cyrilzakka/clinical-trials huggingface dataset:
Circulating Tumor Cells and mpMRI for Non-invasive Diagnosis of Prostate Cancer(CMNDPC)

This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.

This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.

We will enroll 808 men with clinical suspicion of prostate cancer due to higher level PSA（\>4ng/ml）or other examination abnormal. All the participants will receive prostate biopsy，the circulating tumor cells（CTCs）will be detected before biopsy.

This study will evaluate the diagnostic ability of CTCs+MRI and CTCs+MRI+PSA，including sensitivity, specificity, predictive values, diagnostic accuracy and receiver operating curves（ROC）.

Eligibility Criteria:
Inclusion Criteria:

1. No family history of prostate cancer;
2. men ≥ 50 years；
3. tPSA level of 4-10 ng/ml, and fPSA/tPSA\<0.16;
4. tPSA level of \>10 ng/ml；
5. With abnomal mpMRI、PET/CT、TRUS or DRE;
6. fully understand the clinical trial protocol and sign the informed consent;

Exclusion Criteria:

1. Not meet all of the inclusion criteria or any single inclusion criteria；
2. previous diagnosis of prostate carcinoma ;
3. symptomatic of acute prostatitis;
4. local anesthetic allergy patients;
5. cannot tolerate prostate biopsy or has contraindication to biopsy;
6. patients judged by the investigator to be unsuitable to participate in the clinical trial;
WorkWell: Work-based Activity and Metabolic Health

This study will test whether a range of pre-clinical cardiometabolic biomarkers can be improved via regular intervals of standing and light-intensity physical activity in real-world office environments.

This pilot study is being conducted to determine whether a range of pre-clinical cardiometabolic biomarkers (measured via gut microbiome, blood draw) can be improved via regular intervals of standing and light-intensity physical activity (i.e., leisurely walking) in real-world office environments. This trial is meant to generate pilot data which will lead to additional clinical trials.

Primary Hypothesis: Increasing both standing and light-intensity physical activity will improve biomarkers of metabolic function, as measured by blood metabolites and differential abundance of gut microbiome composition, compared to a control condition of normal workplace behavior.

Eligibility Criteria:
Inclusion Criteria:

* Women and men age 18 yrs and older
* Holds a job where primary work activities are done seated
* Has the space and ability to use a sit-to-stand workstation in their primary workspace
* Works in an office setting or remotely for ≥ 4 days per week
* Have a BMI ≥ 25.0 (≥23.0 for individuals of Asian descent)

Exclusion Criteria:

* Currently taking diabetes medication
* Taking any of the following medications or treatments:

  * Medication to control high blood pressure
  * Medication to treat high glucose
  * Blood thinners
  * Hormone replacement therapy (in the past 12 months)
  * Corticosteroids
  * High dose statins (Dr. Reaven, MD to adjudicate eligibility based on dosage)
  * 2nd generation antipsychotics
* Current or previous foot or lower limb injuries
* Current use of sit-stand workstation
* Current smoker
* Neuromuscular or cardiovascular disorders or other serious active medical issues, including deep vein thrombosis or respiratory issues
* Has a physical impairment or musculoskeletal condition that will prevent the subject from standing or light-intensity walking for a maximum of 30 minutes
* Has been advised to avoid prolonged periods of sitting or standing by a physician or other healthcare provider
* History of inflammatory bowel or intestinal malabsorption conditions
* Use of prebiotics, probiotics or antibiotics in the last 3 months
* Serious food allergies or restrictions
* Participants who will be travelling 3 or more days out of their typical week
Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy

This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. the primary purpose of the study is to demonstrate the efficacy of ofatumumab in reducing clinical signs and symptoms in adult RA patients after a single course of ofatumumab.

This study consists of a Double-blind , placebo controlled, and parallel group part with eligible patients enrolled into a 24 week Double-Blind Period, and randomized in a 1:1 ratio to receive ofatumumab (700mg x 2 infusions) or placebo ( saline x 2 infusions) in addition to their background methotrexate treatment. Patients who completed the 24 week Double-Blind period without receiving rescue DMARD treatment will be eligible to proceed into the 120 week Open-Label Period to receive repeat treatment courses with ofatumumab. In the Open-label Period ofatumumab treatment courses will be given at individualized time intervals only if a clinical response has been achieved following the previous treatment course, and followed by a subsequent worsening in disease activity . Patients who have completed the Open-Label Period or have withdrawn will enter a maximum 2 year Follow-up Period, or until their Bcells return to normal or to baseline levels, whichever occurs earlier.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years;
* Active disease at the time of screening as defined by:

