cyrilzakka/clinical-trials huggingface dataset:
Artificial Urinary Sphincter Clinical Outcomes

To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. ≥ 18 years of age
3. Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
4. Demonstrates primary stress urinary incontinence
5. Positive screening 24-hour pad weight test (≥100 grams)
6. Experiences at least 3 incontinence episodes per day during baseline diary or presents with continuous incontinence
7. Negative urine culture
8. Willing and able to undergo surgical implantation of the AUS device
9. Willing and able to comply with the follow-up requirements
10. Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
11. Willing and able to sign the informed consent

Exclusion Criteria:

1. Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
2. Primary urgency incontinence
3. Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
4. Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
5. Known urogenital malignancy other than previously treated prostate cancer
6. Recurrent prostate cancer that is expected to require intervention during the study follow-up period
7. History of recurrent bladder stones within the past 12 months prior to signing the informed consent
8. Neurogenic bladder
9. Need for intermittent catheterization
10. Known history of bleeding diathesis or coagulopathy
11. Immunosuppressed or on medical therapy which would impact the immune system
12. Uncontrolled diabetes, defined as (HbA1c\>10)
13. Has a genitourinary mechanical prosthesis that was implanted within 3 months from the date of consent
14. Had a post-implantation infection associated with the device after genitourinary mechanical prosthesis was implanted
15. Undergone bulking procedure within 6 months of the baseline assessment
16. Poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
17. Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract
18. Irresolvable detrusor hyperreflexia or bladder instability
19. Currently enrolled or plans to enroll in another device or drug clinical trial
20. Currently using an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use at least 4 weeks prior to baseline assessment
21. Known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines (only applicable when implanting with InhibiZone version of this device)
22. Systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition (only applicable when implanting with InhibiZone version of this device)
Descriptive Study of Drug Compliance in Uncontrolled Hypertensive Patients

Therapeutic compliance is defined as the degree of coincidence between a person's behavior and prescribing advice given by his or her physician. According to the World Health Organization (WHO), "insufficient adherence is the main reason why patients do not get all the benefits they could expect from their medicines. It causes medical and psychosocial complications, diminishes the quality of life of patients, increases the likelihood of drug resistance, and waste of resources. " In the case of certain conditions such as high blood pressure (hypertension), poor adherence increases the risk of stroke, acute coronary syndrome, and heart failure.

In patients with uncontrolled hypertension under treatment, the issue of therapeutic non-compliance should always be considered before considering the dose (supplemental drug) of antihypertensive therapy.

For each patient participating in the study, medication adherence (for one of the antihypertensive treatments) will be assessed for 2 months using an electronic pill. The antihypertensive treatments considered for the study belong to the following classes: diuretics, beta-blockers, calcium-blockers, ACE (angiotensin-converting enzyme) inhibitors, sartans.

Main objective: care objective: to provide physicians and patients with assistance in case of ineffectiveness or therapeutic escape in a chronic disease such as hypertension, by assessing the compliance profile of each patient.

Secondary objectives: to carry out a quantitative typology of drug adherence in patients with unbalanced HTA under treatment.


Eligibility Criteria:
Inclusion Criteria:

* patient treated with diuretics and / or beta-blockers and / or calcium-blockers and / or ACE inhibitors and / or sartans
* Holter blood pressure total average of 24h greater than 135/85 mmHg or a daytime average greater than 140/90 mmHg or a nighttime average greater than 125/75 mmHg.
* informed consent given

Exclusion Criteria:

* Adults with severe hypertension (BP ≥ 180/110 mmHg) with or without organ failure requiring therapeutic adaptation
* Adults unable to comply with study procedures
* Patients who do not wish to receive generic drugs.
Blood Test Order and Culture Contamination

A randomized partially controlled study to examine the effect of blood diversion into a heparin lithium tube on the incidence of blood culture contamination.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Presence in Emergency Room during extended office hours (0800-2000 on weekdays(
* Clinical requirement for Blood culture and biochemistry tests from venepuncture

Exclusion Criteria:

* None
Examining the Therapeutic Potential of Botulinum Toxin Type A in the Treatment of Keloids

