cyrilzakka/clinical-trials huggingface dataset:
Restylane Defyne for Correction of Chin Retrusion

This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.


Eligibility Criteria:
Inclusion Criteria:

1. Participated with signed and dated informed consent form.
2. Men or women aged 18 years of age or older of Chinese origin.
3. Subjects who were seeking augmentation therapy for chin retrusion.
4. GCRS score of 1 or 2 as assessed by the Blinded Evaluator

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.
2. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
3. History of severe or multiple allergies, manifested by anaphylaxis.
4. Previous facial surgery, or tissue revitalization treatment with laser or light, needling, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion below the level of the horizontal line from subnasale within 6 months before treatment.
5. Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
6. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the horizontal line from subnasale.
7. Other condition that was preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects

This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).

Subjects with measurable disease will be assessed for response after every 2 cycles of therapy using RECIST 1.1 criteria. In addition, progression free survival (PFS), overall survival (OS) and exploratory biomarkers, imaging, and thrombotic risk parameters will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18
* Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously treated with systemic chemotherapy
* Evaluable disease by clinical or radiographic parameters
* No history or concomitant malignancy
* Adequate organ and marrow function
* Female subjects with negative urine or serum pregnancy
* ECOG must be 0 or 1

Exclusion Criteria:

* Squamous cell, small cell, or mixed histology
* Known history of bleeding diathesis or coagulopathy
* Cavitary tumors or tumors invading or abutting large blood vessels
* Any history of thromboembolic events
* Ongoing therapy with oral or parenteral anticoagulants
* Major surgery within 4 weeks of Day 1 of treatment
* Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease)
* any history of significant vascular disease
* Congestive heart failure
* History of any condition requiring anti-platelet therapy
* Serious non healing wound
* Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis
* Unable or unwilling to discontinue use of prohibited medications
* D-dimers \>2 x ULN as measured on 2 separate occasions at least 1 day apart
Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery

This is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery.

The schedule consists of four visits: screening (visit 1); pre-anesthetic evaluation and randomization (visit 2); treatment (visit 3) and discharge from study (visit 4).


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Both sexes
* Age between 18 and 80 years, inclusive
* ASA category I or II
* Indication of spinal anesthesia for varicose vein surgery in lower limbs with a maximum duration of 3 hours.

Exclusion Criteria:

* Contraindications to spinal anesthesia
* Hypersensitivity or intolerance to local anesthetics or to the components of formula
* Use of any anticoagulant, regardless of type until 60 days before entering the study
* Spinal cord injuries, peripheral neuropathies or any other neurological conditions leading to sensory and / or motor disorders
* Dementia, mental retardation and other major cognitive changes
* Obesity with body mass index (BMI) \> 30 or difficulty in performing the puncture
* Anatomical difficulty in the spine in the opinion of the Investigator that can make puncture difficult
* Any previous surgical intervention of the spine
* Tattoo at the puncture site
* Participants with a history of alcohol or illicit drug abuse, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th edition
* Pernicious anemia
* History of severe anaphylactic reactions or Steven-Johnson disease
* Changes in safety exams (applicable at the time of randomization):

  * International Normalized Ratio ≥ 1.4
  * Hemoglobin \< 10 g / dL
  * Platelet count \<100,000 / mm3
  * Glycemia\> 200 mg / dL
  * Bradyarrhythmias: heart block with clinical repercussion in the investigator's opinion
  * Maximum of eight ventricular extrasystoles per minute, evident on the ECG
* Pregnancy or lactation
* Any other condition that, in the opinion of the Investigator, may lead to an increased risk for the participant.
Treatment of Post Sphincterotomy-bleeding by Epinephrine-injection Versus Insertion of an Plastic Stent

Post sphinterotomy-bleeding (PSB) occurs in 1-2 % of Endosocpic Retrograde Cholangiopancreaticography (ERCP) and usually needs no blood transfusion after endoscopic therapy but can be life-threatening in some rare cases.

There are no prospective comparative studies concerning the endoscopic treatment of PSB due to the rarity of the incident.

