cyrilzakka/clinical-trials huggingface dataset:
Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery

This is a non-interventional, multicenter, post-marketing registry study in three patients with moderate or severe hereditary FX deficiency, to assess Coagadex administered peri-operatively for hemostatic cover in major surgery during routine post-marketing use.

The primary objective is to collect additional surgical data on the clinical effectiveness of Coagadex, in a post-marketing environment, for peri-operative hemostatic cover during major surgery in patients with moderate or severe hereditary factor X (FX) deficiency.

The secondary objective is to review safety data on Coagadex through the collection of any Adverse Drug Reactions (ADRs) from the first dose of Coagadex in the hospital prior to the surgical procedure until the first follow-up after discharge (i.e., follow-up completed) and Serious ADRs up until the post-operative care follow-up has been completed. Data on any deaths and pregnancies reported within this time period will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>12 years of age with severe or moderate hereditary FX deficiency. Severe is defined as \<1 IU/dL and moderate as 1 to 5 IU/dL (3)
* Patients who have given written informed consent (for sites in the USA this will include the Health Insurance Portability and Accountability Act (HIPAA) authorization statement), OR, in the case of 12-18 year olds, written informed consent from the parents/ guardians and where appropriate assent from the child
* Patients requiring major surgery. Major surgery is defined as procedures typically requiring:

  * full anesthesia or regional anesthesia, e.g. epidural or spinal and
  * involving the opening of major cavities such as thoracic, abdominal surgery; orthopedic surgery, and Caesarean section (C-section) and
  * requiring at least one overnight stay in hospital (16)

Exclusion Criteria:

* Patients known to be pregnant, unless the surgery is C-section.
* Patients who participated in a clinical study trial in the last 30 days prior to study enrolment, except if they have been involved in another study involving Coagadex.
* Patients with a known history of inhibitor development to FX.
* Patients who are required or expected to take other factor X-containing medications during or after surgery.
* Patients with existing known thrombocytopenia (platelets \< 50 x 109/L).
* Patients with existing known clinically significant renal disease (creatinine \>200 µmol/L).
* Patients with existing known clinically significant liver disease (ALT levels greater than three times the upper limit of normal).
* Patients with existing known other coagulopathy or thrombophilia.
* Patients with a known intolerance or allergy to Coagadex or its excipients.
* Patients known to have abused chemicals or drugs within the past 12 months.
* Patients with a history of unreliability or non-cooperation.
Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth.

The clinical trial aim to evaluate clinical effectiveness of self-adhesive composite hybrid (Surefil one) versus conventional composite(VOCO Grandio) as restorative material for carious primary teeth.

Composite resin is a continuous improving material as its full fill many requirements seeking in dental restorative materials, but is the new introducing composite resin material is always better than the previous one? This randomized clinical trial is performed to discus and assess that hypothesis. A total of 120 class I restoration(60 Surefil one novel self-adhesive composite hybrid \& 60 VOCO Grandio conventional composite resin) will be placed in posterior teeth of 60 volunteers(splint mouth design) following the manufacturer instruction. age between 4-7 years. The restorations will then be evaluate clinically at baseline, 3, and 6 month intervene. Both the procedure and follow up will done in the out-patient clinic, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.

Eligibility Criteria:
Inclusion criteria:

Children:

Good general health and medically free patients. Age ranges: from 4-7 years old. A provided informed consent by the parents. Acceptable child cooperation.

Teeth:

Class I carious primary teeth. 2 contralateral or adjacent carious teeth. Simple caries, extending to the dentin. No singe or symptom of pulp inflammation. Normal radiographic examination.

Exclusion Criteria:

Children:

Unable to attend follow-up visits. Refusal of participation.

Teeth:

Symptom tooth. Periapical Pathosis. Mobile primary tooth.
Ultra Curto (Ultra Short) TB Prevention Therapy

To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.

Tuberculosis (TB) is the leading infectious killer globally and a major cause of illness and suffering. The World Health Organization has prioritized TB preventive therapy (TPT) for people with latent TB infection (LTBI) as a key strategy for controlling the epidemic. Prevention of TB with isoniazid preventive therapy (IPT) is effective and reduces morbidity and mortality, and has been the mainstay of TB prevention for decades. But for an intervention with an excellent evidence of efficacy, global uptake has been abysmal. Completion rates for IPT when it is administered are poor (Gillespie 2008; Durovni 2010), with a large proportion of patients unable to complete treatment (McClintock 2017; Sterling 2011). While uptake is influenced by a variety of factors, a critical element has been the duration of IPT, with adherence falling sharply over time in clinical trials and practice. Shorter course regimens have a much higher completion rate and are more acceptable to patients, clinicians, and programs.

