cyrilzakka/clinical-trials huggingface dataset:
Does Pregnancy Increase Risk of Ventral Hernia Recurrence?

The investigators will examine if pregnancy increases risk of ventral hernia recurrence

The investigators will establish a cohort of female fertile patients who underwent ventral hernia repair (Umbilical, Epigastric and Incisional hernia repair) registered in the Danish Hernia Database. The investigators will link these data at an individual level with the Danish National Patient Registry (DNPR), Danish Medical Birth Registry (DMBR) and the Danish Civil Registry (CPR).

From DMBR, subsequent pregnancies in the study cohort will be noted. From DNPR, ventral hernia recurrence, defined as clinical recurrence and/or reoperation for recurrence will be noted. Cases registered with both clinical recurrence and reoperation for recurrence, the date of the earliest registration will be defined as the date of ventral hernia recurrence.

From CPR, date of death or emigration will be noted.

Through an extended Cox regression analysis, handling pregnancy as a time-dependent variable, the investigators will examine whether pregnancy is associated with an increased risk of ventral hernia recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Fertile female patient

Exclusion Criteria:

* non-Danish citizen
Fluorescence Guided Minimally-Invasive Resection Of Abdominal Paragangliomas Using Indocyanine Green

This study is exploring whether it's possible to detect paragangliomas (a rare type of tumor) during minimally invasive surgery by using a technique called near-infrared fluorescence imaging, guided by a substance called indocyanine green (ICG). The goal is to see if this method can help surgeons identify and treat paragangliomas more accurately and during minimally invasive procedures.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with abdominal paraganglioma and underwent minimally-invasive surgical resection

Exclusion Criteria:

* Open surgical procedures
Association Between Cardiopulmonary Function and Plantar Pressure in Patients With Chronic Obstructive Pulmonary Disease

It aims to understand the differences in everyday mobility and activity capabilities among patients with varying disease progression and severity, to serve as reference indicators for evaluating the effectiveness of pulmonary rehabilitation exercise training.

Background： Chronic respiratory diseases and Chronic Obstructive Pulmonary Disease (COPD) are major causes of chronic illness and death worldwide. Patients with chronic respiratory diseases experience muscle weakness and respiratory difficulties, leading to restricted physical activity, decreased functional capacity, exercise intolerance, and limb muscle atrophy. While exercise training can effectively improve limb strength, there is a lack of objective data exploring different disease progressions and clinical cardiopulmonary limitations, hence this study utilizes plantar pressure distribution to research lower limb strength and cardiopulmonary function in patients, hoping to identify relevant indicators for necessary exercise training.

Methods： The study plans to enroll 60 participants, divided into two groups (30 in the control group and 30 in the case group) matched 1:1. The study will be conducted at the pulmonary rehabilitation therapy room on the sixth floor of Fu-Jen Catholic University Hospital. In addition to basic demographic and clinical physiological parameters, all participants will undergo the 6-minute walk test, the timed up and go test, simple pulmonary function tests, body composition analysis, and statistical analysis.

Effect： The trial is expected to effectively determine which patients require exercise training based on the correlation between plantar pressure analysis and results from the 6-minute walk test and timed up and go test. These results are anticipated to correlate positively with disease severity.

Eligibility Criteria:
Inclusion Criteria:

* Age between 45 and 65 years
* Patients with chronic respiratory diseases requiring pulmonary rehabilitation
* Signed informed consent form

Exclusion Criteria:

* Current tracheostomy
* Home use of oxygen therapy or ventilators
* Diagnosed with severe left heart failure (NYHA III-IV)
* Patients diagnosed with neuromuscular diseases
* Had an acute exacerbation of COPD in the past three months
* Unable to perform cardiopulmonary exercise testing
Direct Acting Anti-Viral's In Chronic HCV Patients

The objective of the study is to determine the safety of DAA's among chronic HCV patients. The outcomes of the study are; To determine the frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon To calculate the percentage of patients with severity of medical event as per Karch and Lasagna classification To determine the percentage of patient having serious adverse event as per ICH Classification

The cross sectional survey data will be collected on a pre-defined questionnaire from Gastroenterologist and Hepatologist. The questionnaire will provide us information on demographics, relevant patient history, concomitant medication, ongoing treatment plan recommended for chronic HCV and adverse event details.

