cyrilzakka/clinical-trials huggingface dataset:
Topical Myristyl Nicotinate Cream on the Skin of Healthy Volunteers

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of topical myristyl nicotinate cream may stop skin cancer from forming.

PURPOSE: This randomized phase I trial is studying the side effects and best way to give topical myristyl nicotinate cream on the skin of healthy volunteers.

OBJECTIVES:

* To determine if topical myristyl nicotinate (MN) is a safe, tolerable treatment in healthy volunteers.
* To determine if topically administered MN cream is associated with any significant local or systemic toxicity in normal human subjects in a one-month period.

OUTLINE: Participants are randomized to 1 of 2 treatment arms and serve as their own controls.

* Arm I: Participants apply topical myristyl nicotinate to one forearm and topical placebo to the other forearm once daily for 4 weeks.
* Arm II: Participants receive treatment as in arm I but on opposite forearms. All participants undergo blood collection for chemistry analysis (SMA-20 and CBC) at baseline and at 2 and 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older with normal skin
* Have used no topical medications on the skin of the upper extremities, except for emollients or sunscreens, for at least 30 days prior to study entry
* Agree to limit sun exposure as much as possible and wear protective clothing on the forearms in place of using sunscreens or moisturizers
* Ability to understand and willingness to sign an informed consent before initiation of therapy after the nature of the study has been explained to them
* Females must be surgically sterile by hysterectomy or post menopausal

Exclusion Criteria:

* Subjects with no signs of inflammation or irritation of the skin on the forearms
* Subjects with prior history of actinic keratosis or skin cancer on the forearm
* Females of child bearing potential
* Subjects with any concurrent therapy (e.g., retinoids, fluorouracil) on the forearms that may interfere with clinical evaluations
* Subjects taking oral supplemental niacin, by itself or in the form of a multi-vitamin that exceeds 40 mg/day
* No known immunosuppression by virtue of medication or disease, including AIDS patients, subjects taking oral prednisone, and subjects on immunosuppressants/immunomodulators( cyclosporine, chemotherapeutic agents, or biologic therapy), determined by the examining investigator/co-investigator
* Uncontrolled intercurrent illness including, but not limited to any of ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Subjects who have had invasive cancer within the past 5 years
* Skin conditions felt by the study physician to contraindicate enrollment including, but not limited to, psoriasis or atopic dermatitis within a proposed treatment area
* Less than 30 days since prior and no concurrent or planned participation in another clinical trial
Active Cue-Training in Neglect

The presented study investigates standardized visual cueing in reading and visual spatial task as a treatment method for spatial neglect. In a randomized controlled design patients receive either cued reading and visual spatial tasks (intervention) or treatment which is unspecific to neglect (control).

In the intervention condition, patients with left-sided neglect receive intense training, including reading and visual spatial task with standardized and adapted visual cueing by the therapist. Improvements in reading and visual spatial tasks lead to a reduction of cues by the therapist. Accordingly, the patient has to apply self-cueing over time in order to solve the task.

For the control condition, all patients receive unspecific treatment without any standardized adapted cueing implemented by the therapist.

To enhance the effectivity of cueing in reading and visual spatial tasks, the investigators additionally conduct parietal transcranial direct current stimulation (tDCS) in those patients without tDCS exclusion criteria (see exclusion criteria below).

It is hypothesised that systematic and adaptive therapeutic cueing leads to a significant reduction of omissions of word and word parts in reading.

UPDATE: No Add-on tDCS was performed since it was not applicable for our severly impaired patients due to the strict exclusion criteria of tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Left sided neglect
* Capacity of at least 30 minutes
* Ability to read in German language
* Mobilization of 80%

Exclusion Criteria:

* Previous known dementia
* Normal pressure hydrocephalus

Exclusion Criteria for tDCS Add-on (not exclusion of the intervention):

* Shunt
* Craniectomy
* Epilepsy
* Other metal implants
Study of the Preservation of the Left Colic Artery on Rectum Cancer Surgery

To evaluate the influence to the blood supply of the anastomosis and the harvest of the No. 253 lymph nodes in different surgical methods--- preserving the left colic artery (LCA) and resect the No. 253 lymph node specifically in the radical resection of rectal carcinoma or dividing at the root of the inferior mesenteric artery (IMA) in the radical resection of rectal carcinoma.

