cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Preoperative Anaemia Clinic in Patients Undergoing Elective Abdominal Surgery

Efficacy of a preoperative anaemia clinic in patients undergoing elective abdominal surgery diagnosed with iron deficieny anaemia

Objective: this study aims to investigate how preoperative intravenous iron treatment affects hemoglobin elevations in patients undergoing elective abdominal surgery diagnosed with iron deficiency anaemia and when treatment should be administrated for optimal effect.

Methods: the study is a prospective, descriptive cohort study, where patients are included from a quality improvement project at The Departments of Abdominal Surgery and the Department of Anesthesia, Centre for Cancer and Organ Disease at Rigshospitalet in Denmark. Patients undergoing elective abdominal surgery will be screened for iron deficiency anaemia 1-4 weeks prior to surgery and patients diagnosed with iron deficiency anaemia will be included. Intravenous iron infusion will be administrated preoperatively and Hb will be measured 1-2 days prior to surgery or on day of surgery. The preparation used is ferric derisomaltose (MonoFer, Pharmacosmos A/S, Holbæk, Denmark) with a max single iron dose of 20 mg/kg. The dose administrated is calculated using patient bodyweight and Hb value and administered ≥30 minutes followed by 30 minutes observation including monitoring with 3-lead ECG and pulsoximitri.

Study results will be sought to be published in an international peer-reviewed journal.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with preoperative iron deficiency anaemia
* All patients receiving preoperative or postoperative intravenous iron infusion
* Patients undergoing elective abdominal surgery

Exclusion Criteria:

* Patients missing Hb values after intravenous iron infusion prior to surgery
* Patients undergoing acute abdominal surgery
RCT Regarding SDM Online Training and Face-to-face SDM Training

Cancer patients often report that they are not included in important treatment decisions. Numerous studies have shown that a training concerning Shared Decision Making (SDM) for physicians can improve this situation. This does not only lead to a better quality of the doctor-patient interaction, but may have a positive long term impact on treatment adherence, the psychological well-being and the coping abilities of the patients. However, previous experience regarding the implementation of SDM training programs show that it is difficult to recruit physicians for an external SDM group training due to the extensive workload of the physicians. In light of the available evidence on the effectiveness of SDM training and the low motivation by oncologists for traditional SDM group training, this study aims to develop and evaluate a brief SDM intervention. This intervention is disseminated in two different ways which both might be attractive for oncologists. On the one hand an individual face-to-face context-based SDM training is designed and conducted by a trainer at the workplace of the participating oncologists. On the other hand a web-based SDM online training is developed. Both SDM interventions are developed on the basis of an SDM manual evaluated in previous studies.

This study therefore aims to examine the effectiveness of different disseminations strategies (individualized face-to-face context-based SDM individual training vs. web-based SDM online training) compared to a control group without any training. It will be analyzed which improvements in medical SDM competence can be accomplished by the different SDM trainings. Further the effects of the training on SDM knowledge, quality of the doctor-patient interaction and SDM self-efficacy expectation will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Oncologists or physicians treating a significant percentage of breast and/or colorectal cancer patients
2. Internet access

Exclusion Criteria:

* No Exclusion Criteria
Effect of Cryotherpy on Hypertrophic Scar

Purpose of the study:

The purpose of the study is to evaluate the therapeutic effect of cryotherpy in treating hypertrophic scar.

It will be hypothesized that:

Cryotherapy may not have an effect on hypertrophic scar.

The potential of cryotherapy application in vitro data indicated that using freezing treatment on VFFs + TGF-β1 (myofibroblast) modulated ECM turnover toward antifibrosis and normalization, attenuated myofibroblast differentiation, reduced cell migration, and weakened the contractile activity. On both VFFs ± TGF-β1, freezing treatment raised LP regeneration (HAS1, decorin).

The findings indicate that cryotherapy may play a protective role in scar formation and contribute to lamina regeneration.

Furthermore the need of this study was developed from the lack in the quantitative knowledge and information in the published studies about the effect of cryotherapy on hypertrophic scar.

This study will be designed to provide a guideline about the effect of effect of cryotherapy on hypertrophic scar height, thickness and discoloration, and to assist in planning an ideal treatment regimen for reducing hypertrophic scar.

Delimitations:

This study will be delimited in the following aspects:

1. Subjects:

   Sixty patients suffering from hypertrophic scar will be randomly divided into two equal groups each one has 30 patients.
2. Equipment and tools:

2.1. Measurement equipment: Vancouver scar scale. MAPS (Matching Assessment of Scars and Photographs). 2.2. Therapeutic equipment: Gymna Cryoflow ICE-CT. Temperature resistant polymide tape (48 wide).

Hypothesis:

It will be hypothesized that:

Cryotherapy may not have an effect on hypertrophic scar.

