cyrilzakka/clinical-trials huggingface dataset:
Intermittent Oro-esophageal Tube Feeding on Cerebral Small Vessel Disease Patients With Dysphagia

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach.

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia.

This was a randomized controlled study with 60 CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy. Patients enrolled were randomly divided into the observation group (with IOE, n=30) and the control group (with NGT, n=30). At admission and after treatment, Video Fluoroscopic Swallowing Study (VFSS) and Functional Oral Intake Scale (FOIS), body mass index (BMI), serum albumin (Alb), and hemoglobin (Hb), Modified Barthel Index (MBI) and World Health Organization Quality of Life Assessment Instrument Brief Version (WHOQOL-BREF) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (ADL) and quality of life (QOL). The incidence of pneumonia was recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of CSVD, confirmed by MRI;
* Must be able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) ;
* Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS);
* Age between 40 and 70 years;
* Enteral nutrition support was required and feasible.
* No history of prior stroke.

Exclusion Criteria:

* Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases;
* Complicated with severe liver and kidney failure, tumors, or hematological disorders;
* Simultaneously need to undergo other therapy that might affect the outcomes of this study;
* Unable or unwilling to undergo VFSS;
* Pregnant or nursing females.
Methylene Blue for the Prevention of Hypotension During Hemodialysis

Hypotension is a common complication of intermittent renal replacement therapy. Methylene blue, an inhibitor of nitric oxide synthesis, has been suggested to improve hemodynamics during renal replacement therapy in ambulatory patients, but evidence is lacking for critically ill patients.

This trial will assess whether methylene blue can improve hemodynamics and blood pressure for patients with shock requiring renal replacement therapy.

This is a single-center, randomized, non-blind study, with a intention-to-treat analysis, aiming to evaluate whether the use of methylene blue reduces the incidence of hypotension during hemodialysis, resulting in a reduction in the need for therapeutic modifications during the session, defined as interruption session, reduced fluid losses and increased need for vasopressors. Patients will be randomized using RedCap platform in variable blocks of 4-6, stratified by center in a 1:1 ratio and by previous use of vasopressors, into two groups, intervention and usual treatment. Access to randomization will be available 24 hours, 7 days a week. Patients on intermittent renal replacement therapy will be selected to receive or not methylene blue at a bolus dose of 1 mg/kg, followed by a continuous infusion of 0.1 mg/kg of body weight in a total of 200 ml of solution. saline throughout the dialysis session. The usual care group will not receive any intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Patient or legal representative accepted trial enrollment
2. Age above 18 years
3. Chronic or acute kidney injury in need for renal replacement therapy
4. Blood pressure lower than 100 mmHg or in use of any vasopressor

Exclusion Criteria:

1. Pregnancy
2. Death considered imminent in the next 24 hours
3. Patients not on full code status
4. Hypertensive patients where dialysis was indicated to remove fluids
5. Known allergy to methylene blue
6. Known glucose-6-phosphate deficiency
7. Previously enrolled in the trial
8. Acute coronary Syndrome
9. Domiciliary nitrate use
Investigation of Genetic Disease Marker Associated With Spontaneous Haemorrhagic Stroke Complicating Severe Pre-eclampsia in Pregnancy

To search for a genetic marker of hemorrhagic stroke complicating severe eclampsia, a single nucleotide polymorphism (SNP) analysis of DNA obtained from the peripheral blood of patients with hemorrhagic stroke and normal control will be performed.

Detailed Description:

Unrelated Korean subjects who have Spontaneous hemorrhagic stroke complicating severe eclampsia in pregnancy were recruited in the current study. Genotyping for various SNP associated due to the linkage disequilibrium patterns is to be performed. Genotypes would be statistically compared between patients with hemorrhagic stroke and normal control subjects free of hemorrhagic stroke

Eligibility Criteria:
Inclusion Criteria:

-patients with hemorrhagic stroke complicating severe eclampsia in pregnancy

Exclusion Criteria:

patients without hemorrhagic stroke complicating severe eclampsia in pregnancy
Study Of The Efficacy And Security Of Ibandronate For Osteoporosis Treatment In A HIV-Infected Patients Cohort

This project wills to determine the incidence of osteoporosis in our population of HIV-infected patients and to assess the efficacy and security of ibandronate, whose efficacy in post-menopausal women has already been proved.

