cyrilzakka/clinical-trials huggingface dataset:
Implant Placement Using a Newly Designed Single Drill Versus Conventional Sequential Drills

dental implants are usually placed by sequential set of drills which could increase the time of the surgery and could raise the temperature of the osteotomy preparation so a new drill was designed to place the implants fast and easy way

Dental implant success is evident nowadays with the predictable functional and aesthetic results obtained . Simplified techniques and approaches are preferred for the convenience of both the patients and operators . Current research is focusing on decreasing the number of instruments used, shortening of the operation time and performing flapless approaches for implant placement whenever possible. This is done to reduce the postoperative complaints, such as pain, swelling and bleeding; thus decreasing the need for analgesics and minimising the occurrence of morbidity .

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria :

  * implant recipient sites free from any pathological conditions.
  * Patients who were cooperative, motivated and hygiene conscious were selected.
  * non smoker patients
* exclusion criteria :

  * Patients unable to undergo minor oral surgical procedures
  * patients with a history of drug abuse or catabolic drugs were not included.
  * Patients with a history of psychiatric disorder and those with unrealistic expectations about the aesthetic outcome of implant therapy were also excluded.
  * Patients with insufficient vertical inter-arch space, on centric occlusion, to accommodate the available restorative components .
  * Uncontrolled diabetic patients
  * Patient who had any systemic condition that may contraindicate implant therapy (impaired wound healing - bleeding disorders
  * patients who had any habits that might jeopardise the osseointegration process, such as heavy smoking and alcoholism.
  * Patients with para-functional habits that produce overload on the implant, such as bruxism and clenching were excluded.
Influence of Obesity and Gastric Bypass on Medication Absorption

Patients who have scheduled a gastric bypass (RYGB) in UZ Leuven, will be questioned preoperatively and one, three, six and twelve months after gastric bypass surgery. The purpose of this study is to explore current practice regarding the use of medication and medication counseling after RYGB and to examine the changes in dietary pattern before and after RYGB.

Target group: patients who have scheduled a gastric bypass in UZ Leuven. Patients will be questioned preoperatively and one, three, six and twelve months after gastric bypass surgery. Each assessment will be performed during a routine consultation.

The following aspects will be investigated:

* Medication The investigators have composed a questionnaire to examine which drugs the patients use, adherence, information received about medication and from whom,...
* Clinical parameters Every consultation, concentrations of hemoglobin, iron, hepcidin, vitamin B12,.... and a 24h urine collection to determine calcium excretion will be collected.
* Dietary intake The investigators will ask patients to keep a food record during two non-consecutive days preceding each consultation. In this food record patients have to note all consumed foods and beverages with the right/estimated amounts. This makes it possible to see the changes of the composition of the meals before and after RYGB.
* Body composition

Eligibility Criteria:
Inclusion Criteria:

* Patients who have scheduled gastric bypass
* Use of at least one chronic drug (including contraception)

Exclusion Criteria:

* Patients who have undergone another form of bariatric surgery before RYGB
INSURE: INcidence Free SUrvival Before and After Implantable Cardioverter Defibrillator (ICD) Replacement

The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before and after their first elective ICD replacement.

The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before \& after their first elective ICD replacement. For this purpose all consecutive ICD patients will be included in the study, whose first implanted device is replaced due to ICD battery depletion (i.e. arrival at battery indicator ERI). ICD replacements due to other reasons can be included if duration of first ICD implantation was \> 3 years. All patients included in the trial are regularly followed up until delivery of their first adequate ICD therapy. The collected data shall provide statistically valid information about the risk to patients who never have experienced adequate ICD therapy before the ICD replacement investigated in this study. In the future, these statistical risk data can give additional information to implanting physicians, such as whether an ICD replacement can eventually be omitted in those patients who are at very low risk for the occurrence of ICD therapies. All actually available GUIDANT ICDs with CE certificate can be implanted in this trial.

