cyrilzakka/clinical-trials huggingface dataset:
Postoperative Pain of Root Canal Therapy With Three Techniques

The purpose of this prospective, randomized, double-blind study was to compare the prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical lesion using three different instrumentation files: Hand, Protaper Universal, and Wave-One files.

ProTaper Universal system is one of the conventional multi-file rotary systems that prepared root canals with six files: three shaping files and three finishing files. A unique design element is varying tapers along the instruments' long axes. The three shaping files have tapers that increase coronally, and the reverse pattern is seen in the five finishing files. Wave-One is reciprocation-based systems that instrumented root canals with only single file. Some studies demonstrated that it has outperformed conventional continuous rotary nickel-titanium (NiTi) preparation in some aspects. The reciprocating motion of Wave-One relieves the stress on the file by special counterclockwise (cutting action) and clockwise (release of the instrument) movements and, therefore, extends the durability of a NiTi instrument and increases its fatigue resistance in comparison with continuous rotation motion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patient

Exclusion Criteria:

* Allergy to anesthetics, pregnancy, breastfeeding, vital teeth, unrestorable teeth, and teeth associated with pain or swelling
Determinants of Penumbra in Acute Ischemic Stroke Patients

The purpose of the study is to examine the influence of demographic, clinical and laboratory characteristics on the presence and size of penumbra in acute ischemic stroke patients and to determine those of them which related significantly and independently to the presence and size of Penumbra. The examined factors will include demographic variables such as age, gender, ethnic background, vascular risk factors and medical history, clinical parameters such as time from stroke onset until arrival to the hospital, results of neurological evaluation by NIHSS and imaging findings, laboratory tests such as body temperature, blood pressure, glucose level, renal functions etc. and imaging findings - the presence and the size of collateral blood vessels, the state of carotid arteries (by CTA). The possible correlation between all this parameters and the presence and the size of penumbra as detected by CTP will be further examined.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke patients hospitalized in Rambam Health Care Campus between 2008-2010, and which have underwent neurological evaluation including NIHSS scale, Brain CT, CT angio and Ct perfusion.

Exclusion Criteria:

* Intracranial hemorrhage of any other brain condition
National Tunisian Registry of Valvulopathies (NATURE-VALVE)

The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \& ICH (International Conference on Harmonisation) requirements.


Eligibility Criteria:
Inclusion Criteria:

* Patients originated from Tunisia
* Signed informed consent
* Patients with at least one of the following conditions :

  1. moderate to severe native mitral and / or aortic and / or tricuspid native valve disease
  2. and / or a history of a previous percutaneous or surgical valve intervention
  3. and / or a history of infectious endocarditis

Exclusion Criteria:

* Congenital valve diseases not including bicuspid aortic valve
* Isolated pulmonary valvulopathies
Study to Assess Effect of Cyclosporine on the Blood Levels of Ticagrelor

The purpose of this study is to assess the effect of Cyclosporine on the blood levels of Ticagrelor.

A Single-Center,Open-Label,Randomized,3-Treatment,3-Period Cross-Over Study to Investigate the Potential Effect of Cyclosporine on the Pharmacokinetics, Safety, and Tolerability of Ticagrelor and the Effect of Ticagrelor on the Pharmacokinetics, Safety, and Tolerability of Cyclosporine.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated written informed consent prior to any study-specific procedures
* Healthy male subjects aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* A history of hemophilia, von Willebrand's disease, lupus anti-coagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding
* A personal history of vascular abnormalities including aneurysms; a personal history of severe hemorrhage, hematemesis, melena, hemoptysis, severe epistaxis, severe thrombocytopenia, intracranial hemorrhage, or rectal bleeding within 1 year
A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects

A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
* Body weight (at screening); ≥50.0 kg,\<80.0 kg
* BMI(at screening): ≥17.6,\<26.4

Exclusion Criteria:

* Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
* Received medication within 10 days before dose is administered or is scheduled to receive medication
* History of drug allergies
* Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study
* Concurrent or previous hepatic disease
* Concurrent or previous heart disease
* Concurrent or previous renal disease
BETERNet Notch Signaling and Novel Biomarkers for Barretts Esophagus

This research study hopes to identify new molecular markers in the tissue of Barrett's esophagus that will help physicians better understand and manage this condition. Patients undergoing an upper endoscopy will be asked to complete a gastroesophageal reflux disease (GERD) questionnaire, provide a blood sample and allow additional biopsies to be taken during the procedure.

