cyrilzakka/clinical-trials huggingface dataset:
Effect of Hyperthyroidism and Its Treatment in Graves' Disease to Early Marker of Atherosclerosis

During July 2019 to August 2020, a single-blind clinical trial was done to 36 patients with Graves' disease. At the beginning of the study, subjects were accommodated into 2 groups, 17 into PTU groups and 19 into methimazole groups. There were 24 subjects who finished the study, 13 from PTU group and 11 from methimazole group. Blood serum was collected for HOMA-IR, LDL-R, NFĸB, sICAM-1, sVCAM-1 and sE-selectin examination. Meanwhile stiffness and thickness of carotid artery was measured using PWV and cIMT.

This study was a single blind, randomized clinical trial study, conducted in Cipto Mangunkusumo National Referral Hospital from January 2019 to August 2020. We included all adult patient aged 18-65 years with newly diagnosed Graves' disease or no prior anti-thyroid drugs medication for more than 1 month, who agreed to participate in the study. The exclusion criteria was pregnancy, history of coronary heart disease, known malignancy, current use of immunosuppressive medication, sepsis, thyroid crisis, or having allergic reaction to anti-thyroid drugs and other severe side effect. Ethical approval was obtained from the Research Ethics Committee of the Faculty of Medicine, Universitas Indonesia with approval number KET-784/UN.2.F1/ETIK/PPM.00.02/2019.

Study participant was observed every month for 3 months. Anti-thyroid drugs (PTU or methimazole) were given according to true simple randomization with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist. At baseline visit, first and third month follow up, blood serum was collected to analyse HOMA-IR, LDL-R, NFĸB, sICAM-1, sVCAM-1 and sE-selectin, meanwhile PWV and cIMT were measured using radiofrequency ultrasound examination of carotid arteries.

Categorical data was presented in frequency (%), while numerical data was presented using mean (SD) if normally distributed or median (IQR) if not normally distributed. Correlation Pearson test was performed for normal distributed data and Spearman test for not normal distributed data. To analyze the changes in parameter from baseline, first and third month, repeated ANOVA and General Linear Model test was performed. For not normally distributed data, transformation into normally distributed data was performed and the data was presented as geometric mean (CI 95%).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-65 years
* Newly diagnosed Graves' disease or no prior anti-thyroid drugs medication for more than 1 month
* Agreed to participate in the study

Exclusion Criteria:

* Pregnancy
* History of coronary heart disease
* Known malignancy
* Current use of immunosuppressive medication sepsis, thyroid crisis
* Having allergic reaction to anti-thyroid drugs and other severe side effect
The Impact of Perceptual Impairment on Social Participation in Stroke Patients

The perceptual change on stroke patients during the movement recovery and its relationship with social participation still remain unclear. The purposes of this study are: 1) to observe the progression of perception deficit and 2) to understand the relationships among perception deficit and other functional indicators.

A total of 90 stroke patients will be recruited. Each patient will receive three times evaluation, including perception tests, motor function test, daily living ability tests and social leisure participation questionnaires.

According to motor control theory, perception plays an important role in the execution of motion. Although the effect of rehabilitation for motor recovery on stroke patients has been well established, the perceptual change during the movement recovery and its relationship with social participation still remain unclear.

A total of 90 stroke patients will be recruited. Each patient will receive initial evaluation, first follow-up evaluation after four weeks and second follow-up evaluation after five months. The contents include basic clinical screen tests, perception tests, motor function test, daily living ability tests and social leisure participation questionnaires.

The purposes of this study are: 1) to observe the change of the during the experiment and clarify the progression of perception deficit and 2) to understand the relationships among perception deficit and the other functional indicators and determine the impact of perception deficit on activities and participation in stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* the age over 40 years old
* the time of onset more than 3 months
* no cognitive dysfunction
* cerebral stroke
* clinical diagnosis of a first or recurrent unilateral stroke

Exclusion Criteria:

* recurrent of the stroke or epilepsy during the intervention
* patients with the neurological or psychical history, for example, alcoholism, drug poisoning or bipolar disorder
* participate in the other interventional study in the same time
* refuse subscribed the informed consent
Effects of IASTM in the Treatment of Adhesive Capsulitis

This study aimed to determine the effects of IASTM in combination with exercise in frozen shoulder. Thirty-five patients with phase II frozen shoulder included in this single-blind, randomized study. Patients were divided into two groups. In the first group exercise programme (Group 1) and in the second group IASTM in combination with exercise programme (Group 2) were applied for twelve sessions (two days per week for six week). The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score and secondary outcomes were the visual analogue scale (VAS), the range of motion (ROM), The Constant score and Short- Form-36 (SF-36). Outcome measures were performed at baseline, after the 6th session and the 12th session.

