication in pregnancy
* Any history of disease in pregnancy
Pharmacogenetics of Acenocoumarol

The use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE) due to a narrow therapeutic window leading to important medical and economical consequences. The risk of ADE is increased partly by drug interactions and recently identified genetic factors influencing the metabolism of coumarins (polymorphism of the cytochrome P450 CYP2C9) as well as the target enzyme of the coumarins (polymorphism of the vitamin K epoxide reductase complex subunit 1 (VKORC1).

The objective is to determine the impact of several genotypes on acenocoumarol treatment and on vulnerability to drug-drug interactions.


Eligibility Criteria:
Inclusion Criteria:

* Every patients with requiring acenocoumarol therapy for at least 4 weeks and a target INR in the low intensity range (INR range 2-3)
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* Severe cognitive impairment
* Previous or current treatment with any coumarin
Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers

The importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which explains the lack of consensus on how to lay, including or not to include the heel. Studies on adherence to patients with medical compression have been carried out showing that one of the determining factors is comfort. The investigators therefore wish to conduct a randomized open prospective quantitative study comparing these two modes: including or not the heel .


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patient with at least one venous ulcer progressing for at least 4 weeks
* Patient coming for a specialized outpatient consultation called "vascular wound" at Nantes University Hospital
* Informed consent to participate in the study
* Social security insurance affiliation

Exclusion Criteria:

* Patients under guardianship
* Patient with major cognitive disorders incompatible with follow-up of protocol
* Pregnancy
* Patient with an open leg ulcer with a Systolic Pressure Index \< 0.8
A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks

The main purpose of this research study is to try to improve the results of the standard treatment for heart attacks. Normally, heart attack patients get a fast dose and a slow dose of eptifibatide in the emergency room, shortly after arriving. This drug is usually given through a vein in the arm. However, eptifibatide can also be injected directly into the heart's blood supply just before angioplasty, a common procedure to unblock a blood vessel in the heart. This new way of giving the drug is being studying.

The primary objective of the IC-TITAN study is to demonstrate that an IC bolus of eptifibatide added to an upstream double-bolus and infusion regimen of eptifibatide administered intravenously and initiated early in the ER will result in significant additional clot resolution in vivo when compared with an IC injection of placebo (saline). The primary endpoint chosen to evaluate this hypothesis is the improvement in percent diameter stenosis of the culprit artery following the IC bolus administration of eptifibatide vs. IC placebo (saline) as assessed with quantitative coronary angiography (QCA).

Eligibility Criteria:
Inclusion Criteria:

Clinical

* Patients (men or women) at least 18 years of age and
* Presenting with ischemic chest discomfort \>20 minutes and \<6 hours of duration suggestive of acute myocardial infarction

AND:

ECG

* ST elevation \>1mm (\>0.1mV) in two contiguous limb leads OR \>2mm (\>0.2mV) in two contiguous precordial leads

Exclusion Criteria:

CLINICAL

* Maximal systolic blood pressure \<80 mmHg AFTER initial fluid and/or pressor resuscitation
* Uncontrolled hypertension (SBP\>180 OR DBP \>110) at time of enrollment
* Ventricular fibrillation or ventricular tachycardia requiring DC cardioversion
* Sinus bradycardia (HR \<50/min), third degree or advanced second degree heart block.
* Known pregnancy
* New or suspected new left bundle branch block

BIOCHEMICAL

* Known thrombocytopenia (platelet count \<100,000)
* Known severe renal insufficiency (creatinine \>4.0 mg/dL)

INCREASED BLEEDING RISK

* Active or recent (\<1 year) bleeding or gastrointestinal hemorrhage
* Major surgery \<1 month
* Known coagulopathy, platelet disorder or history of thrombocytopenia: If a patient is known to be on chronic warfarin therapy, the International Normalized Ratio (INR) must be known to be \<1.6 in order for the patient to be included
* Known neoplasm
* Any history of hemorrhagic cerebrovascular disorder or active intracranial pathology

MEDICATIONS

* Administration of a fibrinolytic agent within 7 days
* Known allergy or contraindication to eptifibatide OR aspirin OR heparin
* Treatment with another GP IIb/IIIa inhibitor within 7 days
Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)

The aim of the study is to evaluate the level of satisfaction among patients to whom Mirvaso® / Onreltea TM (trade mark) is prescribed.


Eligibility Criteria:
Inclusion Criteria:

* Patients to whom the physician has already decided to prescribe Mirvaso® /OnrelteaTM according to package insert
Ethically Accepted With Code 851/2971 A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator

The aim of this study is to compare the treatment results when treating Class II division 1 malocclusion using the Van Beek-Headgear Activator combination (vBHGA) appliance versus using the Andresen activator.


