cyrilzakka/clinical-trials huggingface dataset:
Acute Effect of Resistance Training in Inflammatory Markers in Women With Rheumatoid Arthritis

ABSTRACT Introduction: Rheumatoid arthritis (RA) is a systemic inflammatory, chronic and progressive disease that can lead to joint destruction and important functional disability. Chronic inflammation, with a substantial increase in the amount of pro-inflammatory cytokines in synovial joint, is one of the biggest challenges in controlling RA. Resistance exercise has been recognized for positively modulate inflammation in healthy subjects. Objective: To evaluate the effect of an acute bout of resistance exercise on serum concentrations of tumor necrosis factor alpha (TNF-α), interleukin 1 receptor antagonist(IL-1ra), interleukin 1 beta (IL-1β), C reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), and cartilage oligomeric matrix protein (COMP) in postmenopausal women with RA and women without the disease. Methods: 17 volunteers with RA and 17 without the disease, with a mean age of 54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM. The exercises performed were: knee extension, knee flexion, hip abduction and hip adduction. Blood samples were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24 hours after the exercise session. Serum glucose concentrations prior to exercise were also measured. The investigators used the Student's't test, the model of analysis of variance with repeated measures and Bonferroni method of multiple comparisons to analyze the data, being considered statistically significant levels of p \<0.05.


Eligibility Criteria:
\*Rheumatoid Arthritis Group

Inclusion Criteria:

* Women classified acording to the American College of Rheumatology's criteria to rheumatoid arthritis
* Post menopausal women
* Stable medication three months before study

Exclusion Criteria:

* Women with rheumatoid arthritis with functional class IV, acording to ACR criteria
* Women engaged in some type of regular exercise program;
* Failure: heart, coronary, respiratory, renal and / or hepatic (uncompensated);
* Uncompensated systemic hypertension;
* Volunteers with other associated inflammatory diseases;
* Unable to perform the exercises.

  * Control group We included in the control group of this study postmenopausal volunteers, without Rheumatoid Arthritis. Exclusion criteria were the same as those adopted for the participants of the Rheumatoid Arthritis Group
Minimally Invasive Management During Endodontic Retreatment

The study compares the prognosis of cases treated with "selective root retreatment" to the cases treated with traditional retreatment approach

Post-treatment apical periodontitis is an inflammatory disorder of peri-radicular tissues caused by either persistent or secondary intra-radicular infection .Conventionally, nonsurgical retreatment has been believed to be an ''all or none'' treatment approach in which the endodontist has to remove all restorations from the tooth and to remove the obturation materials from all the canals in order to perform thorough disinfection of the entire root canal system. Nowadays, All operations in the medical field are aimed basically at the conservation of the human body. The alternative concept allows the endodontist to formulate clinical treatment decisions with respect to the presence of periapical pathosis related to individual roots rather than the tooth as a whole.

The literature is lacking the clinical outcome studies dealing with the prognosis of cases treated with "selective root retreatment" concept so the aim of this study was to compare the prognosis of such cases in comparison to the traditional retreatment approach.

Eligibility Criteria:
Inclusion Criteria:

* endodontically treated teeth
* multirooted teeth
* radiographic evidence of periradicular infection related to one root

Exclusion Criteria:

* medically compromised patients
* fused roots
* root resorption
* root fracture
HES and Acute Kidney Injury in Adult Cardiac Surgery

This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES) 130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 yo
* Having on pump cardiac surgery at CHU of Liège between April 2013 and June 2014

Exclusion Criteria:

* Off pump surgery
* Use of Blood or Albumin in the cardiopulmonary bypass priming solution
* Preoperative dialysis
Impact on Quality of Life 3 Years After Diagnosis of Prostate Cancer

To study the quality of life of patients with prostate cancer at a distance from their care at a time when they are supposed to have taken a "normal" life and compared to subjects without cancer prostate of the same age.


Eligibility Criteria:
- exposed group

Inclusion Criteria:

* prostate cancer diagnosed from 1 December 2011 to 31 December 2014
* under 75 and residing in the Hérault department at diagnosis
* recruited in the EPICAP study

Exclusion criteria:

* having relapsed in the range
* non-exposed group:

Inclusion Criteria:

* controls (without prostate cancer) recruited in the EPICAP study
* matched to cases on age (5 years)
* residing in the Hérault department

Exclusion criteria:

* diagnosis of prostate cancer set in the range
Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis

The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.

