cyrilzakka/clinical-trials huggingface dataset:
Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment

Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 38 years with regular menstrual cycles of 25-35 days
* First or second cycle in the present series of ART
* BMI ≥ 18 ≤ 30 kg/m2
* Basal FSH \< 10 IU/L (cycle day 2-5)
* E2 levels \< 50pg/mL (\< 0.18 nmol/L) at the day of FSH administration
* Antral follicle count (AFC) ≥ 10 to ≤ 25 follicles (sum of both ovaries)
* Infertility due to any of the following factors: tubal factor, mild endometriosis (ASRM stage 1-2), male factor, unexplained infertility
* Presence of both ovaries and normal uterine cavity (confirmed by transvaginal ultrasound within 6 months before randomisation)
* Willingness to participate in the study and to comply with the study protocol
* Informed consent

Exclusion Criteria:

* Presence of pregnancy
* History of ≥2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy
* Presence of clinically significant systemic disease
* Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
* Presence of uncontrolled endocrine disorder
* Previous history or presence of severe ovarian hyperstimulation syndrome
* Presence of polycystic ovaries (PCO)
* Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx
* Neoplasia, including tumors of the hypothalamus and pituitary gland
* Abnormal bleeding of undetermined origin
* History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)
* Male infertility without mobile spermatozoa in the ejaculate, that need testicular of epididymal sperm retrieval (MESA/TESE/TESA)
* Endocrine abnormality such as TSH or prolactin level elevations outside the reference range if clinically relevant at screening
* Any hormonal treatment within 1 month before the start of the FSH treatment (with the exception of levothyroxin)
* History of drug, nicotine or alcohol abuse within the last 12 months (\> 10 cigarettes/day)
* Administration of other investigational products within the last month
* Clinically abnormal findings at Visit 1
* Planned PGS/PGD/PBB or assisted hatching
* Concomitant participation in an other study protocol
* History of extrauterine pregnancy in the previous 3 months
* Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medication (GnRH agonist, vitrelle®, and Utrogestan®)
* Presence or history of thrombophlebitis or thromboembolic disorders
* Presence or history of cerebral haemorrhage
* Presence or history of porphyria
Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance

The investigators expect to find that different intensity and altitude exposure levels will show what kind of intermittent exposure protocol is more beneficial to athletes and healthy individuals that experience acute exposure to altitude during exercise. This may furthermore be related to acute altitude exposure for recreational exercise use as well.


Eligibility Criteria:
Inclusion criteria:

* 18-70 years of age,
* history of good health,
* generally active to competitive athletes.

Exclusion criteria:

* History of cardiac or pulmonary disease,
* not currently active,
* unable to exercise or meet study requirements (e.g., number of sessions),
* live at altitude (\>2,100m or 7,000ft).
Effects of Smoking on Bronchial Epithelium

Asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory airway diseases affecting millions of people worldwide. Inhaled corticosteroids (ICS) are by far the most effective treatment with a broad anti-inflammatory spectrum. Nevertheless, most COPD patients and a proportion of severe asthma patients are corticosteroid-resistant (CR) and to fail to respond to ICS even when higher doses are given. These corticosteroid-resistant patients suffer from persistent symptoms and repeated asthma exacerbations. It has been suggested that smoking and oxidative stress may induce corticosteroid-resistance. The reactive oxygen species (ROS) responsible for oxidative stress can be generated exogenously (air pollutants, cigarette smoke) and endogenously by metabolic reactions. After inhaling air pollutants or cigarette smoke, the bronchial epithelium is exposed. Preliminary data from our own lab suggest that smoking and oxidative stress may decrease epithelial cell-cell contact formation. This results not only in a decreased barrier function, but also in an increased production of pro-inflammatory mediators.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for patients with allergic asthma:

* Age between 18 and 65 years.
* \< 10 packyears, no smoking in the last year.
* The presence of allergy defined as at least one positive wheal/flare reaction (2 mm relative to control) to a skin prick test with sixteen common aero-allergens).
* FEV1 \> 80% predicted.
* PC20 methacholine or PC20 histamine \< 8 mg/ml.

Inclusion criteria for patients with COPD:

* Age between 45-75 years.
* ≥ 10 packyears.
* FEV1 between 30% and 80% of predicted.