Insertion of an endoprosthesis in the common bile duct may be more effective than Epinephrin-injection into the papilla which is the therapy of first choice.

A retrospective single centre analysis on both used methods over a study period of 16 years shall be performed.

Post sphinterotomy-bleeding (PSB) occurs in 1-2 % of Endosocpic Retrograde Cholangiopancreaticography (ERCP) and usually needs no blood transfusion after endoscopic therapy but can be life-threatening in some rare cases.

The increasing use of antiplatelet and/or anticoagulant therapies enhances the risk of PSB.

There are no prospective comparative studies concerning the endoscopic treatment of PSB due to the rarity of the incident.

Insertion of an endoprosthesis in the common bile duct may be more effective than Epinephrin-injection into the papilla which is the therapy of first choice.

A retrospective single centre analysis on both used methods over a study period of 16 years shall be performed.

In detail, clinical success and safety of the procedure, re-bleeding rate, number of re-interventions and days of hospital stay will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Post sphincterotomy bleeding (PSB) of the papilla (time frame: from procedure up to ten days after the procedure)
* Treatment of PSB by epinephrine-injection or insertion of a plastic stent into the common bile duct

Exclusion Criteria:

* Pregnant and/or lactating women
* Complete patient record is not available
Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease

Based on meta-analysis of prokinetics trials in laryngopharyngeal reflux disease (LPRD) (Glicksman et al. 2014), well designed study was performed in 4 articles. But, those studies had several problems including inclusion criteria, randomization methods, and placebo medication. They had similar results that prokinetics and proton pump inhibitor (PPI) had synergistic effect for management of LPRD. Therefore, the aim of study is to evaluate the efficacy of prokinetics as an additional medication to proton pump inhibitor by well designed randomized double blind case-control study.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 65 years
* Reflux Symptom Index (RSI) \> 7 and, Reflux Finding Score (RFS) \> 13

Exclusion Criteria

* Taken proton pump inhibitor within 3months
* Taken steroid within 3months
* Pregnancy
* Breast feeding
Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test

Clinical methods are fundamental in probing the DW. They must be supported by strict BIA protocols. REST appears to be a (the) brilliant solution in solving the old problem of DW in HD patients

Probing the dry weight (DW) was largely dependent on clinical subjective estimates until recently. New bedside non-invasive tools have been developed with the aim of providing more objective information on volume status and guiding physicians in the quest for DW. Among them, bioimpedance (BIA) appears to be very promising.

Very recently, a BIA test aimed at assessing DW in hemodialysis (HD) patients has been developed, the "REsistance Stabilization Test" (REST). It is called BIA DW. Its rationale is based on the achievement of the flattening of the curve of the ratio R0/Rt (R0 is resistance at time 0 and Rt is resistance at a given time t during the HD session) of less than + 1% over 20 minutes in the presence of ongoing ultrafiltration.

Study protocol: the Clinical DW is the gold standard by definition. It is determined under strict clinical surveillance by the same attending physician. She/he will be helped by a clinical score of volume state about symptoms and signs of hypo- or hypervolemia. Then, this Clinical DW will be compared with BIA DW, as obtained after performing REST

Eligibility Criteria:
Inclusion Criteria

* stable uremic patients
* thrice weekly hemodialysis treatment
* start of hemodialysis treatment since at least 3 months

Exclusion Criteria

* overt edema
* liver cirrhosis
* cardiac failure
* serum albumin \< 3g/dl
* pregnancy
* metallic implants or a pacemaker
* limb amputation
Tomotherapy for Refractory Brain Metastases

This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT; the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc; KPS ≥60,or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas; Age: 18-75 years old;

Adequate end-organ function:

WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤ 1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range.

Exclusion Criteria:

* • Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia).

  * Unable or unwilling to comply with the study protocol.
  * The expected survival time is less than 3 months.
  * Patients who are anticipated in other clinical trials of brain metastases.
  * Patients who has been treated with SRT in other hospitals
  * Pregnant patients or female patients whose HCG is positive
  * Unsuitable to participate in study, that in the opinion of the treating physician.
Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training

The purpose of this study is to determine whether a comprehensive, individualized management approach with caregiver training and medication with memantine will alleviate symptoms in community dwelling patients with moderate to severe Alzheimer's disease.