Methods: The patients who got rectal carcinoma are divided into two groups. Both groups will receive the radical resection of rectal carcinoma. We preserve the left colic artery and resect the No. 253 lymph node specifically in Group A and divide at the root of the inferior mesenteric artery in Group B, We insert a trocar into the arterial arcade at the proximal site of the anastomosis and measure the blood pressure of the arterial arcade in the operation, which can reflect the blood supply of the anastomosis. Besides, We will measure the length of the colon from the anastomosis to the level of the root of the IMA. Expecting Results：The blood pressure of the arterial arcade in Group A will be higher than that in Group B. And the patients in Group A will have less chance to get anastomotic fistula. Expecting Conclusions: Preserving the LCA and resecting the No. 253 lymph node specifically in the radical resection of rectal carcinoma can improve the blood supply of the anastomosis and decrease the incidence of anastomotic fistula, and won't affect the harvest of the No. 253 lymph node.

Eligibility Criteria:
Inclusion Criteria:

* Patients coming to FirstJilinU diagnosed rectum cancer by endoscopy and pathology.
* The rectum cancer is the first malignant neoplasm the patient has got.
* The cancer is solitary, and is 3cm to 20cm to the anus.
* The surgical method is limited to Dixon.

Exclusion Criteria:

* Being in the acute phase of inflammation before operation and emergency surgery.
* Patients receiving steroid medication or preoperative radiotherapy。
* Discovering macrometastasis before or in the operation.
* The rectum cancer that can't be radical resected.
Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

The world prevalence of obesity in adult population in 2016 was 650 million while in Indonesia, it has increased from 14,8 percent to 21,8 percent in 2018. Obesity is an established risk factors for metabolic and non communicable- diseases. The purpose of this research was to assess the different effect on waist circumference, insulin resistance and oxidative stress marker between fasting (intervention) group and not fasting (control) group after 8 weeks 5:2 intermittent fasting (IF) among obese male workers.

Intermittent fasting is eating pattern in that cycles between periods of fasting and eating. 5:2 intermittent fasting (IF) is a form of time-restricted fasting which no calories are consumed for at least 14 hours (for 4 am to 6 pm) will done in two non-consecutive days days per week, followed by ad libitum intake on the remaining days, with water restriction too.

Participants will be distributed to each group by simple randomization. This study will access the characteristic data, dietary intake and physical activity from the participants. Anthropometry and blood sample (for insulin resistance (HOMA-IR) and oxidative stress (malondialdehyde and catalase)) were taken at baseline and at the end of the study. Participants from each group will gets counseling at the second week of intervention and they will follow up to 8 weeks with control and evaluation form.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 30-59 years
* Has a BMI ≥ 25 kg/m\^2
* Has a waist circumference of ≥ 90 cm
* Willingness to participate in the whole study by signing informed consent

Exclusion Criteria:

* Doing regular fasting (2 days a week) for 12 weeks before the study begins.
* In a certain diet at the moment
* Participants who are taking drugs that can affect blood sugar, insulin, and drugs (steroids, beta blockers, adrenergics), vitamins or herbal supplements and other drugs that affect oxidative stress.
* Participants suffering from obesity with complications such as impaired liver function, impaired kidney function, heart disease and type 2 diabetes mellitus are known through anamnesis and physical examination as well as fasting blood sugar checks.
* Participants that has a fever with temperatures\> 37.5 ℃
Expectant Versus Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW

Compared the interest of one week expectancy vs immediate medical treatment in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.

Randomized control trial comparing one week expectancy vs immediate medical treatment (mifepristone 200mg and misoprostol 400ug) in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.

