cyrilzakka/clinical-trials huggingface dataset:
Water Method in Patients With Incomplete Colonoscopy

Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Colonoscopy has been considered the gold standard procedure in screening for colorectal disease. However, 5-10% of colonoscopies are incomplete due to patient discomfort, difficult anatomy and prior abdominal or pelvic surgery. The investigators postulate that these patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in patients with immediately failed colonoscopy.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in patients with incomplete colonoscopy. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients with incomplete colonoscopy

Exclusion Criteria:

* History of colorectal surgery
* Severe colonic stricture or obstructing tumor
* Patients who cannot give informed consent and those who are hemodynamically unstable
Systemic Inflammatory Biomarkers in Ovarian Cancer

In cancer patients, prognostic markers are needed to improve the management and clinical course of both the cancer itself and surgery therefor. Elevated systemic inflammatory markers are associated with morbidity and mortality in most cancer types. In this study, the investigators aimed to determine the prognostic value of inflammatory markers such as neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), and lymphocyte to monocyte ratio (LMR) in patients undergoing cytoreductive surgery for ovarian cancer.

Major gynaecological cancer surgery is a procedure with high complication rates and mortality risk due to both the patient' s old age and comorbidities and the extent of the surgery. Among such surgeries, ovarian cancer-related surgery has the highest mortality rate. Despite advances in early drug therapy and improvements in the cytotoxicity of drugs, ovarian cancer is frequently diagnosed at advanced stages, which further increases morbidity and mortality rates. Although many years have passed, the prognostic role of cytoreductive surgery on survival in ovarian cancers continues to be important. Predicting postoperative outcomes in these surgeries may reduce the length of hospital stay, need for stay in the intensive care unit, complications, and mortality. Therefore, the role of systemic inflammatory biomarkers needs to be comprehensively investigated to understand the carcinogenic mechanisms better.

For this purpose, the investigators planned to evaluate the prognostic effect of systemic inflammatory biomarkers on postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age

Exclusion Criteria:

* Patients with acute or inflammatory diseases
* Patients with hematological malignancies
* Patients with autoimmune diseases patients who underwent intraoperative hyperchemotherapy (HIPEC)
Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery

During elective carotid endarterectomy surgery, dexmedetomidine, an FDA approved medication, is now given as part of our standard anesthetic regimen based upon its reported ability to decrease anesthetic requirements and improve the peri-operative hemodynamic profile without compromising the EEG monitoring that is used during these procedures. Although this is consistent with our clinical impression, the effects of dexmedetomidine on the perioperative course and EEG monitoring have not been objectively evaluated at our institution.

Fifty sequential patient records will be identified from a search of the OR surgical schedules and reviewed: 25 patients before the introduction of dexmedetomidine and a standard anesthetic protocol and 25 patients after the introduction of the protocol. Data will be collected during an individual review of the pre-operative anesthetic evaluation, the intra-operative anesthetic record and the post-anesthesia care unit record and collated in an Excel spread sheet kept on a secure personal computer in the PI's office. All personal identifiers will be removed and the patients numbered sequentially before and after introduction of the clinical protocol. The data collected will be used to characterize the intraoperative anesthetic requirements, effects on EEG activity and the immediate postoperative recovery period. The review is expected to require 2 months to complete.

This review will be restricted to records that already exist. No therapeutically removed tissues will be collected. There will be no additional tests. No blood samples will be collected. No additional procedures are involved in this study activity. There is no incomplete disclosure.

The resources and personnel are currently available to complete this review. The entire project including data collection, analysis and summarization will be completed by the PI.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective carotid endarterectomy

Exclusion Criteria:

* Emergency surgery
Institut Paoli Calmettes Hepatic Surgery Database

Database of patients who undergo hepatic surgery for: benign diseases, primary or secondary liver cancer at Institut Paoli-Calmettes


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing liver surgery for benign liver tumor, primary or secondary liver cancer

Exclusion Criteria:

* Patient refusal
Effects of Different Oxygen Devices in Hypoxemic COPD Patients

Taken recent literature together, there is a sufficient number of trials investigating the effect of different oxygen devices. However, studies comparing oxygen delivery via portable oxygen concentrator (POC) and liquid oxygen device (LOD) with appropriate exercise testing and sufficient power are missing.