Presently some 4.5 million people are afflicted with Alzheimer's disease in the United States. At present pharmacologic treatment, although beneficial, is not curative. Certain nonpharmacologic treatments have assisted caregivers of AD patients by reducing their stress and burden, and others have aided patients, by improving their mood and physical functioning. Comprehensive, individualized approaches to improving Alzheimer's patients' symptomatology and caregiver stress and burden have not been systematically investigated in Alzheimer's patient care. This study seeks to train and counsel caregivers as well as develop an individualized, comprehensive management program that will seek to enhance the functioning of each patient participant.

Patients are randomly placed into one of two groups. Both groups receive memantine and comprehensive evaluations at baseline, 4, 12,28 and 52 weeks. Additionally, group 1 receives an individualized management program, which consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.

Eligibility Criteria:
Inclusion Criteria:

* Patients, 50 years of age or greater, residing in the community
* Presence of a family and/or professional caregiver willing and able to participate in all aspects of this study
* A diagnosis of probable Alzheimer's disease by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) and NINCDS-ADRDA (McKhann,et al., Neurology,1984;34: 939-944) criteria
* A CT or MRI brain scan and medical work up compatible with the DSM-IV and NINCDS-ADRDA diagnostic criteria for Alzheimer's disease
* Mini-Mental State Examination scores of 3-14
* Global Deterioration Scale stages of 5 or 6
* A stage of 6a or greater on the Functional Assessment Staging instrument signifying the presence of dementia deficits in the ability to perform one or more basic activities of daily living

Exclusion Criteria:

* Non-English speaking patients and/or caregivers
* Subjects with a diagnosis of dementia due to conditions other than Alzheimer's disease.
* Subjects with a diagnosis of vascular dementia or a score greater than 4 on the modified Hachinski Ischemic Rating scale
* Patients with a major depressive disorder
* Patients with clinically significant laboratory abnormalities
* Patients receiving investigational pharmacologic agents
Oral Mucosal Lesions Among Smokers in an Egyptian Population.

This cross-sectional study will assess the prevalence of oral changes among smokers in an Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo University), aiming that this study can serve as a baseline for future studies with the goal of finding ways to improve oral health and increase awareness of the hazards of smoking in Egypt

The participants will be selected from the pool of the Clinics of Oral Medicine, Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry - Cairo University. For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

Eligibility Criteria:
Inclusion Criteria:

* Gender: males and females.
* Age: all age groups.
* Smokers.
* Individuals who agreed to sign the informed consent.

Exclusion Criteria:

* Individuals suffering from any systemic disease.
* Individuals on medications.
* Non-Egyptians.
Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap

To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC) patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end caps.


Eligibility Criteria:
Inclusion Criteria:

* All patients dialyzing with a central venous catheter

Exclusion Criteria:

* Known allergy to chlorhexidine
Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.


Eligibility Criteria:
Inclusion criteria:

* Meeting diagnosis criteria for acute arthritis of primary gout.
* Start of acute gout flare within 5 days prior to study visit 1
* History of ≥ 3 gout flares within the 12 months prior to study start
* Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines

Exclusion criteria:

* Requirement for administration of antibiotics against latent tuberculosis (TB), e.g., isoniazide
* Refractory heart failure (Stage D).
* Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
* Secondary gout, chemotherapy induced gout, lead induced gout and transplant gout
* Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis

Other protocol-defined inclusion/exclusion criteria may apply
Impact of Sleep Apnea on Sepsis Mortality

By clinical record review, this retrospective study aims to compare the mortality of sepsis patients with versus without obstructive sleep apnea, who were diagnosed and treated in Taipei Veterans General Hospital, Taiwan.

