cyrilzakka/clinical-trials huggingface dataset:
Effect of Kinesio Tape Application and Stretching Exercises on Calf Cramps During Pregnancy

The aim of this study is to investigate the effect of kinesio-tape application and stretching exercise on calf muscle cramp during pregnancy

Up to 30% to 50% of pregnant women suffered from leg cramps, especially in the third trimester. Almost two-thirds of these women experience leg cramps twice per week and they can occur at any time, particularly at night.In mild and moderate cases, calf cramps may last for seconds, but in severe cases, leg cramps in pregnancy may last for minutes .In many cases calf cramps are very painful , which can affect daily activities, restrict exercise and performance, motive sleep disturbance and reduce the quality of life.Non-drug treatments are found to being effective for the treatment of muscle cramps. Non-drug treatments such as muscle stretching, physical exercise, avoidance of physical fatigue, massage, relaxation, heat therapy, weight loss, sensory nerve stimulation, ankle splints worn while sleeping, and changes to sleeping and sitting positions.This study has two groups; one recieved kinesio-tape application and stretching exercises and the second one recieved instructions about dealing with cramps with self low sustained stretch

Eligibility Criteria:
Inclusion Criteria:

* pregnant women who are suffering from calf cramps.
* Their age range from 25 to 35 years.
* Their body mass index range from 25 to 29.9 kg/m2 .

Exclusion Criteria:

* Skin abnormalities (skin malignancy in the treated area or burned).
* History of previous back surgery.
* Neuromuscular diseases like multiple sclerosis.
* Sensory disturbances.
* Evidence of previous vertebral fractures or major spinal structural abnormality, spondylolisthesis or spinal stenosis.
* Systemic disease of musculoskeletal system.
* Viscerogenic cause of back pain.
* Also, women who have eclampsia or pre-eclampsia.
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease

Magnesium exerts analgesic effects in several animal pain models and in patients affected by acute postoperative pain and chronic pain of neuropathic origin. There is no evidence that magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD).

We describe the protocol of a single-center randomized double-blind clinical trial aimed at assessing the efficacy of oral magnesium supplementation in controlling severe pain in patients with advanced PAOD.

* Adult patients admitted to our Acute Pain Service for intractable pain will be eligible if they are affected by PAOD at stages III and IV of Lèriche-Fontaine classification, and are opioid-naïve.
* Patients enrolled will be randomized to the control group, treated with standard therapy, consisting of an oral administration of oxycodone 5 mg and pregabalin 25 mg per day plus placebo (fructose 10 g) twice a day for two weeks, or to the experimental group, treated with magnesium oxide 300 mg twice a day.
* Randomization will be computer-generated, with allocation concealment obtained using opaque, sequentially numbered and sealed envelopes. Trials participants, care providers, data collectors, outcome assessors and data analysts will be blinded to treatment allocation.
* Patients will be evaluated on the day of hospital admission (day 0) and on days 2, 4, 6, 8, 12, and 14 with the following information being collected: daily oxycodone dose received; patient's perceived average and maximum pain using the Numerical Rating Scale (NRS: 0=no pain to 10=worst possible pain); pain relief using Pain Relief Scale (PRS: 0% no pain relief to 100% complete pain relief); characteristics of the pain, using the Neuropathic Pain Scale (NPS: 10 items); impact of pain on the patient's daily activities, using the Brief Pain Inventory (BPI; 9 items).
* A sample size calculation performed for the primary outcome showed that 150 patients (75 per group) are needed to achieve 90% power to detect a minimum reduction of 30% in oxycodone dosage in the experimental group, after allowing for a drop-out rate of around 20%.
* Ethical approval of the study protocol has been obtained from Comitato Etico Provinciale di Brescia, Brescia, Italy.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (18 years or above)
* PAOD at stages III and IV according to the Lèriche-Fontaine classification
* no treatment with opioids at the time of recruitment

Exclusion Criteria:

* renal failure (serum creatinine ≥ 2.0 mg/dl);
* congestive heart failure (New York Heart Association, NYHA \> 3);
* treatment with digoxin and/or calcium channel blockers;
* pre-existing neuromuscular diseases;
* chronic diarrhea;
* acute limb ischemia successfully treated with interventional angiography, Fogarty embolectomy and/or surgical revascularization.
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth

OBJECTIVES:

I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection limited to skin, eyes, and mouth.