  ≥ 8 swollen joints (of 66 joints assessed) and ≥ 8 tender joints (of 68 joints assessed), C-Reactive Protein (CRP) ≥ 1.0 mg/dL or Erythrocyte Sedimentation Rate (ESR) ≥ 22 mm/hour, DAS28≥3.2 (based on ESR);
* Inadequate response to previous or current methotrexate treatment;
* Treatment with methotrexate (MTX), 7.5-25 mg/week, for at least 12 weeks and at a stable dose for at least 4 weeks.

Exclusion Criteria

* Patients with a history of a rheumatic autoimmune disease other than RA or with significant systemic involvement secondary to RA;
* Previous exposure to biologic anti-rheumatic therapies, including investigational compounds;
* Previous exposure to biologic DMARDs; Chronic or ongoing active infectious disease requiring systemic treatment;
* Clinically significant cardiac disease; History of significant cerebrovascular disease;
* Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease;
* Known HIV positive; Serologic evidence of Hepatitis B infection; Positive test for Hepatitis C; Positive plasma / white cell JC Virus PCR;
* Serum IgG \< lower limit of normal;
* Breast feeding women or women with a positive pregnancy test at screening;
* Current participation in any other interventional clinical study;
* Patients known or suspected of not being able to comply with a study protocol.
Relationship Between Serum N/OFQ and Type 2 Diabetic Nephropathy

At present, the early diagnosis ability of diabetic nephropathy (DKD) is relatively poor, leading to some missed diagnosis of early disease patients. At the same time, because DKD patients have complex metabolic disorders, once they develop to end-stage renal disease, compared with other renal diseases, the treatment of DKD is more difficult and the prognosis is poor. At present, the main treatment for DKD is to strengthen blood glucose control and control blood pressure through renin angiotensin aldosterone system (RAAS) to delay the occurrence and development of DKD, but it can not reduce the risk of most patients progressing to end-stage renal disease (ESRD). In recent years, it is becoming a new therapeutic target for DKD to control the inflammatory response by targeting the inflammatory factors and inflammatory signaling pathways. Therefore, this study attempts to explore the correlation between N / OFQ and the occurrence and development of type 2 DKD, and seek new theoretical basis for the potential treatment of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes patients are in line with the relevant diagnostic criteria in China's guideline for prevention and treatment of type 2 diabetes (2017 Edition).
* patients with diabetic nephropathy are in line with the relevant diagnostic criteria in the expert consensus on diabetic nephropathy (2014 Edition).

Exclusion Criteria:

* Primary kidney disease (e.g. acute and chronic glomerulonephritis, immune and hereditary nephropathy, pyelonephritis, gout related nephropathy, etc.)
* Abnormal changes of microalbuminuria and urine glucose caused by other factors (such as urinary system infection, fever, 24-hour strenuous exercise, intractable hypertension, congestive heart failure, pregnancy, ketoacidosis, etc.)
* Failure of other important organs (heart, lung and liver) in the whole body;
* Activity of urinary sediment;
* The glomerular filtration rate decreased by more than 30% within 2-3 months after treatment with angiotensin converting enzyme inhibitor (ACEI) or angiotensin Ⅱ receptor antagonist (ARB);
* Patients with cancer, trauma, stress and other endocrine diseases;
* Patients with type 1 diabetes and kidney injury;
* Congenital mental retardation or poor compliance;
* The informed consent was not signed.
3 Snip Punctoplasty With and Without Mitomycine C.

Punctal stenosis is a progressive constriction of the puncta with resultant epiphora. One of the most effective treatment options is 1- to 4-snip punctoplasty combined with or without Mitomycin-C.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrence of punctal stenosis at the end of 1 month following punctal dilatation.

Exclusion Criteria:

* patients with associated lacrimal passage obstruction
Halitosis During Active Orthodontic Treatment

To determine the effect of different cleaning methods and devices in reducing halitosis during active orthodontic treatment.

. Observer - blind clinical trial, randomly divided into four groups, A, B, C and D. each group will undergo clinical evaluation and oral malodor assessment and they will be assigned electric or manual toothbrushes with super floss or water floss respectively.clinical evaluation will include plaque index (PI), gingival bleeding index (GBI), bracket index.and halitosis will be measured by halimeter .

