cyrilzakka/clinical-trials huggingface dataset:
Association Between Craniofacial Fractures and Brain Injuries: Diagnostic and Therapeutic Considerations

This study evaluates the association between traumatic brain injuries and craniofacial or/and skull fractures. Purpose is to find out the amount of missed diagnoses and improve primary diagnostics of trauma patients.

A part of mild TBIs remains undiagnosed. Therefore the primary diagnostics of trauma patients needs to be improved. According to some studies, a part of trauma patients' concomitant injuries weren't diagnosed in the emergency room (ER) but were diagnosed later in the clinics. In addition to difficult diagnostics the treatment of these patients demands close co- operation between many specialities.

The aim of this study is to evaluate the association between TBIs and facial fractures. The real amount of facial fractures in patients with severe TBI and the clinical significance of these fractures are evaluated. Also the number of patients with facial fractures and a concomitant TBI is evaluated. The aim is to find out the amount of patients with missed diagnoses. Other aims of are to determine the effect of the type or location of a facial fracture on the in- cidence and severity of TBI. With the help of the results it would be possible to improve the comprehensive diagnostics and early treatment of patients with a facial fracture or a TBI.

The retrospective and prospective data on patients with TBI and/or facial fracture are collect- ed at Turku University Hospital. The comparison of the two groups will give information on the amount of patients with missed diagnosis of TBI or facial fracture. The results can be utilised in planning strategy for comprehensive diagnostics and treatment of the patients. In the research group the investigators have specialists in the fields of oral and maxillofacial surgery, neurol- ogy and otorhinolaryngology.

Eligibility Criteria:
Inclusion Criteria:

* Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture

Exclusion Criteria:

* Died before admitted to hospital
The Effect of Doxapram Versus Theophylline on Diaphragmatic Function

Doxapram is licensed for drug-induced post-anesthesia respiratory depression , arousal effect and return airway protective reflexes caused by barbiturates, volatile anesthetics, nitrous oxide or benzodiazepines over dosage.

Value of theophylline to stimulate the respiratory neuronal network has been examined by previous studies and increases the activity of respiratory muscles, including the intercostal , transversus abdominis muscles and the diaphragm, it also has bronchodilator and anti-inflammatory effects.

This randomized comparative study will be conducted in the post-surgical cardio-thoracic intensive care unit in Beni -Suef University Hospital after approval of the department of anesthesiology, surgical ICU and pain management , and cardio thoracic department and the local ethics and research committee, and obtaining written informed consents from the patients to compare the effect of doxapram versus theophylline on diaphragmatic function using ultrasonography parameter: thickening fraction of the diaphragmatic muscle during respiration which defined as \[(thickness at end-inspiration - thickness at end-expiration)/thickness at end-expiration\] during spontaneous breathing trial as a primary outcome and its effect on weaning time and weaning success rate as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria: Patients (males and females) in the age group 20 -60 scheduled for elective open heart surgery ( e.g. coronary artery bypass grafting, valve replacement ) under cardiopulmonary bypass .

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Exclusion Criteria:The preoperative exclusion criteria:

1. Age older than 60 years
2. Preoperative left ventricular ejection fraction less than 30%
3. Chronic obstructive pulmonary disease
4. Significant hepatic disease (alanine aminotransferase or aspartate aminotransferase \>150 U/l).
5. Renal failure (creatinine \>200 μm).
6. History of seizure, or stroke.
7. History of diaphragmatic palsy, cervical spine injury, or neuromuscular disease (eg, myasthenia gravis, Guillain-Barré syndrome).
8. Lesion adjacent to the diaphragm
9. Intra-abdominal hypertension (intra-abdominal pressure ≥12 mm Hg )
10. Known allergy to the study drugs.

The Post enrollment exclusion criteria:

1. Postoperative hemorrhage (chest tube drainage ≥ 200 ml/h).
2. Surgical complications necessitating reoperation.
3. Postoperative cardiac failure necessitating high-dose inotropes or intra -aortic balloon pump.
4. Refractory hypoxemia (ratio of arterial oxygen tension \[PaO2\] to fraction of inspired oxygen \[FIO2\] \<150 mmHg).
5. Occurrence of neurologic deficit.
6. -Myocardial ischemia (ST-segment depression) lasting more than 30 min
7. Failure of spontaneous breathing trial.