II. Determine the neurologic outcome in these patients when treated with this regimen.

III. Evaluate the significance of a positive cerebrospinal fluid (CSF) polymerase chain reaction (PCR) result when all other CSF parameters remain normal in these patients.

IV. Correlate the time to first positive CSF PCR result in the first 12 months of life with clinical neurological assessment in these patients when treated with this regimen.

V. Determine whether the continuous administration of this drug suppresses recurrent skin lesions in these patients.

VI. Determine the safety of this regimen in these patients.

PROTOCOL OUTLINE:

This is a randomized, double blind, placebo controlled, multicenter study.

All patients undergo a lumbar puncture and then receive acyclovir IV every 8 hours on Days 1-14. On Day 12, patients may undergo a lumbar puncture (at discretion of investigator). Whole blood is obtained for herpes simplex virus PCR analysis. Upon completion of intravenous therapy, patients with a negative CSF PCR are randomized to one of two treatment arms.

Arm I: Patients receive oral acyclovir three times daily for 6 months.

Arm II: Patients receive placebo three times daily for 6 months.

In case of cutaneous recurrence during the first 12 months of the study, patients receive open label oral acyclovir (if CSF PCR is negative) or acyclovir IV (if CSF PCR is positive) for 5 days. Patients may or may not continue on study drug following this treatment.

Patients are followed at 6, 12, 24, 36, 48, and 60 months of age.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Infants diagnosed with herpes simplex virus infection limited to skin, eyes, and mouth; HSV-1 or HSV-2 isolated from cutaneous lesions, conjunctivae, or oropharynx (presence of skin lesions not required); normal CSF indices: WBC less than 22/mm3 and protein less than 115 mg/dL for term infants OR WBC less than 25/mm3 and protein less than 220 mg/dL for preterm infants; no evidence of CNS involvement by CT with contrast, MRI with gadolinium, or head ultrasound; no visceral dissemination (normal liver function tests, normal chest x-ray, etc.); negative CSF PCR result

Birth weight at least 800 grams

--Prior/Concurrent Therapy--

No concurrent nursing from a mother who is receiving acyclovir, valacyclovir, or famciclovir for longer than 120 hours or 5 days; no prior prophylactic acyclovir for risk of herpes simplex virus infection

--Patient Characteristics--

Renal: Creatinine no greater than 1.5 mg/dL

Cardiovascular: No prior grade 3 or 4 intraventricular hemorrhage

Other: No infants known to be born to HIV-positive women
The Effect of Intraoperative Goal Directed Restricted Fluid Therapy on Extravascular Lung Water

The aim of this study is to compare the use of Goal Directed fluid therapy guided by Stroke volume variation plus a restricted fluid management approach to standard fluid management in patients undergoing major abdominal operations.

Perioperative fluid management has an important impact on patient outcome. Under-resuscitation leads to hypoperfusion and over-resuscitation leads to tissue oedema. Intraoperative goal directed fluid therapy (GDT) has been reported to improve patient outcome in high risk surgical patients. GDT aims to optimize oxygen delivery through various strategies. The main three GDT strategies are:

1. Stroke volume optimization with fluids
2. Stroke volume variation (SVV) and pulse pressure variation (PPV) optimization with fluids.
3. Oxygen delivery index with fluids and inotropes Although GDT was recommended by professional societies in Europe and United Kingdom, these recommendations were recently challenged in many randomized controlled trials and meta-analysis.The effect of GDT on intraoperative fluid requirements was previously reported, however; its effect on extravascular lung water is not well studied.

