cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Yunnan Baiyao on Minor Recurrent Aphthous Stomatitis

Recurrent aphthous stomatitis (RAS) is a common recurrent oral disorder with no curative treatment available to date. The challenge remains in patients that do develop drug resistance and/or secondary infection, although topical corticosteroids and antimicrobials are the first therapeutic choice. The aim of the study was to evaluate the efficacy and safety of an herbal extract of Yunnan Baiyao formulated in toothpaste as an alternative therapy for minor RAS.

Yunnan Baiyao is a well-known traditional Chinese medicine, formulated in a powder or capsule form. It was initially and widely used in wounds for its anti-hemorrhagic hemostatic function, and further in gastrointestinal bleeding. Yunnan Baiyao powder has been generally applied on RAS among Chinese population.

In this study, a randomized, double-blind, placebo-controlled clinical trial (from March 2010 to March 2011) was conducted on a cohort of 227 minor RAS patients. The toothpaste containing Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days. An assessment of ulcerative size and pain was recorded on Day 0 (baseline), Day 3 and Day 5. Any noted adverse reactions were recorded.


Eligibility Criteria:
Inclusion Criteria:

1. Both male and female aged 18 to 65 years old;
2. Patients diagnosed as minor recurrent aphthous stomatitis with the duration of each ulcer in excess of 5 days;
3. Fresh ulcers available with less than 72 hours eruption.

Exclusion Criteria:

1. Hypersensitive to various medical agents;
2. Concurrent acute infectious disease;
3. Pregnancy or lactation;
4. Concurrent other immunology disorders;
5. Accepting systemic administration of corticosteroids or immunosuppressive agents within 3 months;
6. Aphthous-like ulcers related to certain systemic disorders such as ulcerative colitis, Crohn's disease, Behcet's syndrome, serious anemia;
7. Aphthous-like ulcers related to drug such as non-steroidal anti-inflammatory drugs (NSAIDs) and anti-histamines;
8. Accepting anaesthetic therapy within 24 hours, or systemic antibiotics within 2 weeks, or other management for oral ulcers within 72 hours prior to the study;
9. Neoplasm patients;
10. Volunteers of other clinical trials on medical agents or toothpaste within one month.
Ocular Parameters in Patients With Sleep Apnea

The aim of this study is to assess the ocular parameters of drowsiness in patients with diagnosed Obstructive Sleep Apnea Syndrome through objective methods of ocular imaging and subjective evaluation methods (questionnaire)

This is a single-center prospective comparative observational study. One hundred patients with drowsiness that will be examined in the Sleep Clinic of Alexandroupolis University Hospital, aged between18-70 years old, with Distance Uncorrected Visual Acuity ≥ (dUVA): 5/10 will be recruited. They will be separated into two groups, one consisting of patients with diagnosed Obstructive Sleep Apnea and one without this diagnosis, according to the Epworth Sleepiness Scale - ESS, which is a valid tool for quantifying daily sleepiness. A 10-minute video in a foreign language (not English or Greek) with greek subtitles will be presented to them and a questionnaire will follow to assess the level of concentration during the video (the subtitles are crucial to understanding the video's plot). The video will be displayed in a 11.6" screen with resolution of 1920x1080 pixels, at 70 cm patient-to-screen distance. The patients' eyes will be recorded during the video with a Raspberry Pi Camera Module IR-CUT v2 (5MP,1080p) with 2 IR LED lights, connected to a Raspberry Pi 3 model v1.2, operating at the original resolution of 1080×1920, at 20 cm patient-to-camera distance and an algorithm will be developed to analyze the following parameters: 1. The complete and incomplete blinks defined by the "length of palpebral fissure-to-iris diameter" ratio, 3. Length of palpebral fissure of both eyes.

Eligibility Criteria:
Inclusion Criteria:

* patients with obstructive sleep apnea and controls, aged 18-70 years old, with distance uncorrected visual acuity (dUVA) ≥ 5/10.

Exclusion Criteria:

* (dUVA) \<5/10,
* intraocular pressure lowering medications
* former corneal or fundus disease
* neurological or psychiatric conditions
* mental disability
* difficulty reading
Validation of a Health-Related Symptom Index for Persons Diagnosed With and Either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (HSIL)

The purpose of this study is to finalize development of a questionnaire that measures health-related symptoms and concerns for persons diagnosed with, and either treated or monitored for, anal pre-cancer lesions.


Eligibility Criteria:
Inclusion Criteria:

* Consented to the ANCHOR trial as per self-report and by providing a valid referral code on the information sheet provided by the referring site. Both men and women from the ANCHOR trial will be recruited to this study.
* English fluent as we are only validating this measure in English at this time
* At least one month post-treatment for anal HSIL as per self-report, or if the person is in the ANCHOR trial observation arm, then at least one month post- randomization.
* Within two weeks post initial-treatment for anal HSIL on ANCHOR study or within two weeks post-randomization to ANCHOR study as per self-report.

