cyrilzakka/clinical-trials huggingface dataset:
Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

This study aimed to investigate the clinical benefit contribution and safety of nimotuzumab to the standard combined treatment for patients with newly diagnosed glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, histologically proven single supratentorial GBM (WHO grade 4);
* EGFR positive;
* \>50％ of the gross tumor volume removed by surgery；
* Karnofsky performance score (KPS) ≥ 60;
* Adequate renal function (creatinine ≤1.5×upper limit of normal \[ULN\] or creatinine clearance ≥ 60 mL/min), hepatic function (total bilirubin ≤1.5×ULN and serum transaminases ≤3×ULN), and hematologic function (white blood cell count ≥ 3,000/uL or absolute neutrophil count ≥ 1,500/uL, platelets ≥ 100,000/uL, and hemoglobin ≥ 10 g/dL).
* Tumor tissue was required for central pathology review and re-checking EGFR and MGMT expression status;
* An interval of 2 to 6 weeks between surgery and RT was required.

Exclusion Criteria:

* Negative EGFR expression;
* Prior chemotherapy, anti-EGFR therapy, RT, or a history of malignancy in the previous 5 years;
* Patients with severe complications or active infection;
* Continuous vomiting that could interfere with the oral administration of TMZ;
* Pregnancy
Improving the Cardiovascular Health of High-Risk Families Through an Innovative Home Visitation Intervention

The purpose of this study is to conduct formative work with relevant stakeholders, including families and home visitation program staff involved in previous studies and/or future projects, to understand facilitators, barriers, and other attitudes related to incorporating cardiovascular health topics into existing curricula and to obtain input on treatment modifications for future programs.

Alabama Department of Early Childhood Education administers an annual electronic survey to all home-visiting program staff and enrolled families. The survey queries these individuals about demographics, program satisfaction, and interest in new programming. We will request deidentified survey data to understand what proportion of families currently being served are currently expecting (pregnant) or are within one year post-partum. Those that fall in that category will be asked survey questions gauging their interest in cardiovascular health topics. Additionally, home-visiting staff will be asked about their comfort-level discussing the cardiovascular health topics with their clients. Home-visiting program staff will also be invited to participate in group-setting qualitative interviews focused on facilitators, barriers, and other attitudes related to any new programming or material related to cardiovascular health topics in the future. Interviews will be audio-recorded, transcribed verbatim, and the file will be erased after the transcripts have been verified for completeness. The transcription will not have any identifiable data included as participants will use anonymous names or nicknames and/or their study identification number during the interview sessions.

Eligibility Criteria:
Inclusion Criteria:

- capable and willing to complete an electronic survey and/or an online group interview via Zoom

AND

* participants must be an expectant mother (currently pregnant) OR
* a mother within one year of giving birth AND
* currently enrolled in a partner home-visiting program

OR

- participants are an employee of a partner home-visiting program

Exclusion Criteria:

- individuals are not an employee of a partner home-visiting program

Nor

* an expectant mother (currently pregnant) or within one year of giving birth AND
* not currently enrolled in a partner home-visiting program
Modulation of Benzene Metabolism by Exposure to Environment

The research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. To do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured.

The research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. To do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured. The exposures take place in the Controlled Environmental Facility operated by the Environmental and Occupational Health Sciences Institute (EOHSI). This allows us to control the exact benzene air level and to use benzene containing 13C, a stable (non-radioactive) form of carbon, one of the atoms that make up benzene. Isotopes are different forms of the same atom. Using 13C will allow us to tell the difference between the benzene and the compounds it changes to in the body that come from our experiment compared to what is present in your body from other sources. In addition to just benzene exposure on some days the subject is also be exposed to methyl tertiary butyl ether (MTBE), another component of gasoline, to take an iron supplement pill and/or to take vitamins C and E pills. How benzene is metabolized or changed in the body will be compared for these differences to better understand how the body deals with benzene.

Eligibility Criteria:
Keratinized Tissue Augmentation Using Porcine Collagen Matrix (Mucoderm®) Around Dental Implant

Aim of the Study To evaluate the using of porcine collagen matrix for keratinized tissue augmentation around delayed dental implant.

Primary Outcome:

Peri-implant keratinized mucosal width and thickness following the use of porcine collagen matrix using (Mucoderm®-Botiss gmbh) compared to the gold standard FGG augmentation.