Eligibility Criteria:
Inclusion Criteria:

* All elective ICD replacements due to battery depletion of the first ICD being implanted in the patient

Exclusion Criteria:

* Non-availability to regular follow-up
* Age \< 18 years
* Pregnancy
PET CT With HX4 in Cervix Cancer

The aim of this study is:

1. to determine if tumor hypoxia can be accurately visualised with \[18F\]HX4 PET imaging in cervix cancer,
2. to correlate the \[18F\]HX4 PET images with blood and tissue markers,
3. to investigate the quality and optimal timing of \[18F\]HX4 PET images,
4. to compare \[18F\]HX4 PET uptake with \[18F\]FDG PET uptake before and after treatment and
5. analyze correlation with responses

Tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. Hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. In Cervix cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. \[18F\]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging to find a marker for hypoxia that can be used in standard clinical practice. Current hypoxia tracers lack reliable image quality and kinetics. Because of the short half life and clearance, the investigators expect that \[18F\]HX4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as \[18F\]-misonidazole. In a recent phase 1 clinical study from van Loon et al, PET-imaging with \[18F\]HX4 was feasible without any toxicity. The clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies.

Eligibility Criteria:
Inclusion criteria

* Histologically confirmed cervix carcinoma (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma)
* tumor stages FIGO IB - IVA
* WHO performance status 0 to 2
* Scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia)
* No previous surgery to the Cervix
* No previous radiation to the Cervix
* The patient is willing and capable to comply with study procedures
* 18 years or older
* Written informed consent before patient registration

Exclusion criteria

* Recent (\< 3 months) myocardial infarction
* Uncontrolled infectious disease
* Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study
Biomarkers in Tissue and Blood Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue and blood samples from patients with early-stage non-small cell lung cancer.

OBJECTIVES:

* Evaluate aberrant methylation patterns in tissue and serum samples from patients with early-stage non-small cell lung cancer (NSCLC) to validate the Johns Hopkins single institutional study.
* Attempt to define subgroups of patients at greater risk for recurrent or metastatic disease who may benefit from more aggressive adjuvant therapeutic regimens.
* Develop prognostic indicators for disease-specific and overall survival.
* Define new potential molecular targets for therapy.

OUTLINE: Archived tumor and intrathoracic lymph node tissue samples are analyzed for aberrant DNA methylation (p16/CDKN2A, DAP kinase, H-cadherin, APC, and RASSF1A) by methylation-specific PCR. Analyses are then compared with the preliminary data from the Johns Hopkins institutional study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of early-stage non-small cell lung cancer

  * T1 or T2, N0 disease
  * Had a lobectomy or greater resection with negative surgical margins (R0 resection)
* Available tumor and lymph node specimens from patients enrolled on ACOSOG-Z0040 and ACOSOG-Z0030 trials

  * Node-negative with recurrent disease within 3 years (cases)
  * Node-negative patients without recurrent disease (controls)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions

The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to valacyclovir hydrochloride or any comparable or similar product.
Effectiveness of Online Mindfulness Platform in Improving Anxiety, Depression, and Stress in Adult

During the COVID-19 pandemic, adults may experience emotional stress and impact. To reduce the risk of cross-infection, this study aims to use online mindfulness training to improve emotional well-being during the pandemic and assess their effectiveness.

he COVID-19 pandemic had a detrimental global impact on the health of most populations. It causes and also generates further damage to physiology and psychology. Mindfulness is recognized as an effective method for improving the symptoms of physical and mental problems. The purpose of this review will explore the efficacy of an online mindfulness intervention for individuals or groups that impacted symptoms of physiology and psychology in adults during the pandemic base on the principle of evidence-based medicine. At the same time, a set of mindfulness intervention plans will be developed based on the best evidence searched, and a pilot study will be conducted. Therefore, this research design will be divided into two stages. In the first stage, six electronic bibliographic databases will be comprehensively searched for randomized controlled trials that have been published from February 2020 to currently published articles. The research subjects are adults who live in the community and accept online mindfulness intervention. Quality assessment will be performed according to the Cochrane Collaboration's Risk of Bias tool will be used for randomized controlled clinical trials (RCTs). A meta-analysis of the intervention timing and measurements will be performed using Review Manager 5.1 software. The second phase will be a randomized controlled trial pilot study of mindfulness interventions, The research subjects will be divided into two groups, namely the mindfulness intervention experimental group (E) and the control group (C). The researcher uses structured questionnaires to collect data before intervention (To) and at 4 weeks (T1), 8 weeks (T2) after the intervention. Data will be analyzed using the Generalized Estimating Equation to analyze the repeated measurements and intention-to-treat analysis for reducing attrition bias.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 20 years of age
* Conscious
* Able to communicate in Taiwanese

