cyrilzakka/clinical-trials huggingface dataset:
Haemocomplettan® P During Aortic Replacement

The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Eighteen years of age or older
* Undergoing elective thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacement surgery (TAA)
* Understood and willingly given written informed consent (German language) to participate following an explanation of study background, restrictions, and procedures
* Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery

Exclusion Criteria:

* Positive pregnancy test, pregnancy or lactation
* Women of child bearing age not using a medically approved method of contraception during the study
* Previous aortic replacement at the same aortic site (redo surgeries)
* Undergoing an emergency operation
* Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease)
* Myocardial Infarction (MI) or apoplexy in the 2 months preceding study surgery
* ASA administration in the 3 days preceding study surgery, and a pathological (\<74.5 U) ASPI Multiplate® test immediately preceding surgery begin
* Clopidogrel administration in the 5 days preceding study surgery, and a pathological (\<31.1 U) ADP/PG Multiplate® test immediately preceding surgery begin
* Tirofiban administration in the 2 days preceding study surgery, and a pathological (\<94.1 U) TRAP Multiplate® test immediately preceding surgery begin
* Phenprocoumon administration in the 5 days preceding study surgery, and an INR \> 1.28 immediately preceding surgery begin
* Participation in another clinical study in the 4 weeks preceding aortic replacement
* Sensitivity to any of the components of study medication, or to MPs with a similar chemical structure to any of the components of study medication
* Any indication that the restrictions or procedures of the study may not be adhered to (e.g. an uncooperative attitude)
* Any indication that the study restrictions, procedures, or consequences therein have not been considered or understood, such that informed consent cannot be convincingly given
* Multiple morbidities, with a notably constrained remaining length of life
Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure

Chronic liver diseases are often characterized by portal hypertension, a major complication involving haemodynamic changes due to increased intrahepatic vascular resistance. It has become well established that nitric oxide (NO) plays a crucial role in the haemodynamic abnormalities that develop in chronic portal hypertension.

NCX-1000 is a NO-releasing derivative of ursodeoxycholic acid that would compensate for the defective liver NO production in cirrhosis.

This study intends to demonstrate the desired therapeutic activity (reduction in portal pressure) in a small number of target patients, to assess the safety and tolerability after repeated oral administrations of NCX-1000, and to get preliminary pharmacokinetic data in this population.

Brief summary is complete. Study is closed.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female patients of at least 18 years old
* HVPG \> 12 mm Hg in fasting state on Day 1
* Free of any other condition (except liver failure) that may alter absorption, distribution, or elimination of drugs

Exclusion Criteria:

* Oesophageal bleeding in the previous 30 days
* Known intolerance to ursodeoxycholic acid or nitrates
* Liver cancer or liver metastasis from another cancer
* Portal hypertension secondary to venous thrombosis
* Presence of Transjugular Intrahepatic Portosystemic Shunt (TIPS)
* Severe liver failure (Child-Pugh C)
Effectiveness of a Structured Intervention on the Development of Self-Care Behaviors With AVF in HD Patients

End stage renal disease patients (ESRD) should be educated to take care of their arteriovenous fistula (AVF). Educational programs should have clear objectives and the interventions should be well defined. Therefore, assessing the interventions that can have the strongest impact on the patient's acquisition of self-care behaviors with AVF is extremely important. The aim is to assess the effectiveness of a structured intervention on the frequency of self-care behaviors with AVF by patients with ESRD on hemodialysis (HD).

This was a quasi-experimental study in dialysis units, involving patients using AVF for HD. The dialysis units are located in the north of Portugal (two units) and in the Autonomous Region of the Azores (one unit). The study started after approval by the institution ethics committee.

Study Setting and Population The study was carried out in dialysis units the north of Portugal, identified as Control Group (CG), and on an island in the Autonomous Region of the Azores, identified as Intervention Group (IG).

Data Collection and Instrument All data were collected from January to June 2018. Information concerning the sample demographic characteristics (age, gender, education, employment, marital status) and clinical characteristics (ESRD etiology, dialysis vintage, previous AVFs, AVF duration, information on care with the AVF) was collected with a questionnaire designed by the authors.

Information concerning self-care behaviors with the AVF was collected from the Scale of Assessment of Self-Care Behaviors with Arteriovenous Fistula in Hemodialysis (ASBHD-AVF) (8). This scale has 16 items in two subscales: subscale 1 - Management of Signs and Symptoms (6 items) and subscale 2 - Prevention of Complications (10 items). Responses to each item are based on a 5-point Likert-type scale. Higher scores show patients' higher frequency of self-care with the AVF. The ASBHD-AVF scale has been applied to Portuguese patients with Cronbach's alpha of 0.797, 0.797 and 0.722 for the global scale and sub-scales 1 and 2, respectively.

