cyrilzakka/clinical-trials huggingface dataset:
Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects

This phase Ia study is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904, an anti-immunoglobulin E (IgE) antibody, in healthy Chinese subjects.

This first-in-human study with a dose-escalation design is meant to evaluate the tolerability, safety, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity of single-dose JYB1904 in healthy Chinese subjects.

The sequential dose levels (sample size) of JYB1904 are set at five different dose, with additional two JYB1904 placebo subjects in each group. The active comparator is omalizumab (Xolair).

Dosage and administration: single-dose; subcutaneous injection in the deltoid region of the upper arm.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand the study and provide written informed consent voluntarily, and comply with the requirements;
2. Healthy Chinese subjects aged 18-50 years, male or female;
3. Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others.

Exclusion Criteria:

1. Surgery history within 6 months prior to screening or any surgery schedule during the study;
2. Last visit in previous drug clinical trial within 3 months prior to screening;
3. Acute diseases occur or receive any medication during the screening period;
4. Other conditions unsuitable for the study confirmed by the investigator.
Subacromial Injection of Epinephrine Improves Visualization in Shoulder Arthroscopy

The purpose of this study is to evaluate surgeon-rated visual clarity and the need for increased irrigation pump pressure during arthroscopic shoulder surgery and to evaluate mean arterial pressure, operative time, and any adverse events that occur during arthroscopic shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

* Undergo arthroscopic shoulder surgery in the seated upright (beach-chair) position requiring visualization within the subacromial space

Exclusion Criteria:

* Are unable to provide informed consent
* Non-English speaker
* Have a history of adverse medication reaction to epinephrine
Prospective Evaluation of ENDOSWIR Device Versus Pathology for Squamous Cell Carcinoma of Upper Aerodigestive Tract (ENDOSWIR-VADS)

A new medical optical device named ENDOSWIR is tested to determine its ability to determine if tissues are cancer or normal tissue on ex-vivo condition for specimen of ENT squamous cell cancers.

In vivo short infrared imaging is a real-time, sensitive technique that can be used in the operating room during surgical removal of tumors.

It is essential in the surgery of cancers of the upper aerodigestive tract to be in healthy margins in order to avoid heavier surgical resumption or complementary treatments such as radiotherapy.

The optical imaging device in the short infrared range called ENDOSWIR and tested on tonsil samples has shown its safety on the analysis of tissues and seems to be promising for the detection of tumor tissues or, on the contrary, their absence in the resection margins (animal studies).

The principal objective is to determine the ability of the ENDOSWIR DM-DIV to distinguish healthy tissue from tumor tissue on an ENT squamous cell carcinoma specimen by Concordance rate (in %) between the ENDOSWIR result and the final pathology examination of each tissue portion of a subject (8 per subject)..

secondary objectives are : to demonstrate that analysis of a sample using the ENDOSWIR device is faster than extemporaneous analysis, the safety of SWIR. An ancillary analysis of areas of particular interest such as resection margins or carcinoma in situ/dysplasia areas etc...

Eligibility Criteria:
Inclusion Criteria:

* ENT cancer (buccal or oropharyngeal) for which a surgical resection is planned
* affiliated to the social security
* Having given his non-opposition to participate in the trial.

Exclusion Criteria:

* Patient protected by law (minor, pregnant or breastfeeding woman, patient under guardianship, subject deprived of liberty or hospitalized under restraint).
* Patients who have received radiotherapy treatment in the VADS area
* Patient with a history of VADS cancer or a synchronous location of VADS cancer.
Hypofractionated SBRT For Prostate Cancer

The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.

Radiosurgery should be ideal for treating prostate cancer because:

* targeting accuracy for static targets is excellent, with an error of about 1mm,
* it can adjust for intra-fractional organ motion, reducing the volume of the target PTV and therefore the dose to surrounding organs,
* by using over one-hundred non-conplanar beams, the dose gradient between the prostate and surrounding tissues may be superior to that achieved with conventional linear accelerators,
* the radiobiology of prostate cancer may favor large dose per fractions.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate adenocarcinoma
* Gleason score 2-7
* Biopsy within one year of date of registration
* Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
* T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)
* M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
* PSA ≤ 20 ng/dL
* Patients belonging in one of the following risk groups:
* Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or
* Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/dL, or Gleason 7 and PSA ≤ 10 ng/dL
* Prostate volume: ≤ 100 cc
* Determined using: volume = π/6 x length x height x width
* Measurement from CT or ultrasound ≤90 days prior to registration.
* ECOG performance status 0-1
* Completion of patient questionnaires:FACT-G questionnaire, AUA questionnaire, EPIC-26 questionnaire, SHIM questionnaire, Utilization of Sexual Medications/Devices questionnaire
* Consent signed.