Exclusion Criteria:

* Patients currently receiving antidepressant or anti-anxiety medications
* Patients unable to communicate verbally
* Patients who refuse to provide informed consent
APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism

Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ for Presbyopia or the APIOC™ for Presbyopia Astigmatism contact lenses.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must provide written informed consent.
2. The subject must appear willing and able to adhere to the instructions set forth in this protocol.
3. At least 40 years of age and no more than 70 years of age.
4. ≤ 4.00 D of corneal astigmatism.
5. ≤ 2.50 D of refractive astigmatism.
6. Refractive error range +4.00 DS to -6.00 DS
7. Require a reading addition (bifocal) of at least 0.75 D
8. Flat and steep keratometry readings within 40 to 48 D.
9. Clear, healthy corneas with no irregular astigmatism.
10. Normal, healthy conjunctiva in both eyes.
11. Free of active ocular disease. Refractive error and presbyopia are permitted.
12. Be a current or former (within the last 3 years) contact lens wearer.
13. Best-corrected near and distance visual acuity better than or equal to 20/25.

Exclusion Criteria:

1. Irregular corneal astigmatism.
2. Corneal scarring unless off line-of-site and well healed.
3. Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
4. Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Occasional artificial tear use is permitted.
5. Systemic disease that would interfere with contact lens wear.
6. Currently pregnant or lactating (by self-report).
7. History of strabismus or eye movement disorder, including exophoria at near that is 4 D or greater than at far, and a receded near point of convergence break that is 6 cm or greater.
8. Active allergies that may inhibit contact lens wear.
9. Upper eyelid margin at or above the superior limbus.
10. History of ocular or lid surgery.
11. Immediate family members or significant others of doctors or staff at the clinical site.
PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants

This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of subjects will receive PNEUMOSTEM, while the other half will receive a placebo.

Bronchopulmonary dysplasia (BPD) is a chronic lung disease in which premature infants and it results in significant morbidity and mortality. PNEUMOSTEM is intended to prevent and treat BPD by modulating inflammation and repairing damaged lung tissue in premature infants through paracrine effects.

Eligibility Criteria:
Inclusion Criteria:

at screening and randomization

1. 23 weeks to \< 25 weeks of gestational age
2. 500g to 1,250g body weight at birth
3. premature infant within postnatal 13 days of age
4. use ventilator with ventilation rate \>12 breaths/min or oxygen supply \> 25%, or use high frequency ventilator (HFV)

at IP administration

1. premature infant within postnatal 5 to 14 days of age
2. No improvement in ventilator setting 24 hours prior to administration of IP

Exclusion Criteria:

1. subject with cyanotic congenital heart disease or non-cyanotic congenital heart disease that can cause heart failure
2. subject with pulmonary hypoplasia, congenital diaphragmatic hernia, or serious lung malformation such as congenital cystic lung disease
3. subject with chromosome disorder with serious malformation (i.e. Edward syndrome, patau syndrome, Down syndrome, etc.), severe congenital malformation (i.e. hydrocephalus, encephalocele, etc.), or severe congenital infection (i.e., herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)
4. subject with serious sepsis as active infection or shock due to sepsis
5. subject with grade 3 or 4 of bilateral intraventricular hemorrhage
6. at screening, subject with active pulmonary hemorrhage or active air leak syndrome
7. subject who underwent/will undergo surgery within 72 hours before/after investigational product (IP) administration
8. subject who is expected to be treated with surfactant within 24 hours prior to IP administration
9. subject who is expected to be allergic to gentamicin (Birth mother's allergy for gentamicin will be confirmed).
10. subject who have previously participated in other clinical trials
11. subject who is considered ineligible by investigator due to other medical reasons
A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen

The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.


