cyrilzakka/clinical-trials huggingface dataset:
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)


Eligibility Criteria:
Inclusion Criteria:

* Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to as BPH-lower urinary tract symptoms (LUTS) on the disease diagnostic criteria at the start of study.
* Provide signed informed consent at the start of the study.
* Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study.
* Have not taken finasteride therapy for at least 3 months before study drug is dispensed and dutasteride therapy for at least 6 months before study drug is dispensed.
* Have not taken other BPH therapy (including herbal preparations), OAB therapy, ED therapy for at least 4 weeks prior to study drug is dispensed.
* Have LUTS with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
* Have reduced urine flow (measured by special toilet equipment).
* Demonstrate compliance with study drug administration requirements.

Exclusion Criteria:

* Treated with nitrates
* Have unstable angina or angina that requires treatment.
* Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
* Have very high or very low blood pressure.
* Have certain neurological conditions associated with bladder problems or injuries to brain or spinal cord within a specified time of starting this study.
* Have uncontrolled diabetes.
* Have prostate cancer, are being treated for cancer.
* Have prostate specific antigen (PSA) greater than 10 nanograms per milliliter (ng/mL) at the start of study.
Pain and Microbial Reduction of Antimicrobial Corticosteroid Mixture Versus Cryotherapy in Necrotic Teeth

The aim of this study is to compare the effect of antimicrobial-corticosteroid mixture and cryotherapy as final root canal irrigating solutions on post-instrumentation pain in single-canal teeth with necrotic pulps.

The trial participants are patients with single-canal teeth with necrotic pulps undergoing root canal treatment on two visits. During the 1st visit, access cavity, root canal cleaning and shaping using rotary files and 2.5% NaOCl irrigation. After apical preparation, a final flush with either a levofloxacin-fluconazole-dexamethasone mixture or cold saline will be used then the tooth access cavity will be sealed with a temporary filling. After the first visit, the participants will be given a pain chart with a numerical rating scale to rate their pain levels from zero to 10 at 6, 12, 24, and 48 hours. Three microbial swabs will be collected for each participant: before instrumentation (S1), after instrumentation before final irrigation (S2), and after final irrigation (S3). After collecting data from all participants, statistical analysis will be conducted to compare the pain intensity and microbial load reduction percentages between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients in good physical health; American Society of Anesthesiologists class I or II.
2. Patients whose age ranges between 18 and 50 years.
3. Male and female patients.
4. Patients having a single canal-tooth with necrotic pulp.
5. Patients who can understand the number rating scale (figure).
6. Patients who accept to participate in the trial and can sign the informed consent (figure).

Exclusion Criteria:

1. Pregnant females.
2. Patients with swelling.
3. Patients whose tooth is non-restorable.
4. Teeth with open apices.
5. Teeth with radiographic evidence of root resorption.
Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device

Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders. It is estimated that 80%% of SAS cases are not diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and insufficient availability of these exams. It would therefore be useful to carry out a screening test before directing the patient to a complete test.

Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula, oximetry, heart rate) but they generally record only one night and remain intrusive enough to perturb the sleep.

The Withings HWA09 is a wrist-worn watch, which allows screening of SAS from four signals: movement, heart rate, breathing rate and blood oxygen saturation (SpO2). The objective of the present study is to validate the diagnostic performance of the Withings HWA09 for the detection of SAS compared to PSG.

Subjects are patients having a prescription for a one-night polysomnographic consultation in order to diagnose potential sleep disorders. The investigator will collect the consent before including any patient in this study. The study last one night per patient, during which saturation signal recordings and the sleep apnea detection will be made by the HWA09 watch, in comparison to the polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* Adults, men and women, between 18 and 70 y/o
* Patient addressed for a polysomnography because of a suspicion of sleep respiratory disorders
* Subject having expressed his/her consent to take part in the study

Exclusion Criteria:

* Recording under continuous positive pressure
* Subject having refuse to give his/her consent
* Vulnerable subjects according to regulation in force :
* Pregnant, parturient or breastfeeding women
* Subjects having a known allergy to one of the components of the sensor (silicon, stainless steel, sapphire glass)
* Subjects deprived of liberty by a court, medical or administrative order
* Subjects legally protected or unable to express their non-opposition to take part in the study
* Subjects unable to express their consent due to linguistic or mental incapacities
T Lymphocyte Subsets in Ulcerative Colitis

1. Study the distribution of peripheral blood T lymphocyte subsets among ulcerative colitis patients.
2. Correlation of T-cell subsets to therapeutic response/ disease activity.
3. Assess the value of circulating IgG anti-Integrin αvβ6 in UC.

