cyrilzakka/clinical-trials huggingface dataset:
Effect of Emdogain® on Soft Tissue Wound Healing

The goal of this randomized, controlled, single-center study is to compare the effects of Emdogain®, a regenerative biomaterial, on post-operative pain, wound healing and inflammation of treated sites after surgical crown lengthening. The main question it aims to answer is:

Does the use of Emdogain® in conjunction with crown lengthening surgery improve post-operative soft-tissue healing, decrease inflammation and reduce patient perception of pain compared to crown lengthening without addition of Emdogain®? The treatment group will receive Emdogain® during surgery, and the control group will undergo standard crown lengthening without Emdogain®.

This randomized, controlled, single-center study intends to investigate the effects of Emdogain® on wound healing, postoperative pain and inflammation of treated sites after crown lengthening procedures on a single site, and to compare the results of this therapy with those of standard crown lengthening treatment on a single site. We have hypothesized that the use of Emdogain® in conjunction with crown lengthening surgery improves post-operative soft-tissue healing, decreases inflammation and reduces patient perception of pain compared to crown lengthening without addition of Emdogain®. Patients were recruited from the Graduate Periodontology clinic at the Faculty of Dentistry, University of Toronto. These patients were referred to the department by dental students in the faculty as well as dentists and dental specialists within the community for crown lengthening surgery, and were subsequently screened for eligibility to participate in the study. After confirmation of eligibility and completion of recruitment, patients were randomized, using a computer-generated randomization table, into the following groups:

* Treatment/experimental group: patients undergoing surgical crown lengthening of a single site with application of PrefGel® + Emdogain®
* Control group: patients undergoing surgical crown lengthening of a single site with application of PrefGel® only

Eligibility Criteria:
Inclusion Criteria:

Patients who:

* Were capable and willing to provide consent and complete treatment as well as follow-up appointments
* Were over the age of 18 years old
* Required surgical crown lengthening for functional reasons as outlined in background
* Had no contraindications to surgery (these include periodontal contraindications to crown lengthening such as poor crown-to-root ratio, furcation exposure or esthetic concerns)

Exclusion Criteria:

* Patients who were unable to provide informed consent
* Pregnant women
* Women receiving estrogen therapy
* Patients who had received systemic antibiotics within the past 6 months
* Patients with severe systemic disease (ASA 3+) including: poorly controlled diabetes, blood dyscrasias, liver disease, immunosuppressive disorders, malignancy or who have had previous radiotherapy
* Patients with untreated, active periodontal disease
A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

This study is intended to provide access to Romidepsin for participants who received Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and for participants whom the investigator feels may benefit from continuing treatment with Romidepsin.

Participants must have previously participated in a Romidepsin study sponsored by Gloucester Pharmaceuticals or Celgene Corporation.

Eligibility Criteria:
Inclusion Criteria

1. Previously participated in and fulfilled the inclusion and exclusion criteria in one of the romidepsin clinical trials: ROMI-ADVM-001 (NCT01324310), ROMI-ADVM-002 (NCT01324323). Additional studies added at the discretion of the medical monitor of the study
2. Physician believes continued romidepsin treatment is of benefit to participant.
3. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
4. Able to adhere to the study visit schedule and other protocol requirements.
5. Negative urine or serum pregnancy test for females of child bearing potential; and
6. All females of child bearing potential must use an effective method of contraception (an intrauterine contraceptive device \[IUCD\] or double contraceptive method using condoms and a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male participants should use contraception during the treatment period and for at least 3 months thereafter. Female participants should avoid the use of estrogen-containing contraceptives, since romidepsin may reduce the effectiveness of estrogen-containing contraceptives. An in vitro binding assay determined that romidepsin competes with β-estradiol for binding to estrogen receptors.