Secondary Outcome:

1. Crestal bone change (CBC)
2. Pocket depth (PD)
3. Bleeding on probing (BOP)
4. Plaque index (PI) PICOT

P: Population:

Patient with suitable ridge dimension for delayed implant placement.

I: Intervention:

Implant insertion followed by porcine collagen matrix soft tissue augmentation

C: Control:

Autogenous FGG

O: Outcomes

* Enhancing keratinized mucosal width and thickness
* Evaluating :

  1. Crestal bone change (CBC)
  2. perimplant Pocket depth (PD)
  3. Bleeding on probing (BOP)
  4. Plaque index (PI)
  5. Modified PES. T: Time A 6 months follow up .

this study aiming to augment KMW with FGG and MUCODERM following apically positioned flap the primary outcomes to measure is KMW and MT

Eligibility Criteria:
Inclusion Criteria:

* 1- Partially or fully edentulous sites with previous implant placed in posterior maxillary or mandibular areas.

  2- Inadequate keratinized tissue ≤2 3- Patient age ranged from 20 to 45 years old for both genders. 4- Submerged Osteointegrated implants with no sings of inflammation before implant insertion.

  5- Optimal compliance as evidenced by no missed treatment appointments and positive attitude toward oral hygiene.

Exclusion Criteria:

* 1- Smokers 2- Pregnant or lactating female 3- Treatment with any systemic drug that could affect wound healing (ex- corticosteroids ) 4- History of systemic disease affect wound healing ex diabetes 5- Patient with bruxism and parafunctional habits. 6- Limited inter arch restoration space.
Investigation of Novel and Established Therapies in a Human Intravenous Lipopolysaccharide Model of Sepsis

Sepsis is a common and life-threatening condition caused by a dysregulated host immune response to infection. Given the prominent role of endothelial breakdown and dysfunction in sepsis, therefore, there is an urgent need to establish strategies to protect the endothelium and preserve microcirculatory function.

This study is a randomised clinical study investigating intravenous fluid therapy and oral imatinib therapy in healthy human volunteers exposed to intravenous lipopolysaccharide (LPS).

The objective of the study is to investigate the biological effects of fluid and imatinib therapy on LPS-induced microcirculatory dysfunction.

The benefits of intravenous fluid administration in sepsis remain uncertain. A growing body of evidence suggests that excessive fluid administration is harmful. An association between a more positive fluid balance and mortality in critically ill patients has been repeatedly demonstrated. Moreover, emerging evidence suggests that intravenous fluid administration induces glycocalyx injury, thought to be mediated by shear stress. In sepsis the rapid administration of intravenous fluids is hypothesised to exacerbate glycocalyx injury, capillary leak and tissue oedema formation.

Recent work has highlighted the protective effects of Imatinib, a tyrosine kinase inhibitor, on endothelial barrier function in animal models of microcirculatory dysfunction as well as in patients with endothelial barrier dysfunction. Moreover, Imatinib has also been demonstrated to attenuate markers of systemic inflammation in animals with a LPS-induced lung injury model of acute respiratory distress syndrome. There is, therefore, a growing body of evidence to support a potential therapeutic role for Imatinib in disease states involving inflammatory vascular leak.

The hypothesis being tested is that:

1. Intravenous fluid therapy will exacerbate the degree of vascular dysfunction and systemic inflammation observed in this model.
2. Imatinib pre-treatment will attenuate the degree of vascular dysfunction and systemic inflammation observed in this model.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged between 18 and 40 years of age
2. Informed consent to participate

Exclusion Criteria:

1. Current participation in a clinical trial
2. Pregnant or breastfeeding
3. Current history of smoking
4. Alcohol intake \> 21 units per week
5. Regular intake of any relevant prescription or over-the-counter medication. Any regular medication use will be reviewed on a case-by-case basis as to (a) risk and (b) potential confounding effect.
6. Oxygen saturation \<95% breathing room air
7. Abnormal findings on history, examination or laboratory tests suggestive of underlying illness (in the opinion of the clinician undertaking screening)
8. History of recurrent vaso-vagal episodes
9. Allergy to Imatinib
10. Positive or equivocal hepatitis B or C serology result
Low-level Laser Therapy Versus High Frequency on Pressure Ulcers Treatment

Patients admitted in the Emergency Service that have pressure ulcers will be selected by eligibility criteria and randomized into three groups according to the adopted therapy: wound dressing (CG); wound dressing + high-frequency generator group (GAF); and wound dressing + low-level laser therapy group (GLBP).

