cyrilzakka/clinical-trials huggingface dataset:
Dynamic Navigation System in Implantology

This study consists in a randomized controlled trial which objective is to assess the accuracy of a dynamic navigation system in dental implant placement in partially edentulous patients compared with the conventional freehand method.

This is a prospective randomized clinical trial.

Each patient enrolled in this trial will be randomly allocated to one group ( Navigation group or Freehand groups). Preoperative virtual planification of dental implants on a pre-acquired cone beam computed tomography (CBCT) will be performed for each patient using the same system.

During the surgical phase, depending on which group is allocated the patient one surgical approach or other will be used. Then after the surgical procedure a PROMs questionnaire will be asked to the patients.

Finally a postoperative CBCT will be performed and overlapped with the preoperative CBCT (with the implants planification) and implant position deviations between the planned and final position will be measured.

The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.

Eligibility Criteria:
Inclusion Criteria:

* Partially edentulous patients that requires at least the placement of one dental implant
* Healthy patients ASA I and II (American Society of Anesthesiologists classification)
* Over 18 years old patients

Exclusion Criteria:

* Totally edentulous patients
* Systemic or local conditions that contraindicates dental implant surgery
* Patients with less than 3 teeth in the jaw.
The Impact of Semi-sitting Position Versus Supine Position on Gastric Emptying in Children Using Gastric Ultrasound

The aim of this work is to evaluate the effect of semi sitting versus supine positions on gastric emptying of fluids in children using gastric ultrasound.

The investigators hypothesize that gastric emptying in children might be faster if the patient is in semi-sitting position. This hypothesis could impact the current guidelines for peri-operative fasting. Moreover, if this proved effective, could be used for enhancement of gastric emptying before emergency operations in non-fasting patient.

Dealing with preoperative fasting requires a meticulous balance ensuring patient safety and lessening patient's discomfort. Although fasting is a basic requirement for avoiding pulmonary aspiration, it is sometimes associated with patient discomfort and hypoglycemia. According to the current guidelines for preoperative fasting of children, fasting is required for 2-hours, 4-hours, and 6-hours period after ingestion of water, breast milk, and infant formula respectively. Limited data is available for the effect of patient positioning on gastric emptying. A previous study had reported that gastric emptying of non-nutrient liquids was faster in the sitting position compared with the left lateral position . Another study showed similar findings after nutritive liquid and solid meals; whilst, a third study had reported that gravity has a little effect on gastric emptying.

In pediatric population the effect of posture on the duration of gastric emptying is not well investigated.

Gastric ultrasound is a valid, accurate, reproducible, non-invasive, bedside test for evaluation of the gastric volume. gastric ultrasound has been validated in adults as well as children for estimating the volume of gastric contents and evaluating gastric emptying.

The aim of this work is to evaluate the effect of semi sitting versus supine positions on gastric emptying of fluids in children using gastric ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Children 4 to 16 years of age.
* Fasting for elective surgery.

Exclusion Criteria:

* Gastrointestinal problems that may delay gastric emptying.
* Recent abdominal operations.
* Major systemic diseases which could impact gastric emptying.
The Autonomic Nervous System State and Response to Different Stimuli Among Patients Post Stroke: A Follow-up Study

The study describes the autonomic control system function in subjects post stroke in comparison with healthy subjects.

Aims: To describe the Autonomic hart rate control system function in post stroke subjects in different rehabilitation levels in comparison with healthy subjects.

To examine the reflective reaction of the autonomic control system as reflected in the heart rate variability to stimulations subjects in different rehabilitation levels in comparison with healthy subjects.

To examine the autonomic control system reaction as reflected in the heart rate variability to physical and cognitive action subjects in different rehabilitation levels in comparison with healthy subjects.

Subjects will be examined 3 times: a week 1 and 3 month post stroke. Control consist similar in description healthy subjects, will be examined once. Each test includes 24 hours Holter surveillance and an examine that include general check that reflects the autonomic reaction to different manipulation.

The examination description:

A. Prior to the examination subjects will be asked to fill the mRS, NIHSS forms.

B. Subjects will receive an examination that includes

* General neurological examination (strength, deep and superficial sensation, cognitive test and pain level.) C. Holter will be place for 24 hours. And autonomic examination test will be conducted
* Grip Test: emphases the sympathetic system.
* Breathing Test: emphases the parasympathetic system. D. Manipulation to examine the two sub systems. Each manipulation lasts1 minute.

