cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis

The investigators select 40 postmenopausal women suffering from RA with 2.5\<DAS28\<5.5 referring to rheumatology clinics of Mashhad university of medical sciences and randomly divide them into intervention group and placebo group. Evista tab 60mg/day and placebo are administered double blind. In the beginning, total bone mineral density (BMD) assessment is carried out from all patients and then Alendronate is discontinued in 2 groups. In first 3 months, in addition to Evista and placebo, MTX tab 2.5mg is given to patients and they are allowed to consume NSAID with accurate record of its dosage. Patients visit rheumatologist monthly in these 3 months and NSAID should be discontinued 48 hours before every visit. At the end of month 3, disease activity and probable complications are evaluated and compared in 2 groups. Classic regimen should be started for every patient who doesn't enter remission phase in first 3 months.

In 4th month, DMARD regimen is administered and then patients are visited every 2 months. Clinical findings are collected in month 0, 1, 2, 3, 6, 8, 10, 12. After 12 months, another total BMD test is carried out and then data are analyzed including changes in BMD, DAS28, EULAR response criteria and HAQ-DI score.


Eligibility Criteria:
Inclusion Criteria:

* Patients are postmenopausal women.
* Patients should fit at least 4 criteria of ACR-1987 criteria for rheumatoid arthritis.
* Patients should be in range of 2.5 \<DAS28-ESR \<5.5

Exclusion Criteria:

* Patients with history of thrombotic events
* Patients suffering from another rheumatic diseases simultaneously
* Patients with sever symptoms of menopause
* Patients with known psychological diseases
Cirrhosis Medical Home

To address the health care system's lack of care coordination, the Institute of Medicine and Centers for Medicare and Medicaid Services recommend the development of collaborative care models (CCM) in a wide range of clinical settings. CCMs are intended to provide coordinated, personalized care pragmatically using care coordinators. CCMs have successfully improved care in multiple patient populations, ranging from frail older adults to depression. In contrast, for patients with cirrhosis, there is a paucity of data to support the benefit of CCM in this medically complex and vulnerable population. At Indiana University, researchers have over 20 years of experience in developing, testing, and implementing CCMs successfully for patients living with dementia or depression. Building on these successes, we have customized the CCM to best meet the unique and complex biopsychosocial needs of patients with cirrhosis: the Cirrhosis Medical Home.

In the Cirrhosis Medical Home, a care coordinator, supported by an interdisciplinary clinical team, will deliver a personalized intervention guided by a set of innovative tools: (i) patient-centered care protocols, (ii) a mobile office, (iii) care coordination support software, and (iv) dynamic feedback measures.

The overall goal is to improve quality of life of patients discharged from the hospital with cirrhosis and to reduce acute health care utilization for patients with cirrhosis.

Additionally, up to 40 caregivers will be enrolled in the trial.

Eligibility Criteria:
Inclusion Criteria for patients:

* Age ≥18 years
* Cirrhosis based on:

  * biopsy
  * characteristic clinical, laboratory, and imaging findings
* Decompensated cirrhosis as denoted by either:

  * active ascites requiring paracentesis during hospitalization or
  * active overt hepatic encephalopathy requiring lactulose during hospitalization
* Poor quality of life as defined by:

  * SF-36 Physical and/or Mental Component Summary scale \<40 (1SD below the mean of healthy subjects)
* Discharged to home, skilled nursing facility, sub-acute rehabilitation care, or long-term acute care
* Able to be consented, either in person or through legally authorized representative
* Access to a telephone

Inclusion criteria for caregivers:

* Age ≥18 years
* Identified caregiver of patient
* Able to be consented, either in person or through legally authorized representative
* Access to a telephone

Exclusion Criteria for patients:

* Solid organ transplant of any organ
* Life expectancy of less than 6 months
* Anticipated liver transplant within 6 months
* History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, or vascular dementia
* Unable to complete study questionnaire due to hearing loss
* Legally blind
* Pregnant or nursing
* Incarcerated
* Concurrent enrollment in a related interventional research study

