cyrilzakka/clinical-trials huggingface dataset:
The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe

EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational cohort study has the potential to identify progression factors and biomarkers, and to assess disease stage specific mortality, morbidity and health care costs.

The EuroCYST Initiative aims to build a network of ADPKD reference centers across Europe and to establish a large-scale observational cohort of ADPKD patients for the purpose of studying the pathogenesis, rate of disease progression, progression rate modifiers, disease stage specific morbidity, mortality, health economic issues and the predictive value of biomarkers in ADPKD. Overall 1,100 patients will be enrolled in 14 study sites across Europe and will be followed up for at least three years. The ADPKD reference center network across Europe and the observational cohort study will enable European ADPKD researchers to gain insight into the natural history, heterogeneity and associated complications of the disease as well as how it affects the lives of patients across Europe.

Eligibility Criteria:
Inclusion Criteria:

* Participants ≥ 18 years;
* Clinical diagnosis of ADPKD based on kidney imaging and family history;
* Estimated Glomerular Filtration Rate (eGFR) ≥ 30 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI)- formula);
* Provided written informed consent.

Exclusion Criteria:

* Receiving chronic renal replacement therapy before enrollment (dialysis, allograft) or anticipated in the following 12 months after enrollment;
* Participation in a clinical trial aiming to modify disease outcome one year or less before enrollment in the EuroCYST study;
* New York Heart Association (NYHA) stadium IV.
Analgesia for Pediatric Circumcision : Comparison of the Effectiveness of Pudendal Nerve Block to Penile Nerve Block

Medical or ritual circumcisions are frequent interventions in children. To provide the best comfort to the patients, the anesthetists use regional anesthesia. Complementary to general anesthesia, this method allows to lower the need of opioids during and after the surgery, as well as a faster recovery.

The foreskin is innervated by the dorsal nerve of the penis which is the branch of the pudendal nerve. This nerve arises from the sacral plexus and more precisely the branches S2-3-4. There are two methods to block pudendal nerve. First, the pudendal nerve block is an old anesthetic technique developed in 1908, first for obstetrical analgesia and urological analgesia. It consists in injecting in the ischiorectal fossa, right at the end of Alcock's canal, a solution of local anesthetic. Second, the penile nerve block, described in the middle of the seventies, consists in injecting a solution of local anesthetic that blocks only the terminal part of the pudendal nerve.

Those two nerve blocks have been subject to many publications, especially concerning the method to apply to optimize their efficiency. The literature review led to this conclusion: The penile nerve block should be ultrasound guided and the pudendal nerve block should be done with a neurostimulator.

The aim of this study is to compare the analgesic efficiency of the ultra-sound guided penile nerve block to the pudendal nerve block with neurostimulation, for the pediatric circumcision.


Eligibility Criteria:
Inclusion Criteria:

* One to two years old boys
* Ritual or medical, elective circumcision.

Exclusion Criteria:

* Refusal from parents
* Allergy to local anesthetics
* Documented coagulation disorders
* Epilepsy
The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement

A randomized double-blind clinical trial was performed. There were 4 groups according to catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2) Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus + continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy and the surgeon kept out the surgical field when the resident placed the catheter. The same conventional analgesic schedule was prescribed to all patients: PCA (patient controlled analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects, time to start rehabilitation and time to discharge were also analyzed. A statistical analysis was performed to compare all this variables between the 4 groups (SPSS 18.0).


Eligibility Criteria:
Inclusion Criteria:

* Primary total Hip Replacement

Exclusion Criteria:

* Allergic to Bupivacaine
Stool Collection Sub-Study of Exact Sciences Protocol 2018-01

The primary objective of this sub-study is to obtain de-identified, clinically characterized, stool specimens from subjects with untreated solid tumors for research use in the development and validation of a stool-based test for colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subject is currently enrolled in Exact Sciences Protocol 2018-01.
* Subject is willing and able to provide a stool sample.
* Subject understands the study procedures and is able to provide written informed consent to participate in the study.

