cyrilzakka/clinical-trials huggingface dataset:
MIDAS: Minimal-dataset for the Assessment of Surgical Outcomes - Potential in Hip Surgery

Swiss legislation requires health service providers to collect such information. of medical quality indicators as part of the quality and performance audit (Article 22a KVG). In addition, comparisons of clinics or specialist specialists on cost and quality of results are required (Art. 49 (8)).

Currently, the quality of a medical therapy is evaluated rather negatively on the absence (or occurrence) of complications. In contrast, however, the goal of therapy must be to improve or maintain the health-related quality of life (HRQoL). Accordingly, the Swiss Society of Surgery (SGC-SSC), in collaboration with the Association for Quality Assurance in Surgery (AQC), has developed a minimum dataset designed to assess the quality of life of patients after surgical intervention. In order to enable Switzerland to be comparatively independent of the discipline, generic (in the Research Plan - MIDAS -V2, date 24.05.2017 Page 5/57 Contrary to disease-specific) survey instruments proposed that cover the general quality of life in its different facets, regardless of the function of individual organ systems. The complication documentation was not completely abandoned in this proposal, but is only a quality indicator among many due to patient-related outcome measurements.

However, the development of a minimal data set with quality indicators that are applicable across all surgical sub-disciplines for evaluating the quality of treatment of acute and chronic diseases raises a number of fundamental questions that can only be answered to a limited extent without empirical studies. Five essential questions are:

I. Is it sufficient to work with generic quality of life tools or is it necessary to use disease / indication specific instruments or functional tests? II. Which is the best, solid time for a follow-up? III. Is it possible and useful to make a third-party determination of the quality of life in patients with limited cognitive abilities? IV. Which preoperative risk factors should be documented so that sufficient adjustment for case mix differences in hospital comparisons can be made? V. Which perioperative and postoperative factors, in particular complications, must be raised beyond the quality of life, as they reflect an independent aspect of quality?


Eligibility Criteria:
Inclusion Criteria:

- Standard therapy of one of the following diagnoses

* Femoral neck fracture after low-energy trauma (implantation of a head endoprosthesis)
* Coxarthrosis (implantation of a total hip prosthesis)

Exclusion Criteria:

* Rejection of study participation or standard therapy
* Patients who are unlikely to attend routine follow-up (e.g., tourists)
* Patients in palliative care
* Malignancy (known or diagnosed in the course of time)
* Patients with a limited knowledge of German, who can answer the questionnaire even with the help of a study nurse seems unrealistic
* Participation in an interfering clinical intervention study within the last three months
* persons unable to consent (long-term incapacity to consent)
Bedside Evaluation of Edema

Edema, commonly called swelling, is a common medical condition, with many causes. Clinicians generally find edema by pressing against a patient's skin, usually on the feet or shins, and observing how much dimpling there is in the skin. Most clinicians estimate the amount on a scale of mild to severe, or perhaps state the amount as 1 to 4. There is little agreement between observers, and it is hard to judge different clinicians' use of these scales. The first part of this experiment will demonstrate this inconsistency. After clinicians are shown a new technique for measuring edema, the second part of the study will show more accurate and consistent measurements. This will help clinicians to measure edema better, and to communicate their findings to other clinicians more effectively.

The research team will recruit as many clinicians who are conveniently available for the study. Clinicians will include attending physicians from any specialty, residents, medical students, physician assistants, physician assistant students, nurses, certified nurse practitioners, and certified nurse practitioner students.

Once patients and clinicians have been recruited, the research team will maintain a list of the patients and a grid of which clinicians are to examine which patients. Each clinician will be given a data collection sheet, listing the patients' room numbers, and a grid for recording results for each of the patient's affected limb(s). The first data collection sheet (before instruction on the quantitative method) will just show a blank free text field so that clinicians can record their results as they normally do.

After instruction in the novel quantitative technique, the clinicians will receive another data collection sheet now indicating the intent to have the clinicians record their findings in millimeters.

The expectation is that a minimum of 6 examiners will determine the extent of edema on at least 38 limbs. If possible, the research will continue until approximately 100 limbs have been examined by a total of at least 10 to 20 clinicians.

