cyrilzakka/clinical-trials huggingface dataset:
Mandibular Flexure in Patients

The flexion of the mandible (MF) is a multifactorial phenomenon that occurs simultaneously with mandibular movements determining changes in the shape of the mandible. mandibular flexure (MF) may cause complications and failures in both conventional and implant-supported fixed dental prostheses (FDP) especially when a long-span prosthesis is planned to connect the anterior to the posterior region of the mandible. Previous studies reported increased biomechanical stress at the prosthetic and implant level, poor passivity of fit, impression distortion, pain during function, de-cementation of the prosthesis, porcelain chipping, prosthetic screw loosening and fracture, bone resorption and implant fracture. The aim of this study is to quantify the dimensional changes related to MF by means of a cone beam computed tomography (CBCT) between maximum opening (MO) and maximum intercuspation (OVD) positions. The null hypothesis was that there is no significant difference in terms of length and width of the mandible between maximum intercuspation and maximum opening positions.


Eligibility Criteria:
Inclusion Criteria:

* Dentate patients,
* 18 years of age or older,
* Good health
* Need of implant treatment

Exclusion Criteria:

* active periodontitis with tooth mobility
* neuromuscular disorders
* temporomandibular joint disorders
* parafunctional habits
* systemic condition preventing surgery
* history of oro-maxillofacial radiation therapy
* history of drug or alcohol abuse
* heavy smoking
* uncontrolled diabetes
* pregnancy
* lactation.
Effects of Intrathecal Local Anesthetics on Left Ventricular Global Longitudinal Strain

The objective of this study is to assess the effects of intrathecal local anesthetics on left ventricular global longitudinal strain (LVGLS) using transthoracic echocardiography (TTE).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective knee and hip replacements under spinal anesthesia

Exclusion Criteria:

* Patients who do not wish to consent
* Patients with contraindications to TTE
* Patients with reduced left ventricular systolic function as defined by LV ejection fraction \< 50% on pre-operative echocardiography
* Patients with body mass index greater than 40
* Non-English-speaking subjects
* Cognitively impaired adults
Hemodynamic Effects of Ventilation Modes

Different ventilation modes can be used in laparoscopic surgeries. These surgeries are performed in steep Trendelenburg position with serious hemodynamic disturbances. This study aims to observe the hemodynamic effects of two different ventilation modes in laparoscopic gynecologic surgery performed in steep Trendelenburg position.


Eligibility Criteria:
Inclusion Criteria:

* Women of ASA I and II classification between 18-65 years scheduled for elective gynecologic laparoscopic surgery

Exclusion Criteria:

* Patient refusal to participate
* Patients with severe cardiac (congestive heart failure etc) and pulmonary (COPD, pulmonary hypertension) disease (ASA \> III)
* Morbid obesity
* Negative Allen test
Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury

Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic drug use are common in patients with cirrhosis especially in Eastern countries.These patients are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high short-term mortality. And the natural history of these patients is frequently complicated by bacterial infections, which lead to deterioration of underlying diseases. The present study is aimed to investigate the prevalance and risk factors of bacterial infections in those patients and its impact on in-hospital/short-term mortality.


Eligibility Criteria:
Inclusion Criteria:

1. The presence of cirrhosis confirmed by liver biopsy, endoscopy, radiological examination, or clinical evidence of prior hepatic de-compensation;
2. Flare up of acute severe liver injury within one month before enrollment. Acute severe liver injury is defined as: increase of serum bilirubin \>=85mmol/L and international normalized ratio (INR)\>=1.5 with a definite hepatic insult.

Exclusion Criteria:

(1)pregnancy; (2) disseminated maliganancy; (3)previously received a liver transplant; (4) HIV infection;
Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study

To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair follicle implantation method following a nine month period of post-procedure evaluation.

This comparative study is a multi-center, prospective, blinded, randomized controlled clinical study where subjects act as their own control.

The purpose of this study is to demonstrate that the ARTAS System is safe and effective for implanting follicular hair units.

Patients will be followed for a nine months period of time.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of IV-VI;
* Subject is 29 to 70 years old;
* Subject has black or brown hair color;
* Subject has straight hair;
* Subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation;
* Subject agrees to have 6 dot tattoos placed on scalp;
* Subject is able to understand and provide written consent; and
* Subject consents to post-operative follow-up per protocol.