Exclusion Criteria:

* Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the sub-study protocol, or put the person at undue risk.
Fecal Metagenomics and Metabolomics Analyses to Identify Potential Screening Biomarkers for Colorectal Polyps and Cancer in Chinese Population

Many previous studies had revealed that gastrointestinal microbiome is changed compositionally and ecologically in patients with colorectal cancer comparing with healthy population. These finding provide us with a new sight to take advantage of gut microbiota. The current study aims to explore new potential biomarkers for early screening and prognostic prediction of colorectal cancer and colorectal polyps by analyzing metagenomics and metabolomics of gut microbiota.

Patients who come to the Sixth Affiliated Hospital, Sun Yat-sen University for medical purposes will be invited to participate in the study. Participants will be asked to collect two stool samples. One stool sample will be used for metagenomic sequencing and the other will be used to extract metabolomics data. Meanwhile, participants will be asked to complete a questionnaire about lifestyle and diet habits with the assistance of a well-trained nurse.

We will delineate the community and metabolites differences in the gut microbiota between colorectal cancer patients and healthy populations by comparing cases with controls. Considering the different gut microbiota profiles among different populations caused by varied diet habits and lifestyles, the current study will try to describe the microbiota profiles in the Chinese population. Besides, we will explore new potential biomarkers for early screening and prognostic prediction which is suitable to Chinese populations. Moreover, we will attempt to find out the interactions between diet and microbiota through a comprehensive analysis of the questionnaire and the collected results.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged 18 to 80 years old.
2. Participants who had been diagnosed with colorectal cancer or advanced colorectal polyps for the first time according to pathology results.
3. Participants who had signed informed consent.
4. Participants must have the ability to complete the questionnaires of the study.

Exclusion Criteria:

1. Participants who had a positive personal history of colorectal polyps.
2. Participants who had a positive personal history of colorectal cancer.
3. Participants who had a positive personal history of other gastrointestinal diseases, such as inflammatory bowel disease， intestinal tuberculosis, or irritable bowel syndrome.
4. Participants who had undergone a colonoscopy or other procedure requiring bowel preparation in the last two months.
5. Participants who had been hospitalized for any reason in the last two months.
6. Participants who had consumed antibiotics for any reason in the last three months.
7. Participants who had consumed prebiotic supplements regularly in the last year.
8. Participants who had other physical conditions that didn't suitable to participate in the study, such as severe cardiovascular diseases, serious mental illness, or pregnant status.
Prospective Clinical Evaluation of BD Spinal Needles

Post-market, observational study to assess the real-world safety and efficacy of BD Spinal Needles used in an on-market fashion.

Single-arm, post-market, observational, prospective study of participants who will receive neuraxial procedures with a BD Spinal Needle as part of their routine medical care.

Patients will be followed from BD Spinal needle insertion up to 7 days after the insertion according to the routine medical care and site policy.

Data collected will be gathered from the patient's medical charts.

Eligibility Criteria:
Inclusion Criteria:

* Any patient, regardless of age or gender, for which the investigator has decided that a neuraxial procedure must be performed utilizing BD Spinal Needles as part of their routine medical care
* Expected to be available for observation through the study period (7-days post procedure)
* Provision of signed and dated informed consent form (Note: Consent of guardian or parent may be required for patients under the age of 18 years; participant assent may be required as well.)

Exclusion Criteria:

* Undergoing emergency surgery
* Coagulopathy or bleeding disorder for which regional anesthesia poses an increased risk
* History of neurological impairment or disease of the trunk or lower extremities.
* Infection at or near the site of needle insertion
* Previous spine surgery at the level involved in the study procedure
Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.