Eligibility Criteria:
Inclusion Criteria:

* Post hemispheral ischemic stroke cognitively intact.

Exclusion Criteria:

* Subjects with severe visual or hearing impairments, stroke location brain steam.
Effects of Medical Treatment of ICAS With Hemodynamic Disorders Based on MR-FFR

This multicenter prospective cohort study aims to compare the difference in the effects of medical treatment within 1 year between the two groups of ICAS patients divided hemodynamically by Magnetic Resonance Fractional Flow Reserve. PC MRA will be applied for FFR measurement. The primary outcome is the composite of ischemic stroke or death related to the qualifying artery territory for 1 year.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged from 30 to 80 with symptomatic ICAS lesion in anterior circulation.
2. 50% to 99% stenosis (in accordance with modified WASID method) confirmed by DSA, CTA or MRA.
3. mRS 0-2 points
4. Informed of the study protocol and objectives.

Exclusion Criteria:

1. Previous endovascular treatment or surgery for cerebrovascular diseases
2. Large cerebral infarction (more than 1/2 MCA perfusion area) according to MRI
3. Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
4. Pregnancy or in the preparation for pregnancy
5. Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
6. Contraindication for antiplatelet drugs or statins
7. Patients with severe dementia or mental disorders, who cannot cooperate with examination
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC)in adults taking opioid therapy for chronic non-cancer pain.

This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 600 participants (300 participants per treatment group) with OIC will be randomized at approximately 75 study centers to receive either oral 0.25 mg CB-5945 BID or oral matching placebo BID for the 12-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for clinical response for duration of their study participation. All participants will be followed for safety for 4 weeks after last dose of the study medication, regardless of when they discontinue study medication. The clinical study report for this study includes pooled results for studies 5945-OIC-12-02 (NCT01901302) 5945-OIC-12-03 (NCT01901328), and 5945-OIC-12-04 (NCT01901341).

Eligibility Criteria:
Key Inclusion Criteria:

* Is taking a stable daily dose of opioids of ≥30 mg morphine equivalent total daily dose (METDD) for chronic non-cancer pain
* Has constipation that is caused by the chronic use of opioids
* Is willing to use only the study provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (e.g., lubiprostone) from Screening until the last study assessment

Key Exclusion Criteria:

* Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example \[e.g.\], obstruction) or contribute to bowel dysfunction
* Has evidence of intestinal obstruction
* Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening
* Has an active malignancy of any type (participants with a history of successfully treated malignancy \>5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled)
* Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone)
* Is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)
Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

This is a phase I, double center, randomized, double-blind, single dose and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of MV088 and Prolia® in healthy volunteers. The secondary objectives is to assess the similarity of clinical safety and immunogenicity of MV088 and Prolia® in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 years or ≤65 years, male(including the boundary value).
2. The body weight is within the range of 50\~70kg (including the boundary value) and the body mass index（BMI） is within the range of 19.0\~26.0kg/m2 (including the boundary value).
3. Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements.
4. The volunteers are able to communicate well with the researchers, understand and comply with the requirements of the study, and are expected to participate in all follow-up visits (no long-term plans to leave the study site).

Exclusion Criteria:

1. Have participated in any drug or medical device trials or are participating in other clinical trials within 3 months prior to first administration.
2. Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
3. The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed.
4. Occurred or suffering hypocalcemia.
5. Have taken any medicine (including Chinese herbal medicine) within 14 days before the first administration.
Psychosomatic Factors Influencing the Efficacy of Holistic Care for Migraine

This research project aims at exploring the psychosomatic factors that influence and moderate the efficacy of holistic care and personalized treatment for migraine patients. It is a prospective longitudinal observational study. The project's goal is to understand how physical, psychological, spiritual, and social factors affect the care and treatment outcomes for migraineurs. The study will include participants aged 18 to 65, who meet the International Headache Society's criteria for migraines. It will utilize a range of methodologies including questionnaires, interviews, and medical records to collect data on various factors like lifestyle, psychological state, and social support. The project will assess the effectiveness of treatments, compliance, and other outcomes such as emotional and sleep conditions.

In this study, participants will be recruited through clinics. All the participants will be asked to keep a migraine diary for the duration of three months. In addition to that, the participants will fill out questionnaires that measures depression, anxiety, well-being and migraine related disability. This study does not intervene with the routine clinical care. The investigators merely observe through participant's diary and other patient reports to find out about how psychological and social factors might lead to different clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* individuals aged between 18 and 65 who meet the International Headache Society's criteria for migraines

Exclusion Criteria:

* incapacitate such as dementia or cognitive deficiency
* illiterate, or could not sign informed consents
* severe disorder or co-morbidities that the doctors advice against participation
Activity of AVE1625 in Mild to Moderate Alzheimer's Patients.

Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in patients with Alzheimer's disease that is not too severe. There is also evaluation of whether patients who take the study medication improve compared to patients who take a placebo (sugar pill).

Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in patients who join the study.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of Alzheimer's disease
* Recent brain image(Computerized Axial Tomographic Scan -CAT scan or Magnetic Resonance Imaging - MRI)
* Mild to moderate range of disease; not too severe

Exclusion Criteria:

* Severe or unstable medical diseases
* Neurological disorder other than Alzheimer's disease
* Depression that is not well controlled
* Treatment with memantine
* Inpatient in a total care facility (e.g.: Nursing home)
* Lack of reliable caregiver
Expression and Clinical Significance of IGHD in Pancreatic Cancer

Background ： Pancreatic cancer is the most malignant tumor in the digestive system, with low level of early diagnosis and poor prognosis. There is a lack of high sensitive and specific molecular markers in the diagnosis, treatment and prognosis of pancreatic cancer.

Objective： To explore the expression of IGHD in pancreatic cancer and its correlation with clinical parameters, and to explore its prognostic value in patients with pancreatic cancer.

Methods： In this study, qRT-PCR was used to detect IGHD expression in peripheral blood. The expression of IGHD in pancreatic cancer and healthy individuals was compared. The PCR results were combined with clinical data of patients. To compare the expression of IGHD in different pancreatic cancer stages and evaluate whether IGHD expression in peripheral blood can be a potential biomarker for the diagnosis of pancreatic cancer, chi-square test was used to analyze the factors influencing the expression level of IGHD. Kaplan-Meier was used to analyze patient prognosis, and further Cox regression analysis was used to analyze the factors influencing patient prognosis and independent risk factors.

Methods：The expressions of IGHD in peripheral blood of about 30 patients with pancreatic cancer and more than 30 healthy controls were detected by qRT-PCR, and the differences of IGHD were analyzed.The expression of IGHD in pancreatic cancer and healthy individuals was compared. The PCR results were combined with clinical data of patients. To compare the expression of IGHD in different pancreatic cancer stages and evaluate whether IGHD expression in peripheral blood can be a potential biomarker for the diagnosis of pancreatic cancer, chi-square test was used to analyze the factors influencing the expression level of IGHD. Kaplan-Meier was used to analyze patient prognosis, and further Cox regression analysis was used to analyze the factors influencing patient prognosis and independent risk factors.

Pancreatic cancer is a disease of digestive system with a high degree of malignancy. The level of early diagnosis and therapeutic effect are limited by the research status of pancreatic adenocarcinoma. Conventional CT, MRI and other methods have a limited level of early diagnosis of pancreatic cancer, and EUS and endoscope-guided needle biopsy are in the stage of clinical trials. Studies on novel markers involve protein, miRNA, exosome, methylation, protein and genomics, but there is no mature and practical diagnostic method. Based on the current diagnosis, treatment and prognosis level of pancreatic cancer, I made a bold attempt to study the expression of IGHD in pancreatic cancer and their relationship with clinical parameters and prognosis level, so as to screen molecular markers conducive to diagnosis, treatment and prognosis of pancreatic cancer and provide data support for improving the diagnosis and treatment level of pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically confirmed pancreatic cancer

Exclusion Criteria:

* noperable patients
* other malignant tumors
Molecular Assessment of Artemisinin Resistance Markers in Eastern and Western Border Areas of Myanmar

* Artemisinin resistance have been documented in Myanmar and Myanmar artemisinin resistance containment measures have been launched since 2009-2010.
* It is important to monitor the spread and magnitude of artemisinin resistant malaria in Myanmar.
* So, day-3 surveillance study have been conducted.
* Recently artemisinin resistant molecular marker, K13 have been identified and it was used as a tool in this study.


Eligibility Criteria:
Inclusion Criteria:

* confirmed uncomplicated falciparum malaria patients.
* age \>2 years
* box sex
* given informed consent

Exclusion Criteria:

* severe malaria
* did not give informed consent
* others diseases
Insulin Glulisine in Healthy Lean and Obese Subjects

Primary objective

* To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin glulisine across healthy subjects in 4 different BMI-classes (lean, overweight, moderately obese, severely obese), using the euglycemic clamp technique with the Biostator™.