Eligibility Criteria:
Inclusion Criteria:

* Positive tuberculin skin test or interferon-gamma release assay (IGRA) test and
* Household contact of an infectious TB case within previous 90 days, defined as sleeping at least once in a residence with a person diagnosed with pulmonary TB, or
* Documented conversion of Tuberculin skin test (TST)/IGRA from negative to positive within 2 years

Exclusion Criteria:

* Documented HIV infection
* Evidence of active tuberculosis on clinical exam or chest x-ray
* Known intolerance of any study drug
* Treatment for active or latent TB in the past for more than 14 days
* Known close contact to someone with INH or rifampin resistant TB
* Active liver disease or Aspartate aminotransferase(AST)/Alanine transaminase (ALT) \>3 times upper limit of normal (ULN)
* Neutropenia (ANC \<1000)
* Peripheral neuropathy \>Grade 1 by DAIDS Grading Table
* Pregnant or breastfeeding. Women of childbearing potential must agree to use non-hormonal contraception during study treatment.
* Weight \<40 kg
Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects

The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV gentotype-1 in chronically infected subjects and to further evaluate the safety profile of EDP239.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have chronic genotype-1 hepatitis C virus infection and plasma HCV-RNA ≥ 105 IU/mL at the time of screening.
* Subjects must have chronic HCV infection as determined by any of the following:
* be anti-HCV (+) for at least 6 months per subject history or medical records
* an anti-HCV test, viral load, or genotype \> 6 months ago
* In the setting of a recent positive anti-HCV test (\< 6 months), liver biopsy demonstrating chronicity
* Subjects must have IL-28b genotype "CC"
* Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days (for small molecules) whichever is longer; or longer if required by local regulations.
* Previous treatment, including the use of any investigational agents, for the treatment of HCV infection.
* Women of child bearing potential.
* Subjects with IL-28b genotype "CT or TT".
* ALT γ-GT, and AST must be below 5 x the upper limit of normal (ULN).
* Serum bilirubin must not exceed ULN.
* The PT (INR) must be within normal limits.
* If necessary, laboratory testing may be repeated on one occasion (as soon as possible) prior to randomization, to rule out any laboratory error.
* Use of drugs that inhibit or induce CYP3A4.
Impact of Artificial Intelligence (AI) on Adenoma Detection During Colonoscopy in FIT+ Patients.

The Italian screening program invites the resident population aged 50-74 for Fecal Immunochemical Test (FIT) every 2 years. Subjects who test positive are referred for colonoscopy. Maximizing adenoma detection during colonoscopy is of paramount importance in the framework of an organized screening program, in which colonoscopy represent the key examination. Initial studies consistently show that Artificial iIntelligence-based systems support the endoscopist in evaluating colonoscopy images potentially increasing the identification of colonic polyps. However, the studies on AI and polyp detection performed so far are mostly focused on technical issues, are based on still images analysis or recorded video segments and includes patients with different indications for colonoscopy. At the best of our knowledge, data on the impact on AI system in adenoma detection in a FIT-based screening program are lacking. The present prospective randomized controlled trial is aimed at evaluating whether the use of an AI system increases the ADR (per patient analysis) and/or the mean number of adenomas per colonoscopy in FIT-positive subjects undergoing screening colonoscopy. Therefore Patients fulfilling the inclusion criteria are randomized (1:1) in two arms: A) patients receive standard colonoscopy (with high definition-HD endoscopes) with white light (WL) in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination; B) patients receive colonoscopy examinations (with HD endoscopes) equipped with an AI system (in both insertion and withdrawal phase); all polyps identified are removed and sent for histopathology examination. In the present study histopathology represents the reference standard.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult (50-74 yrs.) outpatients undergoing colonoscopy in the frame of the FIT-based screening program.

Exclusion Criteria:

* patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
* patients with inadequate bowel preparation
* patients in which cecal intubation was not achieved or scheduled for partial examinations
* patients with gastrointestinal symptoms
* polyps could not be resected due to ongoing anticoagulation preventing resection and pathological assessment
Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

Therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging survival and improving the quality of life. The objective of this trial is to assess if an initial chemotherapy followed by an endocrine therapy leads to a longer disease-free interval as compared to chemotherapy alone.


