cyrilzakka/clinical-trials huggingface dataset:
Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track

A blinded randomized trial. Length of hospital stay, nursing hours and recovery after laparoscopic versus open colonic resection without fast track.

CONTEXT: Our preliminary experience (unpublished) indicate that less nursing hours are needed after laparoscopic colon resection without fast track. Length of hospital stay and recovery seems to be reduced as well.

OBJEKTIVE: To compare laparoscopic and open colonic resection concerning nursing hours, length of hospital stay and recovery.

DESIGN, SETTING AND PATIENTS: triple blinded study (Patient, nursing staff and data collector) including 2 x 12 patients needing sigmoid resection due to cancer. Nursing hours, length of hospital stay and recovery (postoperative pain, questionnaire, actigraph ect.)

Eligibility Criteria:
Inclusion Criteria:

* sigmoid resection without stoma
* sigmoid neoplasms localized 20 cm from anus
* age 40-90

Exclusion Criteria:

* conversion from laparoscopic to open surgery
* stoma
* severe postoperative complications (anastomosis leak, intraabdominal abscess, reoperation, stay at intensive care unit, heart attack, pulmonary embolism)
* no informed consent
Swallow Exercise as Prophylaxis of Dysphagia After Radiotherapy

Background: Dysphagia is a common side effect after radiotherapy for haed and neck cancer patients. It may be worsened by immobility of the throat during tube feeding. Hypothesis: Exercises may prevent or reduce late dysphagia. Method: Phase I study to identify the tolerated intensity of exercises and establish the method of measuring training intensity and dysphagia measurement. Endpoint: Objective dysphagia using VF and FEESST. The HN swallowing and HN pain endpoint of EORTC H\&N35 questionnaire. Weight loss, duration of tube feeding.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer
* Planned curative radiotherapy
* Planned irradiation of level II+III lymph nodes \>46 Gy
* \>=18 y
* Speaks and reads Danish
* No previous Surgery to the head and neck area except biopsies

Exclusion Criteria:

-
Effect of Different Bran-based Dietary Platforms on the Colon Metabolism in Healthy Volunteers

During this project the effect of 3 different bran-based dietary platforms on the fermentation on a readily fermentable substrate will be investigated using stable isotope techniques.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Aged between 18 and 65 years
* BMI between 18 and 27 kg/m²
* Stable eating pattern (3 meals/day on at least 5 days/week)

Exclusion Criteria:

* Use of antibiotics in the month preceding the study
* Abdominal surgery (except from appendectomy)
* Use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication
* Use of pre- or probiotic supplements in the month preceding the study
* Chronic gastrointestinal diseases, such as inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease...
* Pregnancy or lactation
* Blood donation in the last 3 months
* Abnormal Hb-level (Standard range between 14 and 18 g/dL for men and between 12 and 16 g/dL for women)
* Participation in clinical studies involving radiation exposure in the past year
Myocardial Protection and Clinical Outcome in Patients Undergoing Tetralogy of Fallot Repair : A Randomized Study of Two Different Cardioplegia Technique

Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair: a randomized study of Two cardioplegic techniques.

Del Nido cardioplegia has not been used for myocardial protection and clinical outcome in patients undergoing tetralogy of Fallot repair, so the investigators hypothesized that a del Nido cardioplegia technique may be beneficial in the pediatric patients undergoing tetralogy of fallot repair.

Eligibility Criteria:
Inclusion Criteria:

* Tetralogy of fallot

Exclusion Criteria:

* TOF with absent pulmonary valve , TOF with pulmonary atresia
Barbershop Talk: HIV Prevention for African American Heterosexual Men

This program utilizes a community-engaged research approach to implementing and evaluating a program that seeks to reduce sexual risk behavior among Black adult heterosexual men. The investigators aims are to assess the impact of this linguistically and culturally tailored HIV prevention program on the sexual risk of heterosexual, African American men aged 18 and older, to assess the intervention's impact on the more proximal social and psychosocial variables that the program is designed to change, and to identify key contextual level factors that may impact the intervention's impact across segments of this priority population.