Wound dressing is considered the standard treatment for pressure ulcers, however, despite its proven efficacy, it's a long-term healing process. Among Physiotherapy resources available for pressure ulcers treatment, the most used are low-level laser therapy and high-frequency generator. Even though the individual effects of both are evidenced on literature, there are no randomized clinical trials evidencing the effects of low-level laser therapy and high-frequency generator in comparison to wound dressing on pressure ulcers treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pressure ulcers with rate II or III;
* Not receiving pressure ulcer treatment.

Exclusion Criteria:

* Presence of necrotic tissue needing debridement
* Pregnancy
* Discomfort during treatment
* Pressure ulcers with area bigger than 30cm2
* Extensive tunneling
* Diabetes mellitus (DM)
* Severe metabolic disease
* Use of corticosteroids or vasopressors
* Immunosuppression
* Pacemaker
* Neoplasia
* Hemorrhage
* Sensibility disorders
* Metalic device.
Single Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Elderly Male and Female Volunteers

The objective of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two increasing doses in healthy elderly volunteers, following the infusion schema of a loading dose (1 hour) and a maintenance dose (5 hours)


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers
* Age \>= 60 years
* Broca index from -25% to +25%
* Written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders (exclusion: substitution therapy regarding thyroid gland and/or ovaries)
* Diseases of the central nervous system (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders and medical history of such diseases or disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
* Intake of any drugs which might influence the results of the trial (\<= one week prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 30g/day for males, \> 24 g for females)
* Drug abuse
* Blood donation (\>= 100 ml within four weeks prior to administration or during the trial)
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range of clinical relevance
Real Life Evaluation of SGLT2 Use in Type 1 Diabetes

The primary aim of the study is to prospectively monitor the risk of diabetic ketoacidosis (DKA) during treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 1 diabetes after the treatment has become available as an adjunct therapy for people with type 1 diabetes.

SGLT2 inhibitors have recently been approved for treatment of type 1 diabetes. SGLT2 inhibitors affect renal glucose transport and promotes glucose excretion in the urine. This have attractive effects, notably by lowering of blood glucose without any increased risk of hypoglycemia as well as a reduction in body weight. Since the risk of hypoglycemia and weight gain during intensification of insulin treatment is a significant barrier for optimal glycemic control, SGLT2 inhibitors could be an attractive adjunct therapy in type 1 diabetes. Furthermore, SGLT2 inhibitors have beneficial cardiovascular and renal effects in persons with type 2 diabetes. This may also benefit persons with type 1 diabetes. However, the major limitation for an universal use of SGLT2 inhibitors in type 1 diabetes is a substantial increase in ketogenesis and the risk of DKA. DKA remain a substantial cause of morbidity and mortality in persons with type 1 diabetes.

Since no data exist on the risk of DKA during SGLT2 inhibition outside the randomized controlled trials, the investigators will initiate a nationwide monitoring study on the use of SGLT2 inhibitors in type 1 diabetes. This will ensure follow-up on the efficacy, safety and patient-reported outcome measures for SGLT2 inhibitors treatment of type 1 diabetes in real-world clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* All patiens with type 1 diabetes on SGLT2 inhibitor treatment or where this treatment is planned.

Exclusion Criteria:

* None
Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System

The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose (BG) reference using the Consensus Error Grid. During the course of the wear duration, the subject is required to test fingerstick glucose measurement at least eight (8) times a day for capillary reference glucose measurements and three in-clinic visits of a maximum 13 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be at least 18 years of age.
2. Subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment.
3. Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily) for at least 6 months prior to enrollment.
4. Subject must be able to read and understand English.
5. In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
6. Subject must be available to participate in all study visits.
7. Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria:

1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
2. Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only).
3. Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
4. Subject currently is participating in another clinical trial.
5. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities.
6. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to:

   • History of HIV, Hepatitis B or C
7. Subject has a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding.
8. Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
9. Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Cardiac Resynchronization Therapy: Relevance of the Surgical Approach in the Implantation of the Left Ventricular Probe

Heart failure is very common and reaches more than 56 million people worldwide. 17 to 45 percent die in the first year of hospitalization. The most affected populations live in Western countries like Europe or the USA.