Eligibility Criteria:
Inclusion Criteria:

* Currently admitted patients
* Patient who can understand the purpose of the study and sign a consent form
* Patient has a measurable amount of edema
* Patient will likely be available during the time the clinicians can examine the patient

Exclusion Criteria:

* Unable or unwilling to sign the consent form
* No measurable edema
* Currently in isolation for infection control purposes
* Patients in the Behavioral Health section of the hospital
* Maternity patients (due to availability of infant rooming-in)
* Prisoners
* Age below 18 years
* Patients with bilateral lower extremity amputation
Exploratory Study on POL6326 in Stem Cell Mobilization

The purpose of this study is to determine whether POL6326 is safe and clinically active to mobilize hematopoietic stem cells followed by transplantation


Eligibility Criteria:
Inclusion Criteria:

1. Have multiple myeloma in Stage II or III, according to the criteria of Durie and Salmon.
2. Male or female between 18 and 70 years of age, inclusive. Male and females capable of reproduction must agree to use adequate contraceptive measures (e.g. condom, intrauterine device, oral contraceptive) until 3 months after termination of treatment.
3. Measurable disease, defined by one of the following:

   * Serum M protein ≥1.0 g/dL by protein electrophoresis
   * Quantifiable immunoglobulin levels and/or
   * urinary M protein excretion ≥200 mg/24 hours.
4. All patients have undergone 3 cycles of chemotherapy, with the last dose of chemotherapy given 3 to 8 weeks before study entry.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 2.
6. Life expectancy of \>6 months.
7. Have given their written informed consent to participate in the study

Exclusion Criteria:

1. Have non-secretory myeloma and/or plasma cell leukaemia.
2. History of other malignancies during the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma, or localised prostate carcinoma.
3. Any other clinically significant medical conditions.
4. History of cardiac disease NHYA classification ≥3.
5. Insufficient bone marrow, liver and renal function as assessed by the following clinical laboratory evaluations:

   Haemoglobin \<9.0 g/L. Absolute neutrophil count \<1500/µL. Platelet count \<50000/µL. Total bilirubin \>1.5 x upper limit of normal (ULN). Alanine aminotransferase (ALT) and alkaline phosphatase (AP) \>2.5 x ULN. Amylase and lipase \>1.5 x ULN. Serum creatinine \>2.0 x ULN. Prothrombin time (PT) and activated partial thrombo-plastin time (aPTT) \>1.5 x ULN.
6. Pregnant or lactating female patients.
7. Known history of HIV infection or chronic hepatitis B or C infection.
8. Receipt of immunotherapy, radiation therapy, or any investigational drug within 30 days of study drug administration.
9. Prior radiotherapy to more than 3 vertebrae.
10. Active serious bacterial or fungal infections; \>grade 3 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
11. Receipt of haematopoietic cytokines within 10 days of study drug administration.
Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury

Identification of risk factors of acute kidney injury (AKI). It is hypothesized that there might be a correlation between brain oximetry, tissue saturation of thenar muscle and marker of AKI in blood - neutrophil gelatinase-associated lipocalin (NGAL) - measured in blood samples during the first post-op day.

The day before operation, after verification of inclusion and exclusion criteria, the visiting anesthesiologist will explain to the patient the aim of the study. By signing an informed consent the patient will be recruited into the study. On the evening before operation the patient will receive the statin in a dose taken along.

In the OR the anesthesiologist will verify if creatinin and blood urea nitrogen were measured the day before operation - if not, a blood sample for the test will be obtained and sent to perform the tests.

Before induction of anesthesia a bi-spectral index (BIS) probe will be placed on the patients forehead. Above the BIS probe a INVOS(TM) probe for brain oximetry (5100 C Cerebral/Somatic Oximeter, Somanetics, Medtronic) will be placed.

Brain oximetry by near infrared saturation (NIRS) and tissue saturation on thenar muscle will be recorded before and during operation on nine timepoints.

As NIRS and thenar muscle saturation are non-routine non-invasive methods of intraoperative monitoring, patient had to sign an informed consent to participate into the study, and ethic committee approval for the study protocol was appealed and granted.

General anesthesia will be induced by: fentanyl 0.2 mg, propofol 0.5-1.5 mg/kg in bolus 200ml/godz.; and rocuronium - 0.5 mg/kg. After induction dexamethasone will be given in a dose of 0,7-1 mg/kg. For conduction of anesthesia before cardiopulmonary bypass (CPB) sevoflurane will be added to the inhaled mixture of air and oxygen. On CPB propofol will be given iv. In case of hemodynamic instability after commencing CPB, which will require catecholamines in a cumulative dose of \> 1.5 standard, or in case of trouble to commence CPB, propofol will be replaced by midazolam in a dose 0.2-0.3 mg/kg/hour.

During anesthesia, first post-operative day and hospital stay a total of 278 variables will be recorded: hemodynamic parameters, iv fluid doses, inotropes, vasopressors, diuretics, urine output, transfusions, etc.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* signed informed consent
* scheduled for elective on-bypass cardiac surgery (aortic valve surgery, mitral valve surgery with/without tricuspid valve surgery, ascending aorta surgery with/without aortic valve surgery).

