cyrilzakka/clinical-trials huggingface dataset:
Resuscitative Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest

The primary aim of this study is to investigate the feasibility and complications of inserting a REBOA-catheter to patients suffering from non-traumatic out-of-hospital cardiac arrest, by anesthesiologist working in the pre-hospital setting. The study will include patients in the catchment population of St. Olavs University Hospital, Trondheim area, Norway. The REBOA technique (resuscitative balloon occlusion of the aorta) is a well-known treatment used on other indications, both in-hospital and pre-hospital. It has also been utilized in several animal studies on non-traumatic cardiac arrest and has shown to augment myocardial and cerebral perfusion during cardio-pulmonary resuscitation. There are no systematic studies on humans with REBOA in non-traumatic cardiac arrest. The study will also investigate the time needed to perform a REBOA procedure in cardiac arrest patients receiving advanced cardiac life support. This additional treatment might contribute to increase the survival rate of cardiac arrest patients.

If return of spontaneous circulation (ROSC) is not achieved after advanced cardiac life support (ACLS as described in the present guidelines from the Norwegian Resuscitation Council) is established, a REBOA catheter is inserted via the femoral artery and the aortic balloon inflated, according to a procedure described in a separate document. Ultrasound is used to limit risk related to cannulation and placement of the guidewire. The ultrasound images will be stored and later processed by the principal investigator. If the physician experiences technical problems during the procedure (i.e. severe difficulties in establishing vascular access, resistance during insertion of the guidewire, introducer or balloon catheter, severe bleeding, prolonged time consumption) the effort will be aborted. If ROSC is achieved, the aortic balloon is deflated gently. If the patient re-enters cardiac arrest, the normal ACLS-guideline is followed. The balloon is then re-inflated, as described in the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Non-traumatic cardiac arrest
* Witnessed cardiac arrest
* Less than 10 minutes from observed cardiac arrest to start of basic or advanced cardiac life support (BCLS/ACLS)

Exclusion Criteria:

* Traumatic cardiac arrest, including patients rescued from avalanches
* Hypothermic patients, including drowning
* Pregnancy
* End-stage terminal illness
* Suspected neurologic injury as the etiology of the arrest
* Strangulations
* Other factors as decided by the treating physician
Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia

This clinical trial is studying the side effects of Erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PRIMARY OBJECTIVES:

I. To determine if the 48-hour trough serum asparaginase activity is ? 0.1 IU/mL in young patients with acute lymphoblastic leukemia treated with Erwinia asparaginase after allergy to PEG-asparaginase.

II. To determine the frequency of asparaginase-related toxicity in these patients.

III. To characterize the pharmacokinetics of Erwinia asparaginase in these patients.

SECONDARY OBJECTIVES:

I. To compare serum asparaginase activity and serum asparagine concentration between patients treated with Erwinia asparaginase on this trial and historical controls treated with PEG-asparaginase on CCG-1961 and CCG-1962.

II. To determine the 72-hour serum asparaginase activity on days 8 or 11 or 13 based on the starting date of Erwinia asparaginase therapy.

III. To determine the presence of anti-Erwinia asparaginase antibodies in patients treated with a course(s) of Erwinia asparaginase following clinical allergy to PEG-asparaginase (PEG, pegaspargase).

IV. To determine if serum asparagine is adequately depleted on days 12 or 13 in a subset of these patients.

OUTLINE: This is a multicenter study.

Patients receive 6 doses of Erwinia asparaginase intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.

Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and antibody studies.

After completion of study treatment, patients are followed periodically.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute lymphoblastic leukemia
* Concurrently enrolled on a frontline Children's Oncology Group treatment trial (i.e., COG-AALL0232 or COG-AALL0531, COG-AALL0331, or COG-AALL0434) at a participating institution

  * Must have 1 or more courses of asparaginase remaining to be administered on the treatment protocol
* Must have had a grade ? 2 hypersensitivity reaction to PEG-asparaginase
* No history of pancreatitis ? grade 2
* No prior Erwinia asparaginase
The Effect of Covid-19 on the Disease Course of Multiple Sclerosis :Belgian Lessons Learned From Rocky I to Rocky IV

Retrospective observational cohort study. ToFCoMS: two years of follow-up of COVID-19 in MS.

