cyrilzakka/clinical-trials huggingface dataset:
A Low Dose Dexmedetomidine in Sedation Colonoscopy

104 patients who undergo painless colonoscopy from January 20,2024 to February 29,2024 will be randomized to two groups: propofol group and dexmedetomidine group.

In the dexmedetomidine group,dexmedetomidine is infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. In the propofol group, Propofol is administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1 during the whole process.

104 patients who undergo painless colonoscopy from January 20,2024 to February 29,2024 will be randomized to two groups: propofol group and dexmedetomidine group.

In the dexmedetomidine group,dexmedetomidine is infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. In the propofol group, Propofol is administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1.For all patients, if Ramsay sedation scale score reach 3, colonoscope will be inserted. During the whole process, maintenance Ramsay score of 3 to 4. Propofol 10 mg will be administrated as the rescue dose if body movement occur during colonoscopy.

The primary outcome is the occurrence of hypotension. Key secondary outcomes are time-weighted average (TWA), area under the threshold (AUT) and cumulative duration of hypotension, as well as the maximum reduction in BP. Other secondary outcomes include(1) the incidence of bradycardia, hypoxemia or body movement；(2) discharge time (from the end of colonoscopy to discharge); (3) patients and endoscopists' satisfaction score (using an 11-point Likert scale, with 0 indicating "very dissatisfied" and 10 indicating "very satisfied"); (4) the incidence of dizziness, fatigue, or nausea and vomiting

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged above 18 years
2. American Society of Anesthesiologists (ASA) physical status of 1-2
3. Patients scheduled for sedation colonoscopy

Exclusion Criteria:

1. Emergency patients
2. Body weight \< 40 kg or \>100 kg
3. Allergy to dexmedetomidine, propofol in this trail, a previous adverse reaction to dexmedetomidine or propofol
4. Pregnancy or lactation
5. Drug abusers
6. Participation in other clinical studies within the previous 3 months
7. renal impairment (glomerular filtration rate \< 60 ml/min), significant hepatic impairment (ascites, cirrhosis, or with international normalized ratio(INR) \>1.5)
Compact Pneumatic Compression Device for Patients With Lymphedema

This is a pilot study for usability and efficacy, and as such it is designed for 15 participants.

The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting.

The primary objective of this study is to assess the usability of the Monterey Investigational System in the home setting over one week of daily use. Usability will be determined using a 11 point Likert Scale where a score of 10 is considered very favorable and a score of 0 is very unfavorable.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are ≥ 18 years, mentally able to understand and follow the instructions of the study personnel.
* A diagnosis of lower limb Lymphedema.
* Able to provide written and informed consent.
* Patient can read and comprehend English.

Exclusion Criteria:

* Subject undergoing cancer treatment.
* Subject has active lower limb wounds.
* Subject is pregnant or trying to become pregnant.
* History of pulmonary edema or decompensated congestive heart failure.
* Subject has any condition in which increased venous and lymphatic return is undesirable.
* Subject has inbuilt electrical stimulator, e.g., cardiac pacemaker
CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery

This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin drift), and reduce the postoperative transfusion requirements, in order to identify a new strategy for pre-hospitalization optimization and post-operative recovery.

This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin drift), and reduce the postoperative transfusion requirements, in order to identify a new strategy for pre-hospitalization optimization and post-operative recovery.

Secondary Objectives are

* Changes in blood chemistry and biochemical tests between pre- and post-intervention
* Evaluation of tolerability and compliance of supplementation with Sucrosomal Iron
* Reduction in the number of transfusions and blood bags used
* Evaluation of cost-effectiveness

Eligibility Criteria:
Inclusion Criteria:

Undergoing elective Heart Surgery -

Exclusion Criteria:

- Emergent or Urgent Indication
Hepcidin After Intravenous Iron Treatment

The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration.

Intravenous iron is often administered when peroral iron is insufficient to correct iron-deficiency or not tolerated. Few studies have shown a relationship between pretherapeutic serum hepcidin levels and response to intravenous iron infusion: the lower the pre-infusion hepcidin level, the fewer red blood cell concentrates were used to correct anaemia. However, there are no studies investigating hepcidin levels after intravenous iron supplementation. Furthermore, some studies showed an increase in hepcidin 24 hours after ingesting oral iron supplements, impairing the iron uptake the next day. However, how long hepcidin is increased after intravenous iron administration is unknown. Prolonged serum hepcidin concentrations after an iron infusion would reduce intestinal iron absorption and continued, simultaneous oral iron therapy would be pointless.

