cyrilzakka/clinical-trials huggingface dataset:
Sitz Bath vs no Sitz Bath in Acute Anal Fissure Treatment

To compare the efficacy of 'sitz bath' and 'no sitz bath' treatment in terms of pain improvement, rate of cure and fissure healing in Acute Anal Fissure.

ABSTRACT Objective To compare the efficacy of 'sitz bath' and 'no sitz bath' treatment in terms of pain improvement, rate of cure and fissure healing in Acute Anal Fissure.

Study Design Randomized Controlled Trial Place and Duration of Study Department of Surgery Combined Military Hospital, Quetta, from15 January 2019 to 15 August 2021.

Patients and Methods Individual patients were randomized to either receive 'sitz baths' or 'no sitz baths' treatment for 4 weeks. Patients were asked to have 'sitz bath' once in morning and again at bedtime, after each week pain scores and healing of fissure were assessed. Main outcome measures were validated.

Keywords Acute anal fissure, pain, sitz bath

Eligibility Criteria:
Inclusion Criteria:

* Patients of acute anal fissure of both genders between 18 to 60 years

Exclusion Criteria:

* While the patients with history of recurrent fissure, chronic anal fissure, pregnant woman and patients who were operated previously for any anorectal pathology were excluded from the study.
The Bioavailability and Effect on Pouch PH of Esomeprazole After Gastric Bypass

The objective of this study is to investigate the effect of Esomeprazol administered in tablets (Esomeprazol MUT Sandoz® 40mg) or in solution (Esomeprazol MUT Sandoz® 40mg in 10ml tap water) on acid production in the gastric pouch by measuring the intragastric pH and the serum concentration of esomeprazole.

To assess the clinical effect of the esomeprazole absorption after Roux-en-Y gastric bypass, we intend to measure the serum concentration after administration as intact capsules or open in solution and correlate it with the pH in the gastric pouch, measured with the wireless BRAVOTM capsule pH measurement system. The feasibility and safety of the wireless pH monitoring system has been shown before.

The patients who met all the inclusion criteria undergo a routine upper endoscopy one year after RYGB. At the end of the endoscopy, the wireless BRAVO™ - pH monitoring device is placed and the participant is discharged with ongoing pH monitoring. The next day, the participant is randomized to either receive Esomeprazol MUT Sandoz® tablet 40mg or Esomeprazol MUT Sandoz® 40mg in solution. Serum concentration of Esomeprazol is measured at 0, 60 and 120 minutes and the patient is discharged after. After 48 hours of pH monitoring, the patient returns the BRAVO™ - recorder, adverse events are assessed and the study is terminated.

Eligibility Criteria:
Inclusion Criteria:

* Proximal Roux-en-Y gastric bypass with linear stapled anastomosis 12 months prior to the study investigation
* Routine administration of proton pump inhibitors for 6 months postoperatively
* No intake of proton pump inhibitors at least 4 weeks prior to study investigation
* No marginal ulcers in upper endoscopy prior to placement of wireless BRAVO™ pH monitoring capsule
* No symptoms related to gastro-esophageal reflux or marginal ulcers (i.e. epigastric pain, retrosternal burning, regurgitation)
* Informed consent as documented by signature

Exclusion Criteria:

* Known intolerance or allergy for Esomeprazol
* Contraindication for upper endoscopy
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Women who are pregnant or breast feeding Major hepatic dysfunction
Quality of Life 12 Months After Cardiac Surgery

Cardiac surgical patients entering the hospital for operation were voluntarily recruited to participate a 12 month follow- up of health related quality of life (QOL)

Cardiac surgical patients entering the hospital for operation were voluntarily recruited to participate a 12 month follow- up of health related quality of life based on established QOL measurements with EuroQol quality of life 5 dimensional 3 level (EQ-5D-3L) description system at preoperative, 6 months and 12 months postoperatively. The study started on May 2013 and ended at the end of 2018. The data has been analyzed for publication in 2021. The total number of patients reached 1594.

Eligibility Criteria:
Inclusion Criteria:

* elective or urgent cardiac surgery (open heart procedure to valves or ascending aorta /arch, on-pump or off-pump surgery to the coronary arteries )
* willingness to participate,
* ability to comprehend Finnish language

Exclusion Criteria:

* emergency surgery (with no time to introduce the study in good time)
* not willing to participate,
* blind or other disturbance in seeing,
* inability to comprehend Finnish language
Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations.

