cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Dynamic Navigation and Static Template in Completely Edentulous Patients

The study was a prospective, multicentre, randomized parallel controlled clinical trial. Randomisation was conducted by central randomisation, with random allocation codes generated by the main central computer. Enrollment was conducted by competition between different centres. In this study, the coronal, apical and angular deviations (mean, standard deviation, median, quartiles, minimum, maximum, 95% confidence interval) of the static template and dynamic navigation group guided implant placement were calculated. The data is proposed to be analysed using a mixed linear effects model.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above
* American society of anesthesiologists (ASA) Levels 1 and 2
* Satisfy any of the following requirements:

  1. Edentulous maxillary patients
  2. Edentulous mandibular patients
  3. Terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4)
  4. Terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4)
  5. Full-mouth edentulous patients
  6. Full-mouth terminally edentulous patients (number of remaining natural teeth in one jaw 1-4)
* Implant-supported fixed restorations or implant-supported overdenture restorations
* Sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software)
* Maxillary and mandibular options for full-mouth patients are based on the inclusion of more single jaws in the non-bone grafted sites (see virtual peri-implant bone volume requirements in the pre-operative preparation phase)
* Mouth opening of 3 fingers or more
* Single-jawed missing patients treated with systemic periodontal therapy

Exclusion Criteria:

* Have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin \>6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.)
* ASA grades 3 and 4
* Acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth \> 4 mm) and untreated acute and chronic apical periodontitis
* Pregnancy or breastfeeding
* History of radiotherapy to the head and neck
* Heavy smokers (more than 10 cigarettes per day)
* Restricted mouth opening (less than three fingers).
* Participation in a clinical trial with another drug or device within 30 days prior to the start of the procedure (study day 0).
Effect of the Visual Information Change in Functional Dystonia

Cervical dystonia occurring only during the writing task is a rare form for which there is no established treatment. Many authors agree that alteration of sensory integration is associated with dystonia. Similar disturbances in the integration of oculomotor information could have a role in cervical dystonia forms involving visuo-cervico-manual coordination such as handwriting. We hypothesize that orthoptic treatment by wearing prisms when writing (i) will reduce the abnormal posture of the head occurring whilst writing and remove the associated nuchal pain; (ii) the correction after a period of systematic wearing of the prisms during handwriting tasks will have a sustainable effect allowing to keep a normal head position after the suppression of the prisms.


Eligibility Criteria:
Inclusion Criteria:

Case

* Presenting a cervical dystonia that occurs only during handwriting tasks, diagnosed by a neurologist specialised in movement disorders
* Being treated or not by injection of Botulinum Neurotoxin (but last injection \> 3 months before the initial assessment)

Control

* No cervical dystonia
* Same sex, age (± 5 years), socio-professional level and hand laterality as the cases

Exclusion Criteria:

Case

* Cervical dystonia occuring in other circumstances than handwriting
* Neurological disease other than cervical dystonia (e.g. Parkinson's syndrome)
* Pain, trauma or pathology of the cervical spine of another cause than cervical dystonia and which have required medical or surgical treatment in the last 6 months preceding the initial assessment

Control

* Cervical disorders requiring medical or surgical treatment in the last 6 months prior to the tests
* Neurological disease affecting the cervical region or the writing hand
* Uncorrected visual disorders
Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues.

This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. There are indications of advantages in combining vascular disrupting agents with standard agents in the treatment of advanced non-small cell lung cancer (NSCLC).

Eligibility Criteria:
Inclusion Criteria:

* Male and females ≥ 18 years of age
* ECOG performance status ≤ 1
* Pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable Stage IIIb or IV) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial
* All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to Grade ≤ 2
* Signed informed consent

Exclusion Criteria:

* Administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames
* Significant cardiac history
* Prior treatment with tumor vascular disruptive agents
* Seizure disorder
* Brain metastases
* Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
* Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or C
* Patients with a prior hypersensitivity reaction to product components
* Pregnant or breast-feeding women.
* Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Unwilling or unable to comply with procedures required in this protocol
REPARA Study: REgistry of PAtients With bioResorbable Device in Daily Clinical prActice

A multicentre, observational, prospective device registry, with no control group, designed to evaluate the efficacy and safety of the bioresorbable coronary device, used according to the indications of use, in daily clinical practice in a consecutive number of patients undergoing PCI in de novo coronary artery lesions. A total of 1,500 patients are planned to be included in the registry.

