cyrilzakka/clinical-trials huggingface dataset:
Outcome of Cardiomyopathic Adults Admission in ICU.

To study the outcome of the cardiac function, and clinical status of the patiants with cardiomyopathy who are admitted in the I.C.U.

Heart failure is not a single pathological diagnosis, but a clinical syndrome consisting of cardinal symptoms (e.g. breathlessness, ankle swelling, and fatigue) that may be accompanied by signs (e.g. elevated jugular venous pressure, pulmonary crackles, and peripheral oedema). It is due to a structural and/or functional abnormality of the heart that results in elevated intracardiac pressures and/or inadequate cardiac output at rest and/or during exercise. Identification of the aetiology of the underlying cardiac dysfunction is mandatory in the diagnosis of HF as the specific pathology can determine subsequent treatment. Most commonly, HF is due to myocardial dysfunction: either systolic, diastolic, or both. However, pathology of the valves, pericardium, and endocardium, and abnormalities of heart rhythm and conduction can also cause or contribute to HF.

Cardiomyopathies are defined by the WHO as diseases of the myocardium associated with cardiac dysfunction, Cardiomyopathies are categorized into dilated, restrictive, hypertrophic, and unclassified based on the predominant pathophysiologic characteristics. A new category has been added to include right ventricular abnormalities. The disorders that are associated with systemic or certain cardiac diseases are called specific heart muscle diseases and include ischemic cardiomyopathy, valvular, hypertensive, inflammatory, metabolic, peripartal, general systemic disease, muscular dystrophies, neuromuscular disorders, and toxic and hypersensitivity reactions. The unclassified cardiomyopathy category includes disorders such as fibroelastosis, noncompacted myocardium, and systolic dysfunction with minimal dilation.

Patiant admitted in I.C.U. with heart failure who already have cardiomyopathy Some patiants discharge without any comorbidies and some acquire renal failure, respiratory failure,MCS, sepsis, and some were associated with mortality . Significant comorbidities associated with these hospitalizations included arrhythmias, renal failure , cerebrovascular disease, and hepatic impairment.

Eligibility Criteria:
Inclusion Criteria:

Cardiomyopathic patiants admitted with heart failure diagonsed clinicaly , by Echocardiograph , or by ECG.

1. Dilated cardiomyopathy\[ Unknown, Uremic cardiomyopathy, Post-partum, Ishemic\].
2. Hypertrophic cardiomyopathy.
3. Acute heart failure caused by A.C.S. , Toxic myocardititis.

Exclusion Criteria:

1. Heart failure due to valvular heart disease.
2. Heart failure caused by hypertension.
3. patiant with COPD
Evaluation of Objective Pain Measurement Device

This study will attempt to objectively measure pain with an experimental device. The investigators will apply the device to measure patients "pain" due to uterine contractions during routine clinical care to correlate patients verbal pain ratings and analgesia requirements to that measured by the device. A brain oxygenation device, Edwards Foresight, will be used to concurrently to monitor brain oxygenation and hemodynamics, so the relationship between the CereVu ROPA device objective measure of pain and brain oxygenation/hemodynamic changes and patient-reported pain can be determined.

Despite all the progress in our understanding of the basic mechanisms of pain, the gold standard for measuring pain is still a subjective verbal numeric rating scale rating (0-10) obtained from the individual reporting pain. This method is not objective and cannot be used in all patient populations. This study will attempt to objectively measure pain in laboring mothers with a pain measurement device. The investigators aim to 1) see if the pain measurement device (CereVu ROPA) is capable of reflecting different levels of pain ratings in patients in labor having uterine contractions and then changes in pain after receiving different neuraxial techniques for labor pain and to 2) additionally determine the relationship between the CereVu ROPA device, brain oxygenation/hemodynamic changes and patient-reported pain scores.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50
* ASA 1 or 3 +/-E
* Patient requesting epidural labor analgesia
* Good toco tracing (clearly showing contractions at least every 5 minutes)
* Pain score greater than or equal to 3 out of 10 with contractions

Exclusion Criteria:

* History of chronic pain
* History of chronic opioid use
* BMI \> 45
* Allergy to sensor adhesive material, local anesthetic or opioids
* Contraindication to neuraxial block
* Patient on magnesium infusion
* Inability to give informed consent or understand English
A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine

Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661.

L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.

L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.

Part 1: Twelve patients are randomly assigned to one of two groups. Group 1 patients receive AZT for 7 days, followed by AZT plus L-697,661 with food for 56 days. Group 2 patients receive no drug for 7 days, followed by L-697,661 with food for 56 days. Antipyrine is administered 1 hour prior to study drug on days 8, 22, and 35.