Memory problems were assessed by the Six-Item Cognitive Impairment Test (6CIT), Portuguese version (9).

Eligibility Criteria:
Inclusion Criteria:

* participants should be 18 years or older;
* have an AVF duration on HD greater than 6 months
* have no memory problems
* be medically stable.

Exclusion Criteria:

* patients with double vascular access (central venous catheter and AVF) or grafts as vascular access
* hospitalized patients at the time of data collection
Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.

Primary: Evaluation of improved vaginal moisture in postmenopausal women.

Secondary: the improvement of symptoms resulting from the dryness Rating (VHI), evaluation of the decrease in vaginal pH, assessment of Sexual Function Index female (FSFI), evaluation of adherence to study treatment by patient diary, assessing the acceptability of the product and subjective assessment of the patient as the itching and stinging / burning, beyond the safety assessment.

ENDPOINT:

* Primary: Evaluation of improved vaginal moisture in post menopausal women through vaginal health index (VHI);
* Secondaryevaluate the increase in fluid volume, vaginal elasticity and integrity of the epithelium by the VHI, evaluate the pH control, improvement of female sexual quality by applying the Sexual Function Index female (FSFI), evaluate through the patient's daily treatment adherence, evaluate the acceptability (welfare, run-off and satisfaction) of the product and the improvement of itching and stinging / burning through questionnaires and verify the tolerability and safety by identifying adverse events.

STUDY DESING: Phase IV study, longitudinal, prospective, open label, non-comparative

POPULATION: Forty-six (46) post menopausal women with vaginal dryness

DRUG: Polimers and Sodium Lactate

TREATMENT: Only treatment - two weekly applications (monday and thursday or tuesday and friday) for 12 weeks

EVALUATION: The evaluation of the effectiveness will be held on all visits by medical clinical evaluation, evaluation of symptoms resulting from the dryness (VHI), pH evaluation (pH tape) and evaluation of female sexual quality (FSFI) and subjective evaluation as well as the compliance through the patient diary. The evaluation of the acceptability of the product will be the last visit by a questionnaire. The safety assessment will be carried out on all visits by identifying adverse events

Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 40 years.
* in healthy postmenopausal women (not menstruating for more than one year).
* Women with vaginal dryness (VHI score in item vaginal moisture between 1-3)
* women with active sex lives of at least one sexual intercourse in the month
* Women without a history of sensitivity to similar formulations.
* understanding and signing an informed consent agreement.

Exclusion Criteria:

* Women in using other intravaginal gel moisturizer.
* Women diagnosed with cancer.
* Women with disease or condition that, in the opinion of the gynecologist, could affect the test results.
* Women using hormone replacement therapy in the last 3 months.
* Absence of history or visible evidence of chronic skin disease or regional infections.
* Women with genital herpes, vaginal infections or urinary tract infection.
* Pregnant women and nursing mothers.
* Personal history of allergy and hypersensitivity to any product of feminine hygiene.
Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Aplastic Anemia

Rationale: Chemotherapy with fludarabine, cyclophosphamide and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, depletion CD3±CD19 cells may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation.

Purpose: This phase I/II trial is to evaluate the safety and efficacy of fludarabine, cyclophosphamide and antithymocyte globulin with CD3±CD19 depleted graft from haploidentical donors in treating patients with aplastic anemia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of life-threatening marrow failure (severe aplastic anemia) of nonmalignant etiology meeting 2 of the following criteria:

  * Granulocyte count \< 500/mm3,
  * Corrected reticulocyte count \< 1%,
  * Platelet count \< 20,000/mm3
* No HLA-identical family member or closely matched (8 of 8 HLA-locus match) unrelated marrow donor available
* HLA-haploidentical related donor available

Exclusion Criteria:

* Paroxysmal nocturnal hemoglobinuria or Fanconi anemia
* Clonal cytogenetic abnormalities or myelodysplastic syndromes
* Active fungal infections
* HIV positive
* Severe disease other than aplastic anemia that would severely limit the probability of survival during the graft procedure
* Pregnant or nursing
Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

RATIONALE: Radical prostatectomy may be an effective treatment for locally advanced prostate cancer.

PURPOSE: Phase II trial to study the effectiveness of radical prostatectomy in treating patients who have locally advanced prostate cancer.

OBJECTIVES:

* Determine the success rate of radical prostatectomy in patients with locally advanced adenocarcinoma of the prostate.
* Determine the serious toxic event rate of this surgery in these patients.
* Determine the pN status of patients treated with this surgery.
* Determine the percentage of patients found to have organ-confined tumors (pT2) after undergoing this surgery.
* Determine the 2-year prostate-specific antigen-free survival rate of patients treated with this surgery.
* Determine the surgical morbidity rates of patients treated with this surgery.