Exclusion Criteria:

* chronic kidney insufficiency (serum creatinine \>2 mg/dL)
* active infection (i.e.: endocarditis)
* shock or tissue hypoperfusion before operation (blood lactate \>3 mmol/L)
* left ventricle ejection fraction \<25%
* vancomycin used for infection prophylaxis (i.e.: in immunosuppressed patients)
* history of ischaemic shock
EFFECTIVENESS of PROBIOTICS in ADULTS with MODERATE to SEVERE PERSISTENT ASTHMA

The objective of this study is to compare the effectiveness of probiotic as an adjuvant to standard therapy versus standard therapy alone in adult with moderate to severe persistent asthma in terms of

1. Frequency of asthma exacerbations in terms of number of asthma attacks and severity of each episode.
2. Improvement in pulmonary function tests as recorded by an increase in FEV1 and FEV1/FVC ratio.

5. HYPOTHESIS Probiotics as an adjuvant to standard therapy is more effective as compared to the standard therapy alone in managing moderate to severe persistent bronchial asthma.

Design of Study This was a Randomized controlled trial

Follow up protocol The patient was evaluated at the beginning of the study, and then again at one and three months following enrolment for a follow-up evaluation of the main and secondary outcomes.

Primary outcome To assess the frequency of exacerbations within 3 months.

Secondary outcome:

To observe improvement in

1. FEV1 and the FEV1/FVC ratio. Improvement in one step and more than 12% Improvement in FEV1 from baseline. Improvement in asthma control test. Sample Size - The calculated sample size is 74 individuals (37 in each category i.e Intervention \& Control arm)

Sampling technique - Simple random sampling Sample selection Inclusion Criteria

1. Patients of both genders between the ages of 18 and 80 years.
2. Diagnosed cases of moderate to severe persistent asthma, as determined by ACT Score and FEV1/FVC ratio as per operational definition.

Exclusion Criteria

1. Patients with Mild asthma.
2. Pregnant females.
3. Patients who have taken fiber supplement or probiotics during the last four weeks.
4. Other pulmonary disorders, such as Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis (ABPA), chest wall deformities, bronchiectasis, pulmonary fibrosis, and lung cancer.
5. Asthma and chronic obstructive pulmonary disease overlap syndrome (ACOS).

Eligibility Criteria:
Inclusion Criteria

1. Patient of both genders between the ages of 18 and 80 years.
2. Diagnosed cases of moderate to severe persistent asthma, as determined by ACT Score and FEV1/FVC ratio as per operational definition.

Exclusion Criteria

1. Patients with Mild asthma.
2. Pregnant females.
3. Patients who have taken fiber supplements or probiotics during the last four weeks.
4. Other pulmonary disorders, such as Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis (ABPA), chest wall deformities, bronchiectasis, pulmonary fibrosis, and lung cancer.
5. Asthma and chronic obstructive pulmonary disease overlap syndrome (ACOS).
Glucose Tolerance, Meal Timing and MTNR1B

The purpose of this investigation is to assess in a community-based cohort of late-night eaters the effect of coincident food intake and endogenous melatonin on glycemic control, and the putative interaction effect of melatonin receptor 1B (MTNR1B) genetic variation on this relationship. With the results from this study, the investigators expect to advance in the understanding of the role of endogenous melatonin on glucose metabolism in late night eaters and carriers of the MTNR1B risk allele, with potential implications on the guidelines to mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.

Late-night dinner eating is associated with increased risk for type-2-diabetes. The underlying mechanism is unclear. One explanatory hypothesis is that the concurrence of elevated circulating melatonin and high glucose concentrations (characterizing late-eating) leads to impaired glucose-tolerance. However, to date, no study has tested the influence of physiological melatonin concentrations on glucose tolerance. The discovery of melatonin receptor MTNR1B as a diabetes risk gene provides evidence for a role of physiological levels of melatonin in glucose control.

The aim of the current study is to test the hypothesis that the concurrence of meal timing with elevated endogenous melatonin concentrations results in impaired glucose control and that this effect is stronger in homozygous MTNR1B risk carriers than in non-carriers. To do so we will test glucose tolerance using identical mixed meals under two dinner conditions: a) delayed dinner or Late Eating (LE): starting1 hour before usual bed time, b) advanced dinner or Early Eating (EE): starting 4 hours before habitual bed time, in a randomized, cross-over study design.

These findings could support a clinical application for the screening of this single nucleotide polymorphism (SNP) and the possibility of implementing tailored and cost-effective behavioral interventions to prevent type 2 diabetes in vulnerable populations.

