cyrilzakka/clinical-trials huggingface dataset:
Anesthesia Information System vs Paper Anesthesia Records for Care Congruency

To date the effect of AIMS on medical interventions has not been studied. We seek to retrospectively evaluate paper and electronic anesthesia records among a single surgical population (esophageal surgery) to ascertain any differences that may exist between cohorts with regards to chart completion, anesthetic management and medical care.

Anesthesia information systems (AIMS) are increasingly used to electronically capture physiologic and management data during anesthesia. Proponents tout an improved accuracy of data yet this has not been formally evaluated. Furthermore, whether AIMS is associated with changes in medical care is unknown. Studies with newer technologies have demonstrated increased medical interventions as a result of implementation. The pulmonary artery catheter was shown to increase medical interventions when used yet no improvement in outcomes are observed and some suggest a deleterious effect. 1 Several studies suggest improved patient care with electronic anesthesia records. 2,3 These all center around clinical decision support that reminds clinicians to give certain medications or ensure chart completion. Despite these advantages there are no studies evaluating the 'hawthorne effect' of AIMS. Physiologic data is now recorded at each data point using AIMS. This differs significantly from paper anesthesia records in which clinicians often chart physiologic trends choosing to omit spurious values. It is possible that a Hawthorne effect may occur in this scenario with increased data collection and an increased ability to scrutinize the medical record. Given the litigious nature of medical practice today, there is concern about the impact of AIMS on medicolegal liability. 4 Yet, to date the effect of AIMS on medical interventions has not been studied. We seek to retrospectively evaluate paper and electronic anesthesia records among a single surgical population (esophageal surgery) to ascertain any differences that may exist between cohorts with regards to chart completion, anesthetic management and medical care.

Eligibility Criteria:
Inclusion Criteria:

* Underwent esophageal surgery and had anesthetic documented in medical record

Exclusion Criteria:

* Cases less than one hour
Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients

Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is common, particularly among Crohn's patients who had a small bowel resection. This patient population experiences a lifetime occurrence of kidney stone formation as high as 25% accompanied with a high rate of recurrence (the typical rate of stone formation is \~10% in the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary oxalate levels. However, there are no defined guidelines for the optimum dosing of calcium. This study's primary objective is to scientifically define an appropriate range of calcium supplementation that reduce the level of oxalate found in the urine of patients living with inflammatory bowel disease.

The primary objective of this study is to establish optimal oral calcium supplementation in Crohn's patients who have had an ileal bowel resection. This population is at high risk for calcium oxalate kidney stones, a direct consequence of extensive gut malabsorption and enteric hyperoxaluria. The benefit of providing oral calcium in this patient population (as a means to reduce intestinal oxalate absorption) is known, however, there are no appropriate targets for calcium dosing, which is presently performed empirically or not at all. Our goal is to establish simple, safe and practical guidelines for calcium supplementation.

Eligibility Criteria:
Inclusion Criteria:

1. a pathologically confirmed diagnosis of Crohn's disease
2. prior ileal resection with an intact colon (surgery\>6 months preceding involvement in study)
3. hyperoxaluria (defined as\> 48 mg (\>0.5 mmol) per 24 hour urine samples.

   * Patients will not be excluded if they are known kidney stone formers.

Exclusion Criteria:

1. current pregnancy
2. patient's without baseline hyperoxaluria (defined as \>48 mg or 0.5mmol per 24 hour urine samples)
3. patients in renal failure assessed by a GFR \< 60
4. inability to provide informed consent
5. active cancer
6. hyperparathyroidism
7. hyperphosphatemia
8. \<19 years of age
SFGT for Persistent Anxiety and Depression

Rationale: Although there are effective treatments available for anxiety and depression, there is a large group of clients that does not benefit sufficiently from first-choice treatment. For this group of clients, no suitable alternative exists yet. One of the main hypothesis about maintaining factors is that there are underlying personality features that impede recovery. Schema focused therapy (SFT) is a transdiagnostic therapy focusing on underlying personality features. It has been proven to be an effective therapy for people with personality disorders and there are initial indications that SFT is also an effective treatment for anxiety and depressive symptoms. A short-term schema focused group therapy (SFGT) has been developed within GGZ-NHN, which is expected to benefit clients with persistent anxiety and depressive symptoms, but has not yet been studied.

Objective of the study: In the present study the effectiveness of short-term SFGT (protocol of De Jager, Burger \& Groot) on (1) persistent anxiety and depressive symptoms, and (2) early maladaptive schemas (EMS), experiential avoidance and the mode of the healthy adult will be investigated.

Study design: A Single Case Experimental Design (SCED), using repeated measures over four different phases.