Basic Assumptions:

It will be assumed that:

* All patients will receive the same kinds of medication and the same nursing care.
* All subjects are free from any chronic disease.
* All subjects will continue in the study.
* All patients will follow the instructions during the treatment

Eligibility Criteria:
Inclusion Criteria:

* Age range between 20- 40 years.
* Both sexes will participate in the study.
* All patients participated will begin treatment program one month after injury depending on injury characteristics.
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

* Diabetes mellitus.
* Individuals with cardiopulmonary conditions.
* Individuals undergoing radiation therapy or chemotherapy.
* Hepatic or pancreatic diseases.
* Sensory impairment
Lopinavir (LPV) Dose Reduction

The purpose of this study is to study the pharmacokinetics profiles of generic lopinavir/ritonavir and Pediatric Aluvia® at reduced dose by assessing safety, tolerability and efficacy.

This is a prospective, 2 arms, randomized intensive PK study with cross over design. This design will provide us optimal information to answer our research question. First and most important, we can assess the PK when lopinavir/r is used in a dose reduced form. By randomizing the patients to either Abbott's pediatric Aluvia dose reduction or India generic LPV/r dose reduction will allow us to assess the differences in AE severity and frequency. Using the standard abbott product as a control our study will provide important information about the bioavailability of the generic product. Although it's not an original BE design we must be able to make preliminary comparisons.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Evidence of HIV infection (confirmed positive ELISA and/or documented history of measurable HIV RNA)
3. Age\> 18 years
4. Have been on standard dose of any PI containing regimen for at least 4 weeks prior to study entry
5. Currently having no AIDS defining illness
6. Plasma HIV RNA \< 50 copies/mL for at least 24 weeks
7. Willing to adhere to the protocol requirements

Exclusion Criteria:

1. Any history of taking CYP450 inhibitors or inducers, or any gastric acid-reducing drugs within 14 days of enrollment in the study
2. Current pregnancy or lactating
3. Active opportunistic infection
4. ALT/ AST more than 2x upper limit
5. creatinine more than 1.5 time the upper limit
6. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion
7. History of sensitivity/idiosyncrasy to the drug or chemically related compounds or pharmaceutical excipients which may be employed in the study.
8. Active drug abuse
FebriDx® Method Comparison Study Protocol

The goal of this observational study is to learn about the performance and ease of use of FebriDx when operated by persons without laboratory experience or training in patients with acute respiratory symptoms. The main question it aims to answer is:

• Is FebriDx accurate at differentiating bacterial from non-bacterial respiratory infections when used by untrained operators? Trained and untrained participants will run the FebriDx test on patients with respiratory symptoms to evaluate comparability.

A prospective, multi-center, blinded observational study to demonstrate that the FebriDx test meets the CLIA statutory criteria for waiver by providing sufficient assurance that the addition of a new operator population (untrained) and environment of use (waived) will not adversely impact the performance or safety of the test.

The study aims to:

* Demonstrate that FebriDx® Test is accurate and the operator can perform the test with a negligible risk of erroneous result.
* As a secondary objective, ease-of-use objective data and subjective feedback relating to the device and its operator interface will be collected at the end of the study and assessed for comparability.

Eligibility Criteria:
Inclusion Criteria:

* Subject exhibits or reports a new onset measured temperature (oral or tympanic) of greater than or equal to 100.5°F/38°C within 3 days (72 hours) of enrollment or at the visit
* Subject has clinical suspicion for Acute Respiratory Infection and presents with at least one (1) of the following new onset symptoms beginning ≤ 7 days of enrollment: runny nose, nasal congestion, sore throat, cough, hoarse voice or shortness of breath

Exclusion Criteria:

* Subject is unable or unwilling to provide signed, Informed Consent
* Subject is less than 12 years old or over 64 years old
* Subject has a fever that started more than 3 days (\> 72 hours) prior to enrollment
* Subject has symptoms of Acute Respiratory Infection that started \> 7 days of enrollment
* Subject is receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in the last 30 days
* Subject is in an immunocompromised state (e.g. HIV) or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral steroids, Methotrexate, Cyclosporine, Antimetabolite chemotherapy, interferon therapy)
* Subject has taken antibiotics or antiviral therapy in the last 14 days
* Subject received a live viral immunization in the last 14 days
* Subject has significant trauma or burns (\> 5% total body surface area or full thickness (3rd°)) in the last 30 days
* Subject has had major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the last 30 days
* Subject has a history of a myocardial infarction or stroke in the last 30 days
A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) or placebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Treatment duration will be 28 weeks or 48 weeks depending on response. Treatment-experienced patients categorized as relapsers, partial responders and viral breakthrough patients to previous pegylated interferon and ribavirin therapy will be randomized to receive either setrobuvir or placebo in combination with Pegasys and Copegus for 48 weeks. Treatment-experienced patients categorized as null-responders to previous pegylated interferon and ribavirin therapy will be assigned to treatment with setrobuvir plus Pegasys and Copegus for 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 to 65 years of age inclusive
* Documented chronic hepatitis C
* Treatment-naïve (no prior exposure to Pegasys, Copegus, or experimental HCV therapy) or treatment-experienced with current standard of care (Pegasys and Copegus) but categorized as null-responder or patients with partial response, relapse or viral breakthrough during or following prior treatment
* Serum HCV RNA \>/= 50,000 IU/mL at screening
* HCV antibody positive at screening
* HCV genotype 1
* Body mass index (BMI) 18-38 kg/m2
* In good health other than chronic HCV infection in the judgment of the principal investigators
* Negative for hepatitis B and HIV infection