Exclusion Criteria:

* Prior prostatectomy or cryotherapy of the prostate
* Prior radiotherapy to the prostate or lower pelvis
* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
* Chemotherapy for a malignancy in the last 5 years.
* History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
* Hormone ablation for two months prior to enrollment, or during treat
Halaven Patient Registry (Metastatic Breast Cancer, MBC)

Since the first marketing authorization in the world in November 2010 granted by US FDA, Halaven has been approved for clinical use in more than 40 countries worldwide, including many Asian countries, e.g. Hong Kong, India, Japan, Malaysia, Myanmar, Philippines, South Korea, Singapore, Taiwan and Thailand. According to two large global phase III study reports of Halaven, very few Asian patients participated in these studies. In a phase II study of Halaven with metastatic breast cancer, the clinical efficacy and toxicity were reported only in 80 Japanese patients. Halaven has been granted its marketing authorization in Singapore since February 2011. However, most of other Asian countries including India have had the approval and launched from middle year of 2013 or in early 2014. Limited information of Halaven using in Asian patients are available except several case experience exchange presented by individual medical centers or as personal experience in the past. Some clinical concerns related to Halaven use are raised by clinicians during their clinical practice, such as how Halaven works on Asian patients, which type of patient obtains better clinical benefit from Halaven, and what are the main treatment related toxicities in Asian which may differ from Westerners due to potential ethnic diversity. Further understanding of Halaven related clinical benefit and toxicity in Asian patients through collecting clinical experience among Asian countries becomes necessary and may provide better information to anticipate these concerns.

The proposed "Halaven Patient Registry" (called the "Registry") will be a patient population-based registry to collect therapeutic related information from patients with metastatic breast cancer who were treated with Halaven that was given as a clinical decision by patient's treating physician based on clinical status of a patient and proper indication of Halaven and to gain a better understanding of the use of Halaven in such Asian patients.


Eligibility Criteria:
Inclusion Criteria:

* An eligible patient to be entered into the Registry is defined as:

  1. Patient with advanced breast cancer.
  2. Halaven was given or has been treating during the period of 1 Jan 2015 to 31 Dec 2016.
  3. Halaven was given as single or combination.
  4. Patient received at least one cycle treatment (a 21-day cycle or 2 doses) of Halaven.
  5. Patient with at least 80% of the required information of the Registry CRF to be entered. It will be calculated automatically by the Registry system.

     Patient to be selected for the Registry will be based on chorological order of a patient occurred in a study center during the defined period of the Registry, if all other eligibility criteria are met.

     Exclusion Criteria:
* Those who not meet the inclusion criteria will be excluded.
IDEntification of New Predisposition Genes in Differentiated THYroid Cancer

The purpose of this research is to find new predisposition genes for differentiated thyroid cancer (DTC).

The purpose of this research is to find new predisposition genes for differentiated thyroid cancer (DTC). Therefore, in the absence of a BAP1 and DICER1 abnormality, we offer to sequence your whole genome (WGS) or partial genome (genotyping) for a previously unknown genetic abnormality.

Furthermore, the discovery of new genes would be a major medical advance that could contribute to the identification of new therapeutic targets.

This research will be conducted at the University Hospital of Nantes and the Hospital of Vendée and 95 people should participate.

Eligibility Criteria:
Inclusion Criteria:

* Probant subjects
* Minor or adult subject
* Adult subject or legal guardian for minor subjects agreeing to sign the study consent and biospecimen consent
* Subject with differentiated thyroid cancer without an identified causative mutation in the BAP1 and DICER 1 predisposition genes
* Patient affiliated to a valid social security plan

Relative subjects

* Adult subjects
* Subject agreeing to sign the study consent and the biocollection consent
* Subject with differentiated thyroid cancer or from a family with several cases of differentiated thyroid cancer without a causal mutation identified in the BAP1 and DICER 1 predisposition genes
* Patient affiliated to a social security plan

Exclusion Criteria:

* Subject refusing to participate
* Subjects with a causal mutation identified in the predisposition genes: BAP1 and DICER 1
* Subjects under guardianship, curatorship or safeguard of justice or not socially insured
* Subjects with another syndromic predisposition to thyroid cancer (Cowden, Werner, PAF)
Proteomics Study of Mild Cognitive Impairment and Alzheimer's Disease

This study intends to adopt standardized and rigorous cross-sectional research, collect biological specimens (including blood, feces, urine, saliva and tongue coating) from eligible subjects, and use liquid chromatography/mass spectrometry (LC-MS/MS) technology to explore early warning indicators of protein in patients with mild cognitive impairment and Alzheimer's disease

The problem of population aging is getting worse, the prevalence of senile dementia is increasing, and Alzheimer's disease (AD) is the most common type of dementia. There is no effective treatment for AD. Most interventions can only alleviate the condition and delay the development. Therefore, early diagnosis and prevention of AD are extremely important. However, the current diagnostic measures are not suitable for clinical promotion due to their traumatic nature, so there is an urgent need for a more suitable clinical early identification and diagnosis method. Proteomics research technology is the leading research technology in China. It can be applied to research on disease markers, pathogenesis, and drug target discovery.