Exclusion criteria for caregivers:

* Impaired cognitive function
* Unable to complete study questionnaire due to hearing loss
* Legally blind
* Incarcerated
Influence of Dalcroze Eurhythmics on Pains in Older Women

In this study, we attempted to answer the question of whether participation in a 12-week rhythmic exercise program using the Dalcroze method affects the level of intensity of pain experienced by women over the age of 65. The level of pain was determined on a numerical scale from 1 to 10 and involved headaches, back pain and leg pain.

Background. Body pain of various degrees and types can complicate human life. Regular physical exercise and good mental health can both have protective effects on the body and its physical health. Physical exercises may also, in some aspects, be particularly important for older women who experience varying degrees of headache, back pain, and/or leg pain chronically. The purpose of the study was to analyze the effects of the Dalcroze Eurhythmic Method on headaches, backaches, and leg pains among older women.

Methods. Sixty-two blinded participants with pain were randomized into two groups. Women (65 to 82 years old) who had reported the occurrence of headaches, backaches, or leg pains during the 3 months prior to the beginning of the randomized controlled trial study were identified. The participants in the pre-test and post-test used the 0-10 Numeric Pain Rating Scale to quantify their pain. Women from the experimental group participated for 3 months in the physical exercise program based on the Dalcroze Eurhythmics Method.

Eligibility Criteria:
Inclusion Criteria:

* female, 65+ years old, physical and mental state that allows them to participate in the exercise program (ability to follow the instructions), community dwelling

Exclusion Criteria:

* taking analgesics indelibly, Parkinson's or Alzheimer's disease, using social assistance or nursing care.
Evaluation of a Novel Mobile Phone Application ( OptiBP) for Blood Pressure Monitoring

Evaluation of a novel smartphone application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) and heart rate based on collected optical signals on patient's finger treated in the emergency department against the reference method (the oscillometric brachial cuff )

The purpose of the study is to compare the blood pressure values measured by a novel smartphone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the oscillometric brachial cuff).

All patients admitted to the emergency department at Erasme Hospital Brussels, Belgium during 5 consecutive weeks will be recruited and their pressure will be measured with both mesurement methods. (novel smartphone application versus upper arm cuff oscillometry).

The OptiBP Application is a mobile application installed on a smartphone which is a non-invasive data-logger intended to acquire physiological data from patients. By applying the patient's finger on a smartphone's camera, a movie is generated and transformed into values of diastolic, mean and systolic blood pressure (+ heart rate), as well as patient's heart rate.

After having compared that the blood pressure in both arms are similar ( maximum of 10 mmHg of blood pressure difference between both arms), three measures will be taken (spaced by one minute) with both methods after a period of 3 minutes of rest (supine position).

The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (the oscillometric brachial cuff).

Then, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the novel mobile application.

The goal is therefore to compare blood pressure values as obtained by the analysis of the data recorded by the OptiBP Mobile Application, against simultaneous measurements provided by the oscillometric brachial cuff

Eligibility Criteria:
Inclusion Criteria:

* Patients (Men or women) older than 18 years old admitted to the emergency department and in relatively good conditions to be able to participate in the study.
* Informed Consent as documented by signature

Exclusion Criteria:

* Minor patients
* Patients unable to participate due to the illness.
* Patients that cannot sign informed consent
* Patients extremely painful at the arrival (not possible for him to stay in a supine position).
* Blood pressure difference between the two arms \>10mmHg
* Unstable patients requiring an urgent management
The Effect of Different Intraradicular Cryotherapy on Post-operative Pain and the Level of Substance P

The aim of this clinical trial is to evaluate the effect of using intra-radicular cryotherapy technique in the form of irrigation with cold sodium hypochlorite

The main questions to answer are:

1. Does Postoperative pain is different between the three groups?
2. Does level of substance P different between the three groups ?