Eligibility Criteria:
Inclusion Criteria:

* Persistent anxiety or depression symptoms (at least moderate score at the subscale depression (≥7 or anxiety ≥6 on the DASS-21).

  * History of at least one previous evidence-based therapy focused on anxiety, depression or PTSD according to the Dutch national guidelines.
  * Able to comprehend Dutch at a level sufficient to complete self-report.

Exclusion Criteria:

* Clients with severe problems that need to be addressed first, including substance abuse, psychosis, anxiety disorder, PTSD or depression that not have been treated.

  * Start of (or change in) medication which is not yet stabilized at the start of this study.
  * Psychosocial problems such as homelessness, no income or high debts which would make the clients unable to participate in a group.
The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.

Recent research has revealed that subtle abnormalities can be found in sperm samples that seem to be normal with conventional analysis techniques. The DNA in the sperm heads is sometimes fragmented and this may be the reason why couples with a diagnosis of unexplained infertility do not achieve pregnancy.

We are planning a study to examine the incidence of DNA fragmentation in the sperm of couples with previously unexplained infertility. In a first treatment cycle with intra-uterine insemination the percentage of DNA fragmentation in sperm will be measured. Afterwards the results of the patients who are pregnant will be compared with those of the not pregnant ones. We expect to find differences between both groups.

100 patients will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Unexplained infertility, i.e. female patients with ovulatory cycles and patent tubes; normal sperm analysis (WHO criteria).
* Patient agrees to have a first treatment cycle with intra-uterine insemination and ovulation-induction with clomiphene citrate.
Comparison of Surgical Extrusion vs. Fibre Post Restoration for Crown-root Fractured Maxillary Incisors.

A total of 124 samples was calculated to be sufficient with G\*power software ver 3.1.9.2 with effect size of 0.4 alpha probability error and power 0.95.With drop out estimate of 10% the final sample size decided was 140 samples. Patients reporting with complicated(pulp exposed or pulpally involved) horizontal crown root fracture with loss of crown structure in maxillary incisors and radiograph evidence of supra alveolar tooth structure are recruited for study. Informed consent from the patients or guardian as appropriate is obtained as suitable prior to treatment delivery. Exclusion criteria were:patients not willing for recall visits, root with evidence of cervical resorption or roor canal filling, open apices, patient with systemic ailments rendering root canal treatment, compromised periodontal health, vertical or horizontal root fracture. Pulpal condition of tooth was assessed using cold sensibility test(Neosnow, orikam health care Ltd, India.) amd confirmed upon access opening with teeth showing evidence of pulpal bleeding wad categorized as irreversible pulpitis and teeth with no evidence of pulpal bleeding categorized as necrotic pulp.

Patients are randomly alloted to treatment groups. Group I-Root canal treatment followed by surgical extrusion of teeth till about 40%supra gingival crown structure is visible clinically.

Group II-Root canal treatment followed by glass fibre post placement (Reforpost, Angelus, Brazil) and composite (charisma smart, Germany) core build up with porcelain fused metal crown.

Post treatment visits are scheduled 6,12,18 months, scheduled visits were planned as close as possible to the study protocol, but for the purpose of data collection, any recall visit occuring within plus or minus 10% of the advocated time was considered aa occuring at that time. Recall visit check up included clinical examination for mobility, periapical tenderness, gingival pocket depth estimation,bleeding on probing and radiographic examination. Patients are asked to report immediately of any unforeseen circumstances arises in the restored teeth.

Eligibility Criteria:
Inclusion Criteria:

* patients with complicated crown root fracture
* patients willing for recall
* Good oral hygiene

Exclusion Criteria:

* patients not willing for recall
* Patients health rendering root canal treatment
Tissue Oxygen Use With Combined Arteriovenous Noninvasive Oximetry

The goal of this observational study is to find out if researchers can measure oxygen consumption in the body without having to draw blood from lines in arteries and central veins.

Participants will undergo measurements of arterial blood oxygen saturation using both finger and neck pulse oximeters.