Electrical cardiometry is a recent non-invasive technology for cardiac output measurement. Electrical cardiometry drive CO measurement from thoracic electrical bioimpedance. Good correlation was reported between CO measurements derived from electrical cardiometry and continuous thermodilution monitoring system.

Although many protocols for GDT have been reported in major abdominal operations, till now there is no consensus about the optimum protocol nor the optimum goals to achieve during fluid management. Major abdominal operations are characterized by major fluid shifts. Moreover, patients undergoing these operations are prone to impaired organ functions due to tissue oedema. Traditional standard care in major abdominal operations usually includes 6 ml/Kg/h balanced crystalloids (to restore insensible losses and maintenance requirements) in addition to replacement of blood losses. We hypothesize that the use of a more restricted fluid approach (2ml/Kg/h) + GDT guided by cardiometry will improve fluid management and decrease extra-vascular lung water.

The aim of this study is to compare the use of Goal Directed fluid therapy guided by Stroke volume variation plus a restricted fluid management approach to standard fluid management in patients undergoing major abdominal operations.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for major abdominal operations

Exclusion Criteria:

* Patients with arrhythmias, pulmonary hypertension or impaired cardiac contractility.
* Patients with impaired liver or kidney function.
* Patients with BMI above 40.
Hydration Monitor Validation in Elderly

The study will aim to determine normal daily variation of the individual hydration level in longitudinal study on elderly in assisted living facility and assess a range of variation of individual hydration baselines for elderly in a normal physiologically hydrated state.

The subject pool will be comprised of 100 elderly (over 65 years old), male and female subjects who are residing in assisted living center. All subjects will provide written informed consent before participation. For the day prior testing and all testing days subjects will be encouraged to follow standard hydration guidelines for older adults by consuming 1200-2400 ml/day depending upon the body weight of subjects. The application of the HM will follow specific protocol based on the prototype HM user manual for specific anatomic locations. Triplicate measurements will be made for each time-point. All subjects will also be measured for bioelectrical impedance analysis (BIA) and estimation of total body water using a leg-to-leg BIA machine. To examine within-day and between-day variability and reliability of the HM a subgroup (N=25) of the 100 initial subjects will be selected. Within-day reliability will be evaluated by taking multiple measurements (3) during the day. Between-day reliability will include measurements (same time) for three consecutive days for the subgroup of 25 subjects. BIA measures will also be included during each of the time points for both within-day and between-day.

Eligibility Criteria:
Inclusion Criteria:

* elderly ( above 65 years old)
* male and female subjects who is residing in assisted living centers

Exclusion Criteria:

* Open wounds or rashes on calf testing area
* Visibly detectable edema
* Active skin infection
* Subjects will be excluded from the study if they can't physically stand on both feet without assistance
Does Extra-fine Hydrofluoroalkane-beclomethasone Dipropionate (HFA-BDP) Suppress Small Airways Inflammation in Chronic Obstructive Pulmonary Disease (COPD)?

Chronic obstructive pulmonary disease or 'COPD' is a chronic disease, which means that it cannot be cured, but that inhalers and tablets can be used to control the symptoms. In COPD, the airways become inflamed which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in COPD.

The airways of the lung start in the windpipe and branch like the branches of a tree, getting smaller and smaller. In COPD the inflammation is deep in the lungs, out to the very small airways.

Different inhalers make the medicines into different sized particles. Most steroid inhalers used for COPD make the medicine into particles which are too big to get into the very small airways ('coarse particles'). Other inhalers make a mist, with much smaller particles ('fine particles'). These are as small as the smallest airways in the lungs.

