cyrilzakka/clinical-trials huggingface dataset:
Thrombophilic Risk Factors in Preterm and Infants Treated at Ha'Emek Medical Center Between the Years 1990 to 2010

There are several factor that can be related to Neonatal Thrombotic events. Among them hypercoagulability can be the cause of those events. Factor V Leiden (FVL) and Prothrombin mutation are the most common causes of hereditary thrombophilia. The incidence of in the arab population is known to be higher than the incidence in another western populations. The purpose of this study is to review retrospectively the thrombophilic risk factors that were found in a cohort of premature babies and term newborns treated and investigated at the Neonatal Intensive Care Unit and at the Pediatric Hematology Unit.

All the demographic and clinical data will be summarized. Factors non related to the coagulation system like catheters, severe infections or congenital heart defects will be recorded. Also a full workup of prothrombotic risk factors are routinely performed in those infants. The study included basic coagulation analysis, Protein C, S and Antithrombin III activity, Activated Protein C Resistance, serum homocystein, lipoprotein (a) and Lupus Anticoagulant.

Also the three common genetic factors are analysed including Factor F Leiden (G1691A), Prothrombin Mutation (G20210A) and MTHFR polymorphism (C677T).

Eligibility Criteria:
Inclusion Criteria:

-All newborns (Term and Premature) diagnosed with Neonatal Thrombotic events between year 1990 to 2010.
Testing Alcohol Interventions Among Job-seekers

The aim of the randomized controlled trial was to test two behavioral interventions among job-seekers with risky drinking. The interventions differed in their theoretical background: Intervention A was tailored to the stage of change, and Intervention B was non-stage-tailored. Over 12 months, job-seekers were pro-actively screened for risky drinking at three job-agencies. Job-seekers with risky drinking were asked to participate in the study. All three groups were assessed at baseline, and 3, 6 and 15 months later. The baseline assessment was self-administered using handheld computers. The follow-up assessments by interviews on the phone, primarily. Both intervention groups received individualized computer generated feedback letters at baseline and 3 months later.


Eligibility Criteria:
Inclusion Criteria:

* Job-seekers with risky drinking (AUDIT-C ≥ 4/5 \[women/men\] and AUDIT \< 20)

Exclusion Criteria:

* Job-seekers already asked to participate during an earlier visit at the job agency
* Job-seekers not intending to talk to a job-agent/ without waiting time
* Job-seekers physically or mentally not capable of participating in the study
* Job-seekers with insufficient language/ reading skills
* Job-seekers with more severe alcohol problems (AUDIT ≥ 20)
* Job-seekers employed at the department conducting the study
Retrospective Comparison of Lap and Robotic-Assisted RYGB and SG

A retrospective, multicenter, comparative chart review study comparing laparoscopic and robotic-assisted Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of procedure
* Undergone either laparoscopic or robotic-assisted Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
* Meets qualification for primary bariatric procedure per American Society for Metabolic and Bariatric Surgery guidelines

Exclusion Criteria:

* Subject who underwent bariatric procedure as an emergency procedure
* Subject who underwent bariatric procedure as an revisional bariatric procedure
* Subject who underwent bariatric procedure as an secondary procedure
Lower Dose Decitabine (DAC)-Primed TC (Carboplatin-Paclitaxel) Regimen in Ovary Cancer

Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer death in women. Most patients are typically diagnosed with advanced-stage disease. Platinum-paclitaxel regimen has been widely adopted as a standard first-line treatment for advanced ovarian cancer. Multiple collaborative randomised phase III trials evaluating the addition of a third chemotherapy agent, maintenance therapy or alternative taxanes failed to demonstrate significant improvements over a standard carboplatin/taxane doublet.

Decitabine (DAC), one major DNA demethylating agent, has been approved for treatment of preleukemic hematological disease myelodysplastic syndrome (MDS) by the Food and Drug Administration. Past trials of these with high doses, i.e., the use of maximal tolerated dose, for patients with solid tumors showed a low therapeutic index, due to extreme toxicities that have probably confounded the ability to document the true clinical response.