Exclusion Criteria:

* Pregnant or breastfeeding women
* For treatment-naïve patients: any previous treatment for HCV infection
* For treatment-experienced patients: previous treatment with an experimental therapy for HCV infection
* Co-infection with HIV or hepatitis C virus (HBV)
* History or evidence of decompensated liver disease
* History or evidence of hepatocellular carcinoma
* History of alcohol abuse and/or other drug addiction \</= 1 year prior to enrollment in the study
* Poorly controlled diabetes mellitus
* One or more additional known primary causes of liver disease other than hepatitis C
* History of acute or chronic pancreatitis
* Participation in an other clinical study of a new chemical entity within 30 days prior to study randomization
Brain Connectivity Marker for Alzheimer's Disease

The main purpose of this project is to establish whether changes in brain connectivity can be used to predict the development of Alzheimer's disease (AD).

To achieve this aim, the investigators will perform six different studies that have been designed to achieve the following specific objectives:

1.1. Identify changes of brain connectivity in individuals who show abnormal AD amyloid biomarkers in the cerebrospinal fluid and blood.

1.2. To assess the correlation between brain connectivity changes and biomarkers of synaptic dysfunction and inflammation as well as alterations of electrical brain signals.

1.3. Establish whether alterations of brain connectivity could be improved after patients start treatment with cholinesterase inhibitors.

1.4. Assess differences in brain connectivity between patients receiving treatment with statins and those not taking this medication.

1.5. Determine whether brain connectivity changes can predict longitudinal cognitive decline and conversion to AD dementia.

1.6. Assess whether different microorganisms can grow more rapidly in the cerebrospinal fluid from AD patients compared to controls and whether their levels are associated with brain connectivity.

1.7. Evaluate the relationship between brain connectivity and the integrity of the locus coeruleus, which is the earliest site of AD pathology

Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria for subjects with subjective cognitive complaints:

   * MMSE (Mini-mental test) or MoCA (Montreal Cognitive Assessment) points between 26 and 30.
   * Absence of cognitive impairment.
   * Memory problems reported by the participant/family member.
   * Do not fulfill criteria for mild cognitive impairment or dementia.
   * Must speak and understand Swedish.
2. Inclusion criteria for patients with mild cognitive impairment:

   * MMSE (Mini-mental test) or MoCA (Montreal Cognitive Assessment) points between 24 and 30.
   * Impaired memory function.
   * Do not fulfill criteria for dementia.
   * Must speak and understand Swedish.
   * Must have abnormal cerebrospinal fluid amyloid-β 42/40 ratio levels, which is a biomarker of Alzheimer's disease.
3. Specific inclusion criteria for patients with Alzheimer's disease:

   * MMSE (Mini-mental test) or MoCA (Montreal Cognitive Assessment) points between 18 and 28.
   * Impaired memory function in addition to impaired executive abilities, language function, visuospatial ability and/or attention/psychomotor speed.
   * Meet NINCDS-ADRDA and DSM-IV criteria for probable Alzheimer's disease.
   * Must speak and understand Swedish.
   * Must have abnormal spinal fluid amyloid-β 42/40 ratio levels, which is a biomarker of Alzheimer's disease.

Exclusion Criteria:

* Alcohol or drug abuse.
* Unstable somatic disease or organ failure.
* Refuse to cerebrospinal fluid testing and/or blood sampling, neuropsychological testing, brain imaging, electroencephalogram or magnetoencephalogram.

In addition, participants who have claustrophobia or some form of metal implant in their body that may interfere with the brain imaging scan will be excluded from the study.
Safety and Efficacy of Medications COVID-19

We performed a quasi-experimental open-label pragmatic study alternating standard of care (SOC) and oral bedtime melatonin (OBM) at different high doses over 4 consecutive time periods enrolling all consecutive RT-PCR SARS-CoV-2 severe Covid-19 admissions.