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Long-term Study of Epiduo in Patients With Moderate to Severe Acne

This observational study is designed to assess the long-term efficacy and safety of Epiduo (alone or in combination with other drugs) under daily clinical practice conditions in patients with moderate to severe inflammatory acne. In addition, the effect of Epiduo on quality of life and patient adherence will be assessed under marketed conditions.

This observational study is designed to assess the long-term efficacy and safety of Epiduo under daily clinical practice conditions. The study includes patients of all ages with moderate to severe inflammatory acne, taking Epiduo alone or in combination with other drugs. In addition, the effect of Epiduo alone or in combination with other drugs on quality of life and patient adherence will be assessed under marketed conditions.

The observational study is designed as a multicentre study, covering all parts of Germany. Participating investigators are dermatologists with an adequate patient pool of acne patients. The observation time per patient will be 9 months. An interim and final examination with subsequent documentation are designated to be performed about 3 and 9 months after the start of treatment, respectively.

Eligibility Criteria:
Inclusion Criteria:

* The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
* Topical therapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study

Exclusion Criteria:

* Use of Epiduo within 3 months prior to inclusion
* Pregnancy or breastfeeding
* Acne inversa
* Acne with preferential manifestation of microcysts, macrocysts and macrocomedones
* Hypersensitivity to the drug or any of its ingredients
* If applicable, other restrictions outlined in the SPC of Epiduo
Safety and Performance of the Glyconics-SX System (ANODE02)

The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or assumed clinical status and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with a validated comparator device.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy adults (≥18 years of age) with known or unknown T2DM status willing to participate in and provide a written consent for the study
* willingness to undertake assisted assessment of glycaemia by both the NIR spectra measurement, and HbA1c by finger prick test
* Individuals with two visually assessed apparently healthy, undamaged, and intact fingernails, one in both right- and left-hand middle fingers

Exclusion Criteria:

Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as

* anaemia (iron deficiency sickle cell anaemia or similar)
* haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular assays,
* severe renal impairment (CKD stage III-IV) or decompensated hepatic disease
* severe Vitamin D deficiency
* known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia
* eating disorders (as per clinical assessment)
* Recent (within 28 days) blood donation

  o Any structural, deviating and visually detectable deviations in the appearance of the nails potentially impacting the spectra measurement, including
* nail dystrophy or deformity
* severe nail infections (onychomycosis causing visual changes in the appearance of the nail)
* rare hereditable conditions impacting the structure of keratin
* mechanical damage or marks on the surface of the nail after removal of nail polish
* use of acrylic or gel nail decoration and polish, which cannot be removed o Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.
Auditory Rehabilitation in Stroke Patients With Auditory Processing Disorders

This study aimed to evaluate long term benefits in speech reception in noise, after daily 10 week use of an assisting listening device (personal frequency-modulates systems) , in non-aphasic stroke patients with auditory processing deficits.

Stroke can affect all levels of the auditory pathway. Approximately one in five stroke survivors report severe difficulties when listening to speech-in-noise, despite normal hearing, attributed to abnormal processing of sounds within the brain, and these individuals are more likely to experience communication difficulties in poor acoustic environments, The patient with significant auditory deficits and functional limitations may require a range of rehabilitation and remediation approaches. Several studies conclusively demonstrate substantial improvements in speech recognition in noise when using personal frequency-modulated (FM) systems. These devices are used to improve speech perception in noise in adults with neurological disorders including stroke with good immediate benefits. However, the long-term benefits of FM systems in stroke patients has not been studies. In this research study the investigators aimed to investigate the long term benefits in speech reception in noise in non-aphasic stroke patients and measure the potential improvement in unaided speech in background noise performance after 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical history of ischaemic stroke verified by brain magnetic resonance imaging (MRI)
* Diagnosis of auditory processing disorders
* Normal pure-tone audiogram

Exclusion Criteria:

* Severe aphasia
* Significant psychiatric illnesses
Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial

Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.

In calender year 2005, 220, 000 men will be diagnosed with prostate cancer and approximately 30,000 will subsequently die of metastatic disease. Although the vast majority of men will be diagnosed with clinically localized and potentially curable disease, the selection of one local modality over another remains a focus of significant controversy within the uro-oncology community. However, patients with higher risk features are most often managed with radiotherapeutic approaches to include androgen deprivation therapy.