Part 2: Fifteen patients receive L-697,661 with food, for 8 weeks. Therapy with L-697,661 may be extended beyond 8 weeks for up to 24 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.

Prior Medication: Included:

* Patients in Part 1 must have received no previous zidovudine (AZT) or a stable dose of at least 500 mg/day without evidence of toxicity.
* Patients in Part 2 must have received no previous AZT or = or \> 300 mg/day for \< 6 consecutive weeks within 1 year prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Acute HIV-related opportunistic infection requiring ongoing treatment.
* Diarrhea defined as 3 or more liquid stools/day for one week.
* Wilson's or Gilbert's disease, porphyria, or other chronic or acute hepatic disease.
* Potentially life-threatening allergic reactions to any of the components of zidovudine.
* Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study.

Concurrent Medication:

Excluded:

* Systemic bronchodilators, acetaminophen, aspirin.

Prior Medication:

Excluded:

* Didanosine (ddI) or dideoxycytidine (ddC) within 14 days prior to entry.
* Immune modulators or investigational drugs within 30 days prior to entry.
* Drugs known to induce hepatocellular enzymes, such as phenobarbital, phenytoin, warfarin, ketoconazole, and oral contraceptives, within 30 days prior to entry.

Patients in Part 2 only:

Excluded:

* Zidovudine within 4 weeks prior to receiving first dose of study drug.

Risk Behavior:

Excluded:

* Patients who the investigator feels would not comply with study requirements.

Patients may not have the following prior conditions:

* Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study.
* Potentially life-threatening allergic reactions to any of the components of zidovudine.
Dynamic Individualized rTMS Based on fNIRS

Stroke patients do not respond well to the traditional repetitive transcranial magnetic stimulation (rTMS) strategy based on the competitive model. The studies found that the contralesional motion cortex has a compensatory effect on the realization of the motor function of the affected side-the compensatory model, and the degree of compensation will change as the function changes. The optimal neural regulation strategies under different models are opposite, so it is important to accurately evaluate which of the two models plays the leading role. And functional near-infrared spectroscopy (fNIRS) may accurately and quickly assess cortical function in order to determine the degree of participation of the contralesional motion cortex. We propose that the dynamic individualized strategy which adjust the rTMS parameters promptly based on the results of fNIRS will be better than the traditional stimulation strategy. This project will apply a blinded-assessment randomized controlled trial. The test group selects either the high-frequency rTMS to the contralesional dorsal premotor cortex (PMd) or the low-frequency rTMS to the contralesional primary motor cortex (M1) based on the lateralization index of the PMd measured by fNIRS. And the control group will always be given low-frequency rTMS to contralesional M1. The difference in the improvement of upper limb function between the two groups of patients was compared.


Eligibility Criteria:
Inclusion Criteria:

* Aged 40-79 years;
* Patients with first-onset subcortical infarcts within1 to 3 weeks after onset;
* TMS on the lesion side can induce motor evoked potential(MEP) of the abductor pollicis brevis muscle of the affected hand;
* Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
* The patient or its authorized agent signs the informed consent form.

Exclusion Criteria:

* Previous seizures;
* Suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset;
* Patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rTMS.
Osteoarthritis Initiative (OAI): A Knee Health Study

Knee osteoarthritis (OA) is the most common cause of disability in adults. The "Osteoarthritis Initiative (OAI): A Knee Health Study" is a nationwide research study that will help researchers gather more information about the physical changes that occur prior to the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to examine people who have knee OA or are at high risk for knee OA; information will be used to better understand how to prevent and treat knee OA.

Knee OA causes more health problems and medical expenses that any other form of arthritis. Symptoms of OA can range from stiffness and mild pain to severe joint pain and even disability. Previous research has shown that certain factors, such as knee pain, prior knee injury or knee surgery, OA of the hand, or obesity, may lead to knee OA. The OAI is a multicenter, observational study of knee OA that will collect information on potential biomarkers for OA and trends in OA onset and progression.

The OAI will recruit and follow participants who have knee OA or are at high risk for developing knee OA for an eight-year period at one of four clinical centers. Blood and urine collection, magnetic resonance imaging (MRI), and X-rays will be completed at each of four annual follow-up visits. A questionnaire and physical examination at screening will assess for risk factors for the development and progression of knee OA. Levels of knee pain and physical disability will be assessed at study start and at each of the follow-up visits by questionnaire and examination.