Doctors have recently found a way to measure the inflammation in the small airways that are affected in COPD. The investigators want to find out if taking one of these 'fine-particle' steroid inhalers can treat that inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Current or ex-smokers
* \> 40 years of age with a greater than 15 pack year history of smoking
* post-bronchodilator FEV1/FVC ratio \< 0.7
* FEV1 \< 80% predicted
* CANO \> 3 ppb at screening
* Informed consent and ability to perform exhaled nitric oxide assessment

Exclusion Criteria:

* Oral steroid use or exacerbation within 6 weeks
* Greater than 2 exacerbations requiring treatment in the previous 6 months
* Requirement for domiciliary oxygen
* Pregnancy or lactation
* Known or suspected contra-indication to any of the IMP's
* Diagnosis of asthma
Energy Load in Patients With Acute Respiratory Distress Syndrome (ARDS)

The investigator would assess if there is an incremental energy load during mechanical ventilation in Acute Respiratory Distress Syndrome (ARDS) patients.

The investigator would study the inspiratory and expiratory pressure volume curve in ARDS patients and investigate if there is a correlation between the energy loss (hysteresis curve) and the severity of disease.

Eligibility Criteria:
Inclusion Criteria:

* ARDS patients

Exclusion Criteria:

* pediatric population
* Chronic Obstructive Pulmonary Disease (COPD)
* patients with hemodynamic instability
Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children

This study compares the lung clearance index (LCI) in cystic fibrosis and healthy children obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each participants will perform the test (LCI) in duplicate on each device.

Using nitrogen as the inert gas, there are currently two commercially available devices that offer the possibility to measure the LCI. However, comparison between them are lacking. The 2 MBWN2 devices are the "EasyOne Pro Lab" (ndd Medical Technologies, Zürich, Switzerland) and the "Exhalyzer D" (Eco Medics AG, Duernten, Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis diagnosis

Exclusion Criteria:

* Respiratory infection within 3 weeks
* Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia
LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration

The purpose of this study is to evaluate the efficacy of 84 successive days of topically administered LHA510 compared to vehicle in reducing the number of patients requiring intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) therapy (Lucentis®) for recurrence of active choroidal neovascularization (CNV).

On Day -1, patients will receive an IVT Lucentis® injection in the study eye, and then will be randomized to receive either topical LHA510 ophthalmic suspension or vehicle in a 1:1 ratio for 84 days. Patients with recurrence of active CNV in the study eye during the study will receive rescue IVT Lucentis® injections. Following the treatment period, subjects will return for a follow-up visit and a disposition visit. Only one eye (designated as the study eye) will be dosed with either topical LHA510 or vehicle per patient.

Eligibility Criteria:
Inclusion Criteria:

* Sign written informed consent form;
* Wet AMD;
* IVT anti-VEGF therapy for at least 6 months and a maximum of 7 years since the 3rd loading dose;
* BCVA 50 letters (approximate Snellen equivalent 20/100) or better in the study eye;
* Demonstrate ability to administer eye drops (subject or care-giver);
* CNV recently demonstrated high need for frequent anti-VEGF therapy and a sustained functional and clear anatomical response to the therapy in the study eye;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any active ocular or periocular infection or intraocular inflammation;
* Current or history of macular or retinal disease (if visually significant) other than wet AMD in the study eye;
* Current clinically significant vitreous hemorrhage or history of rhegmatogenous retinal detachment affecting the macula in the study eye;
* History of hypersensitivity to any of the study drugs or clinically relevant sensitivity to fluorescein dye or povidone iodine;
* Women of child-bearing potential;
* History of a medical condition that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study or a safe administration of investigational product;
* Other protocol-specified exclusion criteria may apply.
Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity

A cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult non-smoking population. Chronic cough has many associated complications including incontinence, muscular chest pains, blackouts and depression. Current treatment is often ineffective in these patients. To develop new medications the investigators need to understand more about the mechanisms that can lead to excessive coughing.