These goals will be achieved through a specific approach:

• Interventional (randomized, cross-over controlled trials) (Aim 1): To study the potential interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index: \>19 kg/m2
* Age: \>18 years of age
* Caucasian

Exclusion Criteria:

* Receiving treatment with thermogenic, lipogenic, or contraceptive drugs
* Diabetes mellitus, chronic renal failure, hepatic diseases, or cancer diagnosis
* Bulimia diagnosis, prone to binge eating
* Undergoing treatment with anxiolytic or antidepressant drugs
Effect of a Proton Pump Inhibitor on the PK of Tepotinib

This study was investigated in healthy participants (i) the effect of omeprazole (proton pump inhibitor) co-administration on the single dose pharmacokinetics (PK) of tepotinib under fed conditions, and (ii) the effect of food on the single dose PK of tepotinib after co-administration of omeprazole and tepotinib. Furthermore, the study assessed the safety and tolerability of tepotinib alone and upon co-administration of omeprazole.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants of non-child bearing potential
* Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m\^2)
* Body weight between 50 to 100 kilogram (kg)
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participation in a clinical study within 60 days prior to first drug administration
* Whole blood donation or loss of greater than (\>) 450 milliliter (mL) within 60 days prior to first drug administration
* Any surgical or medical condition, or any other significant disease that could interfere with the study objectives, conduct, or evaluation
* Other protocol defined exclusion criteria could apply
Lake Washington Vascular VenaSeal™ Post-Market Evaluation (WAVES)

The VenaSeal Closure system offers an outpatient treatment option for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. VenaSeal is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).


Eligibility Criteria:
Key Inclusion Criteria:

* Reflux in at least one target vein;
* One or more of the following symptoms related to a TV: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling;
* CEAP classification of C2 (if symptomatic) through C5;

Key Exclusion Criteria:

* Current, regular use of systemic anticoagulation;
* Previous or suspected deep vein thrombosis or pulmonary embolus, or active acute superficial thrombophlebitis, or thrombophlebitis migrans;
* Previous treatment such as laser or radiofrequency ablation of venous disease in targeted vein segment;
* Known hypercoagulable disorder;
* Pregnant or breast feeding at enrollment;
* Known sensitivity to cyanoacrylate adhesives;
* Venous treatment in the contralateral limb within the last 30 days, or who require contralateral treatment within three months;
* Planned to undergo additional ipsilateral treatments on the same leg within 3 months following treatment.
A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture

an unbalanced (2:1) randomized study comparing two methods of traumatic skin closure in an ER setting: BandGrip vs suture

Up to 45 subjects at up to 2 study sites who present to the ER for treatment of a skin laceration will be consented and randomized to treatment with suture or BandGrip. Subjects will be followed for 30 days post treatment to assess cosmetic quality of wound healing, evidence of adverse events related to closure method, and speed and completeness of wound closure and removal of closure devices.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female age 18-65.
* Subject presents to emergency room with at least one skin laceration that is assessed as requiring a suture closure on the trunk or extremities (excluding hands and feet).
* The length of the laceration is less than or equal to 1.5 inches.
* Subject is otherwise in good general health in the opinion of the investigator.
* Subject must be willing to follow instructions for wound care provided by investigator and refrain from picking at the treatment device, applying topical medications to the wound, and swimming or soaking in a tub until BandGrip or the sutures are removed.
* Subject agrees to return for follow-up evaluations.
* Subject (or guardian) is able to comprehend and give informed consent for participation in this study.

Exclusion Criteria:

* Significant multiple trauma (merely multiple wounds are allowed).
* The wound involves a lower limb with critical limb ischemia.
* Concurrent acute infection requiring intravenous or oral antibiotics.
* Bleeding, coagulation and or clotting disorders.
* Subject is on dialysis.
* Inflammatory and or allergic diseases or conditions of the skin: for example, psoriasis, eczema or dermatitis.
* History of drug abuse.
* Chronic use of oral steroids or immunosuppressants.
* Known personal or family history of keloid or hypertrophic scarring.
* History of abnormal wound healing.
* Burst stellate lacerations due to a crush or hard blow.
* Animal or human bite or scratch.
* Wound is in the head, hands or feet or in a high skin tension area or across an area of increased skin tension on a joint.
* Investigator objects to a patient's involvement in the study protocol.
* Known allergy to components to BandGrip or suture material.
* Known cognitive or psychiatric disorder.
* Wound requiring debridement of devitalized or contaminated tissue.
* Wound at site of active rash/skin lesion making evaluation difficult.
* Previously treated wound or has failed to heal.
* Puncture wound.
Comparison of Triphasic CT, PET and MR Tumour With Pathological Findings in Colorectal Cancer Liver Metastases

The purpose of this study is to correlate the MRI CT and PET appearances of colorectal liver metastases to pathologic appearance ot better understand the accuracy of imaging to determine tumor size.

The purpose of this study is to correlate the MRI CT and PET appearances of colorectal liver metastases to pathologic appearance ot better understand the accuracy of imaging to determine tumor size.

Eligibility Criteria:
Inclusion Criteria:

* liver metastases from colorectal cancer undergoing liver resection

Exclusion Criteria:

* contraindication to CT, MRI or PET