The 4 successive study time periods spanned from March 2020 to April 2021 and included: 1) standard of care (SOC) (C1), 2) SOC + oral bedtime melatonin (OBM) (T1), 3) SOC (C2), and 4) SOC + OBM (T2). During T1, 3 consecutive subgroups received 50 mg, 100 mg and 200 mg OBM. During T2, 100 mg OBM was given. Melatonin was administered from ICU admission to hospital discharge or death.

The main objectives were occurrence of predefined severe adverse events (SAEs), Sequential Organ Failure Assessment (SOFA) scores and day-30 (D30) and 90 (D90) mortality. Study subjects were followed for modified Rankin scale (mRS) at 30 days after the last OBM dose or hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Positive RT-PCR for SARS-CoV-2

Exclusion Criteria:

* Anticipated death within 48 hours or paliative care
Determination of Functional Exercise Capacity, Respiratory Muscle Endurance in Idiopathic Pulmonary Fibrosis

There are not enough studies in the literature comparing functional capacity, respiratory functions and muscle strength of IPF patients with healthy individuals. This study aims to compare functional capacity, respiratory functions and muscle strength of IPF patients with healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* having a clinical, radiological and/or pathological diagnosis of IPF
* volunteering to participate in the study
* not having had a respiratory tract infection in the last month
* not having an accompanying airway disease such as COPD
* being in the stable phase of the disease

Exclusion Criteria:

* Patients who have had an IPF attack within the last three months and/or are in the acute exacerbation of the disease; who use a walking aid; who have unstable angina or class III-IV heart failure according to the New York Heart Association congestive heart failure classification; who have orthopedic, neuromuscular, neurological and cardiac diseases that may affect walking and balance; who have serious comorbid conditions such as cancer or neoplasm; who have a history of sarcoidosis, tuberculosis, emphysema and/or lung surgery; who have communication problems, mental and cognitive problems, and who cannot adapt to the applied assessment methods will be excluded from the study.
Vestibular Stimulation to Treat Hemispatial Neglect

The purpose of the current proposal is to pilot a new and potentially improved treatment for neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the vestibular nerves that lie directly below the mastoid bones.

The purpose of the current proposal is to pilot a new and potentially improved treatment for neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the vestibular nerves that lie directly below the mastoid bones. With the intention of boosting activity in the damaged left hemisphere, positive and negative current is delivered to the left and right mastoids respectively. While successfully used to rehabilitate gait and balance disorders, the procedure has only once been applied to neglect.

In the present investigation, we will first confirm and then optimize the conditions under which galvanic vestibular stimulation (GVS) ameliorates neglect. This in turn will justify subsequent work (in a later funding cycle) that will demonstrate the safety and efficacy of the treatment on a much larger clinical scale, and merit the construction of a miniaturized portable device.

Eligibility Criteria:
Inclusion Criteria:

* All participants must be literate in English
* Right handed
* Have corrected near-visual acuity of 20/40 or better
* Patients must also have a minimum of twelve years education
* These inclusionary criteria are based on the data of both Black, Yu, Martin, and Szalai (90) and our own studies.

  * They are intended to assure that only patients with sufficiently severe symptoms will be admitted to our study.

Exclusion Criteria:

Exclusionary criteria include:

* Homonymous hemianopia
* Presence of a severe field cut extending toward the midline on formal perimetry (however many patients who have field cuts restricted to the periphery will be able to fully perceive our stimulus displays so can be included
* Evidence of aphasia on clinical examination (crossed aphasia)
* A significant history of other neurological or psychiatric illness or drug/alcohol abuse
Exploration of Pupil Dilation in Horner's Patients Taking Flomax

This study is evaluating the pupil dilation of Horner's Patients who have ever taken an alpha blocker such as Tamsulosin. Patients will undergo eye dilation as would occur at a yearly eye examination, but their pupil dilation measurements will be recorded.

This study will enroll 10 participants who have a unilateral Horner's Syndrome AND have a history of taking an alpha blocker such as Tamsulosin. Participants will be recruited based on those two enrollment criteria, and after consenting they will undergo pupil dilation with 10% phenylephrine. Once fully dilated the pupil size will be measured. Pupil dilation size of the eye affected by the Horner's Syndrome will be compared to the eye not affected by Horner's. Primary study outcome is the comparative dilation size of the Horner's affected eye to the non affected eye in all subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Horner's Syndrome
2. History of taking an alpha blocker (tamsulosin/ terazosin/doxazosin/alfuzosin/silodosin) medication

Exclusion Criteria:

1. Subjects with untreated hypertension
2. Subjects with thyrotoxicosis
3. Pregnant women
4. Prisoners
5. Inability to consent
6. Subjects with anatomical narrow angles who have never had a dilated exam