Low dose DNA demethylation agent decitabine (DAC) can resensitize the therapeutic indexes of resistent ovary cancer cells in vivo and in vitro.

The investigators hypothesized that DAC-triggered epigenetic reprogramming of tumor cells and possible immune cells could induce pronounced long-dated clinical effect by chemosensitization- and immunopotentiation-driven maximal eradicating roles on the minimal/residual lesions in primary patients with poor prognosis.

Given the poor prognosis and the currently existed therapeutic strategies, The investigators will perform a prospective, randomized, phase II to III, intergroup trial to compare carboplatin plus paclitaxel (TC) with the DAC-primed TC (DTC) regimen in previously untreated patients with stage II to IV ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stages II to IV fallopian tube cancer, or primary peritoneal cancer. If only the results of cytological examinations were available, patients needed to have the following criteria: a cytological diagnosis of adenocarcinoma; an abdominal mass more than 2 cm in diameter on abdominal images; and a CA125 to carcinoembryonic antigen (CEA) ratio10 of more than 25, or no evidence of gastrointestinal cancer if CA125/CEA ratio was less than or equal to 25. Previous chemotherapy was not allowed.
* All patients had to be at least 18 years of age, to have an Eastern Cooperative
* Oncology Group (ECOG) performance status of 0-3, and were required to have adequate hematologic, renal, and hepatic function.

Exclusion Criteria:

* Patients were excluded if they had an ovarian tumour with a low malignant potential, or synchronous or metachronous (within 5 years) malignant disease other than carcinoma in situ.
Moderate Alcohol Consumption and Heart Function in Patients with a Recent Myocardial Infarction

A total of 220 patients (110 per arm) who report moderate alcohol consumption between 4 and 28 standard units (1 standard unit = \~10 grams) per week in the 12 months prior to hospital admission will be planned for randomization, using a 1:1 ratio to pursue moderate alcohol consumption (1 standard unit per day for women and 2 standard units per day for men for 12 months) or abstinence (except for one drink on predefined/agreed special occasions) for a total duration of 3 months. An echocardiography will be performed at baseline and 3 months to assess changes in systolic cardiac function (LVEF) for the primary endpoint. A core laboratory team blinded to assignment will perform data interpretation.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization for acute ST-elevation MI (STEMI) or non ST-elevation MI (NSTEMI) within 365 days prior to screening
* Men and women aged ≥18 years who are capable and willing to provide consent
* ECG ischemic changes, such as persistent or dynamic ST-segment deviation
* Evidence of positive high-sensitive troponin
* Confirmation of coronary heart disease aetiology by angiography
* Capacity to complete study visits with strict adherence to the protocol assignment
* Self-reported average alcohol consumption of between 4 and 28 standard units per week in the 12 months prior to the index hospitalization.

Exclusion Criteria:

* High alcohol consumption, defined as an average of \>28 alcoholic standard units/week in the 12 months prior to the index hospitalization
* Alcohol use disorder (AUDIT score \>20 at screening)
* History of alcohol or substance abuse
* Naïve to alcohol consumption
* Light alcohol consumption (\<4 standard units by week)
* Prior severe heart failure (NYHA III-IV)
* Severe LV dysfunction at screening (\<30%)
* History of gastric ulcer or gastro-intestinal bleeding
* Serious chronic liver disease or liver test elevation (\> 3 times upper limit normal range)
* Personal history of any colon or liver cancer
* Any active malignancy (less than 5 years or ongoing treatment)
* Estimated glomerular filtration rate 15 ml/min/1.73m² or end-stage renal disease
* Any medication (investigator's discretion) making study participation impractical or precluding required follow-up
* History of organ transplant
* Participation in another trial testing intervention on similar CV outcomes (investigator's discretion)
* Any medical, geographic, or social factor making study participation impractical or precluding required follow-up.
* Pregnant, breastfeeding or planning to become pregnant within 12 months.
Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a confirmed diagnosis of epilepsy.
* Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
* Subjects having participated in the previous double-blind monotherapy trial (N01061 \[NCT00150735\] or N01093 \[NCT00150787\]).
* Male/female subjects (\>= 16 years).

