cyrilzakka/clinical-trials huggingface dataset:
Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis

This research project consists of a prospective diagnostic study conducted on patients with clinical suspicion of rhabdomyolysis admitted to the emergency rooms of the University Hospitals of Nimes, Montpellier, Paris, Nice and Toulon Inter Army Hospital. The main objective of this study is to determine whether the plasma level of Neutrophil Gelatinase Associated Lipocalin (NGAL) may be retained as a predictor of acute renal failure (ARF) occurring within 48 hours after admission for rhabdomyolysis.

The secondary objectives of this are:

* to study plasma NGAL levels on admission to the emergency ward as a marker of morbidity and mortality by considering the following factors: duration of hospitalization, need for extracorporeal blood purification, ICU admission, death.
* to study the delay between the onset of the proposed cause of rhabdomyolysis and treatment initiation
* to study the delay between treatment initiation and the occurrence of ARF.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Patient hospitalized with Creatine Phospho-Kinase \> 1000 UI/l

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* Chronic renal insufficiency with dialysis
* The patient has an acute coronary syndrome
* Nephrotoxic medications within 72 hours prior to admission
* Need for a procedure involving the injection of iodine
* Patient in shock
* Occurrence of acute renal failure can be explained by a cause other than rhabdomyolysis.
Groups for Regaining Our Wellbeing

This study is a randomized clinical trial measuring outcomes up to 6-months post-intervention. The objective of this study is to evaluate outcomes of two different group interventions for Veterans with Chronic Multisymptom Illness (CMI). The interventions to be compared are Mindfulness-Based Stress Reduction and an adapted version of the Chronic Disease Self-Management Program (aCDSMP) for Veterans experiencing symptoms of Chronic Multi-Symptom Illness (CMI) - musculoskeletal pain, fatigue, and cognitive failures - especially those who were deployed to Gulf War I. Hypothesis One (re: Outcomes): Participants randomized to the adapted Chronic Disease Self-Management Program (aCDSMP) will derive benefit for the primary outcomes, but with smaller effects than the participants randomized to Mindfulness-Based Stress Reduction (MBSR). The investigators hypothesize that Veterans randomized to MBSR will report greater reductions in each of the three primary outcome measures (pain, fatigue, and cognitive failures) at 6-month follow-up as compared to aCDSMP. Hypothesis Two (re: Acceptability): MBSR will be an acceptable and satisfactory program for Veterans with CMI, as measured by attendance rates, a self-report measure of satisfaction, and qualitative interviews. The investigators hypothesize that Veterans with CMI randomized to MBSR will report greater satisfaction with care than their peers randomized to aCDSMP.

The investigators will enroll 308 participants. Half of these will be Gulf War Veterans who meet criteria for CMI, and the other half will be Veterans from other periods of service who also meet criteria for CMI. Each participant will be randomized to either participate in MBSR or aCDSMP (stratified by Gulf War deployment status so there are \~7-8 Gulf War Veterans in each group for every cohort). Measures to collect primary outcome data (pain, fatigue, cognitive failures, patient satisfaction), secondary outcomes, and potential mediators will be administered at four assessments: (1) Baseline; (2) Post-Intervention; (3) at 3-months after the group ended; and (4) at 6-months after the group ended. Sample demographic data (age, gender, race, income, education, etc.) will be collected at baseline only. All study procedures will take place at VA Puget Sound Health Care System in Seattle, WA.

Eligibility Criteria:
Inclusion Criteria:

* Self-report all the criteria for Chronic Multi-Symptom Illness
* Fluent in English and able to provide informed consent

Exclusion Criteria:

* Currently drinking with past-year history of alcohol-related seizures or delirium tremens
* Current DMS-V substance use disorder other than cannabis or nicotine
* Moderate or high risk of suicide as assessed with MINI
* Current psychotic disorder
* Current manic episode
* Diagnosis of borderline personality disorder or antisocial personality disorder
* Inpatient admittance for psychiatric reasons in the past month
* Prior participation in MBSR or CDSMP (attended at least one session)
Divided Dose of TRAVATAN®

The purpose of this study is to compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).


Eligibility Criteria:
Inclusion Criteria:

* Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria:

  1. Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1;
  2. Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day 1.
* Must sign an informed consent form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential who are pregnant, test positive on urine pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast-feeding, or are not using highly effective birth control measures.
* Current or history of ocular inflammation or infection in either eye within the past 3 months.
* Corneal thickness greater than 620 µm as determined by pachymetry in either eye.
* Severe visual field loss.
* Cup to disc ratio greater than 0.8 in either eye.
* Intraocular surgery within the past 6 months in either eye.
* Other protocol-defined exclusion criteria may apply.
Spinal Anesthesia Versus Combined Sciatic-femoral Nerve Block for Outpatient Knee Arthroscopy

The aim of the study is to compare the time of home discharge in day-case patients receiving either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy

Two groups: the first receive a spinal anesthesia injecting 2% hyperbaric prilocaine 40 mg with the patients in lateral decubitus and the surgical limb declive, the second a combined ultrasound-guided sciatic-femoral nerve block injecting 25 ml of 2% mepivacaine solution.

