cyrilzakka/clinical-trials huggingface dataset:
Comparison of 3D Printed Composite Resin Crowns With Stainless Steel Crowns

The goal of this splith - mouth clinical trial is to compare 3D Printed Prefabric Composite Resin Crowns with Stainless Steel Crowns in healthy 50 children age between 5 and 9 with caries on more than one surface of the primary second molars.

The main question\[s\] it aims to answer are:

* 3D printed composite resin crown's survival rate is as succesful as stainless steel crowns
* 3D printed composite resin crowns periodontal integrity is as succesful as stainless steel crowns

Condition or disease : Carious Teeth

Intervention/treatment:

Procedure/Surgery: 3D Printed Prefabricated composite resin crown group Procedure/Surgery: Prefabricated stainless steel crown group

In this study, 3D Printed prefabricated composite resin crowns will be compared with prefabricated stainless steel crowns in a randomized controlled manner. The study will be conducted in split-mouth to eliminate the effect of potential confounders. The obtained data will be analyzed using appropriate statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged 5-9 years with caries on second primary molars
* Children without systemic disease or developmental dental anomalies that may affect caries susceptibility.
* Children whose cooperation is 'positive' or 'absolutely positive' according to the Frankl behavioral scale (Frankl et al., 1962).
* Those with deep dentin caries that do not extend to the pulp in the teeth to be treated
* The molars will be treated with a crown indication.
* Presence of symmetry of the primary molar to be treated in the opposite arch.
* The molar to be treated is in occlusion with the antagonist.
* Presence of caries on at least two surfaces of the molars to be treated.
* Absence of spontaneous pain, abscess, mobility, interradicular lesion in the tooth to be treated
* Patients whose parents and themselves agree to participate in the treatment

Exclusion Criteria:

* Children whose treatment cannot be continued on the dental chair due to cooperation
* Molars that will soon be exfoliated, 1/2 of the root has been resorbed
* The presence of bruxism
* The presence of erosion or attrition-related wear on the opposing molar
* The patient does not come to the control appointment or does not want to continue to the research
* Have allergy to local anesthetic, nickel or chromium
* Complications during treatment.
Part of the Modern Art Study

One of the possible treatments for patients with liver tumours (hepatocellular carcinoma (HCC) or liver metastases) at the Erasmus MC is stereotactic body radiation therapy (SBRT) on the Cyberknife. To spare the organs at risk, suboptimal coverage of the planning target volume is sometimes accepted. The Ethos treatment system is equipped with a novel cone-beam CT (CBCT), which provides higher quality images. This makes it possible to consider online adaptive radiotherapy with daily plan adaptation, potentially leading to a higher dose on the tumour whilst sparing the surrounding healthy tissue more.

Liver tumours move with the breathing motion. On the CyberKnife, a tracking technology is used to keep track of the tumour, but this is not available on the Ethos. Because of this, breath holds will be used for breathing management, but appropriate safety margins need to be established under the new treatment conditions. The aim of this study is to determine the reproducibility of the tumour position for each breath hold within a treatment fraction, and also between treatment fractions, which is a crucial component in the establishment of appropriate safety margins.

Rationale:

One of the possible treatments for patients with liver tumours (hepatocellular carcinoma (HCC) or liver metastases) at the Erasmus MC is stereotactic body radiation therapy (SBRT) on the Cyberknife. To spare the organs at risk, suboptimal coverage of the planning target volume is sometimes accepted on the Cyberknife. The Ethos therapy linear accelerator is equipped with a novel cone-beam CT (CBCT), which provides higher quality images. This makes it possible to consider online adaptive radiotherapy with daily plan adaptation, potentially leading to a higher dose on the tumour whilst sparing the surrounding healthy tissue more.

Objectives:

To determine inter- and intra-fraction fiducial and patient position reproducibility in order to determine appropriate safety margins for liver SBRT treatment on Ethos.

Study design:

A prospective, single arm cohort study.

Study population:

Ten patients, either with liver metastases (all ages), or age ≥ 65 years with HCC, who are referred to the department of Radiotherapy for SBRT, able to comply with breath-hold requirements and not eligible for liver transplantation or curative surgery.