Exclusion Criteria

1. Concomitant use of drugs that may cause a significant prolongation of the corrected measurement of the time between the start of cardiac Q wave and the end of the T wave (QTc) .
2. Concomitant use of Cytochrome P 450 3A4 (CYP3A4) strong inhibitors within 1 week of trial medications.
3. Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted.
4. Prior chemotherapy or radiotherapy or any investigational agent after the last dose of romidepsin from the preceding romidepsin study.
5. Participants who are pregnant or breast-feeding.
A Phase 1, Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis® 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

Subfoveal choroidal neovascularization (CNV) due to AMD

Exclusion Criteria:

* Any of the following underlying diseases including:

  * Diabetic retinopathy.
  * History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months, ventricular tachyarrythmias requiring ongoing treatment.
  * History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
  * Clinically significant impaired renal (serum creatinine \>2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function.
  * Stroke (within 12 months of trial entry).
  * Any major surgical procedure within one month of trial entry. Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition.

Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the E10030 formulation.
A Natural History Study of Adult Onset Pompe Disease Using Muscle MRI

This project is an observational prospective study in which patients affected by an adult onset Pompe disease will be followed-up during three years using different clinical, analytical and radiological tests in order to know which is the natural history of the disease and which is the impact that treatment with recombinant enzyme has in the progression of the disease.

Study aim:

The principal objective of the study is to find biomarkers that quantify the natural progression of the disease and to know if they are useful to determine the improvement or lack of impairment of the disease in response to Enzyme Replacement Therapy (ERT).

Study design:

A single center observational prospective study.

Patients:

Patients with adult onset POMPE disease (onset of symptoms after two years old) and molecular diagnosis confirming the disease are eligible

Methods:

Clinical information will be obtained according to a pre-defined protocol including six visits: screening visit, baseline, 6 month, 12 month, 24 month and 36 month.

In each visit we will perform the following tests: clinical assessment (including interview with patients, quality of live questionnaires, timed tests and assessment of muscle balance using a myometer), analytical tests (blood and urine tests), cardiac test (Electrocardiogram (ECG) and cardiac echography), respiratory assessment (using spirometer) and skeletal muscle imaging (Muscle MRI).

All data collect will be introduced in a database and afterwards statistically analyzed.

Expected results:

We expect to find a biomarker useful to follow-up the progression of Pompe disease. This biomarker has to be sensitive to the changes that muscle function may have after treatment with ERT.

Funding:

This project is funded by Genzyme, a Sanofi company

Eligibility Criteria:
Inclusion Criteria:

* Pompe disease confirmed using genetic study
* Onset of symptoms more than 2 years old
* To be able to come to the hospital and follow all the visits
* Patients with respiratory involvement are welcomed

Exclusion Criteria:

* Patients unable to perform a MRI (respiratory problems can be solved using mechanical ventilation)
Effects of Spinal Stabilization Exercises Focusing on the Pelvic Floor in Women With Overactive Bladder

The aim of this study is to examine the effects of spinal stabilization exercises focusing on the pelvic floor on urinary symptoms, spinal stability, pelvic floor muscle functions, quality of life and perception of recovery in women with overactive bladder.

Overactive bladder (OAB) is defined by the International Continence Society and the International Society of Urogynecology as urinary urgency with or without urinary incontinence, usually accompanied by frequency and nocturia. Among the treatment options of OAB; first-line treatments include lifestyle recommendations, exercise approaches, and bladder training. Lifestyle recommendations; healthy lifestyle includes behavioral changes. Spinal stabilization exercise also aims to improve the neuromuscular control, strength and endurance of the muscles that are important in maintaining trunk stability. In recent years, it has been stated that trunk stability is impaired in women with OAB. However, no study was found on spinal stabilization exercises in patients with OAB.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Women with a diagnosis of overactive bladder
* Women who volunteered to participate in the study

Exclusion Criteria:

* Women with only stress urinary incontinence
* Presence of advanced pelvic organ prolapse
* Having a mental problem that will prevent cooperation in assessment and/or practices
* Women with the presence of a malignant condition
* Concomitant neurological disease and/or neurogenic bladder
* Presence of infection
* Pregnancy
Analgesic Effectiveness of PENG Block in Programmed Hip Arthroplasty Surgery

The intra- and peri-articular infiltration of local anaesthetics realized at the end of total hip arthroplasty surgeries is an effective analgesic technique, but it can be insufficient to manage the possibly intense postoperative pain. Regional anaesthesia (RA) like the recently described pericapsular nerve group (PENG) block could provide additional analgesic benefit in this setting.