TOUCAN-1 is a study to estimate the accuracy and precision of pulse oximetry as a noninvasive tool for oxygen consumption measurement. Researchers will use a pair of commercially-available, noninvasive pulse oximeters to estimate the oxygen saturation of blood in the internal jugular vein, and compare it to the directly measured oxygen saturation in sampled jugular blood. Researchers will then measure the arterial oxygen saturation in a finger, and compare it to the directly measured oxygen saturation in sampled radial arterial blood.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient at the University of Wisconsin University Hospital
* Has an internal jugular venous central line
* Has a radial arterial line

Exclusion Criteria:

* Currently receiving extracorporeal membrane oxygenation (ECMO)
* Currently receiving continuous renal replacement therapy (CRRT/CVVH)
* All usable lumens of the participant's jugular catheter are in use, and interruption of any medical or therapy through any lumen would, in the view of the primary care team, compromise the participant's care.
* Jugular venous catheter is not functional or position is not confirmed by radiography
* Arterial cannula is not functional
* Known history of sickle cell anemia or other hemoglobinopathy
* Therapy with any of the following medications:

  * Nitroprusside
  * Hydroxocobalamin
  * Indocyanine green
  * Norepinephrine
  * Vasopressin
  * Epinephrine
  * Any other medication or therapy that, in the judgement of the study investigators, may affect the accuracy and precision of the noninvasive oximetry results
Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality

Primary Hypothesis

* The 24-hour post-transfusion RBC recovery of units obtained from donors exhibiting iron-deficient erythropoiesis will not meet FDA standards for clinical use.
* The 24-hour post-transfusion RBC recovery of units obtained after intravenous iron repletion will improve significantly and will meet FDA standards for clinical use.

Iron deficiency is common among regular blood donors, but the recovery and quality of red blood cell (RBC) units from iron-deficient donors has not been rigorously examined. Evidence from both animal and human studies indicate that when the iron supply for erythropoiesis is inadequate, the RBCs produced have multiple metabolic defects that impair their ability to tolerate refrigerated storage. Studies in a mouse model demonstrated decreased post-transfusion recovery of refrigerator-stored RBCs obtained from iron-deficient donors. The planned studies will identify human donors at greatest risk of providing RBCs with poor post-transfusion recovery by using a combination of a decreased serum ferritin concentration and increased RBC zinc protoporphyrin, as described below. To evaluate unequivocally the role of iron deficiency in poor posttransfusion RBC recovery, intravenous iron will be used for iron repletion.

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old;
2. healthy (by self report);
3. body weight \>110 lbs;
4. female hematocrit \>=38%, male hematocrit \>39%;
5. frequent blood donor (men ≥2 and female ≥1 RBC unit donations in past year);
6. ferritin \<=15 ng/mL; and
7. zinc protoporphyrin \>=60 µmol/mol heme.

Exclusion Criteria:

1. ineligible for donation based on the New York Blood Center donor autologous questionnaire;
2. taking iron supplementation;
3. C-reactive protein \>10 mg/L;
4. sickle cell trait;
5. systolic blood pressure \>180 or \<90 mm Hg, diastolic blood pressure \>100 or \<50 mm Hg;
6. heart rate \<50 or \>100;
7. temperature \>99.5°F prior to donation;
8. temperature \>100.4°F or subjective feeling of illness prior to 51-Chromium 24-hour RBC recovery study (to avoid the subject having a concurrent illness that may affect post-transfusion recovery);
9. positive results on standard blood donor infectious disease testing;
10. pregnancy;
11. taking, or planning to take, iron supplements; and
12. history of severe asthma requiring hospitalization, allergic eczema (atopic dermatitis), or other atopic allergy causing anaphylaxis.
Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece

The primary objective of this non-interventional study (NIS) is to evaluate changes within 3 months in quality of life according to health status evaluated with the COPD Assessment Test (CAT) in COPD patients who have recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics.


Eligibility Criteria:
Inclusion Criteria:

1. Female and male patients ≥40 years of age
2. Patients diagnosed with COPD who have been using tiotropium administered with Spiriva® Handihaler® for at least 3 months before a recent switch (within last week) to a combination therapy with tiotropium bromide plus olodaterol administered with Spiolto® Respimat® has been made
3. Written informed consent prior to participation
4. Patient should be able to read, comprehend and complete study questionnaires

Exclusion Criteria:

1. Patients with contraindications according to Spiolto® Respimat® SmPC
2. Patients who have been treated with inhaled corticosteroids (ICS) as maintenance therapy\* or with a Long-acting beta2 adrenoceptor agonist (LABA)/Long-acting muscarinic antagonist (LAMA) combination (free or fixed dose) in the previous 6 weeks

   \*Note: patients with temporary corticosteroids (CS) use during acute exacerbations in the previous 6 weeks can enter the study
3. Patients who have been treated with Spiriva® Respimat®, with other LAMA different than Spiriva®, or with a combination of Spiriva®+LABA/ICS in the previous 6 weeks
4. Patients diagnosed with asthma or with asthma COPD overlap syndrome (ACO)
5. Patients for whom availability at the enrolling site during the planned study period of approximately 3 months is not possible
6. Pregnancy and lactation
7. Patients currently listed for lung transplantation
8. Current participation in any clinical trial or any other non-interventional study of a drug or device.

