cyrilzakka/clinical-trials huggingface dataset:
Post-op Pain After Fistula Laser Closure or Ligation of the Intersphincteric Tract for Anal Fistula

This is a prospective, double-blinded randomised controlled trial conducted at two tertiary hospitals by a credentialed colorectal surgeon.

Patients with high transphincteric fistulas were blinded and randomized to either laser or ligation of the fistula tract (LIFT). Pain scores at rest and movement, at 6 and 24 hours post operatively were measured using the visual analogue scale (VAS). Operative time was measured in minutes Continence and quality of life was assessed via the Wexner incontinence scale and SF-36 questionnaire respectively at 0, 3 and 6 months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Complex transphincteric fistulas:
* high transphincteric fistula, involving more than 30% of the external anal sphincter
* Multiple fistulas
* Anterior fistulas
* 18-75 years old
* Able to give consent
* New or recurrent fistulas
* Fistulas with or without setons

Exclusion Criteria:

* Active perianal sepsis requiring drainage
* Fistulas of non-cryptogladular origin- Crohn's, TB, malignancy
* Expected lifespan less than 6 months
* Pregnant women
* Patients with more than 1 definitive surgery done for the fistula before
* Patients with human immunodeficiency virus infection
* Patients with pre-existing chronic pain disorders
* Patients with Non-steroidal Anti-inflammatory Drug (NSAIDS) / Paracetamol allergies
Use of a Functional Neuroimaging Battery for the Evaluation of a Meditation Retreat

Over 2 decades scientists have been studying the effect on brain function from meditation practices. The purpose of this study is to measure the effect of a meditation retreat program on serotonin and dopamine transporter binding and changes in cerebral blood flow. The retreat program that will be followed is a week-long retreat called the Ignatian Retreat.

This study will utilize DaTscan single photon emission computed tomography (SPECT) and functional magnetic resonance imaging (fMRI) in healthy subjects within one month of entering the retreat. The study uses DaTscan to measure the effect on serotonin and dopamine transporter binding, and functional magnetic resonance imaging (fMRI) to measure the effect on cerebral blood flow. The Ignatian Retreat is a weeklong retreat which involves meditation and prayer.

Additionally, study participants will complete a variety of questionnaires and scales to measure psychological and spirituality states. The scans and questionnaires will be completed before and after the participant has completed the retreat. The ultimate goal of the study is to analyze and compare pre and post imaging and neuropsychological and spirituality changes in healthy controls who participate in this retreat.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent and willing to complete the study.
* Willing to undergo the full imaging procedures.
* Women of childbearing potential with a negative serum pregnancy test.

Exclusion Criteria:

* Any neurological or psychiatric disorders, including drug or alcohol abuse, that may interfere with cerebral blood flow as determined by the principal investigator.
* Any medical conditions that may interfere with cerebral blood flow as determined by the principal investigator.
* Currently taking medication that might affect cerebral blood flow (i.e. antidepressants, antipsychotics, anxiolytics, benzodiazepines, sedatives, antiseizure medications)
* Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight \> 350 pounds)
* Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
* Previous brain surgery or intracranial abnormalities they may complicate interpretation of the brain scans. (e.g. stroke, tumor, vascular abnormality).
* Pregnancy
* Allergy to iodine or shellfish.
* Concurrent participation in another research protocol that might affect the outcome of this study as determined by the principle Investigator.
Changes in Body Adiposity by Dual Probiotic Strains Positively Correlated With Changes in Lp-PLA2 Activity in Overweight Adults

The objective was to evaluate the effect of the consumption of dual probiotic strains containing Lactobacillus curvatus (L. curvatus) HY7601 and Lactobacillus plantarum (L. plantarum) KY1032 on weight loss, body adiposity and inflammatory markers including lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in overweight subjects.

A randomized, double-blind, placebo-controlled study was conducted on 120 subjects with age between 20 and 65 years, nondiabetic (fasting blood glucose \<126 mg/dL and 2-hour blood glucose \<200 mg/dL), and overweight (25 kg/m2 ≤ body mass index (BMI) \< 30 kg/m2). Over a 12 week test period, the probiotic group consumed 2 g of powder twice a day containing L. curvatus HY7601 and L. plantarum KY1032, while the placebo group consumed the same product without probiotics for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 65 years
* Nondiabetic (fasting blood glucose \<126 mg/dL and 2-hour blood glucose \<200 mg/dL)
* Overweight (25 kg/m2 ≤ body mass index (BMI) \< 30 kg/m2)

Exclusion Criteria:

* Constant consumption of any probiotics products within 1 month before screening
* Unstable body weight (body weight change \> 1 kg within 3 months before screening)
* Hypertension
* Type 2 diabetes
* Cardiovascular disease
* Cerebrovascular disease
* Thyroid disease
* Dietary supplementation within 6 months before screening
* Pregnancy or breast-feeding
* Medication affecting body weight, energy expenditure, glucose control or antibiotic treatment within 3 months before screening
* Acute or chronic infections
* Liver disease
* Kidney disease
* Gastrointestinal disease
* Cancer
* Medication or alcohol abuse
* Any other acute or chronic disease requiring treatment
Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location

Patients who seek medication abortion early in pregnancy may have an ultrasound that does not show a pregnancy in the uterus. This is known as a "pregnancy of unknown location". These patients most likely have a pregnancy in the uterus that is too early to be seen on ultrasound, but it is possible that the pregnancy is not seen inside the uterus because it is outside of the uterus, known as an ectopic pregnancy. Patients with ectopic pregnancies are at risk for serious complications, and the medications used for medication abortion may not end an ectopic pregnancy.

Currently, at Planned Parenthood League of Massachusetts (PPLM), patients seeking medication abortion, including some patients with a pregnancy of unknown location, are given mifepristone to begin the medication abortion at the clinic and then one dose of misoprostol to take at home to cause the pregnancy to pass. However, research suggests that a second dose of misoprostol leads to a higher rate of completed abortion for certain patients.

This research is being conducted to learn if two doses of the at-home misoprostol during the medication abortion process leads to a higher rate of completed abortion for patients with pregnancy of unknown location. In this study, all participants will receive mifepristone as they normally would. Then, participants will be randomly assigned to receive either one dose of misoprostol or two doses of misoprostol.


Eligibility Criteria:
Inclusion Criteria:

* Positive urine or serum hCG test
* No evidence of gestational sac on transvaginal ultrasound
* No evidence of ectopic pregnancy on transvaginal ultrasound
* Desire for same-day start medication abortion as method of pregnancy termination
* Eligible for same-day-start medication abortion based on PPLM clinical guidelines at the time of enrollment
* English-speaking

Exclusion Criteria:

* Ineligible for medication abortion at PPLM based on current PPLM clinical guidelines at the time of enrollment

  o PPLM clinical guidelines for medication abortion currently exclude those with chronic adrenal failure, concurrent long-term corticosteroid use, hemorrhagic disorders or concurrent anti-coagulation, porphyria, allergies to mifepristone or misoprostol, or an IUD in place.
* Ineligible for same-day-start medication abortion with PUL based on PPLM clinical guidelines and clinician assessment at the time of enrollment

  o PPLM clinical guidelines for initiating medication abortion with PUL currently exclude those with major ectopic risk factors (IUD in situ, prior ectopic, history of tubal surgery) or symptoms concerning for ectopic (i.e. pain, bleeding) per clinician discretion.
* Age less than 18 years old
* Prior participation in this study
* Anticipated inability to adhere to follow up protocol or complete the survey
* Unable to give informed consent or to complete all study procedures
Metabolomics Explores Biomarkers for Metastatic Breast Cancer

RATIONALE: Studying samples of plasm by metabolomics-based approach from women with metastasis breast cancer may help doctors understand the biomarker of visceral metastasis.

PURPOSE: This clinical trial is studying the biomarker of visceral metastasis by metabolomics approach in metastasis breast cancer undergoing treatment.

Imaging evaluation of the effect of chemotherapy on patients with visceral metastases from breast cancer, metabolomics was used to analyze the changes of metabolites in plasma, and to find biomarkers that could reflect visceral metastasis and treatment effects. The purpose is to help clinicians predict whether patients have potential visceral metastases, evaluate the effects of visceral metastasis treatment, and reflect the patient's prognosis.

Patients with visceral metastases on imaging examinations received chemotherapy as planned, and blood samples were collected from patients before and during imaging assessments. Analysis of metabolites in plasma using ultra high performance liquid chromatography. Patient information were collected through medical record, including race, age, height and body mass index, menarche age, menstrual status, menopausal age (if applicable), tobacco and alcohol history, motherhood history, family history, etc.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70 yrs.
* Any menopausal status.
* Any hormone receptor status.
* Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.
* Patients must have measurable disease, per RECIST criteria v1.1.21.
* Estimated life expectancy of ≥ 12 weeks.
* Ability to swallow oral medications.
* Participants must have adequate organ function as defined by:

  1. ANC ≥1.5 x 109/L, platelet count ≥100 x 109/L, haemoglobin ≥ 10 g/dL.
  2. creatinine \< 1.5 x UNL (upper normal limit).
  3. Total bilirubin \< 1.5x UNL.
  4. ALT \& AST \< 2.5xUNL; alkaline phosphatase \< 2.5xUNL.
  5. Creatine phosphokinase (CPK) ≤ 2.5 x UNL.
* Patients with CNS metastatic disease are allowed if the disease is controlled and stable for at least 3 months by CT or MRI.