Exclusion criteria:

* Any disease that, as judged by the Investigator, could have affected the outcome of this study.
* A respiratory tract infection within 4 weeks of the start of the study.
* A history of life-threatening asthma, defined as exacerbation of asthma or COPD that required intubation or was associated with hypercapnea.
* History of myocardial infarction or documented myocardial ischemia.
* Pregnancy, or the possibility of being pregnant (a pregnancy test will be performed in women of childbearing potential who do not use adequate anticonception as judged by the investigator).
A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer

This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel combination in patients with advanced breast cancer. Preliminary information about the efficacy of the combination will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer with evidence of a) metastatic or b) locally recurrent/advanced disease.

Exclusion Criteria:

* Prior treatment with a gamma secretase inhibitors or other Notch signaling inhibitors.
Clinical Evaluation of a New Reduced Volume Bowel Preparation

Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.

Open prospective pilot monocentric phase II clinical trial evaluating the therapeutic efficacy of a new "Low Dose Bowel Prep" formulation for gut cleansing prior to colonoscopy.

Thirty patients admitted to the hospital (inpatients) planned to undergo a complete colonoscopy will have gut cleansing with the "Low Dose Bowel Prep" using a one-step intake mode.

Eligibility Criteria:
Inclusion Criteria:

* male or female, inpatients 18 to 65 years old with indication for complete colonoscopy
* the patient's written informed consent must be obtained prior to inclusion
* willing and able to complete the entire procedure and to comply with study instructions

Exclusion Criteria:

* ileus or toxic megacolon
* intestinal obstruction or perforation
* known of G6PD insufficiency
* history of any colonic surgery
* ischaemic cardiovascular disease
* untreated or uncontrolled arterial hypertension (max \>170mmHg, min \>100mmHg)
* renal insufficiency (creating above 45µmol/l)
* abnormal laboratory values (clinically significant) for sodium, potassium,chloride, creatinine and hematocrit
* cirrhosis of liver (Child-Pugh grade B or C)
* females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
* concurrent participation in an investigational drug study or participation within 30 days of study entry
* subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results or may interfere significantly
Video Support Program For Families With a Parent Newly Diagnosed With Cancer

RATIONALE: A videotape support program may help families improve communication and coping skills when a parent is diagnosed with cancer.

PURPOSE: Randomized trial to study the effectiveness of a video support program for families who have a parent who has been newly diagnosed with cancer.

OBJECTIVES: I. Determine if families who participate in a video support program function better as a family in the areas of communication, togetherness, and overall increased ability to cope when a parent is newly diagnosed with cancer. II. Determine if participation in this program decreases stress-related illness in the well members of the family. III. Determine the safety of this program. IV. Determine patient/family and medical provider satisfaction with this program.

OUTLINE: This a randomized study. Adult parent participants and spouses undergo a baseline assessment over approximately 1 hour comprising completion of a self-assessment form followed by an interview. Families are then randomized to one of two arms. Arm I: Adult parent participants receive a video support program comprising 3 videotapes (parent tape, adolescent tape, and child tape) and a parent guidebook. The parents are encouraged to screen the videotapes and decide whether to have their child and/or adolescent view the program. Arm II: Adult parent participants receive no video support material. Families may view the video program after study completion. Adult parent participants in both arms complete follow-up assessments at 6 and 12 weeks. This clinical trial is being conducted at the locations listed below. If you are interested in this clinical trial but unable to visit these locations, please call #1-800-848-3895 ext. 226 and ask for more information about the We Can Cope study.