Instrument Assisted Soft Tissue Mobilization (IASTM) is a popular treatment for myofascial restriction based on the logic developed by James Cyriax. IASTM is applied using specially designed instruments to provide a mobilizing effect on soft tissue (eg scar tissue, myofascial adhesion) to reduce pain, improve joint range of motion and function. IASTM can help improve fibroblast proliferation and promote normal collagen sequencing, however, there is no enough study evaluating the results of IASTM use in patients with frozen shoulders in the literature. This study aimed to determine the effects of IASTM in combination with exercise in the treatment of frozen shoulder. Therefore, it was hypothesized that exercise programme combined with IASTM are more effective in improving pain, range of motion (ROM), and functionality than are the exercise programme alone.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 30 and 65 years;
* Duration of complaint of more than three months
* ROM in external rotation, abduction and flexion less than 50% in comparison to uninvolved shoulder in one or more of three movement directions

Exclusion Criteria:

* Having cervical radiculopathy
* Thoracic outlet syndrome
* Rheumatological disorders
* Fractures or tumors of either upper extremity
* Corticosteroid injections in the affected shoulder within the previous 4 weeks
Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients

Systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the microcirculation (small blood vessels) and progressive fibrosis of the skin and internal organs. It is believed that vascular changes, expressed early by the Raynaud phenomenon, precede fibrosis and organic dysfunction. There is no available treatment that reverses the vascular damage caused by the disease to the moment, although there are several medications recommended for the relief of manifestations due to vascular injury. Acetylsalicylic acid (ASA) is one of the medications that can be used for the treatment of vascular injury present in systemic sclerosis, but still without a fully proven benefit. This study aims to evaluate the effectiveness of ASA on microcirculation alterations in patients with systemic sclerosis by performing three exams: periungual panoramic capillary microscopy, videocapillaroscopy and laser Doppler imaging. In addition, a blood sample will be collected for dosing the following vascular lesion markers: endothelin-1, von Willebrand factor, thromboxane, and platelet-derived, endothelial-derived and monocyte-derived microparticles.


Eligibility Criteria:
Inclusion Criteria:

* Fulfill Systemic sclerosis EULAR/American College of Rheumatology 2013 classification criteria;
* Pharmacological treatment with stable dosages for the last three months.

Exclusion Criteria:

* Pregnancy;
* Use of anticoagulants, NSAIDs or antiplatelets drugs;
* Diagnose of other autoimmune rheumatic diseases, coronary diseases, cerebrovascular diseases and severe peripheral artery diseases;
* Active infection;
* Contraindication to acetylsalicylic acid use.
CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.

This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to \<2 year). The study will enroll 20 evaluable patients as follows:
* Age 6-65 years.
* Left ventricular ejection fractions≥ 0.5 by echocardiography.
* Creatinine \< 1.6 mg/dL.
* Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal.
* Bilirubin \<2.0 mg/dL.
* Karnofsky performance status ≥ 60
* Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

* Pregnant or lactating women.
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Class III/IV cardiovascular disability according to the New York Heart Association Classification.
* HIV infection.
* Patients with history of seizure
* Active central nervous system leukemia
Effect of Myofascial Release on Scoliotic Females With Dysmenorrhea.

PURPOSE:

The purpose of this study is to determine the effect of myofascial release on spinal curvature, premenstrual symptoms, and quality of life in scoliotic females with dysmenorrhea

Adolescent idiopathic scoliosis (AIS) is a complex 3D structural disorder of the spine seen in children from 10 years old until skeletal maturity and confirmed by a Cobb angle of 10° or more and accompanied by vertebral rotation (Addai et al., 2020). It is the most common types of scoliosis and it is predominantly seen in girls at low curve magnitudes ( LeBauer et al., 2008).

A previous study reported the beneficial effect of myofascial release (MFR) on adults with idiopathic scoliosis (LeBauer et al., 2008). MFR showed a decrease in pain, improved posture, and advancement in quality of life, which may include physical, social, and pulmonary function (las Penas, 2005). HYPOTHESES:

There will be no effect of myofascial release on spinal curvatures, menstrual pain, and quality of life in young scoliotic females with primary dysmenorrhea .

Eligibility Criteria:
Inclusion Criteria:

1. All young females have primary dysmenorrhea and idiopathic scoliosis.
2. They are diagnosed with idiopathic scoliosis; their trunk rotation and rib hump measured by scoliometer will be more than 5.
3. They will experience pain in abdominal region, back and/or referred to the thigh during menstruation.
4. They experience a regular menstrual cycle
5. Their age will range from 18 to 25 years old.
6. Body mass index (BMI) will range between 18.5 to 24.9 kg/m2.

Exclusion Criteria:

1. Females who have any pelvic diseases or secondary dysmenorrhea.
2. Females who had received any spinal surgeries.
3. Females with irregular menstrual cycles.
4. History of gynecological interventions and having received manipulative treatment within the 2 months before the beginning of the study.
Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion

Primary Objective:

- To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI \[Cutaneous Lupus Erythematosus Disease Area and Severity Index\] activity score is ≥4) concomitant treatment with or without corticosteroid.

Secondary Objectives:

* To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of once daily regiment of HCQ versus placebo as the reference group in patients with CLE and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant treatment with or without corticosteroid.
* To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in patients with CLE and SLE with active skin manifestation concomitant treatment with or without corticosteroid.
* To investigate the safety and efficacy of 52 weeks long-term treatment of once daily regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with corticosteroid
* To investigate efficacy of once daily regimen of HCQ on systemic symptoms, musculoskeletal symptoms and immunological parameters in SLE patients.