Exclusion Criteria:

* Current severe, uncontrolled systemic disease (e.g. pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
* History of other malignancies.
* No measureable lesion is present, as defined by RECIST 1.1.
* Patients who suffer from a medical or psychiatric condition that, in the opinion of the principal investigator, would impair their ability to participate in the study.
* Concurrent interventional studies.
Association of Renal-tubular Acidosis in Children With Cow Milk Protein Allergy

Our study aims to detect renal manifestations of children proved to be with cow milk protein allergy special focusing on tubular dysfunction.

This is a cross-sectional study that will be conducted over 6 months at the pediatric department, Sohag University Hospital, Sohag, Egypt.

Children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with Age group from 3 months up to 3 years attending outpatient clinic at Sohag University Hospital will be included in the study.

The study participants will be subjected to full history taking and thorough clinical examination at the pediatric outpatient clinic and their medical files will be reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with Age group from 3 months up to 3 years attending outpatient clinic at Sohag University Hospital will be included in the study

Exclusion Criteria:

-
Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis

Vaccines against human papillomaviruses are now commercially available. One of the commercial vaccine contains antigens of both LR HPV types which cause virtually all cases of RRP. Clinical trials have documented the safety and immunogenicity of this vaccine as well as its effectiveness in prevention of incident and persistent infection of the vaccinal types as well as a development of lesions caused by these types. After vaccination the antibodies level increases dramatically and the high levels of antibodies are present in the blood still after 6 years. Furthermore, the neutralization antibodies to the vaccinal antigens have been detected in the cervical mucus of vaccinated women. The preliminary data are now available showing the presence of HPV-specific antibodies in the oral cavity in women after vaccination. The level of antibodies has been dependent on time since vaccination.

In our previous studies we have documented that in patients with RRP the level of HPV-specific antibodies is low and increases only after numerous surgery procedures. Therefore the application of this vaccine to patients with RRP can stimulate increased level of antibodies in the blood as well as presence of virus-specific neutralization antibodies on the surface of upper aero digestive tract and neutralize viruses shed from new papillomas and in this way protect patient from spreading of the infection as well as to facilitate the decrease of load of infectious virus shed from the lesion. This can possibly lead to the inhibition of growth of the papillomatous lesion.

Eligibility Criteria:
Inclusion Criteria:

Patients with RRP which sign the informed consent form with both parts of the study will be enrolled.

Exclusion Criteria:

Patients who experience severe side effects of vaccination after the first or second dose will not be vaccinated with the third dose and they will be excluded from the study. Patients who will not receive all three doses within one year and 30 days will be also excluded.
Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma

The goal of this phase 2 trial is to test the safety and efficacy of azacitidine when given together with PD-1 therapy in treating patients with relapsed/refractory classic Hodgkin lymphoma.

The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with PD-1 therapy in classic relapsed/refractory Hodgkin lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed Hodgkin Lymphoma according World Health Organization (WHO) classification.
* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements.
* Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below).
* Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if bone marrow (BM) involvement by lymphoma); Platelet ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma); Hemoglobin ≥ 8 g/dL.
* Anticipated life expectancy at least 3 months.

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
* Pregnant or lactating women.
Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic sachet as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and monitored clinically and microbiologically at baseline and 3-6 months after therapy. All patients will receive scaling and periodontal treatment and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The sachet will be used once per day during 3 months.

Gingivitis is the most prevalent worldwide periodontal disease, is characterized by inflammation of the tissues surrounding the tooth without causing periodontal attachment loss. Preventive and / or therapeutic measures to facilitate or improve their control are therefore very important, much more if you consider that gingivitis and periodontitis are considered part of an ongoing inflammatory process. Treatment of gingivitis, like that of all periodontal diseases has been based on the implementation of control measures personal and professional plaque. Notwithstanding the foregoing, it has been reported that although mechanical therapy achieved significantly decrease the periodontopathogens, this may be only temporary since bacteria can recolonize the treated niches in the oral cavity. In this context, it has emerged as a new treatment strategy complementary use of probiotics such as Lactobacillus rhamnosus, which possess anti-bacterial and anti-inflammatory properties. Generally speaking, probiotics would promote health by competitive exclusion of some or positive pathogenic bacteria. Objective: To evaluate the effect of the administration of Lactobacillus rhamnosus as an adjunct to conventional periodontal therapy in adolescent and young adult patients with gingivitis. Methodology: A randomized double-blind clinical trial to evaluate the effect of sachet probiotic Lactobacillus rhamnosus as an adjunct to conventional periodontal treatment of patients with gingivitis will be performed. Expected Results: Statistically significant decrease in levels of periodontopathogens (P. gingivalis, A. actinomycetemcomitans, T. forsythia and A. viscosus) in the experimental group compared with the control. Association between clinical and microbiological parameters.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Gingivitis
* Gingival index \> 1.5 (\> 10 % of the sites examined)
* Index increased bleeding on probing 10% of the sites surveyed
* Probing Depth \< 3 mm
* Systemically healthy (except for the presence of gingivitis)
* Patients who have not received periodontal treatment and before no intake of medicines such as antibiotics and / or anti-inflammatory in the last 3 months prior to the start of the study

