cyrilzakka/clinical-trials huggingface dataset:
Chinese Spondyloarthritis Inception Cohort (CESPIC)

The Chinese Spondyloarthritis Inception cohort (CESPIC) was started 2000 as a prospective, longitudinal, multicentre, nationwide study in China on patients with early SpA including ankylosing spondylitis (AS, also known as radiographic axial spondyloarthritis) and non-radiographic axial SpA. The objectives of CESPIC are to learn about the course of SpA during the very early stage of the disease, to appropriately assess the outcome including radiographic progression of patients after several years of follow-up, to identify outcome predictors, to assess quality of life, function, and costs (direct and indirect costs). CESPIC has been recently expanded to recruit patients with other forms of SpA / conditions associated with SpA: reactive arthritis, acute anterior uveitis, Crohn's disease as well as with psoriasis / axial psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

Crohn's disease. Acute anterior uveitis. Psoriatic arthritis with axial involvement. Reactive arthritis.

Exclusion Criteria:

Infections, Malignancies, Major cardiovascular events, Lower intestinal perforations Other adverse events
Systemic Consolidation Therapy After Chemoradiation Therapy Following Operation for High Risk Early Stage Cervical Cancer

The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following radical hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.

Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (3 cycles per 3 weeks) for high risk early stage cervical cancer will elevate the therapeutic efficacy by removing the microscopic metastatic lesions which could not be identified by naked eye and diagnostic imaging tests.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent radical hysterectomy for cervical cancer stage IB-IIA
* Patients who had at least one of the following risk factors in pathologic results; lymph node metastasis, positive residual resection margin, parametrial invasion
* above 20 years
* GOG performance status 0-2
* Informed consent
* Platelet\>100K, Hb\> 10.0 g/dl, ANC\>1500/mm3, Cr \<1.25\*upper normal limit, bilirubin\<1.5mg/dl, AST \& ALT\<\*3 upper normal limit
* Expected life \> 6 months

Exclusion Criteria:

* Peripheral neurotoxicity \> NCI grade 2
* Sever infection
* Previous history with chemotherapy or radiation therapy
* Pleural effusion, pericardial effusion, and ascites which could cause dyspnea \> NCI grade 2
* Paraaortic lymph node metastasis
* Allergy with platinum
* Previous history of atrial or ventricular arrhythmia or congestive heart failure
* Uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease, myocardiac infarct within 6 months
* Severe disease such as acute or chronic renal failure and acute cerebral infarct, cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39 degrees centigrade
A Study of Pentasa in Patients With Ulcerative Colitis

Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from ulcerative colitis

Exclusion Criteria:

* Hypersensitivity to mesalazine, salicylates or to any excipient
* Severe damage to liver or renal functions
Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional Outcome, oncological outcome and toxicity in patients treated with neoadjuvant short term radiation or long-term chemoradiation followed by surgery

Observational study to evaluate longitudinal quality of life in patients treated with neoadjuvant short-course Irradiation or neoadjuvant Long-Course chemoradiation followed by surgery. QoL will be evaluated by standardized EORTC questionaires QLQ C30 and CR29. Acute and late toxicity will be assessed according to CTCAE 4.03. Oncological Outcome will be assessed with regard to local and distant Control, Patterns of recurrence, freedom from Treatment failure and Overall survival. Correlations of physicians- and Patient-assessed functional outcomes are planned.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven rectal Cancer without distant metastases
* indication for neoadjuvant Radiation or chemoradiation therapy according to multidiciplinary Evaluation
* age \>=18 years
* written informed consent
* ability to answer the standardized questionaires according to the treating physician

Exclusion Criteria:

* age \< 18 years
* prior systemic therapy with regard to rectal Cancer
* distant metastasis
* second malignancy
Cardio-metabolic Diseases in Immigrants and Ethnic Minorities: From Epidemiology to New Prevention Strategies

The aim of the study is to evaluate the efficacy of the co-created, culture-sensitive intervention to promote healthy diet, physical activity, and to improve compliance to therapeutic protocols in immigrants with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Immigrant status: Self-identification of being born in High migration pressure countries from parents born in High migration pressure countries
* Age ≥ 18 years
* Type 2 diabetes newly diagnosed or with HbA1c \> 8% in the last assessment within 24 months before the visit

Exclusion Criteria:

* Patients who will not provide the informed consent
* Patients with HbA1c ≤ 8% in the last assessment within 24 months before the visit
* Severe psychiatric disorders
* Pregnant women
* Critical illness
* Impaired cognitive or physical ability that could make the intervention not feasible, as judged by clinical staff members
VEGF In Systemic Circulation Of ROP-infants

The purpose of this study is to measure systemic levels of vascular endothelial growth factor (VEGF) and other proteins (e.g. IGF-1) in the systemic circulation of infants with retinopathy of prematurity (ROP) following ocular treatment with either intravitreal injections of anti-VEGF agents or retinal laser photocoagulation. The primary aim is to determine if serum VEGF levels change after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of retinopathy of prematurity requiring treatment

Exclusion Criteria:

* Anemia
A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients

The purpose of the study is to compare the efficacy and safety of nivolumab administered alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab administered alone or in combination with ipilimumab in patients with different lines of GBM therapy.

