cyrilzakka/clinical-trials huggingface dataset:
Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation

The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops in the prevention of infection and inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0% prednisolone acetate as isolated eye drops formulations. The study treatment is randomized, double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days of study treatment administration after the ocular surgery is performed. Candidates for the study are patients with indication for ocular refractive surgery (Lasik) for correction of visual acuity.


Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated to have an ocular refractive surgery performed (myopia, astigmatism, hypermetropy) by the Lasik method.
* Patient presents a normal eye fundus.
* Patient has intraocular pressure (IOP) ≤ 20 mmHg.

Exclusion Criteria:

* Surgery and/or previous ocular pathology (presence of scar/change in the cornea, glaucoma, retinopathies, etc.).
* Patient has diabetes or is immunodepressed.
* Any systemic infection during the study.
* Signs and/or symptoms of ocular inflammation/infection (bacterial, viral, fungal, caused by Chlamydia, by Mycobacterium, Acanthamoeba or of allergic etiology).
* Have used any systemic or topical antibiotics for ocular infection in the previous 14 days.
* Patient has known hypersensitivity to any of the components of the formulations used in the study.
Comparing Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program

The purpose of the present study is to evaluate the effect of sleep duration on weight loss of obese and overweight adult when they are in a weight loss plan (NovinDiet Protocol). The investigators aim is to compare the effects of short term sleep duration with normal sleep duration with respect to body weight (and abdominal adiposity).


Eligibility Criteria:
Inclusion Criteria:

* Must be female
* Must have \< 7 hour sleep per night
* Must be 18-45 years of age.
* Must have Body mass index (BMI) between 27-35 kg/ m².
* Must be able to have moderate exercise.
* Must be interested to have weight loss.

Exclusion Criteria:

* Participating in a research project involving weight loss or physical activity in the previous six months.
* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medication that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.


Eligibility Criteria:
Inclusion Criteria:

* Must not be pregnant or breastfeeding and agree to use birth control;
* Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings;
* Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria;
* Demonstrates English fluency and has access to a touch-tone telephone.

Exclusion Criteria:

* Recent history of mushy or watery stools;
* Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study;
* Clinically-significant alarm symptoms;
* Secondary causes of constipation or evacuation disorders;
* Surgery to the gastrointestinal tract;
* Usage of prohibited medications.
Single Neurons Responses During Visual Recognition in Epileptic Patients

The purpose is to evaluate specific capacities of face detection of individual neurons by comparison with their capacity of object detection in medial temporal lobe and ventral temporal cortex in epileptic patients.

Secondary purpose is to evaluate specific capacities of detection of known faces of individual neurons by comparison with their capacity of detection of unknown faces in medial temporal lobe and ventral temporal cortex in epileptic patients.

In this interventional study, patients explored with mixed intracerebral electrodes (micro and macro-contacts) will be presented sets of images (objects, unknown faces, famous faces). Spikes and Multi-Unit-Activity will be recorded and analyzed and compared between conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patient with temporal or occipito-temporal drug-resistant partial epilepsy, symptomatic, needing surgical treatment
* Patient having signed informed consent
* Patient affiliated to social security
* Patient having undergone preliminary medical examination

Exclusion Criteria:

* Persons under legal protection or incapable to consent
* Persons deprived of liberty by juridical or administrative decision
* Patient with severe visual disorders of neurological or ophthalmological origin
* Patients with infection risk according to doctor or surgeon
* Women without effective contraception
* Pregnant or breast-feeding women
Blended Depression Therapy: Cognitive Behaviour Therapy Face-to-face and Via Internet

To asses the clinical effectiveness of blended cognitive behavior therapy (CBT): face-to-face and internet-based treatment for adults with Major Depressive Disorder (MDD) in primary care compared to treatment as usual.

The study is part of a EU-project. Participants are recruited via regular routes from primary care settings. Following the Mini International Neuropsychiatric Interview (M.I.N.I.) participants will be randomly allocated to either blended treatment for 10 sessions/weeks or to treatment as usual. We will include 150 participants in total.