Methods The Nationaal Multiple Sclerose Centrum (NMSC) Melsbroek is a large highly-specialized center specifically focusing on neurological management, multidisciplinary care and rehabilitation in patients with MS. Since March 2020 (i.e., the onset of the pandemic in Belgium, and the first of five waves of spiking infection numbers thus far in our country), clinical data of patients followed at the center have been collected in a local database in case of COVID-19 diagnosis. The following items have been recorded: name, gender and date of COVID-19 diagnosis; age, Expanded Disability Status Scale score, MS duration, clinical subtype and DMT regimen at time of COVID-19 diagnosis; COVID-19 severity (method 1: categorized as ambulatory, hospitalized, death; method 2: categorized as asymptomatic, mild illness, moderate illness, severe illness, critical illness and death); vaccination status (categorized as non-vaccinated, fully vaccinated, fully vaccinated + booster) at time of COVID-19 diagnosis. On February 28, 2022, this database was locked and consisted of 234180 unique individual COVID-19 cases.

The NMSC Melsbroek features a second and more large database containing a broad variety of (para)clinical information gathered during routine follow-up, which includes regular testing of general disability with the EDSS, leg function/ambulation with the Timed 25-Foot Walk Test (T25FWT), hand function/dexterity using the 9-Hole Peg Test (9HPT) and cognition/information processing speed with the Symbol Digit Modalities Test (SDMT). For each of these parameters, the first two assessments before COVID-19 diagnosis (labelled T0 and T1, respectively; T1 is the closest to COVID-19 diagnosis), and the first thereafter (labelled T2), were retrieved for each COVID-19 subject. If clinical measurements were performed during an in-house stay for rehabilitation purposes, only those performed on admission were retained (thus not necessarily those the closest to the COVID-19 infection).

Eligibility Criteria:
Inclusion Criteria:

diagnosis of Multiple Sclerosis Covid 19 infection with PCR test

Exclusion Criteria:

other diagnosis than Multiple Sclerosis
Study of Hepatic Glucose Production and De Novo Lipogenesis in Patients With Cystic Fibrosis

OBJECTIVES:

I. Determine the amount of hepatic glucose production derived from gluconeogenesis and glycogenolysis in the post-absorptive state in patients with cystic fibrosis.

II. Determine de novo lipogenesis in relationship to resting energy expenditure in this patient population.

PROTOCOL OUTLINE:

Patients undergo an oral glucose tolerance test (OGTT) in which blood is drawn from an IV in the arm 6 times over 3 hours. After the first blood draw, patients receive a beverage containing sugar and write down everything they ate and drank during the 24 hours before study entry. Patients also undergo a dual energy x-ray absorptiometry (DEXA) scan over 15 minutes.

Within 2 weeks after the OGTT, patients keep a journal of everything they ate and drank over 3 days. Patients are fed a selected meal the following evening and receive saline fluids IV overnight. During the night, patients receive 2 doses of oral doubly labeled water. The next morning, patients receive \[1,2-13C\]acetate IV. A liquid mixed meal (Ensure Plus) is ingested hourly throughout the day. Patients also undergo hood indirect calorimetry over 30 minutes twice to measure resting energy expenditure. All urine is collected.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of cystic fibrosis OR Normal healthy volunteer; not an endurance-trained athlete No colonization with Burkholderia cepacia

--Prior/Concurrent Therapy--

Endocrine therapy: At least 2 months since prior oral or IV corticosteroids; low-dose inhaled corticosteroids allowed

