cyrilzakka/clinical-trials huggingface dataset:
Comparison of Atrophogenic Effect of Hydrocortison 1% Cream and Pimecrolimus 1% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHz Ultrasound of Uninvolved Skin in Patients With Atopic Dermatitis

to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on unaffected forehead skin


Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years
* diagnosis of atopic dermatitis (Hanifin \& Rajka Criteria)
* patients with atopic dermatitis not affecting the forehead

Exclusion Criteria:

* pregnancy / nursing mothers
* women in reproductive age without adequate contraception
* severe atopic dermatitis (IGA \>= 4)
* UV-Therapy in past 4 weeks
* patients receiving any topical treatment on the face in past 6 month
Information Flow of Waiting List for Scheduled Surgical Admissions

Definition and experimentation of the aforementioned information flow within the Regions participating in the three-year project, a Technical Subgroup was identified on a voluntary basis in charge of defining the design and following the experimental operational phases


Eligibility Criteria:
Inclusion Criteria:

* all adult patients

Exclusion Criteria:

* Minor patients
Laparoscopic Versus Open Resection of Cancer Stomach

The aim of surgical procedures for resection of cancer stomach is to resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).

There are two main types of techniques (open \& laparoscopic) Many studies were done comparing these two techniques showed that Laparoscopic resection is superior in early postoperative recovery (less pain ,less bleeding and shorter hospital stay) but less radical than open resection (less safety margin \& less lymphadenectomy) but because of the ongoing advances on laparoscopic surgery these results needs more and more revision.

So the investigators conduct this randomized controlled trial aiming at comparing open and laparoscopic resection of cancer stomach to choose the best surgical procedure for resection of cancer stomach.

The surgical procedure for resection of cancer stomach aiming at resection of the tumor mass with safety margin and its drainage lymph nodes (lymphadenectomy).

# Tumor resection;

Will be done by one of the following techniques:

1. laparoscopic gastrectomy (totally laparoscopic, laparoscopy-assisted, and hand-assisted) types of gastrectomy (according to site of tumour)
2. Open gastrectomy (according to the site of tumor). # Lymphadenectomy; Will be done according to Japanese Gastric Cancer Association guidelines for optimal lymph node dissection levels for Early Gastric Cancer (1):

   * D1+alpha -(perigastric lymph node dissection) for mucosal cancer, for which EMR is not indicated and for histologically differentiated submucosal cancer of \< 1.5 cm in diameter;
   * D1+ beta for preoperatively diagnosed submucosal cancer without lymph node metastasis (N0), for which D1+ alpha is not indicated, and for early cancer \< 2.0 cm in diameter with only perigastric lymph node metastasis (N1);
   * D2 for early cancer \> 2.0 cm in diameter. Follow up: all patients will be followed up clinically for the outcomes for each surgical technique.

Eligibility Criteria:
Inclusion Criteria:

* All patients with primary carcinoma of the stomach, where the tumor is considered surgically resectable (T1-3, N0-1, M0).

Exclusion Criteria:

* Pregnancy.
* Infiltration to the( pancreas ,liver ,colon or vital vascular structure).
* Metastasis to the (liver, lung, brain, paraaortic LN involvement).
* Peritoneal deposit.
* Surgically unfit patient.
Effects of Transcutaneous Electrical Nerve Stimulation on Cortical Excitability in the Primary Motor Cortex in Healthy Adults

Recently, non-invasive brain stimulation has become a powerful tool in both basic research and clinical application. Among several non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) have received the most attention. About DC stimulation, the change of polarity could modulate the spontaneous neuronal activity and make effect on decision making, language, memory, sensory perception, and pain. In spite of that the concept of transcranial alternating current stimulation (tACS) is not novel, AC is relatively safe compared to DC, and researches have revealed that AC might potentially have the effect on the cortical excitability. However, there are still many areas about AC stimulation which remain unknown, such as mechanism, application, and potential influence on cortical excitability.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
Treating Major Depression With Yoga Mono-therapy

The goal of this single-center, single-blind, randomized, controlled, parallel group, interventional trial is to evaluate antidepressant efficacy of yoga monotherapy of 12-weeks duration in 180 adults meeting diagnostic criteria for mild-to-moderate major depression at the Zuckerberg San Francisco General Hospital. Researchers will compare the yoga interventions to an education control intervention on holistic healthcare.