Allocation: Randomized (Cohorts 1, 2 and Part B of 1c/1d), Non-Randomized (Cohorts 1b, and Part A of 1c/1d)

Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically confirmed Grade IV malignant glioma
* Previous treatment with radiotherapy and temozolomide (Cohorts 1, 1b and 2 only)
* First recurrence of GBM (Cohorts 1, 1b and 2 only)
* First diagnosis of GBM with resectable disease (Cohorts 1c Part A only)
* First diagnosis of unmethylated MGMT GBM (Cohort 1d and Cohort 1c Part B only)
* Karnofsky performance score of 70 or higher

Exclusion Criteria:

* More than 1 recurrence of GBM (Cohorts 1, 1b and 2 only)
* Any recurrence of GBM (Cohorts 1c and 1d only)
* Presence of extracranial metastatic or leptomeningeal disease
* Active, known or suspected autoimmune disease
* Clinically significant cardiovascular disease
* Prior bevacizumab or other Vascular Endothelial Growth Factor (VEGF) or anti-angiogenic treatment (Cohort 2 only)
Pathogenic Mechanisms in C Diff Infection and Colitis

The purpose of this study is to learn more about infection by Clostridium difficile (also known as C. difficile). C. difficile is a common bacterium (a germ that may cause disease) that can live in the human gut. Some people have it without having any symptoms. In other people it can cause illness ranging from mild diarrhea to severe colitis (infection of the colon).

C. difficile makes toxins that damage the cells that line the colon. The study doctors want to find out how these toxins cause damage to the cells in the colon.

The purpose of this study is to examine pathogenic mechanisms of Clostridium difficile toxin-mediated intestinal injury and inflammation. Two primary mechanisms will be examined.

* To examine the hypothesis is that microRNA expression profiles are dysregulated by Clostridium difficile toxin exposure and that dysregulation of miRNA expression plays a role in the pathogenesis of C. difficile associated diseases.
* To examine the hypothesis is that the TLR9 receptor mediates key inflammatory events in response to Clostridium difficile toxin exposure.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 yrs and less than 75 years
* Undergoing a clinically indicated colonoscopy

Exclusion Criteria:

* Known, active or recurrent colonic disease including: Clostridium difficile infection, inflammatory bowel disease, microscopic colitis, colon resection for any reason, ischemic colitis, recurrent diverticulitis, colon cancer. Note: Diverticulosis without recurrent diverticulitis, colonic adenomatous or hyperplastic polyps or colonic arteriovenous malformations will not constitute an exclusion
* Diarrhea (an average of more than 3 bowel movements per day at baseline)
* Constipation (an average of fewer than 2 bowel movements per week at baseline).
* Use of systemic steroid or systemic immunosuppressive medication
* Severe renal impairment
* Relative contraindication to colon biopsy including a bleeding diathesis or anti-coagulant use. Note: nonsteroidal antiinflammatory drug or asprin use will not constitute a contra-indication.
Are Two Antidepressants a Good Initial Treatment for Depression?

Relatively drug naive patients will receive two antidepressant medications as initial treatment.

While antidepressant medications are often effective in relieving depressive symptoms, at least 60% of patients do not remit with the first agent tried. This pilot study will assess whether giving two standard medications simultaneously (i.e., Escitalopram and Bupropion) is both tolerated and improves response while decreasing drop outs. This is a replication of a previous study.

