cyrilzakka/clinical-trials huggingface dataset:
PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.

60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel)，group C (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）, lipid, blood pressure, course of disease, Wound healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, one way Analysis of Variance will be analyzed the significantion among 3 groups.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic foot according to The Wagner is 2-3 graded;

Exclusion Criteria:

* Type 1 diabetes mellitus,presence of autoimmune diabetes;
* Gestational diabetes;
* Patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease.
Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent before starting the study-related procedures and examinations
* Patients who have the history of gastric and/or duodenal ulcer.
* A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period.

Exclusion Criteria:

* Having gastric or duodenal ulcer (except for ulcer scar).
* History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.
Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212

This is an open-label safety extension study to assess the safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in participants with nontuberculous mycobacterial (NTM) lung infections due to Mycobacterium avium complex (MAC) who were refractory to therapy and failed to convert in Study INS-212 (NCT02344004).

Safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in participants with non-tuberculous mycobacterium (NTM) lung infections due to Mycobacterium avium complex (MAC) who are refractory to therapy and failed to convert in Study INS-212.

Participants participating in Study INS-212 who had not achieved the INS-212 protocol definition of culture conversion (3 consecutive monthly negative sputum cultures) or who had experienced a relapse or recurrence (agar positive or more than 2 consecutive broth positive results after culture conversion had occurred) by Month 6, as determined by their sputum culture results from Day 1 through Month 6 and confirmed at their scheduled Month 8 visit, were eligible to participate in Study INS-312. For participants who chose to participate in Study INS-312, the Month 8 visit of Study INS-212 became their end of treatment (EOT) visit; these participants were then asked to provide written informed consent for Study INS-312 and were enrolled directly into Study INS-312 after having met all eligibility criteria.

Participants in Study INS-212 had either received 590 mg LAI plus an MDR (LAI + MDR arm) or a multidrug regimen alone (MDR alone arm). All participants in this safety extension study were to continue the multidrug antimycobacterial regimen that they were receiving during Study INS-212 and will receive LAI 590 mg administered daily (QD) for up to 12 months. The participants will remain in the study for up to a total of 13 months (up to 12 months on-treatment plus 1 month off LAI treatment for safety follow up).

Eligibility Criteria:
Key Inclusion Criteria:

1. had successfully completed the Month 6 and End of Treatment visits in Study INS-212
2. had not achieved the INS-212 protocol definition of culture conversion by Month 6 in Study INS-212 OR had experienced a relapse or recurrence by Month 6 in Study INS-212.

Key Exclusion Criteria:

1. achieved culture conversion without relapse or recurrence in the Study INS-212 study by Month 6
UK Post-market Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

A post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS).

The study is a post-market, non-interventional, two-arm, long-term follow-up study of patients previously enrolled in the WATER Study (NCT02505919) - which was a prospective multi-centre randomized blinded study comparing Aquablation of the prostate with the AQUABEAM Robotic System with standard transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS). In POST WATER, up to 46 WATER Study subjects in the United Kingdom who were active on the study at 36 months will be invited to participate, across 3 clinical study sites in England and Wales. The study will consist of one follow-up time-point at 60 months (5 years) from the time of initial WATER Study treatment date.

Eligibility Criteria:
Inclusion Criteria:

1. Subject was randomized and received treatment in the WATER Study.
2. Subject is mentally capable and willing to sign a study-specific informed consent form
3. Subject is willing and able to comply with all study requirements

Exclusion Criteria:

Dementia or psychiatric condition that prevents the participant from completing required follow up 2. Participating in another investigational study that could affect responses to the study assessments
Cardiac Stunning After Electrical Cardioversion

The goal of this observational study is to evaluate cardiac stunning and electrocardiographic parameters through transthoracic echocardiography and 24 hours ECG conducted immediately following electrical cardioversion. The main question it aims to answer is:

Do echocardiographic and electrocardiographic parameters relating to cardiac stunning predict atrial fibrillation (AF) recurrence rates after electrical cardioversion?