Eligibility Criteria:
Inclusion Criteria:

* Agreed women aged over 18 yrs old

Non evolutive pregnancy before 13GW :

* Non evolutive pregnancy with no fetal cardiac activity
* Non evolutive pregnancy with embryonic structures
* Trophoblastic material in uterine cavity P bhCG \< 10UI/L

Exclusion criteria:

* Age \< 18 years
* pregnancy evolutionary
* not evolutionary pregnancy after 13 weeks of amenorrhoea characterized by the presence of an scan image intra-uterine ANECHOGENE furthermore of 50mm of diameter
* amenorrhoea of more than 13 weeks
* pregnancy twin
* pregnancy molar
* pregnancy extra-uterine
* Extra-uterine pregnancy
* one or many contraindications in the mifepristone:
* Allergy known about the MIFEPRISTONE
* Incapacity suprarenal
* corticosteroid therapy in the long price
* confusions of the haemostasis (thrombopenia \< in 100000 / mm3)
* anaemia (rate Hg \< in 9 g / dl)
* contraindication in the misoprostol
* allergy known about PROSTAGLANDINES
* BEANCE cervical
Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer

A Pilot study on circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)

Prospective single-center feasibility study of 30 patients with carcinoma breast with low levels of HER2 expression, defined as 1+ or 2+ expression levels by the IHC technique (immunohistochemistry) and the gene not amplified by the ISH test (in situ hybridization)

Eligibility Criteria:
Inclusion Criteria

* Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing.
* Participants should be at advanced or metastatic setting prior to treatment.
* Written informed consent (Accordo di Partecipazione alla Ricerca Scientifica) and specific informed consent to the study must be signed and dated by the patient and the doctor prior to inclusion.
* Patients must be accessible for follow-up.
Pathways 2 Success

This study involves a 3-arm randomized controlled trial designed to investigate the feasibility and acceptability of three preventive interventions designed to reduce risk for escalations in adolescent conduct problems. High school students identified to be at risk for conduct problems will be randomly assigned to one of three intervention options, including a mindfulness-based program, a mindfulness-based program augmented by a new mobile app, and a life skills program. Assessments related to intervention outcomes will be completed by adolescents, parents/guardians, and teachers at baseline, 2 weeks post-intervention, and at a 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. A 9th or 10th grade student in a partner school district
2. Referral due to elevated social/emotional risk indicated on a standardized screening tool or a referral from school support staff due to concerns about school-based conduct problems
3. Adolescents and their parents must be fluent in English

Exclusion Criteria:

1. Currently receiving special education services (i.e., an IEP) due to a behavioral or emotional disturbance
2. Existing diagnoses of autism spectrum disorder, pervasive developmental disorders, developmental/intellectual disability, or serious psychiatric disorders requiring specialized mental health treatment (e.g., psychosis, bipolar, substance use disorder, etc.)
Huperzine-A to Help With Mental Problems and the Inability to Care for Onself in Patients With Schizophrenia

Use Huperzine-A, a herbal supplement normally used for treatment of Alzheimer's disease, to potentially improve cognitive dysfunction (memory problems) and functional capacity (ability to perform common daily tasks such as cooking, bathing, telephone, shopping) in people with schizophrenia.

HupA, an alkaloid initially identified from the Chinese herbal medicine Huperia serrata, is a potent reversible acetyl cholinesterase (AChE) inhibitor with additional unique properties including NMDA-receptor antagonist properties, neuroprotective and antioxidant effects. In animal studies, HupA was shown to possess greater inhibitory, longer-lasting, and more selective effects on AChE activity than donepezil. In clinical studies HupA improved memory, mood, and activities of daily living in patients with Alzheimer's dementia. Adverse effects have been reported at a very low rate in all the clinical trials, and are mainly cholinergic, such as dizziness, nausea, gastrointestinal symptoms, headaches and depressed heart rate. Thus, HupA is an attractive option which may have beneficial effects not only on cognitive but also functional domains of schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

1. age 19-59
2. diagnosis of schizophrenia by MINI
3. cognition score 1 standard deviation below published norms in controls
4. clinically stable for 12 weeks i.e. on the same antipsychotic(s) for 8 weeks and stable dose for at least 4 weeks
5. have no more than moderate severity rating on hallucinations, delusions formal thought disorder (BPRS), negative symptoms (PANSS_N)
6. minimal EPS (Simpson-Angus \<6)
7. minimal depression (Calgary \<10)
8. stable dose of other psychotropics (2 months)
9. not pregnant.