Exclusion Criteria:

- Need for an additional Antiepileptic Drug (AED).
Six-month Performance of Meniscal Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries.

The main hypothesis of the study is that in situ infiltration of the meniscal lesion would provide patients with lasting and greater relief than intra-articular infiltration. A statistically significant difference would be if the Lysholm score of the meniscal wall group at 3 months is 9.5 points higher than that of the intra-articular infiltration group.

The aim is to evaluate the effectiveness of meniscal wall infiltration under ultrasound in the treatment of stable degenerative meniscal lesions versus intra-articular infiltration (Gold standard) at 3 months by Lysholm's algo-functional score.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a symptomatic meniscal lesion of a degenerative nature, isolated or associated with early osteoarthritis or chondropathy (Ahlbach stages 1 and 2).
* Indication for peri-meniscal infiltration under ultrasound control of the knee for a clinically stable degenerative meniscal lesion confirmed by MRI and radiography.
* Patient who has given free and informed consent.
* Patient who has signed the consent form.
* Patient affiliated or beneficiary of a health insurance plan.
* Adult patient (≥18 years of age).

Exclusion Criteria:

* No iconographic evidence of meniscal injury.
* Associated lesions of the central pivot of the knee.
* Knee pain of osteoarthritic origin strongly suggested by the clinic associated with an advanced radiological stage of osteoarthritis (Ahlbach stages 3 and 4).
* Presence of a skin lesion at the infiltration sites.
* Suspected soft tissue or joint infection.
* Patient participating in research involving human subjects defined as Category 1.
* Patient in an exclusion period as determined by another study.
* Patient under court protection, guardianship or trusteeship.
* Patient unable to give consent.
* Patient for whom it is impossible to give informed information.
* Pregnant, parturient or breastfeeding women.
Desmopressin Melt: Impact on Sleep and Daytime Functioning

Nocturnal enuresis affects 10% of the 7-year-old children and is essentially caused by a mismatch between nocturnal bladder capacity and the amount of urine produced during the night together with failure of the child to awaken in response to a full bladder.Urine overproduction at night or nocturnal polyuria (NP) is a major factor contributing to monosymptomatic nocturnal enuresis (MNE) pathophysiology in a large proportion of patients.

Since NP is related to an abnormal circadian rhythm of arginine vasopressin (AVP) secretion, the synthetic AVP analogue desmopressin is widely used to treat MNE.

It is recommended by the International Consultation on Incontinence (grade A,level 1). Desmopressin is available in 3 different formulations: nasal spray, tablet and the newest form melt.

Baeyens et al demonstrated an increased prevalence of attention deficit-hyperactivity disorder (ADHD) in children with MNE According to recent data there is a high incidence of periodic limb movements in sleep at night in children with nocturnal enuresis. Those children have an increased cortical arousability leading to awakening.

The frequent awakening most likely has an influence on concentration and other ADHD-symptoms in daily life.

This study will assess the impact of desmopressin melt on prepulse inhibition, ADHD-symptoms, cognition and learning, sleep, quality of life and self esteem.

New patients aged 6-16 years with monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems are tested before the start of the study medication desmopressin melt (T1) and 6 months later (T2). It is a multi-method, multi-informant study.


Eligibility Criteria:
Inclusion Criteria:

* New patient
* age 6 to 16 years
* monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems

Exclusion Criteria:

* mental retardation
* autism spectrum disorders
* daytime incontinence resistant to therapy
* dysfunctional voiding
* poor therapy-compliance
* diuretics, antihypertensives, uropathy, renal abnormalities
Noninvasive Examination of the Work of Breathing in Patients With Amyotrophic Lateral Sclerosis (ALS).

