cyrilzakka/clinical-trials huggingface dataset:
The Survey of Satisfaction in Chinese Rheumatologists and Patients With Rheumatoid Arthritis

A questionnaire for this research is designed, which initiated from TSQM-II treatment satisfaction questionnaire and based on research launched by rheumatology and immunology departments of Chinese 12 public tertiary hospitals distributed directionally by Chinese Rheumatism Data Center (CRDC). The research is about treatment satisfaction and its influencing factors for Chinese rheumatoid immunologists and rheumatoid arthritis (RA) patients as well as their expectations for treating this disease. This research will explore the matching degree between treatment satisfaction and expectation about rheumatoid arthritis from doctors and patients.

In the last decade, China has made quick progress on treatment of rheumatoid arthritis. However, the improvement of remission rate cannot fully represent needs of patients for health. To meet health demands of patients and improve their satisfaction, an efficacy evaluation system based on the outcome report of patients should be established. A questionnaire for this research is designed and mended in view of TSQM-II treatment satisfaction questionnaire and the actual situation of RA diagnosis and treatment in China. An investigation on treatment satisfaction and its influencing factors for Chinese rheumatoid immunologists and rheumatoid arthritis (RA) patients as well as their expectations for this disease is carried out based on 120 rheumatoid immunologists and 1,200 rheumatoid arthritis patients (1:10) from Chinese 12 public tertiary hospitals distributed directionally by Chinese Rheumatism Data Center (CRDC). The research concludes rheumatoid specialist physicians for doctor population, and persons aged over 18 for patient population who has been confirmed as RA for 6 months above, excluding patients with Chinese reading comprehension barriers or without any RA treatment. Finally, summarize and analyze the total score of satisfaction from doctors and patients, average score of doctors and patients for various medical demands, as well as the satisfaction of patients about communication and service during medical treatment.

Eligibility Criteria:
Inclusion Criteria:

Doctors - registered rheumatoid specialist physicians subordinated to the 12 designated hospitals Patients - aged over 18, confirming RA for more than 6 months

Exclusion Criteria:

Doctors - N/A Patients - with Chinese reading comprehension barriers (unable to complete the questionnaire independently), without any RA treatment
Fatigue, Sleep Disorders and Endocrine Abnormalities in TBI Patients

This study will test if patients with moderate to severe traumatic brain injuries also have endocrine abnormalities, examine any existing relationships among fatigue, depression and endocrine abnormalities, and the relationship between endocrine abnormalities, quality of life, and community integration.


Eligibility Criteria:
Inclusion Criteria:

* Having moderate to severe TBI at least 3 months prior to enrollment. This can be demonstrated by a history of loss of consciousness, amnesia or another neurologic deficit after brain injury
* Be between the ages of 18 and 70 years

Exclusion Criteria:

* History of prior TBI, stroke, seizures, severe psychiatric disturbances (i.e., those known to influence memory performance, such as schizophrenia, bipolar disorder), or drug abuse will be excluded.
* Pregnant, nursing, or planning pregnancy during the study period.
* Dementia
* Other neurological conditions which are associated with aging and known to cause fatigue (e.g. Parkinson's Disease)
Observatory of Patients With Haemophilia B Treated by IdElvion®

OrPHEe is a non-interventional, prospective and national study which aim is to record real life data in haemophilia B French patients treated with Idelvion® to confirm the efficacy and safety of this product established in clinical development studies.

Haemophilia B is a congenital coagulation disorder caused by a deficiency or anomaly of coagulation factor IX (FIX).

The severity of the haemophilia depends on the extent of the FIX deficiency with clinical manifestations differing depending on the location of the bleed.

Treatment of this disease involves the administration of the deficient factor, i.e. FIX, to patients. Depending on the severity of the disease and context, a range of treatment regimens are available (long-term prophylactic treatment for the prevention of non-surgical bleeds, short-term prophylactic treatment for high-risk periods, treatment for the prevention of surgical bleeds or on-demand curative treatment).

CSL Behring has developed a long-acting recombinant FIX, i.e. rIX-FP (Idelvion®), to extend the intervals between the administrations of treatment while also providing a therapeutic benefit. Data from clinical studies clearly confirm the therapeutic benefit of Idelvion® in adult and paediatric patients with haemophilia B previously receiving an on-demand treatment for bleeding episodes, for long-term prophylaxis, as well as in patients undergoing surgery.