Given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of two different oxygen delivery systems during walking in hypoxemic COPD patients (POC vs. LOD).

The endurance shuttle walk test (ESWT) is well validated for measuring endurance walking capacity in COPD patients with good repeatability. The advantage of this test over the 6MWT is that the ESWT is performed at 85% of the individual maximum which is close to the intensity of typical daily activities. Due to the fact that the ESWT enables us to determine the maximum duration of exercise and to compare values at isotime (at the point of time when the shortest of the 3 ESWTs ends), we use the ESWT as exercise test in our trial.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise (paO2\<60mmHg)
* Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL)
* Written informed consent

Exclusion Criteria:

* General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency
* Signs of acute exacerbation
* Any orthopedic or neurological disabilities that prevent patient from walking
Ultrasound-guided Percutaneous Electrolysis in Female Soccer With Soleus Injury

This study evaluates if the physiotherapy treatment based on combination of therapeutic exercise program and ultrasound-guided PNE on chronic soleous injuries may cause changes in pain, dorsal flexion of the ankle and muscle fatigue in female dance


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* having a soleus muscle injury
* chronic injury (\> 3 meses)
* pain at stretch \> 3 points measured by NRS

Exclusion Criteria:

* belenophobia
* other accuse injury
* lumbar back pathology
An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor

This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant to a single TNF-inhibitor therapy
* Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy, in accordance with the relevant Summary of Product Characteristics

Exclusion Criteria:

* Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment
The FACE Self-help App for Fostering Resilience

The FACE self-help app is an online intervention for young adults with Adverse Childhood Experiences (ACEs). It was developed based on well-established cognitive-behavioural therapy principles. The self-help app contains two components, one targeting emotion regulation (ER), the other social information processing (SIP).

The FACE self-help app is an online intervention for young adults with Adverse Childhood Experiences (ACEs). It was developed based on well-established cognitive-behavioural therapy principles. The self-help app contains two components, one targeting emotion regulation (ER), the other social information processing (SIP).

The goal of the present study is to evaluate the efficacy of the FACE self-help app, which aims to foster resilience and improve well-being by enhancing emotion regulation, social skills and minimizing biases in social information processing.

The primary objective is to examine the efficacy of the FACE self-help app for improving resilience and well-being in young adults with a history of ACEs compared to a waiting list control group and to examine the stability of a possible effect.

Secondary objectives are to test

1. the differential efficacy of the self- and emotion regulation and the social skills and social information processing component
2. the effects of the FACE self-help app on real life data in affective states, social interactions, the use of coping strategies and state resilience.

To assess real life data, additionally to questionnaires (Q), an ecological momentary assessment (EMA) will be conducted in three one-week episodes, with 6 daily assessments each.

Procedures: After giving informed consent, participants will receive the online questionnaires and one week of EMA (t0, week 1). Then, participants will be randomly assigned to either the intervention or waiting list control group. Within the intervention group, participants are randomly assigned to start with the ER or SIP component. After 5 weeks of using the first component of the FACE self-help app, participants fill out the intermediate measure (t1, week 7). After another week of EMA, the next component (ER or SIP) of the self-help app is available for 5 weeks. Subsequently, the post-measurement and the last EMA period start (t2, week 13). This results in a total intervention period of 11 weeks. A follow-up measure will be conducted after another 11 weeks (t4, week 25). Participants will receive online guidance from trained e-coaches.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported ACEs
* An informed consent
* The possession of a smartphone
* Mastery of the German language.
* Age between 18 and 25

Exclusion Criteria:

* Inability to follow the procedures of the study, e.g., due to comprehension problems, visual impairment, lack of sufficient motor skills or severe psychological or somatic disorders which require immediate treatment which impedes the continuous work on the self-help programme. These points will be discussed with the participant in the screening telephone call.
* Acute suicidality.
Family Habit Physical Activity Study

The purpose of this study is to examine physical activity habit formation in parents and if this can increase moderate to vigorous physical activity behavior in their children over six months. The Primary Research Question is:

Does the habit formation condition result in increased moderate-vigorous intensity physical activity of the child compared to the control (education) and education + planning conditions at six months? Hypothesis: Child physical activity will be higher for the habit formation condition in comparison to the more standard physical activity education and planning conditions at six months.

