cyrilzakka/clinical-trials huggingface dataset:
REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men

The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.

STUDY OBJECTIVE - To compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.

STUDY DESIGN - Multicenter open-label randomized controlled parallel-group post-market trial.

STUDY TREATMENTS AND RANDOMIZATION - Subjects will be randomly assigned to REZŪM or dual drug therapy treatments; 1:1 randomization via the electronic data capture (EDC) system. Both treatments are commercially available. Subjects randomized to receive the REZŪM treatment will receive standardized treatment and subjects randomized to dual drug therapy will receive the local formulary preferred choice of urinary selective alpha blocker and 5-alpha reductase inhibitor.

VISIT SCHEDULE - Study visits are at: enrollment/baseline, treatment, 3 months, 6 months, and yearly follow-up through 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Sexually active male subjects ≥ 45 years of age who have persistent non-neurogenic lower urinary tract symptoms refractory to first-line treatment with single agent Alpha Adrenoceptor Antagonist therapy
2. Subject is willing and able to answer all domains of MSHQ
3. Completed IPSS questionnaire with score ≥ 13 within 6 months prior to enrollment
4. Peak urinary flow rate (Qmax): ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment
5. Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment
6. Prostate volume ≥ 30 ml as measured by transrectal ultrasound or Magnetic Resonance Imaging within 3 months prior to enrollment
7. Subject is willing and capable of providing informed consent
8. Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigational Plan (CIP)
9. France subjects only: subjects must be affiliated to national security insurance

Exclusion Criteria:

1. Inability to participate in full duration of study
2. Prior surgical treatment for BPH
3. Increased risk of bleeding
4. Presence of Genitourinary Cancer or other pelvic cancer
5. Functional issues with bladder
6. Presence of active infection in genitourinary tract
7. Structural and Anatomic issues with urinary tract and renal function
8. Concomitant Drug Therapy
9. Temporal restraints and risks for general anaesthesia or comorbidity that would elevate risk of participation
Effect of a Lacidofil® STRONG in Healthy Adults Taking Antibiotic Treatment

The objectives of this study are to evaluate stool consistency and stool frequency during and up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid 875mg BID.

It is hypothesized that the proportion of subjects having a diarrhea-like defecation, defined as a stool frequency ≥ 3 per day and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days will be lower in the group receiving Lacidofil® STRONG compared to the group receiving placebo and therefore mean Bristol Stool Scores will be lower in subjects receiving Lacidofil® STRONG compared to those receiving placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 50 years inclusive
* Body mass index 18.0 - 29.9 kg/m2
* Healthy as determined by laboratory results, medical history and physical exam
* Agrees to comply with study procedures
* Agrees not to change current dietary habits (with the exception of avoiding pro- and prebiotics) and activity/training levels during the course of the study
* Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
* Body mass index ≥ 30 kg/m2
* Average number of formed bowel movements \> 3 per day or \< 3 per week
* Participation in a clinical research trial within 30 days prior to randomization
* Use of antibiotics within 60 days prior to randomization.
* Habitual use of pro- and/or prebiotic products. Subjects must not consume foods or supplements containing added pro- and/or prebiotics within 3 weeks prior to randomization and during the course of the study
* Use of laxatives, enemas or suppositories 1 week prior to randomization and for the duration of the study
* Follows a vegetarian or vegan diet
* Unstable medical conditions, as determined by the Qualified Investigator
* History of chronic gastrointestinal disorders including irritable bowel syndrome; chronic constipation; chronic diarrhea; dyspepsia; gastroesophageal reflux disease; diverticulitis; colitis; Crohn's disease; or any other malabsorption or gastrointestinal disorder
* Subjects with an immuno-compromised condition (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment)
* Alcohol use \> 2 standard alcoholic drinks per day and/or alcohol or drug abuse within past year
* Allergy or sensitivity to test product ingredients or Amoxicillin/Clavulanic Acid
* Individuals who are cognitively impaired and/or who are unable to give informed consent
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Comparison of Conventional Free Gingival Grafts With Partially De-epithelized Free Gingival Grafts

In this study, the conventional SDG method applied to increase the adherent gingival band and partial de-epithelialized SDG methods were evaluated in terms of aesthetics and color compatibility of the recipient area with adjacent tissues.

This study is a controlled double-blind clinical trial randomized by split-mouth, envelope method.Clinical parameters and aesthetic harmony were compared at postoperative 1st, 3rd and 6th months after surgical procedures.Color harmony evaluation was made in 2 different ways, both by photo analysis of a blind researcher using computer software and by visual evaluation of the same blind researcher.