This study plans to compare a group of 12 healthy volunteers and 12 patients with a chronic cough. The investigators hypothesise that that chronic cough patients have a more sensitive cough reflex as a result central nervous system hyper-excitability (central sensitisation). The investigators will measure cough reflex sensitivity before and after administration of ketamine, a medication that blocks an important receptor in the central nervous system.


Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers:

* Over 18 years old
* Measurable cough reflex sensitivity
* No current or past history of chronic cough or chronic respiratory disease.
* No symptoms of gastro-oesophageal reflux disease, asthma or post-nasal drip.

Chronic Cough Patients

* Over 18 years old
* Chronic persistent cough (\> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post nasal drip and gastro-oesophageal reflux disease.
* Normal CXR
* Normal lung function
* Measurable cough reflex sensitivity

Exclusion Criteria:

* Recent Upper Respiratory Tract Infection (4 weeks)
* Pregnancy/breast feeding
* Current smokers or ex-smokers with \< 6 months abstinence or cumulative history of \> 10 packyears
* Diabetes Mellitus
* Opiate or ACE Inhibitor use.
* Any centrally acting medication which has the potential to alter cough reflex sensitivity.
* Significant and ongoing chronic respiratory, cardiovascular (in particular hypertension), gastro-intestinal, haematological (porphyria), neurological or psychiatric illness.
* Drug or alcohol abuse
* History of allergy or reaction to ketamine of other NMDA receptor antagonists.
Sleep Apnea in Type 1 Diabetes

Sleep apnea syndrome is strongly associated to type 2 diabet, partly and this is partly due to obesity. Treatment of sleep apnea may improve hypertension, cardiovascular risk and in some studies diabetes status. Few data are available for type 1 diabetes but suggest that the prevalence of sleep apnea syndrome may be high. We plan to compare the prevalence of sleep apnea syndrome assessed by polysomnography in a sample of type 1 diabetic patients and a control group matched by age, gender and body mass index. The secondary objective is to determine if the presence of an autonomic neuropathy or poorly controlled diabetes (assessed by glycosylated haemoglobin) may or not contribute to the presence of sleep apnea in the diabetic group.

Diagnostic protocol designed to evaluate if if sleep apnea syndrome is more frequent in type 1 diabetes than in general population and therefore deserves to be more systematically suspected and actively diagnosed in this patients. Sleep apnea syndrome is a heavy burden as a matter of quality of life: it is responsible for fatigue, diurnal sleepiness, cognitive impairment, poor and /or non restorative sleep, morning headaches, depressive mood...Adequate treatment provides a rapid and, most of the time, complete relief of these symptoms.

On an other hand, Sleep Apnea is and independent risk factor for cardiovascular mortality and morbidity in young and middle aged subjects, also reversed by treatment. It might be therefore important for type 1 diabetic patients who have already an increased cardiovascular risk to be properly diagnosed for sleep apnea. A systematic screening for sleep apnea is already recommended for patients with type 2 diabetes by experts.

A secondary objective is to determine if the presence of a sleep apnea syndrome in type 1 diabetic patients is associated to an autonomic neuropathy, a poor glycemic control , a poorer quality of life , a poorer quality of sleep, more severe cardiovascular consequences and biological impairment.

Eligibility Criteria:
Inclusion Criteria:

* 99 Type 1 diabetic patients

  * man or woman aged 18 to 60 years
  * diagnosed since at least a year
  * having signed a consent
  * with in a national insurance scheme
* and 46 healthy volunteers matched by age , gender and body mass index

  * man or woman aged 18 to 60 years
  * having signed a consent
  * with in a national insurance scheme

Exclusion Criteria:

for both

* sleep apnea syndrome already known
* acute respiratory or cardiovascular disease
* impairment of consciousness
* sepsis
* cirrhosis
* hypnotic, opiate or psychotropic drug treatment 2 weeks ago
* Pregnant or breast-feeding woman
* Do not speak French
* Benefiting from a legal protective measure
* diabet 1 or 2 just for volunteers people