The literature to date indicates that noninvasive positive pressure ventilation (NIPPV) provides effective noninvasive ventilator support, prolongs survival, and improves quality of life (QOL) in Amyotrophic Lateral Sclerosis (ALS) patients. It is generally recommended to patients when their pulmonary function testing demonstrates a drop to 50% forced vital capacity (FVC). One result of using NIPPV may be a reduction in the work of the breathing which would lead to decreased caloric needs. However, the work of breathing and the effects of noninvasive ventilation on caloric use have not been studied in patients with ALS. This is extremely important since there may be a reduction in the caloric needs when ALS patients are placed on NIPPV and if the caloric intake is not adjusted, overfeeding can occur. Overfeeding with too many calories can lead to an increase in carbon dioxide which would actually worsen the respiratory failure.

The overall aim of this project is to evaluate how many calories are used by ALS patients while at rest, when placed on NIPPV, and when breathing against a resistance. This will be accomplished using a metabolic cart during these activities. At present, the metabolic cart is routinely used in ALS patients at the time of feeding tube placement to calculate caloric needs. Using the cart to calculate the caloric expenditure on and off the ventilator will aid in calculating the work of breathing and the effects of NIPPV on work of breathing.


Eligibility Criteria:
Inclusion Criteria:

* Patients with probable or definite ALS by El Escorial Criteria between ages 20-85 will be included for evaluation. They must have progression of disease over the preceding 6 months and duration of disease less then 5 years.

Exclusion Criteria:

* Patients who do not meet clinical criteria of the diagnosis including those with pure upper motor neuron syndromes (PLS) or pure lower motor syndromes (SMA, Multifocal conduction block, motor neuropathies).
Effect of Two Toothpastes on Bacteria in Saliva

This study investigated the ability of two zinc-containing toothpaste formulations (Zinc A and Zinc B) to reduce the level of bacteria in saliva in the two-hour period after their use, compared to the effect of rinsing with water alone.

This was a single centre, three treatment, randomized, blinded, cross-over study which involved rinsing with slurries of two sodium fluoride-silica dentifrices containing zinc chloride and sodium citrate, and with water alone. The study consisted of four Visits: Visit 1 (Screening), Visit 2 (Treatment 1), Visit 3 (Treatment 2), Visit 4 (Treatment 3). There was a minimum two days wash out period before the first treatment visit and between treatment visits to avoid any treatment carry-over effect. During that time participants brushed as normal (twice-daily) at home with a washout toothpaste and a toothbrush which was provided at screening. Participants were required not to brush their teeth on the morning of the treatment visits and not to eat or drink for 2 hours prior to the treatment visits.

Eligibility Criteria:
Inclusion Criteria:

* Personnel: GSKCH permanent and contract/contingency workers.
* Consent: Demonstrated understanding of the study and was willing to participate and had received a signed and dated copy of the informed consent form.
* Compliance: Understood, was willing and able and complied with all study procedures and restrictions.
* General Health: Good general health
* Oral Health: Good oral health
* Salivary Flow Rate: Had a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2milliliter per minute (ml/min); stimulated whole saliva flow rate ≥ 0.8ml/min)

Exclusion Criteria:

* Study personnel: Members of the clinical study staff.
* Pregnancy: Pregnant Women
* Breast-feeding: Women who were breast-feeding.
* Allergy/Intolerance: Had Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
* Medication: a) Used an antimicrobial mouthwash within 48 hours of the test visit e.g. Listerine, Corsodyl etc. b) had taken, antibiotics within 2 weeks of the test visit.
* Oral Surgery and Dental Conditions: a)Had an on-going dental treatment b) Had any oral surgery or extraction within 6 weeks of screening c) Symptoms of oral pain or any self-reported oral ulcers or herpetic lesions
* Clinical Study Participation: a) Participation in a clinical study where they received an investigational drug within 2 weeks of the screening visit b) Previously participated in this study.
* Substance Abstinence: Participant who were unwilling to abstain from smoking for at least 2 hours prior to treatment visits.
Neovascularization Patterns in Corneal Graft Rejection

Corneal transplantation is the most commonly performed human tissue transplant worldwide. Over 40,000 corneal transplants occur in the US each year. .

This study will determine specific corneal neovascularization (CN) patterns in human corneal allograft recipients to determine the characteristics that worsen the prognosis for graft survival. We will test the hypothesis that specific characteristics of CN are prognostic for corneal allograft rejection.