Eligibility Criteria:
Inclusion Criteria:

* Female subject of non-childbearing potential or of childbearing potential agreeing not to become pregnant during the study.
* Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
* Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by protocol

Exclusion Criteria:

* Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
* Have used forbidden concomitant medications as defined by the protocol
Glycaemic Index of Fibre-rich Flours in Healthy Volunteers

The project aims to evaluate the glycaemic index of breads from different types of flour. In particular, we aim to understand the glycaemic and insulin responses as well as satiety and sensory profiles of the products.


Eligibility Criteria:
Inclusion Criteria:

* Having a Body Mass Index (BMI) between 18.5 and 30 kg/m²
* Non-smoker for more than three months
* Having signed the informed consent form
* Likely to follow the constraints generated by the study (one morning per week for 9 weeks)
* Social insurance

Exclusion Criteria:

* Pregnant woman
* Subject with a known progressive somatic or psychiatric disease
* Fasting blood glucose greater than 6.1 mmol/L (1.10 g/L), postprandial blood glucose greater than 7.7 mmol/L (1.4 g/L) or known diabetes treated or untreated
* Hyperinsulinemia or a history of insulinoma
* HbA1c greater than 7 %
* History of hypercholesterolemia, hypertension, diabetes or glucose intolerance
* History of food allergy or digestive pathology likely to affect digestion or absorption
* Renal failure
* ASAT or ALAT elevation beyond 1.5 times the upper limit
* Subject consuming more than three glasses per day of alcohol or suffering from various addictions
* Weight change of more than 3 kg in the last three months
* Person participating in another clinical study, or in a period of exclusion from another study
* Person deprived of liberty or under judicial protection
RNA Biomarkers in Tissue Samples From Infants With Acute Myeloid Leukemia

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying RNA biomarkers in tissue samples from infants with acute myeloid leukemia.

OBJECTIVES:

* Sequence the microRNAs present in 20 infant AML samples as a pilot study.
* Compare microRNAs present in infant AML samples to infant ALL samples that are being concurrently sequenced in a separate study to identify lineage- and translocation-specific microRNAs.

OUTLINE: This is a multicenter study.

Previously collected cryopreserved cells from diagnosis are sequenced using reverse transcriptase-PCR.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Available cryopreserved cells from diagnosis

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Retrolaminar Block for Postoperative Analgesia in Lumbar Herniectomy Surgery

This retrospective study included 30 patients scheduled for lumbar herniectomy under general anesthesia. The patients were randomized to receive either retrolaminar block or intravenous analgesia treatment.Numeric Pain Rating Scale (NPRS) was used to measure the pain intensity of patients in postoperative period. Postoperative analgesic requirements were recorded to asses effectiveness of regional anesthesia.Opiod and NSAİD as rescue medication were recorded postoperatively.

This retrospective study included 30 patients scheduled for lumbar herniectomy under general anesthesia. The patients were randomized to receive either RLB or intravenous analgesia treatment. All patients were routinely monitored and their heart rate, blood pressure and pulse oxymetry recorded during the anesthesia. Numeric Pain Rating Scale (NPRS) scores evaluated at 2, 8, 12, 24 and 48 h after the surgery. Opiod and NSAİD as rescue medication were recorded postoperatively

Eligibility Criteria:
Inclusion Criteria:

* patients accepted to part in the study

Exclusion Criteria:

* patients not accepted to part in the study
* allergic reaction to local anesthetics drugs
* lumbar herniectomy of more than two levels
Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms

The primary goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected. The results of this study will permit the establishment of endpoints and clinical design for a subsequent U.S. trial.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement
* Subjects with an infrarenal AAA that is \>/= 4.5 cm in diameter for males, or \>/= 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months
* Subjects who consent to participate
* Subjects who agree to comply with the follow-up schedule

Exclusion Criteria:

* Subjects with dissections, ruptured aneurysms, or symptomatic aneurysms
* Subjects with prior AAA repair
* Subjects with medical conditions that would complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
* Subjects who are pregnant or lactating
* Subjects participating in other investigational studies
* Subjects with less than 2 years life expectancy