The lower bone mineral density that has been described in patients with HIV-infection has not meant an increase of long term complications. Nevertheless, it could involve an increase if the associated co-mordibity in the future, taking in care that in general population osteoporosis increases 4 times the pathologic fracture risk. That's why it is necessary to know the real prevalence of osteoporosis in this population of patients so the real dimensions of the problems can be defined.

This project wills to determine the incidence of osteoporosis in our population of HIV-infected patients and to assess the efficacy and security of ibandronate, whose efficacy in post-menopausal women has been already proved. If the quarterly use of endovenous ibandronate obtains equivalent results to those obtained with oral and weekly alendronate in other studies with the same population, its use would be justified because of its posology benefits. The monthly or quarterly administration can improve compliance in patients who are recieving a big quantity of drugs, as HIV infected patients do and who probably have to be treated for life. Moreover, its elimination is renal so there is absence of interactions with antiretroviral drugs what mades of ibandronate a very promising alternative. Finally, there's no risk of digestive intolerance because of its parenteral administration and it has a better posology than oral bifosfonates.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or elder.
2. Documented HIV-1 infection, with or without antiretroviral treatment.
3. Presence of WHO osteoporosis criteria, defined as t-score under -2.5 in lumbar, hip and/or trochanter. (DEXA in the last 6 months is needed)
4. Willing to follow the study protocol.
5. Informed Consent signature.

Exclusion Criteria:

1. In women, pregnancy or breastfeeding.
2. Other possible causes of secondary osteoporosis.
3. Creatinin over 2.3mg/mL
4. Glomerular filter less than 50 mL/min (estimated through MDRD)
5. Alendronate treatment in the last 6 months.
Effects of Chronic Intake of Cannabis on Contrast Sensitivity

Rates of driving under the influence of cannabis have risen in recent years. Cannabis is involved in 1/3 of motor vehicle collisions. The chronic use of cannabis is known to affect dopaminergic regulation and may thus impair contrast sensitivity. In turn, contrast sensitivity disorders could originate difficulties to anticipate and avoid collision with objects, especially when objects are in movement. The investigators goal is to examine the effects of a chronic intake of cannabis on contrast sensitivity. The observed values will be compared to standard references. In addition, since smoking cannabis is always associated with tobacco, the investigators will control the effects of tobacco on contrast sensitivity.

In this study, the investigators will include 36 cannabis addicts, 36 tobacco addicts and 36 no smokers. The investigators will present gratings with different spatial frequencies and the investigators will determine contrast thresholds for static and dynamic (moving) gratings. The investigators predict that cannabis addicts will present abnormal contrast sensitivity especially in case of dynamic presentation of gradings.


Eligibility Criteria:
Inclusion Criteria:

"Cannabis" Arm

* patient addicted to cannabis
* Positive CAST test result
* Urine tested positive for cannabis metabolites

"Tobacco" Arm

* positive Fagerström test result
* No cannabis intake in the last year before inclusion
* No previous history of cannabis use

"Healthy Volunteers"

* No tobacco or cannabis intake in the last year before inclusion
* No history of addictive disorders

Exclusion Criteria:

* addiction to other substances than cannabis or tobacco
* benzodiazepine treatment
* patient with history of benzodiazepine treatment
* patient with history of general anesthesia in the last 3 months before inclusion
* patient with history of head trauma
* Pregnant woman
* breast feeding woman
* Adults under supervision or guardianship
Non-invasive Ventilation Versus High Flow Oxygen

The purpose of the study is to compare the efficacy of alternating Non Invasive Ventilation NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and prognosis in pneumonia-associated acute hypoxemic respiratory failure

Both Non Invasive Ventilation (NIV) and High Flow Oxygen through nasal cannula (HFO) are widely used in the setting of hypoxemic respiratory failure of heterogeneous etiology, with no definitive evidence for the superiority of one technique on the other. The purpose of this study is to determine whether alternating NIV and HFO brings any advantage on gas exchanges and prognosis compared to the use of HFO alone in the homogeneous setting of pneumonia-associated acute hypoxemic respiratory failure

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pneumonia based on at least two clinical/laboratory criteria and 1 radiologic criterion among the following:

  * Clinical criteria: fever, cough, purulent sputum, pulmonary examination positive for signs consistent with pneumonia
  * Laboratory criteria: leukocytosis (White blood cells \>10000/mcL) or leukopenia (White blood cells \< 4000/mcL), rise of the inflammatory markers
  * Radiologic criteria: consolidations at Chest X-ray or CT scan
* Hypoxemic respiratory failure, based on all the following criteria