Secondary Research Questions

1. Does the habit formation condition improve child health-related quality of life, and health-related fitness outcomes compared to the control and planning conditions at six months? Hypothesis: Child health-related fitness and quality of life will be higher for the habit formation condition in comparison to the control and planning conditions.
2. Can group differences among behavioural, and health-related fitness outcomes be explained through a mediation model? Hypothesis: The covariance of the assigned conditions (habit formation, planning + education, education control) on child physical activity will be explained by parental support habit, and through the use of consistency and cues regulation strategies (i.e., manipulation check). In turn, the covariance between support habit and health-related outcomes will be explained by physical activity among conditions. The habit formation condition will not affect parental support intentions or underlying outcome expectations (benefits of physical activity) for support of child physical activity because its effect on behavior is to tie initial intentions to behavioural action or to work independent of goals and intentions.
3. Is there an intergenerational, seasonal, or gender difference across primary outcomes by assigned condition? Hypothesis: Parents in the habit formation condition will show higher physical activity via some activities being performed with their children in comparison to the other conditions. No differences in gender or season are hypothesized but these are exploratory research questions because there is limited research at present \[28\] to make any definitive statement.

Eligibility Criteria:
Inclusion Criteria:

* parents with children between the ages of 6 and 12 years
* self-report low family physical activity
* target child is not meeting Canada's Physical Activity guidelines

Exclusion Criteria:

• participant is unsafe to participate in physical activity as determined by answers to the Physical Activity Readiness Questionnaire (PAR-Q)
Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus

Hallux valgus is one of the most common forefoot deformities. Its prevalence increases with age, representing approximately 23% in adulthood, being more common in females. Some studies indicate that the use of the insole associated with the finger separator promotes pain relief and that this may be related to better alignment of the hallux. However, there is still no consensus about the ideal insole or how long it should be used to relieve pain or improve function in patients with hallux valgus. Therefore, the objective of this study will be to evaluate the effect of the customized insole on pain and function of individuals with symptomatic hallux valgus.

This is a protocol for a randomized, controlled, blinded clinical trial. Eighty participants with hallux valgus pain will be evaluated and randomized into two intervention groups (40 per group): customized insole group or sham insole group. Assessments will be performed at baseline (T0), after six weeks (T6) and twelve weeks (T12) of insoles use, in addition to the follow-up that will be performed four weeks after the end of the intervention (T16). The primary outcome will be pain, assessed by the Numerical Pain Scale and the secondary outcome will be foot functionality, assessed by the Foot Function Index questionnaire. Statistical analysis: For normal data, analysis of variance with a mixed design will be considered, and for non-normal data, the Friedman test will be used, in addition to the interaction of time per group and intergroup and intragroup differences. The Bonferroni test will be performed in post hoc analyses. Intent-to-treat analysis will be used. A significance level of 5% and CI 95% will be adopted for all statistical analyses.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of both sexes aged over 18 years;
* Presence of mild to moderate hallux valgus, according to the Manchester scale;
* Presenting no hallux with intensity greater than or equal to 3 points up to 8 points, according to the Numerical Pain Scale (END);
* Be available to actively use the insole for at least 4 hours/day;
* Commitment to wear closed shoes, for example (sneakers, shoes used by the patient, due to: wide toe cap and heel height of 2 to 3 cm) during the study.

Exclusion Criteria:

* Being in physical therapy treatment for hallux valgus concomitantly with the research;
* Previous hallux valgus surgeries performed in the last 5 years;
* Presence of foot wounds and wounds, dislocations or metatarsophalangeal fractures in the foot with HV, in the last 5 years
* Presence of diseases such as rheumatoid arthritis, decompensated diabetes, gout, neurodegenerative diseases;
* Cognitive and mental disorder being unable to respond; those related to the study
Pirfenidone LP or Collagen-polyvinylpyrrolidone in COVID-19

Collagen-polyvinylpyrrolidone (collagen-PVP) and pirfenidone have the ability to control cytokine storms. This work explores the therapeutic effects of both, on the early treatment of patients with severe COVID-19. The hospital stay, quick COVID-19 severity index (qCSI) and admission to the ICU were statistically significantly lower when the patients were treated with collagen-PVP or pirfenidone, compared to the controls treated with dexamethasone alone.

