cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Marginal, Internal Adaptation and Clinical Performance of Endo-crowns Fabricated From Nano Hybrid and Lithium Di-silicate Ceramic Materials.

Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.

Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.

Primary outcome: Marginal gap of the two groups will be measured using Silicon replica technique, Each replica will be sectioned bucco-lingually and mesio-distally into four segments named (MB, DB, ML, DL) and each segment has five reference points assigned at different positions, An overall of twenty reference points will be measured in each replica sample using a digital microscope.

Secondary outcome:

* Internal gap of the two groups will be measured using Silicon replica technique, which will be measured by digital microscope.
* Clinical Performance of the two groups will be evaluated using modified USPHS scoring system. (Color match, Marginal discoloration, Surface texture and Gross fracture)

Eligibility Criteria:
Inclusion Criteria:

* From 18-50 years old, be able to read and sign the informed consent document.
* Have no active periodontal or pulpal diseases, have teeth with good restorations.
* Psychologically and physically able to withstand conventional dental procedures.
* Patients planned for a single coverage restoration in the posterior area.
* Able to return for follow-up examinations and evaluation.
* Patients have root apex of molar without evident damage and no root fracture.
* Good oral hygiene habits.
* Have a complete root canal therapy molar necessitating an Endo-crown restoration.

Exclusion Criteria:

* Patient less than 18 or more than 50 years
* Patients with severe clenching or bruxism.
* Patient with active resistant periodontal diseases
* Patients with poor oral hygiene and uncooperative patients
* Pregnant women
* Patients in the growth stage with partially erupted teeth
* Psychiatric problems or unrealistic expectations
* Patients with inadequate or low quality endodontic treatment.
The Effects of Cannabis on Male Reproductive Functions

The purpose of this study is to understand the direct effects of cannabis on male reproductive functions. The investigators plan to conduct a double-blind, placebo-controlled clinical trial to examine both the chronic and acute effects of cannabis use on male reproductive functions. Specifically, the investigators will examine the dose-dependent effects of acute cannabis use on male reproductive parameters, including sperm counts, motility, morphology, and testosterone levels, as well as sperm epimutations.

Participants \[cannabis users will be randomly assigned to 1) non-vaping, 2) placebo (vaping without cannabis), and 2 doses of cannabis, 3) 20 and 4) 40mg of THC in cannabis flower obtained from the NIDA drug supply\], and 5) non-cannabis users (naïve control, no cannabis or placebo exposure).

Participants will provide surveys (cannabis use and sexual functioning and satisfaction etc.), peripheral blood, and semen.

The Volcano Vaporizer will be used to expose cannabis or placebo plants.

Eligibility Criteria:
Inclusion Criteria:

* Regular cannabis users (21\~64 years-old men) who have used cannabis at least once a week for at least once a year or who have never used cannabis.
* Willingness to abstain from using cannabis on the day of the testing session (minimum 5 hours abstinence).

Exclusion Criteria:

* Women
* Adult men, 65 or older, and men under the age of 21
* Serious psychiatric conditions (e.g. psychosis, bipolar I and panic disorder)
* Family history of psychosis
* Chronic medical conditions (e.g., heart disease, diabetes)
* History of adverse experiences with cannabis (e.g., anxiety and panic attacks)
* Use of other illicit drugs (not cannabis) in the past 2 months
* Heavy alcohol use (\>4 drinks, \>4 times/week)
* Smoking/nicotine use
* Infrequent cannabis use (less than once a week for only cannabis users)
* BMI over 34
* Current use of corticosteroids and blood thinners
Sleep and Daytime Activity in Healthy Subjects

Sleep relate to cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* patients
Laparoscopic Surgery Versus Radiofrequency Ablation for Recurrent HCC

Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of death from cancer worldwide1 . Hepatectomy is still the main effective treatment for HCC accompanying with well-preserved cirrhosis when liver transplantation is not feasible due to the lack of donors Recurrence of tumor within the liver remnant is also common, with a reported 5-year recurrence rate of 50-70%, in patients who have undergone "curative" hepatectomy. Management of recurrent HCC is still urgent and several treatments have been developed. Repeat hepatectomy is considered to be the first choice for recurrent HCC with a 5-year survival rate of 19.4 to 56%. Unfortunately, repeat hepatectomy can be performed only in a small proportion of patients with HCC recurrence due to the poor functional liver reserve or because of widespread recurrence. With a 3-year survival rate of 62% to 68% after treatment, radiofreqency ablation (RFA) has been used as an effective treatment for recurrent HCC. The efficacy of RFA for recurrent HCC has been reported to be comparable to those achieved by surgery. Laparoscopic surgery was considered not to be a suitable treatment for recurrent HCC due to postoperative adhesions that can make laparoscopic surgical procedure more difficult and less safe. Recently, several studies reported that laparoscopic surgery for recurrent HCC in cirrhotic patients is a safe and feasible procedure with good short-term outcomes. By far, no study has been performed to compare the efficacy and safety of laparoscopic surgery with RFA for treatment of recurrent HCC.


Eligibility Criteria:
Inclusion Criteria:

1. age 18-75 years;
2. recurrent HCC after curative partial hepatectomy;
3. no other treatment received except for partial hepatectomy;
4. a solitary recurrent HCC ≤ 5.0 cm in diameter, or multiple recurrent HCC ≤ 3 lesions, each ≤ 3.0 cm in diameter;
5. no radiologic evidence of invasion into major portal/ hepatic vein branches ;
6. no extrahepatic metastases;
7. Child-pugh class A or B liver cirrhosis;
8. American Society of Anesthesiologists (ASA) score ≤ 3;
9. Eastern Co-operative Oncology Group performance (ECOG) status 0;

Exclusion Criteria:

1. coagulation disorders (prothrombin activity \<40% or a platelet count of \<80,000/mm3);
2. Child-Pugh class C liver cirrhosis;
3. history of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding;
4. a history of a secondary malignancy;
5. active infection (except viral hepatitis);
6. severe dysfunction of the heart, kidney, or other organs
A Study of LY3832479 (LY-CoV016) in Healthy Participants

The main purpose of this study is to learn more about the safety of LY3832479 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3832479 is in the bloodstream and how long it takes the body to eliminate it. Participation could last up to 16 weeks and may include up to 10 visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation including medical history and physical examination

Exclusion Criteria:

* Test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
* Pregnant women and women of childbearing potential
* Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that, in the opinion of the investigator, are capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk while taking the investigational product, or of interfering with the interpretation of data
* Have participated in a clinical study involving an investigational product, with last dose within the past 30 days or 5 half-lives (whichever is longer) prior to dosing
Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP

LASIK is a refractive surgery technique widely used in France. Postoperatively, the classic treatment after LASIK consists of instilling drops to reduce dry eyes. REPADROP® is an innovative eye drops stimulating corneal innervation. To date no study has quantified the improvement in dry eye syndrome and thus the quality of life of patients using REPADROP®.


Eligibility Criteria:
Inclusion Criteria:

Age over 18

* Planned bilateral LASIK surgery
* Use of Repadrop as postoperative eye drops
* Patient agreement to participate

Exclusion Criteria:

* History of corneal pathology
* Diabetes
* History of treatment with REPADROP® or CACICOL® or NGF® (other eye drops which are no longer available on the market to date but which would also improve corneal healing)
* Ongoing treatment with topical cyclosporine
* Presence of punctal plugs
* Adults who are the subject of a legal protection measure (guardianship, curators)
* Pregnant or breastfeeding women
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:

   1. 14 or less headache days per month during the 3 month period prior to the Screening Visit
   2. 6 or more migraine days during the Observation Period
   3. 14 or less headache days during the Observation Period
   4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
   5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
   6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
   7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \<18 years; subjects must be less than 18 at the time of signing assent / consent.

      3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.

Exclusion Criteria:

1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
3. The subject has a history or diagnosis of complications of migraine
4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
5. The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
7. History of major psychiatric disorder.
8. The subject has a current diagnosis or history of substance abuse
9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.
Trail Evaluating Apatinib With IMRT for Inoperable or Iodine Refractory Thyroid Cancer

To determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand character and individual consequences of the clinical trial. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;
* Aged ≥ 18 years old;
* Pathologically confirmed inoperable or iodine refractory thyroid cancer, or postoperative residual disease detected by imaging studies, or progression disease within 12 months before enrollment. (all with measurable disease ≥10mm according to RECIST 1.1);
* ECOG0-2;
* Adequate laboratory values within 14 dyas of enrollment to study defined as follows: N ≥ 1500/mm\^3; PLT ≥ 80,000/mm\^3; HB≥90g/L;total bilirubin \< 1.25ULN; AST/ALT \< 2.5 ULN or \< 5 ULN with metastasis; SCr ≤1ULN; CCR \> 50ml/min;
* The survival period is expected to be greater than 3 months;
* Willing to accept adequate contraception for patients with childbearing potential.