Eligibility Criteria:
Inclusion criteria

* Histologically proven metastatic breast cancer
* Measurable disease, patients with bone only disease are not eligible
* Age ≥ 65 years
* Performance status ≤ 2 (World Health Organization)
* Estimated life expectancy under therapy of at least 3 months
* Estrogen-/progesterone-receptor status positive or unknown
* Signed informed consent

Exclusion criteria

* Prior chemo- or hormone therapy for metastatic breast cancer; prior therapy with aromatase inhibitors in the adjuvant setting
* Disease-free interval after adjuvant therapy \< 1 year
* Clinical signs of central nervous system metastases
* Renal, bone marrow, or liver insufficiency
* Severe coronary heart disease, cardiac insufficiency or other severe concomitant internal diseases
* Pulmonary fibrosis/alveolitis Additional protocol-defined inclusion/exclusion criteria may apply.
Laryngeal Motor Evoked-potentials as a Biomarker of Vagus Nerve Stimulation in Epileptic Patients

The goal of this study is to record and characterize larynx evoked motor potentials induced by vagus nerve stimulation. This study will include 10 adult patients implanted with a Vagus nerve stimulator, followed at the Center for Refractory Epilepsy at Cliniques St Luc. The inclusion criteria are: (1) patient aged between 18 and 65 years ; (2) cervical VNS device (Cyberonics, Houston, TX, USA) implanted for at least 6 months, (3) normal electrode impedance of the electrode. Exclusion criteria are (1) presence of a concomitant laryngeal pathology or recurrent laryngeal nerve damage, independent from VNS ; (2) important VNS side effects reported by the patient, such as severe dyspnea (grade III-IV) or severe pain in the neck/ear region.


Eligibility Criteria:
Inclusion Criteria:

* patients aged between 18 and 65 years
* Vagus nerve stimulation implanted for at least 6 months
* No impedance issues with the VNS electrode

Exclusion Criteria:

* presence of a concomitant laryngeal pathology or RLN damage, independent from vagus nerve stimulation
* important side effects of the VNS reported by the patient such as dyspnea, pain in neck/ear region and gastrointestinal complaints.
A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide

The purpose of this study is to identify how certain parts of the brain that help control body weight respond to an infusion of hormones called leptin and amylin.

Following an overnight fast, subjects will undergo fMRI measurements of the hypothalamus, brainstem and whole brain during an infusion of either normal saline, pramlintide, leptin, or the combination leptin and pramlintide.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 year to 45 years of age
* MI 18 to 25 kg/m2 or ≥ 30 kg/m2
* At maximal lifetime weight
* Weight stable for at least 3 months

Exclusion Criteria:

* Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
* Subjects taking psychiatric or centrally-acting (CNS) medications or who are diagnosed with a psychiatric or neurological illness, including:

  * depression
  * anorexia
  * bulimia
  * seizure disorder.
* Exercise \> 30 minutes, 3 times a week
* Alcohol consumption \> 2 drinks / day
* Weight \> 350 lbs (159 kg) (weight limit for MR machine)
* Illicit drug use
* Pregnancy
* Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate or fat intakes
* Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips
* Those with claustrophobia
* Anaphylaxis and known hypersensitivity to E. coli-derived proteins
* Allergies or contraindications to metreleptin or pramlintide
* Renal or hepatic impairment
* Women who are lactating
* Tobacco use
Ultra-long Acting Bronchodilator Therapy in Asthmatics

Asthma is a common condition which produces a significant workload for general practice, hospital outpatient clinics and inpatient admissions. Asthma is caused by inflammation of the airways which irritates the muscles around the airways causing them to constrict. The mainstay of asthma treatment is inhaled steroids. If the patients' symptoms are still not adequately controlled, then a long-acting beta agonist (LABA) inhaler which relaxes the muscles in the airways and opens it up is frequently added to the inhaled steroids. Despite this, a substantial proportion of asthmatic patients still do not achieve adequate control of their symptoms. Recent studies have shown when an alternative inhaler called a long-acting muscarinic antagonist (LAMA) is added to a LABA - it reduced the number of asthma exacerbations (flare-ups) and improved airway narrowing.

The mannitol challenge is a test of airway 'twitchiness', an important feature of asthma. There have been no previous studies assessing the combined effects LABA and LAMA inhalers on mannitol challenge. The mannitol challenge is particularly relevant as it mimics stimuli encountered in real life which provoke an asthma attack.