Exclusion Criteria:

1. history of active peptic ulcer disease within 1 year of screening
2. clinically significant cardiac arrhythmia
3. resting pulse less than 50
4. active cancer (skin tumors other than melanoma are not excluded)
5. history of clinically significant stroke
6. current evidence or history in the past 2 years of epilepsy, focal brain lesion
7. start of cholinesterase inhibitors/ cognitive enhancers (galantamine, rivastigmine, donepezil, vitamin E and memantine) within 2 months of screening, 8. use of medications with significant central nervous system anticholinergic activity within 2 months of screening.
Study of Use of Synera for Pain During Local Skin Infiltration With Lidocaine Before Epidural Placement

Local infiltration with lidocaine prior to epidural placement for cesarean section, although brief, can be painful. This pain can lead to increased anxiety and distress, adversely affecting patient's overall experience. This study proposes to examine the application of Synera pain patch prior to lidocaine infiltration to reduce this pain and anxiety.

The primary objective of this study is to determine the effect of the Synera on maternal experience during epidural placement. The efficacy of Synera pain patch in reducing subject pain during skin infiltration with lidocaine prior to epidural placement in subjects presenting for scheduled cesarean section will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old;
* Undergoing pre-scheduled cesarean section;
* Expected singleton birth;
* BMI \<=35kg.m-2;

Exclusion Criteria:

* Undergoing emergency cesarean section;
* Complications during pregnancy;
* History of hypersensitivity to study medication(lidocaine or tetracaine) or para-aminobenzoic acid;
* Allergies to bird proteins, feathers, or egg products; or any other skin allergies; dermatitis an open wound at the patch site or a history of difficult epidural placement;
IRIS-PREMIER REGISTRY

The purpose of this study is to evaluate effectiveness and safety of Promus PREMIER in Routine Clinical Practice


Eligibility Criteria:
Inclusion Criteria:

* Age 20 and more
* Intervention with Promus PREMIER everolimus eluting coronary stent
* Agreed with written informed consent form

Exclusion Criteria:

* Intervention with Promus PREMIER everolimus eluting coronary stent and other drug eluting stent at the same time
* Life expectancy of 1year and under
* Cardiac shock
Identification of Non-responders to Levothyroxine Therapy

The purpose of this study is to assess differential effects of T4 and T3 on cell and tissue level

15-20% of the patients with hypothyroidism remain symptomatic, despite adequate thyroxine substitution. Endocrinologists are split in their opinion on combination therapy with T4 and T3 on patients with poorly regulated hypothyroidism. There are no objective means, by which to identify individuals who would benefit from combination therapy. The purpose of this study is to assess differential effects of T4 and T3 on body temperature, metabolism, muscle strength and brain function. The main aim is to try to identify biomarkers reflecting different effects of T4 and T3 on cell and tissue level.

Eligibility Criteria:
Inclusion Criteria:

* Poorly regulated hypothyroidism
* Female aged between 18 and 65 years
* Written informed consent obtained from the patient according to national regulations

Exclusion Criteria:

* Cardiovascular disease
* Chronic liver disease
* Chronic kidney disease
* Any other endocrinological disease
* Use of beta blockers
* Pregnant or lactating females
* Hormonal substitution other than T3 and T4
* Known psychiatric disease
Effect of the Use of a Visual Feedback Device in RCP Trainings

To verify the efficacy of manikins with feedback in the training of physicians and nurses in the courses of Advanced Cardiac Life Support (ACLS) authorized by the American Heart Association (AHA) when compared to the traditional training form.