Eligibility Criteria:
Inclusion Criteria:

* Have agreed to participate in the observatory after receiving written information on the purpose of the study and the personal data to be collected (agreement of parents for under-age patients);
* Present with haemophilia B and are currently being treated or have previously been treated with Idelvion® as a long-term prophylactic treatment, on-demand treatment or short-term treatment for surgical procedures or to cover periods with a high-risk of bleeding.
* Do not have FIX targeted antibodies at the time of the inclusion visit

Exclusion Criteria:

* Refusal by the patient or his/her legal representative to participate in the study;
* Existence of a contraindication to the use of Idelvion® treatment (known hypersensitivity to FIX or hamster proteins);
* Simultaneous participation in an interventional clinical study on a drug
Mindfulness, Emotional Well-being, and Sleep Quality

The purpose of this study is to determine whether participating in a Mindfulness-Based Stress Reduction (MBSR) program increases mindful attention and awareness, and whether anticipated changes in mindfulness relate to improved emotional well-being, sleep quality, physical symptoms of stress, sense of spirituality, and quality of life following MBSR.

This study will be conducted among men and women participating in 8-week Mindfulness-Based Stress Reduction (MBSR) classes at Duke Integrative Medicine in Durham, North Carolina. The central hypothesis of this NIH-funded clinical trial (K99 AT004945, PI: Greeson) is that mindfulness meditation training is associated with increased levels of mindfulness and improved cognitive-emotional functioning that, together, are associated with reduced psychological distress, improved sleep quality, and decreased stress-related physical symptoms, including muscle tension, headache, and gastrointestinal complaints. This study is designed to examine psychological mechanisms that may explain individual differences in MBSR outcomes. This knowledge is important because it will help us better understand who is most likely to benefit from mindfulness meditation training, and why. The results from this study are expected to elucidate mechanisms underlying the mental and physical health benefits of stress reduction, which can help guide clinicians in referring the most suitable patients to local MBSR programs.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in a self-pay MBSR course at Duke Integrative Medicine
* Must be able to speak and read English

Exclusion Criteria (Apply to Duke's MBSR program, and thus to the research study):

* Active substance abuse/dependence
* Severe mental illness
* Difficulty being redirected to task in a group setting
Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma

This is a single-arm phase I/Ib study of crenolanib combined with ramucirumab/paclitaxel as second line therapy for patients with advanced/metastatic adenocarcinoma of the esophagus, GEJ or stomach. Patients will be enrolled in two phases; dose escalation phase and dose expansion phase.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of the esophagus, GEJ or stomach.
* Stage IV disease or locally advanced/unresectable tumors
* Prior progression on only 1 line of chemotherapy in the advanced/metastatic setting containing a fluoropyrimidine and/or platinum compound
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion Criteria:

* Prior treatment with a taxane is not permitted in the dose-expansion phase. Patients in the dose escalation component may have received a taxane in the peri-operative setting, provided they developed disease recurrence \>6 months after the completion of this therapy
* Known pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)
* Patients with any clinically apparent ascites or who have undergone a paracentesis within 7 days of enrollment
* Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic pressure \> 90 mm Hg on repeated measurement) despite optimal medical management
* Active or clinically significant cardiac disease
* Patients with arterial thrombotic events, such as cerebrovascular accident or myocardial infarction, within 6 months of enrollment
Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication

Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in select patients. Advances in battery and electronics technology allow for the entire pacemaker system to be implanted into the right ventricle, bypassing many of the weaknesses of transvenous pacemakers. Traditionally leadless pacemakers have been implanted in the right ventricular (RV) septum to prevent cardiac perforation, and much emphasis is placed during implantation to ensure a septal implant. However, in Asians with smaller heart sizes, septal implantation may be unfeasible. Cases of RV free wall implant have been achieved without any complications. This study aims to examine patients previously implanted with LP and determine their final attachment location. If a substantial portion of complication-free patients had RV free wall implants, then it can be argued the additional effort to ensure a septal implant is unnecessary. Additionally, intraoperative data, such as the intracardiac electrogram, may contain parameters correlated with implant position. This study also aims to study this correlation to guide future implant procedures.