Exclusion Criteria:

* Take chemotherapeutic chemotherapy (the use of low-dose chemotherapy for radiosensitization was allowed) or thalidomide and its derivative treatments;
* Take VEGFR-TKI within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib;
* Allergic to apainib;
* Uncontrolled high blood pressure and heart disease;
* Patients with gastrointestinal bleeding risk;
* Coagulation disorders(INR\>1.5×ULNAPTT\>1.5×ULN);
* Uroprotein positive (Uroprotein≥2+ or 24-hour urinary protein quantity \>1.0g);
* Pregnant or lactating women.
A Study to Determine the Safety, Tolerability and Efficacy of KP-413 in Subjects With Atopic Dermatitis(AD)

The purpose of this study is to assess the safety, tolerability and efficacy of KP-413 topical ointment compared with vehicle ointment in treating adult subjects with atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Has a clear diagnosis of AD meeting the Hanifin and Rajka criteria for AD that involves both the head/neck and the torso/limbs, and affects 5-30% of the subject's total BSA as determined using the rule of nines
* Has a Baseline IGSS of 3(moderate) or 4(severe) in the selected treatment area on the torso/limbs, and a Baseline IGSS of 2(mild), 3(moderate) or 4(severe) in the selected treatment area on the head/neck.
* Female of childbearing potential has a negative pregnancy test and will be using an effective method of contraception during the study.

Exclusion Criteria:

* Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
* Has a Baseline oozing/crusting score of 3(moderate) or greater at the selected treatment area on the head/neck or torso/limbs.
* Presence of a concurrent skin condition that could interfere with assessment of treatment.
* Treatment with any investigational drug or device within 30 days or 5 half lives(whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.
Fluid at Work Study

The aim of the Fluid at Work Study is to develop and evaluate a fluid intake measurement tool for use in the UK working population.

From the results of a systematic review and a round table discussion a novel fluid measurement tool has been developed - the Workplace Beverage Intake Questionnaire (WBIQ)

The observational evaluation study will measure the relative validity and reliability of WBIQ for assessing fluid intake in a workplace population.

The aim of the Fluid at Work Study is to develop and evaluate a fluid intake measurement tool for use in the UK working population.

From the results of a systematic review and a round table discussion a novel fluid measurement tool has been developed - the Workplace Beverage Intake Questionnaire (WBIQ)

WBIQ will be used to conduct a preliminary investigation of relative validity and reliability. Relative validity of the tool will be tested, rather than 'absolute validity', as there is no 'gold' standard measure for exact fluid intake in free living population groups.

Individuals responding to local advertisements will complete an initial telephone or email questionnaire, and then eligible respondents will be asked to attend King's College London for a screening visit where they will be asked questions to confirm their inclusion criteria. Inclusion criteria: full-time disked based/ office workers. Following confirmation of eligibility and written consent participants will be asked to attend two study visits 7-days apart and complete three on-line fluid intake surveys.

Eligibility Criteria:
Inclusion Criteria:

* Full-time employee working in a desk-based role
* No history of heart attack, stroke, angina, thrombosis, liver or kidney diseases, diabetes, chronic gastrointestinal disorder, or cancer
* Able to remain within the UK during the 8-10-week period of testing
* No history of excess alcohol intake or substance abuse
* Agree to not drink alcohol for the 7-day period of dietary data collection
* Not already participating in a clinical trial
* Not currently taking medication that is likely to alter kidney function or fluid balance
* Able to understand the information sheet and willing to comply with study protocol
* Able to give informed written consent

Exclusion Criteria:

* Pregnant or breast feeding
Assessment of the Skin-concentration of Vildagliptin 50 mg Every 12 Hours for 10 Days in Healthy Subjects and Patients With Type 2 Diabetes