Participants will undergo echocardiography and a 24-hour Holter monitoring immediately after electrical cardioversion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with atrial fibrillation
* Patients with persistent or symptomatic atrial fibrillation who are candidates for electrical cardioversion
* Patients eligible for anticoagulation therapy for thromboembolism prevention before and after the procedure
* Patients who can understand and provide written informed consent

Exclusion Criteria:

* Patients under 18 years of age or over 80 years of age
* Patients who do not consent to participate in the study
* Patients with severe coronary artery stenosis
* Patients with severe hepatic dysfunction
* Patients with severe renal dysfunction
* Patients with severe valvular heart disease
* Patients with a high risk of severe bleeding
* Patients with a history of atrial fibrillation-related catheter ablation or cardiac surgery
* Patients with an expected life expectancy of less than 1 year
* Potentially pregnant individuals
* Patients deemed unsuitable for the study by the investigator
Citrulline and Protein Metabolism in the Malnourished Elderly People

The aim of this study is to evaluate the effects of a supplementation of citrulline for three weeks in elderly malnourished and hospitalised subjects on muscle protein synthesis.

Malnutrition in the elderly causes an important public health problem because their response to re nutrition is highly decreased. Several experimental studies have shown that an amino acid named citrulline could avoid this, by restoring protein synthesis.

The treated group will receive each morning for three weeks a supplementation of 10 g of citrulline and the control group, non essential amino acids in iso-nitrogenous quantity to the 10g of citrulline.

During the three weeks of supplementation, clinical tolerance and physical exercise will be evaluated regularly.

On the 21st day, whole body protein synthesis rate in the post-absorptive state will be measured by the isotopic dilution of L-leucine (1-13C expressed in g / kg of lean mass / 24h) as well as other parameters of the protein turn-over in the post-absorptive and post-prandial state.

Eligibility Criteria:
Inclusion Criteria:

* elderly hospitalised in geriatric medicine or in following care and rehabilitation, moderately malnourished
* aged more than 70 years
* recent moderate undernutrition (30 g/l \< albuminemia \< 35 g/l and 18 \< BMI \< 22 or a score of the Mini Nutritional Assessment (MNA) \< 17 with albuminemia \> 30 g/l)
* ingesta of at least 20 kcal / kg / d and 0,8 g / kg / d of proteins

Exclusion Criteria:

* hospitalisation \< 21d
* C reactive protein (CRP) \> 50 mg / l
* end-stage cardiac insufficiency
* severe digestive incapacity
* renal insufficiency (Creatinine Clearance \< 30 ml / mn)
* respiratory failure
* MMS \< 18
* uncontrolled acute or chronic infectious pathology (HIV, tuberculosis)
* corticoids treatment
* evolutionary neoplasia
* palliative phase of severe pathology
* Mental Mini Score status of Folstein (MMS) \< 8
* parenteral nutrition
* active chronic hepatitis or cirrhosis
* participation in another trial
Study of Blood Flow Changes and Microemboli During Carotid Surgery

The purpose of this study is to determine the clinical and radiologic implications of the intraoperative microemboli during carotid revascularization.


Eligibility Criteria:
Inclusion Criteria:

* acoustic window for transcranial Doppler
* surgical criteria proposed by the NASCET and ACAS studies
* postoperative follow-up for at least six months
* patient consent

Exclusion Criteria:

* carotid restenosis
* combined surgery
* emergency surgery
Pharmacist Led Educational Intervention on QOL, Medication Adherence & Satisfaction on Patients With Type 1 DM

There was no previous study in Iraq to evaluate the efficacy of pharmacist-led educational intervention on patient glycemic control, quality of life and medication adherence among type 1 diabetic patients in Iraq.

Improving diabetes patients' information's about their disease control, the role of insulin and the right technique to administer it, how to deal with hyper- and hypoglycemia, about their diet and exercise.

It is important to conduct a study to evaluate the pharmacist's role in education and improving patients' quality of life.

Aim of the Study:

The aim of the current study is to evaluate the impact of pharmacist-led educational intervention on glycemic control, quality of life and medication adherence among type 1 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* - Patients age ≥ 16 years old who can speak and read the Arabic language.
* Had been diagnosed with T1DM for at least 6 months ago.
* Had uncontrolled hyperglycemia (glycosylated hemoglobin HbA1C ≥7% and/or fasting blood glucose \>130 mg/dl)
* Patients on the same regimen the last 3 months.
* patients (or parents) acceptance to participate in the study.