The primary objective of this study is time -to - healing with wound size determination at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria and Population:

* Male or female age 18 or older
* Informed consent must be obtained
* Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
* Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
* Patient's ulcer must exhibit no clinical signs of infection.
* Patient is of legal consenting age.
* Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
* Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:

  * Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
  * ABIs with results of ≥0.7 and ≤1.2, OR
  * Doppler arterial waveforms,which are triphasicor biphasic at the ankle of affected leg

Exclusion Criteria:

* Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
* Patients whose index diabetic foot ulcers are greater than 25cm2.
* Patients considered not in reasonable metabolic control, confirmed by an HgA1c greater than 12% within previous 90 days,
* Patients whose serum creatinine levels are 3.0mg/dl or greater.
* Patients with a known history of poor compliance with medical treatments.
* Patients who have been previously randomized into this study, or are presently participating in another clinical trial
* Patients who are currently receiving radiation therapy or chemotherapy.
* Patients with known or suspected local skin malignancy to the index diabetic ulcer.
* Patients on anticoagulant medication will as in any surgical procedure, be monitored According to the protocols employed at the enrolling center.
* Patients diagnosed with autoimmune connective tissues diseases.
* Nonrevascularable surgical sites
* Active infection at site
* Sensitivity to the following antibiotics: Gentamicin, Cefoxilin, Linocmycin, Polymyxin B, Vancomycin
* Any pathology that would limit the blood supply and compromise healing;
* Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days
Early Feasibility Study of the Reia Vaginal Pessary

This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse (POP). Recruited patients will have Stage II POP or greater and will be current users of a legally marketed vaginal pessary. In a single visit, data will be collected on the performance and comfort of the subject's current pessary. After placement of a study pessary, comparative data will be collected between subject's current pessary and the study pessary on ability to support prolapse. The study pessary's function will be assessed under controlled circumstances. The patient will have her current pessary replaced at the conclusion of the visit. Results will be used to inform future design modifications of the study pessary.


Eligibility Criteria:
Inclusion Criteria:

* Women with Stage II pelvic organ prolapse or greater
* Current ring style or Gellhorn pessary users inclusive of sizes 1.5"-3.5"
* Capable of giving informed consent

Exclusion Criteria:

* Pregnancy
* Deep vaginal erosion noted with removal of current pessary
* Presence of vesicovaginal fistula
* Presence of rectovaginal fistula
* Vaginal, rectal, or bladder tumor
* Inflammatory Bowel Disease
* Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary
* Current vaginal or urinary infection requiring treatment
* Previous pelvic floor surgery in last 12 months
* Congenital malformation of bladder, rectum, or vagina
* Significant medical condition interfering with study participation (psychologic, neurologic, active drug/alcohol abuse, etc.)
* Planning pregnancy in next 6 months
Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers

The purpose of this study is to evaluate the amount of GLPG0187 present in the blood (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy subjects.

Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and dose proportionality of the best formulation.

Furthermore, during the course of the study, safety and tolerability will be characterized.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine

Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May, 2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza vaccine of Hualanbio has obtained production permission and marketing authorization in May, 2008.

In order to further investigate the safety and immunogenicity of the vaccine in the market, The clinical observation was planned to be conducted in Mianyang city (Yanting County), Sichuan Province, China.

Dosage and administration route in this clinical trial:

Subjects age 3 years or older was vaccinated following a single 0.5ml dose immunization regime.

The preferred site of injection was the at the skin near outboard deltoid muscle of the upper arm.

The administration route is after the sanitization with 75% alcohol, intramuscularly inject the test vaccine or the control vaccines when the skin was slightly dried for those subjects complied with the inclusion requirements.

Safety indicators:

* Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reaction within 30 minutes ;
* Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reactions through 6 hours to the 29th day ;
* Summarize the adverse events/severe adverse events and the incidence levels from the inclusion of the subjects to the completion of the clinical trial.

Immunogenicity indicators:

Evaluate the Post-vaccination immunogenicity of the test and the control influenza vaccines in persons age 3 years and older by its HI antibody level on Day 28.

Take 1:10 serum dilution as the minimum dilutability. The seroconversion in this trial was defined as the post-vaccination HI antibody titer ≥ 1:40 when the HI antibody \< 1:10 before the vaccination or the post-vaccination HI antibody titer quadruply increased when HI antibody ≥ 1:10 before the vaccination.