This retrospective study aims to compare the mortality of sepsis patients with versus without obstructive sleep apnea (OSA). Patients with a diagnosis of sepsis, who had received a prior polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017 will be enrolled. Obstructive sleep apnea (OSA) is defined by an apnea-hypopnea index at least 5/hr with compatible symptoms. Their clinical record will be reviewed and data including demography, polysomnography and details related to sepsis (source of infection, number of organ dysfunction at initial diagnosis of sepsis and survival time) will be collected. The start of the survival time (follow-up time) is the date when sepsis is diagnosed. The end of the survival time (follow-up time) is the date of death or end of hospitalization (date of discharge). Survival analyses will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who received received a polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017
2. Patients who were admitted with a diagnosis of sepsis after the polysomnography
3. The diagnosis of sepsis fulfilling the clinical criteria

Exclusion Criteria:

1. Younger than 20 years
2. Not compatible with a definition of sepsis
3. subjects with incomplete data
Outcomes in Hepatitis C After Living Donor Liver Transplantation in Association With Interleukin 28 B

Hepatitis C is the leading cause of liver transplants in the USA. Given that there is a national organ shortage, living donor liver transplantation has became a viable option for patients with end stage liver disease who are not severely ill. Recently particular polymorphisms of IL-28B gene were reported to correlate with histological recurrence and antiviral treatment response after orthotopic liver transplantation for hepatitis C. Similar results have not been described yet in living donor liver transplant patients.

There is data suggesting slightly inferior outcomes in living donor liver transplants when done for hepatitis C. The investigators postulate that such inferior outcomes may be related to IL28 polymorphism concordance (i.e., unfavorable recipient polymorphism patients receive similarly unfavorable polymorphism livers from their relatives).


Eligibility Criteria:
Inclusion Criteria:

* Patients who received a living donor liver transplant for chronic hepatitis C who are 18 year or older
* Patients who donated part of their liver to patients suffering from chronic hepatitis C. Donors must be 18 years or older

Exclusion Criteria:

* Patients who are not willing to sign the consent
* Inability to obtain liver specimen (recipients)
* Inability to obtain blood sample (donors)
Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home.

Single-center, prospective pilot study on patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. The objective is to assess the satisfaction of remote monitoring of patients on non-invasive ventilation after 12 months.

The non invasive ventilation is one of treatments used during the amyotrophic lateral sclerosis when patients have a chronic respiratory failure with alveolar hypoventilation signs. It is demonstrated to improve quality of life and prognosis of the disease. These patients, often severely disabled, generally have a negative experience of repeated hospitalizations. Despite everything, medical and paramedical monitoring is necessary, especially when they are fitted with non invasive ventilation (NIV). A quarterly reassessment is recommended . The possibilities of telemonitoring at home have grown considerably in recent years. In addition, the fans are currently able to remotely transfer a certain amount of data to the service provider, making remote monitoring feasible.Our project therefore aims to assess the feasibility of remote monitoring of patients with Amyotrophic Lateral Sclerosis (ALS) fitted with non invasive ventilation (NIV) through the assessment of their satisfaction, using both medical data and data provided by the ventilator. It is a single-center, prospective pilot study on 30 patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. Patients will benefit from a quarterly teleconsultation to assess the study criteria through questionnaires during 12 months. Ventilation machines make it possible to carry out remote monitoring, with the help of healthcare providers.

Eligibility Criteria:
o inclusion criteria:

* Patient over 18 years,
* Patient with Amyotrophic Lateral Sclerosis (ALS),
* Already fitted by Non Invasive Ventilation (NIV),
* Patient having signed the informed consent
* Patient affiliated to a social security scheme,
* Patient with a correct understanding of the French language,
* Patient with access to an internet connection at home.

For the caregiver:

* Adult person
* Be the patient's primary caregiver
* Have signed the informed consent intended for the caregiver

  o exclusion criteria:
* Patient with another cause of chronic respiratory failure: other neuromuscular diseases, Chronic obstructive pulmonary disease (COPD), diffuse interstitial lung disease,
* Patient under guardianship or under judicial protection,
* Patient dependent at least 20 hours out of 24 of the non invasive Ventilation (NIV).