Therefore, this study intends to adopt standardized and rigorous cross-sectional research, collect biological specimens (including blood, feces, urine, saliva and tongue coating) from eligible subjects, and use liquid chromatography/mass spectrometry (LC-MS/MS) technology to explore early warning indicators of protein in patients with mild cognitive impairment and Alzheimer's disease

Eligibility Criteria:
Inclusion Criteria:

1. Older than 55-year-old，male or female.
2. patients meet the diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease(AD) or whose family members were diagnoed with AD
3. Complete self-rating scale for memory impairment (AD-8 scale)
4. Those who agree to participate in clinical research and sign informed consent.

Exclusion Criteria:

1. Patients with acute cardiovascular and cerebrovascular diseases, acute infections (pneumonia, urinary tract infection, oral infection, digestive tract infection), severe renal dysfunction, and uremia;
2. Pregnant or lactating women;
Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

This is a single center, randomized, unblinded study to compare the rate of occlusion of plastic, uncovered metal, or fully covered metal biliary stents in patient's with surgically resectable disease or those undergoing neoadjuvant chemoradiotherapy. We will also compare occlusion rates between uncovered metal and fully covered metal biliary stents in those patients determined to have surgically unresectable disease.

Malignant biliary obstruction can result from extrinsic processes, such as proximal pancreatic ductal adenocarcinoma or metastatic lesions, or from intrinsic lesions such as cholangiocarcinoma. Malignant biliary obstruction is typically treated endoscopically with placement of either plastic (polyethylene) or metal biliary stents. Metal stents have a wider diameter than plastic stents, and have been shown to have higher patency rates, but are also 15-40 times the cost of plastic stents. Metal stents with a polymer coating have been developed to prevent tumor ingrowth into the stent, which can lead to stent occlusion. Cost analysis has demonstrated an advantage to the use of metal stents in patients with unresectable disease, or who may achieve operable status following neoadjuvant chemotherapy, while either plastic stents or metal stents are used when patients are deemed to have a surgically resectable lesion. Patient's determined to have resectable, or borderline resectable malignancy (those who may achieve resectability status following neoadjuvant chemotherapy) will receive either plastic, uncovered metal, or covered metal stents in a randomized fashion, while patients determined to have surgically unresectable malignancy will randomly receive either covered or uncovered metal biliary stents. The primary aim of this study is to prospectively evaluate stent occlusion rates in patients presenting with malignant biliary obstruction. Secondary aims of the study will include a cost analysis of each stent type, rate of hospital admission following stent placement, days off of chemotherapy due to procedural complication, and rate of acute cholecystitis associated with stent placement.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female older than 18
2. Capable of providing written informed consent
3. Presenting with malignant biliary obstruction requiring biliary drainage either from proximal pancreatic malignancy, metastatic disease, or intrinsic biliary malignancy. The patient must have an established diagnosis of underlying malignancy, and surgical resectability status established, prior to enrollment in this study.

Exclusion Criteria

1. Inability to undergo conscious sedation or monitored anesthesia
2. Prior pancreatico-biliary surgery
3. Evidence of acute cholecystitis at time of endoscopic procedure
4. Intraluminal filling defect requiring endoscopic removal prior to stent placement
5. Inability to provide written informed consent
6. Malignancy not verified prior to stent placement
Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury

Returning to sport is one of the primary concerns of athletes following injury. Yet, after serious injury, up to 50% of athletes do not return to competitive sport. Psychological factors play an important role in the athlete's return to sport after anterior cruciate ligament (ACL) reconstruction, and physical and psychological readiness to return to sport often do not coincide. There are currently no easily accessible programs for non-professional athletes to help address the psychological factors that impact on their return to sport after injury.

The aim of this trial is to test whether a smartphone application (app) delivering cognitive-behavioural therapy to address psychological factors including fear, confidence and recovery expectations, is effective for improving the number of people who return sport following ACL reconstruction.