Other: Short-acting insulin therapy allowed; at least 24 hours since prior long-acting insulin (i.e., neutral protamine Hagedorn, or ultalente); at least 4 weeks since prior oral or IV antibiotics; no hospital admissions within the past 6 weeks

--Patient Characteristics--

Hepatic: No elevation of SGOT or SGPT within the past 3 months

Other: Must be medically stable; diabetes mellitus allowed; weight stable within the past 3 months; not pregnant; no prisoners
Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease

The purpose of this research study is to determine the safety of IL-2 and the highest dose of this drug that can be given safely to people with chronic graft versus host disease (GVHD). Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize their body (the host) as foreign and attempt to "reject" it. Traditional standard therapy to treat chronic GVHD is prednisone (steroids). Treatment options are limited, and it is thought that IL-2 may help to control chronic GVHD.

* IL-2 will be given daily through an injection under the skin for a period of 8 weeks. To determine the highest safest dose of IL-2, the dose participants receive will increase as lower doses are determined to be safe. There will be three dose levels.
* Participants will be seen periodically while they are receiving IL-2. Physical exams and blood tests will be performed weekly for the first two weeks and then every other week until week 8.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens
* Patients must be at least 180 days from the allogeneic stem cell transplantation procedure
* Steroid refractory cGVHD, defined as having persistent symptoms and signs of GVHD despite the use of prednisone for at least 4 weeks in the preceding 12 months without complete resolution of signs and symptoms.
* Stable dose of corticosteroids for 4 weeks prior to enrollment
* No addition or subtraction of other immunosuppressive medications for 4 weeks prior to enrollment.
* Adequate bone marrow, renal and hepatic function as outlined in the protocol
* 18 years of age or older
* ECOG Performance Status of 0-2

Exclusion Criteria:

* Ongoing prednisone requirement \> 1mg/kg/day (or equivalent)
* Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment
* Concurrent ECP therapy within 4 weeks prior to enrollment
* Post-transplant exposure to any novel immunosuppressive medication within 100 days prior to enrollment
* Donor lymphocyte infusion within 100 days prior to IL-2 therapy
* Active malignant disease relapse
* Active, uncontrolled infection
* Positive serologic test for Hepatitis B or a positive serologic or nucleic acid test for Hepatitis C
* HIV seropositivity
* Life expectancy \< 3 months
* Pregnancy or lactation
* Inability to comply with IL-2 treatment regimen
* Uncontrolled cardiac angina or symptomatic congestive heart failure
* Organ transplant (allograft) recipient
Multi-morbidity Screening in People With Type 2 Diabetes and Pre Diabetes

People with type 2 diabetes are at risk of complications linked with high blood sugars and these are monitored for in healthcare appointments. However, people with type 2 diabetes commonly suffer with additional health conditions that can affect the liver, heart and their breathing while sleeping. These conditions are thought to be caused by a similar underlying process that causes type 2 diabetes, as a result they are very common in people type 2 diabetes. Despite this they are not part of the routine health check for these people. Worryingly, current research suggests that the risk for developing these health problems, and direct complications of type 2 diabetes, can start at blood sugar levels below the threshold of type 2 diabetes. In a group of people said to have prediabetes. These people do not currently undergo annual healthcare appointments to monitor for these health complications or other linked health conditions.

This study aims to pilot a new style of clinic to address these issues. The investigators will perform a multi-morbidity assessment, where they will look for several different health problems at the same time. The investigators will be looking at health problems linked with high blood sugars, this will include problems with the liver, heart, nerves, eyes, and participants breathing overnight. They have developed a clinic visit which uses questionnaires, simple examination techniques and modern devices to try and identify these health problems.

An important part of healthcare is the burden it places on people with health problems, with this in mind the investigators will be giving the people involved in their study a voice to try and direct future research and healthcare, the investigators will ask them to provide feedback on their experience in taking part in the study and what their thoughts are in undergoing a longer but more comprehensive health appointment.


Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes study group

* Participants with a documented diagnosis of type 2 diabetes or HbA1c ≥48mmol/mol.
* Age ≥18 years

Prediabetes study group

* HbA1c 42 - 47 mmol/mol (inclusive) or enrolled in the diabetes prevention programme.
* Age ≥18 years

Exclusion Criteria:

* Type 1, 3 or Maturity onset diabetes of the young.
* Participants who are pregnant at the time of screening
* Unable to give informed consent
Post-Operative Evaluation of Endodontic Microsurgeries Done Using a Piezoelectric Ultrasonic Technique: An in Vivo Study

The aim of the study was to evaluate the effect of Piezosurgery and Trephine bur as cutting tools on post-operative sequelae including pain and swelling following guided endodontic microsurgeries.

Materials and Methods: Twenty healthy male patients aged between 18 and 45 years old were selected in the study. Mandibular first molar teeth with failed non-surgical treatment or re-treatment due to iatrogenic errors at the apical 3mm of the mesial root canal including canal ledging, zipping and transportation, root perforation, separated instrument, and canal calcification were selected. Piezosurgery assisted cavity preparation and root-end resection were performed in Groups I and II, and Trephine bur assisted cavity and root-end resection was performed in Groups III and IV. An apical curettage was performed and the over-extended objects such as separated instruments or gutta percha were removed. The PRF clots was placed inside the bone cavity in groups I and III while the bone cavity was kept for 2 min to allow the blood clots to be formed in groups II and IV. The degree of pain and swelling were recorded for five days every 24, 48, 72, 96, and 120 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

Mandibular first molar teeth were selected according to specific inclusion criteria including:

1. Teeth presented with failed non-surgical treatment or re-treatment. Failure is due to iatrogenic errors at the apical 3mm of the mesial root canal including canal ledging, zipping and transportation, root perforation, separated instrument and canal calcification.
2. Teeth presented with normal pocket depth ranges from 1 to 3mm, up to grade II tooth mobility.
3. Teeth presented without periapical radiolucency (Class A) or with periapical radiolucency not more than 1 mm in diameter both mesiodistally and buccolingually (Class B) according to the preoperative endodontic microsurgical classification of teeth.
4. Teeth presented with non-fused mesial and distal roots and the mesial roots are range from 10 to 15 mm. in length, Type III root canal configuration (Two canals run separately from orifice to apex). The root canal curvature angle was measured using the Weine technique to be not less than 160° in both directions buccolingually and mesiodistally.
5. At the apical 3 mm of the mesial radiographic root apex, the distance from the outer surface of the buccal cortical plate of bone to the buccal side of the mesial root is 1.5 mm (Depth I). The buccolingual dimension of the mesial root is 7 mm mm (Depth II). The distance from the lingual surface of the mesial root to the outer surface of the lingual cortical plate of bone is 3.5 mm. (Depth III).
Factors Affecting the Endodontic Treatment Outcome

The aim of this prospective cohort observational study is: (i) to assess the endodontic treatment outcome in a private specialist endodontic office in Slovenia; (ii) to estimate the effect of various pre-, intra- and postoperative factors onto endodontic treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* patients referred to the private endodontic specialist office for endodontic treatment
* written informed consent was obtained prior beginning of the treatment.

Exclusion Criteria:

* preoperative advanced periodontal disease
* prior microsurgical root-end resection performed
* apices of the tooth were not clearly discernible on any of periapical radiographs
* endodontic treated teeth were extracted for non-endodontic reason
* the patient did not attend a follow-up examination.
Weight Loss Maintenance (WLM)

To determine the effectiveness of continuous patient contact on weight loss maintenance.