The purpose of this study is to develop robust protocols for the optimisation of novel hardware, software and exercise equipment in the magnetic resonance imaging (MRI) environment in various cohorts with cardiovascular disease (CVD) with the first study focusing on those with established heart failure with preserved ejection fraction (HFpEF) or those at risk of or with pre-HFpEF.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged \>18 years
* Either a clinical diagnosis of HFpEF, be at risk of or pre- HFpEF

Exclusion Criteria:

* Absolute contraindication to MRI
* Unable to read/understand English sufficiently to provide informed consent
* Pregnancy
* Unable to consent due to lack of mental capacity
* Current cancer diagnosis and actively undergoing treatment
* Inability to exercise on the MRI ergometer
* Severe claustrophobia
Checking Wether the m-ALA Cream Could Mark Correctly the Borders of BCC's Tumors

Correlation between Mohs surgery and microscopic fluorescence photometry in determination of histological borders in Basal Cell Carcinoma .

Background: Basal Cell Carcinoma (BCC) is the most common form of nonmelanoma skin cancer worldwide. BCCs are slow-growing, locally invasive tumors that rarely metastasize but can cause extensive morbidity through local tissue destruction. Recurrence is often the consequence of incomplete removal of the cancer tissue. Mohs' micrographic surgery is considered the most effective treatment modality for BCC with a recurrence rate of less than 5 %, however, the technique requires specialized training and is labor-intensive and costly. Fluorescence imaging by topical application of a tumor-localizing agent such as methyl 5-aminolevulinic acid (MAL), resulting in buildup of photosensitizing porphyrin IX (PpIX) that can be visualized by Woods' light fluorescence, might serve as a quick and simple "bed-side" technique for demarcation of BCC tumor borders prior to surgical excision Objective: To test the reliability of MAL-induced porphyrin fluorescence tumor demarcation by comparison with the tumor borders determined by Mohs' surgery Methods: Twenty eight patients with facial BCCs (17 nodular, 3 superficial, 1 morphea type, 3 ulcerated and 4 recurrent tumors) scheduled for Mohs' surgery were recruited for the study. The night before the surgical procedure, crusts were gently removed and an approximately 1 mm thick layer of a cream containing 16 % MAL (MetvixR) was applied to the tumor area as well as to the surrounding skin and covered by a transparent occlusive dressing. The following morning (10-17 hours after MetvixR application), the dressing was removed, and the lesion size was determined with a caliber by measuring the largest perpendicular diameters under natural (clinical size) and Woods' (fluorescence size) illumination. The patients then underwent the scheduled Mohs' surgical procedure, and the tumor size (Mohs' size) was determined when reaching the tumor free margins.

Eligibility Criteria:
Inclusion Criteria:

* A- bove 18 years

Exclusion Criteria:

* Childern
* Pregnant women
The Association Between Physical Activity Level and Post-operative Prognosis

The study primarily focuses on adult patients who underwent elective surgery at Peking Union Medical College Hospital. The physical activity level before surgery within the past 3 months is the main exposure factor and postoperative quality of life score (EQ-5D-3L utility index) is the main outcome indicator. The correlation between patients' preoperative physical activity level and their surgical outcomes will be explored in this study.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective surgery at Peking Union Medical College Hospital

Exclusion Criteria:

* 1. Patients scheduled for surgery with minimal impact on overall health (including eye surgery, abortion, hysteroscopy, conization, gastroscopy, vascular angiography, and superficial surgery, etc.) 2. Orthopedic and cardiac surgery patients 3. Patients who are unable to live independently or have significant limitations in physical activity prior to surgery 4. Patients who have difficulty communicating verbally and cannot complete the questionnaire 5. Pregnant women.
Immune Characterization of Subcutaneous Adipose Tissue

The overall goal of this proposal is to characterize the immune cell profile of subcutaneous abdominal adipose tissue in lean, overweight, obese and lipedema adults, and to evaluate potential associations between different adipose tissue immune cell types and metabolic profile.