We hypothesise that patients who use the app in addition to receiving usual rehabilitation care after ACL reconstruction will return to sport in greater numbers than patients who receive usual rehabilitation care only.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral primary anterior cruciate ligament rupture
* Time between injury and anterior cruciate ligament reconstruction not greater than 12 months
* Playing contact pivoting or non-contact pivoting sport at least twice per week prior to anterior cruciate ligament injury
* Intend to return to sport following anterior cruciate ligament reconstruction
* Age 15 to 30 years at anterior cruciate ligament injury
* Normal/healthy contralateral knee

Exclusion Criteria:

* Collateral ligament injury requiring surgery
* Posterior cruciate ligament injury
* Meniscus injury/treatment that requires alteration to usual rehabilitation programme
* Articular cartilage injury/treatment that requires alteration to usual rehabilitation programme
* Previous anterior cruciate ligament injury to either knee
* Injury to either leg that required medical care during the previous 12 months
* Other injury or illness that could affect knee rehabilitation
* Taking medication for mental health problems
TELMA - Observational Study in Daily Medical Practice of the Effectiveness of Telmisartan for Treatment of Hypertension in Patients With and Without Confirmed Albuminuria in Belgium

This study was carried out in the context of daily medical practice to compare the effectiveness of telmisartan in the treatment of hypertension complicated or not with the presence of protein in the urine, which is called albuminuria. Hypertension is a chronic, treatable but not curable disease and is defined as a combination of a systolic blood pressure of 140 mmHg or more and a diastolic pressure of 90 mmHg or more. The kidneys are often the first organs damaged by hypertension; renal damage could easily be diagnosed using a urine dipstick and should be part of a routine examination in hypertensive patient. The aim of the study is to see if the decrease of blood pressure (both systolic and diastolic) after approximately 12 weeks of treatment with telmisartan in patients with albuminuria is the same or different to that in patients without albuminuria. Every patient participating should have two visits, approximately 12 weeks apart where his/her blood pressure was checked and a few questions about is concomitant disease and drugs were asked.


Eligibility Criteria:
Inclusion criteria:

Age above or equal to 18, no upper limit Patient has been treated and followed up for more than 6 months by the same general practitioner (GP) Hypertension treated for at least 3 months and not under control at the time of inclusion in the study \[systolic blood pressure (SBP) above or equal to 140 mmHg and diastolic blood pressure (DBP) above or equal to 90 mmHg, or SBP above or equal to 130 mmHg and DBP above or equal to 80 mmHg if patient has chronic renal insufficiency or diabetes\] Results available from at least two tests of albuminuria Antihypertensive treatment remained unchanged during the month prior data collection Decision by the GP to introduce telmisartan (either in combination with hydrochlorthiazide \[HCTZ\] or not) in the antihypertensive treatment (normal prescription) Written informed consent of the patient to collect his/her data

Exclusion criteria:

Blood pressure under control \[SBP below 140 mmHg and DBP below 90 mmHg or SBP below 130 mmHg and DBP below 80 mmHg if patient has chronic renal insufficiency or diabetes\] The patient refuse to allow his/her data to be collected Women of childbearing potential not using an effective contraception method, as well as women who are breastfeeding Patients with proteinuria above or equal to 1g/l or with glomerular filtration rate (GFR) below 15 ml/min/1.73 m² Current or prior use of telmisartan within the last 12 months Change in the antihypertensive treatment during the month prior to collection of the data
Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study

The objective of our study is to evaluate the efficacy of the laparoscopic robot-assited approach after 1 year of follow-up, on pain experience, and anxiety, depression, post-traumatic stress syndrome and quality of life.

Pudendal and inferior cluneal neuralgias are responsible for chronic pelvic perineal pain. The compression of both of the nerves are thought to be associated in approximately 25% of the pudendal neuralgias. The failure of the isolated pudendal decompression led in the early 2000s to the identification of an entrapment syndrome of the posterior femoral cutaneous nerve and its inferior cluneal branche around the ischial tuberosity. This subsequent neuralgia affects the posterior part of the perineum, lower buttock, and the posterior part of the thigh, without any associated neuro-vegetative symptoms, unlike in pudendal neuralgia. In case of failure of the medical treatment, the open trans-gluteal decompression was proposed as a gold standard. However, this technique remains invasive and requires a long recovery. In a previous study, the investigators demonstrated the feasibility of double decompression via a minimally invasive robot-assisted laparoscopic approach, and described a 4-step technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patients presenting a pudendal and inferior cluneal entrapment neuralgia with 5 positive"Nantes criteria", and failure of the medical treatment
* Patient having given consent after reading the information note

Exclusion Criteria:

* Absence of any "Nantes criteria",
* Patient non suitable for surgery/general anesthesia