Intervention:

Nine CBCTs for each patient in end-exhalation breath hold on t Main study parameters/endpoints: The primary parameters are inter- and intra-fraction fiducial position reproducibility on the Ethos.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent;
* Patient discussed in multidisciplinary tumor board;
* Patient diagnosed with liver metastases and referred to the dept. of Radiotherapy for SBRT OR patient ≥65 years, diagnosed with HCC and referred to the dept. of Radiotherapy for SBRT;
* Able to comply with breath-hold requirements.

Exclusion Criteria:

* Eligibility for surgery, ablation or liver transplantation.
TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure

To verify the efficacy of transcutaneous vagus nerve stimulation (tVNS) on and autonomic balance in patients with chronic heart failure and reduced (HFrEF) or mildly reduced (HFmrEF) left ventricular ejection fraction. The study hypothesis is that tVNS increases baroreflex gain, with consequent benefits on sympathovagal balance (at short- and mid-term), and on quality of life and bio-humoral parameters (at mid-term).

Pilot phase: comparing the effects of right- (10-minute) vs. left-sided tVNS (10-minute) on BRS and heart rate variability (HRV) in a subset of patients.

Short-term phase: comparing the effects of active- (10-minute) vs. sham-tVNS (10-minute) on BRS, HRV, and sympathetic nerve activity.

Mid-term phase: comparing the effects of active- (4-week) vs- sham-tVNS (4-week) on BRS, HRV, biomarkers, exercise performance, and cardiac function.

Eligibility Criteria:
Inclusion criteria

* Aged ≥18 years;
* Ability to consent to enrollment;
* Diagnosis of chronic heart failure (CHF= and left ventricular ejection fraction \<50% according to the latest European guidelines.

Exclusion criteria

* History of acute coronary syndrome within 3 months of enrollment;
* Clinical need to modify CHF therapy during the study;
* History of recurrent syncope, orthostatic hypotension, severe bradycardia (average heart rate \<50 bpm), or second or third-degree atrioventricular block;
* Neurological conditions characterized by dysautonomia (e.g., Parkinson's disease);
* Unstable major psychiatric disorders or treatment with psychoactive drugs or drugs that can act on the autonomic nervous system (e.g., antidepressants, antipsychotics, opioids, benzodiazepines);
* Uncontrolled thyroid disorders;
* Active neoplasia;
* Severe renal insufficiency (estimated glomerular filtration rate \<15 ml/min/1.73 m2);
* Moderate or severe chronic obstructive pulmonary disease (FEV1/FVC \<70% of predicted and FEV1 \<70%);
* Liver insufficiency (AST/ALT \>100 U/L and/or gamma-GT \>150 U/L);
* Participation in other clinical studies in the 3 months preceding;
* Women in pregnancy, breastfeeding, or of childbearing age not following adequate contraception (the woman must agree to abstain from heterosexual intercourse or use at least two effective contraceptive measures such as bilateral tubal ligation, male sterilization, use of hormonal contraceptives that inhibit ovulation, intrauterine devices releasing hormones, copper intrauterine devices; all barrier devices must be used in combination with a spermicidal cream).
Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis

This Phase 1 study has been designed to determine the safety, tolerability and pharmacokinetics (PK) of UHE 103 Cream compared to Naftin Cream, 2% under maximal use conditions for 2 weeks treatment in subjects with tinea cruris and/or tinea pedis


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male or non-pregnant female 18 years of age or older.
2. Subject has provided written informed consent.
3. Subject has a clinical diagnosis of moccasin-type tinea pedis with at least moderate scaling on at least 1 foot at Visit 1/Screening;
4. Subject has a clinical diagnosis of interdigital tinea pedis with at least moderate scaling on at least 1 foot (without moccasin-type tinea pedis) and tinea cruris at Visit 1/Screening.
5. Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.