The primary aim of this split mouth randomized controlled clinical trial is to compare the partial de-epithelialized free gingival grafting technique with the conventional free gingival grafting technique from an aesthetic point of view. The secondary aim of the study is to evaluate both techniques in terms of periodontal clinical parameters.

This study is a controlled double-blind clinical trial randomized by split-mouth, envelope method. Fifteen patients with attached gingiva width ≤2 mm in the lower jaw bilateral canine and premolar regions were included in the study. De-epithelialized free gingival grafts were applied to the region determined by envelope randomization, and conventional free gingival grafts were applied to the other region. The areas of the patients with insufficient attached gingiva were photographed before the operation, post-op 1st, 3rd, and 6th months, and visual aesthetic evaluations were made with photo analyzes. Clinical parameters such as keratinized gingival width, probing pocket depth, and recession depths were recorded at baseline and at 6 months. Results were represented as mean ± standard deviation and median, and a p value of \<0,05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Absence of known systemic disease
* Not using any medication that may affect the periodontal tissues or prolong the bleeding time
* Having not previously operated on the palate area, which is both the receiving area and the donor area.
* The depth of the probing sulcus of all teeth is \<3 mm
* Whole mouth plaque index and gingival index scores \<1
* The teeth in the operation area are vital
* Absence of caries and / or restoration on the root surfaces of the teeth in the operation area
* Lack of attached gingiva in opposite jaws

Exclusion Criteria:

* Pregnant or lactating women,
* Smoking individuals,
* Individuals under the age of 18
Fluorescence Guided Surgery in Breast Cancer

A need for further investigation for fluorescence image-guided surgery in breast conserving surgery (BCS) has arisen following the results obtained from a phase I feasibility breast cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system.


Eligibility Criteria:
Main Inclusion Criteria:

1. Females aged ≥ 18 years.
2. Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery.
3. Tumor size ≥ 5 mm (0, 5 cm) diameter according to anatomical imaging data.
4. WHO performance score 0-2.
5. Life expectancy greater than 12 weeks
6. Written informed consent has been obtained
7. In the Investigator's opinion, patient is able and willing to comply with all trial requirements.

   For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:
8. A negative serum pregnancy test prior to receiving the second generation tracer
9. Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.

Main Exclusion Criteria:

1. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
2. Breast prosthesis in the target breast
3. History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
4. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment
5. Significant renal or hepatic impairment.
6. Inadequately controlled hypertension with or without current antihypertensive medications.
7. History of myocardial infarction, transient ischemic attack, cerebro vascular accident, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment.
8. Patients receiving anticoagulant therapy with vitamin K antagonists.
9. Patients receiving Class IA (e.g. Quinidine) or Class III (e.g. Dofetilide, Amiodarone, Sotalol) antiarrhythmic agents.
10. Evidence of QT prolongation on pre-treatment ECG (Males \>440 ms, Females \>450 ms).
11. Magnesium, potassium and calcium levels below lower normal limit which is regarded clinically relevant with regards to study participation.
Urethral Sensory Profile: a New Technique to Evaluate Urethral Sensation Prospective Evaluation in Patients With or Without Neurological Disorders

This is a routine evaluation of urethral sensation during urodynamic studies. The record has been realized retrospectively. The investigators propose a new way to represent urethral sensation, in a simple and non-invasive way.

All patients consulting for urodynamics were included. During the introduction of the urinary catheter for urodynamic evaluation, patients were asked to report pain and/or desire to void felt at every centimeter (cm)of insertion, on an analogic visual scale graded from 0 to 10. The USP was defined by the graphic representation of the successive values of these sensations , from the urinary meatus, to the urinary bladder.

Eligibility Criteria:
Inclusion Criteria:

* patients consulting in our department for a urodynamic study

Exclusion Criteria:

* chronic pelvic pain
* difficulties for understanding or for communicating
Validation and Application of a Multi-dimentional Frailty Assessment Tool-Cohort Intervention and Follow up

We aim to (1) use a multifaceted, frailty assessment model. (2) use randomized controlled trials to deal with and intervene with cross-field, multi-faceted and intelligent remote management strategies for the elderly with different degrees of frailty, to further observe functional changes and analyze the probability of adverse prognosis such as falls, hospitalization, and death in the future

Background: Frailty is a common problem among the elderly, and it is closely related to their own age, chronic diseases, physical function, and nutritional status. The higher the incidence, the higher the age. Frailty is also associated with many adverse outcomes, such as falls, disability and even mortality. At present, there is no ideal treatment for frailty. It is best to start with prevention and take precautions against various frailty factors in advance. There are two types of frailty assessments in this study. The Clinical Frailty Scale is a single observational assessment method, which can roughly know your frailty degree. Frailty indicators are further combined with questionnaires and instrumental measurements, which can be subdivided to explore different weaknesses such as subjective frailty, objective frailty, sarcopenia, osteoporosis risk, and fall risk for analysis.