The patients will be included consecutively at each site for one year. They will be individuals from both sexes, requiring endovascular intervention and meeting the authorised criteria for the indications of use of the device to be used and where dual anti-platelet therapy (DAPT) with aspirin and thienopyridines is considered.

STUDY OBJECTIVES To evaluate the MACE rate after implantation of the bioresorbable coronary device in patients with de novo coronary artery lesions, where a follow-up of 12 months will be performed.

Primary objective:

MACE rate at 12 months of follow-up:

Cardiac death Myocardial infarction TLR driven by ischaemia of the lesion treated or of the region of 5 mm proximally or distally to the site of implantation of the device (ID-TLR).

Secondary objectives:

* Angina
* Death due to any cause.
* Myocardial infarction of any type (MI: QMI, NQMI, TV, NTV)
* All TLR driven or not by ischaemia
* All TVR driven or not by ischaemia.
* All coronary revascularisations performed (PCI vs CABG)
* Device thrombosis (acute, sub-acute, late) and evidence (definitive, probable, possible).
* Immediate success of the device.
* Immediate success of the procedure.
* Rate of patients with DAPT at \< 1 month, 1-3 months, 3-6 months, and 6-12 months and relationship with the occurrence of events
* Composite endpoints:

Cardiac death, TV-MI and ID-TLR: (Target Lesion Failure (TLF)) Cardiac death, any myocardial infarction (MI) and ID-TVR: (Target Vessel Failure (TVF))

* Rate of overlapping devices: characteristics and relationship with occurrence of events
* Collection of imaging data of the cases where, according to the judgement of the investigator, intravascular imaging tests have been performed (IVUS, OCT).

Eligibility Criteria:
Inclusion Criteria:

* Patient must be at least 18 years of age at the time of signing the Informed Consent Form
* Patient is to be treated for de novo coronary lesions in a native coronary artery and amenable to receive a bioresorbable device
* The length of the treated lesion should be inferior to the nominal length of the device (12 mm, 18 mm, 28 mm) with a reference vessel diameter \> 2 mm y \< 3,8 mm.
* The patient will not have any relative contraindication for double antiplatelet therapy, with aspirin indefinitely and with a thienopyridine for at least 6 months

Exclusion Criteria:

* Cardiogenic shock
* Left main disease
* Aortocoronary graft
* Intrastent restenosis
* Potentially child-bearing women with no contraceptive methods
* Pregnant or breast-feeding women
Hemi-diaphragmatic Paresis and Erector Spinae Plane Block

To assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane (ESP) block

The aim of the study is to assess the effect of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane block.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 85 years
* American Society of Anesthesiology (ASA) I-III
* elective shoulder surgery

Exclusion Criteria:

* patient's refusal
* under 18 years of age or over 65 years of age
* ASA IV and above
* known allergy to local anaesthetic drugs
* the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
* history of neurological and/or neuromucular disease
* history of severe bronchopulmonary disease
* a moderate to severe decrease in preoperative pulmonary function, or abnormality in preoperative chest radiography data (pleural effusion, pneumothorax, or hemidiaphragm elevation)
Randomized Trial of a Smartphone App Designed to Reduce Unhealthy Alcohol Consumption

Smartphone apps targeting alcohol consumption are increasingly employed as a means to help people reduce their alcohol consumption. Recognizing this potential, there has been an explosion of app development for unhealthy alcohol use, as well as other health-related behaviours. This study will recruit people who consume alcohol in an unhealthy manner. Participants will be assigned by chance to one of two groups and will be contacted 6 months after consenting to the study to assess changes in their drinking. In addition, this study will help us understand which components of the smartphone app are important to use in order to promote reductions in alcohol consumption. An app with proven efficacy, made widely available and free-of-charge to Canadians, will provide a much needed option to help those in need to reduce their alcohol use.

Unhealthy alcohol use is common and causes tremendous harm. Most people with unhealthy alcohol use will never seek formal alcohol treatment. As an alternative, smartphone apps have been developed as one means to provide help to people concerned about their alcohol use. While such apps are widely available, the large majority have little or no evidence base, and research has indicated that some may actually do more harm than good. An app with proven efficacy at reducing alcohol consumption is needed in order to capitalize on this opportunity to motivate the large number of people seeking assistance using this promising technology.