Exclusion Criteria:

* Subject has prior history of scalp reduction surgery(s);
* Subject has prior history of hair restoration procedure(s) using the strip excision technique;
* Subject has bleeding diathesis;
* Subject has active use of anti-coagulation medication;
* Subject has used finasteride in the previous 6 months, or plans to use finasteride during the study;
* Subject has used minoxidil in the previous 2 weeks, or plans to use minoxidil during the study; or
* Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study.
Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium

Postpartum hemorrhage (PPH) continues to be an increasing problem globally. Uterotonics play an essential role in the pharmacological management of uterine atony. Carbetocin, a long acting analog of oxytocin has been recommended as a first line uterotonic for PPH prophylaxis at cesarean delivery. Considering many woman have associated comorbidities and are at high risk of PPH, finding alternative pharmacological agents is essential. Calcium is a key factor for myometrial contractions and calcium blood levels can be low at the end of pregnancy. Both hypocalcemia and hypercalcemia could lead to a decrease in myometrial contractions. It is already been demonstrated that in both desensitized and naïve myometrium, normocalcemia provides a better uterine tone compared to hypo and hypercalcemia when oxytocin is given as the first uterotonic drug.

Currently, the role of extracelullar calcium in carbetocin- induced contractility is unknown. This will be the first ex vivo study to test the effects of extracellular calcium on oxytocin pretreated and naive myometrium. The results of this study will provide evidence on the use of this safe drug in clinical practice, particularly in women with labour arrest, and provide alternative pharmacological strategies to both prevention and treatment of PPH, thus improving our clinical practice.

The investigators hypothesize that extracellular normocalcemia would provide superior carbetocin-mediated contractility in both naive and oxytocin-pretreated myometrium compared with hypercalcemia and hypocalcemia.


Eligibility Criteria:
Inclusion Criteria:

* non-laboring women with gestational age between 37 to 41 weeks
* not exposed to exogenous oxytocin, scheduled for a primary or first repeat cesarean delivery under neuraxial anesthesia.

Exclusion criteria:

* patients requiring general anesthesia
* more than 1 previous cesarean delivery
* history of uterine atony
* emergency cesarean section in labor
* patients using medications that could affect myometrial contractility such as nifedipine, labetalol, or magnesium sulphate.
* patients with any condition of predisposing to uterine atony and postpartum hemorrhage, such as abnormal placentation, multiple gestation, severe preeclampsia, macrosomia, polyhydroamnios, large uterine fibroids, chorioamnionitis, previous history of postpartum bleeding.
To Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release Capsules

* Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in both fed and fasted states
* Evaluate the safety and tolerability of the test compound administered orally

Safety parameters assessed included medical history, physical examination, vital signs, 12-lead ECGs, clinical laboratory testing and adverse event assessment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers.
* Aged greater than 18 and less than 45 years.
* Were medically healthy with no clinically significant abnormality on the basis of medical history, physical examination and laboratory evaluations
* Volunteer consented to participate in the study.
* Female volunteers were included if they were surgically sterile, or using an acceptable method of birth control defined as either oral, injectable, implantable, or barrier methods of contraception (ie, diaphragm with spermicidal cream, intrauterine device (IUD) with spermicidal cream or condom with spermicidal cream).

Exclusion Criteria:

* Participants were in a clinical trial within the previous 90 days or participants in a narcotic analgesic study within the previous 12 months.
* Deviation in excess of 10% from the ideal body weight for height according to the Metropolitan Life Insurance Tables (1983 edition).
* History of drug or alcohol abuse at any time in the past
* History of hypersensitivity to the study drug or similar compounds or to acetaminophen.
* Therapeutic use (for any reason) of narcotic analgesics within the previous year.
* Subjects who used tricyclic antidepressants or monoamine oxidase inhibitors at any time in the past.
* Subjects with a history of, or clinical signs suggestive of, chronic obstructive airways disease.
* Receipt of any prescription medication (except birth control) within 2 weeks prior to entry into the study or receipt of non-prescription or over-the-counter medication within one week of study commencement. (Vitamin supplements were acceptable).
* Blood donation within the 90 days previous to study entry.
* Female volunteers with a positive serum pregnancy test, or at risk of becoming pregnant during the study.
* Volunteers with a history of smoking (must not have smoked within the last 6 months).
* Volunteers with any clinical/biochemical impairment of liver function, or receipt of known hepatic enzyme inducing or inhibiting agents within 30 days prior to entry into the study.
* History or presence of significant hepatic, renal, endocrine, cardiac, nervous, gastrointestinal, pulmonary or metabolic disorders.
* Any condition or history that the investigator considered might increase the risk to the volunteer or interfere with the evaluation of data.
Impact of Beetroot Juice Ingestion on Female Rugby Performance

Rugby is a team sport characterized by high-intermittent efforts, due to the importance of realizing intermittent and explosive efforts in rugby the use of nutritional strategies such as beetroot ingestion should be explored with the aim to enhance the capacity for repeating high-intensity actions in female players.