Consenting participants will be randomized equally to one of three in-person group interventions for 12 weeks: Standard yoga practice, Ayurvedic yoga practice, or educational attention-control modules. The primary outcome is depression severity, measured by Beck Depression Inventory-II (BDI) scores. Secondary outcomes include perceived stress, measured by Perceived Stress Scale (PSS) scores, and several biomarker assays associated with depression: methylation of the GrimAge epigenetic clock, nuclear factor kappa-B (NF-κB) transcription, leucocyte telomere length, interleukin-6 (IL-6) and brain-derived neurotropic factor (BDNF). Blinded assessors will conduct all outcome analyses at 12 weeks. The primary analysis will test whether the yoga groups combined achieve statistically greater change in BDI scores compared to the control group. Secondary analyses will test whether the yoga groups combined, compared to the control group, demonstrate statistically greater change in PSS scores and the aforementioned biomarker assays. In sub-analyses, investigators will assess whether Ayurvedic yoga participants, compared to Standard yoga participants, demonstrate statistically significant improvements in BDI scores, PSS scores, and depression biomarker assays over the 12-week intervention period.

Eligibility Criteria:
Inclusion criteria:

* 18 years of age or older
* Able to give voluntary, informed consent
* English-speaking
* Diagnosis of clinical depression

Exclusion criteria:

* Current use of antidepressant medication
* Current engagement in psychotherapy
* Current pregnancy
* Significant medical issues interfering with yoga practice
Study of Telitacicept in Generalized Myasthenia Gravis

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in the treatment of patients with generalized myasthenia gravis.

This study consists of a screening period, a double-blind treatment period (part A) and an open-label treatment period (part B). After screening, eligible subjects will be randomized in a 1: 1 ratio to receive either subcutaneous Telitacicept 240 mg or placebo once a week for 24 doses (part A). Completing part A, subjects will automatically enter part B. In part B, all subjects will receive weekly subcutaneous Telitacicept 240 mg for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent provided;
2. Male or female patients aged 18-80 years;
3. Diagnosis with generalized myasthenia gravis;
4. MGFA Class II, III, or IVa;
5. AChR-Ab or MuSK-Ab positive;
6. A total MG-ADL score of ≥ 6 with less than 50% of the total score due to ocular symptoms;
7. QMG ≥ 8, with ≥ 4 items score at least 2;
8. Have been on a stable MG SoC regimen.

Exclusion Criteria:

1. Patients with autoimmune diseases other than MG;
2. Abnormal laboratory results；
3. Significant cardiovascular disease, liver, kidney, respiratory, endocrine or hematologic disease, or other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study or require hospitalization during the study;
4. Acute or chronic infection requiring treatment;
5. Current active hepatitis;
6. HIV antibody positive;
7. Current thymoma-associated immunodeficiency syndrome (Good's syndrome) or thymic surgery within 6 months prior to screening;
8. Received or plan to receive any live vaccine within 3 months prior to randomization;
9. Patients with malignant tumors;
10. Allergy to biological products of human origin;
11. Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer);
12. Pregnant or lactating women, and those intending to become pregnant during the trial;
13. Patients considered unsuitable by the investigator to participate in the trial (e.g., patients with severe mental disorders);

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT)

The purpose of this study was to determine the effect of a primary care intervention on reducing suicidal ideation and depression in older patients.

Suicide rates are highest in late life; the majority of older adults who die by suicide have seen a primary care physician in preceding months. Depression is the strongest risk factor for late-life suicide and for suicide's precursor, suicidal ideation.