NOTES:

* ANCHOR participants who are randomized to the treatment arm must have completed initial treatment and are within two weeks of initial treatment completion.
* ANCHOR participants who were treated initially with topical treatment are only eligible within two weeks after the last topical treatment application.
* ANCHOR participants who were treated initially with both topical and ablation treatments are eligible within two weeks of completing both treatments.
* ANCHOR participants who are randomized to the active monitoring arm are eligible if they are within two weeks of randomization

Exclusion Criteria:

* Has a scheduled ANCHOR follow-up appointment in the next two weeks as per self report. The purpose of this exclusion criterion is to minimize the impact on a participant's responses to a post-test evaluation the potential occurrence of an interim diagnosis or treatment event, or anxiety related to an upcoming medical follow-up.
Cognitive Intervention For Delirium in Dementia

The purpose of this study is to test the effectiveness of cognitively stimulating activities for resolving delirium in people with dementia.

The primary aim in this RCT is to test the efficacy of Recreational Stimulation for Elders as a Vehicle to resolve DSD (RESERVE- DSD). The investigators will randomize 256 subjects, newly admitted to post acute care, to intervention (RESERVE-DSD) or control (usual care). Intervention subjects will receive 30-minute sessions of tailored cognitively stimulating recreational activities for up to 30 days. The investigators hypothesize that subjects who receive RESERVE-DSD will have: decreased severity and duration of delirium; greater gains in attention, orientation, memory, abstract thinking, and executive functioning; and greater gains in physical function compared to subjects with DSD who receive usual care. The investigators will also evaluate potential moderators of intervention efficacy (lifetime of complex mental activities and APOE status). The secondary aim is to describe the costs associated with RESERVE-DSD.

Eligibility Criteria:
Inclusion Criteria:

* presence of delirium
* mild to moderate cognitive impairments
* 65 years of age or older
* English speaking
* community-dwelling
* legally authorized representative available

Exclusion Criteria:

* severe vision or hearing problems
* diagnosis of

  1. major depression
  2. Parkinson's with Lewy Body disease
  3. Huntington's disease
  4. normal pressure hydrocephalus
  5. seizure disorder
  6. subdural hematoma
  7. head trauma
  8. known structural brain abnormalities
  9. acute CVA/stroke
  10. acute psychiatric condition
* life expectancy \< 6 months
Diagnosis of Subclinical Urinary Tract Infections Using Advanced Microbiome Survey Techniques in High Risk Trauma Patients

The purpose of this study is to see if the investigators can identify early those patients who are admitted to the hospital and have a urinary tract infection (UTI) or those patients that develop a UTI during their hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* 65 years old or older admitted as a result of trauma to Saint Marys Hospital at Mayo Clinic

Exclusion Criteria:

* Prisoners
* Pregnancy
* Active urinary tract stones
* Less than 65 years of age
Reborn Lifestyle Adjustment Program

The aim of this study is to investigate the effects of the reborn lifestyle regulation program on physical activity, fatigue level, pain, mental health burden and quality of life in breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Being a female individual aged 18 or older
* Have been diagnosed with Stage I, II, or III breast cancer
* At least 6 months have passed since the completion of chemotherapy
* Approval by an oncologist to participate in the study
* Having internet access and the ability to connect online
* Scoring above 23 on a standardized Mini Mental Status Examination Test
* Being in the contemplation stage according to the Transtheoretical Model

Exclusion Criteria:

* Having a neurological or systemic disease that could significantly affect the course of the intervention
* Having metastasis that could impact the sustainability of the study
* Suffering from neuropathic pain
* Having participated in a healthy lifestyle program within the last 3 months
Pilot Study Evaluating the Role of Histopathology Correlation in Treatment Planning

This clinical research study tests the Uronav system. Patients with prostate cancer will be asked to take part in this study.

Uronav system is an investigational device that is used on this study to help place markers in the patient. These are called fiducial markers and they are placed in the patient to help plan radiation treatment. Radiation therapy treatment will be planned by the treating physician and will not be experimental or part of this research study.

This study will also test the similarities and differences of biopsy tissue structures and the findings from the intraprostatic MRI (internally guided MRI).

Study Objectives

Specific Aim 1: Evaluate final pathology post-operatively for histopathology confirmation of multiparametric MRI targets detected during treatment planning. This will be accomplished by using transperineal biopsies obtained prior to interstitial brachytherapy during the procedure, while under anesthetic just prior to the placement of the brachytherapy needles and sources.