Rugby is a team sport characterized by high-intermittent efforts, thus, to the importance of realizing intermittent and explosive efforts in field hockey is crucial. For this reason, the use of nutritional strategies in field hockey should be explored with the aim to enhance the capacity for repeating high-intensity actions. However, scientific evidence supports only a few numbers of dietary supplements that have reported good evidence for improving sports performance, between we can mention beetroot juice supplementation with doses \> 5 mmol of NO3-. Beetroot juice is a NO3- precursor with recognized effectiveness to elicit performance due to different physiological mechanisms associated with its ingestion such as increment in vasodilatation, skeletal muscle contractility, or delaying fatigue development that could be linked with an enhance or performance in team-sports athletes. However, the majority of the studies has been realized in male athletes being female athletes underrepresented in beetroot juice supplementation research. Thus, the aim of this study was to analyze the effects of beetroot juice ingestion on neuromuscular performance in female rugby players.

Eligibility Criteria:
Inclusion Criteria:

* More than 5 years of rugby training experience.
* Active rugby player

Exclusion Criteria:

* Concurrently participating in other studies.
* Contraindications to beetroot juice ingestion.
* Physical limitations, health problems, or musculoskeletal injuries.
Anatomy Based Selection of CI Array for SSD Patients

The purpose of the study is to evaluate cochlear implant speech outcomes and subjective benefit for cochlear implant recipients with single-sided deafness using patient-specific, anatomy-based array selection versus standard of care with a fixed array size for all patients. Subjects will prospectively be assigned to receive an Anatomy-Based Electrode (FLEX26, FLEX28, or FLEXSOFT) or the Standard of Care Electrode array (FLEX28). Speech performance and subjective benefit will be evaluated between these two groups.

To determine the effectiveness of Anatomy-Based Electrode selection versus Standard of Care Electrode selection in SSD listeners a prospective, single-blinded study design will be used to evaluate the outcomes in these two groups by evaluating speech understanding in quiet, speech understanding in noise, subjective listening difficulty and sound quality, and datalogging.

Subjects will be randomly assigned to either group to receive an electrode based on their anatomy (ABE) or the Standard of Care electrode (SOCE). Five participants will be in each group, for a total of 10 participants.

All subjects will receive a MED-EL Cochlear Implant and will subsequently be fit with an audio processor approved by Health Canada. Post-operative evaluations will occur at one and six months post-activation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at the time of implantation
* Unilateral severe to profound sensorineural hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 70 dB HL or greater
* Normal hearing mild hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 40 dB or less
* Deemed an appropriate candidate by the investigator
* Fluent in English

Exclusion Criteria:

* Duration of profound hearing loss of 10 years or more
* Sudden onset of hearing loss within six months of implantation
* Evidence of non-functional cochlear nerve using appropriate imaging modality to be determined by the investigator
* Other retrocochlear hearing loss
* Evidence of severe cochlear malformation (i.e., common cavity or ossification)
* External or middle ear infection
* Suspected developmental or cognitive concern
* Other medical contraindication for surgery or anesthesia
Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients

The purpose of this study is to determine whether treatment with daily oral dose of AZD8529 40 mg administered over 28 days is safe, well tolerated and improves main symptoms of schizophrenia in adult schizophrenia patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient will need to read, understand and sign an informed consent prior to any study specific procedures
* Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry

Exclusion Criteria:

* Patients will be excluded based on recent history of significant illness or current disease as assessed by the investigator during screening process (based on physical examination, laboratory studies and electrocardiogram studies)
* Patients will be excluded if urine drug screen test show positive results
* Smoking of more than 2 packs of cigarettes a day
Control of Edema in the Knee in Patients With Knee Osteoarthritis

The aim of this study was to compare the effectiveness of exercise and classical massage in the control of knee edema in patients with knee osteoarthritis.

This study will be a prospective randomized controlled study. It is planned to include 75 patients with knee osteoarthritis in this study. It was categorized as osteoarthritis(OA) stages according to Kellgren-Lawrence criteria. Patients were randomly divided into three groups. the investigators first group is the control group (KG) and this group will receive classical physical therapy with ultrasound and subcutaneous electrical nerve stimulation. Exercise therapy will be applied to the second group in addition to the classical physical therapy applied to the KG. The third group will be given classical massage in addition to the classical physical therapy applied to the KG. The treatments to be applied to the patients will be 3 sessions per week and it is planned to continue for 4 weeks. Knee edema, pain severity, functional status and daily life activities will be measured at the beginning and in the 4th week of the patients. The data obtained will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 30-65
* Patients with a diagnosis of osteoarthritis in stage 2 and stage 3 according to Kellgren-Lawrence criteria(1) and also with measurable edema

Exclusion Criteria:

* Inability to continue treatment regularly
* situations that prevent you from doing the exercise
* inflammation that interferes with massage.
Dexmedetomidine Versus Ketamine-midazolam Sedation in Awake Fiberoptic Intubation in Suspected Difficult Airway

The goal of this clinical trial is to obtain the optimal patient's comfort and cooperation during awake fiberoptic intubation with prototype device. The main question it aims to answer is:

Which drug provides better sedative effect during awake fiberoptic intubation, dexmedetomidine or ketamine- midazolam combination with prototype supraglottic topical anaesthesia device?