PROJECTED ACCRUAL: A total of 230 families will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Parent with a first diagnosis of cancer within the past 5 years No recurrence of a previously diagnosed cancer Must have at least 1 child between the ages of 6 and 18 Ill parent must live with child/children at least 50% of the time No plans to move out-of-state within the next 3 months

PATIENT CHARACTERISTICS: Age: See Disease Characteristics Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No psychotic disorder (such as schizophrenia) or a brain/psychiatric disorder due to disease/illness

PRIOR CONCURRENT THERAPY: Not specified
Effect of Liraglutide on Epicardial Fat in Subjects With Type 2 Diabetes

The purpose of this research study is to learn about the effect of Liraglutide, (Victoza®), on the fat surrounding the heart.Excessive amount of the fat around the heart is common in people with type 2 diabetes and can be associated with poor sugar control. Liraglutide is an injectable prescription medicine that can improve blood sugar control in adults with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, as defined by ADA criteria
* HbA1c \< 8% measured at least 1 month prior to this study
* BMI ≥27 kg/m2
* Pre-treatment with Metformin
* Age \> 18 and \< 65 years old

Exclusion Criteria:

* • Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza®

  * Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
  * Insulin dependent or treated type 2 diabetes
  * Current use of other injectable incretins
  * History of diabetes ketoacidosis
  * Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) \< 30 mL/min/1.73m2
  * Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
  * Clinical or laboratory evidences of chronic active liver diseases
  * Acute or chronic infective diseases
  * Cancer or chemotherapy
  * Current use of systemic corticosteroids or in the 3 months prior this study
  * Known or suspected allergy to Liraglutide, excipients, or related products
  * Pregnant, breast-feeding or the intention of becoming pregnant
  * Females of childbearing potential who are not using adequate contraceptive methods
End-of-Life Decisions in Surgical Intensive Care Medicine - The Relevance of Treatment Withholding

The purpose of this retrospective observational study is to describe the sequence of ICU-therapies that are limited and to compare characteristics and the decision making process in surgical ICU-patients.

Decisions to limit life-support therapy are common on the intensive care unit (ICU). End-of-life decisions (EOLD) underlie a dynamic process and limitation of ICU-therapies is done sequentially. Questionnaire-based and observational studies on medical ICUs and in palliative care reveal blood transfusions as the first therapy physicians withhold in EOLDs. Whether this practice also applies to surgical ICU-patients is unknown.

The purpose of this retrospective observational study is to describe the sequence of ICU-therapies that are limited and to compare characteristics and the decision making process in surgical ICU-patients.

Eligibility Criteria:
Inclusion Criteria:

* All surgical patients admitted to the ICU All surgical patients discharged death from the ICU

Exclusion Criteria:

* All patients discharged alive from the ICU
A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants

The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed \[high-fat meal\]) on the drug levels after administration of BMS-986196 tablet formulation at two dose levels in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
* Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m\^2), inclusive, and body weight ≥ 50 kg.
* Participant must agree and be willing to consume a standard high-fat meal (for example, which may contain gluten).

Exclusion Criteria:

* Any significant acute or chronic medical illness in the assessment of the investigator.
* Current or recent (within 3 months of study intervention) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g., bariatric procedure)
* Any major surgery, including GI surgery (for example, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).

Note: Other protocol-defined inclusion/exclusion criteria apply.
Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique

This study is a comparison of the surgical techniques and postoperative outcome between the two intrascleral IOL fixation techniques: Yamane technique versus the 4-flanged technique.

The main objectives are postoperative lens tilt, duration of surgery, intra- and postoperative complication rates and scleral integrity around the flanges.


Eligibility Criteria:
Inclusion Criteria:

* - Necessity for IOL (re)fixation in the absence of capsular support
* willing to give informed consent and follow-up the duration of study

Exclusion Criteria:

* Anatomical or other contraindications for suture less IOL fixation, such as presence of a trabeculectomy bleb or scleromalacia
* active inflammatory diseases of the eye
Pattern of Chronic Disease in Adult attendantsabove18years Old in New Vally Elkharga Family Medicine Clinic

Globally one in three of all adult suffer from multible Chronic condition six in ten adult has achronic disease and four in ten adult have twoor more.It has been calculated that 58million death in2005 approximately 35million will be aresult of chronic disease health damaging behavior tobbaco use, poor physical activity and poor eating habbits are major contributors to the leading chronic diseases the leading chronic diseases in developed countries including arthritis, cardiovascular diseases,heart attacks,stroke,cancer, diabetes,breast\&colonic cancer , Aging increasing the risk of chronic diseases like dementia ,heart diseases,cancer these are the nation's leadingdrivers of illness,disability,death and health care costs.