Eligibility Criteria:
Inclusion Criteria:

* Unprotected sex in the past three months
* Identify as Black or African American

Exclusion Criteria:

* Having been in an HIV prevention research study in the last six months
* Reporting a history in the past five years of injection drug use
* Reporting a history in the past five years of having sex with other men
* Reporting an HIV-positive serostatus
* Inability to understand spoken English.
Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy

Narrow band imaging or electronic chromoendoscopy might provide similar adenoma detection capabilities while limiting time spent when compared to conventional chromoendoscopy method.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 40 years
2. Referral for screening, surveillance or diagnostic colonoscopy

Exclusion Criteria:

1. Inflammatory bowel disease
2. History of colorectal cancer or colon resection
3. Indication of positive FIT or cologuard
4. Any colorectal cancer syndromes (FAP, HNPCC, SPS)
5. Patient with poor bowel preparation identified during insertion
Respiratory Variations for Assessing Blood Withdrawal 2

OBJECTIVES: To investigate whether respiratory variations of the inferior vena cava (ΔIVC) and internal jugular vein (ΔIJV) diameters during standardized breathing (ΔIVCST and ΔIJVST) increase after a therapeutic bleeding in spontaneously breathing and obese patients with dysmetabolic hyperferricemia.

DESIGN: Prospective, monocentric study in the EFS Nord-de-France blood center.

PATIENTS: Obese patients with dysmetabolic hyperferricemia undergoing a therapeutic bleeding.

INTERVENTIONS: The investigators performed ultrasound measures and collected clinical parameters before and after a therapeutic bleeding, during a standardized respiratory maneuver.

MAIN OUTCOME AND MEASURES: The primary endpoint was the ΔIVCST change induced by a 300 to 500ml therapeutic bleeding. The investigators measured the minimal and maximal IVC and IJV diameters during a standardized respiratory maneuver. ΔIVCST and ΔIJVST were calculated as follows: \[(maximal diameter - minimal diameter)/maximal diameter\].100.


Eligibility Criteria:
Inclusion Criteria:

* adult patients of \> or equal 18 years
* dysmetabolic hyperferritinemia
* undergoing a therapeutic blood withdrawal
* health insured
* obese (body mass index \> or equal 30Kg/m²)

Exclusion Criteria:

* pregnancy
* transthoracic echogenicity unsuitable for measuring the inferior vena cava diameters
* clinical signs of active exhalation
Evaluation of the Efficacy and Safety of Microneedling Combined With Botulinum Toxin-A Versus Meso-Botox Injection in the Treatment of Atrophic Acne Scars: A Split-face Comparative Study

Post-acne scars are psychologically disappointing and therapeutically challenging condition. No standard treatment for atrophic acne scars.

Micro-Botox, is a highly diluted BTX-A which could be injected safely intra-dermally. It targets the superficial fibers of facial muscles, sweat, and sebaceous glands inducing pores shrinkage, decreasing the sebum and excessive sweating, in addition to face lifting and reducing fine wrinkles without affecting emotions, this subsequently makes the skin tighter and gives the facial skin a smooth appearance.

Also, BTX-A appears to have an inhibitory effect on fibroblasts and collagen remodeling activity, in addition to releasing muscular tension at scar edges through superficial muscle relaxation. So, it can reduce the tethering and pulling effect of the muscles surrounding the acne scars. Also, it has anti-inflammatory and angiogenesis induction effects. Therefore, micro-Botox is believed to improve acne scars.

Therefore, it will be interesting to compare the efficacy and safety of microneedling combined with BTX-A versus meso-Botox injection in the treatment of atrophic acne scars through a split-face clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with atrophic post-acne scars.