Exclusion Criteria:

* 1-Patient who have hearing, speech or cognitive deficits that would impair understanding of the questions and receiving the education.

  2- Patients with comorbid conditions that may interfere with the study such as asthma, thyroid disorders, adrenal gland disorders, celiac disease, or significant renal impairment.

  3-Patients who are taking corticosteroids. 4- Patients who required changing their insulin regimen, increasing the dose \>20% of the previous dose. (21) 5- Patients with conditions that affect red blood cell turnover (hemolytic and other anemias, G-6-PD deficiency, recent blood transfusion, use of drugs that stimulate erythropoiesis, end stage kidney disease and pregnancy.

  6-Patients unwilling to participate.
Tarceva With or Without Apatinib in the Advanced Lung Adenocarcinoma

Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.

Lung adenocarcinoma is the most common NSCLC,most patient were diagnosed to advanced stage.The first-line therapy include chemotherapy of targeted therapy .Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.We designed the study to find out whether the addition of apatinib to the Tarceva would enhance the efficacy of Tarceva.

Eligibility Criteria:
Inclusion Criteria:

* lung adenocarcinoma proved by histology;with mutant EGFR;ECOG PS 0-2;Clinical stage IIIb or IV;without other fatal disease;without hemorrhagic disease;normal liver,renal and bone marrow function,not pregnant.

Exclusion Criteria:

* ECOG PS 3-5;abnormal liver,renal and bone marrow function,pregnant;with severe diseases;wild type EGFR
Effects of Antioxidant Dentifrice on Gingivitis

The purpose of this study is to investigate the effect of a dentifrice containing L-ascorbic acid 2-phosphate magnesium salt on gingival inflammation, gingival bleeding and gingival redness.


Eligibility Criteria:
Inclusion Criteria:

* Age between ≥ 20 and \< 65 y with at least 16 permanent teeth.
* Gingival inflammation or mean baseline GI ≥ 0.5 without severe periodontal disease enough to require professional therapy.
* Written informed consent to participate.

Exclusion Criteria:

* Taking medications that could influence periodontal tissue health, such as antimicrobials and antihypertensives within 1 month before starting the trial.
* Use of orthodontic appliances.
* Pregnancy or planning to become pregnant during the trial period.
* Previous participation in any other clinical trial.
* Inability of patient to understand the study purpose and/or study protocols.
* Judged unsuitable by investigators for other reasons.
SWOG-S9635 Fluorouracil Plus Ethynyluracil in Advanced Colorectal Cancer Not Responded to Fluorouracil

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ethynyluracil may help fluorouracil kill more cancer cells by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of fluorouracil plus ethynyluracil in treating patients with advanced colorectal cancer that has not responded to fluorouracil.

OBJECTIVES: I. Assess the confirmed response rate to fluorouracil (5-FU) plus ethynyluracil (776C85) in patients with metastatic colorectal cancer that has been demonstrated to be resistant to 5-FU. II. Assess time to progression and survival in this group of patients. III. Assess the frequency and severity of toxicities associated with this treatment.

OUTLINE: Patients are stratified according to relapse while receiving adjuvant therapy (relapse within 12 months of completing adjuvant therapy vs relapse while receiving adjuvant therapy). Patients receive oral doses of ethynyluracil (776C85) and fluorouracil twice daily for 28 days followed by 1 week of rest. Treatment continues every 5 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months the first year, every 4 months the second year, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 35-75 patients will be accrued for this study.