Investigators main objective is to demonstrate the analgesic benefits (postoperative pain score and morphine consumption) of the PENG block when added to intra- and peri-articular infiltration of local anaesthetic following total hip arthroplasty. Investigators make the assumption that i) the PENG bloc could reduce the postoperative 24 first hours morphine consumption by 30%, ii) the PENG block could spare the motor function of the quadriceps and adductor muscles, and iii) the PENG bloc could be well tolerated allowing a high level of patient satisfaction.

A recent study has revealed a region of pericapsular terminal branches of the femoral nerve and the obturator nerve accessible to ultrasound-guided regional anaesthesia. This technique, also called the PENG block, has recently been described with a substantial benefit on pain at rest and induced by mobilization in cases series of patients undergoing hip fracture surgery. To investigators knowledge, no randomized data concerning the analgesic efficacy of the PENG block has been published in the setting of elective total hip arthroplasty.

The PENG block would allow a significant analgesic contribution when added to intra- and peri-articular infiltration of local anaesthetics while being well tolerated with few undesirable effects. Moreover, the PENG block could spare the motor function of the quadriceps and adductor muscles allowing enhanced recovery after surgery

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for total hip arthroplasty surgery under general anaesthesia
* Affiliated of a social security scheme
* Having signed the written informed consent

Exclusion Criteria:

* Total hip arthroplasty revision surgery
* Refusal of the patient to participate
* Existence of major spontaneous or acquired haemostasis disorders
* Infection at the puncture site
* Allergy to local anaesthetics
* Pregnancy or breast-feeding
* Patients under the protection of adults (guardianship, curatorship or protection of justice)
* Patients whose cognitive state does not allow assessment by the scales used.
Use of Bedside Ultrasonography on the Incidence of Acute Renal Failure in High-risk Surgical Patients

The mortality and postoperative complications of high risk surgeries vary in the different series. The management of this group of patients in intensive care unit (ICU) is fundamental to improve these outcomes. The objective of this study will be to evaluate whether the use of bedside ultrasound has an impact on the management of this group of patients with a consequent reduction in the incidence of acute renal failure in ICU and, secondarily, the incidence of associated complications. All adult patients (≥ 18 years old) admitted to ICU at Hospital das Clinicas of UFMG in the immediate postoperative period of major surgery with indication of ICU monitoring will be included and randomly randomized to the control or intervention group. The control group will be conducted by the intensive care physicians in charge without the US, while the second group will be conducted based in US findings. The US protocol will consist of a pulmonary US in four windows in each hemithorax , qualitative assessment of contractility and variation of inferior vena cava diameter. The primary outcome will be the development of acute renal failure as measured by the KDIGO score. Secondary outcomes will be length of ICU and hospital stay, ICU and 28 days mortality, length spent in mechanical ventilation, accumulated water balance, noradrenaline and dobutamine dose. Serum and urinary biomarkers will also be evaluated. Key words: ultrasound, high-risk surgery, intensive care

This is a single-center randomized clinical trial to be performed at the Adult Intensive Care Unit (ICU) of the Clinical Hospital of the Federal University of Minas Gerais, Belo Horizonte. The ICU is a clinical-surgical unit that has 18 beds with admission of approximately 100 patients per month, being 70% surgical patients and 30% clinical patients. Postoperative patients who meet the inclusion criteria reported below will be randomized to guide therapy according to ultrasound findings at the bedside versus a group that will not perform this method. Serum and urine samples will be collected in three times: admission (T0), after 12 hours (T1) and after 24 hours (T2) to analysed urine and serum biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Age equal or superior to 18 years.
* Major surgeries requiring ICU admission associated with one of the following criteria:

  * Use of vasoactive drugs
  * Use of inotropic drugs
  * Mean blood pressure less than 65 mmHg or SBP \<90 mmHg.
  * Hyperlactatemia\> 2 mmol / L
  * Heart rate\> 90 bpm.
  * Invasive mechanical ventilation required for at least 6 hours at the time of inclusion.
  * Hypoxia: satO2 \<92% in ambient air.
  * Length of surgery greater than 4 hours.
  * Request for transfusion of blood products in a surgical block
  * Oliguria during procedure, defined as diuresis \<0.5 ml/kg/h.

