cyrilzakka/clinical-trials huggingface dataset:
The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence

This is a prospective, post-market, single arm, multicenter study comparing Baseline data to the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence

This study is a prospective, European Post-Market, one non-controlled arm, multi-centre clinical trial conducted at up to 10 centers in Europe. It is designed to get more clinical information for users (uro-gynecologists) of the Altis Single Incision Sling System for female stress urinary incontinence treatment in terms of objective and subjective cure rate, quality of life improvement, patient satisfaction and safety, especially in long term follow-up (3 years). Clinical data will be collected at baseline, implantation procedure, post-operative at 6 weeks, 6 months, 1, 2 and 3 years

Eligibility Criteria:
Inclusion Criteria:

* The subject is female at least 18 years of age
* The subject uses a method of contraception considered effective by the investigator or is not of child-bearing potential
* The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
* The subject has confirmed stress urinary incontinence (SUI) through cough stress test at baseline.
* The subject has failed first line treatments (non-invasive therapies, eg. behavioral modification, Pelvic Floor/Kegel exercises, or biofeedback) with good compliance for the treatment

Exclusion Criteria:

* The subject had a prior surgical SUI treatment (including bulking agent).
* The subject is having a concomitant Pelvic Organ Prolapse repair or hysterectomy during Altis procedure.
* The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).
* The subject has predominant or uncontrolled or primary urge incontinence according to investigator judgment
* The patient has detrusor overactivity determined through urodynamics
* The subject has intrinsic sphincter deficiency defined urodynamically as a Maximal Urethral Closure Pressure \< 20 cm H2O and/or Valsalva Leak Point Pressure \< 60 cm H2O
* The subject has atonic bladder, a persistent post void residual (PVR) \> 100 ml or chronic urinary retention.
* The subject has untreated urinary malignancy
* The subject has undergone radiation or brachy therapy or chemotherapy to treat pelvic cancer.
* The subject has urethrovaginal fistula or urethral diverticulum or congenital urinary anomalies
* The subject has serious bleeding disorder or requires anticoagulant therapy
* The subject is pregnant and/or is planning to get pregnant in the future.
* The subject has a Body Mass Index ≥ 35 (obese class II).
* The subject has a contraindication to the surgical procedure according to the the Altis SIS System IFU.
* The subject has an active urogenital infection or active skin infection in region of surgery mainly at the time of implantation.
* The subject is enrolled in a concomitant clinical trial.
Oral Sedation in Vitreoretinal Surgery

The purpose of this study is to compare the efficacy of oral sedation to intravenous sedation with anesthesiology support and monitoring.

After being informed about the study and potential risks, and providing written informed consent, a total of 40 patients will undergo vitreoretinal surgery with oral Triazolam and 40 patients will undergo vitreoretinal surgery with intravenous sedation. The IV sedative will be determined by the anesthesiologist or certified registered nurse anesthetist but limited to midazolam, propofol, and fentanyl. The study will be a prospective, cross-sectional study with a 1:1 randomized procedure and unmasked.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing vitreoretinal surgery for a variety of indications including, but not limited to, epiretinal membrane (ERM), macular hole, vitreous opacities, vitreous hemorrhage, aphakia, dislocated or displaced intraocular or crystalline lens, silicone removal, endolaser, and retinal detachment.
* American Society of Anesthesiologists rating of I-III

Exclusion Criteria:

* Undergoing vitreoretinal surgery requiring general anesthesia
* Allergy or hypersensitivity to benzodiazepines
* Pregnant or nursing females
* Previous delirium after anesthesia
* Current use of drug or alcohol on the day of surgery
* Currently on medications inhibiting cytochrome P450
* Failed anesthesia clearance
* Reported anxiety or a history of anxiolytic use
* Vitreoretinal surgery performed within the last 3 months of the current procedure
* Impaired renal or liver function
Modified Dantien Salee Yoga Training Program in Chronic Obstructive Pulmonary Disease Rehabilitation

COPD patients will be recruited and assigned into one of each group: 1) Control group or 2) Yoga group. In Yoga groups, subjected will be asked to participate in Modified Dantien Yoga training for 12 weeks (3 times/week, 60 min/time). The subjects will be evaluated their pulmonary function, functional fitness performance, dyspnea score, and quality of life at baseline and after 12 wk training.