Prostate brachytherapy represents the ultimate-three dimensional conformal therapy and permits dose escalation far exceeding other modalities. Following permanent prostate brachytherapy with or without supplemental external beam radiation therapy, favorable long-term biochemical outcomes have been reported for patients with low, intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities (1,2).

Several prospective randomized trials have demonstrated that androgen deprivation therapy in conjunction with conventional doses of external beam radiation therapy (65-70 Gy)results in improvement in disease-free and overall survival in patients with locally advanced prostate cancer (3,4).

Eligibility Criteria:
Inclusion Criteria:

* High risk patients - Two to three of the following: PSA 10-30 ng/mL, Gleason score greater than or equal to 6, clinical stage greater than or equal to T2c (2002 ACJJ).
* CT of the abdomen and pelvis and bone scan without evidence of metastases.
* An enzymatic prostatic acid phosphatase must be obtained prior to randomization.
* A serum testosterone must be obtained prior to initiation of androgen deprivation therapy.
* No prior pelvic external beam radiation therapy for prostate cancer or other malignancies.
* No prior androgen deprivation therapy.
* Minimum 5 year life expectancy.
* No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years.

Exclusion Criteria:

* Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age

The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.

Purpose:

Eligibility Criteria:
Inclusion criteria:

* Neonates and infants with aged \< 12 months at Visit 1
* Objective diagnosis of VTE
* End of planned treatment course with anticoagulant therapy as per standard of care at the investigator site.
* Written informed consent provided by the patient's parent(s) (or legal guardian) according to local regulations at Visit 1.

Exclusion criteria:

* Weight less than 3 kg at Visit 1
* Conditions associated with an increased risk of bleeding
* renal dysfunction
* hepatic disease
* Anemia or thrombocytopenia at screening
Immunotherapy Following Reduced Intensity Conditioning and Allogeneic Stem Cell Transplant for Poor Risk CD30+ Hodgkin Lymphoma Patients

Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard of care reduced intensity regimen and an allogeneic stem cell transplant (from another person, related or unrelated). Following recovery, patients will receive a medication called Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that this treatment will be safe and well tolerated in children and young adults.


Eligibility Criteria:
Inclusion Criteria:

* 45 years of age or less.
* Patients with Hodgkin Lymphoma with either of the following:

  • Primary induction failure (failure to achieve initial CR) and/or primary refractory disease OR First, Second or Third relapse AND History of prior ablative auto HSCT or ineligible for an ablative auto HSCT or ≥25% residual disease after at least two reinduction chemotherapy cycles AND HLA matched family donor (6/6 or 5/6) or matched unrelated adult donor (MUD) (8/8) or matched umbilical cord blood unit (≥5/6) with prethaw cell dose of at least 3 x 107/kg TNC.
* off other investigational therapy for one month prior to entry in this study.
* adequate organ function

Exclusion Criteria:

* Patients with HD with 4th or greater CR, PR, and/or SD are ineligible.
* Patients with rapidly progressive disease (PD) unresponsive to reinduction chemo, radio, or immunotherapy are ineligible.
* Patients who don't have an eligible donor are ineligible.
* Women who are pregnant are ineligible.
Impact of High Protein and Low Carbohydrate Smoothie Drinks in Type-2 Diabetes Mellitus

We compared between a regular high protein or a high protein and low carbohydrate smoothie drinks with conventional diabetic enteral drinks (Glucerna) on glucose homeostasis, insulin and lipid metabolism in type 2 diabetic and obese individuals.

We aimed to determine the effect of high protein and low carbohydrate smoothie drinks on glucose homeostasis, insulin and lipid metabolism in type 2 diabetic and obese individuals. We compared between a regular high protein or a high protein and low carbohydrate smoothie drinks with conventional diabetic enteral drinks (Glucerna). A crossover design study was done in 60 diabetic participants. Participants consumed 300 kilocalories of each drink at a time with one week wash out period between drinks and glucose response curves at baseline, 30, 60, 90, 120, 180 and 240 minutes were monitored and compared. The products were formulated to supply 1 kilocalorie/milliliter (kcal/ml). Dietary compositions in regular formulas (smoothie, SM) were 30-40% carbohydrate, 20-30% protein and 30-50% fat. While in smoothie with low carbohydrate formulas (SMLS), they were 25-35% carbohydrate, 25-30% protein and 35-55% fat vs. a control formula (Glucerna).