Exclusion Criteria:

Patients who do not agree to the terms of the

* Dying patients with impending death in the first 24 hours
* Patients in a previous renal replacement therapy program
A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 20 weeks prior to screening - Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form
* Non-fasting peak C-peptide higher or equal to 0.2 nmol/l at visit 2
* BMI (body mass index) higher or equal to 18.5 kg/m\^2
* Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening
* Insulin dependence unless in temporary spontaneous remission (honeymoon period)

Exclusion Criteria:

* Daily insulin usage above 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII)
* History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis)
* History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy
* Vaccination within 4 weeks before randomisation, Visit 3 (V3)
* Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1)
* History of pancreatitis (acute or chronic)
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
* Any past or current diagnosis of malignant neoplasms
* Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Elevations of plasma cortisol, a stress hormone, during prior episodes of low blood sugar (hypoglycemia) appear to be responsible for the deficient responses during subsequent hypoglycemia. Our specific aim is to determine if dehydroepiandrosterone (DHEA), a hormone with anti-corticosteroid actions, can prevent hypoglycemia associated autonomic failure in type 1 diabetic volunteers.

DHEA is the acronym for dehydroepiandrosterone, a steroid hormone produced naturally from cholesterol in the adrenal glands of males and females. It is also sold as an over-the-counter dietary supplement, and seems to have anticorticosteroid effects. DHEA antagonizes the effects of corticosterone on hippocampal function in rats and reduces responses to neural stress in mice. In our lab we have found that administration of the DHEA to rats during antecedent hypoglycemia, preserves counter-regulatory responses to subsequent hypoglycemia. The purpose of this study is to determine if the same response occurs in humans.

Eligibility Criteria:
Inclusion Criteria:

* 28 (14 males, 14 females) Healthy volunteers aged 18-45 yr.
* 28 (14 males, 14 females) Type 1 diabetic patients aged 18-45 yr.
* HbA1c \< 11.0%
* Has been diagnosed Type 1 DM
* No major diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
* Body mass index \< 40kg/m-2

Exclusion Criteria:

- pregnancy

Medical history-

* Hepatic Failure/Jaundice
* Renal Failure
* Acute Cerebrovascular/ Neurological deficit

Physical Exam-

* Pneumonia
* Fever greater than 38.0 C
* Blood labs according to protocol
Association of Plasma PTX3 Concentration and Outcomes of STEMI

335 of patients with STEMI treated by primary PCI were assayed for PTX3 measurement by ELISA method. The angiographic and clinical outcomes were evaluated according to the PTX3 concentration.

335 of patients with STEMI treated by primary PCI were assayed for PTX3 measurement by ELISA method using human PTX3 kit. Blood was drawn at the emergency department before primary PCI. The angiographic and clinical outcomes were evaluated and analyzed according to the PTX3 concentration. The angiographic outcome were thrombus grade on initial angiogram and final TIMI flow. The clinical outcome were ECG resolution after primary PCI and all-cause death at 30 days. The plasma PTX3 concentration was then compared based on the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute STEMI with symptom onset \<12 h undergoing primary PCI

Exclusion Criteria:

* Acute STEMI patients who received fibrinolytic therapy
Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX

The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for FOLFIRI or FOLFOX therapy
* ECOG performance status score 0-1
* At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with:
* At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance tamoxifen or Tarceva)
* No maximum age for Study Arm A (FOLFOX)
* 18-65 years of age for Study Arm B (FOLFIRI)

Exclusion Criteria:

* Treatment with other TKIs within the past 4 weeks
* Active inflammatory bowel disease
* Major gastrointestinal surgery which may affect absorption of the drug, any surgery within the last 4 weeks
* History of thromboembolism
* Severe unmanageable diarrhea
* Uncontrolled or significant cardiovascular disease