Eligibility Criteria:
Inclusion Criteria:

1. Stable COPD patients \> or equal 6 weeks.
2. Age \> or equal 50-80 years.
3. FEV1 \> or equal 30% predicted after take bronchodilators drug.
4. Resting SpO2 \> or equal 90% room air.
5. Did not pulmonary rehabilitation program before start the yoga

Exclusion Criteria:

1. Subjects with musculoskeletal disorders, mental and neurological disorders, and acute coronary heart disease.
2. Blood Pressure (systolic) \> 180 mmHg.
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.

The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

The valve can be set to 8 different performance settings for intraventricular pressure and drainage of CSF. The performance setting of the valve can be set preoperatively and can also be noninvasively changed post-implantation.

This clinical investigation will maintain data for each patient from the date of implant through 3 years post-implantation.

Data collection for each patient will occur per standard of care.

However, the clinical investigation specifically aims to collect and analyze data from the day of procedure, and post-operatively at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months.

Data from follow-up visits will be analyzed according to pre-defined time-intervals referring to these follow-up moments.

Eligibility Criteria:
Inclusion Criteria:

1. Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
2. Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves.
3. Patient (legally designated representative) is willing to comply with the study protocol timelines \& requirements.
4. For patients who have had the Codman CERTAS Plus Programmable Valve implanted prior to study enrollment, have available data from implantation to the current time.

Exclusion Criteria:

1. Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
2. Patient's planned shunt has distal drainage to the heart.
3. Patient has ventriculitis, peritonitis or meningitis.
4. Patient has sepsis.
5. Patient has a history of poor wound healing.
6. Patient has symptoms pertaining to a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this study.
7. Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant.
8. Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
9. Patient is currently enrolled in another drug or device trial or has been previously entered in this trial.
10. Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
11. Patients with known hypersensitivity to rifampin or clindamycin hydrochloride. This criterion applies for patients to be treated with the BACTISEAL Catheters (included in some models of the valve) only.
The Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics

The goal of this interventional study is to test whether consumption of Wonderlab probiotics with prebiotics could improve obesity and overweight in Chinese people who are aged 25-45 and overweight. The main question it aims to answer is:

- whether the weight of participants can be lost after 10 weeks' intervention

150 participants will be randomized into 3 study groups (50 each group) in the two study sites, who will consume assigned product according to instructions for 10 weeks. Three site visits will be made for each participant and all relevant clinical data will be captured and recorded into CTMS(Clinical Trial Management System) for statistical analysis.

Researchers will compare the three groups to conclude whether the Wonderlab study product can improve obesity and overweight over placebo product.


Eligibility Criteria:
Inclusion Criteria:

* Chinese males or females, age between 25-45;
* Overweight population: BMI 24-27.9 \& obesity population: BMI \>=28;
* Blood lipids in high potential risks but without medication:TG \> 5mmol/L or LDL \>= 3.4 mmol/L or TC \>= 5.2 mmol/L.
* Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate;
* Agree to avoid medication treatment for weight management, including blood lipids and sugar control.

Exclusion Criteria:

* Have used any medication for weight management at least one month before this study.
* Subject having done plastic surgery for weight management.
* Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
* Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
* Have a history of any type of metabolic syndrome, including but not limited to any type of diabetes, obesity and heart disease.
* Have a history of any disease or the presence of health condition on the study sites that the Investigator feels would interfere with the study.
* Be taking antihistamines (\> 3x/week) or anti-inflammatory (\> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment.
* Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, pregnancy, lactation and hepatitis.
* Have any cuts/abrasions on the test site at baseline.
* The subject is an employee of sponsor or the site conducting the study.
Optimization of Antiviral Therapy of Chronic HBV Infection

Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible. Currently, the recommendation of optimized treatment especially interferon therapy are mainly based on retrospective studies, it still lacks prospective evidence. This study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg positive CHB with inadequate response to 24 weeks interferon treatment.