Keloids are a common form of hypertrophic scars that by definition last beyond 6 months and grow beyond the site of initial injury. Keloids are a common complaint from patients in dermatology and cause significant functional impairment due to cosmetic disfigurement, itching and pain. Current treatment modalities include intralesional corticosteroids, chemotherapeutic agents and laser therapy. Initial reports have demonstrated that Botulinum toxin type A may be a viable treatment option for keloids that can reduce keloid size and reduce associated symptoms while having fewer side effects when compared to intralesional corticosteroid injection, which can cause unnatural blood vessel growth or skin thinning. To date, no study has carefully examined the efficacy of Botulinum toxin type A in treating keloids or its mechanistic effects on keloid biology. Our aim in this study is to pursue a rigorous, randomized control trial to assess the potential use Botulinum toxin type A to treat keloids. Efficacy will be objectively be mentioned by change in keloid size after treatment, along with subjective measures of patient satisfaction and symptoms, and finally physician rated scores. Also, samples from three patients will be analyzed in the laboratory setting to determine the underlying molecular mechanism behind the effects of Botulinum toxin type A on keloid biology.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 to 80
2. History of keloid scar for at least 12 months
3. Absence of keloid treatment for past 12 months
4. Participant must have a keloid scar of at least 4cm in length.
5. Participants who score at least 8 or higher on the Vancouver Scar Scale
6. Subjects who score 5 (neither satisfied nor dissatisfied) to 10 (maximally dissatisfied) on the patient subjective score of dissatisfaction with keloid.
7. Participants must be in stable health, as confirmed by medical history, per investigator judgment
8. Participants must be able to read, sign, and understand the informed consent
9. Participants must be willing to avoid any other treatments to the keloid that will be treated including corticosteroid injections, surgical excision, chemotherapeutic injection, lasers, light-based therapy, radiation therapy, cryotherapy, or pressure therapy, during the study period.

Exclusion Criteria:

1. Pregnant women
2. Keloids on face, neck or scalp
3. History of hypersensitivity to botulinum toxin
4. Ongoing or planned treatment with chemotherapy, radiation, isotretinoin, cytokine-based immunotherapies
5. Any planned surgery during study period
6. Known diagnosis of insulin dependent diabetes mellitus
7. Patients being treating with dupilumab for any indication
8. Patients taking aminoglycoside antibiotics
9. Patients with pre-existing neuromuscular disorders
10. Patients with infection around potential injection sites
Listening for Leisure After Stroke

Stroke is the biggest cause of disability in older adults. Early poststroke rehabilitation focuses primarily on physical disability and activities of daily living. By contrast, relatively little research attention has been paid to the potential for cognitive rehabilitation and mood enhancing interventions in the early stages after stroke. Low mood and cognitive difficulties with attention and memory are common post stroke leading to poorer recovery, emotional wellbeing and quality of life yet accessible and effective therapies are lacking.

Engagement in leisure activities may enhance recovery after stroke but participation in leisure activities is reduced following stroke. Music listening is a low cost and accessible leisure activity that has been suggested to improve mood and cognition poststroke. The investigators speculate that music listening may enhance control of attention in a similar way to mindfulness interventions, that have been demonstrated to be beneficial in the treatment of mood disorders. The investigators propose that adding a brief mindfulness intervention to music listening might enhance the effect on control of attention, with positive effects on cognition and mood poststroke but the feasibility and acceptability of this intervention needs to be evaluated before attempting a further trial assessing the effectiveness of this intervention. The investigators aim to recruit 100 patients within two weeks poststroke.

Participants will be randomly assigned to receive an 8 week music listening alone, music listening with brief mindfulness or audiobook listening intervention alongside treatment as usual. Neuropsychological assessment of cognition and mood will be performed at baseline, 3 months, and 6 months poststroke In addition, participants will be interviewed about their experience of engaging in the interventions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ischaemic stroke (confirmed clinically and/or radiologically and subclassified according to the Oxford Clinical Stroke Classification)
* ≤14 days poststroke at time of recruitment (expression of interest to participate either verbally or in writing)
* Native English speaking

Exclusion Criteria:

* Comorbid progressive neurological or neurodegenerative condition
* Major psychiatric disorder (Prestroke history of mood disorder or stable antidepressant medication will not lead to exclusion)
* History of major substance abuse problems
* Unable to give informed consent
* Unable to cooperate with the study protocol (e.g. due to severe aphasia, uncorrected impairment of hearing or vision, or illiteracy)
* Clinically unstable (e.g. due to major intercurrent illness).
Role Of Metabolic Adaptation In Weight Regain

In a previous study (NCT04081337), 55 participants with obesity participated on a 18-week lifestyle intervention to reduce their body weight, targeting 10% body weight loss. The participants received tirzepatide (15mg after titration) or placebo during the weight loss intervention. Before and after the lifestyle intervention, energy expenditure (48-h room indirect calorimetry) and body weight and composition (dual-X-ray absorptiometry) were measured, thus enabling the assessment of metabolic adaptation. In this study, participants having provided their consent to be re-contacted will be invited to attend the research center 12,18 and 24 months after completing the lifestyle intervention. Body weight and composition will be measured, aiming to explore the association between metabolic adaptation and changes in body weight and composition after a weight loss intervention. In addition, we will explore whether weight and fat mass changes are different between groups, and whether these effects are mediated by metabolic adaptation.