Exclusion Criteria:

1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
2. Subject has any skin pathology or condition that could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
3. Subject has any clinically significant medical abnormality or history of chronic disease (cardiovascular, gastrointestinal, neurological, hematopoietic, immunosuppression \[HIV\], hepatic \[Hepatitis B or C\], psychological, renal systems, or respiratory), including conditions (e.g., gastrointestinal surgery) that may interfere with the absorption, metabolism, or excretion of investigational product.
4. Subject has used any of the following topical products on the feet or groin within 4 weeks of Visit 2/Enrollment: antifungals, antibacterials, or corticosteroid therapy.
5. Subject has applied any topical naftifine products to any part of their body within 4 weeks of Visit 2/Enrollment.
6. Subject has used topical keratolytics (e.g., urea, ammonium lactate, salicylic acid) on the feet or groin within 1 week of Visit 2/Enrollment.
7. Subject has used any other topical products on the feet or groin within 24 hours of Visit 2/Enrollment including, but not limited to non-medicated moisturizers, antipruritics, analgesics, anesthetics, etc.
8. Subject has received systemic antifungal therapy within 8 weeks or 5 half lives of the antifungal (whichever is longer) of Visit 2/Enrollment.
9. Subject is currently enrolled in an investigational drug, biologic, or device study.
10. Subject has previously been enrolled in a study for UHE-103.
11. Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 2/Enrollment.
12. Subject has a history of sensitivity to any of the ingredients in the test articles.
Population Health Approach to Optimizing Medications in Older Adults

This randomized controlled pragmatic pilot study examines the feasibility and acceptability of a population health-based deprescribing intervention that leverages a polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design.

This pilot clinical trial will examine the feasibility and acceptability of a medication management intervention that uses risk stratification to identify older adults (including older adults with Mild Cognitive Impairment or Alzheimer's Disease and Related Dementias) at greatest risk for polypharmacy-related adverse events. The intervention will use a risk prediction model to identify potential study participants for inclusion and enroll them and their care partners into a polypharmacy clinic. The study will stratify patients by cognitive impairment status. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be invited to enroll in the study if they are in the top decile of risk selected by a risk prediction model of polypharmacy-related adverse events. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.
* 65 years of age or older
* Have a primary care clinician within the Cedars-Sinai Health System who uses MyCSLink (electronic health record used by Cedars-Sinai).
* Part of a Cedars-Sinai Health System population health registry (e.g., enrolled in an Accountable Care Organization, Medicare Advantage plan, or Primary Care First program)
* Diagnosis of Mild Cognitive Impairment or Dementia at baseline (for one intervention group) on the problem list

Exclusion criteria include:

* Patients for whom there is an active substance use disorder (defined by a physician) and thus for whom the intervention may not be appropriate
* Patients with an organ transplant
* Visits with a Cedars-Sinai Medical Center pharmacist for a polypharmacy consult within the last 6 months
* Patients who previously indicated in the EHR that they wish to opt out of participating in research studies.
* Patients enrolled in CS360, a program for highly complex medical patients, who already receive polypharmacy services.
Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)

This observational study of a national cohort of 600 Swedish PSC patients include yearly MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions, symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC patients and provide future possibilities to evaluate biomarkers for prognosis and early cancer detection.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PSC by MR/MRCP
* Life expectancy \>1 year
* Informed consent

Exclusion Criteria:

* Liver transplantation or on the waiting list
* Secondry SC
* Diagnosis of CCA
Memantine and Validation of a New Alzheimer's Disease Scale

To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of Alzheimer's type.
* Signed informed consent prior to the initiation of any study specific procedures.
* Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests.

Exclusion Criteria:

* Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
* Intake of any medication that is contra-indicated in combination with memantine.
* History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose.
* Known or suspected history of alcoholism or drug abuse within the past 2 years.
* Current or previous treatment with memantine or participation in an investigational study with memantine.
Transcutaneous Electric Nerve Stimulation for Pain Relief During Extracorporeal Shock-wave Lithotripsy

This study evaluates pain relief during extracorporeal shock-wave Lithotripsy by using transcutaneous electrical nerve stimulation (TENS) and comparing it with fentanyl which is a narcotic analgesic. Half of the participants will receive a primary fentanyl dose together with TENS application, another half will receive a primary fentanyl dose. All patients will receive fentanyl increments if they still complained of pain.