A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed ulcerative colitis at least 90 days prior randomisation.
* Men or women age 18 - 75 years.
* Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable background UC therapy (e.g. containing 5-aminosalicylates, and/or low dose of glucocorticosteroids, and/or purine analogue) prior to randomization.
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1.
* Nonsterilized males or sterilized males who are ≤1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* History of colostomy.
* Current diagnosis of indeterminate colitis, Crohn's disease, ischemic colitis, fulminant colitis and/or toxic megacolon and patients with ulcerative colitis limited to the rectum (ulcerative proctitis).
* Hepatitis B, C or HIV.
* History of cancer.
The Effect of Web-based Training Given to Mothers of Babies With Congenital Heart Disease

This study was assessed the impact of a web-based education program provided to mothers of infants with congenital heart diseases on their quality of life and self-efficacy levels. The study is a mixed-method approach with a qualitative and pre-test post-test design, utilizing randomized controlled quasiexperimental type.

The research was conducted with mothers of infants diagnosed with congenital heart disease who sought care at the Pediatric Cardiology Outpatient Clinic of a university hospital and were followed up. There are two groups in the study. Web-based education was provided to mothers in the intervention group (n=30). No intervention was applied to the mothers in the control group (n=30) other than the outpatient clinic routine of the hospital.

Materials and Methods: study is a mixed-method approach with a qualitative and pre-test post-test design, utilizing randomized controlled quasiexperimental type. The research was conducted with mothers of infants diagnosed with congenital heart disease who sought care at the Pediatric Cardiology Outpatient Clinic of a university hospital and were followed up. There are two groups in the study. Web-based education was provided to mothers in the intervention group (n=30). No intervention was applied to the mothers in the control group (n=30) other than the outpatient clinic routine of the hospital. "Qualitative interview form, Parent-infant Introductory Information Form, Quality of Life Scale and Generalized Perceived Self-Efficacy Scale" were used. The research process had two stages; in the first stage, qualitative data was collected and after qualitative interviews with mothers, the content of the web-based training was created in line with the needs of the mothers. In the second stage, quantitative data were collected, and a web-based training program was applied to the intervention group and an outpatient clinic routine to the control group.

Eligibility Criteria:
Inclusion Criteria:

* For mothers;
* Having a baby with congenital heart disease
* Being over 18 years of age
* Being literate
* Being able to speak and understand Turkish
* There is no health problem that may prevent participation in training.
* Being able to use a computer/mobile phone
* Being able to use and have internet access
* Volunteering to participate in research

For babies;

* Those born at or after the 37th week of gestation and those with congenital heart disease, aged 0-12 months
* Has not had heart surgery
* Babies who do not have any other chronic diseases

Exclusion Criteria:

* Filling out forms incompletely
* Being a foreign national
* Having vision or hearing problems
* To give up participating in the research
* Mothers and babies who have physical/mental problems that may affect the research results during the study period.
Internet- Based Cognitive Behavioral Therapy Among Women With Fear of Childbirth

Fear of Birth is common in pregnant women and associated with physiological and psychological consequences. Fear is mostly associated with fear of losing control, fear for the baby's life or health or own life threatening events .

Cognitive Behaviour Therapy (CBT) is the treatment of choice for most anxiety disorders and for women with mental health problems during pregnancy and postpartum.. It has been suggested for perinatal women as with Fear of Birth. Internet-based cognitive behavioural therapy have shown it is efficiency as treatment for anxiety and depression as traditional face-to-face CBT in managing emotional problems for women

Fear of Birth is common in pregnant women , the current study aims to examine the efficacy of an Internet-based Cognitive behavioral therapy compared to standard of care for women with fear of child birth( moderate /severe).