Secondary objective

* To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous administration of insulin glulisine in comparison to insulin lispro and to investigate the safety and tolerability after subcutaneous administration of insulin glulisine in comparison to insulin lispro.


Eligibility Criteria:
Inclusion criteria :

* Normal HbA1c
* Women have to either be postmenopausal, surgically sterilized, or not pregnant and using adequate contraception.

Exclusion criteria :

* Systemic concomitant medication
A Single Ascending Dose Study of PCO371 in Healthy Volunteers

This is a single-center, placebo-controlled, randomized, double-blind, dose-escalation study to evaluate safety, tolerability, and PK of a single oral (PO) administration of PCO371 in healthy adult males.

Caucasian and Japanese subjects will be randomized to receive either PCO371 or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18 to 45 years.
* Caucasian(BMI 18-30 mg/kg2) or first generation japanese(BMI 18-25kg/m2)
* Able and willing to abide by the protocol

Exclusion Criteria:

* Evidence of any medical condition that could affect renal, hepatic, or cardiopulmonary functions.
Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction

A Phase 4 clinical trial that is open, with no blinding of subjects or randomization of treatment. Patients with erectile problems will be given the approved drug Vitaros to treat their condition. They will be given forms and questionnaires to complete. The information collected will be used to assess the effectiveness, safety and the satisfaction levels with this drug.

Transdermal topical alprostadil has been approved for use in Canada as a treatment for erectile dysfunction. However, as this form of treatment is new, and Canada is the first country in the world to approve its use. There are very few published articles in literature to evaluate its clinical acceptance. By performing a Phase 4, Open-Label, Non-Randomized, Clinical Trial to Evaluate the Efficacy, Safety and Satisfaction of VITAROS (transdermal topical alprostadil) in Men with Erectile Dysfunction, this study can improve understanding of this method of treatment as compared to conventional treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18y rs old and above
* Has mild-to-moderate erectile dysfunction
* Currently or previous treated for erectile dysfunction using PDE5 inhibitors, vacuum erection devices (VED), intra-cavernosal injections (ICI) and medical urethral system for erection (MUSE).
* Sexually active
* Has a regular sexual partner

Exclusion Criteria:

* Known allergy to alprostadil
* Unable to provide own informed consent
* Unable to understand and complete a questionnaire in English
* Unable to return for a post-treatment clinic evaluation
* Regular sexual partner is unable to understand and complete a questionnaire in English
* Sexual partner is a pregnant or lactating female
Unintentional Overfeeding of Formula Fed Infants

Although breast milk is recommended exclusively until 6 months of age, two-thirds of infants in the U.S. are fed infant formula. Despite an almost identical energy density between infant formula and breast milk, formula fed infants experience greater weight gain in the first year of life. The investigators propose that unintentional overfeeding, of nearly one additional day of calories per week, due to the "over-scooping" of powdered formula contributes significantly to this phenomenon and potentially to the early development of childhood obesity, a significant public health problem.

In the proposed study the investigators will assess the literacy and understanding of individuals to follow commercially available infant formula instructions. The investigators will collaborate with the LA CaTS Health Literacy Core to improve the reading and comprehension of the manufacturer package instruction, and will solicit the input of caregivers and key stakeholders to inform the development of educational intervention around infant feeding. Following modification of infant formula preparation instructions, the investigators will conduct a randomized controlled trial that will test the efficacy of the modified instructions on infant overfeeding in comparison with the manufacturer package instructions. One hundred and fifty participants will be asked to complete one study visit during which they will be asked to measure various serving sizes of infant formula following either the manufacturer package instructions or the modified instructions.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Willing to participate in 1 assessment visit at Pennington Biomedical Research Center
* English speaking

Exclusion Criteria:

* \<18 years of age
* Not willing to participate in 1 assessment visit at Pennington Biomedical Research Center
* Non-English speaking
Postoperative Analgesic Efficacy of Pericapsular Nerve Group Block (PENG) Block for Knee Arthroscopy

Pericapsular nerve group block (PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee arthroscopy.

Pericapsular nerve group block(PENG) has been deemed as a safe and effective regional technique for postoperative pain after knee artroscopy. Blockade of the branches of the femoral and obturator nerves that provide innervation to any structures distal enough to be useful in knee.

Eligibility Criteria:
Inclusion Criteria:

* Patients agreed to receive PENG block
* Knee arthroscopy

Exclusion Criteria:

* Other kinds of knee surgery
* Patients refuse to receive PENG block