Eligibility Criteria:
Inclusion Criteria:

* Currently depressed (DSM-IV Major Depression, Dysthymia or Depression NOS)
* HAMD-D (21-Item) \> 9

Exclusion Criteria:

* Prior ineffective adequate trial on either study medication ($ 4 weeks on either escitalopram \>20 mg/d or bupropion \>300 mg/d; \>4 weeks on citalopram \>40 mg/d)
* History suggesting increased risk for Seizures (e.g., prior Seizure as an adult, diagnosed Seizure Disorder, taking medication known to increase seizure risk, history of significant head trauma, history of Bulimia or Anorexia)
* History of intolerance to either study medication unless patient and M.D. agree side effect is probably manageable
* Alcohol and/or drug abuse/dependence during past year
* Major medical problems that are not well controlled (e.g., untreated hypertension or diabetes)
* Bipolar I, Bipolar II
* History of Psychosis, or current Psychosis
* Currently taking antidepressants or mood stabilizers, which is judged unwise to discontinue (occasional sleep medication or benzodiazepine for Anxiety is allowed)
* Not currently depressed (whether considered due to current treatment or not)
* Active suicidal risk (history of suicide attempts will be evaluated on a case by case basis)
* Pregnant or breast-feeding
* Premenopausal women not using known effective birth control
Treatment of Epiretinal Membranes With Ranibizumab

The purpose of this study is to determine whether intraocular injection of ranibizumab decreases the retinal thickness in patients with epiretinal membranes and reduces associated symptoms.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic idiopathic epiretinal membrane

Exclusion Criteria:

* vision worse than 6/18 and fit for surgery
* prior vitreoretinal surgery or injection
* diabetes
* any past or current form of retinal vein occlusion or neovascularization
* age-related macular degeneration
* other condition causing significant limitation of visual potential
Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis

This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the CMC joint in the hand.

This is a prospective traditional feasibility study evaluating Cartiva® SCI for CMC for the treatment of first carpometacarpal joint osteoarthritis.The objectives of this clinical study are to evaluate the safety and effectiveness of Cartiva® SCI for CMC in terms of pain relief and improvement of joint function in the treatment of first CMC OA and to evaluate Cartiva® SCI for CMC device performance in order to establish the parameters for a pivotal trial. Follow up visits will occur at the following time points after the surgical procedure: 14 days, 42 days, 90 days, 180 days, 1 year and 2 year.

Data will be summarized using descriptive statistics. Continuous variables will be summarized using the number of observations, mean, standard deviation, median, and range as appropriate. Categorical values will be summarized using the number of observations and percentages as appropriate. Chi-square or Fisher exact tests will be used for comparisons of categorical data. Paired t-tests will used for the comparisons of continuous data. For statistical testing, an alpha of 0.05 is used as an acceptance standard and all testing are conducted as two tailed. Also, 95% confidence intervals for mean values or proportion values will be provided as appropriate.

Since this is a feasibility study and no formal hypothesis is to be tested, p-values will be reported without adjustment for multiple comparisons. All analyses will be conducted using SAS version 9.1 or later.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Osteoarthritis of the first carpometacarpal joint
* Presence of good bone stock without the need for bone graft
* Capable of completing self-administered questionnaires

Exclusion Criteria:

* \< 18 years of age
* Active bacterial infection of the hand
* Previous CMC implant and/or surgery to the affected joint to be treated that would prevent implantation and fixation of Cartiva® SCI for CMC
* Patient has osteoarthritis of the scaphotrapeziotrapezoidal (STT) joint in the hand to be treated
Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema

To assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with diabetic macular edema.

This is an open label study. Initially, 5 patients with DME will receive an ITV injection of VEGF Trap into the study eye. Additional patients may be enrolled at the same or additional dose levels. Patients will be observed for six weeks following the injection for assessments of ocular and systemic safety.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus (type 1 or type 2).
* Best corrected E-ETDRS visual acuity score of ≥ 24 letters (i.e., 20/320 or better) and ≤ 73 letters (i.e., 20/40 or worse).
* On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula.
* Retinal Thickness at the center point ≥ 250 microns.
* Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.

Exclusion Criteria:

* History of any vitreous hemorrhage within 4 weeks prior to Visit 2 (Day 1).
* Macular edema due to causes other than diabetic macular edema. An eye should be considered ineligible: (1) if the macular edema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggests that vitreoretinal interface disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema.
* An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition).
* An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.).
* Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase 1 study.
Development and Validation of the Periodontal Aesthetic Perception Scale in Patients With Periodontal Problems

Aesthetics for individuals become increasingly important, while the aesthetic effects of periodontal disease is an important issue that should be assessed by the patient's perception.

The results demonstrate that the periodontal aesthetic perception scale showed reliable and valid scores in healthy controls and periodontal patients.

The periodontal aesthetic perception scale may be an appropriate tool to assess periodontal esthetic in clinical and research settings.

Aim: The aim of this study is to develop and validate a periodontal aesthetic specific tool to assess aesthetic conditions perceived by patients with periodontal problems.