Exclusion Criteria:

* Pregnancy and lactation. Ongoing infection within the targeted treatment region or active acne lesions. Skin cancer, or precancerous lesions. History of keloid formation. History of allergy to BTX. Patients with neuromuscular diseases, patients with pre-existing medical conditions that cause muscle weakness as myasthenia gravis.

Patients who underwent Botox injection, during the last 6 months. Patients who were under treatment by systemic retinoids in the previous 6 months.

Patients with a history of chemical peels or laser procedures within 6 months of the study period.

Patients with bleeding disorders.
Effect of African Leafy Vegetables on Nutritional Status of South African School Children.

The combination of poverty-related infectious and lifestyle-related non-communicable diseases, both driven by malnutrition, causes a high burden for South Africa. Healthy and nutritious diets for populations depend on availability and accessibility of a variety of plant and animal foods, within a context that promotes and supports healthy behaviour. Food based strategies, such as supplementation, food fortification, and diversification of crops, are used to achieve optimal dietary requirements to combat malnutrition, including micronutrient deficiencies. A more sustainable food based strategy is the (promotion of) use of indigenous and traditional foods, such as African Leafy Vegetables (ALVs). Unfortunately, several studies from all over Africa have shown that there is a shift from traditional diets as result of the preparing techniques and the absence of women in homes. Furthermore, indigenous and traditional foods are considered as "poor people's food".

Against this background, a joint project between South Africa, Kenya and Benin is designed to fill the gaps in knowledge in these countries regarding the availability, acceptability and consumption and evidenced based benefits of foods from local biodiversity. The main aim of the study in South Africa is to provide empirical evidence of how the role of biodiversity can be translated into improved health status in contemporary poor rural and urban communities in the North West Province of South Africa. In order to achieve this it is important to gain knowledge on the possibility of using ALVs as a strategy to alleviate micronutrient deficiencies. Therefore an intervention study to determine the effect of selected ALV on the nutritional status (including zinc, iron, and vitamin A status) of school children (grade R-4) residing in contemporary poor rural community in the North West Province, South Africa has been designed.


Eligibility Criteria:
Inclusion Criteria:

* apparently healthy and had no signs and symptoms of acute illness at the time of baseline blood collection
* attending grade R - 4 of one of the selected schools

Exclusion Criteria:

* Children with a haemoglobin concentration \<8 g/dL were excluded from the study and referred for medical treatment.
* Children who received micronutrient supplements were also excluded from the study.
Total Motile Sperm Count and Pregnancy Rate From Intrauterine Insemination

Intrauterine insemination (IUI) is one of the most important infertility treatments. Infertility is failure to establish pregnancy (\>12 months) with regularly unprotected sexual intercourse. Post-wash total motile sperm count (TMSC) vaguely defined as a predictor of IUI pregnancy rate. The minimum value required is also not clear. This study aimed to further define the relationship and determine the minimum recommended value to achieve a satisfactory IUI pregnancy rate.

Post-wash TMSC is predictive of IUI success. No optimal cut-off could be identified. In conclusion, post-wash TMSC is highly suggested as a quantitative predictor along with others in counseling and informed consent. The recommended threshold value is \>3 x 106.


Eligibility Criteria:
Inclusion Criteria:

* post-wash total motile sperm count needed to be over 5 x 10\^5

Exclusion Criteria:

* missing data on pregnancy outcome and missing medical records
AVEIR Remote Care System Non-Significant Risk Study

The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP devices.