This study investigates whether and how serum hepcidin concentrations change after intravenous iron therapy. Women with iron deficiency (serum ferritin below 30ng/ml) without anaemia (hemoglobin \>117g/l) receive 500mg iron (Ferinject®) intravenously. Serum hepcidin levels are measured before therapy (day 0) 2 days (day 2) and 7 days (day 7) after infusion.

Eligibility Criteria:
Inclusion Criteria:

* informed consent as documented by signature
* iron-deficiency (serum ferritin \<30ng/ml)
* female gender
* premenopausal
* age \>18 years
* body mass index (BMI) in normal range (18-25 kg/m²)
* the participant is linguistically and cognitively able to understand the study procedure

Exclusion Criteria:

* anaemia (hemoglobin \<117g/l)
* allergy or contraindications for iron infusions
* anamnestic current pregnancy
* breastfeeding
* chronic inflammatory diseases (e.g. colitis)
* liver disease (alanine transaminase (ALT) \>35 U/l)
* increased C-reactive protein (CRP) (\>5mg/l)
* intake of dietary supplements containing iron (last 7 days)
RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child

Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic regimes per os on pain due to not compound bone fractures in child 4-17 years old:

* ketorolac 0,5 mg/kg (1 drop every 2 Kg)
* tramadol 2,5 mg/Kh (1 drop every 2 Kg)

Intensity of pain will be estimated with linear 1 to 10 or analogic McGrath type scale every 20 min.

The main objectives are the evaluation of pain decreasing in every group, the time of decreasing, the intensity of pain during procedures (ex. Xray) and the occurrence of side effects Secondary outcomes are comparison between the two groups on effectiveness on pain and on side effects


Eligibility Criteria:
Inclusion Criteria:

* Children 4-17 years old with not compound bone fracture presenting in emergency room

Exclusion Criteria:

* Compound fracture
* Occurring pain still treated
* Contraindicated ketorolac or tramadol use
* Informed consensus not obtained
A Study of Ro 24-7429 in Patients With HIV-Related Kaposi's Sarcoma

To study the effects of Ro 24-7429 on tumor growth in patients with HIV-related Kaposi's sarcoma. To study the safety and tolerance, effects on HIV replication, and immunologic effects of Ro 24-7429 in this patient population. To explore relationships between exposure to Ro 24-7429 and its metabolites with its antitumor and antiviral activities and drug toxicity.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV seropositivity.
* Biopsy-proven mucocutaneous Kaposi's sarcoma with fewer than 50 skin lesions and measurable disease.
* No active opportunistic infection. NOTE:
* Patients with CD4 count \>= 200 cells/mm3 must have no prior opportunistic infection, as well as no active opportunistic infection.
* Life expectancy of at least 24 weeks.
* Stable weight (+/- 2 kg) by 28 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Other active malignancies (except basal cell carcinoma of the skin and in situ cervical cancer).
* Known or suspected hypersensitivity to benzodiazepines.
* Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, dermatologic, or allergic disease as determined by the investigator.
* Ongoing diarrhea (\> two liquid stools per day).
* Grade 2 or worse signs and symptoms of AIDS Dementia Complex.
* Alteration of mental status that may interfere with study compliance.

Concurrent Medication:

Excluded:

* AZT, ddI, or ddC.
* Experimental antiretrovirals.
* Biologic response modifiers or immunomodulating agents (e.g., interferon).
* Colony stimulating factors (erythropoietin, GM-CSF, G-CSF).
* Ganciclovir.
* Foscarnet.
* H-2 antagonists (cimetidine, ranitidine, famotidine, nizatidine).
* Omeprazole.
* Benzodiazepines.
* Any other investigational compound.
* Ongoing systemic treatment with corticosteroids (other than replacement therapy for adrenal insufficiency or short-term therapy of no more than 28 days for bronchial asthma).
* Cytotoxic chemotherapy (systemic and local).
* Drugs known to cause systemic toxicity, if avoidable (e.g., myelosuppressive, hepatotoxic, nephrotoxic, or neurotoxic drugs).
* Paromomycin sulfate.
* Chronic suppressive therapy for CMV and/or MAI.

Patients with the following prior condition are excluded:

History of serious adverse reactions to benzodiazepines.

Prior Medication:

Excluded:

* Interferons or immune modulators within 4 weeks prior to study entry.
* Prior systemic cytotoxic chemotherapy (patients with CD4 counts \>= 200 cells/mm3 only).
* Benzodiazepines within 14 days prior to study entry.
* Intralesional chemotherapy for Kaposi's sarcoma within 2 weeks prior to study entry.
* Therapy with antiretroviral drugs (including AZT, ddI, ddC, d4T) or investigational drugs within 14 days prior to study entry.