This research study hopes to identify new molecular markers in the tissue of Barrett's esophagus that will help physicians better understand and manage this condition. Currently there is very little understanding as to how Barrett's esophagus develops and why some people with Barrett's esophagus go on to develop esophageal cancer. The purpose of this study is to develop a better understanding of how these processes occur. The investigators also hope to use the information from this study to identify new molecular markers that the investigators can use to better determine who will or will not go on to develop esophageal cancer. Patients who have been diagnosed in the past with Barrett's esophagus will be asked to participate. Patients without Barrett's esophagus will be asked to take part so that the investigators can compare tissue from patients without the conditions to those with the conditions.

Eligibility Criteria:
Inclusion Criteria:

For BE patients:

* History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal metaplasia with globlet cells on esophageal biopsies,
* BE length C1M1 or C0M2
* Age 18 years

Exclusion Criteria:

* History of gastric or esophageal surgery
* Inability to give informed consent
* Erosive esophagitis seen on upper endoscopy
* History of prior endoscopic therapy for BE 5 (for controls) History of intestinal metaplasia on previous esophageal, GE junction or cardia biopsies.
Safety and Efficacy of IBI306 in HeFH Patients

IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol (LDL-C) uptake. In the phase I study, IBI306 was shown to be safe and well tolerated. There was robust reduction in LDL-C, Apo(B), non-HDL-C and lipoprotein (a) in healthy subjects. This study is a randomized, double-blind, placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the efficacy and safety of a novel PCSK-9 anti-body, IBI306, in Chinese patients with heterozygous familial hypercholesterolemia.

The study plans to enroll 148 patients with heterozygous familial hypercholesterolemia. Subjects will maintain a low-fat diet and stable current lipid-lowering therapy for at least 4 weeks and will be randomized into different dose groups at a 1:1 ratio, followed by a 2:1 randomization double-blind treatment with subcutaneous IBI306 150 mg (n=49) or placebo (n=25) every two weeks; or subcutaneous injection of IBI306 450mg (n=49) or placebo (n=25) every four weeks. Treatment lasts for 12 weeks. After 12 weeks, each group enters a 12-week open-label treatment, in which IBI306 subjects continue to receive IBI306, and placebo subjects shift to receive IBI306. The primary endpoint is the percent change in LDL-C levels relative to baseline at 12 weeks. Secondary endpoints include changes in baseline lipid levels, drug safety, and immunogenicity at 12 weeks and 24 weeks. The exploratory endpoint is the population pharmacokinetic profile of IBI306 in Chinese subjects with heterozygous familial hypercholesterolemia. If necessary, the dose of IBI306 will be adjusted accordingly based on the results of the ongoing multi-dose escalation study. After the open period, the subjects will be given a safety visit for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria in order to be included in the study:

* Provide a signed and dated informed consent form
* Men or women 18 to 70 years of age at screening
* Weight ≥ 40 kg during screening
* Confirmed diagnosis of heterozygous familial hypercholesterolemia
* Maintain a low-fat diet and stabilize the current lipid-lowering therapy

Exclusion Criteria:

• Subjects who do not meet any of the following exclusion criteria cannot be included in the study:

* Patients diagnosed as homozygous familial hypercholesterolemia
* Dialysis or plasmapheresis performed within 4 months prior to screening
* History of liver transplant
* Subjects adjusted for treatment of statins, ezetimibe, niacin, omega-fatty acids within 4 weeks prior to screening
* New York Heart Association (NYHA) grade III or IV heart failure, or recent detection of left ventricular ejection fraction ≤ 30%
* Have serious cardiovascular, cerebrovascular, liver and kidney related diseases
A Trial Investigating the Accuracy and Precision of the BGStar® and iBGStar® Blood Glucose Meter in Subjects With Type 1 Diabetes