This study will recruit people who consume alcohol in an unhealthy manner. Participants will be assigned by chance to one of two groups to either receive access to: 1) the full app; or 2) a copy of the app where only the educational content is provided (as opposed to the full intervention content of the app). Participants will be contacted 6 months after consenting to the study to assess changes in their drinking. We predict that the full app will lead to larger reductions in drinking and a more sustained impact than the educational content only app. In addition, this study will help us understand which components of the smartphone app are important to use in order to promote reductions in alcohol consumption.

Eligibility Criteria:
Inclusion Criteria:

* score of 8 or more on the Alcohol Use Disorders Identification Test
* currently us a smartphone running iOS or Android

Exclusion Criteria:

-
Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne

The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.


Eligibility Criteria:
Inclusion Criteria:

* subject has a clinical diagnosis of acne vulgaris with facial involvement
* the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face

Exclusion Criteria:

* subject has a severe acne form or secondary acne form
* the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face
* the subject has a known allergy or sensitivity to any of the components of the study products
* subject is not willing to respect wash-out periods for topical and/or systemic treatments
Effect of Betaine and Food on Gastric pH

Food will decrease stomach acidity due to its buffering effect.This has implications when providing drugs that are dosed with food but require higher levels of stomach acid, such as some medications commonly used for HIV patients. This study will attempt to determine the dose of betaine hydrochloride (over the counter acid supplement) at which the effect of food on stomach acid could be countered. Additionally, this study will evaluate the ability of a natural supplement (betaine hydrochloride) to affect the gastric pH following a standardized meal in healthy volunteers. The investigators predict that 4500mg of betaine hydrochloride will have the greatest effect on gastric pH.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-64 years of age;
* Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam;
* BMI between 18.5 - 32 kg/m2;
* Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or OTC medications (except acetaminophen);
* Be able to provide written informed consent and comply with requirements of the study;
* Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until completion of the entire study;
* Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 3pm the night before a study day until completion of that study day;
* Fast from food and beverages at least 8 hours prior to the study day;
* Be able to read, speak and understand English

Exclusion Criteria:

* Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease or dyspepsia.
* Subjects with a fasting gastric pH of \> 4 (i.e. hypochlorhydria)
* Subjects with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills.
* Subjects on prescription or chronic over-the counter medications (including hormonal contraceptives);
* Subjects with liver failure or LFTs \>2x upper limit of normal;
* Subjects with clinically significant elevations in SCr, BUN or other screening laboratory tests as determined by study physician;
* Subjects with Hct \< 30 mg/dL, WBC \< 2000/μL, ANC \< 1000/μL, or platelet count \< 150,000/μL;
* Subjects with a history or presence of an abnormal ECG, including demonstration of a baseline corrected Fridericia's QT interval (QTcF) \>450ms, which in the opinion of the study physician, is clinically significant;
* Subjects who smoke tobacco;
* Subjects with ongoing alcohol or illegal drug use;
* Subjects who are pregnant, lactating or attempting to conceive;
* Subjects unable to follow protocol instructions or protocol criteria.
* Anyone who in the opinion of the study investigators is unable to participate in the study.
Benefits of Relaxation by Music Therapy on PTSD Symptoms

PTSD is a debilitating mental disorder that may develop after experiencing or witnessing a life-threatening event. With appropriate care, treatment efficiency is variable and around 20% of the patients do not respond to psychological treatment. Complementary treatments are needed.

as PTSD implied autonomic nervous system (ANS) dysfonction, complementary treatment focusing on ANS regulation, as welle as musicotherapy, may have an interest.

The aim is to evaluate the impact of musicotherapy on PTSD symptoms, and severity using a RCT Symptoms will be evaluated using questionaires (PCL and quality of life) severity will be measured using neurological soft signs assessment, connectomic functions and ANS regulation

Eligibility Criteria:
Inclusion Criteria:

* PTSD

Exclusion Criteria:

* neurological diseases
* addiction
The Clinical and Prognostic Features of PRES

The purpose of this study is to determine the features of clinical imaging, disease severity and pregnancy outcomes in posterior reversible encephalopathy syndrome with preeclampsia or eclampsia.

The investigators retrospectively collected data (General information, clinical data, biochemical indicators, imaging features, and pregnancy outcome) from pregnant woman diagnosed with PRES with preeclampsia or eclampsia to analyze features of clinical imaging, disease severity and pregnancy outcomes during 2012 to 2021.Then, the investigators grouped all the patients into early onset group and late onset PE group according to gestational weeks to analyze differences of clinical imaging. Finally, the investigators grouped all the patients into good pregnancy outcomes group and poor pregnancy outcomes group according to diagnostic criteria, including the incidence of stillbirth and premature birth, to analyze differences of clinical imaging .