Localized radiotherapy. Radiotherapy (other than localized). Active drug or alcohol abuse.
Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter

TOTEME offers to treat certain chronic strictures of the ureter with MEMOKATH 051 to assess its effectiveness, tolerance and mean durability during a 3 years follow up period.

Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. After this procedure, the patients will have medical examinations, blood exams, radiography and renal sonography during 3 years. If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent.

Introduction:

The chronic strictures of the ureter are usually treated by double J stents. They allow the emptying of the kidney and avoid the deterioration of renal function. Unfortunately, double J stents have to be replaced every 6 month and are at the origin of irritative lower urinary tract symptoms and lumbar pain which corrupt the quality of life of the patients.

Ureteral stricture could also be treated with MEMOKATH 051. These new ureteral stents seem not to require iterative changes and also not to cause irritative symptoms and lumbar pain. MEMOKATH 051 could therefore allow to reduce the number of changes and to ameliorate the quality of life of the patients.

Main objective:

Main objective is to assess effectiveness and tolerance of the MEMOKATH ® 051 in the treatment of chronic strictures of the ureter.

Resume:

Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy.

After this procedure, the patients will have medical examination, blood exams, radiography and renal sonography at 1 month, 3 month and every 6 month during a 3 years follow up period.

If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent and an adverse event will be declared.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-year-old or superior
* Chronic stenosis of the ureter treated by placement of a ureteral endoprosthesis for more than six months;
* No possibility for surgical or endoscopic treatment of the ureteral stricture
* Free Consent, dated and signed by the patient
* Affiliated Subject of a regime of French national health and pensions organization.

Exclusion Criteria:

* Age under 18 year old
* Pregnant or nursing Women
* Patient having a life expectancy of less than 1 year
* Patient having unique kidney
* Patient having severe renal insufficiency (creatinin clearance under 30 ml/min)
* Possible surgical or endoscopic treatment of ureteral stricture
* Repeated urinary tract stones
* Urothelial tumor of the bladder
* Retro peritoneal fibrosis in the course of evolution
* Complications of double J stents requiring more thanks a lot every 6 months
* Against anaesthetic indication
* Lithiasic inlay probe Double J with obstruction within 6 months
* Persons put under maintenance of justice
* Persons in inability to understand the sequence of try
Baby Sickness Evaluation

The goal of this prospective single center feasibility study is to assess the feasibility of using BabyCheck and PO by GPs as an illness severity score for young infants \> 6 months of age in order to aid the decision for referral to hospital.

The emergency GP posts in Leiderdorp will add the BabyCheck and PO to their standard evaluation of infants presenting with systemic illness \< six months of age for a period of six months.

The feasibility will be determined by calculating the percentage of eligible infants in whom a complete BabyCheck score and PO data were retrieved. The investigators consider the protocol feasible if this is done in 80% of all eligible infants.

Young infants frequently visit general practitioners (GP) with acute pathology, such as infections. Assessing severity of illness in this group is often challenging, since the likelihood of serious illness in this group is low, deterioration of the clinical condition can occur more rapidly. Therefore, early recognition of pathology in young babies is pivotal.

The Netherlands Triage System (derived from the Manchester Triage System) is a reliable tool for both children and adults to decide if a patient should be seen by the GP. However, after presentation at the GP, a scoring system to assess illness severity in babies with a decision aid for referral to hospital, is currently lacking.

The BabyCheck is a scoring system developed and validated as a clinical checklist to assess young infants up to six months of age. The BabyCheck is validated in multiple low illness prevalent settings.

In addition, abnormal oxygen saturation and/or heart rate can be an early sign of infection, respiratory or circulatory pathology in infants. Since it is difficult to adequately judge oxygen saturation solely by skin colour, it is preferable to objectify this parameter via pulse oximetry (PO).

The aim of this study is to assess the feasibility of using BabyCheck and PO by GPs as an illness severity score for young infants \< six months of age in order to aid the decision for referral to hospital.

Eligibility Criteria:
Inclusion Criteria:

* Infants up to six months of age.
* Presenting with systemic illness (no injuries or traumata).
* Presenting at the emergency GP post of Leiderdorp.

Exclusion Criteria:

* Infants up to six months of age, presenting with traumata or that are in a resuscitation setting.
* Infants with referral to other hospitals than the Alrijne hospital. The location for referral is coded and available from the anonymized database of the emergency GP post.
* Infant \< 1 month of age presenting with fever (body temperature \> 38.0 ⁰C), with or without unknown origin, since these infants should always be referred according to the national guidelines for GPs.
* Infants \< 3 months of age presenting with fever of unknown origin (temperature \> 38.0 ⁰C), since these infants should always be referred according to the national guidelines for GPs.
Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients

The investigators would like to conduct a prospective, randomized non-inferiority study to compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis patients.