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease of the large intestine, frequently involving the rectum, and characterized by chronic and recurrent mucosal inflammation and ulceration. Although its cause is not well understood, current evidence suggests innate and adaptive immunity play critical roles in its pathogenesis.

One of the main classes of immune cells that are affected by and contribute to UC is T cells. T-lymphocytes comprise a complex collection of highly differentiated T-cell subsets playing key roles in the regulation and the effector phase of the immune response. CD4+ T cells were found over-activated and proliferated in UC patients, which can induce disorders of the cytokine network and increase the occurrence of colitis.

Once intestinal pathogens or inflammatory mediators are not cleared in time, pro-inflammatory mononuclear phagocytes (MNPs) or polymorphonuclear leukocytes (PMNs) are often recruited to promote the polarization of naive CD4+ T cells into Th1, Th2, Th17, Treg and other subsets of cells.

The balances Th17/ Treg cells are important for maintaining intestinal homeostasis. Once the proportion Th17 cells increases, it often induces the production of pro-inflammatory cytokines that promote colonic inflammation, whereas Treg cells are usually secrete interleukin-10 (IL-10) and transforming growth factor-β (TGF-β) for anti-inflammatory regulations.

UC-associated inflammation is also characterized by huge number of activated B cells and plasma cells, the latter being involved in the production of cytotoxic granules, immunoglobulins, and various autoantibodies, Recent studies have highlighted a novel autoantibody against integrin αvβ6 in the serum of patients diagnosed with UC.

Recently, targeting immune cells to inhibit inflammation has become a research hotspot. Biological therapies are highly effective hallmark therapies in UC. Despite their widespread use, the impact of these agents on the composition of the adaptive immune system is largely unexplored. Knowledge on such effects in UC could clarify the mechanism of action of these therapies, provide information about the status of the adaptive immune system, and could help finding cell-based markers.

Eligibility Criteria:
Inclusion Criteria:

* patients with clinical diagnosis of ulcerative colitis among both sexes.
* Age \>18 years Old.

Exclusion Criteria:

* Age \<18 years old.
* Patients who refuse to participate in the study.
* Patients who have other autoimmune disease.
Efficiency of Bumetanide in Autistic Children

The purpose of this study is to determine if a treatment by bumetanide presents an efficiency at the level of the neuronal maturation in the autism


Eligibility Criteria:
Inclusion Criteria:

* Children from 3 to 10 years old, answering the diagnosis of typical autism according to the diagnostic criteria of autism of the classification of the WHO ( CIM-10) and the parents of which gave a free, enlightened and written consent.

Exclusion Criteria:

* Patients epileptic autistics treated by anticomitiaux or having hurts of the central nervous system
* Patients autistics receiving a psychotropic treatment
* Patients presenting disorders electrolytes
* Patients presenting a hypersensibility known about sulpha drugs
* Presenting patients against indications relative to the treatment by bumetanide
* Patients already treated by diuretics
* Patients presenting a hepatic or renal incapacity
* Patients presenting an elongation of the QT to the electrocardiogram.
* Patients autistics of CARS sore is lower than 30.
Functional Outcomes Following Anal Cancer Treatment

Anal cancer is treated with chemoradiotherapy- combined chemotherapy and radiotherapy. This is very successful (75% long term survival). During the course of the radiotherapy, other organs in the pelvis may be damaged. This can lead to long-term problems with possible changes to the skin, bowels with diarrhoea and incontinence problems, bladder shrinkage and incontinence of urine, sexual problems including impotence and ejaculatory problems, or pain during sexual intercourse with vaginal dryness and shrinkage. Patients should be offered help with these side effects. At present, there is very little information on the effect treatment has on a patient's quality of life, making it difficult to judge if new treatment methods are better.