Awake fiberoptic intubation is the gold standard technique for managing patients with anticipated difficult airway. Conscious sedation and topical anesthesia is desirable, not only to make the procedure more tolerable and comfortable for the patient but also to ensure optimal intubating conditions. Ideal Topical Anesthesia and sedation regime for Awake fiberoptic intubation should provide comfort, cooperation, hemodynamic stability along with maintenance of spontaneous respiration. Several sedative agents have been assessed in previous studies) for this purpose (like benzodiazepine ,opioids ,ketamine , propofol and dexmedetomidine So it is important to know which has the best sedative effect dexmedetomidine or ketamine - midazolam combination with undisturbed respiratory function .

Eligibility Criteria:
Inclusion Criteria:

* Patient consent
* Age 21 to 60 years
* Both male and female
* ASA I and ASA II
* BMI : ((18.5 - 35 kg/ m2 )),
* Patient scheduled to undergo elective surgeries under general anesthesia.
* Patient with suspected difficult airway.

Exclusion Criteria:

* Sever chronic disease (cardiovascular, respiratory, renal and hepatic).
* Coagulopathies
* Mental retarted or psychiatric disorder.
Interest of Biofer ® Compound Used in Blédilait Follow on Milk in Infant With Latent Iron Deficiency

The primary purpose of the study is to demonstrate the superiority of Bledilait milk (Biofer® 2mg/100kcal) in comparison with ferrous sulphate supplemented milk (2 mg/100 kcal) in infants (6 to 12 months) with latent iron deficiency by measuring serum ferritin value after 2 months of consumption of studied milks.


Eligibility Criteria:
Inclusion Criteria:

* infant between 6 and 12 months of age,
* preterm infant, low birth weight infant (\< 2,5 kg), multiple pregnancy, infant from mother with close pregnancies (2 babies in 2 years),
* infant with a serum ferritin value \< 12ng/ml and with a normal haemoglobin value (\> 11 g/dl), i.e. with a latent iron deficiency,
* infant whose parents or legal tutors have given written informed consent,
* parents or legal tutors agreeing for 4 month follow-up by the investigator,
* infant for which a clinical exam has been performed,
* infant with health insurance.

Exclusion Criteria:

* infant with serum ferritin value \< 12 ng/ml and haemoglobin value \< 11 g/dl
* infant already receiving medicinal iron supplementation,
* infant with acquired or congenital defect,
* infant presenting a significant metabolic, organic or digestive disease able to interfere with study (including hemochromatosis)
* infant with congenital and/or chromosomal malformation
* infant receiving a drug susceptible, according to the investigator, to interfere with the measured study parameters
* infant needing specific infant formula (hypoallergenic, without cow milk proteins)
* infant in a situation that could, according to investigator, interfere with an optimal participation to the study or be a health risk
Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles

To determine whether colonic bubbles associated with CT colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation.

CT colonography (CTC) is a recently developed radiological examination to find colorectal neoplasia. Fecal/fluid tagging using oral administration of contrast is an essential procedure for CTC. Iohexol, which has recently started being used as an agent for fecal/fluid tagging, has great advantages as it has much more tolerable taste and much lower rates of adverse effects such as clamping or diarrhea compared with traditionally used Gastrografin/Gastroview. However, iohexol is frequently associated with an occurrence of a lot of bubbles in the colon, which makes CTC interpretation more time-consuming and laborious.

Past experience in colonoscopy field suggests that simethicone, a safety-proven highly inexpensive over-the-counter medicine, might resolve this issue. Given the fact that patient convenience is an important factor for a successful CTC and the fact that time-intensive nature of CTC interpretation is one of the major deterrents to wide spread adoption of CTC while CTC also needs to be as time efficient as possible in order to effectively serve the role of population screening for colorectal cancer, investigating the effect of simethicone to prevent the colonic bubbles on the time efficiency of CTC interpretation would be important. If simethicone can resolve the colonic bubble problem, CTC can be performed more conveniently for the patients as well as for the interpreting radiologists.

This study is to determine whether colonic bubbles associated with CT colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are schedule to undergo colonoscopy for a suspicion of colonic neoplasia at the investigators' institution
* Those who agree to participate in the study

Exclusion Criteria:

* Colonoscopy for reasons other than detecting colonic neoplasia, e.g. evaluation of inflammatory bowel disease
* Contraindications to iodinated contrast including renal insufficiency, hypersensitivity, and hyperthyroidism
* Acute severe colonic obstruction which is likely preclude safe and successful performance of CTC
* Patient who is suspicious for colonic perforation
* Pregnancy
* Phenylketonuria (contraindication to simethicone)