Introduction: The Cardiopulmonary Arrest (CRP) is the largest medical emergency, training is fundamental for a good performance in Cardiopulmonary Resuscitation (CPR). In a realistic simulation scenario, the results tend to improve with the use of feedback manikins that evaluate the quality parameters in CPR and show in real time what the rescuer needs to improve in order to be successful in training and increase the probability of success in future real care. Objective: To verify the efficacy of the manikins with feedback in the training of physicians and nurses in the courses of Advanced Cardiac Life Support (ACLS) authorized by the American Heart Association (AHA). Methods: Comparison of CPR performance of ACLS students. The intervention group will be submitted to the real-time feedback of the manikins, the control group will receive feedback from the instructor. Statistical analysis will consist of inter-group comparisons and will cover mean, standard deviation, and parametric tests such as Student's T test. The results will be related to the characteristics of the sample, including anthropometric profile, profession, training time, practice area, previous training with a focus on CPR and physical exercise practice.

Eligibility Criteria:
Inclusion Criteria: Be an ACLS student and sign the TCLE. -

Exclusion Criteria: Refusing to sign the TCLE

-
Enteral Nutrition in Acute Generalized Peritonitis

Hospitals in South Kivu always have problems supplying artificial enteral nutritional products because of their high cost and low availability in our areas. While the Province has cereals, knowing their nutritional composition would enable the formulation of a nutritional product based on local protein-energy products. Hence the questions below: Can a local cereal-based protein-energy ration be used instead of a costly imported artificial nutritional solution to improve the nutritional status of patients operated on for PAG? What is the tolerance of this early enteral nutrition on the healing and functional recovery of patients compared with an artificial nutritional solution? To answer these questions, a randomized clinical trial has been designed with the following objectives:

* To formulate an enteral diet using cereals available in our environment with a protein-calorie composition superimposable on the artificial enteral ration,
* Evaluate the tolerance and advantages of early enteral nutrition with a locally manufactured protein-caloric ration vs. a commercially available artificial nutritional solution in patients undergoing surgery for PAG.


Eligibility Criteria:
Inclusion Criteria:

* patient operated for peritonitis with intestinal suture during treatment
* have a q-SOFA score of 1 to 2
* surgeon's agreement to enteral feeding
* at risk of malnutrition (BMC)

Exclusion Criteria:

* q SOFA score \> 2
* patients with tare (diabetes, HIV, renal failure)
The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy

This is a clinical study focused on the use of fiducial marker-guided stereotactic body radiotherapy (SBRT) for treating malignant tumors, including lung, liver, pancreatic, and kidney/adrenal cancers. Here's a breakdown of the key components of the study:

Study Design: Prospective, single-center, exploratory clinical study.

Patient Enrollment: The study intends to enroll patients diagnosed with malignant tumors requiring fiducial marker-guided SBRT. Each tumor type (lung, liver, pancreatic, kidney/adrenal) aims to include 15 cases.

Informed Consent: Patients are required to sign informed consent before participating in the study, indicating their understanding of the procedures, risks, and benefits involved.

Intervention: Enrolled patients will undergo stereotactic radiotherapy for their respective malignant tumors. During this process, fiducial markers will be implanted according to the study protocol.

Monitoring: Following implantation of fiducial markers, the study will monitor adverse events associated with the procedure. This includes any complications or side effects resulting from the marker implantation process.

Success Rate: The study will assess the success rate of fiducial marker implantation. This likely involves evaluating the accuracy and reliability of marker placement for guiding SBRT treatment.

SBRT Treatment Error: The study will also monitor SBRT treatment errors. This involves tracking any deviations or inaccuracies in the delivery of stereotactic radiotherapy, potentially caused by issues such as improper fiducial marker placement or technical errors in treatment administration.

Overall, the study aims to explore the feasibility and effectiveness of using fiducial marker-guided SBRT for treating various types of malignant tumors to assess both the safety and the efficacy with a focus on patient outcomes and treatment accuracy.


Eligibility Criteria:
Inclusion Criteria:

* Patient with lung cancer, liver cancer, renal cancer, pancreatic cancer.
* Going to have SBRT.

Exclusion Criteria:

* Needle insertion route impeded by skeletal structures and close to blood vessels which have high risks of puncture bleeding;
* Poor organ function (e.g. poorly controlled high blood pressure);
* Poor compliance, unable to complete coordination;
* Participant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.