cyrilzakka/clinical-trials huggingface dataset:
An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis

The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study.

The study provides 7 years of additional treatment with baricitinib.


Eligibility Criteria:
Inclusion Criteria:

* Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705)

Exclusion Criteria:

* Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction \[MI\], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered
* Have a known hypersensitivity to baricitinib or any component of this investigational product
* Had investigational product permanently discontinued at any time during a previous baricitinib study
* Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study
* Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol
Prognosis and Survival Estimates in Palliative Therapy

The accuracy of clinical survival estimates is tested in comparison to objective prognostic scores.

* At presentation a clinical survival estimate is obtained in each patient.
* Survival is also estimated using published prognostic scores in palliative care.
* Prognostic scores based on blood samples, general symptoms, complaints, and performance status are calculated and validated, respectively
* Each patient completes questionnaires on psychological distress
* Survival estimates are limited to 6 months.
* Each patient is followed for at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* oncologic disease confirmed
* incurable locally advanced or metastatic disease
* palliative treatment intended
* age \> 18
* able to understand the study protocol
* able to complete the forms with assistance if necessary

Exclusion Criteria:

* therapy with curative intent
* regular clinical follow-up visit without disease progression
* ongoing therapy
ACT and Virtual Reality for Public Speaking Fear

Investigation of Acceptance and Commitment Therapy (ACT) for the psychological treatment of public speaking fear. Two ACT-based treatment delivery modalities (in vivo exposure vs. virtual reality) were compared.

After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.

The clinical trial will include a control group (waiting list).

Patients who meet eligibility requirements will be assigned to a waiting list, in vivo exposure and Virtual Reality.

Psychological intervention consisted in a 5-session individual face-to-face delivered ACT-based treatment.

The participants will be assessed through self-report instruments and observational measurements before and after treatment and at 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Student at European University of Madrid, Spain
* Significant social anxiety (LSAS Liebowitz Social Anxiety Scale)
* Subjective fear intensity and interference \> 5/10

Exclusion Criteria:

* Alcohol or drugs abuse
* Psychotropic drug consume
* Following psychological/psychiatric treatment
* Serious mental disorder
Validation of a Swiss German Language Test for Children

The aim of this study is to validate a Swiss German children's language test. Standard values for the speech intelligibility of Swiss German monosyllables and disyllables for children with normal hearing aged 4-6 years are recorded.


Eligibility Criteria:
Inclusion Criteria:

* Native Swiss German speakers
* Hearing threshold better than 20dB HL at 0.5, 1, 2 and 4kHz
* Written informed consent by the parents

Exclusion Criteria:

* Hearing loss
* Cognitive impairment
MRI Biomarkers in Diabetic Kidney Disease

Diabetic kidney disease is one of the most severe and frequent complications of diabetes. Few preclinical markers are available apart from plasma creatinine and microalbuminuria. These markers are imperfect (some patients with advanced renal disease do not have an increase in markers) and late. Therefor there is an uncovered need to identify complementary biomarkers. Magnetic Resonance Spectroscopy (MRS) is a Magnetic Resonance Imaging (MRI) technique that allows the physiology and biochemistry of human body tissues to be studied in a non-invasive and non-irradiating manner.


Eligibility Criteria:
Inclusion Criteria:

Common to all 3 category

* Male or female,
* Age≥ 35 years,
* Subject free, with legal protection guardianship or curatorship;
* Enrollment in the French Social Security system;
* Informed consent signed by the patient

Obese patients

* BMI \>30 kgm² ;
* With no known diabetes;
* estimated glomerular filtration rate (eGFR) \> 60 ml/min/1.73m² and urine albumin-creatinin ratio (ACR) \< 3 mg/g

Type 2 diabetic patients without kidney disease

- eGFR \> 60 ml/min/1.73m² AND ACR \< 3 mg/g,

Type 2 diabetic patients with diabetic kidney disease defined as eGFR 30 to 60 ml/min/1.73m² OR ACR \> 30 mg/mmol.

Exclusion Criteria:

Age \< 35 years History of kidney transplant Any contraindication to an MRI examination Legal protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons residing in a health or social establishment, adults under legal protection and finally patients in emergency situations Pregnant or lactating women, women of childbearing age who do not have effective contraception
CGH-array in Prenatal Diagnosis of Isolated Severe and Early Intra-uterine Growth Restriction

According to french recommandations for IUGR management we have to propose a CGH-array analysis if the IUGR is severe (bellow the 3rd percentile) and early (in the second trimester). However there is no data to support this point of view.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* fetus with an isolated intra-uterine growth restriction (IUGR) severe (bellow the third percentile on CFEF curves) and early (between 21 and 24 gestational weeks).

Exclusion Criteria:

* associated IUGR (with other abnormalities during prenatal screening)
A Diagnostic Nomogram for Predicting Vaginal Invasion in Cervical Cancer

This study aims to develop a diagnostic nomogram based on clinical factors with the prediction values of vaginal invasion in cervical cancer to optimize the treatment plan and surgical procedures.