Specific Aim 2: Evaluate the ability of the Uronav system in a transperineal setting to guide biopsy needle placement using the electromagnetic guidance system and transperineal ultrasound probe stabilization device and stepper.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histopathology confirmed prostate cancer that is Gleason score ≤7(4+3) clinical stage ≤ T2bN0M0 with a Prostate-specific antigen (PSA) below 15 ng/mL.
* Patients must have MRI findings reporting intraprostatic lesions suspicious for malignancy.
* Patient must not have had any prior treatment for prostate cancer
* Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
* Subjects must have an International Prostate Symptom Score of ≤ 15.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Gleason score of ≥ 8(4+4)
* PSA ≥ 15 ng/mL.
* Clinical stage \>T2b or evidence of nodal
* Patients who are on anticoagulants or high dose aspirin therapy that cannot be safely stopped for greater than 10 days prior to treatment should be excluded to limit increased risk for urinary obstruction.
* Patients with uncontrolled intercurrent illness including, but not limited to 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.
* HIV-positive patients on combination antiretroviral therapy are ineligible because of the unlikely risk of prostate cancer being life threatening in this population.
Opioid Sparing Anesthesia in Lumbar Spine Surgery

The aim of this double blind randomized study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus remifentanil analgesia in lumbar spine surgery

Lumbar spine surgery is associated with high pain scores and perioperative disability. Ketamine, lidocaine and dexmedetomidine have all proven but varied analgesic effects. High opioid consumption has been associated with multiple side effects.

This double blind clinical trial aims to investigate the possible reduction of opioid use during lumbar spine surgery by administering ketamine, lidocaine and dexmedetomidine. Sixty patients will be randomly allocated into two groups. The control group will receive a continuous infusion of remifentanil, while the Dexmedetomidine-Ketamine-Lidocaine (DKL) group will receive a continuous infusion of ketamine, lidocaine and dexmedetomidine, during the surgery and shortly after

Both infusions will be administered blindly. Fentanyl and morphine will be administered to each patient so as to maintain hemodynamic stability and pain relief. The study will eventually compare the need for bolus doses of fentanyl during the surgery and morphine shortly after in each group.

Multiple hemodynamic parameters, analgesic consumption, possible side effects, patient satisfaction and the Oswestry low back pain disability questionnaire will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult patents
* American Society of Anesthesiologists (ASA) class I-III
* elective spine surgery

Exclusion Criteria:

* body mass index (BMI) \>35 kg/m2
* contraindications to local anesthetic administration
* systematic use of analgesic agents preoperatively
* chronic pain syndromes preoperatively
* neurological or psychiatric disease on treatment
* pregnancy
* severe hepatic or renal disease
* history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
* bradycardia(\<55 beats/minute)
* drug or alcohol abuse
* language or communication barriers lack of informed consent
Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)

This is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor to standard of care radiation and hormone therapy improve quality of life.

Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3). Participants will be routinely follow-up in clinic or remotely for up to 5 years.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Able to provide informed consent
3. Histologic diagnosis of prostate adenocarcinoma
4. ECOG performance status 0-2
5. Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases

   1. Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR)
   2. Additional metastases can be detectable by PSMA PET only
6. All sites of disease are amenable to and can be safely treated with radiotherapy
7. Patients decline continuous use of ADT

Exclusion Criteria:

1. Significant comorbidities rendering patient not suitable for ADT, enzalutamide and SBRT
2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively
3. Prior use of salvage systemic therapy
4. Evidence of spinal cord compression
Anogenital Distance Differences Between Transgender Males and Female Individuals

This study evaluates the anogenital distance measurement differences between transgender male individuals and normal healthy female individuals. Half of the participants will be selected from the men with a masculine gender identity who were assigned female sex at birth (Woman who wanted to be a man). Transgender men will be evaluated with the vaginal examination, and anogenital distance will be measured at the time of gynecological medico-legal evaluation before the sex reassignment surgery. While the other half of the participants will be selected from healthy female individuals, ordinary healthy women will be selected from patients who come to the gynecology clinic for another reason (Women with normal sexual orientation).

There is considerable evidence in human beings and in animal models supporting that anogenital distance as a sensitive biomarker of prenatal androgen reflection of reproductive health and sexual orientation. Anogenital distance is approximately twice as long in male animals compared to female animals, and it is routinely used to determine the natal or birth-assigned sex.

Studies have shown alterations in anogenital distance associated with reproductive health and sexual orientation. For instance, shorter anogenital distance has been reported in boys with hypospadias and cryptorchidism. Men with reduced testicular volume have significantly shorter anogenital distance compared with controls. Increased anogenital distance has been indicated in girls with congenital adrenal hyperplasia.