Eligibility Criteria:
Inclusion Criteria:

Must meet one of the following criteria:

* Overweight
* Previous knee injury or surgery
* Knee pain during the past year. Participants do not need to have current knee pain to take part in the study.
* Parent or sibling who had knee replacement

Exclusion Criteria:

* Rheumatoid arthritis
* Joint replacements in both knees
* Unable to walk without assistance
* Unable to undergo MRI of the knee
Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria

Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and impact, ACTs should be deployed in HMM programmes, as well as in formal health facilities. Up to 80% of malaria cases are treated outside the formal health sector and shops are frequently visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role of shops in home management and to ensure that drugs sold are appropriate. The current practice of presumptive treatment of any febrile illness as malaria (both at health facilities and in the context of HMM) based solely on clinical symptoms without routine laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT being a more costly regimen, it is important to be more restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in remote locations lacking electricity and qualified health staff.

This study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by community-based drug distributors.The accuracy of RDTs, and the acceptability of this approach, will be evaluated in both low and high transmission areas.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 6 months and 5 years (\< 5 years)reported with fever by the mother/ caretaker of the child
* Children with uncomplicated malaria/ fever episodes
* Children whose mothers consent to participate

Exclusion Criteria:

* Children aged less 6 months or greater than 4 years (≥ 5 years)
* Children requiring referral to a health facility (severe malaria, complicated fever episode, convulsions/fits, loss of consciousness, and other danger signs)
* Children whose mothers refuse to consent
Clinical Evaluation of the Storz CMAC Laryngoscope

This study aims to evaluate the utility of a video assisted device for intubation (placement of a breathing tube) during surgery. This study specifically aims to compare a video assisted intubation with the CMAC laryngoscope to conventional devices in the setting of intubations predicted to be difficult.

Patients will be specifically screened for predictors by history and physical exam of potential airway difficulty. The role of video laryngoscopy in airways predicted to be difficult is poorly defined. This study aims to recognize if video laryngoscopy is more useful than conventional laryngoscopy as a first attempt for those with anticipated difficulty.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients presenting for elective surgery who are fasted and who have one of the following difficult airway predictors:

  * mallampati classification 3
  * mallampati classification 4
  * Reduced mouth opening (\<3cm)
  * reduced cervical motion
  * history of previous difficult intubation or multiple laryngoscopy attempts

Exclusion Criteria:

* Patients less than 18 years old, patients who are not fasted (\>6 hrs. NPO)
* Patients who have contraindications to the administration of neuromuscular blocking drugs
* Patients who have a documented history of intubation on first attempt with C-L grade 1 laryngeal view
* Patients who are deemed to difficult and dangerous to anesthetize without first securing an airway.
Impact of a Proactive Strategy of General Practitioners on CRC Screening

In this registry-based cluster randomized controlled trial, we will assess the impact of a proactive strategy of general practitioners (GP) who will systematically provide screening kits of colorectal cancer (CRC) to all patients of even age (50, 52, 54...up to 74 years) versus usual practice where the eligible population receive an invitation letter to visit the general practitioner and receive the screening kit.

Colorectal cancer is one of the leading causes of cancer and death in France in both men and women. The generalized screening rate is about 30% in France, far from the expected 65%, despite the fact that screening is free and a letter of invitation is sent to the individual's home, and despite the financial incentives provided to the practitioner. Different studies have looked for the causes of non-implementation by the individual: negligence, "dirty"; forgetfulness, and the practitioner: organizational problem, communication problem. A few intervention studies have been carried out with little success: sending the invitation to the individual's home, sending a letter of reminder, sending a letter of general information on screening to the practitioner, sending the list of patients who have not taken the test to the practitioner allows for a few percent improvement in screening. In this registry-based cluster randomized controlled trial, we will assess the impact of a proactive strategy of general practitioners who will systematically provide screening kits of colorectal cancer to all patients of even age (50, 52, 54 years...up to 74 years) versus usual practice where the eligible population receive an invitation letter to visit the general practitioner and receive the screening kit. The screening rate will be calculated for each arm at the end of the 2-year study with data from the health insurance.

Eligibility Criteria:
inclusion criteria:

- medical practices in Aquitaine region and their visiting patients eligible for colorectal cancer screening individuals aged between 50 and 74 years at intermediate risk of colorectal cancer).

Exclusion criteria:

* medical practices with less than five individual eligible for colorectal cancer screening.
* visiting patients aged less than 50 years or more than 74 years or at high or very high risk of colorectal cancer.
Effect of Metformin and Rosiglitazone Over no Diabetic With Metabolic Syndrome Patients.