Objects: Elderly people in the community (over 65 years old) who seek medical treatment in the Geriatrics Department of National Taiwan University Hospital, and who are willing to accept the frailty index test are eligible for admission. We expect to enroll about 216 cases from 2023.2.1 to 2024.12.31 with intervene and follow up for 1 year.

Method:. All the elders were given questionnaires and instruments to measure various frailty indicators, such as walking speed, standing up and walking test, muscle mass index, grip strength, 5 times of sitting and standing speed, and various physiological indicators such as blood oxygen, body fat, etc. The subjects will be randomly assigned to the intervention group or the control group. The control group will receive routine outpatient care. The intervention group will receive multi-faceted frailty prevention and treatment programs such as physical exercises, nutritional advice, cognitive training, and drug education. After that, the prognosis will be tracked by telephone every 3 months, and the self-evaluation questionnaire and the measurement of frailty indicators will be carried out at the 6th and 12th months. In order to observe the changes in the prognosis and frailty indicators of the two groups in one year.

Eligibility Criteria:
Inclusion Criteria:

* adults aged greater than 65 years in outpatient department

Exclusion Criteria:

* with dementia
* with active cancer and those unable to operate or follow measuring instructions.
* Individuals with pacemakers or metal implants were excluded because those devices may interfere with measurement of body composition using the bioelectrical impedance analysis (BIA) technique
Biomarkers of aHSCT

The underlying disease mechanisms which occur in patients with immune mediation neurological diseases, such as Multiple Sclerosis (MS), are incompletely understood. For such patients, autologous haematopoietic stem cell transplantation (aHSCT) has been increasingly used as a highly successful one-off treatment for some patients. This treatment aims to delete the faulty immune system with a course of chemotherapy and then 'reboot' the immune system using a patients' own stem cells (a cell with the unique ability of being a building block to create many different cells in the body) to stop further damage. Over the last 20 years more than 1800 patients with MS have been treated in Europe with high levels of success. It may be more successful than disease modifying treatment but unfortunately, a small portion of people do not respond to this treatment optimally and continue to accumulate disability. There is a risk of side effects, restricted largely to the time of treatment, which necessitates the need to ensure appropriate patients are treated. Whilst aHSCT is a very effective therapy, it is still in its early phase of development, is not in widespread use, and there is incomplete knowledge regarding how it works and importantly, why it does not work in some patients, and how to monitor response to treatment.

Unfortunately, there is no way of detecting which patients will, and will not, benefit from the different treatments available or a way of monitoring the immune system to ensure further treatment is provided before irreversible damage occurs.

This study will investigate the immune system which is found in the fluid surrounding the brain and spinal cord, blood and stool of patients undergoing aHSCT and compare it to those receiving disease modifying treatment. This study will therefore further the understanding of biomarkers of aHSCT to develop an awareness of how it can be refined, may improve monitoring of patients following treatment and permit the development of markers which can predict potential treatment success or failure before patients are exposed to the risks.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of a immune mediated neurological disease according to disease specific criteria (active treatment arm) or diagnosis of relapsing remitting multiple sclerosis (control arm).
2. Treatment with autologous haematopoetic stem cell transplantation (active treatment arm) or high efficacy disease modifying treatment (control arm).
3. Willing to provide biological samples for analysis and undergo clinical assessments for the duration of follow up.
4. Able to understand English and provide informed consent.

Exclusion Criteria:

1. Inability to provide informed consent.
Provide Pre-approval Single Patient Expanded Access (Compassionate Use) of Etrasimod for Patients.

Provide pre-approval single patient Expanded Access (Compassionate Use) of Etrasimod for patients.

In Expanded Access, treating physicians are the Sponsors. Expanded Access requests from treating physicians may be submitted to www.pfizercares.com. Availability will depend on location and country.

Eligibility Criteria:
Patient must be intolerant, have a contraindication or had inadequate response to at least 3 therapies available for Ulcerative Colitis (UC) in this country or provide a rationale of why therapy was not used.
Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma

This study will evaluate the efficacy and safety of 1st line therapy with gemcitabine plus S1 and tislelizumab in participants with advanced biliary tract carcinoma (BTC).