The primary outcome is to compare clinical resolution rate of EUS-guided gallbladder drainage versus percutaneous transhepatic gallbladder drainage in acute cholecystitis patients with high risk.

The secondary outcome is to compare complications, conversion rate to open cholecystectomy during laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)

Exclusion Criteria:

* Age below 18 years
* Pregnancy
* When the risks of endoscopy to patient are judged to outweigh the most favorable benefits of the procedure.
* Unstable or unwilling to comply with follow-up
* When a perforated viscus is known or suspected
* Simultaneously participating in another investigational drug or device study
Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health

This study evaluates the addition of an interdental cleaning device paired with a manual toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival bleeding and reduction of gingival inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Between 25 and 70 years of age
* Able to provide written informed consent prior to participation
* Agree to not participate in any other oral/dental products clinical study for the study duration
* Good general health and be a non-smoker
* A minimum of 50% bleeding on probing sites
* A minimum pre-brushing plaque score of 0.6
* A minimum of 1.75 gingivitis score Have no probing depths greater than 5 mm
* A minimum of 20 teeth (not including 3rd molars)
* No partial dentures, orthodontic brackets, wires or other appliances
* Agree to refrain from the use of any non-study dental device or oral care product for the study duration
* Agree to return for the scheduled visits and follow study procedures
* Agree to delay dental prophylaxis until study completion
* Have a minimum pre-brushing plaque score of 0.6
* Have a minimum of 1.75 gingivitis score

Exclusion Criteria:

* Probing depth greater than 5 mm
* Systemic disease (ex. Diabetes, autoimmune disease)
* Advanced periodontitis
* Taking medication that can influence gingival health such as seizure meds, calcium channel blockers, Cyclosporine, anticoagulants
* Orthodontic appliances or removable partial dentures
* Pregnant at time of study
* Use of antibiotics within 6 months of study
Early Experience With Descemet's Stripping Automated Endothelial Keratoplasty

The purpose of this study is to report the early clinical outcomes in patients undergoing Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) for corneal edema secondary to corneal endothelial cell dysfunction, and to correlate this clinical data with the latest generation of imaging modalities available for the anterior segment.

A concurrent study for retrospective as well as prospective cases of patients undergoing DSAEK procedures for indication of corneal endothelial cell dysfunction. For the retrospective study, all cases of DSAEK procedures performed at UT-Southwestern for corneal edema secondary to endothelial cell dysfunction will be considered. The clinical outcomes of these surgeries will be analyzed and correlated with the anterior segment imaging from each case. Statistical analysis will then be performed on the data collected. For the prospective arm of this trial, we propose to recruit up to 200 current patient cases of corneal edema second corneal endothelial cell dysfunction. These patients will undergo ocular imaging studies in addition to routine ocular exams performed before surgery and at the discretion of the investigational physician at 3 to 6-months and 6 to 9-months after surgical treatment. Various imaging modalities would include corneal topography, pentacam, anterior segment OCT, wavefront measurement and Tandem Scanning Confocal Microscopy (TSCM). The patients who have already had the DSAEK procedure done in the past will undergo ocular examination as well as various imaging studies at their post op follow up visits. All these modalities are routinely used as standard of care practice and are non-invasive. The data from the ocular examination and various imaging techniques will be pooled and analyzed at the end of the study in order to identify the factors that influence the visual outcome. We believe this will help us learn more about this interesting and innovative technique while at the same time help us improve the method further in order to obtain better results in future patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and up, where any age over 89 will be recorded as 'greater than 89', who have reviewed and understood the study consent form will be invited to participate in this study.
* They will be recruited based on diagnosis of corneal edema secondary to endothelial cell dysfunction undergoing DSAEK either alone or in conjunction with phacoemulsification and intraocular lens implantation at the University of Texas Southwestern Medical Center at Dallas.

Exclusion Criteria:

* Patients younger than 18 years will not be considered for this trial.
* The study will include all patients (no exclusion criteria) who have undergone and will undergo DSAEK implantation for corneal edema secondary to corneal endothelial dystrophy with an effort to determine its success.
To Determine the Accuracy of SCreening for Occult REnal Disease (SCORED) Questionnaire for CKD Risk Among Asian Patients

To determine the accuracy of SCreening for Occult REnal Disease (SCORED) questionnaire for CKD risk among Asian Patients


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-