The questions related to Pharmacovigilance and safety assessment includes the International Nonproprietary Names (INN) unless it is prescribed brand of Getz Pharma. All adverse events associated with the prescribed treatment will be recorded. Data on outcome assessment will be based on action taken due to AE and other reported details. Seriousness of adverse event will also be recorded as per the ICH classification and severity of medical event will be assessed as per Karch and Lasagna classification.

All the information will be recorded by the healthcare professionals on the questionnaire during direct interaction with the patients.

Patients' written authorization to use and/or disclose the patient's personal and/or health data will be obtained. However, patient data secrecy will follow ICH GCP requirements.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Male or Female patient
3. Age of patient ≥18 years
4. Patients already diagnosed with HCV and on DAAs therapy.

Exclusion Criteria:

1. Written informed consent
2. Male or Female patient
3. Age of patient ≥18 years
4. Patients already diagnosed with HCV and on DAAs therapy.
8 Weeks Study to Evaluate the Efficacy and Safety of Valsartan in Combination With Aliskiren Compared to Valsartan Alone in Patients With Stage 2 Hypertension

To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 2 hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
* Men or women 18 years and older.
* Patients with Stage 2 systolic hypertension; defined as having a MSSBP ≥160 mmHg and \<180 mmHg at Visit 5 (randomization).

Exclusion Criteria:

* Use of aliskiren or participation in a clinical trial that had aliskiren as treatment within 30 days of Visit 1.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>5 mIU/ml).
* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
* Severe hypertension (an office cuff MSDBP ≥110 mmHg and/or MSSBP ≥180 mmHg).
* Refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg).
* Patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually).
* History or evidence of a secondary form of hypertension.
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation

The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.

This is a single center pilot study conducted in 30 patients scheduled for therapeutic intervention. As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) remaining following treatment, OFDI imaging of study participants will occur prior to the scheduled BARRX RF treatment, and at the standard 3 and 6 month follow-up visits.

Following initial visual surveillance of the esophagus, the study experimental procedure will begin. Imaging will be performed with the OFDI system in 4 longitudinal (\~5cm) volumetric segments that are spaced equally circumferentially along the esophagus in a similar fashion to the standard 4-quadrant biopsy protocol.

Each of the 4 OFDI imaging segments will be acquired in less than 1 minute.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Barrett's esophagus
* Patients undergoing an Esophagogastroduodenoscopy (EGD)
* Patients scheduled for treatment with RF ablation or patients that have had previous BARRX RF ablation
* Patients must be over the age of 18
* Patient must be able to give informed consent
* Women with child bearing potential must have a negative pregnancy test prior to procedure

Exclusion Criteria:

* Patients on oral anticoagulation medications
* Patients with a history of hemostasis disorders
* Patients that are pregnant
* Patients with esophageal strictures
Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

This study will evaluate the efficacy and safety of methylphenidate for treating hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD symptoms in PDD are limited. Children and adolescents who do not show a positive response to methylphenidate will be invited to participate in a pilot study of the non-stimulant medication guanfacine (Tenex).

The safety and efficacy of methylphenidate (MPH) in 60 children and adolescents with PDD and behavioral difficulties (such as hyperactivity, impulsiveness and distractibility) will be evaluated in a multi-dose, 4-week randomized, crossover, placebo-controlled study. The MPH study has three parts: a Test-Dose Period, a Double-Blind trial and an 8-Week Extension Period (open-label). After a screening visit, eligible children will start a 1-week Test-Dose Period. During this week, each child will be given the three MPH doses that are used in the Double-Blind trial to make sure there are no serious side effects. If problems are encountered at the high dose level, that dose will not be given in the Double-Blind phase. The Double-Blind phase lasts 4 weeks and consists of three different MPH dose levels and a week of placebo. Each treatment/dose is given for 1 week, and neither the researcher nor the participants' families will know whether the medication is placebo or MPH. Children who do well during this phase will continue on the best dose of MPH (determined during the Double-Blind phase) for an additional eight weeks (open-label).

Those who do not show significant improvement during the Double-Blind phase, do not tolerate MPH during the Test Dose Period, or are not able to take MPH before beginning the study are offered open-label treatment with guanfacine for 8 weeks.

Prior to randomization in the MPH trial OR entry into the open-label guanfacine trial, there will be a medication-free period for children who are currently on medication. The withdrawal will be conducted in clinically appropriate way (depending on drug and duration of treatment) to minimize withdrawal effects. This period is to establish a drug-free baseline measurement and to minimize drug-drug interaction. No participant will be withdrawn from a currently effective medication.