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≤ 18 years old ≤ 75 years old, regardless of gender.
* 2. Diagnosed as malignant tumor of biliary tract by histopathology or cytology, including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, common bile duct carcinoma or gallbladder carcinoma.
* 3. The disease is not suitable for radical surgery and/or local treatment;
* 4. At least one measurable lesion according to RECIST 1.1 standard
* 5. The ECOG score is 0-1
* 6. The expected survival ≥ 12 weeks.
* 7. The Child-Pugh score is 5-7
* 8. Within the past 2 years, there was no active autoimmune diseases that require systemic treatment, replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction)
* 9. Women with fertility: agree to abstain during treatment and at least 6 months after the last dose (to avoid heterosexual intercourse) or use contraceptive methods with an annual contraceptive failure rate of less than 1%.
* 10. Male: Agree to abstain (not engage in heterosexual intercourse) or use contraception, agree not to donate sperm
* 11. The subjects voluntarily participated in the study and agreed to sign written informed consent, with good compliance and cooperation in follow-up.

Exclusion Criteria:

* 1. who have any of the following: (1) suitable for surgical radical treatment, (2) have undergone radical surgery without assessable lesions, (3) have received first-line systemic treatment
* 2. Known to be allergic or intolerant to recombinant humanized PD-1 monoclonal antibody drugs and their components.
* 3. ECOG PS ≥ 2
* 4. metastasis site\>2 organs
* 5. Pregnant or lactating women
* 6. Received local anti-tumor therapy within 4 weeks prior to the first study drug treatment, including but not limited to radiotherapy, radiofrequency ablation, cryoablation, or percutaneous ethanol injection
* 7. Receiving approved or developing systemic anticancer therapies, including chemotherapy, biological immunotherapy, targeted therapy, or Chinese herbal therapy with clear indications for anti-tumor effects
* 8. There are multiple factors that can affect the oral administration of S1 (such as inability to swallow, chronic diarrhea, intestinal obstruction, or other conditions that significantly affect drug administration and absorption)
* 9. Simultaneously participating in another clinical study
* 10. After comprehensive assessment of the condition by the investigators, it is deemed unsuitable to participate in this study
Smoking Effect on Lumbar Intervertebral Disc Degeneration

Besides normal aging, genetic and environmental factors are important potential determinants of lumbar disc degeneration. Smoking causes serious health problems, particularly lung and other cancers, heart disease and respiratory diseases, and is among the most common causes of death worldwide. Besides these commonly known diseases related to smoking numerous studies have shown that smoking has detrimental effects on the musculoskeletal system and worsens the prognosis and treatment of leukomotor diseases. In the literature there are studies examining the effect of smoking status on disc degeneration. The aim of the study was to investigate the effect of current, former and passive smoking status on degeneration of lumbar intervertebral discs.

This retrospective study was performed by obtaining medical records of patients who underwent lumbar spinal MRI between September 2019 and February 2020. After the application of exclusion criteria 955 patients determined between the specified dates. These patients were called by phone to be questioned about their smoking status and whether they were working in heavy work and whether they were athletes. Heavy workers and athletes were also excluded from the study and a total of 360 patients whose smoking status information could be obtained were included in the study.The patients were grouped according to their smoking status as "current smoker", "former smoker", "non-smoker" and "passive smoker". The cumulative smoking dose for current and former smokers was calculated in terms of pack-years and categorized further into two subgroups: smoked ≤9 pack-years or \>9 pack-years. The number of pack-years was calculated by dividing the number of cigarettes consumed per day by 20 and multiplying by the years that the patient had smoked. Age, gender, weight, and height were recorded, and body mass index (BMI) was calculated as weight/(height)2. Lumbar spinal MRI was performed using a 1.5 Tesla imaging system (General Electric Healthcare, Milwaukee, WI), using the following settings: amplitude: 44 mT/m; slew rate gradient configuration: 200 T/m/s. MRI images were evaluated using a GE Advantage Workstation (GE Healthcare, Buc, France) and Volume Share software v.7.0. The lumbar lordosis angle was measured and the lumbar intervertebral discs were evaluated by Pfirrmann disc degeneration grading system using sagittal T2-weighted MR images (TR/TE: 2500/85 ms, matrix: 320x224, slice thickness: 4 mm, FOV: 32) (23). The degree of degeneration was classified into five grades with Grades IV and V considered as "severe disc degeneration". Radiologist reviewing the MRI studies was blinded to the smoking status of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent lumbar spinal MRI between September 2019 and February 2020.

Exclusion Criteria:

* a history of spinal surgery or instrumentation, spinal fracture, trauma, congenital or acquired spinal deformity tumor or infection,
* heavy physical workers,
* athletes