The therapeutic target of COVID-19 is focused on the control of inflammation and the prevention of fibrosis. Collagen-polyvinylpyrrolidone (collagen-PVP) and pirfenidone have the ability to control cytokine storms observed in rheumatic and fibrotic disorders. In this work, the investigators explored the therapeutic effects of both, in addition to dexamethasone, on the early treatment of patients with severe COVID-19. The hospital stay, quick COVID-19 severity index (qCSI) and admission to the ICU were statistically significantly lower when the patients were treated with collagen-PVP or pirfenidone, compared to the controls treated with dexamethasone alone. Furthermore, only collagen-PVP normalized serum glucose at discharge. Since the intracellular mechanism of action of pirfenidone is partially known, it was performed a whole human genome microarray assay with total RNA isolated from fibroblast and macrophage cultures treated with collagen-PVP. Ingenuity Pathway Analysis showed that cell cycle, inflammation, and cell surface-extracellular matrix interaction could be regulated by the collagen-PVP copolymer, by down-regulation of pro-inflammatory cytokines, such as IL-6 and -8, while Th2 anti-inflammatory response signaling could be up-regulated. Additionally, down-regulation of some of the genes involved in nitric oxide production by inducible nitric oxide synthase showed a possible control for JAK, in the IFN-γ pathway, allowing the possibility of controlling inflammation through the JAK/STAT pathway, as has been observed for pirfenidone and other immunomodulators, such as ruxolitinib. In summary, once again, collagen-PVP and pirfenidone have demonstrated to favor inflammatory control and stand out as a possible therapy for inflammatory disorders derived from viral or microorganism infections.

Eligibility Criteria:
Inclusion Criteria:

* patients infected with SARS-CoV-2, hospitalized, with total bilirubin ≤1.5

Exclusion Criteria:

* if the patient underwent treatment with biological antirheumatic drugs, disease modifiers (DMARDs) or other immunosuppressive agents, patients who required continuous therapy with systemic corticosteroids in a dose greater than 10 mg of prednisone per day or equivalent; pregnant women, calculated creatinine clearance (or estimated glomerular filtration rate less than 10 ml/min or patients requiring renal replacement therapy
Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal

The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3 (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal associated with the administration of the supplement.

Clinical randomized controlled double-blind study with healthy subjects to investigate the effect of low and high fat of meal on absorption of vitamin D supplement. Participants were randomly in two groups according to sex and BMI.

In the same date, each group of participants received a meal and dietary supplement of vitamin D3 (cholecalciferol) after the first blood sample and a urine sample. Others samples were collected in the seventh and fourteenth day after intake the supplement.

Eligibility Criteria:
Inclusion Criteria:

* Residents of the hospital clinics of Porto Alegre

Exclusion Criteria:

* Don't drink milk
* Obesity
* Malnutrition
* Liver disease
* Kidney disease or diabetes
* Use of dietary supplements containing calcium and vitamin D
* Medications
* Anticonvulsants
* Barbiturates, or steroids.
* Having performed a journey the last four months to locations near the Earth's equatorial plane, due to sun exposure that may have occurred during this period, or vacations planned during the study period.
Correlating Real and Virtual World Behavioral Fluctuations in Adolescence

The present study will explore a new approach to ongoing evaluation and monitoring of fluctuations in personality traits via commercial video games. The aim of this longitudinal study is to examine the influence of everyday life event on video games performance as a function of individual differences in gaming behavioral patterns. focusing on the ongoing performance vacillations of the patient on commercial video games will offer insights in to possibly new generation of real time assessment medium of ongoing behavior.


Eligibility Criteria:
Inclusion Criteria:

* All subjects will have normal or corrected to normal vision with no sensory/motor disturbance
* An accessible computer at the house hold
* Previous experience in playing computer games.

Exclusion Criteria:

* drug abuse
* head injury
* living in a boarding school and a major psychiatric or neurological disorder.