The study comparing internet -based Cognitive Behavioral therapy in addition to routine stander of antenatal care (interventional group) with others who are receiving stander of care alone( control group). The study is the second phase of the study project named "Prevalence of childbirth fear and associated factors among pregnant women.

based on inclusion and exclusion criteria, the total participants who have moderate and severe level of child birth fear is 169 pregnant women . The final sample eligible is 96 participants . Those will assign randomly to either interventional / control group

the interventional group will receive internet -based cognitive behavioural therapy program accompanied with stander of care providing at antenatal clinics . through whats app group the researchers will provide the program contents

Eligibility Criteria:
Inclusion Criteria:

* accepting and willing to engage in an ICBT program
* participants experienced a fear of childbirth score ranging from 40 to 64 based on the Childbirth Attitude Questionnaire (CAQ)
* Aged between 18 and 35 years
* Gestational age of at least 28 weeks (determined by an accurate last menstrual period)
* singleton pregnancy
* (Capability to read, write, and understand the essence of the provided questionnaires
* have a smartphone with internet access
* had not participated in any antenatal intervention or education.

Exclusion Criteria:

* women diagnosed with pathological anxiety or depression
* Pregnancies associated with serious health issues (e.g., hypertension, infections, diabetes, obesity, etc.)
* A recent history of pregnancy complications
* women not respond for at least two modules of intervention program
* A recent history of miscarriage or neonatal loss
* A history of infertility
* Lack of access to the internet.
Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan

This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.


Eligibility Criteria:
Inclusion Criteria:

* World Health Organization (WHO) Performance Status of ≤ 2
* Histologically-confirmed, advanced solid tumors
* Progressive, recurrent unresectable disease
* Age ≥ 20

Exclusion Criteria:

* Hematopoietic:
* No diabetes mellitus or history of gestational diabetes mellitus
* No acute or chronic renal disease
* No acute or chronic liver disease
* No acute or chronic pancreatitis
* No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
* No acute myocardial infarction or unstable angina pectoris within the past 3 months
* Not pregnant or nursing and fertile patients must use barrier contraceptives

Other protocol-defined inclusion/exclusion criteria may apply.
The Role of Aquatic-Based Plyometric Exercises for Patients With Juvenile Idiopathic Arthritis

This study was designed to assess the effect of a 12-week aqua-plyometric (AquaPlyo) training on muscle strength, bone health, and physical ability in children with juvenile idiopathic arthritis (JIA). Forty-eight patients with JIA were randomly allocated to the AquaPlyo group (n = 24, received an aquatic-based plyometric training program, twice/week, over 12 weeks) or the control group (n = 24, received standard exercise program). Both groups were assessed for muscle strength, bone health, and physical ability pre and post-treatment.

Forty-eight patients with JIA were recruited from the pediatric rheumatology clinics of three large referral hospitals in Riyadh, Saudi Arabia. The study included patients who had a confirmed diagnosis of Polyarticular JIA (according to the criteria set forth by the International League of Associations for Rheumatology), aged 12-18 years, identified being stable cases, and did not participate in a regular exercise program (in the past six months). Patients who had fixed deformities, a history of joint surgery, or whose radiological investigations revealed erosive changes of bone, ankylosing, or fractures were excluded.

Outcome measures

1. Muscle strength: The peak concentric torque of the right and left quadriceps muscle was measured through an Isokinetic Dynamometer.
2. Bone health: Areal bone mineral density, volumetric bone density, and bone mineral content of the lumbar spine and neck of femur were measured through Dual-Energy X-ray Absorptiometry (DEXA) scanning.
3. Physical ability: The physical performance was assessed using the 6-minute walk test.

The AquaPlyo group received a 12-week AquaPlyo training, 45 minutes per session, two times a week for 12 consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The AquaPlyo program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities conducted in a water medium. The AquaPlyo training included a warm-up for 10 minutes and a cool-down for 5 minutes. The control group received the standard exercise program, 45 minutes per session, two times a week for 12 consecutive weeks. The program consisted of flexibility exercise, strength training, weight-bearing, proprioceptive training, and free treadmill walking or cycle ergometry.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of JIA
* Polyarticular onset of JIA with bilateral involvement of the knee joint
* Age between 12 and 18 years
* Stable conditions (i.e., receive stable doses of medications in the past three months)
* Not participating in a regular exercise program in the past six months

Exclusion Criteria:

* Fixed deformities
* History of joint surgery
* Ankylosing or fractures
* Bone destruction (erosive changes of the knee joint)
* Cardiopulmonary comorbidities
* Recommendation against engaging in potentially explosive physical activities by the attending Rheumatologist.
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,

This is a prospective, multicenter, randomized, single-blinded design trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a stented surgical bioprosthesis with a labeled size ≤25 mm. Following the Heart Team's decision to proceed with a ViV-TAVR procedure with the SAPIEN 3 ULTRA valve (or its subsequent iterations), patients will be randomized to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team
* Surgical stented bioprosthetic valve (label size ≤25 mm)
* TAVR with the SAPIEN 3 Ultra valve

Exclusion Criteria:

* Stentless or sutureless surgical valves
* Trifecta bioprosthesis
* Hancock II bioprosthesis
* High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT \<4 mm or based on the criterion of the heart team responsible for the procedure).
* Impossibility to obtain written informed consent
Re-Induction After Initial Response With Immune Therapy With Radiotherapy in Lung Cancer

Radiotherapy in combination with different forms of immune therapy improved consistently local tumor control and very interestingly, lead to better systemic tumor control and the induction of specific anti-cancer immunity with a memory effect. In small series, it has been shown that a new long-lasting remission can be induced by irradiating one tumor site in patients who showed cancer progression after an initial response to immune therapy. In these series, the original immune therapy was continued and the treatment was very well tolerated. In this study the progression-free survival after radiotherapy to a single lesion will be investigated in patients with stage IV non-small cell lung cancer (NSCLC), who have at least achieved stable disease with immune therapy alone or concurrent immune therapy and chemotherapy.

Radiation has consistently been shown to activate key elements of the immune system. Radiotherapy in combination with different forms of immune therapy such as anti-PD-(L)1, anti-CTLA4,immunocytokines, dendritic cell vaccination and Toll-like receptor agonists improved consistently local tumor control and very interestingly, lead to better systemic tumor control (the "abscopal" effect) and the induction of specific anti-cancer immunity with a memory effect. Moreover, as PD1/PD-L1 is upregulated by radiation and radiation can overcome resistance for PD-(L)1 blockage, their combination is logical.

In small series, it has been shown that a new long-lasting remission can be induced by irradiating one tumor site in patients who showed cancer progression after an initial response to immune therapy. In these series, the original immune therapy was continued and the treatment was very well tolerated. In this study the progression-free survival after radiotherapy to a single lesion will be investigated in patients with stage IV non-small cell lung cancer (NSCLC), who have at least achieved stable disease with immune therapy alone or concurrent immune therapy and chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Stage IV non-small cell lung cancer
* Initially a Complete Remission, Partial Remission or Stable Disease under immune therapy alone or concurrent immune therapy and chemotherapy and now progressive disease
* Able to continue the immune therapy

Exclusion Criteria:

* Not able to continue the already initiated immune therapy
* Patients with any grade 3 toxocity
* Patients in whom radiotherapy cannot be delivered, according to the radiation oncologist at the multi-disciplinary patient discussion
A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Brain.Pad (iCOOL 3)

Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling associated cerebrovascular disease. The narrow-time-frame is a major issue ("time is brain"). To provide immediate cooling without delay, easy to use, mobile and effective methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS Brain.Pad (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling system. A comparison of these two induction methods has never been done before. Neither was the effect of the EMCOOLS Brain.Pad on brain-temperature measured. For the first time iCOOL 3 compares feasibility, safety and efficacy of the two methods.


Eligibility Criteria:
Inclusion Criteria:

* Sedation
* Combined ICP-temperature-probe
* Indication to lower body temperature ≤ 1.5°C
* Age ≥ 18 years

Exclusion Criteria:

* Body weight \> 120 kg
* Severe renal insufficiency
* Acute pulmonary embolism
* Acute myocardial infarction
* High-grade heart valve stenosis or insufficiency
* Severe cardiac insufficiency (NYHA ≥ III)
* Threatening ventricular dysrhythmia
* Cardiac dysrhythmia with bradycardia (heart rate \< 45 /min, QTc \> 450 ms, sick sinus syndrome, AV-block II-III°).
* Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
* Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
* Skin lesions not allowing a secure application of the EMCOOLS Brain.Pad