This is a prospective-retrospective cohort study. Patients who will implant leadless pacemakers or already implanted leadless pacemakers since 1 Jan 2015 will be recruited. After the implantation, patients will be invited back for a noncontrast ECG-gated CT heart. It will be timed at the end diastole and a 3D reconstruction will be performed. The attachment of the leadless pacemaker to the RV will be adjudicated from the CT. The patients' pre-operative laboratory tests, baseline demographics, medical history, LP electrical data and pre- and post-operative medication regiment will be collected retrospectively from their medical records in the Hospital Authority's Clinical Management System (CMS) and Clinical Data Analysis and Reporting System (CDARS).


Eligibility Criteria:
Inclusion Criteria:

* Patients who will implant leadless pacemaker or already implanted leadless pacemaker since 1 Jan 2015
* Patients with ability to provide informed consent

Exclusion Criteria:

* Patients who cannot provide informed consent
* Patient \&lt; 18 years old
* Pregnant patients
Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) \> 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Drug naive
* Hemoglobin (Hb) A1c \>= 7.0% and \<= 10.0% (\>10% and \<= 12% for open label arm)
* Fasting C-peptide \>= 1 ng/mL
* Body mass index \<= 40 kg/m2

Exclusion Criteria:

* Symptomatic poorly controlled diabetes
* Recent cardiac or cerebrovascular event
* Serum creatinine \>= 1.5 mg/dL for males and \>= 1.4 mg/dL for Women of Child Bearing Potential
clinIcal Efficacy and Safety of Incadronate in Breast Cancer With Bone Metastases

This is a real-world study to explore the efficacy and safety of incadronate in the treatment of breast cancer patients with bone metastases.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 years or above;
2. Can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent
3. The physical status score of the Eastern Cooperative Oncology Group (ECOG) was ≤3;
4. Histologically or cytologically confirmed breast cancer;
5. Imaging or histocytology confirmed bone metastases;
6. There were indications of useing Incadronate and no contraindications in the use of Incadronate;
7. New York Heart Association（NYHA）cardiac function grade ≤II, No serious heart disease;
8. All women of childbearing age, fertile men or their spouses did not plan to have children or donate sperm throughout the trial period until 6 months after the last dose, or voluntarily took effective contraceptive measures.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Patients with acute and chronic infections, or with other serious diseases at the same time, were judged not suitable for this study;
3. Other malignant tumors within 5 years (except the following cases: cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma; A second primary cancer that has been eradicated and has not recurred within five years; Investigators have identified the primary tumor source of the metastases);
4. Mental illness or mental disorder, poor compliance can not cooperate with and describe treatment response;
5. There are serious organic diseases or major organ failure, such as decompensated heart, lung, liver, kidney failure, which can not tolerate treatment;
6. Patients with bleeding tendency;
7. The researcher believes that the patient has other conditions that are not suitable for participating in this study.
Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain

There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with scrotal pain that we found published.

We proposed a pilot study using Botox to block the nerves on a small group of men with chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using local anaesthetic drug.

The encourage results of the pilot study has given us the background information to proceed with a formal randomised control trial of Botox vs placebo.

We hypothesized that Botox injections to block the testicular nerve will be effective in providing long term pain relief for men with scrotal pain.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Have nociceptive scrotal pain,
* Have no identifiable, reversible causes for the scrotal pain
* Have failed standard medical therapy
* Have responded temporarily to cord blocks

Exclusion Criteria:

* Are interested in trying to conceive with their partners in the next 6 months,
* Have any local infection near the site of the injections,
* Have had an allergic reaction to Botox in the past,
* Are unable to provide informed consent
* Have a history of motor neuron disease or neurogenic bladder
* Who have hemostatic disorder or who are taking aspirin, Coumadin (warfarin), Xarelto (rivaroxaban) or other blood thinners
ROCC Knee Data Collection

This observational study intends to collect efficacy and safety data on ROCC Knee system.

The ROCC® prosthesis is a rotating platform with:

* Highly congruent surface contact,
* NON CONSTRAINED kinematics allowing posterior roll back until 110° then anterior in hyperflexion like a normal knee
* Allowing asymmetric movement

Eligibility Criteria:
Patients suitable for Knee Replacement for:

* osteoarthritis,
* rheumatoid arthritis
* bone necrosis affecting two knee compartments,
* correction of genu varus, genu valgus or post-traumatic deformities,
* sequelae of prior procedures.
Efficacy and Safety of CKD-828 to Stage 2 Hypertension

The aim of present study is to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.