Eligibility Criteria:
Inclusion Criteria:

* Women of all races and ethnicity
* Age between 18 and 65 years
* Body Mass Index (BMI) ≥ 18.5 kg/m²
* Weight stable (+/- 3% during the last 2 months before enrollment)
* Women already scheduled for above mentioned procedures

Exclusion Criteria:

* Diabetes Mellitus
* Recent (\<5 years) history of cancer (except in situ ductal breast carcinoma)
* Chemotherapy and/or radiation therapy within 4 months before enrollment
* Immune system diseases (i.e., autoimmune disorders, acquired immunodeficiency syndrome)
* Pregnant or breastfeeding
* Take any medication that might affect immune function
* Severe organ dysfunction
* BMI \<18.5 kg/m² or size of each breast is \>600 grams, if scheduled for bilateral breast reconstruction
Obstructive Sleep Apnoea in Children and Adolescents With Ehlers-Danlos Syndrome

Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of inherited connective tissue disorders characterized by joint hypermobility, skin hyperextensibility, and tissue fragility. EDS features such as genetically related cartilage defects, craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to cause obstructive sleep apnoea (OSA). There is evidence from studies based on questionnaires that EDS patients might be more frequently affected by OSA and sleep disturbances than the general population. However, the actual prevalence of OSA in children and adolescents with EDS is unknown.

The primary objective of this study is to assess the prevalence of OSA in children and adolescents with EDS (25) compared to a matched control group (25). The secondary objective of this pioneer study is to assess the quality of life in children and adolescents in EDS in comparison to healthy children and adolescents.

Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of inherited connective tissue disorders characterized by joint hypermobility, skin hyperextensibility, and tissue fragility. EDS features such as genetically related cartilage defects, craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to cause obstructive sleep apnoea (OSA). There is evidence from studies based on questionnaires that EDS patients might be more frequently affected by OSA and sleep disturbances than the general population. However, the actual prevalence of OSA in children and adolescents with EDS is unknown.

The primary objective of this study is to assess the prevalence of OSA in children and adolescents with EDS compared to a matched control group. The secondary objective of this pioneer study is to assess the quality of life in children and adolescents in EDS in comparison to healthy children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Diagnosis of Ehlers-Danlos Syndrome (not for control group)

Exclusion Criteria:

* Moribund or severe disease prohibiting protocol adherence
* Continuous positive airway pressure treatment for OSA during sleep study
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Pregnant patients
Observational Study on Chronic Kidney Disease Treatment With a Ketosteril Supplemented Protein-restricted Diet

The purpose of this study is to characterise the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA), focusing on the progression of chronic renal insufficiency, calcium and phosphorus metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as the persistent dietary education to ensure compliance in a large group of pre-dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* non-dialyzed patients with CKD
* indication for Ketosteril according to Summary of Product Characteristics (SmPC), including a glomerular filtration rate (GFR) \< 25 mL/min
* accepted supplemented protein-restricted diet and newly starting with Ketosteril (treatment naïve, i.e., never treated with Ketosteril before)
* adult patients ≥ 18 years

Exclusion Criteria:

* active cancer diseases
* pregnancy or breast feeding
* hypersensitivity to active substances or to any of the excipients in Ketosteril
* hypercalcaemia
* major disorder of amino acid metabolism, e.g., hereditary diseases
* participation in any clinical trial with an investigational drug within 30 days prior to start of study or during the study
* illiteracy or incapability to read or write
CELTIC Bifurcation Study

This study will examine outcomes for patients treated by planned culotte stenting and compare outcomes with 2 different stent platforms, the next generation Synergy II and the Xience Xpedition DES platforms.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient \>18 years old
* Females of childbearing potential with a negative pregnancy test
* Coronary artery disease requiring revascularization that is amenable to PCI
* Medina 1,1,1 bifurcation lesion \[13\] with \>70% lesion in both the main vessel and the side branch by visual assessment
* Main branch and side branch ≥ 2.5mm in diameter by visual assessment
* Both vessels require stenting in the opinion of the operator

Exclusion Criteria:

* Acute myocardial infarction with ongoing ST-elevation
* Cardiogenic shock
* Lesion involves the left main coronary artery
* Lesion involves bypass graft
* Plan to treat \>1 other coronary vessel at the time of inclusion
* Chronic total occlusion of any target vessel
* Left ventricular ejection fraction \<20%
* Requirement for ongoing haemodialysis
* Life-expectancy limited to \<12 months due to co-morbid condition
* Known allergy to Aspirin
* Known allergy to Clopidorel and Prasugrel and Ticagrelor
* Known allergy to stent drug elutant
* Known allergy to any other component of either the Synergy II or Xience Xpedition stents systems
* Ongoing participation in another investigational device or drug study
* Inability to provide informed consent
Infectious Pseudochromdrosis Caused by Bacillus Cereus

Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus.