Eligibility Criteria:
Inclusion Criteria:

1. people with type 2 diabetes mellitus or use blood glucose-lowering drugs more than 3 months
2. BMI \> 25 kg/m\^2
3. HbA1c 6.5 - 8.5
4. use stable level of blood glucose-lowering drugs and blood lipid-lowering drugs more than 3 months

Exclusion Criteria:

1. pregnancy or breastfeeding
2. people with chronic diseases or tube feeding or dysphagia i.e. pneumonia
3. people with insulin injection or use GLP-1 analogues drugs or DPP-4 inhibitors drugs
4. people with history of bariatric surgery, gastroparesis, malabsorption
5. people with history of diseases that affect blood glucose/lipid control i.e. hyperthyroidism, endocrinology and kidney disorders
6. use long-term immunosuppressants
7. cancer patient
VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients

This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with intravenous ganciclovir for the treatment of CMV disease in solid organ transplant recipients. Eligible patients will be randomized to receive either 1)Valcyte 900mg po bid or 2)ganciclovir 5mg/kg iv bid. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* recipients of solid organ(s) transplant;
* virologic and clinical evidence of CMV disease after transplantation;
* patients of childbearing potential must be prepared to use effective contraception throughout, and for 90 days after the end of the study.

Exclusion Criteria:

* life-threatening CMV disease according to the investigator's judgment;
* pregnant or lactating women.
TBS Over DLPFC in Elderly Refractory Depression

The study aim to examine the effect of Thea-burst stimulation over bilateral dorsolateral prefrontal cortex (DLPFC) among patients with LLD on mood condition and relevant biomarkers.

Thea-burst stimulation (TBS) is a novel form of rTMS, providing greater modulation effect on neural activity. So far, no study was conducted to use TBS as treatment in LLD. Therefore, we aim to examine the effect of TBS over bilateral dorsolateral prefrontal cortex (DLPFC) among patients with LLD on mood condition and relevant biomarkers. The study used a two-arm, parallel, double-blind, randomized, and sham-controlled design. We plan to enroll sixty patients with LLD, thirty for active intervention and thirty for sham-controlled group. An Magstim Rapid2 stimulator with eight-figure coil was used for stimulation. Location of brain area are based on bilateral DLPFC. 3-pulse 50-Hz bursts was given every 200ms (at 5 Hz) and an intensity of 80% active motor threshold was settled. We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses). Each patient received daily stimulation for two weeks with total ten sessions. The primary outcomes were change of depression severity including response and remission rate. Secondary outcome were biomarkers related to depression. Assessments were administered at baseline, immediately after 5 and 10 sessions of stimulation, and 3 months after the completion of stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 to 85 years
* Major depression disorder
* Under a stable dose of all psychotropic medication during the stimulation period.

Exclusion Criteria

* Having any current psychiatric comorbidity or history of substance dependence.
* Having active suicidal ideation currently.
* Having severe physical illness, recent and/or current unstable medical disorders.
* Having history of cancer or chemotherapy.
* Dementia or MMSE\<24.
* Having TMS contraindicated (seizure disorder, history of seizures, metal in the head, pacemakers, history of craniotomy)
Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study

The goal of this clinical trial is to test in 10 patients with advanced furcation involvement on molars. The main question\[s\] it aims to answer are:

• Is it possible to carry out root resection without endodontic treatment on molars? Tooth vitality will be checked (positive response to cold test). Root resection will be carried out under local anestesia.

Following visits will be carried out for re-evaluation/maintenance according to clinical care every 3 mounths until 3 years follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with stage III-IV periodontitis
* Compliantpatient, as shown by full mouth plaque score\<30%
* Previous non-surgical periodontal therapy within 6 mounths
* Maxillary or mandibular molar affected by periodontal furcation involvement and scheduled for root resection
* Positive to sensibility testing (cold/electric pulp tests)
* No prosthesis or large restorations
* Sufficiently divergent roots to make root resection feasible
* Root trunk lenght at 3 mm as measured in periapical radiograph

Exclusion Criteria:

* Systemic contraindications to perform periodontal surgery/root resection
* Fused roots
* Presence of periapical radiolucency
* Furcation class III affecting all roots of maxillary molar