To compare the effect of insulin sensitizing drugs (metformin and rosiglitazone) over glucose homeostasis (GH) in no diabetic metabolic syndrome individuals. A randomized blinded clinical trial did in patients with metabolic syndrome (n=30), without diabetes. Prior to detailed information and signature of informed consent by patients were done three treatment groups by randomized technique; a) Placebo, b) Metformin (850 mg/day), c) Rosiglitazone (4 mg/day), treatment was administered for 8 weeks. GH was measured before and after treatment using oral glucose tolerance test (OGTT), and IR-index (Homeostatic Model). Determination was performed on weight, size, body mass index, plicometry, blood pressure, fasting glucose levels, triglycerides, HDL-cholesterol and insulin.

Metabolic syndrome is a risk factor for diabetes mellitus characterized by insulin resistance, hypertension, triglyceride elevation, low levels of high-density lipoproteins, and obesity. Metformin and rosiglitazone are two insulinosensensitizers used in the treatment of diabetes. Now there is controversy over the use of insulinossensitizers in non-diabetic patients with metabolic syndrome. To compare the effect of insulin sensitizing drugs (metformin and rosiglitazone) over glucose homeostasis (GH) in no diabetic metabolic syndrome individuals. Randomized blinded clinical trial in patients with metabolic syndrome without diabetes was done, sample size (n=30). Prior to detailed information and signature of informed consent by patients was randomized forming three treatment groups, a) Placebo, b) Metformin (850 mg/day), c) Rosiglitazone (4 mg/day), treatment was administered for 8 weeks. GH was measured before and after treatment using oral glucose tolerance test (OGTT), and IR-index (Homeostatic Model). Determination was performed on weight, size, body mass index, plicometry, blood pressure, fasting glucose levels, triglycerides, HDL-cholesterol and insulin. Statistic no parametric (Kruskal Wallis, Wilcoxon, U Mann Whitney) to compare characteristics inter o intra groups was done. Exact Fisher test was used for qualitative variable, and consider significance with p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old.
* Metabolic Syndrome criteria of World Health Organization .

Exclusion Criteria:

* Diabetes Mellitus
* Allergic to Metformin,
* Allergic to rosiglitazone.
* Hepatic disease.
* Hearth disease.
Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma

Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a documented diagnosis of persistent asthma and who were currently treated with or qualified for treatment with both ICS and long-acting beta2-agonist (LABA) combination
* Patients demonstrating an increase in forced expiration volume in 1 second (FEV1) of ≥ 12% or ≥ 200 mLs within 30 minutes after administration of short-acting beta2-agonist (SABA)
* Patients with an FEV1 ≥ 50% of predicted normal

Exclusion Criteria:

* Patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD)
* Patients who had an asthma attack/exacerbation requiring hospitalization/emergency room visit or respiratory tract infection within 1 month prior to randomization
* Patients who had ever required ventilator support for respiratory failure
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Patients with concomitant pulmonary disease
* Patients with certain cardiovascular co-morbid conditions
* Patients with any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels

The aim of this study is to assess the safety and tolerability of varying dose and load regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>/= 25 to \</= 32 kg/m\^2
* fasting stable LDL-cholesterol \>/= 130 mg/dL (3.36 mmol/L) and triglycerides \< 400 mg/dL (4.55 mmol/L)
* Females not of childbearing potential

Exclusion Criteria:

* No endocrine, hematologic, renal, hepatic, metabolic, psychiatric, neurology, pulmonary or cardiovascular disease
* Subjects who test positive for hepatitis B, C or HIV
* Current diagnosis or known history of liver disease, such as acute or chronic hepatitis, liver cirrhosis, liver steatosis, or liver function abnormalities such as AST, ALT, GGT, or total bilirubin \>/= 1.5 x ULN at Screening
* A systolic blood pressure \>/= 160 mmHg or a diastolic blood pressure \>/= 95 mmHg on 2 occasions during Screening
* Concomitant medications within 14 days of dosing, except hormone replacement therapy for post-menopausal women and acetylsalicylic acid or paracetamol dosed for fewer than five consecutive days
* Subject has taken any lipid-lowering drug within 30 days or five half-lives (of the lipid-lowering drug) whichever is longer, prior to Screening
* Alcohol or drug abuse within 2 years of Screening
* Donated blood (450 mL) within the 3 months prior to Screening or suffered significant blood loss equal to a blood donor portion
* Subject smokes \> 10 cigarettes, or more than one pipe or one cigar per day