The investigators propose to directly compare indacaterol, a new once-daily LABA with indacaterol plus tiotropium, a once-daily LAMA, as add-on treatment to inhaled steroids in persistent asthmatics using the mannitol challenge. The investigators hope that this study will help us understand how the combination of a LABA and LAMA might help protect against flare-ups.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers aged at least 16 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms of beclomethasone dipropionate or the equivalent
* FEV1 \> 50 % predicted
* Mannitol PD15 \< 635 mg
* Ability to give informed consent
* Agreement for their general practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being

Exclusion Criteria:

* Other respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis or allergic bronchopulmonary aspergillosis
* An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 3 months of the study commencement
* Any clinically significant medical condition that may endanger the health or safety of the participant
* Smoking within one year or \>10 pack year history
* Participation in another trial within 30 days before the commencement of the study
* Pregnancy or lactation
* Unable to comply with the procedures of the protocol
Feasibility of Continuous Sleep Recording in Patients Undergoing Deep Brain Stimulation for Parkinson's Disease

This pilot study aims to assess a new device designed for an objective measure of sleep parameters. The purpose of the device is to assess, in a more simple and precise way, the impact of deep brain stimulation on patient's sleep.


Eligibility Criteria:
Inclusion Criteria:

* patient \> 18 years old
* with Parkinson disease
* scheduled for implantation of electrodes for deep brain stimulation

Exclusion criteria:

* pregnant or breast feeding patient
* refusal to participate in the study
* patient under legal protection
* no health insurance coverage
The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections

The primary purpose of this study is to asses the effect of caudal epidural injection guided by a combination of ultrasound and fluoroscopy on the duration of the procedure and the amount of radiation exposed during the procedure, compared to the application of only fluoroscopy-guided.

Secondary aims are to reveal the presence of structural variations that prevent injection by examining the morphology of the sacral hiatus by ultrasonography.

The study was designed as prospective, randomized, controlled trial. The patients who meet the eligibility requirements will be randomized into two groups in a 1:1 ratio to fluoroscopy and ultrasound+fluoroscopy. Before the procedure, all patients will be scanned with ultrasonography to examine the caudal region morphology.

Processing time will be recorded during injection. "Fluoroscopy time" (sec) and "kerma-area product" (μGy) automatically measured by the fluoroscopy device will be used to evaluate the radiation exposure.

Pre-procedural visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) values were noted all the patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged\> 18 years
* Participation in the study voluntarily
* Diagnosis of radiculopathy caused by spinal stenosis or disc herniation after physical examination and imaging (BT or MRI)

Exclusion Criteria:

* Cauda equina syndrome or rapidly progressing neurological deficit
* previous spine surgery
* local site infection
* history of allergy to local anesthetic and contrast agents
* acute or chronic unstable medical disease
* psychiatric illness
* anticoagulant therapy
Endoscopic Screening on Esophageal Cancer

Importance: There are no global screening recommendations for esophageal squamous cell carcinoma (ESCC). Endoscopic screening has been investigated in high incidence areas of China since 1970's. But up until now there no apparent evidence that would lead to a reduction in disease morbidity and mortality.

Objective: To evaluate whether endoscopic screening and early intervention program could reduce the incidence or mortality of ESCC.

Design: Community-based, controlled cohort study among 45 386 residents, Endoscopy screening was completed from November 1999 to May of 2000. Subjects in intervention group were examined once during intervention period. The study follow-up concluded in December 2009.

Setting: High risk area of ESCC in China

Participants:Cluster sampling from communities with high rates of esophageal cancer. A set of villages with was selected as the study intervention community. Age 40 to 69 years residents were selected as an eligible population. Another set of villages was select as the control population. Buffer villages were set up between intervention and control group.

Intervention: Endoscopy with Lugol's iodine staining and early treatment on precancerous lesions was undergone for the intervention group.

Main Outcome(s) and Measure(s): Incidence and mortality ESCC


Eligibility Criteria:
Inclusion Criteria:

* local residents
* Men and women aged 40 to 69 years
* no contraindications for endoscopic examinations (e.g. history of reaction of iodine or lidocaine), and who were mentally and physically competent to provide written informed consent.
* informed consent

Exclusion Criteria:

* Not local residents
* age younger than 40 yrs and older than 69 yrs
* History of reaction of iodine or lidocaine
* contraindications for endoscopic examinations