To collect acute performance data about the AVEIR Remote Care System in participants implanted with a compatible dual or single chamber Aveir Leadless Pacemaker System by participants completing remote transmissions with the system

Eligibility Criteria:
Inclusion Criteria:

* Subject must provide written informed consent prior to any study-related procedure.
* Subject is willing and has consented to study clinical procedure.
* Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
* Subject has an active, appropriately functioning Aveir leadless pacemaker system
* Subject is willing to use the device

Exclusion Criteria:

* Subject is unable to read/write at a sufficient level to provide informed consent.
* Subject is unable to make the decision to participate in a clinical investigation on their own or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate.
* Subject has presence of medical, social, or psychological conditions that, in the investigator's opinion, could confound the study, limit the subject's ability to participate in the clinical investigation .
Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease

Cholinergic deficiency in the brain can be related to gait and balance problems in Parkinson disease (PD). Recent clinical trials suggested a beneficial role of acetylcholinesterase inhibitors (AchEI) on gait in PD. In this study, the investigators are planning to study the influence of AchEI on a brain network for gait and balance in PD. As gait problem is prominent in postural instability and gait disturbance (PIGD) subtype, this study will focus on the patients with PIGD phenotype.

PD patients with PIGD subtype will be included.

1. Assessment:

   * Overall features of PD are assessed by Unified Parkinson Disease Rating Scale (UPDRS). Non-motor features including cognition will be assessed by standard scales. Gait and balance will be assessed by gait analysis system, which measures physiological parameters of gait such as velocity, variability and center of pressure. Positron emission tomography using 18F-fluorodeoxyglucose (FDG PET) will be done to brain activities related to gait and balance.
   * Clinical evaluation will be done at the baseline, 4th, 8th and 12th week
   * Gait analysis and FDG PET will be done at the baseline and 12th week
2. Drug dosage

   * For the first 4 weeks, 5 mg/day
   * Then, 10 mg/day for 8 weeks

Eligibility Criteria:
Inclusion Criteria:

* Parkinson disease diagnosed by United Kingdom Parkinson's disease Society Brain Bank Criteria
* Postural instability and gait disturbance phenotype
* Hoehn and Yahr stage ≤ 3
* Mini-Mental status examination ≥ 24

Exclusion Criteria:

* Significant motor complication affecting daily activities
* Drugs related to acetylcholine metabolism
A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers

The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.

GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.

Eligibility Criteria:
Inclusion Criteria:

* 20\~45 years old, Healthy Adult Male Subject
* Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

* ALT or AST \> 1.25 times (Upper Normal Range)
* Total Bilirubin \> 1.5 times (Upper Normal Range)
* CPK \> 2 times (Upper Normal Range)
* BUN or Creatinine \> Normal Range
* Systolic BP \> 160mmHg or \< 80mmHg, Diastolic BP \> 100mmHg or \< 50mmHg
L-arginine in Severe Asthma Patients Grouped by Exhaled Nitric Oxide Levels

The major impact of this study will be to identify the adult severe asthma cohort that will benefit from supplemental L-arginine therapy. The investigators hypothesize that a subset of adult severe asthma patients will respond to supplemental L-arginine and derive clinical benefit from the addition of this therapy to standard-of-care asthma medications. The investigators hypothesize that the patients that benefit most will have low exhaled nitric oxide concentrations (\< 20 ppb) at baseline.

We hypothesize that a subset of adult severe asthma patients will respond to supplemental L-arginine and derive clinical benefit from the addition of this therapy to standard-of-care medications. We hypothesize that these patients will have lower exhaled NO concentrations (\<20 ppb) and lower nitric oxide synthase 2 (NOS2)/ arginase I (Arg1) mRNA ratios in their airway epithelial cells than "non-responders." The aim is to test the hypothesis that adult severe asthma subjects with exhaled breath NO concentrations \< 20 ppb will have fewer American Thoracic Society (ATS)-defined asthma exacerbations over 3 months when treated with L-arginine compared to subjects with exhaled nitric oxide concentration (FeNO) \> 25 ppb. The major impact of this study will be to identify the adult severe asthma cohort that will benefit from supplemental L-arginine therapy to define the underlying mechanisms of arginine benefit in asthma. This follows our initial 20 subject trial of L-arginine in asthma subjects (Kenyon et al., Pharmaceuticals 2011) that was designed to determine how L-arginine was metabolized (by testing serum markers) and whether certain participants had clinical benefit.