This study will look at the skin accumulation of vildagliptin and its two major metabolites, LAY151 and LAF237-O-Glucuronide, after vildagliptin 50 mg given orally twice a day for 10 days in both healthy volunteers and patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers and patients with type 2 diabetes
* Non-smoking, Caucasian and African American, male and female (postmenopausal, surgically sterile or using double-barrier method of contraception) subjects between 30 and 65 years of age (inclusive)
* Type 2 diabetics on metformin and/or sufonylurea

Exclusion Criteria:

* History of type 1 diabetes or insulin use
* History of coagulation abnormalities
* History of abnormal heart conditions
* Pregnancy or breastfeeding

Other protocol-defined inclusion/exclusion criteria may apply
Validation of Frontal EEG to Formal Polysomnography in the ICU

The purpose of this study is to compare a 2-lead frontal electroencephalogram recording to a formal polysomnography (PSG) in detecting sleep vs. wake and depth of sleep in both healthy and ICU patients.

Sleep in the intensive care unit (ICU) is poor and not well understood. Formal polysomnography (PSG) is the gold standard measure, but impractical for critical care. The relative influence of environment, illness and interventions on sleep in critically ill patients is therefore essentially unknown. Interventions to improve sleep have been pragmatic and outcomes subjective or indirect, and uninformed. When it is done, formal PSG in critical illness demonstrates fragmented, shortened, interrupted and non-circadian sleep, with environmental noise, light, and frequent physical stimulation causing arousals.

Eligibility Criteria:
Group 1: Healthy Subjects in Sleep Lab:

Inclusion Criteria

* Age 18 or older
* Scheduled for a standard of care polysomnography lasting at least 8 hours for any condition

Exclusion Criteria

* Patient/Legally Authorized Representative declines consent

Group 2: ICU patient, not sedated, not ventilated

Inclusion Criteria

* Age 18 or older
* Anticipated to stay in intensive care unit overnight (minimum 8 hours)
* Glasgow Coma Scale score of 13 or great

Exclusion Criteria:

* Intubated with endotracheal tube
* Sedated (includes sedative drugs such as propofol, Dexmedetomidine, versed infusion above 2mg/hr, ketamine infusion above 0.2 mg/kg/hr).

Group 3: ICU patient, sedated and ventilated

Inclusion Criteria:

* Age 18 or older
* Anticipated to stay in the intensive care unit overnight (minimum 8 hours)
* Intubated, sedated, and ventilated

Exclusion Criteria:

* Presence of traumatic brain injury
* Planned extubation in next 8 hours
* Scheduled to leave the intensive care unit for any reason in the next 8 hours
* Anticipated life expectancy of less than 24 hours
* Electroencephalogram monitoring (current or scheduled in the next 8 hours)
* Hemodynamic instability (defined as: (i) mean arterial pressure \<60mmHg for \>20 minutes with efforts to raise it or (ii) \>2 liter fluid administered in 2h after operating room and anticipating on-going needs for fluid resuscitation or (iii) ICU MD determination of "atypical and profound hemodynamic instability" or (iv) PI determination after evaluation.
* Refractory hypoxemia - defined as Saturation \<88% on Sp02 despite efforts to increase it
* Hemorrhage - defined as \>500cc chest tube output in 2h and anticipated need of more than 2 units of packed red blood cells in immediate post op period. This does NOT include cell-saver.
Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging

Apply the LASCA for follow-up the postocclusive microcirculation after strangulation of the gingiva in order to characterize the kinetics of the blood flow changes in human subjects.

During surgical endodontics the cortical bone is exposed by elevating a full- thickness tissue flap. Cutting across mucosal blood vessels disturbs perfusion and causes ischemia. On the other hand, preserving sufficient blood flow of the soft tissue segment is important for the postoperative wound healing. In order to minimize the damage of the microvasculature of the operated area, the incision should be properly designed.

The investigators will model surgical incisions by strangulation of the gingiva of healthy human subjects based on the commonly applied endodontic incision such as horizontal, vertical and papilla base. The primary aim is to determine the effect of a short term disruption of the blood flow at the respective region on the surrounding area in order to assess the functionally active collateral circulation. Using Laser Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation during and after a short term of strangulation. The secondary aim is to assess the time course of the restoration of the circulation on the affected area.

Eligibility Criteria:
Inclusion Criteria:

* general good health

Exclusion Criteria:

* pregnancy
* smoking
* general diseases
* medicine taking except contraceptives