Vaginal invasion is a crucial index participant in cervical cancer tumor staging and prognosis prediction. However, the roles of vaginal invasion are overlooked in the literature, compared with those of lymph node metastasis and parametrial invasion. As far as we know, this study is novel to construct a nomogram to predict the probability of pathologic vaginal invasion occurrence.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed cervical cancer;
* FIGO2018 stage IB-IIA according to the result of physical examination and images;
* No preoperative treatment before surgery;
* Abdominal MRI is performed within three weeks before surgery. Blood routine, biochemistry, blood tumor markers and coagulation function were examined within 1 week before surgery.
* All patients undergo radical hysterectomy (RH) with bilateral pelvic lymphadenectomy or paraaortic lymph node dissection.

Exclusion Criteria:

* Accompanied with other tumors;
* Accompanied with chronic infectious and immune diseases;
* Incomplete clinical data.
Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer

This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed, unresected cancer of the pancreas or ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma, neuroendocrine carcinoma).
* Patients must have measurable radiographic disease.Patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease.
* Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of RT.
* Age \> or = 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2 (Karnofsky \> or = 60%)
* Life expectancy of greater than 3 months.
* Patients must have normal organ and marrow function.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Concurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicity.
* Prior radiation therapy to the abdominal area which would overlap with the proposed area of treatment.
* Pregnancy.
* Primary disease \> 7.5 cm in largest diameter as measured by CT or MRI.
* Gross extension of tumor into the lumen of the duodenum.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before RT or 6 months after RT.
Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with Osteoarthritis (OA) of the knee.

A double-blind, multicenter, randomized, saline-controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with symptomatic osteoarthritis (OA) of the knee who have not been able to get satisfactory pain relief with prior treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 21 and ≤ 80 years old at the time of screening
* Willingness and ability to comply with the study procedures and visit schedules and ability to follow oral and written instructions
* A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 and an absence of severe osteoarthritis
* Body Mass Index ≤ 40
* A qualifying WOMAC LK 3.1 pain subscale total score
* Has undergone at least one prior conservative osteoarthritis treatment
* Signed an institutional review board approved informed consent

Exclusion Criteria:

* Presence of clinically observed active infection in the index knee
* Presence of symptomatic osteoarthritis in the non-study knee
* Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis
* Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment
* Untreated symptomatic injury of the index knee
* Presence of surgical hardware or other foreign body intended to treat arthritis or cartilage-related pathology in the index knee
* Previous cartilage repair procedure on the injured cartilage surface of the index knee
* Arthroplasty or open surgery of the index knee within 6 months of screening
* Intra-articular steroid injection in the index knee within 3 months of screening
* Intra-articular hyaluronic acid injection in the index knee within 6 months of screening
* Other intra-articular therapy in the index knee within 6 months prior to screening
* Orally administered systemic steroid use within 2 weeks of screening
* Planned/anticipated surgery of the index knee during the study period
* Skin breakdown at the knee where the injection is planned to take place
* Pregnant or nursing mothers or women planning on getting pregnant during the time they will be participating in the study
* Participated in any investigational drug or device trial within 30 days prior to screening
* Participated in any investigational biologic trial within 60 days prior to screening
Evaluation of Sirolimus-Eluting, Heparin-Coated CoCr Stent in the Treatment of de Novo Coronary Artery Lesions in Small Vessels(EVOLUTION)

The objective of this study is to assess the performance and safety of a sirolimus-eluting, heparin-coated, cobalt chromium balloon-expandable stent (Small Vessel Stent) in patients with de novo native coronary artery lesions in small vessels as compared to historical data from small vessel patients in the RAVEL trial receiving the Sirolimus-eluting Bx VELOCITY™ stent.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be minimum 18 years of age;
2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;

3 Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target vessels are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;

4. The target lesion is \>/=2.0 mm and \</=2.5mm in diameter (visual estimate);

5. The target lesion can be covered with a single 18mm stent;

6. Target lesion stenosis is \>50% and \<100% (TIMI I) (visual estimate);

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK\>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
2. Target lesion is due to in-stent restenosis;
3. Ejection fraction 30%;
4. Totally occluded vessel (TIMI 0 level);
5. Impaired renal function (creatinine \> 3.0 mg/dL);
Investigation on Medical Management of Dry Eye Patients

Dry eye is a common complaint in patients encountered by ophthalmologists, which may result from the inflammatory response and can occur in the absence of systemic disease. However, the management of dry eye syndrome in real setting warrants assessment but remains lacking in Taiwan. We conducted an perspective observational study to evaluate the medical management of dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

* Have given a written informed consent
* Clinical diagnosis of dry eye syndrome
* Have at least one Schirmer's test positive result (less than 10mm/5min) in at least one eye within one year

Exclusion Criteria:

* Pregnancy
* Cognitive or psychiatric deficit that precludes informed consent
* Cognitive or psychiatric deficit that precludes ability to perform requirements of the investigation
Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone

It is the aim of this study to detect the effect of Betamethasone on the maternal inflammatory parameters C-reactive protein (CRP) and leukocytes of a pregnant woman under threat of preterm delivery, for example because of a cervical infection.