Eligibility Criteria:
Inclusion Criteria:

* Having participated in the study NCT04081337.

Exclusion Criteria:

* Being pregnant.
The Clinical and Radiographic Outcomes of a 3D-printed Patient-specific Biomimetic Bone Substitute in Maxillofacial Indications: an Interventional, Multi-centred, Open-label, Post-market Clinical Investigation.

The purpose of the study is to evaluate the clinical and radiographic outcome of MimetikOss 3D as a patient-specific bone substitute in regeneration of osseous defects in several maxillofacial indications. The primary objective is to evaluate the capacity of MimetikOss 3D to perform bone substitute requirements, i.e long-term regeneration of bony tissue in complex defects without detrimental resorption. The secondary main objectives are to assess the versatility of MimetikOss 3D by the variety of maxillofacial sites regenerated and the surgical technique improvement (in terms of surgery duration, blood loss, ease-of-use of the product and surgeon satisfaction).


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 years or over at the time of inclusion into the study;
* Ability to obtain written informed consent from the recipient;
* Patients in need of craniomaxillofacial bone regeneration;
* Ability and capacity to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient;
* Patients with good general hygiene;
* Radiographic exam allowing a complete observation of the osseous defect;
* Mimetis approval of the feasibility.

Exclusion Criteria:

* Active tumour;
* Passive tumour with cancer recurrence within 10 years;
* Practice of intensive contact sport exercise during the clinical trial duration;
* Concomitant participation in other clinical trials;
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
* Women who are breastfeeding;
* Alcohol or drug abuse as noted in subject records or in subject history;
* Patients with a medical condition that may compromise the healing process or history of systemic diseases that would contraindicate the surgical treatment or any other disease that might have an influence on the involved tissues, such as: severe metabolic disorders, osteogenesis imperfecta, osteoporosis, infectious and degenerative bone diseases, immunodeficiency (congenital or acquired), autoimmune disease, Osler-Weber-Rendu syndrome, unbalanced diabetes, transient hypercalcemia, allergic disposition to phosphate calcium components, titanium or collagen etc; immunosuppressive therapy, steroid therapy, heparin treatment, corticoid treatment, treatments that interfere in the calcium-phosphate metabolism, bisphosphonate intake, Paclitaxel treatment, methotrexate medication etc);
* Acute and chronic infections in the surgery area (e.g. soft tissue infections, inflammatory and bacterial osteopathy, osteomyelitis) and / or mucosal diseases in the areas to be treated;
* In case of intraoral surgery, heavy smokers (\>10 cigarettes) excluded;
* Inability to return for follow up visits.
Success of Zirconia and Composite Strip Crowns for Primary Incisors

The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and composite strip crowns bonded on primary incisors

Zirconia and composite strip crowns will be placed on at least two primary incisor teeth, in a split mouth design. A caries-free primary incisor tooth will be used as control. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type.

Group 1: Zirconia crown 2: Composite Strip Crown 3: Control tooth. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension, color match of the crowns and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments.

The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.

Eligibility Criteria:
Inclusion Criteria:

* Patients and parent of the patients who accept to participate and sign the informed consent
* Patients who have at least two primary maxillary incisor with caries that require crown restoration
* Teeth that have healthy lamina dura and periodontal ligament
* Teeth with no mobility and enough root length
* Patients that have good cooperation to the procedure

Exclusion Criteria:

* Patients and parent of the patients who don't accept to participate and sign the informed consent
* Teeth that are previously restored
* Patients who are uncooperative
* Teeth that doesn't have opposing primary incisors
* Patients who have bruxism or deep-bite
* Teeth that are close to be erupted
* Teeth that have vital or non-vital pulp therapy
Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section

Spinal canal anesthesia is marked the most commonly used method of cesarean section. Traditional spinal anesthesia may cause post-dural puncture headache and low back pain.Plenty of parturients are undergoing anticoagulation therapy.They may be forced to accept general anesthesia in order to avoid epidural hematoma.Therefore, we propose minimally invasive spinal anesthesia.

Traditional group patients will receive cutting type 22 gauge needles, while minimally invasive group patients will receive pen type 27 gauge needles.Patients will be blinded to the intervention allocations. Spinal anesthesia will be performed with a standardized technique. Lumbar puncture will be performed through an interspace (L3-4 or L2-3) with patients in a lateral decubitus position. After free flow of cerebrospinal fluid through the needle tip be verified, 2ml ropivacaine will be injected. We will record puncture situation, anesthesia plane and measure post-dural puncture headache, post-operative back pain and epidural hematoma.