OUTLINE: This is a multicenter study.

Patients undergo limited pelvic lymphadenectomy and then radical retropubic prostatectomy.

Patients who are found to have pN-positive disease receive further treatment according to the investigator's discretion. Patients with pN0 disease are followed every 3 months for 1 year and then every 4 months for 1 year.

PROJECTED ACCRUAL: A total of 32-74 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Unilateral cT3a, cN0, M0
* Well or moderately differentiated tumor

  * Gleason score no greater than 7 (4 plus 3 or 3 plus 4)
* Total serum prostate-specific antigen no greater than 20 ng/mL (Hybritech equivalent)

PATIENT CHARACTERISTICS:

Age:

* 70 and under

Performance status:

* WHO 0-1

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 9 g/dL

Hepatic:

* Bilirubin no greater than 1.5 times normal
* ALT or AST less than 3 times normal
* PT and PTT normal

Renal:

* Creatinine no greater than 1.5 mg/dL

Cardiovascular:

* No preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
* No myocardial infarction within the past 6 months

Pulmonary:

* No gross abnormalities on chest x-ray

Other:

* No other disease that would preclude surgery
* No other prior malignancy except adequately treated basal cell skin cancer
* No other concurrent primary malignancy
* No psychological, familial, sociological, or geographical condition that would preclude compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* No prior hormonal therapy that would affect assessment of clinical T staging, margin positivity, or definitive pT staging

Radiotherapy:

* No prior pelvic radiotherapy that would affect surgical resectability and perioperative morbidity

Surgery:

* No prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any surgery for benign prostatic hypertrophy, or transurethral resection of prostate) that would preclude prostatectomy
Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency

The aim of our study was to compare the effectiveness of active and passive practices in patients with CVI.

Volunteers who have been diagnosed with venous insufficiency according to the criteria of inclusion, who applied to Cardiovascular Surgery Department will be included this study.

Participants will be randomly allocated 3 groups using the 'Research Randomizer' website. In all groups, a common evaluation protocol will be applied to the patients.

Compression therapy will be applied to the first group. Active treatment in addition to compression therapy will be applied to the second group. Passive treatment in addition to compression therapy will be applied to the third group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of venous insufficiency with duplex ultrasonography
* Classification of CEAP (Clinical-Etiological-Anatomical-Pathological) used in venous insufficiency is C3-C4-C5-C6
* Ankle-brachial index (ABI) is less than 0.7
* Possibility to communicate in written and verbal in Turkish
* Have a level of cognitive ability to understand the instructions given

Exclusion Criteria:

* Presence of deep vein thrombosis
* Ulceration or open burn wound in lower extremity greater than 4 cm
* Presence of infected ulceration
* Cardiorespiratory insufficiency
* Orthopedic, rheumatologic or neurological comorbidities restrain the exercise in the lower extremity
* Presence of a psychiatric illness requiring the use of prescribed medicines
A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights

The purpose of this study is to compare the blood levels of valproic acid in subjects with different body weights and to evaluate whether the pharmacokinetic parameters of this drug is altered in the obese population.

Many pharmacologic agents are dosed based on the weight of the patient, and studies are conducted to determine the appropriate doses of drugs for patients with different weights in order to find the safest and most effective dose for various weights. Valproic acid is a commonly used agent for the treatment of epilepsy, as well as migraine headaches and psychiatric disorders. This prospective study is designed to evaluate the effects of obesity on the pharmacokinetic parameters of valproic acid when compared to individuals at their healthy weight.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female age 21-60 years
* Normal healthy volunteers as per interview at screening
* Willing and able to provide written informed consent and comply with the study protocol

Exclusion Criteria:

* Inability to take oral medications
* pregnant or lactating females
* known hypersensitivity to valproic acid
* BMI less than 18.5 kg/m\^2
* BMI between 25 and 29.9 kg/m\^2, inclusive
* Taking any drug or dietary supplement within one week prior to study period
* Consumption of food 6 hours prior to study drug ingestion
* Know family history or history of urea cycle disorders
* Past history of pancreatitis
* Past history of liver disease
Subarachnoid Block Versus Ultrasound Guided Transversalis Fascia Plane Block for Postoperative Analgesia of Inguinal Hernia Repair in Adults

The aim of our study is to investigate the effect of the ultrasound guided transversalis fascia plane block on the postoperative opioid consumption as a part of multimodal analgesia in patients undergoing inguinal herniorrhaphy under spinal anesthesia.