BACKGROUND:

Overweight/obesity is the second leading cause of death in the US, and is growing in prevalence at an alarming rate. Control of overweight/obesity is increasingly recognized as a high national priority because of its contribution to cardiovascular (CVD) risk factors and ultimately to CVD itself. The short-term success of behavioral interventions for weight loss has been repeatedly documented. Unfortunately, because weight re-gain is extremely common, a disappointingly, small proportion of individuals achieve long-term weight control. Of the factors that are associated with sustained weight loss, one of the most important is continued intervention with frequent contacts.

DESIGN NARRATIVE:

The study is a multi-center, randomized, controlled trial \[Weight Loss Maintenance Trial (MAINTENANCE)\] to determine the effects of two innovative behavioral interventions, each designed to maintain frequent contacts, compared to a usual care control group. Overweight and obese individuals (60% women, 40% African Americans) who are taking medication for hypertension, dyslipidemia and/or type 2 diabetes will enter a 6-month, weight loss program. Those 800 individuals who lose at least 4 kg (approximately 9 pounds) will then be randomized into one of three groups: a Personal Contact (PC) Intervention that provides monthly personal contacts with a trained interventionist, primarily via telephone; an Interactive Technology (IT) Intervention that provides frequent contacts through a state-of-the-art interactive web-based program supplemented by other communication technologies; or Usual Care (UC). The primary outcome will be weight change from the end of the initial weight loss program to the end of the 30-month weight maintenance intervention period. Other outcomes will include weight change in subgroups, prevalence of CVD risk factors, measures of behavior change, and cost of implementation. For each outcome, the Personal Contact and Interactive Technology interventions will be compared to Usual Care and, if different from Usual Care, to each other. To successfully combat the obesity epidemic, clinicians and health care systems must have options that are effective and feasible and that can be provided to large numbers of individuals.

Phase II intervention completed: July 2007

Phase III intervention completed: October 2009

Eligibility Criteria:
Overweight men and women who took medication for hypertension, type 2 diabetes and/or hyperlipidemia in the six month weight loss phase. and who were able to lose approximately 9 pounds. There will be approximately 60% women and 40% African Americans.
Effect of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Patients With Intravenous Thrombolysis (SRICDCA-IVT)

The purpose of this study is to determine the effect of serial remote ischemic conditioning on dynamic cerebral autoregulation in patients with intravenous thrombolysis with alteplase.

In this study, cases of ischemic stroke who undergo intravenous thrombolysis with alteplase within 4.5 hours from the onset are included according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Both groups underwent dynamic cerebral autoregulation measurements at days 1,3,and 7 of onset and recorded the relevant indexes. We aimed to determine the effect of serial remote ischemic conditioning on dynamic cerebral autoregulation in patients with intravenous thrombolysis with alteplase.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age≥18 years, regardless of sex;
* 2) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis with alteplase in 4.5 hours;
* 3) Baseline mRs 2-5; and Premorbid mRS ≤ 1；
* 4) Baseline NIHSS\>= 4, and \<= 24;
* 5) Signed and dated informed consent is obtained;

Exclusion Criteria:

* 1) Patients who have the contraindication of intravenous thrombolysis with alteplase;
* 2) Patients with consciousness disorder or restlessness who cannot cooperate with dynamic cerebral autoregulation;
* 3) Patients whose stable cerebral blood flow velocity envelope cannot be obtained by transcranial Doppler ultrasound or whose cerevral blood vessels have not been detected;
* 4) The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
* 5) Pregnant or lactating women;
* 6) Previous remote ischemic conditioning therapy or similar treatment;
* 7) Laboratory indicators are not qualified: Alanine transaminase (ALT) or glutamic-oxalacetic transaminase (AST) continued to rise more than 3 times the upper limit of normal, Serum creatinine \> 265 umol/l (\> 3.0 mg/dl);
* 8) Previous history of atrial fibrillation or ECG showing atrial fibrillation or arrhythmia;
* 9) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
* 10) Unwilling to be followed up or treated for poor compliance;
* 11) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
* 12) Other conditions that the researchers think are not suitable for the group.