Total 59 weeks (screening;4 weeks, treatment;52 weeks, Follow-up; 3 weeks)

Eligibility Criteria:
Inclusion criteria :

* Patients diagnosed as cutaneous lupus erythematosus (CLE)

Exclusion criteria:

* Patients receiving corticosteroid more than 15mg/day of the equivalent dose of prednisolone.
* Patients whose CLASI activity scores were less than 4 point at the initiation of Screening (Visit 1) and Day1 (Visit 2) (evaluated by a dermatology specialist).
* Patients whose fluctuations of CLASI activity scores were ≥20% between Visit 1 and Visit 2 (evaluated by a dermatology specialist). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine for Pain Management

The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.

The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing abdominoplasty or TRAM flap breast reconstruction

Exclusion Criteria:

* A medical condition that could interfere with study participation
* Body weight less than 50 kg
* Participating in another study involving an investigational medication
Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer

The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. This aims to elucidate the mechanism linking gut microbiome dysbiosis with radiotherapy sensitivity, thereby providing new combined treatment strategies to enhance the efficacy of radiotherapy.

The study is expected to enroll 100 patients with locally advanced rectal cancer, including 50 patients in the radiotherapy-sensitive group and 50 in the radiotherapy-resistant group. Each participant will provide stool and blood samples before treatment for subsequent metagenomic and metabolomic sequencing analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with late-stage rectal cancer (stages IIIB to IV), including those with postoperative recurrence re-staging or those intending to receive neoadjuvant treatment,
2. Pathological type is adenocarcinoma,
3. Have measurable lesions before radiotherapy or chemotherapy,
4. Age between 18 and 75 years,
5. A WHO Performance Status (PS) score of 0 to 2, capable of tolerating radiotherapy or chemotherapy,
6. An expected survival period of 6 months or more;
7. Able to understand the study and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe complications or other malignant diseases.
2. Known severe allergic reactions to components of radiotherapy or chemotherapy.
3. Significant cardiac, hepatic, renal, or other vital organ dysfunction.
4. Pregnant or breastfeeding women.
5. Patients unable to comply with study requirements or affected by psychiatric or psychological diseases.
6. Participation in other clinical trials recently that could affect the assessment of this study's results.
Lifestyle Intervention With an Interactive Video Game for Type 2 Diabetes Patients

Due to overweight and unhealthy lifestyle the number of patients with type 2 diabetes mellitus is increasing. Although in early phases the disease might be successfully treated by lifestyle change patients lack for motivation. Instead of increasing anti-diabetic medication a highly motivational system with low inhibition threshold is needed. Therefore, the investigators analyzed if regular use of the interactive videogame Wii Fit Plus over 12 weeks is able to improve HbA1c and weight in patients with type 2 diabetes.

Patients with type 2 diabetes were recruited via treating physicians or articles in magazines and newspapers. Participants were randomized in an intervention and a control group. The intervention group was sent the Wii, the balance board and the interactive video game Wii Fit Plus and were instructed to use these items 30 minutes each day during the next 12 weeks. The control group got the items 12 weeks later. At begin and after 12 weeks of intervention participants (and additionally for the control group: after 12 weeks of waiting phase) sent their health parameters, which had been measured in the context of the disease management program type 2 diabetes as well as questionnaires about physical activity and quality of life to the study center.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* diabetes duration \< 5 years
* age 50-75 years
* body mass index \> or equal to 27 kg/m2
* participating in the disease management programme type 2 diabetes mellitus
* physical and mental able for study participation

Exclusion Criteria:

* insulin or antidiabetic medication (exception: Metformin and DPP-IV-Inhibitors)
* regular physical activity
* depression
* tumors
* change of smoking status during the past 6 months or during the study
* participation in other studies during the past 6 months
2nd Study to Assess ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of inflammation and pain associated with cataract surgery.

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-305 (0.1% dexamethasone in DuraSite® 2) compared with Vehicle when dosed twice daily for 1 day prior to surgery, the day of surgery and 14 days post cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 17 years of age
* Are scheduled for uncomplicated unilateral cataract surgery
* Signature of the subject or parent(s) or legally authorized representative on the Informed Consent Form, and when appropriate the minor's assent in accordance with local regulations
* Are willing and able to follow all instructions and attend all study visits
* Are willing to avoid disallowed medication for the duration of the study
* If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study
* Male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility)
* Additional inclusion criteria also apply

Exclusion Criteria:

* Have known sensitivity or poor tolerance to any component of the study drugs
* Have any sign of iritis or scleritis in the study eye
* Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
* Have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to affect wound healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease)
* Have known blood dyscrasia or bone marrow suppression
* Have any active corneal pathology in the study eye
* Have had radial keratotomy, corneal transplant, or LASIK in the study eye within the last 2 years
* Be currently pregnant, nursing, or planning a pregnancy; or have a positive urine pregnancy test
* Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
* Have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
* Use of any medication the investigator feels may interfere with the study parameters
* Additional exclusion criteria also apply