The aim of our study is to investigate the efficacy of the ultrasound-guided transversalis fascia plane block as a postoperative analgesia as a part of multimodal analgesia in patients undergoing inguinal herniorrhaphy under spinal anesthesia.

The ultrasound (US)-guided transversalis fascia plane (TFP) block was first described by Hebbard in 2009. A local anesthetic (LA) injected between the transversus abdominis muscle, and its deep investing fascia will block the anterior and the lateral branches of the T12 and L1 nerves (4). The efficacy of this block has been demonstrated in iliac crest bone graft harvesting, caesarean section and inguinal herniorrhaphy

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing inguinal herniorrhaphy.
* Patients 18-60 years.
* ASA I and II.
* Both sexes.
* Having no contraindication for spinal anesthesia or TFP block.

Exclusion Criteria:

* Refusal of regional anesthesia.
* Infection in the back or at the site of injection for TFP block.
* INR \> 1.5.
* Platelet count \< 80000 per microliter of blood.
* Patients known to be allergic to amide local anesthetics.
* BMI greater than 35 kgm_2.
* Opioid addiction.
* Have communication problems that may hinder the assessement of pain postoperative.
Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique

The aim of this study is to evaluate the transcrestal sinus lift using Osseodensification versus lateral window technique with simultaneous implant placement.

In Group 1, crestal maxillary sinus floor elevation will be done using Osseodensification. An incision will be made near the palate, and a conservative flap will be elevated. Osseodensification burs will be used to create an osteotomy and elevate the sinus membrane gradually. The osteotomy will be filled with bone graft, and the implant will be inserted.

In Group 2, lateral maxillary sinus floor elevation will be performed by creating a bony window in the lateral wall of the sinus. The sinus floor will be carefully elevated using sinus elevation curettes. If there's a membrane perforation, a collagen membrane will be applied. Bone substitute material will be packed into the sinus, and a resorbable membrane will be placed over the window before suturing.

Both groups will use Nanobone as the graft material.

Eligibility Criteria:
Inclusion Criteria:

* Patient with residual bone height from 4-6 mm and bone quality is D3 or D4.
* Patients had to require implant treatment in the posterior maxilla.
* All patients will sign a consent form before the study.

Exclusion Criteria:

* 1- Sinus pathology that precludes routine sinus augmentation.
* All contraindications of dental implants.11,12
* Heavy smokers.
Is There a Difference in Pulmonary Functions and Craniovertebral Angle Among Adolescent Based on Smart Phone Usage

The smartphones have become a necessity for most adolescents as they are used for communication and entertainment and education purposes especially in the period of COVID pandemic. They spend most of their time in using smartphones. This could have side effects on their health.

While using a smartphone, adolescent usually flex their neck and maintain the head in a forward position for long periods of time, which may affect the craniovertebral angle and pulmonary functions as sustained forward neck posture may lead to respiratory dysfunction.The purpose of the study is to investigate the effect of smart phones and tablets usage time on craniovertebral angle and problems of pulmonary functions among adolescents between 14-18 years' old.

A well-developed adolescents of both genders will participate in this study after signing institutionally approved consent form prior to data collection

* They will be recruited from many secondary schools in Cairo. Their ages range from 14 to 18 years. They will be subdivided into two groups according to Smartphone addiction scale-short version (SAS-SV) into an addict group who use smart phone not less than 4 hours/day for at least 4 years and non-addict group who used smart phone less than that.
* Design of the study: Cross sectional design will be applied in this study.
* Smartphone addiction scale-short version (SAS-SV) will be used to divide the subjects into two groups addict and non-addict groups
* (Image J) image processing and analysis in Java system will be used to measure the craniovertebral angle for both groups.
* Micromedical Gold standard fully computerized portable auto spirometer will be used to measure Pulmonary functions test in the form of forced expiratory volume in one second (FEV1), forced vital capacity (FVC)and FEV1/FVC for both groups.
* All data will be recorded and statistically analysis.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of late childhood ( adolescence)
* Age of participants ranged from 14 to 18 years.
* Subjects with normal development.

Exclusion Criteria:

* Athletic one.
* Genetic spinal deformity.
* Injury to the neck.
* History of inflammatory joint disease.
* History of surgical intervention at the neck. Patients with neuropediatric problem.
Laser-Mediated Photodynamic Therapy of Acne Vulgaris and Rosacea

To evaluate efficacy and adverse effect from long-pulsed dye laser versus long-pulsed dye laser-mediated photodynamic therapy for acne vulgaris and rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Inflammatory acne and rosacea
* Skin types I-IV

Exclusion Criteria:

* Patients younger than 18 years
* Skin types V and VI
* Topical and systemic conventional acne treatments