Further exclusion criteria apply.
Safety and Dose-Finding Study of DTX401 (AAV8G6PC) in Adults With Glycogen Storage Disease Type Ia (GSDIa)

The primary objective of the study is to determine the safety of single doses of DTX401, including the incidence of dose-limiting toxicities (DLTs) at each dose level.

Participants enrolled in the 401GSDIA01 study will be monitored for 52 weeks following DTX401 administration. Participants in Cohorts 1, 2, and 3 will receive reactive oral steroid treatment for possible vector-induced hepatitis following treatment with DTX401. Participants in Cohort 4 will receive prophylactic oral steroid treatment to prevent possible vector-induced hepatitis. After completion of the Week 52 visit or early withdrawal, participants will be offered enrollment into a 4-year extension study.

Eligibility Criteria:
Key Inclusion Criteria:

* Males and females ≥18 years of age
* Documented GSDIa with confirmation by molecular testing
* Documented history of ≥1 hypoglycemic event with blood glucose \<60 mg/dL (\<3.33 mmol/L)
* Patient's GSDIa disease is stable as evidenced by no hospitalization for severe hypoglycemia during the 4-week period preceding the screening visit

Key Exclusion Criteria:

* Anti-AAV8 neutralizing antibody titer ≥1:5
* Screening or Baseline (Day 0) blood glucose level \<60 mg/dL (\<3.33 mmol/L)
* Liver transplant, including hepatocyte cell therapy/transplant
* Presence of liver adenoma \>5 cm in size
* Presence of liver adenoma \>3 cm and ≤5 cm in size that has a documented annual growth rate of ≥0.5 cm per year
* Significant hepatic inflammation or cirrhosis as evidenced by imaging or any of the following laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> upper limit of normal (ULN), total bilirubin \> 1.5 x ULN, or alkaline phosphatase \> 2.5 x ULN

Note additional inclusion/exclusion criteria may apply, per protocol.
Analysis of Clinical Characteristics of Hemodialysis Patients With Omicron Infection

By collecting the clinical data of hemodialysis patients with Omicron infection in RenJi Hospital from April 7, 2022 to June 10, 2022, the clinical characteristics of this population were analyzed. And to analyze the risk factors of different clinical outcomes according to the clinical outcome of this population.

This study was a single-center, retrospective, observational study. The research subjects were hemodialysis patients admitted to the Hemodialysis Center of Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine because of omicron infection during the Omicron epidemic period from April 7, 2022 to June 10, 2022. 65 cases were included in the study after excluding those patients who underwent hemodialysis due to acute kidney injury. And they were compared with 195 non-dialysis patients admitted to the hospital in the same period,who were randomly selected, according to the ratio of 1:3.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients due to chronic kidney disease stage 5 with omicron infection

Exclusion Criteria:

* Patients on hemodialysis due to acute kidney injury
Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity

The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as based on medical history and physical examination
* BMI between 25 and 30 kg/m2
* Willing not to serve as blood donor during the study
* Informed consent signed

Exclusion Criteria:

* Food allergy
* Female subjects who are pregnant or nursing a child
* Participation in any clinical trial up to 90 days before Day 01 of this study
* Renal or hepatic dysfunction
* Heart disease
* Under medication
* Subjects who are taking functional food designed for weight loss or serum lipid reduction
LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer

A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anticancer therapy and/or died. LDK378 was continued beyond RECIST defined progressive disease (PD) as assessed by the investigator, if in the judgment of the investigator, there was evidence of clinical benefit. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator. Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were screened for eligibility. Patients had to have received no prior crizotinib, and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).


Eligibility Criteria:
Key Inclusion criteria:

* Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carried an ALK rearrangement, as per the FDA-approved Vysis ALK break-apart FISH assay (Abbott Molecular Inc.)
* Age 18 years or older at the time of informed consent.
* Patients must have NSCLC that had progressed during or after the last chemotherapy regimen received prior to the first dose of LDK378, if chemotherapy was received
* Patients must have been chemotherapy-naive or had received 1-3 lines of cytotoxic chemotherapy to treat their locally advanced or metastatic NSCLC
* Patients must have had a tumor tissue sample available, collected either at the time of diagnosis of NSCLC or any time since.
* Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who were not allowed to participate in the study.

Key Exclusion criteria:

* Prior treatment with crizotinib, or any other ALK inhibitor investigational agent, for NSCLC
* Patients with known hypersensitivity to any of the excipients of LDK378.
* Patients with symptomatic central nervous system (CNS) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
* History of carcinomatous meningitis.
* Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
* Clinically significant, uncontrolled heart disease.