cyrilzakka/clinical-trials huggingface dataset:
Effect and Safety Study of Atorvastatin to Treat Chronic Subdural Hematoma

To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).

Study design:

Multi-center, randomized, double-blind, placebo parallel controlled

Subjects:

Patients with chronic subdural hematoma (CSDH)

Sample size:

200, including an Atorvastatin-treated group of 100 patients and a control group of 100 subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and \<90 years old, male or female;
2. CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
3. Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)\<Grade 3;
4. Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted;
5. Patients have never undergo surgery on the hematoma
6. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.

Exclusion Criteria:

1. Allergic to the statin or its ingredients
2. Cerebral herniation might occur at any time;
3. Hematoma leads to herniation and warrants surgical operation.
4. Hematoma caused by tumors, blood and other known comorbidities;
5. Abnormal liver function
6. Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study
7. Patients have been on oral Statin treatment for a long time.
8. Patients have been on oral Steroids treatment for a long time.
9. Participate in clinical trials in the past four weeks;
10. Pregnant or breastfeeding
11. Failure of completing the trial by poor compliance;
12. For any reason, the researchers believe that the case is not suitable for inclusion.
Application of Dietary Guidelines for the Brazilian Population by Teleconsultation in Obesity in Primary Care

Obesity is a chronic disease that is highly prevalent in Brazil. It is associated with diabetes and hypertension. Obesity may decrease quality of life. Communication tools, such as mobile devices and social media, are helping to control and prevent obesity. In this 2-arm randomized clinical trial, the investigators aim to evaluate the efficacy of the Dietary Guidelines for the Brazilian Population through 8 weekly video nutritional monitoring sessions with nutritionists. Both groups will receive guidance from reference professionals from primary health care (physician and nurse). Throughout the intervention program, both groups will be equally evaluated in order to verify at the end of the study effectiveness in weight loss and life quality improvement.

Obesity is a multifactorial disease of epidemic proportions worldwide. The use of telecommunication tools has been used in health and nutrition in different contexts, seeking to reduce the burden of non-communicable chronic diseases. Telehealth interventions are effective to increase quality of life and to improve the dietary food intake of participants; this kind of treatment seems feasable, cost-effective and has promising results to induce weight loss in obese individuals. This project will evaluate the impact of a remote nutritional intervention in short (8 weeks) and long term (24 and 48 weeks) on the weight fo obese individuals. The intervention will be based on the Dietary Guidelines for the Brazilian Population. It will focus on primary care patients and will have a multidisciplinary approach. It is an open-label pragmatic multicentre randomized controlled trial, with an 1:1 allocation: (1) intervention group (n = 289): Remote consultation with nutritionists based on the Dietary Guidelines for the Brazilian Population; (2) control group (n = 289): usual follow-up in Primary Health Care (PHC). The primary outcome will be weight change at 8 weeks. Additionally, the investigators will evaluate food consumption and quality of life at 8 and 24 weeks as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Female and male individuals, with BMI ≥30 kg/m²;
* Age over 18 years;
* Internet access by phone or tablet or computer and WhatsApp multi-platform application (Facebook Inc.);
* Weekly time availability (10-20 minutes).

Exclusion Criteria:

* Individuals who do not have access to the WhatsApp multi-platform application (Facebook Inc.).
Silent Cerebrovascular Lesion and Cognitive Decline Prevention by Cholesterol Lowering in Elderly AF Patients

In elderly patients with atrial fibrillation (AF) the presence of silent brain infarcts and neurocognitive deficit is high despite adequate treatment with oral anticoagulation. Atherosclerosis is considered to be a chronic inflammatory disease and thrombosis and inflammation are strongly correlated. Atrial fibrillation is linked with increased levels of inflammatory markers and intensive cholesterol lowering has proven to reduce inflammation. In a prospective double-blind randomized pilot-study we want to test the hypothesis, that addition of intensive cholesterol lowering treatment besides adequate oral anticoagulation will reduce cerebrovascular lesions and will be beneficial for neurocognitive status in elderly AF patients.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (\>68 and \<82 years) with atrial fibrillation and adequate oral anticoagulation therapy and cholesterol levels between 4,5 mmol/l and 7 mmol/l

Exclusion Criteria:

* Indication for cholesterol lowering treatment according to Dutch CBO-cholesterol guidelines (2004)
Bryostatin 1 Plus Paclitaxel in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 plus paclitaxel in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

OBJECTIVES: I. Determine the overall, partial, and complete response rates in patients with stage IIIB-IV or recurrent non-small cell lung cancer treated with bryostatin 1 and paclitaxel. II. Determine the overall survival and time to tumor progression in patients treated with this regimen. III. Determine the T cell subset analysis and serum levels of interleukin-6 and tumor necrosis factor alpha in these patients after receiving bryostatin 1 and correlate with clinical endpoints.

OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 2 years for survival.

PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage IIIB, IV or recurrent non-small cell lung cancer (NSCLC) Patients with stage IIIB disease must have pleural effusion Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT less than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Blood urea nitrogen less than 1.5 times normal Cardiovascular: No symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months No heart block worse than first degree, bundle branch block, or ventricular or supraventricular arrhythmia by 12 lead electrocardiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled concurrent illness including, but not limited to, ongoing or active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony-stimulating factors Chemotherapy: No prior chemotherapy for NSCLC Endocrine therapy: Not specified Radiotherapy: Greater than 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No concurrent antiretroviral therapy (HAART) in HIV positive patients
Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.

The performance of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer will be compared to that of standard "white light" visualization in a multicenter, open-label, randomized, controlled, parallel arms clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer.
* Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection.

Exclusion Criteria:

1. Other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
2. Primary appendiceal cancer;
3. Laboratory abnormalities defined as:

   * Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;
   * Total bilirubin above 2 times the ULN or;
   * Serum creatinine above 1.5 times the ULN or;
   * Absolute neutrophils counts below 1.5 x 109/L or;
   * Platelet count below 100 x 109/L or;
   * Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
4. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
5. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis

Background:Knee osteoarthritis is more common in patients with type-2 diabetes mellitus, however it is not known whether this effect is caused by diabetes itself or concominant abdominal obesity.

Objectives:The aim of this study is to determine whether type-2 diabetes itself, independent of abdominal obesity, is a risk factor for femoral cartilage, knee osteoarthritis and poor quality of life.

Design:A cross-sectional design. Settings:Training and research hospital in Turkey. Patients and Methods:Female patients was enrolled in this study and divided into two groups: according to presence or absence of diabetes. Later, both the patients with and without abdominal obesity was divided into two groups according the presence of diabetes.

Main Outcome measures:Clinical parameters were visual analog-scale, gait speed and short form-36. Knee radiographs were evaluated according to Kellgren Lawrance-Scale. And ultrasonography parameters were the measurements of distal femoral cartilage thickness.

Sample size:126


Eligibility Criteria:
Inclusion Criteria:

* being female
* aged between 40 and 70.

Exclusion Criteria:

* Patients with any concomitant chronic disease
* rheumatoid arthritis
* cardiac diseases (except type 2 diabetes mellitus and hypertension)
* knee surgery
* trauma
* bone mass or cancer
* inflammatory arthritis
* impaired cognitive status
* immobilized patients
* type 1 diabetes mellitus
Femoral Artery Hemostasis Without Manual Compression

FAST trial is a prospective, randomized, controlled, multicenter study in participants needing hemostasis after femoral arterial puncture. All eligible participants will be randomly assigned to either manual compression or novel method without manual compression after femoral arterial puncture. This study is aimed to investigate if novel method without manual compression is noninferior to manual compression regarding access site complications.

The common femoral artery is the most frequently used access site in cardiovascular interventional therapy. Closure of the arteriotomy site is usually achieved by manual compression after femoral arterial puncture. There are many disadvantages of this standard method for hemostasis which is still related to high rate of access-site complications such as pseudoaneurysm, major bleeding, ipsilateral groin hematomas and so on. Several vascular closure devices are emerging as novel means for improving patient comfort and accelerating ambulation after invasive cardiovascular procedures performed via femoral arterial access, however, the cost performance and other aspects limit its wide application especially in developing countries.

Actually the investigators found a novel method for femoral artery hemostasis without manual compression. After sheath removal, four or five sterile gauzes were overlaid layer by layer and then bandaged without the procedure of manual compression.

FAST trial is aimed to investigate if the safety and efficacy of this novel method without manual compression is noninferior to the standard manual compression.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing femoral access cardiovascular interventional therapy
* Patient must be competent for providing informed written consent

Exclusion Criteria:

* Peripheral arterial occlusive disease
* Prior peripheral artery surgery
* Critical limb ischemic
* Femoral arterial intubation failure
* Uncontrolled hypertension \>220/110 mmHg
* Coagulopathy (bleeding disorder)
* Local infection
* Pregnancy
Direct Evaluation of Postoperative Myocardial Injury Using Coronary Computed Tomography Angiography After Non-Cardiac Surgery

This is a prospective study in patients who undergo routine postoperative troponin assessment after major (semi-)elective noncardiac surgery. Two groups are created based on postoperative troponin levels: Postoperative myocardial injury (PMI) group with troponin I levels ≥ 60 ng/L and a control group with troponin levels \< 60ng/L. The primary aim of this study is to assess the association of PMI with pulmonary embolism. Additionally, the association between PMI and obstructive CAD will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 60 years old
* Major noncardiac surgery, defined as non-cardiac surgical procedures requiring hospital admittance \> 24 hours
* Semi-elective surgery, defined as surgery that that has been preceded by a preoperative evaluation.
* ≥ 1 troponin assessment in the first 3 postoperative days as a part of the routine 'postoperative troponin assessment' protocol.
* For patients who undergo surgery more than once, the first surgery will be included in the analysis. Reoperations will not be included.