It is defined by a set of signs and symptoms such as dyspnea, asthenia, edema or tachycardia but must be objectified, preferably by ultrasound. Its basic treatment is based on a lifestyle improvement and a reduction of the risk factors (hypertension, dyslipidemia, diabetes, ...), as well as an optimal medical treatment based on ACE inhibitors, B-blockers, ARA2 (Sartans), spironolactone or digoxin.

When the optimal treatment is no longer working and that the cardiac desynchronization is demonstrated, be it atrio-ventricular, inter-ventricular or intra-ventricular, the patient can benefit from a three-probes cardiac resynchronization to resynchronize the two ventricles. The classic approach, performed by a cardiologist, is to perform an endovenous procedure in order to place the 3 probes under local anesthesia.The first one goes in the right atrium, the second one in the right ventricle and the third one goes in the left ventricle. It is the placement of this third one that often causes trouble. It is more difficult to place since it must pass through the coronary sinus, outside of the heart, unlike the first two probes that are placed endocavitary. When the practitioner fails to place the probe correctly or obtains inappropriate levels of detection, stimulation, or impedance thresholds, a cardiac surgeon must intervene and carry out a mini-thoracotomy.

The CHU Brugmann Hospital is in favor of a mixed surgical approach. The probes are placed by a cardiac surgeon, who first starts by a endo-venous placement under local anesthesia. If that approach fails, the local anesthesia can be transformed into general anesthesia at the same operative time and a mini-thoracotomy is performed.

The aim of this study is to evaluate the immediate impact of this surgical management within the CHU Brugmann hospital, in patients suffering from cardiac insufficiency despite proper medication.The hypothesis is that the mixed surgical approach improves the prognosis of cardiac resynchronization.


Eligibility Criteria:
Inclusion Criteria:

* Patient who underwent cardiac resynchronization within the Brugmann University Hospital from 2003 til July 2016
* Cardiac insufficiency, whatever the origin, demonstrated by a cardiologist with demonstrated ventricular asynchronism.

  * With left ventricular ejection fraction \<35%
  * And / or a left ventricular diastolic diastolic diameter\> 55 mm
  * And / or QRS measuring\> 130 milli sec
  * And / or left branch block
* Redo procedure on a pacemaker

Exclusion Criteria:

• Change of case on a patient who has already benefited from a triple chamber stimulator
Photobiomodulation and Implant Stability

Objective: The aim of the present study was to address the following questions: does photobiomodulation therapy (PBMT) improve implant stability and affect microbiota around dental implants in the early stage of osseointegration.

Material and Methods: Implants will randomly be divided into two groups and implants will be placed in the test group treating with Gallium-aluminum-arsenate (GaA1As) diode laser with photobiomodulation therapy immediately after surgery and for 15 days. In the control group, implants are not irradiated. The primary stability of the implants will measure by the Resonance frequency analysis (RFA) after insertion and the secondary stability values will record at 30th, 60th, and 90th days after surgery as implant stability quotient (ISQ). Plaque samples will collect for microbiological analyzes at the first 24 hours after implant surgery and six days after 90 days at six sterile endodontic paper points.

The same surgical procedure will be operated in the test and control groups by the same surgeon. Full-thickness flaps were raised and dental implant osteotomy preparation will be completed according to the manufacturers' instructions. Laser treatment will be completed using Gallium-Aluminum-Arsenide diode laser. The photobiomodulation application will v-be completed by laser energy immediately and three times a week for just 15 days after surgery. The control group will consist of laser application without energy delivery to the tissue. Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer will be applied for direct measurement of implant stability and the value will be recorded. The microbiological plaque samples will be collected at specific times, according to the following schedule; at the first 24-hour and 90 days after implant surgery. All bacterial DNA specimen will be analyzed with qPCR technique to evaluate Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) , Tannerella forsythia (Tf ) and total amount of bacteria.

Eligibility Criteria:
Inclusion Criteria:

* at least one tooth loss in left and right posterior sides of upper and lower jaws
* adequate alveolar bone volume as horizontal and vertical

Exclusion Criteria:

* uncontrolled systemic diseases
* parafunctional (bruxism and/or clenching)
* smoking habits
* any allergies or metabolic bone diseases,
* pregnancy
* surgical periodontal treatment in 6 months
* using antibiotics in the last 6 months