Eligibility Criteria:
Inclusion Criteria:

* depressive symptoms according to DSM-IV
* have access to a computer with internet connection
* have good knowledge of the Swedish language

Exclusion Criteria:

* recent (during last 6 weeks) change in psychiatric medication
* presently in any other psychological treatment
* severe depression
* suicidal ideation
Comparison of Ultrasound Versus Radiography for Diagnosis of Nasal Fractures

The standard imaging procedure to diagnose a nasal fracture still is radiography (lateral nasal view and occipitomental view). But technological advances in ultrasonography during the last few decades have made high-resolution ultrasound devices available to the majority of medical centers. It has been shown that the bony structures of the nose can be well examined by ultrasound in the last few years. The hypothesis: "Is ultrasound of equal diagnostic accuracy in diagnosing nasal fractures as radiography" is being tested in the investigators' study. Patients with suspected nasal fracture undergo ultrasound examination in addition to the routine x-ray imaging. After completion of treatment, the readings of both ultrasound and radiographs are compared in terms of sensitivity and specificity to diagnose nasal fractures.


Eligibility Criteria:
Inclusion Criteria:

* suspected nasal fracture

Exclusion Criteria:

* further fractures
* pregnancy
* unstable condition
* refusal to undergo ultrasound examination
Timing of Thyroxine Dose In Ramadan

A Randomized trial comparing two different timing of taking thyroxine in patients with Hypothyroidism during fasting the month of Ramadan.

To date there is debate regarding the best timing of L-thyroxine administration during Ramadan as sufficient evidence is lacking. This study aims to compare two-time points of levothyroxine intake during Ramadan focusing on change in TSH, satisfaction and compliance.

A prospective, randomized, open label, multicenter Study. The first group will be will be instructed to take their L-thyroxin dose as per current guidlines at breaking of fast time (sunset) with sip of water then wait 30-60 minutes to consume Iftar meal. The second group (pre-Fajer prayer), patients are going to be instructed to take L-thyroxin dose immediately before start of fast, i.e. Alfajer (dawn) regardless of Suhoor time. The values of Thyroid stimulating hormone (TSH) will be measured two weeks before Ramadan, and 2-4 weeks after Ramadan for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Saudi patient (males and female) above 18 years with Primary hypothyroidism on levothyroxine replacement who are willing to fast during Ramadan.
* Patients with controlled thyroid function for last 3 months on same dose of levothyroxine.

Exclusion Criteria:

* Pregnant or lactating women.
* Uncontrolled thyroid function test three months prior Ramadan.
* Thyroid cancer patients who require suppressed TSH.
* Central Hypothyroidism, patient with acute illness.
* Patients diagnosed with malabsorption i.e., Celiac Disease, Short bowel, Bariatric surgeries

  * Use of certain Medications like systemic glucocorticoids, activated charcoal, sucralfate, aluminum hydroxide antacid, bile acid sequestrants, iron, calcium carbonate, PPI, rifampicin, and antiepileptic medications
  * Renal or hepatic disease:
  * Creatinine clearance \<0.6 ml/s or serum creatinine ≥200 μmol/l
  * Alanine transferase ≥2.5 times the upper limit of normal
  * Active liver disease including jaundice, chronic hepatitis, previous liver transplant
  * Unwillingness to be randomized or to sign informed consent
  * Known Psychiatric Disorders
  * Known uncontrolled substance abuse or alcoholism
A Case-control Study to Assess the Association Between Facial Characteristics and Coronary Artery Diseases

The purpose of this study is to explore the facial characteristics associated with the increased risk of coronary artery diseases. The secondary purpose is to evaluate the diagnostic efficacy of appearance factors for coronary artery diseases.

Several age-related appearance factors were described associated with increased risk of coronary artery diseases (CAD). However, several limitations made these facial risk factors hard to be utilized in clinical practice, including 1) low prevalence in CAD patients, 2) lack of specific definition, 3) poor reproducibility in artificial recognition.

Thus, we designed a case-control study to explore new, common and well-defined facial characteristics associated with CAD and evaluate the diagnostic efficacy of appearence factors in CAD. We will recuit 1150 patients with at least one coronary lesion stenosis ≥50% according to coronary angiography or coronary computer tomography (CAD group) and 1150 patients without coronary lesion stenosis≥ 50% (No CAD group) judged by coronary angiography or coronary computer tomography. We will collect patients' baseline information and facial images. One hand, we will explore the facial factors associated with CAD by comparing the exposure rates of different facial factors in CAD group and No CAD group based on artificial intelligence technology. On the other hand, we will build a CAD risk model based on facial factors, and evaluate the diagnostic effect of the model.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing coronary computer tomography or coronary angiography
* Written informed consent

Exclusion Criteria:

* Prior percutaneous coronary intervention (PCI)
* Prior coronary artery bypass graft (CABG)
* Without blood biochemistry outcome
* With artificially facial alteration (i.e. cosmetic surgery, facial trauma or make-up)
* Other situations which make patients fail to be photographed
Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer

This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab and docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic breast carcinoma that is HER2 positive
* Measurable disease as defined by the RECIST criteria
* Life expectancy greater than or equal to 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Received any anticancer medications in the 28 days prior to enrollment into this study
* Received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study.
* History of deep venous thrombosis within the last year
* Contraindication to low dose warfarin therapy
* Clinically significant cardiomyopathy
* Prior treatment with INCB007839 or trastuzumab or lapatinib
Comparative Bioavailability Study of an Immediate Release and Controlled Release Oral Formulations of Huperzine A

The purpose of this study is to develop oral controlled release formulation of Huperzine A that will provide optimal pharmacokinetic profile of the drug enhancing safety and compliance, as possible cure to neurodegenerative disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males between the age of 18 and 35, inclusive (ASA = 1)
2. Body weight \> 50 kg
3. Subject has a BMI less than 27 and more than 20
4. Participants should be able to ingest oral medication
5. The ability to understand and sign a written informed consent form, prior to participation and the willingness to comply with all study requirements

Exclusion Criteria:

1. History of drug sensitivity or drug allergy
2. History of sensitivity to eggs
3. Subject has a BMI less than 20 and more than 27
4. Previous participation in an investigational trial involving administration of any investigational compound within 1 month prior to the current study
5. History of alcoholism or drug addiction
6. Any medication taken including over-the-counter medications and herbal products within 14 days of commencing study drug dosing with the exception of vitamins and/or paracetamol. When a concomitant medication is necessary, this will be reviewed by the investigator and if not contraindicated, may be continued at the same dose and frequency during the study period
7. History of clinically important illness (ASA\>1); Disorders or conditions that could affect the absorption, distribution, metabolism and/or excretion of drugs (e.g. malabsorption, edema, renal or hepatic insufficiency)
8. Inability to relate to and/or cooperate with the investigators
9. Blood loss or donation greater than 200ml in the 3 months prior to the trial
10. Exhausting physical exercise during the previous 48 hours to drug administration
11. Subjects who have smoked or used nicotine-containing products within 6 months prior to study entry
Evaluating Vibrational Anesthesia in Scalp Platelet Rich Plasma (PRP)

This study is prospective, single-site, randomized split-scalp pilot and survey study of patients at the NYU Skin and Cancer Clinic or the Faculty Group Practice. The investigators will randomize half of the scalp of each patient: one half will receive vibrational anesthesia (VA) via a device and the other half will not. Approximately 100 unique patients will be recruited (there will only be one study group). During the standard of care platelet rich plasma (PRP) procedure, a REDCap survey questionnaire will be provided asking the patients to rate their pain with the visual analogue scale (VAS). A simple paired t-test will be used to test significant improvement in pain scores between the two halves of the scalp.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have received at least one treatment of PRP to the scalp, which may include the PRP procedure performed day of.
* Able to participate in study procedures.
* Able to provide consent.

Exclusion Criteria:

* Patients missing the following data will be excluded from the final analysis: Patient age, gender, type of alopecia, PRP documentation.
* Patients unable to consent.
Combined Corticosteroid With Low Volume Compared to High Volume in Impingement Syndrome

This study aims to assess and compare the effectiveness of two different volumes of local anesthetic combined with 40mg of triamcinolone for subacromial injections in treating patients with rotator cuff impingement syndrome

Patients with rotator cuff impingement syndrome were randomized to undergo subacromial injection with 10mL total volume of 1% lidocaine plus 40mg triamcinolone acetonide (n = 22), or a 4mL total volume of 1% lidocaine plus 40-mg triamcinolone acetonide (n = 23). Evaluations using a visual analog scale (VAS) for pain during motion, and the Western Ontario Rotator Cuff Index (WORC) were completed before treatment and 30 minutes, 2 weeks, and 8 weeks after injection.