The investigators hope to enroll 240 subjects into the study. These patients will be enrolled prior to penetrating keratoplasty. They will be examined by the full protocol preoperatively, and postoperatively at 1 week, 1, 3, 6, 12, 18, and 24 months. During these visits slit lamp biomicroscopy will be used to study CN patterns, and take slit lamp photographs if there is any neovascularization detected, permitting us to develop algorithms of CN characteristics that are predictive for corneal allograft rejection and failure. The corneal tissue removed during these patients' surgeries will be evaluated histopathologically to identify inflammation and neovascularization to confirm and compare to what is seen clinically. There will be two short questionnaires conducted at each visit to assess stress levels.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for corneal transplant

Exclusion Criteria:

* previous corneal transplant
Rate of Postpyloric Migration of Spiral Nasojejunal Tubes in Brain Injured Patients

The success rate of unguided nasojejunal feeding tube insertion will be determined in acute brain injured patients. Factors influencing tube self-progression will be evaluated.

Nutrition support is important in brain injured patients. Several studies have shown that small bowel feeding compared with gastric feeding may be associated with a reduction in pneumonia in critically ill patients. The Canadian Clinical Practice Guidelines recommended that small bowel feedings should be considered for patients at high risk for intolerance to enteral nutrition.

There are several methods to place postpyloric tube, but there is a high success rate with endoscopic or radiological assistance. However, they are time consuming procedures, which is of limited availability at bedside and requires trained staff.

Nasojejunal tube with spiral end (Flocare Bengmark NJ tube) has been used for bedside placement for 10 years. But only limited data are available for success rate, especially in brain injured patients. The aim of this study is to access the success rate and influencing factors of spiral end nasojejunal tube in such a population.

Eligibility Criteria:
Inclusion Criteria:

* Acute brain injured patients admitted to Neuro-ICU

Exclusion Criteria:

* Patients' stay in ICU shorter than 3 days
* Patients with contraindication to naso-feeding tube placement
TreatmENT of AnastomotiC LeakagE After COLON Cancer Resection

This international multicentre retrospective cohort study aims to research anastomotic leakage after colon cancer resection and has two main objectives:

1. To identify predictive factors associated with 90-day mortality and 90-day Clavien-Dindo grade 4-5 complications amongst patients who developed AL following colon cancer resection and to develop and validate a prediction model for predicting 90-day mortality as well as the co-primary composite endpoint Clavien-Dindo grade 4-5 complications.
2. To explore and compare the effectiveness of various treatment strategies for AL following colon cancer resection, considering patient, tumour, resection and leakage characteristics.


Eligibility Criteria:
Inclusion criteria:

* Aged 18 years or older;
* Surgical resection for primary colon cancer (cT1-4b, N0-2, M0-1) with formation of a primary colonic anastomosis and with or without diverting stoma;
* Postoperative AL defined as: "any clinical, radiological or intraoperative signs of disrupted integrity of the anastomosis. This also includes suspected leaks with any degree of extraluminal air or fluid on CT, perianastomotic abscess, purulent peritonitis without clear anastomotic defect, or any other suspicious condition in which there is no ultimate macroscopic proof of disrupted anastomosis."
* Regarding the type of colon cancer resection, the following patients will also fulfil the inclusion criteria: patients who underwent cytoreductive surgery (CRS) simultaneous with resection of the primary colon cancer with or without hyperthermic intraperitoneal chemotherapy (HIPEC), simultaneous ablations/resections of metastasis, multivisceral resection, emergency resection, patients diagnosed with perforated disease/peritumoral abscess or fistula, and acute obstructions.

Exclusion criteria:

* Surgical resection for benign colon disease;
* Recurrent colon cancer resection;
* Any primary colon malignancy other than adenocarcinoma (e.g. neuroendocrine tumour, gastrointestinal stromal tumour);
* Any clinical condition that does not fulfil the broad definition of AL as used in this study (e.g. only free air on CT that is considered to be compatible with an appropriate postoperative day in the absence of any other clinical signs related to a potential anastomotic leakage)