Case series/observational study. Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus. Demography, clinical presentation, diagnosis, treatments, microbiology and causality.

Eligibility Criteria:
Inclusion Criteria:

* Infectious pseudochromhidrosis caused by Bacillus cereus

Exclusion Criteria:

* Other types of blue chromhidrosis
Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery

Hemodilution reduces concentrations of blood constituents: concentration of hemoglobin, red blood cells (hematocrit), physiological ions and coagulation factors that can contribute to impaired hemostasis and increasing the risk of perioperative blood transfusions. This pilot study will assess the feasibility of a large RCT to evaluate 2 techniques for reducing hemodilution during cardiac surgery: 1) retrograde autologous priming and 2) intraoperative mannitol. The aim of this pilot trial is to demonstrate feasibility of a larger trial to evaluate whether retrograde autologous priming and/or mannitol are superior to conventional priming alone.

The use of large volumes of artificial priming fluids is still very high in cardiac surgery for routine CABG surgery with cardiopulmonary bypass. The resulting hemodilution is deleterious for patients and often requires counter measures to maintain fluid balance during and after surgery. Retrograde autologous priming and mannitol are simple low-cost solutions to the problem of hemodilution but their effectiveness, either alone or in combination, is unclear due to a lack of high-quality evidence. RAPPER-MAN is a single-centre 2x2 factorial cluster randomized trial. Participants will be randomly assigned (1:1:1:1 ratio) to the intervention groups: 1) Retrograde autologous priming (≥600 mL) + mannitol (0.3 g/kg bolus), 2) Retrograde autologous priming (≥600 mL) alone, 3) Conventional priming + mannitol (0.3 g/kg bolus), and 4) Conventional priming alone. The primary outcome is the change in hemoglobin concentration during cardiopulmonary bypass. Retrograde autologous priming will be performed within 10 minutes before, and mannitol will be added to the venous reservoir of the CPB machine within 5 minutes before, the start of cardiopulmonary bypass. The results of the larger trial are expected to have broad implications for fluid management in cardiac surgery in Canada.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age.
2. Undergoing a first-time cardiac surgical procedure (i.e. isolated CABG, isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass (CPB) and median sternotomy.

Exclusion Criteria:

1. Left ventricle ejection fraction \<25%
2. Emergency surgery
3. History of bleeding disorder
4. Inherited thromboembolic or infective endocarditis (active)
5. Previous cardiac surgery
6. Severe renal impairment (serum creatinine \>250 μmol/L)
7. Hemoglobin \<80 g/L
8. Thrombocytopenia (\<50,000 platelets per μL)
9. Expected circulatory arrest
10. Body weight ≤50 kg
11. Allergy to mannitol
12. Pregnancy or breast feeding
A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects

A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Is in good general health as determined by the Investigator's review
* Has a body mass index (BMI) between 18 and 35kg/m\^2, inclusive
* For females, is not currently pregnant or breastfeeding and is either of non-childbearing potential or willing to use an adequate method of birth control
* For males, must agree to use barrier contraception and not to donate sperm

Key Exclusion Criteria:

* Has a history of cardiac disease, including congestive heart failure, angina, or any arrhythmia
* Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy
* Has any history or currently active type of cancer except excised or cured basal cell carcinoma
* Has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs
* Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine
* Currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease
* Has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment
* Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection
* Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV);
* Is pregnant, lactating, or planning a pregnancy during the study
* Has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives)
* Has used within 14 days prior to the first admission or has plans to use during the study any over-the-counter medicinal products, including herbal and dietary supplements (except for occasional use of acetaminophen or NSAIDs, such as ibuprofen or naproxen; calcium; or Vitamin D)
* Use of any of the following:

  * Human growth hormone, octreotide, anti-diabetic medication, or thyroid suppressors or supplements
  * Immunosuppressive drugs within 30 days of study start, or 5 half-lives of the drug (whichever is longer), or plans to use during the study