This project will measure quality of life from the patient's perspective after treatment for anal cancer. It will also gather preliminary data on quality of life after the introduction of a new technique for more precise 3D-targeting of radiotherapy beams at the cancer, called IMRT.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Squamous cell or basaloid carcinoma of the anal canal

Exclusion Criteria:

* adenocarcinoma, melanoma, lymphoma, sarcoma or other malignancy of anal canal
* Any synchronous or metanchronous pelvic malignancy of non-anal origin (eg. prostatic, genital tract)
* unable to complete questionnaire
Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder

The main purpose of this study is to investigate how the brain responds to a procedure known as transcranial direct current stimulation (tDCS) and how tDCS affects performance on a behavioral task. Research suggest that this procedure leads to improvement in brain and behavioral measures of inhibitory control (controlling impulses) in healthy control participants. The investigators want to explore whether the same improvement will be seen in kids with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ADHD
* Parent informed consent and child assent

Exclusion Criteria:

* Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis Type 1 (NF1), tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology
* History of fainting spells of unknown or undetermined etiology that might constitute seizures
* History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
* Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
* History of head injury resulting in prolonged loss of consciousness
* Substance abuse or dependence within the past six months
* Chronic treatment with prescription medications that decrease cortical seizure threshold that the patient is unable to withhold from taking during study visits
* Damaged skin on the scalp (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer.

Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.

To find out if there is prognostic value which to the performance of SOX-9 of oral cancer in Taiwan and provide some reference for future treatment.

We anticipate to enroll 40 persons with normal oral mucosa, 65 persons with oral dysplasia and 150 persons with oral cancer and collect the tissue which was stained for pathological sections over a 3 year period.

We also collect the blood and saliva samples from patients and the results along with patient-specific information such as tumor phases, tumor size, lymph node metastasis, cancer metastasis, prognosis and betel nut chewing, smoking and drinking habits and other parameters are statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Dysplasia or cancer of the oral cavity.

Exclusion Criteria:

* pregnant woman
Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase

This project attempts to correlate wireless activity data with quality of life and sleep surveys in order to find a new method of monitoring patients during their treatment.

This project proposes the investigation, validation, and use of a wireless activity tracker to better understand and improve the quality of life of patients suffering from brain tumors. The Fitbit flex wireless syncing activity tracker will be distributed to 75 patients, and the electronic infrastructure to automatically track patients will be created and adapted for the cohort. Surveys will routinely assess the ease-of-use and any problems arising. This heterogenous population of patients suffering from brain tumors will be tracked and compared through routine evaluation of their quality of life through well-established surveys, including the SF-36 and FACT-Br. The association between data recorded from the activity tracker and the QOL surveys will be quantified to validate the activity tracking data as a surrogate measure of part, if not all, of QOL as well as sleep.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with primary or metastatic brain tumor
* able to wear wireless activity tracker
* able to complete QOL and sleep surveys every 3 months

Exclusion Criteria:

* unable to provide consent
* age \< 18
* lack of use of the wireless activity tracker for more than 2 consecutive months
Phase 1 Study of LQT-1213 in Healthy Adults

This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy adult male or female participants
* Females of childbearing potential must agree and commit to use an adequate form of contraception.
* Men who are biologically capable of fathering children must agree and commit to use an adequate form of contraception.
* Aged at least 18 years but not older than 60 years (inclusive)
* Body mass index (BMI) within 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusively.
* Non- or ex-smoker
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator.

Exclusion Criteria:

* Clinically significant diseases or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.
* Clinically significant abnormal findings on the physical examination or medical history during screening as deemed by the principal investigator
* Female who is lactating
* Female who is pregnant
* Male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system
* Male participants who are undergoing treatment or evaluation for infertility.
* History of significant hypersensitivity to LQT-1213, kinase inhibitors or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
* Use of immunosuppressant in the 28 days prior to the first study drug administration
* Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
* Intake of an investigational product or participation in a clinical trial in the 90 days prior to the first study drug administration
Combined Systemic Inflammatory Indices and Birth Weight

The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight

The research was structured as a prospective observational study. It was conducted at a second-level University Hospital over the period from December 2019 to February 2021.