The aim of the study was to determine the extent to which an intervention taht combined treatment guidelines with care management reduced rates of depression and suicide ideation in older primary care patients. The study randomized 20 primary care practices from New York City, Philadelphia, and Pittsburgh regions into intervention or usual car. The used a two-stage sampling design that resulted in a representative sample with an oversample of depressed patients (total n=1238 subjects including 598 with a depression diagnosis and 640 with no depression diagnosis). Patients were assessed at baseline, 4, 8, 12, 18 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

upcoming appointment with primary care clinician

Exclusion Criteria:

* inability to give consent
* minimental status examination \<18
* ability to communicate in English
Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease

Depression is one of the most important nonmotor features of idiopathic PD（Parkinson's disease ）which may not just interfere with the motor symptoms of PD but can also cause immense personal suffering as well as decreased quality of life with increased disability and caregiver burden. However,there is little hard evidence to guide clinical treatment. Although some newer dopamine agonists also have antidepressive effect, the use of tricyclic or nontricyclic antidepressants is frequently required.However, the side-effects of these agents may also worsen some preexisting nonmotor problems in PD. Wuling powder is a Chinese medicine which is made by cultivating Xylariasp mycelium using submerged fermentation technology. Xylariasp is the fungus sclerotia which grow in termite nests. Wuling powder is mainly used to soothe nerves and anti-insomnia in clinical. The antidepressant effect of Wuling powder has been confirmed in clinical, but not in the patients of Parkinson's disease. Therefore, the investigators design a randomized, double-blind, placebo-controlled study to evaluate the antidepressant effect of Wuling powder in PD patients and its underlying mechanism.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease according to the 2015 MDS（Movement Disorder Society）-PD criterion
2. Hoehn-Yahr stage: 1-3
3. Under steady therapy of antiparkinsonian drugs for at least 28 days
4. HAMD≥13
5. MMSE（Mini-Mental State Examination）≥24
6. Neither use antidepressant drugs nor antipsychotic drugs within 4 weeks
7. Signed informed consent

Exclusion Criteria:

1. Have other psychotic symptoms
2. Suicide ideation or behavior
3. Severe cognitive impairment，chronic organs failure，malignant tumors
4. Glutamic-pyruvic transaminase or glutamic oxalacetic transaminase≥1.5 times of the high normal range or white blood cell\<4\*10\^9/L or serum creatinine\>84umol/L
5. Pregnancy or lactation period
6. Participant in other trials or have taken other experimental drugs within 90 days
7. Allergic to fungal food or fungal drugs
Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placement of Device

To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.

To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.

Five hundred (500) males scheduled for voluntary circumcision performed by clinicians or nurses using the PrePex.

Theses clinicians and nurses have already been trained in the Prepex procedure and will undergo further training in the modification to the technique. Study duration per participant will be up to 8 weeks and will include three follow up visits and one phone call follow up.

Eligibility Criteria:
Inclusion Criteria:

* Ages - 13 to 49 years
* Uncircumcised
* Participant wants to be circumcised
* Participant assent to the procedure
* Legal guardian consent to the procedure for ages 13-18 years
* Able to understand the study procedures and requirements
* Agrees to abstain from sexual intercourse for 8 weeks after circumcision
* Agrees to abstain from masturbation for at least 2 weeks after Removal
* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 weeks total)
* Participant able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study

Exclusion Criteria:

* Legal guardian withholds consent for ages 13-18 years
* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the participant from undergoing a circumcision
* Participant with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
* Known bleeding / coagulation abnormality, uncontrolled diabetes
* Participant that to the opinion of the investigator is not a good candidate
* Diabetes Mellitus
* HIV Sero-positive
Comparison of Meal Replacements Versus Protein Supplements and Utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) Method

The purpose of this research study is to compare the varying qualities of protein supplements utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) method and evaluating the clinical outcome related to protein stores and absorption.

The PDCAAS has been adopted by the Food and Agricultural Organization (FAO) of the World Health Organization (WHO) and is currently recognized as the standard method to evaluate protein quality. This study will also examine patient tolerability, satiety, and satisfaction while using meal replacements versus protein supplements. This research study looks to gain knowledge on the varying qualities of protein and find the most effective protein supplement and/or meal replacement that provides increased patient compliance and promotes a healthy recovery.

Eligibility Criteria:
Inclusion Criteria:

* Persons that are scheduled to undergo the adjustable gastric banding (AGB) surgery utilizing the AP Lap-Band System.
* Not having any medical confounding factors as described in exclusion criteria.
* Willing to comply with food and exercise logs and comply with the full-liquid diet, both pre-and-post-operatively.