To do this, we will recruit a total of 50 ATS-defined severe asthmatic subjects with ongoing asthma exacerbations in past two months and enroll them in a randomized, blinded, placebo-controlled, cross-over designed trial of L-arginine and placebo. We will compare 25 subjects with "low" FeNO \< 20 with 25 subjects that have "high" FeNO \> 25 ppb.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 yrs of age
* Diagnosis of severe asthma based on American Thoracic Society Workshop definition (Am J Respir Crit Care Med 2000; 162:2341)
* Active asthma medications of high dose inhaled corticosteroids plus long-acting beta agonist
* History of recent asthma exacerbations or Asthma control test score \< 20/25

Exclusion Criteria:

* \<19 yrs of age
* Forced expiratory volume 1sec \<30% predicted
* Pregnant or nursing women
* Current smokers or smoking history \> 15 pack years
* Actively taking or known intolerance to L-arginine
Perspectives of Parents About Their Infants' Sleep

Behavioral insomnia of childhood (BIC) is a common problem in early infancy. The whole family is affected by the problem, but research usually relies only on maternal perception and report. This mixed-method study aimed to explore maternal and paternal perspectives about their child's sleep and sleep problems in early childhood. Secondly, infants' sleep will be measured objectively with actigraphy. Parental mental health, marital relationship and sleep will be evaluated in order to explore the effects on the perception of their infant's sleep.

Sleep is essential for healthy growth and development of children. Behavioral insomnia of childhood is reported as a common sleep problem of early childhood with a prevalence of 26-68% according to the definition and study population.

Behavioral insomnia of childhood not only affects children's health but also has impacts on parental mental health and family functioning. Most studies on early childhood sleep problems rely on maternal report. However, both parents are affected by children's sleep problem. It is therefore essential for pediatric healthcare professional to understand both mothers' and fathers' perception and interpretation of their children's sleep and sleep problems in the context of family and culture to suggest culturally appropriate intervention according to the family's needs.

This study is designed to thematically analyze maternal and paternal perspectives of their child's sleep and sleep problems in early childhood.

Parents of children aged 6-36 months with and without sleep problems will be invited to participate into the study. Both parents of 10-15 children applying for sleep problems to Sleep Outpatient Clinic and both parents of 10-15 children followed up in Well Child Clinic without sleep problems will be included from October 2021 to June 2022. Semi-structured individual in depth interviews will be conducted with both mothers and fathers but in different sessions separately to explore parental views and perception of their child's sleep and sleep problems. The interviews are expected to last between 30-45 minutes and will be audio-recorded and transcribed for thematic analysis. Through these interviews the investigators will learn what kind of differences are present between the parents' perspectives of infants with and without sleep problems.

Sleep of all children will be evaluated by Turkish version of the expanded brief infant sleep questionnaire, actigraphy and sleep diary. Sociodemographic information will be collected. Parents in patient and control group will be assessed for the confounding factors by Patient Health Questionnaire-9, Generalized Anxiety Scale-7 test, Relationship Satisfaction Scale, Marital Life Satisfaction Scale and Pittsburgh Sleep Quality Index.

Eligibility Criteria:
Inclusion Criteria:

* Parents and their 6-36 months old children

Exclusion Criteria:

* Divorced or separated couples
* Infants less than 37 weeks of gestational age
* Children with diagnosed developmental problems
Hematocrit Effect on a Blood Glucose Monitor

This study assesses the repeatability precision of a blood glucose monitoring system pursuant to ISO 15197

This study assesses the repeatability precision the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with clinical indication for blood glucose testing
* Signed form of consent
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study

Exclusion Criteria:

* Pregnancy or lactation
* Severe acute disease (at study physician's discretion)
* Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
* Current constitution that does not allow participating in the study (e.g. hematocrit out of
* the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
* Being unable to give informed consent
* Age younger than 18 years
* Legally incompetent