Patients with inadequate response to interferon therapy at 24 weeks were enrolled in this study and accepted the optimized therapy (add on ADV or switch to LDT) for 48weeks. All these patients were followed for 48 weeks and the HBeAg seroconversion and HBV DNA level were observed. Safety and the economic effect of the two optimized therapy methods also were observed.

Eligibility Criteria:
Inclusion Criteria:

patients receiving Peg interferon α-2a with inadequate response at 24 weeks (HBeAg titer ≥ 100Paul Ehrlich Institute Unit (PEIU)/ml and HBV DNA ≥ 5.0 Log copies/ml or HBV DNA titer decline \<1 Log copies/ml) were enrolled into this study.

Exclusion Criteria:

* no decompensated cirrhosis,
* no hepatitis C, hepatitis D or human immunodeficiency virus (HIV) co-infection,
* no hepatocellular carcinoma and other tumors or history of severe hepatitis,
* no other systems diseases, such as a history of cardiopulmonary diseases, thyroid disorders, immune system disorders, epilepsy or mental illness (such as severe depression).
The Impact of Endoscopic Pituitary Surgery on Nasal Function

The aim of this study is to determine the impact of endoscopic transsphenoidal pituitary surgery on nasal function using a numerical simulation and to compare the difference between two kinds of transsphenoidal approachese(single nostril approach and bilateral nostril approach)．

Neuroendoscopic surgery is the first treatment for most pituitary adenoma patients. Because transsphenoidal surgery exploits the nasal corridor and paranasal sinuses to reach the skull base, sinonasal trauma is a primary source of postoperative morbidity in many of these patients. The aim of this study is to determine the impact of endoscopic transsphenoidal pituitary surgery on nasal function using a numerical simulation and to compare the difference between two kinds of transsphenoidal approachese(single nostril approach and bilateral nostril approach)．

Eligibility Criteria:
Inclusion Criteria:

1. Enhanced MRI shows a pituitary tumor
2. Endoscopic surgery is required according to the pituitary tumor treatment guidelines.
3. Karnofsky performance status ≥ 70.
4. The patient has signed the informed consent.

Exclusion Criteria:

1. Patients who have undergone previous transsphenoidal surgery or other nasal surgery.
2. Patients who had a history of nasal tumors.
3. Patients who had a history of severe head or face trauma.
4. Patients with congenital sinus malformation.
5. Pregnant or lactating women.
6. Patients with serious systemic diseases without control.
7. Patients with poor compliance, who cannot implement the program strictly.
A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)

This is a study for participants with type 2 diabetes mellitus. The main purpose of this study is to learn more about how tirzepatide, semaglutide and placebo affect the body's ability to respond to blood sugar levels after a meal. The study will last up to 40 weeks, including a 28-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Have T2DM for at least 6 months
* Treated with diet and exercise and stable dose(s) of metformin, with or without 1 additional stable dose of oral antihyperglycemia medication other than metformin, 3 months prior to study entry
* Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia medications other than metformin
* Have a body mass index (BMI) between 25 and 45 kilograms per square meter (kg/m² ) inclusive, at screening; are of stable weight (±5%) \>3 months prior to screening

Exclusion Criteria:

* Have a history of proliferative retinopathy or maculopathy as determined by the investigator based on a recent (\<1.5 years) ophthalmologic examination
* Impaired renal estimated glomerular filtration rate (eGFR) \<45 milliliters per minute per 1.73 square meters (mL/min/1.73 m²) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
* Have a history or current cardiovascular, respiratory, hepatic, renal, GI,endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function

The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged between 50 and 75 years (inclusive)
* BMI ≥18.5 kg/m2 and ≤32 kg/m2 at the Screening Visit.
* Group A: Patients with severe renal impairment renal impairment (creatinine clearance (ClCr) ≤29 mL/min)
* Group B: Healthy subjects with normal kidney function (creatinine clearance (ClCr) ≥90 mL/min, inclusive)
* Group C: Patients with moderate renal impairment ((creatinine clearance between 30 - 59 mL/min, inclusive)
* Group D: Patients with mild renal impairment (Creatinine clearance between 60 - 89 mL/min, inclusive)

Exclusion Criteria:

•The subject has taken disallowed medication \<1 week prior to the first dose of IMP or \<5 half-lives prior to the first dose of IMP for any disallowed medication taken, whichever is longer)

Other protocol defined inclusion and exclusion criteria do apply
Physiologic MR Imaging of Salivary Gland Tumors

The goal of this study is to use advanced Magnetic Resonance Imaging (MRI) techniques to help identify the difference between cancerous and non-cancerous salivary gland tumors for improving treatment strategies and to aid in the prediction of disease progression.