Exclusion Criteria:

* Persons who are not undergoing AGB surgery or are unwilling to comply with study methods or are medically not eligible.
* Taking diuretics
* Have been diagnosed with unstable diabetes, unstable neurologic conditions, unstable cardiac conditions or gastro-intestinal disorders, renal dysfunction, wounds, and autoimmune disorders that may increase protein needs.
* Uncontrolled gastrointestinal disease, such as Crohn's disease, diverticulitis, Celiac disease, or ulcerative colitis.
* Active malignancy
* Patients will also be excluded if pre-operative vitamin deficiencies are not corrected by surgery.
Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain

Pain is a most common symptom and it has a high impact on quality of life in cancer patients. Many cancer patients have received opioid therapy, but also many of them have suffered from side effects of opioids. Drowsiness and confusion are common side effects of opioids. Caffeine is a well known psychostimulant,and it is widely used as an analgesics. Thus, the investigators aimed to prove the efficacy of intravenous caffeine administration as an adjuvant analgesics to opioids. At the same time, the investigators tried to find that the side effects of opioids could be ameliorated by caffeine.

Previous studies on cancer pain lacked assessment of quality of life. And most of previous studies on cancer pain did not give attention to symptoms accompanied with pain. We include such variables as outcome measures, and aimed to evaluate the efficacy and the safety of intravenous caffeine in advanced cancer inpatients.

Eligibility Criteria:
Inclusion Criteria:

* Advanced (Stage IV) cancer inpatients
* Adults aged over 18 years
* Patients who have received opioid therapy and whose pain scales are under 6 (by numeric rating scale)
* Patients who do not take caffeine beverage 48 hours before study period
* Volunteers who provided written informed consent

Exclusion Criteria:

* Sensitivity (palpitation,headache,irritability,insomnia) to caffeine
* Uncontrolled hypertension and/or heart disease
* Liver failure (alanine aminotransferase \>= 100 IU/L)
* Kidney failure (serum creatinine \>= 2.0 mg/dL)
* Patients taken theophylline
* Gastroesophageal reflux disease
* Chronic glaucoma
* Cognitive impairment
* Progressive pain over 7 (by numeric rating scale)
Urinary Sensor for Cystourethrography

Evaluation of urinary sensor that will be activated by the urine during voiding cystourethrography in pediatric patients

It is of immense importance to perform fluoroscopy during voiding phase of VCUG (Voiding Cystourethrogram) procedures in order to rule out vesicourethral reflux. It is difficult to know exactly when a child will start voiding, so the child is intermittently imaged by fluoroscopy. Fluoroscopy involves radiation, and this we try to diminish as much as possible. We suggest application of small urinary sensor in the perineum of the patient, that will signal the beginning of urination, and only then fluoroscopy will begin. This urinary sensor should cut down substantially radiation dose to the patient.

Eligibility Criteria:
Inclusion Criteria:

* children referred for VCUG procedure at out department

Exclusion Criteria:

* children with pacemakers
* decline to participate
In Situ Caries Model of Fluoride Toothpastes

This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model


Eligibility Criteria:
Inclusion Criteria:

* Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
* Age:Aged 18 to 80 years inclusive
* Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
* General Health:Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period
* Residency: Currently living in the Indianapolis, Indiana area
* Dentures: a) Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 millimeters (mm). b) Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. c) All restorations in a good state of repair
* Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute).

Exclusion Criteria:

* Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
* Breast-feeding: Women who are breast-feeding
* Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
* Clinical Study/Experimental Medication: a. Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study GSK dental studies where the wash in period prior to treatment is sufficient. b. Previous participation in this study
* Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
* Fluoride: Prescribed or professionally recommended use of fluoride supplements or fluoride mouthrinse
* Substance abuse: Recent history (within last year) of alcohol or other substance abuse
* Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects
* Personnel: a. A member of the site study staff who is directly working on the project or living in that staff's household. b. An employee of the sponsor c. Any employee of any toothpaste manufacturer or their spouse or family member