Eligibility Criteria:
Inclusion Criteria:

1. participants with clinically diagnosed the rotator cuff impingement
2. participants aged 20 years and older
3. at least 1 month's duration
4. pain of moderate to severe intensity, defined as a score of 5 or more points on a 10-cm visual analog scale (VAS) rated from 0 (no pain) to 10 (worst imaginable pain)

Exclusion Criteria:

1. patients with adhesive capsulitis of the shoulder (normal radiograph of affected shoulder, and restriction of passive motion \>30° in ≥2 planes of movement)
2. previous trauma history at currently affected shoulder
3. previous corticosteroid injection history at the affected shoulder
4. abnormal calcification and/or primary osteoarthritis of the shoulder joint on plain radiographs
5. use of medication such as antiplatelet agent or anticoagulation.
Benefits of Mild Body Exercises in Parkinson's Disease

The purpose of this study is to learn the effects of two mild body exercises on quality of life, non-motor symptoms, anxiety, depression, fatigue, sleep quality, cognition, and executive function on people with Parkinson's Disease (PD).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD
* Currently taking levodopa with some improvement in motor symptoms, and on a stable dose for a minimum of 4 weeks prior to starting the study
* Hoehn \& Yahr stage I to III (mild to moderate PD)

Exclusion Criteria:

* Mini Mental State Examination (MMSE) score \< 24
* Central neurological diseases other than PD or prior major head trauma with loss of consciousness, including other forms of parkinsonism, uncontrolled or significant cardiovascular diseases, orthopedic or medical problems that would interfere with gait
* Being primarily wheelchair bound
* Deep brain stimulation
* Expected change in PD medications over the course of the study
* Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia.
Detection Medication Administration Errors Using Bar-code and RFID Technology (DREAM)

Serious medication administration errors are common in hospitals. Various interventions were developed to help prevention of such errors such as bar-code technology. Investigators aimed to study the effect of bar-code-assisted medication administration (BCMA) system on the rate of medication errors in two hospitals.

They will conduct a randomized controlled trial in 6 care units of two hospitals in Paris, France. Each unit will be randomized in either the control group or the intervention group using the bar-code system to help drug administration. The observation method will be used to evaluate the error rates in the 2 groups at baseline and when BCMA will be implanted. Nurses of the unit will be randomized to determine who will be observed during the administration rounds.

Considering the results of a passed observational study in 4 units (Berdot, BMC Health Serv Research 2012) and the results of the study by Poon and al. (NEJM 2010), investigators estimated that 5.981 TOE (Total Opportunities for Errors) are needed to detect a relative reduction of 45% of error rate.

The ADIM system (Aide a la Distribution Informatisee des Medicaments) consists of 2 machines with photographic reconnaissance and readers: one for preparation assistance that can be placed at the pharmacy or in the clinical service and one to assist the administration by the nurse in the clinical service.

The system ADIM preparation consists of a working area with 2 reader devices (a RFID reader and a bar code reader) and a touch screen . It allows selection from the list of patients, the patient's prescription for which the preparation will be made. It is linked to the drug data base.

The system ADIM administration is composed of a laptop with touch screen, 2 readers (a RFID reader and a barcode reader) , the elements needed to care and a work plan and drawers containing unit dose drugs for patients for a specific nurse. The nurse scans her/his badge, the patient's wristband and each dose administered and prepared by the pharmacy. If the dose is not prepared by the pharmacy, the nurse takes the dose in the automat cabinet. The nurse scans the drug's barcode or select on the touch screen the drug and the required dose of the drug. In case of discrepancy with the prescription, there is a visual alert. However, the alert can be override by the nurse if she/he gives a justification.

Eligibility Criteria:
Inclusion Criteria:

* Nurses of the 6 care units who have drugs to deliver during medication administration rounds will be included

Exclusion Criteria:

* Nurses who refuse to be observed during medication administration rounds and nurses replacement that did not work usually in the studied units will not be included.

Medication administrations during emergencies (e.g., cardiopulmonary resuscitation) will also be excluded from this study.
Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

The treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on Day 90 (+ 7 days). Participants who did not complete the treatment period also entered the follow-up period. It was also possible that participants did not enter the follow-up period, e.g. due to withdrawal of consent or termination of study participation.

Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 40 years or more
* Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:

  * Heart failure, New York Heart Association (NYHA) class III or IV
  * Active cancer
  * Acute ischemic stroke
  * Acute infectious and inflammatory diseases, including acute rheumatic diseases
  * Acute respiratory insufficiency
  * Additional risk factor for VTE, including reduced mobility

Exclusion Criteria:

* Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
* Conditions that may increase the risk of bleeding, including intracranial hemorrhage
* Required drugs or procedures which may interfere with the study treatment
* Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
* General conditions in which subjects are not suitable to participate in the study