Exclusion Criteria:

* Typical anginal complaints
* Acute ST-elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB) on ECG
* Patients unable to fully comply to study needs (e.g. incompetent patients or patients unable to communicate in Dutch or English)
* Severe claustrophobia.
* Patients who have a life expectancy of less than three months.
* Patients who are too ill to undergo a CCTA or Ventilation/Perfusion (V/Q) scan.
Systemic Metabolic Contribution From Continuous Renal Replacement Therapy (CRRT)

The purpose of this observational study is to measure the number of calories delivered from fluids used in continuous renal replacement therapy (CRRT). We are doing this research study because the fluids used in this treatment may deliver an important number of calories. In the future this could help better estimate how much nutrition patients in the Critical Care Unit should get every day from other sources like tube feeding or nutrition through a person's veins.

The goal of this study is to quantify the specific metabolic contribution of standard continuous renal replacement protocols (including citrate anticoagulation) in the intensive care unit patient population at Mayo Clinic in Rochester, Minnesota utilizing a prospective, observational study. This data will allow practitioners to better tailor caloric provision with nutrition support programs, minimizing the risk of overfeeding in this complex critical care patient population.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Patients in an intensive care unit anticipated to receive greater than or equal to 24 hours of continuous venovenous hemofiltration.
* Receiving regional citrate anticoagulation with ACD-A solution.

Exclusion Criteria:

* Vulnerable adults
* Pregnant
* BMI \> 40
* Patient on extracorporeal membrane oxygenation therapy
* Reversal of port connections on the dialysis catheter and dialysis circuit lines
A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer

This is a Phase II, randomised, double-blind, placebo-controlled study. Subjects with histologically-confirmed oestrogen receptor negative (ER-), progesterone receptor negative (PgR-) primary breast cancer breast cancer will be randomly assigned in a 2:1 ratio to receive ZD1839 250 mg once daily or matching placebo for a total period of 5 weeks. Surgical intervention will take place after 4 weeks (on Day 29) and treatment will continue for 1 week after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed ER- and PgR- primary breast cancer
* Stage T .5 cm, N0-1, M0
* No previous treatment for breast cancer

Exclusion Criteria:

* ALT or AST greater than 2.5 times the ULRR
* Metastatic disease
Angiogenic Biomarkers in Juvenile Idiopathic Arthritis

The aim of the study is to determine whether serum inflammatory angiogenic markers (eg, semaphorins, CCN1) predict severity of juvenile idiopathic arthritis defined by structural progression and/or therapeutic escalation.

Juvenile idiopathic arthritis (JIA) is a heterogeneous group of chronic inflammatory rheumatic diseases beginning before the age of 16. The most common pediatric rheumatologic disease. JIA is the most common pediatric rheumatologic disease. Apart from clinical features and the biological inflammatory syndrome, no predictive parameter for the severity of JIA, especially polyarticular JIA, has been identified. The team has been interested in the prognosis of RA for many years. Thus, the investigators have conducted various studies in search of biological parameters associated with the joint prognosis of RA patients, which allowed the investigator to discover the interest of angiogenic and inflammatory biomarkers such as semaphorins and CCN1 protein. This has been demonstrated in vitro but also in vivo from sera of RA patients. These markers are associated with activity and structural damage in RA.

The project aims to study the interest of these same angiogenic biomarkers in the serum of JIA patients in order to establish whether, as in RA, they are also associated with disease severity.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 16 years-old
* Diagnosis of Juvenile Idiopathic Arthritis with specialized follow up in Rheumatology at Cochin Hospital
* No-opposition to the research
* Patient with health insurance
* Mastery of the French language

Exclusion Criteria:

* Patient under curatorship or guardianship
* Patient receiving french state medical aid
Preoperative Serum FGF19 in the Prognosis of Biliary Atresia

To investigate the role of preoperative serum FGF19 level in the prognosis of biliary atresia.

Kasai portoenterostomy is currently one of the main treatment methods for biliary atresia, but about 30% of children still require liver transplantation even after receiving the surgery. Accurate prognosis will help select the most suitable treatment method for children, but there is currently a lack of effective preoperative predictive indicators. Serum FGF19 has recently been considered a possible preoperative predictive indicator for biliary atresia, but its predictive value has not been confirmed in a large sample and in Asian population, thus the investigators try to further explore the prognostic value of serum FGF19 in children with biliary atresia based on a large sample.

Eligibility Criteria:
Inclusion Criteria:

* Samples diagnosed as biliary atresia in Children's Hospital of Fudan University
* Samples with one-year follow-up records after surgery
* Samples with a record of serum total bilirubin levels three months after surgery
* Samples with preoperative serum left（volume \> 500ul)

Exclusion Criteria:

* None
Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia

The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
* pain score at least 4 on 11-point numerical rating scale (0-10)
* stable doses of analgesic medications for at least 1 month"

Exclusion Criteria:

* diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
* pain score at least 4 on 11-point numerical rating scale (0-10)
* stable doses of analgesic medications for at least 1 month"