Eligibility Criteria:
Inclusion Criteria:

1. patients were diagnosed of PRES with PE or E
2. all patients provided written informed consent

Exclusion Criteria:

1. patients combined with other neurological disorders
2. patients combined with mental illness
Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina

This study of 402 cases of stable angina subjects who were diagnosed as Coronary Heart Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Subjects who are taking standard treatment with stable symptoms will receive a 24-hour ambulatory electrocardiogram (ECG) (Holter) examination. They will be randomly divided into two groups. The nicorandil group will receive nicorandil 5 milligram (mg) (3 times a day = tid) on top of the standard treatment for 12 weeks, while the control group will stay on standard treatment. Nitrates and beta blockers need to be maintained on a stable dose. Other drugs that do not affect the primary endpoint may be adjusted per investigators decision.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be diagnosed as stable CHD, and must have at least one of these histories:

  1. A history of coronary revascularization Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Surgery at least 3 months ago
  2. Myocardial infarction
  3. More than 50 percent (%) stenosis detected by angiography
  4. Exercise Tolerance Testing (ETT) or Computed Tomography Angiography (CTA) showed more than 50% stenosis with typical angina symptoms
* Subjects must have at least 2 times of typical symptoms of myocardial ischemia occurred within a week Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Coronary syndrome or considering acute coronary syndrome (ACS)
* Left main coronary artery disease without revascularization
* Aortic stenosis
* Obstructive hypertrophic cardiomyopathy
* Subjects with hypertension systolic blood pressure (SBP) greater than (\>) 170 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) \>100 mmHg) or hypotension (SBP less than \[\<\] 90 mmHg or DBP\<60 mmHg)
* Diagnosis as postural hypotension before
* Congestive heart failure (New York Heart Association \[NYHA\] class III - IV
* Ejection fraction (EF)\<40% by Echocardiography
* Arrhythmias requiring active treatment
* Gastro-intestinal ulcer
* Concomitant medication such as Sulphonyl urea, PDE-5 inhibitor such as sildenafil, Trimetazidine for treatment of angina pectoris Other protocol defined exclusion criteria could apply
The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in the Elderly

Ten patients 70 years and older having elective total hip/knee replacement surgery will be recruited to receive a continuous IV infusion of naloxone and oral tramacet for analgesia. Postoperative analgesia, satisfaction, side effects, need for rescure analgesia, and length of stay.


Eligibility Criteria:
Inclusion Criteria:

* aged 70 years or older able to give consent able to communicate in English having elective hip/knee arthroplasty ASA physical status 1-3

Exclusion Criteria:

* allergies to any of the following: naloxone, tramacet, NSAIDs, sulpha, or local anesthesic contraindication to spinal anesthesia contraindication to use of tramacet or celebrex ASA physical status4 chronic opiod use chronic pain syndrome
Monitoring of Vital Signs During Skin-to-skin Holding by Mothers of Their Preterm Babies

This observational study aims to monitor the vital sign changes in both mother and baby that occur during kangaroo care in preterm infants and to investigate any potential correlations between maternal measurement values and those of the infant. The purpose of this observational study is to look for a method to track the earliest responses that could, theoretically, be considered as 'social responses' in hopes of providing developmental interventions earlier to at-risk infants.

The goal of this observational study is to identify any signs of early "social response" in order to be able to assist infants that lack this response with early neurobehavioral modifications.

Eligibility Criteria:
Inclusion Criteria:

* inborn at Mount Sinai
* gestational age between 30 0/7 weeks and 34 6/7 weeks gestation
* only one infant of a multiple gestation
* plan by family to do kangaroo care during NICU stay

Exclusion Criteria:

* outborn infants
* gestational age less that 29 6/7 weeks or greater than 35 0/7 weeks
* other infants of multiple gestation (see inclusion criteria)
* any major congenital anomalies
* sepsis and/or any other serious clinical complication precluding kangaroo care
A Healthy Volunteer Study to Evaluate Reversibility of Induced Impairment of Cognition

The purpose of this study is to determine if cognitive impairment induced by scopolamine is reversed using donepezil and/or AZD1446 as compared to placebo, as assessed by electroencephalogram (EEG) measures.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-30
* Non-smoker for at least 4 weeks

Exclusion Criteria:

* Any clinically relevant acute or chronic disease
* Hypersensitivity to scopolamine
* History of substance abuse