Eligibility Criteria:
* Histologically or cytologically proven metastatic colorectal cancer
* Prior surgery required
* No prior treatment for metastatic disease
* Disease progression while on fluorouracil adjuvant therapy
* Bidimensionally measurable disease
* Age: Over 18
* Performance status: SWOG 0-2
* Hematopoietic: Platelet count at least 100,000/mm3, Absolute granulocyte count at least 1,500/mm3
* Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 3 times ULN (no greater than 5 times ULN if liver involvement)
* Renal: Creatinine clearance at least 50 mL/min
* Other: Must be able to swallow and retain oral medications No nutritional support by gastrostomy feeding tube or parenteral support No intractable vomiting or nausea
* Patients with history of prior malignancy must be currently disease free and off all therapy for that malignancy
* Not pregnant or nursing Fertile patients must use effective contraception
* Biologic therapy: No concurrent immunotherapy Chemotherapy; At least 3 weeks since prior chemotherapy and recovered; No concurrent flucytosine; No other concurrent chemotherapy
* Endocrine therapy: No concurrent hormonal therapy
* Radiotherapy: Prior adjuvant pelvic radiation or radiation to one area of recurrence allowed At least 4 weeks since prior radiotherapy and recovered Total area of bone marrow irradiation must not exceed 25% No concurrent radiotherapy
* Surgery: At least 2 weeks since prior surgery for colorectal cancer and recovered No prior resection of the stomach or small intestine
* Other: No other concurrent anticancer therapy
Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin

The proposed project is a prospective observational, single-center cohort study aimed to examine the progression of atherosclerotic alterations of the carotid arteries (IMT, plaque volume) during a follow-up of up to four years and to correlate the observed changes with traditional and novel biomarkers of atherosclerosis. A total of 600 subsequent patients with or established cardiovascular disease or at least one cardiovascular risk will be tested with a high-frequency ultrasound probe equipped with automated IMT measurements and 3D quantitative plaque volumetry. Plasma samples will be collected and tested for traditional and novel cardiovascular risk factors. Both ultrasound examinations and blood sampling will be repeated once per year to assess changes in these parameters over time depending on treatment modalities, which are left to the discretion of the treating physicians. The primary endpoint of the planned study will be the correlation between P-selectin and the progression of atherosclerosis as measured by plaque volume and IMT in the carotid and femoral arteries, respectively. Secondary endpoints will include the correlation of established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP, P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1 (ICAM-1), CETP TaqIb polymorphism) with the progression of atherosclerosis, the correlation of cardiovascular events with the progression of atherosclerosis and the additional predictive value of plaque volume and IMT compared to an established risk score (SCORE card).


Eligibility Criteria:
Inclusion Criteria:

* Patients (male and female) aged 30 to 85 years
* with at least one traditional cardiovascular risk factor (hypertension, smoking, diabetes, dyslipidemia, family history) or established coronary artery disease, cerebrovascular disease, or peripheral artery disease diagnosed by objective testing

Exclusion Criteria:

* lack of informed consent
* the impossibility of follow-up testing once per year for the following four years
Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety

The researchers aimed to investigate that preoperative anxiety scores of patients who are informed about the anesthesia before surgery with using State-Trait Anxiety Inventory and Amsterdam preoperative anxiety and information scale tests together.

Patients will be informed about the anesthesia procedure in service ad then It will be held anxiety questionnaires one day before surgery and operation rooms.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 80,
* both women and men,
* Patients will be operated

Exclusion Criteria:

* psychiatric and neurologic diseases,
* hearing and speech disorders,
* Psychiatric drug and chronic alcohol use
FRench-speAking Icu (Intensive Care Unit) Nutritional Survey

Assessment of nutritional practices in french intensive care units.

Assessment of nutritional practices in french intensive care units.

Eligibility Criteria:
Inclusion Criteria:

* Adults hospitalized patients in intensive care units for an expected period of stay\> 3 days

Exclusion Criteria:

* Refuse to participate in the Protocol
Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly).

Exclusion Criteria:

* Any significant health problem other than rheumatoid arthritis
* Any clinically significant laboratory abnormalities
* Any prior use of B cell-depleting therapy
Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age

In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.

Women \> 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups:

300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.

Patient can be eligible for several cycles in same protocol.

Eligibility Criteria:
Inclusion Criteria:

* Women \> 38 years with insufficient response to stimulation with 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol.
* Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
* Patient can be eligible for several cycles in same protocol.

Exclusion Criteria:

* Patients who already received doses \> 225 IU
* Patients older than 42 years
* Patients with basal FSH concentrations ≥ 15 mU/ml at day 3