Exclusion Criteria:

* Patients who develop systemic disease during the study.
* Patients who have to ingest antibiotics and / or antiinflammatories during the study.
* If you are a woman becomes pregnant during the study.
The Impact of AI-Based Fundus Imaging on Blood Glucose Control and Fundus Examination Completion Rates in Outpatient Diabetic Patients

This study aims to evaluate the impact of AI-based fundus imaging on blood glucose control and fundus examination completion rates in diabetic patients by comparing outcomes between those who undergo AI fundus imaging and those who do not. The study is designed as a parallel randomized controlled trial (RCT).

Using a random number table, 200 diabetic patients visiting the Department of Endocrinology at Sichuan Provincial People's Hospital between December 2024 and December 2025 will be equally divided into two groups: an intervention group and a control group. Each group will consist of 100 patients, assigned unique random numbers. The intervention group will undergo AI-based fundus imaging once, with the imaging process taking approximately 5 minutes. The control group will receive standard eye health education without AI fundus imaging.

The primary outcomes, including blood glucose control, systemic indicators, and fundus examination completion rates, will be assessed and compared between the two groups at 3-month and 6-month follow-ups. This study seeks to determine the value of AI-based fundus imaging in improving diabetes management and complication prevention in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of Type 2 Diabetes Mellitus.
* Patients with a glycated hemoglobin (HbA1c) level \> 7%.
* Ability to comply with all required examinations and provide signed informed consent.

Exclusion Criteria:

* No previous diabetic fundus examination.
* No known diabetic retinopathy.
* Absence of other ocular diseases that could lead to retinopathy.
* Subjects from whom clear fundus photographs could not be obtained.
* Patients with comorbid malignant tumors or severe cardiovascular diseases.
* Patients anticipated to have difficulties with follow-up or those residing in other provinces.
HCAPPED I: HCAP-Pcr in Emergency Department

Prospective Observational Study (on Diagnostic Procedure) - Single-Center, Non-Profit.

A pilot study will be conducted on a prospective cohort of patients with HCAP (Healthcare-Associated Pneumonia). This study will be conducted on a single arm of patients. No control group or randomization is planned.

The use of syndromic molecular panels in pneumonias with risk factors for MDR (multidrug-resistant) pathogens, such as in patients with HCAP, has become common practice. However, the use of this tool is reserved for patients with severe forms of HCAP (PIRO\&gt;2, at least moderate ARDS, and respiratory failure requiring high-flow oxygen during sepsis) (30), and it is not yet standardized by international guidelines. The decision to use this tool or not is currently at the clinician\&#39;s discretion and is usually reserved for the severe forms mentioned above. The study aims to determine if the early use of this tool has a real benefit on the management of antibiotic therapy for these patients in terms of therapeutic changes compared to corporate and international guidelines.

Duration of patient enrollment: 1 year. Duration of the study: 1.5 years.


Eligibility Criteria:
Inclusion Criteria:

All patients over the age of 18 who undergo bronchoalveolar lavage (BAL) in the Emergency Department (DEA), with a Rankin score of less than 5, and who are admitted to the Emergency Department with a diagnosis of healthcare-associated pneumonia (HCAP) of bacterial, viral, or fungal origin. The diagnosis must be confirmed by clinical and radiological criteria according to the IDSA guidelines, which include: New pulmonary infiltrate on chest X-ray, Evidence that the infiltrate is of infectious origin, At least two of the following three clinical signs: Fever higher than 38 °C, Leukocytosis or leukopenia, Purulent secretions.

Additionally, patients must meet at least one of the following criteria:

* Need for high-flow oxygen therapy (VM35 or FiO2 \&gt;35%, Reservoir, HFNC, NIV, CPAP)
* Intubation (IOT)
* SOFA score ≥2 or PSI score \&gt;85 (age 75 + IR)
* Horowitz index (PaO2/FiO2) \&lt; 200

Exclusion Criteria:

* Lack of consent
* Age under 18 or over 90
* Pregnancy
* Life expectancy less than 3 months
* Hospital admission \&gt;48 hours (hospital-acquired pneumonia - HAP)
* Rankin score ≥ 5
* Community-acquired pneumonia (CAP)