The ideal anesthesia technique for ESWL must provide good analgesia, sufficient sedation, and rapid recovery with minimal side effects. Opioids are commonly used analgesics during ESWL. Fentanyl is a potent synthetic narcotic, which has rapid onset and a short duration of action, it offers an acceptable analgesia during ESWL but has a noticeable respiratory depression.

Transcutaneous electrical nerve stimulation (TENS) is a method in which low voltage electrical impulses transmit through electrodes attached to the skin over a painful area. It is usually used to relieve a variety of painful conditions. A TENS unit contains electrical signal generator, a battery in addition to a set of electrodes. The TENS is small, programmable and the generator can deliver stimuli with different current intensities, pulse rates and pulse width.

The mechanism of analgesia by TENS has been explained by many theories. the gate control theory by Melzack and Wall, stated that "when an electrical current is applied to a painful area, transmission of pain through small diameter fibers is inhibited by the activity of the large diameter, fast-conducting proprioceptive sensory fibers, closing the gate to the pain perception to the brain". Another mechanism suggested is activation of descending inhibitory pathway, via release of endogenous opioids.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for extracorporeal shock-wave Lithotripsy (ESWL), having a solitary renal stone 6 - 15 mm.
* Age18 to 75 years old.
* ASA physical status I -II.
* BMI of 25- 30.

Exclusion Criteria:

* Patients with bleeding and coagulation disorder.
* Hypertension.
* Pregnancy,
* Patient with demand pacemaker.
* Dermatological lesions at the site of ESWL e.g. eczema or dermatitis.
* Drug or alcohol addiction.
The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients

This study evaluates the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. Sleep deprivation and chronobiological augmentation may offer a rapid and sustained antidepressant response in mood disorder patients treated with medication, sleep deprivation, bright light therapy and sleep phase advance compared with medication only. The chronobiological treatment is rapid, non-invasive and has few side effects and could be of significant clinical benefit.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include:

1. Subjects must be English speaking
2. Subjects must have either bipolar or unipolar depression diagnosis or be a normal control.
3. Subjects must be between : 18 to 75

Non-English speaking subjects will be excluded since scales for measuring depression have not been validated in languages other than English.

Exclusion Criteria:

Exclusion criteria include:

1. Suicidality, or psychosis
2. Unstable medical conditions
3. Epilepsy, serious head injury, or other significant neurological disorders
4. Dementia, mental retardation (moderate or severe), coma
5. Prior exposure to radiation which might cause the subject to exceed standard guidelines
6. Substance abuse or alcoholism in the past six months
7. Unreliability or inability to adhere to the requirements of the study
8. Irregular sleep-wake schedules (nightshift, jet lag)
9. Use of CNS medications which may affect sleep or functional brain imaging (i.e., use of sleeping pills, antidepressants or other mood stabilizers or other medications which may affect the sleep EEG)
10. Sleep apnea, periodic limb movements of sleep, narcolepsy, circadian sleep phase disorders
11. Donation or loss of blood (\>400 ml) within the past month
12. Current or very recent intercurrent illnesses, painful conditions or other disorders, which in the judgement of the investigators, might invalidate the scientific goals of the study or pose undesirable difficulties or risks for the subject.
13. Hamilton Rating Scale of Depression (HRSD-17 items)\<17 unless subject is a normal control subject.
14. Pregnancy or breast feeding
15. Individuals who would be unable to undergo a magnetic resonance imaging (MRI) scan, for example, individuals who suffer from claustrophobia, or who have metal clips in their body.
16. Unable to cease taking psychoactive medications which are not part of this protocol (2-5 weeks) prior to PET scans.
17. Patients with previous history of significant adverse reactions to sertraline or sertraline-like drugs or other SSRI's such as Paxil or Prozac
18. Subjects with diagnosis of eating disorder/bulimia
Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection

The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma（cT1-4a, N-/+, M0）.

Indocyanine Green Tracer is often applied in surgery for early gastric adenocarcinoma. Its application in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma.

On the basis of more than 3000 cases of laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in gastric adenocarcinoma, to guid the scope of laparoscopic lymph node dissection for gastric adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years
* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* American Society of Anesthesiology score (ASA) class I, II, or III
* Written informed consent

Exclusion Criteria:

* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
* History of other malignant disease within past five years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values
* Diffuse; widespread; plastica