Measurements and time frame: Initial measurements (T0), after two weeks (T1), and after four weeks (T2) ( according to previous studies that uses the same period of time for measurements),17, 18 plaque index (PI), gingival bleeding index (GBI), bracket index and halimeter reading .

During the first week after the start of the study (T0)

Eligibility Criteria:
Inclusion Criteria:

1. participants with fixed orthodontic appliance.
2. participants age 14 years and above and didn't have mental of physical disabilities.
3. participants willing to comply with given oral hygiene instructions.

Exclusion Criteria:

1. patients with mental retardation.
2. patients with systematic diseases.
Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.


Eligibility Criteria:
Inclusion Criteria:

* Male or female infants 6 weeks to \< 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.
* Infants who have received Prevnar are eligible to participate, but this is not required.
* Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)

Exclusion Criteria:

* Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED)

The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with Human Immunodeficiency Virus (HIV).


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is human immunodeficiency virus (HIV) positive
* Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) \<50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen
* Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
* Patient has no documentation of HIV RNA \>50 copies/mL for at least 3 months while on the KALETRA based regimen

Exclusion Criteria:

* Patient is or plans to become pregnant, or is nursing a child
* Patient plans to donate eggs or impregnate/donate sperm
* Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
* Patient is currently receiving a second protease inhibitor in addition to KALETRA
* Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
* Patient has used another experimental HIV-integrase inhibitor
* Patient has a current (active) diagnosis of acute hepatitis due to any cause
Quantification of Viral Load in the Upper Respiratory Tract in Patients Treated With Olsetamivir for Influenza

Seasonal influenza is a frequent disorder with high impact on morbidity and mortality and significant burden on healthcare-related cost. In France, the 2018-2019 flu epidemic has led to 13,100 all-cause death including 9,900 death directly related to the viral infection.

As cross-transmission of influenza is responsible for nosocomial outbreaks, preventing transmission of infectious agents in healthcare settings is a major issue. If vaccination of patients and healthcare givers remains cornerstone, control procedures are mandatory. Therefore patients admitted with influenza require isolation precautions including admission in a single room and protective measures. Based on experts advise, isolation is currently recommended for 5 to 8 days. Duration of isolation depends on immune status and antiviral therapy. However, during periods of epidemic, every hospital room is valuable and each ressource has to be tightly used. Risk of contamination is related to the presence of influenza in the upper airways. To the Promoteur 's knowledge, presence of influenza in the upper airways has not been studied in patients receiving oseltamivir. The question is : Do duration of isolation in patients admitted with flu decreas when they are treated with antiviral therapy. To answer this question The Promoteur would aim to determine influenza carriage in the upper airways in in-patients treated by olsetamivir.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years)
* Positive testing for influenza (A or B)
* Patients hospitalized and treated with olsetamivir
* Signature of informed consent
* Affiliation to healthcare insurance (France, Monaco)

Exclusion Criteria:

* Refusal to participate
* Admission to intensive care
* Palliative care
* Unable to give inform consent
* Patients under legal protection
Platelet Activation Affecting the Rate of Vascular Access Patency

In the case of cardiovascular diseases such as coronary artery disease, cerebrovascular disease, and peripheral arterial disease, there are many studies that the use of antiplatelet agents is very helpful in improving the vascular patency rate, but there are not many studies on the use of antiplatelet agents in the dialysis approach. The basis for use is insufficient. There is a lack of research on whether maintaining a state in which platelet activation is suppressed is helpful in improving dialysis access patency. Therefore, we conducted this study to determine whether the degree of platelet activation affects the patency of vascular access.


Eligibility Criteria:
Inclusion Criteria:

* Patients 19 years of age or older who are undergoing hemodialysis during renal replacement therapy
* Patients undergoing arteriovenous fistula formation and hemodialysis to the affected area
* Patients who have the ability and willingness to consent to participate in the clinical study, have signed the consent form in accordance with the appropriate procedures, and can visit and participate in the clinical study as planned

Exclusion Criteria:

* Patients who failed to start hemodialysis with an arteriovenous fistula within 3 months
* Patients who have had stent implantation or surgery during the study period due to cardiovascular disease
* Patients with severe hepatic impairment
* Patients with coagulopathy and liver disease associated with clinically significant bleeding risk
* Patients with clinically significant bleeding or bleeding risk
* Patients who underwent artificial heart valve replacement requiring anticoagulant administration
* Patients with pulmonary embolism who are hemodynamically unstable or require thrombolysis or pulmonary embolization.
* Pregnant and lactating women
A Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility

The study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate.