Eligibility Criteria:
Inclusion Criteria:

1. puerpera accept anticoagulation therapy
2. American society of anesthesiologists(ASA) classification I to II level
3. Willing to participate in this study and signed an informed consent
4. pregnancy at least 37 weeks

Exclusion Criteria:

1. platelet count less than 50\*100000000
2. International Normalized Ratio more than 1.5
3. site of puncture with infection
4. with intracranial hypertension
5. with lumbar spine or spinal cord disorders
Complete Endosonographic Intrathoracic Nodal Staging of Lung Cancer Patients in Whom SABR is Considered

Rationale: Accurate staging of lung cancer is important because it directs treatment and determines prognosis. The development of Stereotactic Ablative Radiotherapy (SABR), has revolutionized radiation therapy for early stage lung cancer and results demonstrate similar outcomes in comparison to surgical resection of the lung tumor. The staging work-up program for patients with a potentially resectable Non-Small-Cell Lung Cancer (NSCLC) includes at least a computed tomography (CT) scan of the chest and integrated Positron Emission Tomography - Computed Tomography (PET/CT) scans, and when indicated, invasive mediastinal staging. However, patients who are treated with SABR do not routinely undergo the same nodal staging work-up as do surgical candidates. As both surgery and SABR appear to achieve comparable rates of local and regional tumor control, it appears only logical to perform a similar staging work-up in all patients with early stage lung cancer who will be treated with either of the two curative local modalities. In the past, a lack of invasive nodal sampling before SABR was considered acceptable as invasive surgical staging (mediastinoscopy) was widely considered the preferred procedure. However, with minimally invasive and safe endosonography procedures now available, improved pre-treatment staging has become possible for patient groups who are eligible for SABR, including those with significant comorbidities.

Hypothesis: Complete endosonographic (combined endobronchial and esophageal) staging of hilar and mediastinal lymph nodes in patients with (suspected) non-small cell lung cancer (NSCLC) will result in change of loco-regional nodal status in 20% of patients, in comparison to staging by PET-CT alone.

Study population: Patients with either established or suspected early-stage NSCLC who are medically inoperable, or who refuse surgery but are potential candidates for SABR with curative intent (provided no intrathoracic metastases are present). Patients will undergo a single scope complete mediastinal and hilar staging procedure (combined EndoBronchial UltraSound (EBUS) and Transesophageal Endoscopic Ultrasound with EBUS scope (EUS-B)).


Eligibility Criteria:
Inclusion Criteria:

* Proven, or highly suspected, non-small cell lung cancer (NSCLC)
* Absence of distant metastases based on PET-CT
* Stereotactic ablative radiotherapy (SABR) with curative intent is contemplated
* One of the following features based on PET-CT:
* Centrally located clinical T1-T2 N0 tumor
* Peripheral located clinical T2 N0 tumor
* Suspicion of N1- N2 disease based on either size (short axis \> 10mm CT) or FDG uptake
* Non-FDG avid primary lung tumor and lymph nodes

Exclusion Criteria:

* Medically operable patients with a resectable lung tumor (unless SABR is the explicit preference of the patients or treating physicians preference).
* Bulky nodal disease based on PET-CT
* Contra-indications for endosonography and / or bronchoscopy
* Pregnancy
* Age under 18
* No informed consent
KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma

comparison results of treatment of early stage glottic cancer between two methods of surgical treatment - CO2 laser and KTP laser

Randomized controlled double-blinded study. The study group includes patients diagnosed with early glottic cancer, either carcinoma in situ or T1a-b,N0M0 squamous cell carcinoma.

Patients will undergo examination and treatment and at least 3 years of follow-up.

40 cancer patients will be included. The participants will be randomly divided into two groups: the first will be treated by KTP laser and the second by CO2 laser.

The patients will be blinded to the method of treatment. To enable double-blinding, the investigator performing the surgery would be the only one knowing which research group the patient belongs to. The investigator in charge of collecting the data after the operation will be blinded to the treatment method.

Each participant will undergo pre-operative evaluation and follow-up after surgery in both arms.

Preoperative evaluation will include:

* Voice Handicap Index questionnaire
* GRBAS - subjective assessment of voice quality.
* Video-stroboscopy of vocal cords
* Voice Analysis .

Follow-up after surgery:

* Visit 6 weeks after surgery (± two weeks), and then every three months (± 6 weeks).
* repeated full evaluation (questionnaire, GRBAS, Stroboscopy, voice analysis) in 30 weeks of follow up and 3 years of follow up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pre-operative diagnosis of squamous cell cancer of the vocal cords at an early stage ( Carcinoma in situ or T1-glottic carcinoma).

Exclusion Criteria:

* Patients who underwent previous significant vocal cords surgical intervention , or irradiation.
* Contraindications to any endoscopic surgical treatment (general health condition, patient refusal, technical surgical difficulties)