BACKGROUND

Cortisone influences the maternal number of leukocytes and CRP of a pregnant woman. Because of that, it is difficult to know if the medical treatment of an infection was successful and accordingly if the diagnosis was justified.

METHODS

In this study, the blood results of 75 pregnant women under threat of preterm delivery (week of gestation 23+0 to 34+6), treated with Betamethasone will be analysed. 65 pregnant women without complications serve as control group.

Eligibility Criteria:
Inclusion Criteria:

* week of gestation 23+0 until 34+6

Exclusion Criteria:

* infectious diseases f.e. hepatitis B or C, HIV
* diseases of the thyroid gland

  75 Patients facing preterm labour 65 Patients acting as a control group, without preterm labor
Measurement of Cerebral Oxygen Extraction Fraction Using MRI Technique

All images in this study were acquired on a 1.5 T Sonata whole body scanner (Siemens Medical Inc., Erlangen, Germany) using 2D multi-echo gradient echo/spin echo sequence and 2D single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility contrast medium. The quantitative estimates and mapping of cerebral metabolic rate of oxygen utilization were calculated and plotted in all subjects.

All images in this study were acquired on a 1.5 T Sonata whole body scanner (Siemens Medical Inc., Erlangen, Germany) using 2D multi-echo gradient echo/spin echo sequence and 2D single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility contrast medium. The quantitative estimates and mapping of cerebral metabolic rate of oxygen utilization were calculated and plotted in all subjects.

Eligibility Criteria:
Inclusion Criteria:

* normal volunteer
* stroke

Exclusion Criteria:

* who is unable receiving MRI examination
* pregnancy
Effect of Position on Back Pain and Comfort After Angiography

After coronary angiography, back pain and comfort levels were measured while the intervention group was positioned and the control group was not positioned

Patients were assigned to the control and intervention groups by the minimization method. Data were collected using the Visual Analog Scale (VAS) and a Patient Introduction Form to assess the pain and comfort levels of the patients. Prior to the starting the research, the necessary permissions were obtained from the institution where the study was conducted, from the patients and the ethics committee. In the analysis of data, frequency and percentage values, Kolmogorov-Smirnov test for the normal distribution of continuous variables, chi-square for comparisons of qualitative variables, two-way analysis of variance for comparison of repeated measurements of pain and comfort scores according to groups, and the relationship between two continuous variables were evaluated with the Pearson correlation coefficient. p\<0.05 was considered statistically significant. IBM SPSS Statistics 23 package program was used for the analysis of the date. The intervention group was hospitalized in supine position after coronary angiography. The first measurement was taken when the patient was placed in bed after the procedure, and the Patient Introduction Form and VAS for comfort and pain were applied (Hour 0). Following the withdrawal of the mattresses, the patient was given the semi-fowler position. VAS was applied at the 2nd and 4th hours after the positioning. Patients in the control group were placed to bed in the supine position in accordance with the routine practice of the clinic at the exit of coronary angiography and were allowed to stay in this position for six hours. When the patients were put to in bed, the Patient Introduction Form, VAS were applied for comfort and pain (0. hour). VAS was applied at the 2nd and 4th hours following the removal of the mattresses. Patients' back pain and comfort were evaluated, and the results were recorded on the relevant forms.

Eligibility Criteria:
Inclusion Criteria:

* Coronary angiography for the first time in the coronary intensive care unit and cardiology clinic
* Volunteer to participate in the study
* Femoral angiography procedure performed
* It created patients who had no obstacle to communication.

Exclusion Criteria:

* More than one coronary angiography procedure was performed
* Not volunteering to participate in the study
* Radial angiography procedure was performed
* Having a history of back surgery, existing hernia, or chronic waist or back pain
Cytokine Changes After Colorectal Cancer Resection

Based on our previous research, this study aims to determine reliable surgical stress response markers in patients undergoing radical resection of colorectal cancer.

Every surgical intervention represents a stress for patient's organism. During the operation, numerous changes in the patient's metabolism take place, that are termed surgical stress response. Leading cause of surgical stress response is tissue destruction that always accompanies operations. Surgical stress response is effected through activation of hypothalamus-pituitary-adrenal axis and through sympathetic activation.

The consequences of surgical stress response are numerous. Surgical stress response is essential to uneventful postoperative recovery. On the other hand, excessive surgical stress response may lead to serious postoperative complications, such as heart and kidney failure, venous thrombosis, disruption of operative wound and wound infection.

In prior studies the investigators have shown the kinetics of postoperative serum interleukin changes after radical resection of gastric cancer.

This study aims at determining reliable markers of surgical stress response severity in patients undergoing radical resection of colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Pathohistologically verified colorectal cancer

Exclusion Criteria:

* Distant metastases noticed before or during surgery
* History of autoimmune diseases or immunodeficiencies
* Use of immunomodulatory drugs within 1 year prior to surgery