  * PaO2/FiO2 \< 300 after at least 15 minutes conventional oxygen therapy with a FiO2 ≥ 50%
  * Respiratory Rate (RR) ≥ 25/min or need for use of accessory muscles
* Informed consent to study participation

Exclusion Criteria:

* Age \< 18 years
* Hypercapnic respiratory failure (pCO2 \> 60 mmHg at presentation) such as in Chronic Obstructive Pulmonary Disease
* Presence of another cause of hypoxemic respiratory failure - e.g. pulmonary embolism, acute respiratory distress syndrome (ARDS), pulmonary oedema
* Hemodynamic instability with necessity for use of inotropes and/or vasopressors
* Indication for endotracheal intubation (ETI): Glasgow Coma Scale (GCS) \<8, agitation, device intolerance, respiratory arrest
* Immunosuppression (chronic immunosuppressive therapy, clinical history positive for any immunodeficiency - congenital or acquired)
* Do Not Resuscitate (DNR) and Do Not Intubate (DNI) indication
* Tracheostomy
* Nocturnal CPAP ventilation therapy
* Any other condition which the clinician would considered an adjunctive risk for taking part in the study or that would not permit the participant to complete it
Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.

Objective: To evaluate the effect of interdisciplinary home rehabilitation of patients with acute stroke. The trial seeks to evaluate:

1. Can early home rehabilitation affect the degree of independence (motor capacity, activities of daily living and cognitive status), quality of life and the possibility of discharge to own home?
2. Can home rehabilitation influence the length of admission at a rehabilitation centre in the municipality, readmission to hospital, the use of healthcare services and death?
3. To what extend can home rehabilitation be implemented according to finances? Materials and methods: Patients at the age 18 years or more admitted to the stroke unit at the University Hospital of Gentofte. The patients were eligible when meeting the following criteria: symptoms of stroke, need of rehabilitation tree days after admission, living in own home in the Municipality of Gentofte, Lyngby-Taarbaek or Rudersdal and Modified Rankin Score between 0 and 3.

The trial was conducted as a randomised controlled trial. The control group patients were rehabilitated according to normal procedure. The intervention group patients were rehabilitated according to normal procedure and were additionally rehabilitated at home during admission and four weeks after discharge.

Objectives were to assess the efficacy of home-based stroke rehabilitation compared to standard care in stroke patients using an interventional, randomised, safety/efficacy open-label trial and parallel assignment. The setting was single-center, stroke unit at the University Hospital of Copenhagen, Gentofte, although patients were recruited through a collaboration of several municipalities.

Participants were eligible patients with a clinical diagnosis of stroke and focal neurological deficits hospitalised in a stroke unit for more than three days and in need of rehabilitation.

Interventions patients were randomised to home-based rehabilitation during hospitalization and for up to 4 weeks after discharge to replace part of usual treatment and rehabilitation services. Control patients received treatment and rehabilitation following usual guidelines for the treatment of stroke patients.

Main outcome measures 90 days post-stroke, modified Rankin Scale, and motor rehabilitation, cognitive abilities, quality of life and treatment-associated economy as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or more,
* Symptoms of stroke,
* Need of rehabilitation tree days after admission,
* Living in own home,
* Modified Rankin Score between 0 and 3

Exclusion Criteria:

* Terminal care,
* Discharged from another department, Living in nursery home,
* Can not understand the Danish language,
* Memory difficulties
Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions.

This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions. Participants will attend two quantitative sensory testing visits in order to determine their level of pain sensitivity, one at the beginning of the study and the second at the 3-month Follow-up session. Participants will be asked to test out the Quell device to check for sensation tolerance, and will then be randomized into one of the two treatment groups: the High Intensity Quell group or the Low Intensity Quell group. Participants will be asked to wear the device for at least 3 hours every day and to complete daily assessments, along with a total of three sets of questionnaires: one at the start of the study, the second 6 weeks from the date of consent, and the third 3 months after the date of consent. A member of the research staff will call participants once a week for a brief phone interview throughout the study. Participants will be in this study for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Ages 21 and older
* Pain duration \> 3 months
* Diagnosed by physician with multiple chronic pain conditions
* Have chronic pain related to multiple chronic pain diagnoses (headaches, joint pain, back pain, or any of the other COPCs)
* Average 4 or greater on pain intensity scale of 0 to 10
* Pain is not accounted for by any other progressive disease (e.g., cancer, MS)
* Meets sensory hypersensitivity cutoffs based on QST-assessed evidence
* Own a smartphone (iPhone or Android device) and can download the pain app (MasterMyPain) and the Quell Relief mobile app onto their device
* Able to speak and understand English