Onset time, performance time, duration of the block, time of voiding, as well as the time of home discharge will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* outpatients knee arthroscopy

Exclusion Criteria:

* diabetes
* allergy to local anesthetic
* patient refusal
* chronic opiods assumption
Development of an Urticaria Control Test

The aim of the project is to develop a patient reported outcome instrument to assess disease control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.


Eligibility Criteria:
Inclusion Criteria:

all patients suffering from chronic forms of urticaria are eligible
Electromyography in Patients on Chronic Pyridostigmine Therapy

We intend to measure evoked EMG at two sites in subjects who are chronically taking pyridostigmine.

The investigators are intending to enroll Patients who are chronically treated with pyridostigmine for the treatment of any medical condition and presenting at the investigators' outpatient clinics for follow up appointment. Subjects taking pyridostigmine for the treatment of myasthenia gravis will be excluded. Both adults and children older than 12 years of age will be approached. Those subjects that agree to participate will be asked to sign an informed consent. For the participation of minors a parental (or guardian) consent and subject assent will be obtained. Those that participate will answer a few questions pertaining to their medical history and will then undergo electromyograph (CMAP) measurement with repetitive stimulation at 2 sites (ulnar nerve at the wrist and the accessory nerve in the neck). Evoked electromyogram will be recorded on a computer hard drive. Eight percent or greater decrement in the CMAP response on repetitive stimulation will be considered positive.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been taking pyridostigmine for the treatment of any condition other than myasthenia gravis

Exclusion Criteria

* Subjects taking pyridostigmine for the treatment of myasthenia gravis will be excluded.
Early Mobilization of Knee Joint After ACL Surgery. Continuous Passive Motion Versus Manual Passive Mobilization

Anterior Cruciate Ligament (ACL) injuries by trauma are a prevalent pathology. In the USA, about 200.000 injuries are estimated per year, half of which implicate a total rupture of the ligament. Data indicates that the number of ACL injuries is increasing in young athletes and presents a common problem, especially people playing agility sports.

One of the most widely used methods for the post-surgical mobilization after ACL is the use of Continuous Passive Motion (CPM) devices. These machines are meant to drain residual fluid from the articulation and maintain the mobility of the joint and muscles in the knee. Even though studies show that, an early mobilization after surgery is beneficial to the rehabilitation of the knee joint, recent studies are questioning the efficiency of the CPM when compared with the goal of application. While literature suggests that efficacy of CPM are related with the magnitude of knee flexion and the Range of Motion (ROM) achieved some studies show that the range of motion measured by the CPM is considerably less than the actual ROM.

As other therapy that provides an effective mobilization of the knee joint, the Specific Manual Physical Therapy method (Kaltenborn method) takes in account the physiological combination of rotation and gliding of the two joint surfaces. This technique mobilizes the femorotibial joint by controlling the tibial plateau anteroposterior during flexion and posteroanterior during extension of the knee. Therefore, in the past 30 years there are not studies comparing ROM measurements obtained with CPM and manual physical therapy methods.

It is hypothesized that the benefits of the early passive mobilization after ACL reconstructive surgery are diminished by the limited efficacy of currently used CPM devices. The aim of our study was to determine the range of motion achieved with the passive mobilization using a CPM device compared with a manual method (Kaltenborn method) and to assess that ROM measurements provided by the CPM correlates the real ROM.


Eligibility Criteria:
Inclusion Criteria:

* Rupture of Anterior cruciate ligament
* Ligamentoplasty with partial meniscectomy when necessary using arthroscopy technique

Exclusion Criteria:

* Patients operated after three weeks post-injury because of greater risk of arthrofibrosis
* Patients who had medical complications during surgery
* Patients unable to understand the study protocol and those unwilling to give informed consent
Radiological Evaluation of Sarcopenia in Patient Received Chemotherapy

Radiological evaluation of sarcopenia in patients receiving chemotherapy

Evaluation of muscle mass by using sonoelastography and computed tomography

Eligibility Criteria:
Inclusion Criteria:

* all cancer patients receiving chemotherapy referred to radiodiagnosis department for routine examination Patients must be between 18 and

Exclusion Criteria:

* Previous or current history of any musculoskeletal or neurological disorder including strokes.
* Systemic atrophy affecting CNS ( Huntington disease ,hereditary ataxia ,spinal muscular disorder and related syndromes ,post polio syndrome )
* Central nervous system demyelinating disease ( Multiple sclerosis , acute disseminated demyelinated syndromes..
* Corticosteroids undertaken currently or for the past 3 years with doses \>5mg/day.
Reliability of the 4 Metre Gait Speed in Idiopathic Pulmonary Fibrosis

This study is investigating the reliability of the 4 metre gait speed test (4MGS) in patients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF).