* The patients will be randomly divided into three groups Group 1: control group (n=25) Regular root canal treatment with regular irrigant will be used. Group 2: (n=25) Intraradicular cryotherapy will be performed where :
* Normal root canal treatment will be done with irrigation using sodium hypochlorite cooled to 2°C continuously during our mechanical instrumentation. Then a final flush will be done with cold saline 2°C for 5 minutes. Group 3: (n=25) Normal root canal treatment will be done with irrigation using sodium hypochlorite at room temperature during our mechanical instrumentation. Then a final flush will be done with cold saline 2°C for 5 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients that will be diagnosed with symptomatic apical periodontitis
* Single-rooted premolars (radiographically and clinically assessed)
* Medically free patients.
* Teeth with mature apex

Exclusion Criteria:

* Patients with other pulpal diagnosis.
* Medically compromised patients.
* Pregnant females.
* Patients taking analgesics or anti-inflammatory drugs.
A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients

This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma (SGC) that have progressed after one or two prior systemic treatments.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced/metastatic scirrhous gastric carcinoma
* Evidence of diffusely infiltrating gastric lesions and/or at least one measurable extra-gastric lesion
* Patients previously treated with one or two systemic lines
* Documented radiological confirmation of disease progression
* ECOG performance status of 0 to 2
* Male and female patients aged 20 years or greater
* Adequate liver, renal, and hematologic function

Exclusion Criteria:

* Patients who received prior treatment with an FGFR inhibitor
* Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
* Patients with another primary malignancy within 3 years prior to starting study treatment

Other protocol-defined inclusion/exclusion criteria may apply
Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.

The investigators will employ a double-blinded randomized placebo-controlled trial to determine the effects of 12 weeks of SGLT2 inhibition with empagliflozin (10mg daily), or matching placebo, on arterial stiffness in Veterans with obesity. Fifty Veterans with obesity (BMI 30-45kg/m2), 30-60 years of age, will be recruited from the Harry S. Truman Memorial VA Hospital in Columbia, Missouri.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 30-45 kg/m2
* 30-60 years of age at randomization
* Evidence of arterial stiffening (defined as Carotid femoral PWV\>age-predicted) at screening visit (PMID: 20530030)

Exclusion Criteria:

* Unable to provide consent
* Diabetes mellitus
* Uncontrolled hypertension (\>180/90mmHg) or systolic \<100mmHg at screening visit
* Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
* Diagnosis of chronic kidney disease
* Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
* Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
* Use of GLP-1 analogs or SGLT2 inhibitors
* Use of hormone replacement therapy
* Use of pharmacological therapy for weight loss
* Body weight changes \>10% within the past 6 months
* History of hypersensitivity to nitrates
* History of ketoacidosis
* History of recurrent UTIs or mycotic genital infections
* Use of anticoagulants
* Change in anti-hypertensive medication regimen (if in use) during the last 90 days
* Pregnancy
Comparison of Kinesiotaping and Pressure Garment on Women With Upper Extremity Lymphedema Following Mastectomy

Breast cancer is a standout amongst the most widely recognized cancer among women. It is observed that upper extremity lymphedema is one of the most dangerous and prevalent complication following breast cancer surgery which prompts functional impairment, psychological disaster and social problems

This study aimed to compare the effects of Kinesio taping and the pressure garment application on secondary lymphedema of the upper extremity and quality of life following mastectomy after breast cancer.

Material and Methods: In this experimental study with pre and post-tests, 66 women with lymphedema following mastectomy were randomly allocated to Kinesio taping (KT) group (n=33) and pressure garment (PG) group (n=33). The KT group received Kinesio taping application, while the PG group received pressure garment (40-60 mmHg) for at least 15-18 hours per day through the study. All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life at baseline and end of intervention.

66 women with unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side. The participants were randomly assigned to 2 groups. Kinesio taping group included 33 patients receiving Kinesio taping (KT) and pressure garment (PG) included 33 patients.