Eligibility Criteria:
* Diagnosis of PDD (including Asperger's Disorder and Autistic Disorder)
* Clinically significant symptoms of ADHD
* Mental age of at least 18 months
* Blood pressure within normal ranges for age and gender
* Weight 16 kg or more
* Absence of chronic tic disorder
* Absence of any medical condition that would be incompatible with the study treatments
* Absence of evidence of hypersensitivity to study treatments
Effect of L-Arginine and Pycnogenol on Light to Moderate Hypertension and Endothelial Function

The effect of a combination product (Verum ) with L-arginine, Pycnogenol, vitamin K2, R-(+)-alpha-lipoic acid and vitamins B6, B12 and folic acid is investigated in a double blind placebo-controlled cross-over study. Volunteers with hypertension and hyperhomocysteinemia are randomly assigned to the dietary supplement or placebo.

25 patients were included in the trial. Intervention period was 4 weeks with 2 months wash out phase. The screening visit of all volunteers before study start included volunteer information, signature of informed consent, anamnesis, medical history, ECG and blood routine analysis.

Efficacy parameters were measured at visit 1, 2, 3, and 4. Endothelial function and postprandial endothelial Reaction was tested using EndoPAT (validated diagnosis tool). Blood pressure was measured by volunteers over a period of 7 days before each visit. As additional parameters homocysteine and ADMA (assymmetric dimethyl arginine) were determed. For safety evaluation AEs (Adverse Events), CC (compliance control), tolerability, blood routine parameters and vital signs were assessed.

Eligibility Criteria:
Inclusion Criteria:

* borderline blood pressure (systolic 130-149)
* homocystein level \>10µmol/l

Exclusion Criteria:

e.g.

* BMI \<20kg/m2 and \>32kg/m2
* use of antihypertensives, anticoagulants, and statins
* cardiovascular diseases e.g. stroke, myocardial infarction
* use of L-arginine and other dietary supplements
Haemoglobin Measurement for Babies

In this prospective study different methods of haemoglobin measurement in term and preterm neonates are compared with the gold standard. Non-invasive haemoglobin measurement with the Radical-7® (SpHb, Masimo®), point-of-care haemoglobin-measurement (HcHb, HemoCue@, Radiometer), blood-gas-analysis (BGAHb,ABL800®, Radiometer) are compared with haemoglobin measurement by an automated hematology analyzer (labHb, Siemens Advia®).

Neonates admitted to neonatal intensive care unit or to a normal neonatal ward are enrolled in the study, if parents have given their written informed consent. Non-invasive SpHb measurements are recorded prior to routine venous sampling. Routine venous sampling includes labHb and BGAHb. Additionally HcHb is taken from the routine venous sampling (HcHbart/ven) and from an additionally capillary puncture of earlobe or heel (HcHbcap). Every neonate can participate in two measurements.

Eligibility Criteria:
gender both

age limits minimum age 3 days of life maximum age 44 postmenstrual weeks

accepts no healthy volunteers

Inclusion Criteria:

written informed consent of the parents

-

Exclusion Criteria:

* allergy against sensor patch
* medical or psychological factors that inhibit a correct finazilation of the study
Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery

The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site infections (SSI) in patients who underwent colorectal resection for malignancy.


Eligibility Criteria:
Inclusion Criteria:

* Patients bearing solid tumours who are candidate to open radical surgery for colorectal cancer (histology proven)
* Age 18-75
* Informed signed consent
* Performance Status 0-2 (according to ECOG score)
* Platelets \> 50.000/mm3
* Prothrombin Time (Quick) \> 60%
* White Blood Cells \> 2500/mm3
* Life Expectancy \> 3 months

Exclusion Criteria:

* Intestinal obstruction
* Severe intestinal bleeding requiring blood transfusion
* Age under 18 or over 75
* Severe hepatic failure (ascites, portal hypertension, jaundice or encephalopathy)
* Renal failure (hemodialysis, creatinin \> 2.5 mg/dL)
* Active infections
* Coagulopathy
* Inability to give an informed consent
* Known allergies to dressing components
HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B

Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of this study is to evaluate the efficacy and safety of HAIC combined with H101 compared with HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic liver cancer A-B stage.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC
* Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
* With no previous treatment
* Single lesion with tumor size larger 7cm or multiple lesions
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* BCLC A-B stage
* The following laboratory parameters:

Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

Exclusion Criteria:

* Patients complicated by history of heart disease, history of gastrointestinal bleeding within 1 month, severe infection (\> grade 2 National Cancer Institute \[NCI\] -common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0) or other serious associated diseases will not be able to tolerate treatment
* With other malignant tumors
* Known or suspected allergy to the investigational agents or any agent given in association with this trial
* History of organ allograft
* Pregnant or lactating woman
* patients with poor compliance
A Sequential Allocation Study to Determine the ED50 of Dexmetedomidine as an Adjuvant to Lidocaine Intravenous Regional Anesthesia

Intravenous Regional Anesthesia (IVRA) is an easy and reliable anesthetic technique for hand and forearm surgery. Its use is however limited by the presence of tourniquet pain during the surgery and the absence of postoperative analgesia. Many adjuvants to local anesthetics have been studied in order to overcome these shortcomings, including α2 adrenergic agonists. Clonidine has been shown to be efficacious when used with IVRA at a dose of 1µg/kg. Dexmetedomidine (DEX) is a recent more selective α2 adrenergic agonist that has been used successfully during IVRA at a dose of 0.5µg/kg. However when comparing potency ratios of Clonidine and DEX (8 to 1), the investigators hypothesize that a lower DEX dose would provide patients with adequate anesthesia.

We will determine the population average dose of DEX (ED50) that provides 50 minutes of tolerance to the tourniquet during a Lidocaine IVRA by a sequential Dixon up-down allocation study.

Eligible patients will be enrolled after obtaining informed consent. Patients will receive a standardized IVRA with Lidocaine and DEX adjuvant following a sequential allocation scheme. The first patient will receive a dose of 0.5 µg/kg of DEX. The dose will be then adjusted in 0.1 µg/kg increments for the following patients dependent on the success of the previous patients block. If a patient experiences tourniquet pain prior to 50 minutes after inflation of the distal tourniquet the next patient will receive a higher dose, if he does not experience pain prior to 50 minutes after inflation of the distal tourniquet the dose for the following patient will be decreased.

Recruitment will continue until 6 independent crossovers are observed with a minimum of 20 patients. The mean and the standard deviation of the ED50 of DEX will be calculated using the modified up-down method.

This study will help determine the ED50 of DEX used as an adjuvant in IVRA. Based on the potency ratios of Clonidine vs. DEX, the investigators hypothesize that the dose of DEX needed to achieve 50 minutes of pain free tourniquet time will be closer to 0.125 µg/kg rather than 0.5 µg/kg, a 75% reduction in the dose studied.


Eligibility Criteria:
Inclusion Criteria:

• Patients 18 to 70 years of age, ASA physical status I-II, undergoing unilateral hand or forearm surgery (that require 30 minutes or more) under IVRA.

Exclusion Criteria:

•Patients with Raynaud's disease, sickle cell anemia, heart block, allergy to any of the anesthetic drugs used, patients on α-adrenergic agonists, ASA III or IV, emergency surgery and pregnant patients., Weight greater than 100Kg.
Measuring the Peripheral Optical Quality of The Eye

The goal of the study is to quantify wavefront aberration profiles of the eye with and without contact lens across the visual field. This will enable us to investigate the impact of the aberration on retinal image quality.

The goal of this study is to investigate the effects of monofocal and bifocal soft contact lenses in the changes of peripheral optical quality and through-focus visual performance on real eyes. The goal will be accomplished by performing optical measurements using Shack-Hartmann wavefront sensor with and without the use of single vision and bifocal soft contact lenses.

Eligibility Criteria:
Inclusion Criteria

A person will be included in the study if he/she:

* Is 18 years or older and has full legal capacity to volunteer.
* Has no ocular condition or pathology, which may impact visual acuity e.g. keratoconus, amblyopia, cataract, macular degeneration;
* Has no active ocular disease or allergic conjunctivitis;
* Is not using any topical ocular medications;
* Is willing and able to follow instructions;
* Has voluntarily agreed to participate in the study by signing the statement of informed consent.

Exclusion Criteria

A person will be excluded from the study if he/she:

* Is under the age of 18 or over the age of 60 yrs.
* Correctable with high contrast logMAR acuity (EDTRS) testing to 20/20 or better;
* Pregnant at the time of enrolment in the study;
* Unable to handle, insert, remove or care for the study lenses;
* Considered by the Investigator to not be a suitable candidate for participation.