This observational study is investigating a simple test of walking speed, measured using the 4 metre gait speed test (4MGS), in patients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). Drug development for this disease is slow in part because there is a lack of reliable measurements that can assess effectiveness of treatment. Slow walking speed has been shown to relate to poor outcomes in older adults and people with another lung disease called Chronic Obstructive Pulmonary Disease (COPD. The investigators are interested to see whether usual walking speed is a reliable measure in patients with IPF as this will help inform us of its potential use as an outcome measure. To do this, participants who consent to taking part in the study will be timed walking at their usual walking speed over a distance of 4 metres (13.12 feet). Participants will be asked to do this twice with a rest in between if required. One week later, participants will be asked to repeat the walking tests again.

Eligibility Criteria:
Inclusion Criteria:

* IPF diagnosis according to NICE guidelines
* Provision of informed consent

Exclusion Criteria:

* Significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation)
* Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease)
* Any condition that precludes providing informed consent e.g. cognitive impairment or poor English
White Fish for Cardiovascular Risk Factors in Patients With Metabolic Syndrome: the WISH-CARE Study

The investigators performed this study to evaluate the efficacy of regular ingestion of white fish to reduce cardiovascular risk factors in patients with the metabolic syndrome, compared to a diet with no fish or seafood at all.

This study was designed as a randomized cross-over multicenter clinical trial with participating centers from the CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn), coordinated by the Hospital Universitario Ramón y Cajal, Madrid. The investigators included adult patients with the metabolic syndrome as defined by the Third Report of the National Cholesterol Education Program, Adult Treatment Panel III. All the subjects were Caucasian from European ancestry. Patients were randomized after the screening visit to one of two sequences: 1) Sequence 1 to receive fish consumption first and then no fish. The individuals randomized to this arm continued with their previous alimentary habits, avoiding any significant nutritional imbalance, and with an ingestion of 7 serves of hake (each serve consisted of 100g of frozen Namibia hake, Pescanova S.A., Pontevedra, Spain) per week for a period of 8 weeks. Afterwards they continued for another 8 weeks with the same diet except for the avoidance of fish and any other seafood; 2) Sequence 2 for which they started with their previous alimentary habits, avoiding any significant nutritional imbalance, as well as any fish or seafood for the first 8 weeks. Afterwards they were changed to the same diet but with 7 serves of hake per week.

Eligibility Criteria:
Inclusion Criteria:

* We included adult patients with the metabolic syndrome as defined by the Third Report of the National Cholesterol Education Program, Adult Treatment Panel III.

Exclusion Criteria:

* Fish allergy and positive antibodies to Anisakis spp.
* Morbid obesity with BMI ≥40kg/m2.
* Chronic renal failure.
* Chronic psychopathy.
* Neoplasia.
* Refusal to participate in the study.
Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.

This is a prospective observational study to characterize longitudinal BMD of premenopausal women with uterine fibroids or endometriosis over the 52-week observational period.

Approximately 660 participants will be recruited into two cohorts: (1) premenopausal women with uterine fibroids confirmed by an ultrasound (approximately 260 participants), and (2) premenopausal women with endometriosis diagnosed or confirmed by surgical or direct visualization, or histopathology within 10 years of the Screening visit (approximately 400 participants).

Since age is a strong risk factor for BMD change over time, participants in this observational study will be matched by age category (18 to 24, 25 to 34, 35 to 44, and ≥45 years old), with participants enrolled in the interventional studies of relugolix.

During the Screening/Baseline period, the participant should be assessed for eligibility, and baseline dual-energy X-ray absorptiometry (DXA) scan will be obtained. Bone densitometry (lumbar spine \[L1-L4\], total hip, and femoral neck) will be obtained and submitted for central reading at Baseline, Week 24, and Week 52.

Information related to health care utilization for uterine fibroids or endometriosis and concomitant medications will be collected at every visit and during the phone calls at Week 12 and Week 36.