The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.

All patients were evaluated to record the changes of the limb circumference, Shoulder Pain and Disability Index (SPADI), hand grip strength and quality of life

Eligibility Criteria:
Inclusion Criteria:

* unilateral breast cancer related to lymphedema (stage II and III) for at least for 6 months were invited to participate in the study. Lymphoma was more than 2 cm in arm circumference or less than 8 cm in comparison with the other side.

Exclusion Criteria:

* The exclusion criteria were any active disease which leads to swelling, medications, especially diuretics, allergy, infection, pregnancy, heart and kidney diseases, bilateral lymphedema and cellulitis.
Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes.

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* HbA1c less than or equal to 11%
* Body mass index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria:

* Total daily insulin dosage more than 100 IU or U/day.
* Current smoking or smoking within the last 6 months
* Impaired hepatic or renal function
* Cardiac problems
* Uncontrolled hypertension
* Current proliferative retinopathy or maculopathy requiring acute treatment
Effectiveness of a Digital Health Application for Psoriasis

This clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of a self-guided online program for patients with psoriasis.

Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive 12-month-access to an online program for psoriasis in addition to treatment as usual (TAU, n = 174), or to a control group, in which they will receive only TAU (n = 174). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e.g. dermatologist, psychiatrist), which may include topical therapy, phototherapy, pharmacotherapy, psychosocial therapy, etc.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Presence of psoriasis vulgaris or psoriatic arthritis
* Submission of a specialist medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses: Psoriasis vulgaris (L 40.0, L 40.7), Psoriatic arthritis (L40.5, M07.x)
* Impaired health-related quality of life (DLQI \> 10)
* Consent to participate
* Sufficient understanding of the German language

Exclusion Criteria:

* Presence of another subtype of psoriasis (pustular psoriasis, guttate psoriasis, inverse psoriasis, erythrodermic psoriasis, or drug-induced psoriasis) or psoriatic arthritis without skin involvement
* Presence of malignancies
* Presence of other chronic diseases with strong negative influence on quality of life
* Currently undergoing psychiatric treatment / current presence of a severe psychiatric diagnosis
* Insufficient language and/or IT skills
Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification

The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.

Postsurgical inflammation is an inevitable condition after cataract surgery. The use of non-steroidal anti-inflammatory drugs is a safe option for treating ocular inflammation.

This is a phase II randomized double-blind clinical trial. The aim is to compare and to evaluate efficacy and safety of two ophthalmic solutions in patients post phacoemulsification. Patients will be randomized to receive either PRO-155 or Nevanac for 60 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years who require cataract surgery
* Both genders
* Provide informed consent
* Normal Laboratory results

Exclusion Criteria:

* Patients with visual acuity of 20/40 or less in the contralateral eye of the surgery
* Patients with any trans-surgical complication
* Patients with a cataract \>NC4, C4 or P4 classified with the system LOCS
* Patients with any active corneal pathology
* Patients under any steroidal treatment (topic, systemic or inhaled)14 days prior surgery or NSAIDs 7 days before the surgery (except low-dose aspirin)
* Patients with IOP \<5 or \>21 mmHg
* Patients that have ocular pain, cellularity or flare at the moment of selection
* Patients with ocular exfoliation, trauma or any inflammatory disease
* Patients with diabetic retinopathy that need treatment or uncontrolled diabetes mellitus
* Patients who are planning cataract surgery of the contralateral eye 14 days after surgery of the study eye
* Patients with history of hypersensitivity or contraindication for any drug used in the study
* Patients under anticoagulant treatment
* Contact lens users
* Pregnant patients, at risk of pregnancy or breastfeeding
* Patients without birth control treatment
* Patients with any active toxicomania (alcoholism, cigarette, cannabis or others)
* Patients who had participated in any clinical trial in the last 90 days
* Legal or mentally disabled patients who could not give informed consent
* Patients who cannot comply with all study requirements