Methods: With patient interviews were identified a total of 22 statements that describe the non-aesthetic gingival appearance. These 22 items were reviewed by the dentists and then Periodontologists and the number of items in the survey was reduced to 7. Subsequently, three groups of patients were included in the study: Gingival recession (GR) group, gingival enlargement (GE) group and periodontal healthy (H) group. Consequently, the validity and reliability of the periodontal aesthetic perception scale (PAPS) were examined.

Results: According to the results of the Exploratory Factor Analysis (EFA), 1 item was removed from the scale. The final 6-item questionnaire was shown to have a two-domain structure. Cronbach's alpha for the whole scale was .766. The interclass correlation coefficients (ICCs) values were between 0.98 and 1.00, demonstrating excellent agreement. Overall, these findings indicated that the PAPS has good reliability.

Conclusion: This reliable, valid and short questionnaire specific to aesthetic conditions perceived by patients with periodontal problems may serve as a valued instrument in future clinical trials.

Eligibility Criteria:
Inclusion criteria for gingival recession group:

- The presence of gingival recession (Miller Class I, II, III, or IV) in maxillary and mandibular anterior teeth.

Inclusion criteria for gingival enlargement group:

-The presence of gingival enlargement (Grade 0, I, II, III, or IV) in maxillary and mandibular anterior teeth.

Exclusion Criteria for all groups:

* The presence of prosthesis, tooth loss or caries in the anterior teeth
* The precence of the psychological or systemic disease
Muscle Energy Technique and Mulligan's Mobilization in Breast Cancer Surgery Patients

A recent study aimed to examine the combined effect of Mulligan and muscle energy techniques on postural changes and shoulder kinematics among women who had undergone breast cancer surgery with axillary dissection.

90 female patients who had undergone breast cancer surgery with axillary dissection were recruited and randomly assigned to three groups. Group A received Mulligan and muscle energy technique, group B received Mulligan technique only, and group C received muscle energy technique. The study measured shoulder kinematics and postural changes using a digital inclinometer for range of motion, PAS/SAPO for cervical angle, and the horizontal alignment of acromions and quick DASH for upper extremity activities. Outcome measurements were taken at three different time points: baseline, six weeks post-intervention, and eight weeks after the intervention during a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* female
* between 50 and 65 years
* limited shoulder range of motion

Exclusion Criteria:

* having metastases
* lymphedema
* traumatic or musculoskeletal disorders affecting the arm
* not taking anticoagulants
* not having undergone bilateral breast cancer surgery
* not having a locoregional recurrence
* not having vascular disorders in the affected arm
Duration of Chest Tube Suction in Traumatic Pneumothorax

The purpose of this pilot study is to determine whether chest tube suction duration, 24 hours vs 48 hours, prior to water seal affects outcome and length of stay after placement for traumatic pneumothorax.


Eligibility Criteria:
Inclusion Criteria:

* Trauma service consult/patient
* Traumatic pneumothorax with chest tube placed within 0-24 hours of presentation and confirmation of adequate position
* Age \>18
* Blunt or penetrating mechanism
* Chest tubes sizes 14 to 32Fr
* Chest tubes placed by residents on the trauma surgery service supervised by attending trauma surgeons or placed by the attending surgeon themselves
* Presence of single chest tube in one or both pleural cavities (single unilateral or bilateral tubes)
* Subjects with decision making capacity (DMC) who are able to provide written consent. DMC will be determined by the consenting physician through a teach back mechanism. Subjects must demonstrate understanding of the situation, appreciation of the consequences of their decision, reasoning of their thought process, and be able to communicate their wishes.

Exclusion Criteria:

* Age \<18
* Pregnant patients
* Prisoners
* Mechanically ventilated in ICU for more than 24 hours while chest tube in place
* Chest tubes placed as part of, or present during, a thoracic operation
* History of surgery involving pleural cavity ipsilateral to chest tube
* Subjects with more than one chest tube on the ipsilateral side at any time prior to study chest tube removal
* Subjects with chylothorax or empyema
* Subjects with chest tubes that are withdrawn or removed unintentionally
* Subjects with known or suspected bronchial injury
* Subjects with bullous emphysema.
Silybin - Vitamin E- Phospholipids Complex Reduces Liver Fibrosis in Patients With Chronic Hepatitis C Treated With Peg-IFN-a and RBV

Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting mainly from the complications of cirrhosis and HCC.

The investigators' aim will be to evaluate the impact on of supplementation with a new pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis C treated with Pegylated-Interferon-α2b plus Ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* infection by HCV
* under treatment with pegylated interferon 2 alpha and ribavirin

Exclusion Criteria:

* other liver diseases
* cancer
* severe jaundice
* pulmonary and renal chronic diseases
* prostatic diseases
* autoimmune diseases
* diabetes mellitus