In a prospective study, patients were randomized during a clomiphene citrate stimulated cycle to either pertubation with low-dose lidocain or no pertubation before insemination.

Eligibility Criteria:
Inclusion Criteria:

* Female,
* 20-40 years of age,
* If presence of peritoneal endometriosis they must be of minimal or mild without adhesions (verified by laparoscopy),
* Normal menstruation cycle,
* Male partner 20-70 years of age,
* Male partner,
* Normal sperm sample within 5 years (\>20x106/mL, total sperm count \>30x106, normal morphology 5%),
* Duration of infertility more than one year,
* Signed informed consent

Exclusion Criteria:

* Treatment with NSAID, corticosteroids or other drugs, which can cause an increased risk of infection,
* Clinical signs of PID,
* Known hypersensitivity to local anesthetics,
* Non-patent fallopian tubes,
* Pathological uterine cavity,
* Pathological PCT, myoma \> 2 cm diameter,
* Any disease or laboratory finding considered of importance by the investigator not to include the patient
Expanded Access of Pemigatinib to Treat a Single Patient With Metastatic Pancreatic Cancer

Expanded access of Pemigatinib to treat a single patient with metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
First-Line Intervention for PTSD - Intensive Treatment

The goal of this clinical trial is to learn if an intensive program can treat post-traumatic stress disorder (PTSD) in adults getting treatment for the first time, and whether it has lower societal costs. The main questions it aims to answer are:

* Does an intensive program reduce PTSD symptoms?
* How expensive is it on a societal level? Researchers will compare the intensive program to the standard weekly treatment to see if the intensive program works to treat PTSD.

Participants will:

* Get 5 days of intensive treatment in two weeks (with two preparatory and closing sessions), or weekly sessions
* Get questionnaires and interviews 5 times in 9 months


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* PTSD diagnosis according to DSM-5 (CAPS-5);
* PTSD diagnosis stemming from 2 or more potentially traumatic events (PTEs)
* seeking first-time treatment for PTSD (or less than 8 sessions);
* employed (working or on sick leave for less than two years)

Exclusion Criteria:

* Current psychotic disorder, severe alcohol or substance use disorder, high suicidal intent (MINI-S for DSM-5) and a concrete suicide plan, or severe aggressive behavior that poses danger for others
* insufficient command of the Dutch language to be able to complete the assessments. This will be determined through clinical judgment at intake.
Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples

The purpose of this study is to investigate the pathogenic mechanisms of Port Wine Stain, collect biopsy samples and blood samples to characterize exosomes and metabolites from Port Wine Stain.

The researcher can detect the defects in nervous system innervation to cutaneous blood vessels contribute to the pathogenesis of Port Wine Stain . Unveiling the pathogenic mechanisms of PWS is crucial to the design of new therapeutic strategies and can use the results to improve current PWS therapeutic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of all ages.
* Not pregnant.
* Has diagnosis of port wine stain on the arms, legs, chest, bac.
* Ability to understand and carry out subject instructions.
* Subject willing to have skin biopsies on port wine stain and normal skin areas.

Exclusion Criteria:

* Pregnant women.
* Port Wine Stain on the face.
* History of skin cancer.
* Current participation in an investigational drug evaluation
* Concurrent use of known photosensitizing drugs.
Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?

Aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable technique for extended, one sided, breast surgery.

Usually breast tumour surgery in the Academic Hospital Maastricht is performed under general anaesthesia. Perioperative pain management consists of paracetamol and naproxen preoperatively, opioids during surgery and local wound infiltration at the end of surgery with 10cc Bupivacaine 0.25%. Postoperative pain management consists of paracetamol, occasionally combined with Naproxen, and if necessary Piritramide 0.2 mg/kg i.m.

Alternatively there is the possibility to perform breast surgery under a thoracic paravertebral block (PVB) with or without general anesthesia.

A PVB according to Eason and Wyatt (1) can be performed preoperatively with insertion of an end-hole catheter T3-T4. With this technique we expect a better pain relief postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Extended mamma surgery one-sided
* ASA class I and II

Exclusion Criteria:

* All contra indications for local anaesthesia
* Coagulation disorders
* Infection
* Allergic reactions