The investigators hypothesized that a prenatal pathological androgenic environment, resulting in a longer anogenital distance, will be able to be associated with a higher risk of sexual orientation disorders like transsexualism. This cross-sectional study aimed to assess the anogenital distance measurement differences between transgender male persons and normal healthy female individuals.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are 18-50 years old.
* Healthy transgender male individuals whose gender identity (Male) are different from their birth-assigned sex (Female). The participants will be invited to the study at the time of medico-legal evaluation before the sex reassignment surgery.

Exclusion Criteria:

* Individuals who are older than 50 (People older than 50 cannot change their gender legally in Turkey).
* Other sexual orientation disorders. (Lesbian, Gay, Bisexual, Queer, Intersex, or Asexual persons)
Effect of Alexander Technique on Neck Pain and Quality of Life in Lactating Women

This study will be conducted to investigate the effect of the Alexander technique on neck pain and quality of life in lactating women.

During breastfeeding, incorrect positioning and placement of hands to support the baby's weight can irritate the musculature of the hands. Repeating the same position frequently can lead to radiating pain in the elbows and hands. Additionally, adopting different postures to compensate for the pain while sitting, standing, or lying down can cause mechanical changes in the cervical, thoracic, and lumbar spine, altering the body's correct posture.

The Alexander Technique is a non-exercise approach focused on improving the modulation of postural muscle activity. It offers an individualized approach to developing skills that help people recognize, understand, and avoid poor habits that affect postural tone and neuromuscular coordination. Its lessons are associated with clinically relevant long-term reductions in neck pain and disability.

Some previous studies examined effect of Alexander technique on neck pain and on quality of life in different population, but in our knowledge this is the first study will be conducted to investigate effect of Alexander technique on neck pain and quality of life in lactating women, so this study will be conducted to provide an insight about the beneficial effect of the Alexander Technique on neck pain and quality of life in lactating women which will be of valuable benefits in the women's health field.

Eligibility Criteria:
Inclusion Criteria:

* Lactating females experiencing neck pain (six weeks to 1year postpartum).
* Able to understand and follow the Alexander Technique instructions.
* Their age will be ranged from 20-35 years old.
* Their BMI will be less than 30 kg/m2 .
* Their pain level is ≥ 4 on numeric pain rating scale.
* They have mild disability on Neck Disability Index Questionnaire (NDI).
* They have limited cervical range of motion (the normal flexion range of motion is 80° to 90°, extension 70°, lateral flexion 20° to 45°, and rotation up to 90°).

Exclusion Criteria:

* Neck pain as consequence of disc protrusion or prolapse, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory rheumatic disease, neurological disorder, and psychosis.
* Women who had invasive treatment of the spine within the previous three weeks, or spinal surgery or presence of neck history of trauma.
* Presence of contraindications to spinal movement, such as fracture or dislocation.
Oral Microbioma and Oral Malignant Disease

This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years in case of oral malignancy or premalignant disease, ≥40 years in case of no malignant disease
* Patients are (partially) dentate (≥20 teeth)
* Patients who have given written informed consent to participate in this study

Exclusion Criteria:

* Patients with a history of radiotherapy in head and neck region
* Patients with a history of chemotherapy, immunotherapy or immunomodulating drugs
* Patients with a previous malginancy in head and neck region
* Edentulous patients (with or without implants)
* Patients with removable (partial) dentures
Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety

The purpose of this study is to investigate efficacy and safety of intra-operative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The hypothesis is intra-operative intervention might be the best timing for cancer cells killing by cytotoxic agents, when most of residual cancer cells may get a rapid growth after tumor debulking and may become more chemotherapy-sensitive. A three-step procedure is designed for intra-operative chemotherapy with 5-FU of 1500 mg/m2, including step 1 of intraluminal 5-FU injection with 1000 mg/m2 at beginning of resection, step 2 of 200mg/m2 5-FU injection into portal vein system via mesentery vein after tumor removal and finish of bowel reconstruction, and step 3 of 300mg/m2 5-FU left into the abdominal cavity before incision closure. The controlled arm receive curative resection only. All the other treatments will stick to the guidelines.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed as adenocarcinoma of colon and rectum
* age 18-75 years
* eligible for curative surgical resection
* performance score: ECOG 0-1
* normal blood cells counts: WBC ≥ 4.0×10\*9/L，PLT ≥ 100×10\*9/L
* normal blood chemistry test: ALT/AST ≤ 2.5 ULN, TBil ≤ 1.5 ULN, BUN ≤ 1.5 ULN,Cr ≤ 1.5 ULN
* normal ECG
* no history of other malignant tumors
* no concomitant anti-cancer therapy

Exclusion Criteria:

* clinical bowel obstruction
* anticipated into another clinical trial within three months
* uncontrolled infection, serious internal medical diseases
* Pregnant or lactating women
* mentally abnormal patients
* patients known allergic to 5-FU