Exclusion Criteria:

* Diagnosis of cancer or any other malignant disease
* Acute osteomyelitis or acute bone disease
* Present of past DSM-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation
* Pregnancy
* Any clinically unstable systemic illness judged to interfere with treatment
* A pain condition requiring urgent surgery
* An active substance use disorder, such as cocaine or IV heroin use that would interfere with study participation
* Have an implanted cardiac pacemaker, defibrillator, or other implanted device.
* Reynaud's syndrome
* Open cuts/sores
Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer

To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous infusion in patients with pretreated metastatic colorectal cancer.

Previous lines of treatment recorded. Adjuvant and palliative.

Treatment will continue until clinical indication due to PD or toxicity, or until completion of 6 cycles of gemcitabine, whichever comes first.

All patients will be assessed for toxicity and followed up for disease recurrence/progression.

The study will be divided into two accrual stages - the first consisting of 17 patients. If 6 or more patients achieve tumour response or stabilisation in the first stage, the second stage will commence accrual of a further 20 patients. Hence, the total planned accrual will be 37 patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Histologically proven colorectal adenocarcinoma.
* Locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen.
* Progressive disease documented by CT either during or within 3 months of completion of previous chemotherapy
* No previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
* Unidimensional measurable disease as assessed by CT.
* Adequate bone marrow function; Hb \>10g/dl, platelets \>100 x109/l, WBC \>3x109/l, Neut \>1.5x109/l.
* Adequate liver function: Serum Bilirubin \<1.5 x upper limit of normal
* Adequate renal function: Serum Creatinine \< 0.11 mmol/L
* No concurrent uncontrolled medical conditions
* WHO performance status 0,1 or 2
* Adequate contraceptive precautions, if appropriate
* Informed written consent
* Negative pregnancy test in women of child bearing age
* Life expectancy \> 3 months

Exclusion Criteria:

* Medical or psychiatric condition that comprise the patient's ability to take informed consent.
* Patients within 4 weeks of chemotherapy or radiotherapy (6 weeks for nitrosureas or mitomycin C).
* Previous treatment with gemcitabine.
* Patients with uncontrolled cerebral metastases.
Impact of Readability Improvements on the Comprehension of Written Information Given to Clinical Trial Patients: a RCT

The principle objective of this randomised controlled trial is to assess whether an improvement in lexico-syntactic readability combined with adherence to French recommendations for good practice in writing the Information and Consent Form (ICF) given to patients participating in clinical trials, increases their understanding of the information compared to conventional written information, in real (not simulated) conditions.

The quality of written information given to people participating in clinical trials is essential as by law all volunteers have to be informed of a certain number of key elements. Those elements that are necessary to understanding and making a decision as to whether to participate in the trial are presented to the volunteer in the information and consent document (ICD).

Many terms used in the ICD are of necessity medical terms and sometimes difficult to understand for the person who may participate in the study.

Several factors are involved when a reader receives a text, and one of the difficulties of intelligibility can be the lexico-syntactic readability.

The lexico-syntactic readability is the only element of intelligibility that can be readily quantified, using the Flesch-Kincaid index. It is also an element that can be very easily modified without changing the sense of the information.

In the QuIP-3 study, which we performed in 2003, it appeared that the lexico-syntactic readability of ICF is very low, lower than that of texts used in university level classics examinations. Furthermore, there is no correlation between the density of information and readability (QuIP-5 study).

It seems to be necessary to assess the understanding of those participating in clinical trials in terms of logical and cognitive intelligibility (representativeness and interpretability of the information and consent forms). Indeed, a text may be unreadable according to the Flesch score, in lexico-syntactic terms, but perfectly understood and interpreted.

As no questionnaire had been validated in French, we validated the " Questionnaire d'Evaluation de la Compréhension de l'Information Ecrite par les Malades or QECIEM " (Questionnaire measuring patient comprehension of written information) (QuIP-4). This questionnaire can be used to measure both objective and subjective general understanding by a patient to be included in a therapeutic study, irrespective of the pathology.

Eligibility Criteria:
Inclusion Criteria:

* Subject considered suitable to participate in one of the clinical trials selected for the LISYCOM study
* Age \> 18 years

Exclusion Criteria:

* Illiteracy or inability to read French
* Neurological deficiency making reading impossible (attention disorders, aphasy, etc)
* Refusal to participate