The Immunogenicity criteria set for this clinical trial is the seroconversion shall be \> 40% after 14 days of the vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female age 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
* Healthy male or female by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product;
* Be able to comply with the requirement of clinical trial protocol;
* Have no history of vaccination within the past 6 months and vaccination with other product within the latest 1 week;
* Axillary temperature \<37.1℃.

Exclusion Criteria:

* Subject that was allergic to eggs and any component of the vaccine, or has history of other allergy;
* Fever, acute disease or acute onset of chronic disease and influenza;
* Guillain-Barre Syndrome
Metabolomics Fingerprinting and Metabolic Dynamics After HIV Infection

The purpose of this plot study is to find out the relationship between metabolic changes and anti-retroviral therapy (ART), life style and clinical conditions of HIV-infected patients using nuclear magnetic resonance (NMR) based systems biology approach and metabolomics methodology.

Since the clinical application of anti-retroviral therapy (ART) in 1997, the life expectancy of HIV infected patients has been prolonged greatly. However,side effects of ART including metabolic abnormalities have become the main factors influencing patients' quality of life. Among which the abnormal lipid metabolism plays an important role. Meanwhile, metabolic conditions differ from patients applying to different combinations of ART drugs,life style and clinical conditions.

Metabolomics can measure the dynamic metabolic responses of the body to stimuli or modifications. Using nuclear magnetic resonance (NMR) as tools can systematically analyse the process of lipid metabolism. Metabolomics fingerprinting can be defined as the complete complement of small molecule (\< 1500 Da) metabolites found in a specific cell, body fluid, organ or organism.

Therefore, the study of the impact of metabolic changes and anti-retroviral therapy (ART), life style and clinical conditions is of importance in enhancing the adherence and improving the clinical outcomes of HIV infected patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HIV infection

Exclusion Criteria:

* Pregnancy
* Individual who is participating in other trial(s)
Study to Image the Esophagus Using the OFDI Capsule

The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)

A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.

Eligibility Criteria:
Inclusion Criteria:

* A previous diagnosis of Barrett's Esophagus
* OR a previous diagnosis of EoE
* OR a previous diagnosis of Gastroesophageal reflux disease (GERD)
* Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE
* Subject must be able to give informed consent

Exclusion Criteria:

* Subjects with known esophageal strictures, intestinal strictures or dysphagia
* OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease
Evaluation of Quality of Care - Patient Empowerment Programme, HA

Diabetes mellitus (DM) and hypertension (HT) are major causes of morbidity and among the top 10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has initiated service improvement through introducing the patient empowerment programme (PEP) to improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Family Medicine Unit (FMU) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme.

The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the PEP programme is achieved. Each PEP participating clinic and non-government organization (NGO) will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the PEP for more than one year will be included in the evaluation on the process and outcomes of care. A hundred and thirty participants will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline and 6 months after enrolment. Data on the process of care will be retrieved from the HA medical records. Main Outcome Measures: The primary outcomes are the proportion of participants who have received the planned process of care and achieved the target HbA1c and blood pressure levels.

Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The changes in clinical, service, and patient reported outcomes at 6 and 12 months will assessed by paired sample t-test. The audit cycle will be repeated annually over a period of 5 years.

Results: The QOC of the PEP programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. Conclusion: The results of this study will provide empirical evidence on whether the HA's PEP programme can enhance QOC for patients with diabetes mellitus (DM) or hypertension (HT). The information will be used to guide service planning and policy decision making.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients who are ambulatory, have stable mental and emotional conditions, and follow up at general outpatients clinics (GOPC) and family medicine specialist clinics (FMSC) regularly will be recruited for the PEP programme.

Exclusion Criteria:

* Patients will be excluded if they have severe heart failure, end stage renal failure (ESRF) or advanced eye diseases, are unable to understand or communicate in Chinese language, or refuse to give consent.