In2008 more than1,2million people died from non communicable diseases accounting for nearly 60% of all death inthe region with wide several outbreaks of hospital acquired infection in the midlle east have occurredwith substantial morbidity and mortality.Egypt currently has the third highest prevelance of obesity inMena region after saudi arabia and Emirates similar to the Hispanic and native.American population central adiposity is particularly common among egyptienand is probably inherited the Egyptian national survey individual have central obesity.this be found strongly associated with increase risk of dm and cardiovascular diseases

Eligibility Criteria:
Inclusion Criteria:

* Attendands above18years

Exclusion Criteria:

* Attendants below18 years
Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).

This study describes patient perceptions related to device attributes, which are of importance in describing overall patient perception. A range of potential device benefits (e.g. ease of use, convenience, confidence, presence or absence of fear, side effects related to administration) is captured using a questionnaire based on the outputs of patient interviews.

The study aims to characterize patient attributes that will indicate when one device may result in greater patient satisfaction than another. Patient attributes are composed of patient characteristics (e.g. age, sex, self efficacy, expectations of treatment, perception of their illness) and RA characteristics (e.g. disease severity, disease duration, prior treatment, functional impairment).

Eligibility Criteria:
Inclusion:

* Diagnosis of RA according to the ACR-Criteria.
* Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
* Willing and able to self-inject etanercept.

Exclusion:

* Prior experience of biologics and anti-TNF treatment for their RA including etanercept.
* Sepsis or risk of sepsis.
* Current or recent infections, including chronic or localized.
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

* Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
* No standard postoperative adjuvant chemotherapy has ever been established.


Eligibility Criteria:
Inclusion Criteria:

* ability to give informed consent
* histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
* node-positive and pathologic stage M0 .
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients were enrolled 4 to 10 weeks after surgery.
* Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin\<2 times of upper normal institutional limits.

Exclusion Criteria:

* prior chemotherapy or concurrent radiation therapy before esophagectomy
* R1 or R2 resection
* clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination
Anthropometric Predictability of Full-Thickness Peroneus Longus and Semitendinosus Autograft Size

The study is aimed to determine correlation between autografts used in anterior cruciate ligaments and anthropometric variables e.g. height, sex, weight, BMI etc..

Categorical data: Age, Sex, Height, Weight, BMI, Preoperative parameters: cruris length, cruris circumference, thigh length, thigh circumference Intraoperative Info: Tendon Type, Tendon length (total-muscular part-tendinoz part), Graft Length, Graft Diameter.

After the data collected, correlation analysis will be held and determine the both tendons preoperative size predictability before acl reconstruction surgery.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18-45 years
* Diagnosed Acl rupture preoperavitely with mri imaging
* Diagnosed Acl rupture and having symptoms related to acl rupture
* Eligible for harvesting same side semitendinosus or peroneous longus tendon

Exclusion Criteria:

* Previous surgery history on donor side knee or ankle
* Congenital defect on donor extremity
* Multiple Ligament Injury History
Akathisia in Post Operative Outpatients Surgery

The main objective of this study is to evaluate the incidence of akathisia with Droperidol, the prophylactic treatment of post operative nausea and vomiting, used at two different doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to compare the number of observed akathisia (Barnes score \> 1) in the Droperidol arms (0,625 mg and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is that there is a greater risk of akathisia among patients taking Droperidol in prevention of NPVO, that among patients taking Ondansetron.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 and under 65 year-old
* Having a moderate to severe POVN (post operative vomiting and nausea) risk, meaning with at least two risk factors in the simplified Apfel score
* Outpatient surgery associated to a general anesthesia
* Patient having signed an informed consent- Patient having a social protection

Exclusion Criteria:

* Contraindication to Droperidol
* Contraindication to Ondansetron
* Patients usually treated with benzodiazepine or having been treated with benzodiazepine within 2 days prior to anesthesia
* Psychiatric and Neurodegenerative diseases
* Severe Anxiety
* Contraindication to general anesthesia or one of its components
* Allergy to propofol
* Inability to get informed (patient in an emergency situation, difficulties to understand)
* Patient under judicial protection
* Patient under tutorship or curatorship
* Pregnancy reported by the patient- Breastfeeding
* Patient in an exclusion period