Participants:

Blood samples were collected at hospital admission. These samples were used for a complete blood count, focusing specifically on deriving systemic inflammatory indices.

The primary inflammatory indices studied were Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), and Monocyte-to-Lymphocyte Ratio (MLR).

The birth weight was registered.

Eligibility Criteria:
Inclusion Criteria:

* physiological Full-term pregnancies

Exclusion Criteria:

* gestational diabetes
* pregestational diabetes
* Chronic Hypertension
* Gestational Hypertension
* Preeclampsia
* Eclampsia
* Intrauterine Fetal Growth Restriction
* Preterm Delivery
* Multiple Pregnancies
* Fetal malformations
CRP and Lung Ultrasound in Respiratory Evaluation

Lower respiratory tract infections (LRTIs) are one of the most common reasons for consultation in Primary Care centres. Differentiating between viral and bacterial aetiologies can be challenging, leading to inappropriate antibiotic prescribing. Lung ultrasound (LUS), an imaging test that gained particular relevance since the beginning of the SARS-CoV-2 pandemic, offers several advantages over the classic chest X-ray in detecting and monitoring LRTIs, especially when pleural involvement exists.

This study aims to correlate LUS findings with capillary blood C-Reactive Protein (CRP) values in patients with LRTIs, evaluating LUS as a diagnostic tool and its impact on therapeutic decisions. The descriptive observational study, conducted from January 2024 to December 2026 in Lleida, will include LRTI patients attending Primary Care centres. By validating LUS as a rapid and non-invasive diagnostic tool, unnecessary antibiotic prescriptions can be reduced, promoting LUS as a complementary test in Primary Care consultations. This will facilitate appropriate diagnosis and treatment decisions for patients with LRTIs, enhancing the overall management of respiratory infections.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Clinical suspicion of LRTI defined as acute illness lasting less than 21 days, with cough as the main symptom, accompanied by at least one other lower respiratory symptom (such as sputum production, dyspnoea, difficult breathing, or chest pain) without any other explanation for the clinical picture.
* Ability to read, understand and willingness to give written consent to participate in the study.

Exclusion Criteria:

* Patients who have been treated with antibiotics during the last 14 days up to inclusion.
* Patients with hemodynamic instability or that need emergency medical care due to the current clinical condition.
* Previous diagnosis of lung or pleural cancer.
* Thoracic surgery within the past 60 days.
* Lung interstitial diseases.
* Patients who refuse to participate in the study
Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients

The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled comparative trial.

This was a 4-week, randomized, double-blind, controlled study. Fourteen subjects received treatment lotion (1% pramoxine HCl) and the remaining 14 received a bland emollient (Cetaphil lotion). A target lesion limited to one anatomic site, excluding face and genitals, was selected at baseline. Each subject was instructed to apply lotion twice daily to all affected areas of pruritus for four weeks. The use of any other topical or systemic medication to treat uremic pruritus was not permitted while participating in the study. Subjects were clinically evaluated for erythema, xerosis, lichenification and overall severity at baseline, week 1, and week 4 (end of study)

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years of age to 70 years of age.
* A diagnosis of moderate to severe pruritus.
* At least 3 episodes of itch over a period of 2 weeks, each lasting for 2 minutes or more.
* Symptoms of itch in regular pattern over 6 months.
* Itch Visual analog scale (VAS) of 3cm or more out of 10 cm.
* All subjects will be end stage renal failure patients undergoing hemodialysis for at least 3 months, who have substantial pruritus for more than 6 months. Substantial pruritus is defined as persistent pruritus impairing sleep or daytime activity.
* Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study
* The ability to understand and sign a written informed consent form, which must be obtained prior to treatment.

Exclusion Criteria:

* Presence of infection (as defined by the investigator) on the area to be treated.
* Subjects with history of pruritus predating renal failure and subjects with skin disease unrelated to uremia, such as atopic dermatitis, will be excluded.
* Use of systemic medications for treatment of pruritus including corticosteroids within the past 4 weeks and during the study.
* Use of topical medications for treatment of pruritus, including corticosteroids, within the past week.
* Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study.