Eligibility Criteria:
Inclusion Criteria:

* Class II division 1 indicated by ANB angle value ≥ 4º
* Class II division 1 with overjet \> 5mm.
* An age range between 8 and 13 years growing patient using cervical vertebral stage assessment (CVS).
* No previous orthodontic treatment
* No indications or symptoms of periodontal disease in the past or present, as determined by clinical and radiographic examination

Exclusion Criteria:

* Missing teeth (excluding 3rd molars).
* Craniofacial anomalies.
* Medical condition or prescription medication that may affect growth.
* Lack of compliance whenever documented in the charts.
Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents

Insulin Resistance is the best predictor of whether the obese adolescent will develop type 2 diabetes. The present studies will focus on determining what might cause fat to accumulate in the subcutaneous fat regions and lead to local inflammation, causing insulin resistance to develop in obese adolescents.

The purpose of this study is to test whether the reduced transcription of key lipogenic/adipogenic genes in abdominal subcutaneous adipose tissue (SAT) in obese adolescents with a High VAT/SAT (visceral adipose tissue/subcutaneous adipose tissue) ratio translates functionally into a reduced in vivo triglyceride (TG) synthesis and adipocyte proliferation, which in turn will contribute to ectopic fat accumulation and insulin resistance (IR). To test whether the storage capacity of gluteal SAT is linked to the level of VAT/SAT fat distribution in obese adolescents. To explore if changes in dietary fat intake (palmitate intake) alters ceramide concentration in both plasma and adipose tissue (AT) and the Inflammasome complex in the different fat distribution phenotypes and their associations with IR.

Eligibility Criteria:
Inclusion Criteria:

* Overweight (85-95th% age and gender specific) or Obese (\>95th% age and gender specific)
* Ages 12-18 years
* Absence of any endocrinopathy
* Absence of any therapy with medication known to alter glucose metabolism (i.e.: Oral steroids, certain psychiatric medications such as Xeleca, Lithium, Paxil)
* English Speaking subjects

Exclusion Criteria:

* Any disease known to alter glucose metabolism (T2DM)
* Diuretic Medication
* Pregnant or breastfeeding
* Type 1 or 2 diabetes
The Importance of Delayed Cord Clamping

After birth, the umbilical cord is usually clamped and separated from the placenta within the first 30 seconds. Although the exact time to clamp the umbilical cord is unknown, allowing placental transfusion after birth has many benefits for the newborn.

Increased bleeding control, which is reported as a maternal complication, has not been found in studies. Approximately 28ml/kg additional blood volume is transferred to the baby with placental transfusion. The hemodynamics of the newborn are positively affected as the blood volume increases the right ventricular volume and the pulmonary pressure begins to decrease with the first breath. In addition, due to this additional blood volume, stem cells and erythrocytes pass through more. There are studies showing that it reduces iron deficiency that occurs in infants at the 4th month. In our study, we aimed to examine the effect of allowing placental transfusion until cord pulsation stopped and the effect of delayed cord clamping on iron deficiency at the 4th month in babies.

Healthy term newborns who will be born in our gynecology clinic; type of birth, week of gestation, birth weight, cord clamping time, cord blood gas, APGAR score, complete blood count, maternal complete blood count, maternal complications, baby's first body temperature, postnatal day 3 hematocrit and bilirubin level, diet, phototherapy treatment application Measurements will be determined and evaluated in terms of the baby's condition, monthly routine baby follow-up (anthropometric measurements and physical examination), and routine 4th month iron deficiency screening. These measurements and applications will be made by the baby nurse, pediatric assistant and pediatrician who will be present during the birth.

Eligibility Criteria:
Inclusion Criteria:

* The healthy babies of healthy mothers (no pre-eclampsia, no diabetes, no prolonged rupture of membranes or signs of infection) term (gestational age ≥ 37 weeks) and no additional abnormality were included in the study.

Exclusion Criteria:

* . Babies who needed resuscitation were excluded from the study
Clinical Efficacy of Glucosamine Plus Diacerein Versus Mono-therapy of Glucosamine

The purpose of this study is to compare pain scores, WOMAC total and subscores, actual and change of joint space width and the rate of gastrointestinal side effects at 4, 8, 12, and 24 weeks between dual-therapy of diacerein and glucosamine versus a mono-therapy of glucosamine in OA patients


Eligibility Criteria:
Adult patients age 50 years or older who have been diagnosed as primary or secondary osteoarthritis of the knee base on clinical criteria of American College of Rheumatology

Inclusion Criteria:

* Clinical diagnosis of primary osteoarthritis
* Mild deformity Clinical (having no varus or valgus deformity, no crepitus) ? Physical examination grade 0 assessed by stress test Radiographic assessment (Kellgrane-lawrance type II-III), a minimum baseline medial tibiofemoral JSW of _2 mm.
* Willing to participate and provide written informed consent

Exclusion Criteria:

* Non-secondary osteoarthritis Rheumatoid arthritis, inflammatory arthritis (e.g. SLE, Gout), post traumatic osteoarthritis, those who received intra-articular treatment of the signal joint with any product (corticosteroids in the previous 2 months, or glycosaminoglycans/hyaluronic acid in the previous 6 months) or had undergone joint lavage andarthroscopic procedures in the previous 6 months.
* No contraindication of using diacerein and glucosamine
* Non-current or ex-users of oral SYSADOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics known hypersensitivity to diacerein, to similar compounds, to the excipients or to paracetamol
Alcohol Consumption and Stress at Patients Alcohol-dependants

This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design.