Due to continuing technological progress and better understanding of the needs for glucose monitoring, the performance requirements of blood glucose meters, primarily regarding their accuracy, are constantly debated and keep evolving as a consequence. Recently a discussion was initiated by the Food and Drug Administration (FDA) to improve the accuracy of BG meters in the point-of-care testing setting by asking for fulfilment of higher requirements.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
2. Male or female subjects aged 18-74 years (both inclusive).
3. Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months.
4. Body mass index 18.0-28.0 kg/m2 (both inclusive).
5. HbA1c ≤ 9.0 % by local laboratory analysis.

Exclusion Criteria:

1. Known or suspected hypersensitivity to lancet fingerpricks / needle injections.
2. Previous participation in this trial. Participation is defined as having performed at least one BG meter measurement as part of the study.
3. Receipt of any investigational medicinal product within 30 days before randomisation in this trial.
4. Formation of callus on the fingertips or any other skin condition that may hamper fingerprick blood sampling and/or insufficient capillary blood volume sampling (\< 50 μL) during test fingerprick(s).
5. Haemoglobin \< 8.0 mmol/L (male) or \< 6.4 mmol/L (female), total leukocyte count \< 3.0 x 109/L, thrombocytes \<100 x 109/L, serum creatinine levels ≥ 126 μmol/L (male) or ≥ 111 μmol/L (female), bilirubin \> 3x the upper limit of normal (ULN), and alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (γ-GT) \> 2 x ULN.
6. Suffer from or history of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or any clinically significant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), haematological, dermatological, venereal, -
Metabolism, Circadian Rhythms and Ovarian Function

Chemotherapy for cancer, due to its gonadotoxicity, can lead to impaired female fertility, resulting in the occurrence of transient or prolonged chemo-induced amenorrhea (CIA). According to recent data from the National Cancer Institute, 11.9% of women under the age of 40 diagnosed with cancer have been offered a fertility evaluation within five years of diagnosis. Predicting the risk and especially the duration of the CIA remains difficult. Known factors predicting a rapid return of menstruation are a young age at diagnosis, a low gonadotoxic treatment (absence of alkylating agents) and a high pre-chemotherapy blood level of AMH reflecting a large pool of growing follicles. A body mass index (BMI) ≥ 25 kg / m² could also be a positive predictor, but this remains debated.

The objective of this project is to assess the impact of metabolism and energy reserves, physical activity and the chronotype on the recovery of ovarian function in patients with breast cancer who have developed CIA


Eligibility Criteria:
Inclusion Criteria:

* Women with a chemotherapy-induced (CIA) amenorrhea who asked for post-cancer fertility follow-up at the University Hospital of Lille, France.
* Women between 25 to 35 years age at inclusion
* Chemotherapy protocol: FEC 100 (3 cycles) + docetaxel (3 cycles

Exclusion Criteria:

* Women without CIA
* Women who refuse to participate in the study
* Women older than 35 years at inclusion
* Women who received another chemotherapy protocol
The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines

The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of mild headaches in people who have migraines.

This multi-center, adaptively randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (CO2) in the treatment of mild headaches. An estimated 250 patients who meet the eligibility criteria will be enrolled into this study at approximately 15 sites to ensure that about 220 patients are randomized and complete the study.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and understand informed consent form and voluntarily consent to participate in this study by signing the IRB-approved informed consent form
* Established diagnosis of migraine with or without aura per ICHD-II (patients with a diagnosis of only menstrual migraine are not eligible)
* History of 2-8 migraine attacks per month during the 3 months prior to randomization
* Have a typical migraine which progresses from a distinct mild headache to a moderate or severe migraine
* Able to recognize a mild headache that could develop into a moderate or severe migraine

Exclusion Criteria:

* Have less than 48 hours of freedom from headache between attacks of migraine
* Have 15 or more headache days per month
* Are females who are pregnant or lactating
* Use antipsychotic or antidepressant medications (unless only for migraine prophylaxis) within 12 weeks prior to randomization and for the duration of the study
* Have a concurrent diagnosis of TMD or trigeminal neuralgia requiring treatment
* Clinically significant deviated septum, nasal polyps or other nasal condition that prevents unrestricted breathing through each nostril
* Have participated in another study with nasal CO2
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants

This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born between 27 weeks 0 days to 31 weeks 6 days of gestation
* Preterm infants who did not require endotracheal intubation immediately after birth in the delivery room or operation room.

Exclusion Criteria:

* Preterm infants born before 27 weeks of gestation
* Preterm infants who require endotracheal intubation due to severe respiratory distress immediately after birth in the delivery room or operating room
* Preterm infants with congenital anomalies affecting the lungs, heart, or other organs that could influence breathing
* Infants whose parents do not consent to participate in the study
Study Evaluating Effexor® (Venlafaxine) in Achieving Response and Maintaining Remission

This is a study to determine the utility of Effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor® (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D.


Eligibility Criteria:
INCLUSION CRITERIA:

* Patients meeting criteria for a diagnosis of major depression, single or recurrent episode as described by the DSM-IV manual (appendix 1).
* A HAM-D 17 total score of at least 16 at baseline (DSM-IV manual, appendix 2).
* Patients above 18 years of age who meet the eligibility requirements.

EXCLUSION CRITERIA:

* Patients taking MAOI's within 2 weeks prior to the survey.
* Patients known to be suffering from bipolar disorder or schizophrenia.
* Patients who are treatment-resistant, i.e., in the past 3 years have failed (a) three previous adequate trials of greater than or equal to 2 classes of antidepressant medication, or (b) electroconvulsive therapy.
* Drug or alcohol dependence or abuse in the past 6 months per DSM IV criteria.
Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection

This is a phase 2b prospective, randomized, single-blind, controlled trial of a single subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2 infection in non-hospitalized participants at high risk for infection due to household exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All participants will be followed for up to 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Peripheral capillary oxygen saturation (SpO2) ≥ 95% on room air at screening
* Age ≥18 years

Exclusion Criteria:

* Hospitalized or impending hospitalization at the time of screening
* Symptoms of cough, fever or shortness of breath within 72 hours
* Prior or current treatment with other experimental or approved agents targeting SARS-CoV-2 or SARS-CoV-1
* Positive pregnancy test
* Active autoimmune disease or sarcoidosis (with the exception of controlled thyroid disease)
* Active decompensated liver disease (ascites, encephalopathy)
* Active congestive heart failure
A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers

The purpose of this study is to evaluate the comfort of color contact lenses in a population of clear contact lens wearers who have an interest in wearing color contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign an Informed Consent Document or Assent, if applicable.
* Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses.
* Manifest cylinder (at screening) less than or equal to 0.75 diopters (D) in each eye.
* Successful wear of clear/handling tint, single-vision spherical, bi-weekly/ monthly replacement soft contact lenses in both eyes during the past 2 months for a minimum of 5 days per week and 8 hours per day.
* Requires spherical contact lenses within the available range of powers (i.e.,-1.50D to -5.00D in 0.25D steps).
* Interested in wearing contact lenses that change the appearance of the color of the eyes.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current).
* History of herpetic keratitis.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear, except for rewetting drops.
* Corneal vascularization greater than 1 millimeter (mm) of penetration.
* Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
* Previous corneal or refractive surgery or irregular cornea.
* Monovision and monocular (only 1 eye with functional vision) or fit with only 1 lens.
* Anisometropia ≥1.50D (study contact lens prescription).
* History of intolerance or hypersensitivity to any component of the test articles.
* Eye injury or ocular or intra-ocular surgery within the last 6 months (excluding placement of punctal plugs).
* Participation in any clinical study within 30 days of Visit 1.
* Other protocol-specified exclusion criteria may apply.