Collection of adverse events in this study will be limited to protocol-specified procedure-related adverse events. Reports of pregnancy will also be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Is a premenopausal female 18 to 50 years old
2. By the participant's report, had two consecutive regular menstrual cycles immediately prior to enrollment in the study. Participants with hormonal intrauterine devices or on other hormonal contraception methods that disrupt cyclic bleeding are not required to have two consecutive regular menstrual cycles.
3. Has one of the following conditions:

   1. Diagnosis of uterine fibroids that is confirmed by an ultrasound within 5 years prior to screening.
   2. Diagnosis of endometriosis confirmed by surgical or direct visualization and/or histopathologic confirmation.
4. Has not and is not expected to undergo a surgical procedure with bilateral oophorectomy within the 12 months following enrollment.

   Exclusion Criteria:
5. Has a weight that exceeds the weight limit of the dual-energy X-ray absorptiometry scanner
6. Has a baseline BMD z-score \< -2.0 at spine, total hip, or femoral neck
7. Has a history of or currently has osteoporosis, or other metabolic bone disease
8. Use within the past 3 months prior to Screening or anticipated use of systemic glucocorticoids
9. Is currently pregnant or lactating, or intends to become pregnant during the study period
The Effect of Prophylactic Pre Operative Probiotic Therapy on Endotoxin Levels in Cardiac Surgery Patients

The primary hypothesis for the study is that pre-operative prophylactic probiotic Lactobacilli tablets will reduce the severity and incidence of endotoxin rise in post cardiopulmonary bypass in cardiac surgery patients.

Endotoxins are large heat stable lipopolysaccharides, which are found in the cell wall of gram negative bacteria. It has been assumed that the intestinal bacteria are the primary source of the plasma endotoxin in cardiac surgery patients.Lactobacilli have been reported as effective in counteracting gram negative bacteria in the gut.Thus Lactobacilli may be effective in reducing the endotoxin rise associated with cardiopulmonary bypass, which may potentially reduce the incidence of the syndrome of generalised inflammation and low systemic vascular resistance post cardiopulmonary bypass.

The study compare endotoxin levels of post operative cardiac surgery patients who have received pre operative prophylactic probiotic Lactobacillus tablets. Compared to patients who have received a placebo.

Two different lactobacillus strains will be assessed in the study: Lactobacillus Acidophilus and Lactobacillus Fermentum. There are 4 treatment groups in this study. Lactobacillus Acidophilus,Lactobacillus Fermentum, Lactobacillus Fermentum and Lactobacillus Acidophilus and Placebo.

The probiotic/placebo will be given to the patient 2 a dy for between 2-7 days preoperatively. Participation in this study requires 6 separate blood tests commencing at the start of surgery and continuing for 24 hours immediately post operatively.A total of 30 mls of blood is required.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for cardiac surgery requiring cardiopulmonary bypass will be approached for consent to participate in the study.

Exclusion Criteria:

* Age greater than or equal to 18 years
* Current usage of a probiotic product
* Past history of asthma or recurrent urticaria, pregnancy, HIV infection, immunosuppression and pre existing intestinal disorder.

The Lactobacillus acidophilus preparation to be used in this study contains a very small amount of MSG (total dose 20mg/day, equivalent to 10% of the total dose used to test MSG sensitivity) and as a precaution patients with asthma or recurrent urticaria will be excluded. As the Lactobacillus preparation contains live micro organisms, immunosuppressed and pregnant patients will be excluded.
Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease

The aim of this study is to investigate the effect of genistein administration on coronary arteries in humans. We will measure the size of a coronary artery and the speed and amount of blood flow in response after subjects have ingested Supro® drinks (a soy protein drink containing genistein).


Eligibility Criteria:
Inclusion Criteria:

* Aged 30-75 years
* Patients requiring diagnostic coronary angiography
* Presence of coronary artery disease on angiogram but with at least one non-obstructed (lesions \<70% narrowed compared with the adjacent normal part of the vessel) atheromatous vessel (confirmed at diagnostic cardiac catheterisation)
* Female patients must be postmenopausal (FSH\>40 IU/L)
* Willing to give informed, written consent

Exclusion Criteria:

* Age \<30 or \>75 years
* Allergy to radiographic contrast media
* Sino-atrial disease or significant bradycardia
* Concomitant medication with persantin (dipyridamole) or theophyllines
* Asthma
* Hypertension
* Left ventricular hypertrophy or dysfunction (clinical/ECG/echo/CXR)
* Female patients with FSH\<40 IU/L (postmenopausal)
* Female patients currently taking hormone therapy, or who have taken hormone therapy in previous 6 months
* Unwilling to give written informed consent
* Participation in another study within previous 60 days