This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design. Participants will be given phone calls 4 times a day for 3 weeks, assessing perceived stress and alcohol related craving.

Eligibility Criteria:
Inclusion criteria:

* Males or Females aged 18-65 years
* Alcohol use disorder defined by DSM 5 criteria
* Fluent in French
* Hospitalized for alcohol withdrawal for at least 7 days
* Viable (working) telephone number

Exclusion criteria:

* Participants without social care insurance
* Any DSM Axis I disorder not defined in the inclusion criteria
* Mandatory psychiatric treatment
EMDR Psychotherapy for Anxious-depressive Symptoms in Breast Cancer Patient

The study will consist in an evaluation of the EMDR (Eye Movement Desensitization and Reprocessing) psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score (CES-D) and PTSD score, and a higher increase in quality of life.

The study will consist in an evaluation of the EMDR psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score and PTSD score, and a higher increase in quality of life (QLQ)

Eligibility Criteria:
Inclusion Criteria:

* Being a 18 or more year old woman
* Having primary breast cancer or going to start treatment or having completed treatments for less than 6 months
* Presenting a state-anxiety level a score higher than 35.
* Being able to complete questionnaires.
* Having signed the consent letter
* Be affiliated to a social security system

Exclusion Criteria:

* Have contraindications for EMDR psychotherapy (neurological disorders, dissociative states, oculomotor problems)
* Have metastatic breast cancer
* physical multiple pathologies
* Have a psychiatric history (including anxio-depressive disorders). Background Assessment from M.I.N.I. (Sheehan et al., 1997)
* Present an addiction, an abuse of drugs or alcohol
* Person placed under the protection of justice, guardianship or trusteeship.
* Pregnant or lactating woman
Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.

Vaginal prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with women's sex life. There are a number of different surgical procedures which are used to repair prolapse. Sometimes a mesh is placed in the pelvis to support the weakened tissues. There is a lot of research going on to find the most suitable type of mesh to repair vaginal prolapse. The GYNECARE PROLIFT + M\* Pelvic Floor Repair system is similar to a mesh already used for this procedure called ULTRAPRO\*, but is lighter in weight. Currently, ULTRAPRO\* is only approved for use in hernia repair and is not licensed for gynecological procedures. This study will be the first clinical investigation of this mesh in vaginal prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair. Perineal repair, vaginal hysterectomy and/or mid urethral sling procedures for incontinence may be performed concurrently.
* Age \> or = 18 years.
* Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.

Exclusion Criteria:

* Additional surgical intervention for POP repair concurrent to the Gynecare Prolift+M procedure (e.g. paravaginal repair, sacrocolpopexy, colporrhaphy in a non-Gynecare Prolift+M treated compartment).
* Previous repair of pelvic organ prolapse involving insertion of mesh.
* Previous hysterectomy within 6 months of scheduled surgery.
* Experimental drug or experimental medical device within 3 months prior to the planned procedure.
* Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
* Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
* History of any pelvic radiation therapy.
* History of chemotherapy within 6 months of the planned procedure.
* Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
* Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
* Nursing or pregnant or intends future pregnancy.
* In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty

The purpose of the study is to compare the safety and efficacy of two drops used to lower eye pressure when given prior to a glaucoma laser procedure.

This is a prospective randomized double blind trial of patients undergoing selective laser trabeculoplasty for primary open angle glaucoma and ocular hypertension. Enrolled patients are randomized to receive one drop of brimonidine 0.1% in one eye and one drop of apraclonidine 0.5% in the fellow eye. The trabecular meshwork in both eyes of each enrolled patient is treated 360 degrees at the same sitting. Intraocular pressure is measured in each eye one hour before applying the study medications and at one hour and one week after laser surgery.

Eligibility Criteria:
Inclusion Criteria:

* male or female, at least 18 years of age
* Open Angle Glaucoma with inadequate intraocular pressure (IOP) control or evidence of progression (based on optic nerve head appearance and/or visual field changes) despite current medical therapy
* Ocular Hypertension requiring lowering of IOP
* ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

* inability to understand and provide informed consent to participate in this study
* inability/unwillingness to follow study instructions and complete all required visits
* Documented allergy to either brimonidine or iopidine
* Angle Closure Glaucoma
* Congenital/Juvenile Glaucoma
* Neovascular Glaucoma
* Active uveitis