The goal of this proposed study is to investigate the potential utility of combined analysis of parameters (Ktrans, ti and ADC) in discriminating benign from malignant salivary glands tumors (SGTs). A total of 30 treatment naïve patients suspicious of SGT as observed on clinical evaluation and prior routine CT, MRI, Ultrasound, FNAC and/or PET will undergo 3T MRI. The MRI protocol will include acquisition of anatomical images with and without contrast agent injection, diffusion imaging and dynamic contrast enhanced-MRI.

Eligibility Criteria:
Inclusion Criteria:

* Possess a salivary gland lesion of 1cm3 size
* Have no prior history of treatment for salivary gland lesion

Exclusion Criteria:

* Has any prior history of cancer other than SGT
* Has any MRI contra-indications
* Has a history of known renal disease.
* Has history of prior radiation to head and neck region
* Is pregnant
Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)

Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related to acne vulgaris. However, it has not been clinically tested for this purpose. The current study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris and PIH.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 12 years of age
* Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline
* Fitzpatrick skin type IV to VI
* Acne IGA (Investigator Global Assessment) score of 2 or 3
* Inflammatory lesions of 15-60 (with no more than 2 nodules)
* Non-inflammatory lesions of 20-100
* Post Inflammatory Hyperpigmentation Investigator Global Assessment (PIH IGA) score of 3,4 or 5
* Able to understand the requirements of the study and sign Informed Consent/HIPAA forms. Subjects under the legal age of consent must have the written informed consent of a parent or legal guardian

Exclusion Criteria:

* Female subjects who are pregnant, breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control
* Allergy or sensitivity to any component of the test medication
* Subjects who have not complied with the wash out periods for prohibited medications
* Medical condition that contraindicates participation
* Skin disease/disorder that might interfere with the diagnosis of acne vulgaris or PIH
* Evidence of recent alcohol or drug abuse
* History of poor cooperation, non-compliance or unreliability
* Exposure to an investigational drug study within 30 day of Baseline visit
Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD.

The secondary objectives of the study are:

* To assess the long-term efficacy of dupilumab in pediatric participants with AD
* To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumab

Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to \<12 years of age with AD

Co-Primary Objectives are:

* To evaluate the pharmacokinetic (PK) of dupilumab PFPs
* To evaluate the safety of dupilumab PFPs

Secondary Objective is:

- To evaluate the immunogenicity of dupilumab PFPs


Eligibility Criteria:
Key Inclusion Criteria:

* Participated in a prior dupilumab study in pediatric participants with AD and adequately completed the visits and assessments required for both the treatment and follow-up periods, as defined in the prior study protocol
* PFP Sub-Study Only:
* Age ≥2 to \<12 years at time of screening
* Body weight ≥5 kg and \<60 kg at time of screening
* Must have received the same dupilumab dose regimen to be used in the PFP sub-study during the previous 12 weeks in the main OLE study using the prefilled syringe, as defined in the protocol

Key Exclusion Criteria:

* Participants who, during their participation in a prior dupilumab study developed an adverse event (AE) or serious adverse event (SAE) deemed related to study drug which could indicate that continued treatment with study drug may present an unreasonable risk for the patient
* Participants, who during the participation in a prior Dupilumab study, developed an AE that was deemed related to study drug and led to study treatment discontinuation, which in the opinion of the investigator or medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient
* Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
* Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
* Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
* Diagnosed active endoparasitic infections or at high risk of these infections
* Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study
* PFP Sub-study Only:
* Poor compliance as defined by having missed 1 or more of the planned last 3 injections in the main OLE study prior to entering the sub-study
* Switched dupilumab doses within the past 12 weeks
* Meet criteria for temporary/permanent discontinuation of study drug at time of screening into PFP sub-study, as defined in the protocol.

Note: Other protocol defined Inclusion / Exclusion criteria may apply