* In patients with Stage 2 hypertension to determine the efficacy and safety of S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 10 weeks.
* This study is consist of placebo run-in period(2 weeks_single blind) and treatment period(10 weeks_double blind.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* at the screening visit

  * antihypertensive drugs not taking: 160mmHg ≤ sitSBP \< 200mmHg
  * antihypertensive drugs taking: 140mmHg ≤ sitSBP \< 180mmHg
* at the randomization visit(160mmHg ≤ sitSBP \< 200mmHg)
* willing and able to provide written informed consent

Exclusion Criteria:

* mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit
* for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs
* known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
* has severe heart disease(Heart failure NYHA functional class 3, 4), ischaemic heart diseasesstatus need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty
* has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
* Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) \> 8%)
* known severe or malignant retinopathy
* defined by the following laboratory parameters:

  * hepatic dysfunction(AST/ALT \> UNL X 3)
  * renal dysfunction(serum creatinine \> UNL X 1.5)
  * hypopotassemia(K \< 3.0mmol/L) or hyperpotassemia (K\>5.5 mmol/L)
* acute or chronic inflammatory status need to treatment
* need to additional antihypertensive drugs during the study
* need to concomitant medications known to affect blood pressure during the study
* history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
* known hypersensitivity related to either study drug
* history of drug or alcohol dependency within 6 months
* any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding)
* administration of other study drugs within 4weeks prior to randomization
* premenopausal women(last menstruation \< 1year) not using adequate contraception, pregnant or breast-feeding
* history of malignancy including leukemia and lymphoma within the past 5 years
* in investigator's judgment
The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

This study is designed to estimate the effect of fluconazole (200 mg BID for 2 days), a moderate CYP3A4 inhibitor on the pharmacokinetics of a single 8 mg oral dose of fesoterodine in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between the ages of 18 and 55 years

Exclusion Criteria:

* Not healthy subjects. subjects with acute or chronic medical or psychiatric condition or laboratory abnormality
Comparison of Pupillometry-guided Anesthesia With Surgical Pleth Index Guided Anesthesia

In this study, the investigators measure a pupil size every 5 minutes during the operation in patients undergoing laparoscopic cholecystectomy under general anesthesia. The investigators would compare the intraoperative opioid consumption and postoperative pain between the group adjusted the anesthetic drug concentration based on the changes of the pupil (Pupil group) and the group based on the changes of a surgical pleth index (SPI group).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 to 65 yr, American Society of Anesthesiologist Physical status(ASA PS) I to II, scheduled for a laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* Presence of ophthalmologic diseases such as Horner's syndrome or Sjogren's disease.
* Presence of neurologic or metabolic diseases
* Medicated that could interfere with the autonomous nervous system (e.g., b- blockers, anticholinergics)
* History of substance abuse or psychiatric disease
* with chronic pain or preoperative analgesics
* with pacemaker or arrhythmia
Brain-Gut Interactions in Crohn's Disease

The primary aims for this research are to 1) characterize brain changes in patients with CD compared to age and gender-matched controls and 2) relate these brain changes to measures of disease activity and pain severity.

Brain-gut interactions have been studied in chronic pain conditions of the gastrointestinal (GI) tract such as irritable bowel syndrome (IBS) and chronic pancreatitis. These studies suggest that alterations in the brain-gut axis may relate to disease severity and pain perception. Inflammatory bowel disease (IBD) is a chronic inflammatory disorder characterized by periods of disease activity and periods of disease quiescence. Crohn's disease (CD) is one of the two major subtypes of IBD. Patients with CD typically experience abdominal pain when the disease is active; however, many also report experiencing pain in the absence of objective evidence of inflammation. Alterations in brain-gut interactions may explain the perception of pain in these patients. Currently, there is a paucity of data regarding brain changes in patients with IBD and CD, specifically. We are proposing a pilot study to characterize brain-gut interactions of disease activity and pain modulation mechanisms in patients with IBD using advanced neuroimaging tools.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* A diagnosis of Crohn's disease by endoscopy or radiographic imaging
* Must have Crohn's disease in symptomatic remission as defined by a Harvey-Bradshaw score of 3
* No contraindications to MRI per UWHC screening form
* Able to provide informed consent

Exclusion Criteria:

* Women that are pregnant
* Contraindications to MRI per UWHC screening form
* Other chronic pain disorders (e.g. fibromyalgia, rheumatoid arthritis, irritable bowel disorder) unrelated to their diagnosis of IBD.
* Scheduled medications for the treatment of pain (e.g. acetaminophen, non-steroidal anti-inflammatory drugs, narcotics) will be excluded.