cyrilzakka/clinical-trials huggingface dataset:
Effect of Progressive Early Mobilization in Patients With TBI

traumatic brain injury (TBI) is a major public health concern worldwide. Patients with moderate-severe TBI have high rates of disability at the acute phase and frequently require protracted rehabilitation with prolonged periods of recovery. Recently, it has been found that the use of progressive early mobilization (EM) protocols for critical trauma patients may minimize the functional declines during intensive care unit (ICU) stays. However, prior early mobilization studies have found that the survivors of moderate-severe TBI often experience a greater incidence of neurological injuries with other organ injury than other critical care patients. No randomized controlled trials thus far have utilized measure the influence or effect of early progressive EM protocols on the functional recovery of moderate-severe TBI patients.

Objective: The goals of this proposed research study are (1) to investigate the feasibility of using a structured progressive EM protocol for patients with moderate-severe TBI in a trauma ICU and (2) The goal is to investigate and compare the intervention effects of a progressive EM protocol (aimed at bringing patients at least to the mobility level-3 of sitting on the edge of bed) in an ICU on short-term and long-term functional abilities in patients with moderate-severe TBI.

Eligibility Criteria:
Inclusion Criteria:

* Expected to stay for at least 72 hours in the ICU,
* \>20 years of age with living independently before the onset of critical illness
* relatively stable vital signs with a Glasgow Coma Scale (GCS) score of ≥6
* relatively stable respiratory status (SpO2 \>92%, high mechanical ventilator setting: FiO2 ≤60%, and positive end-expiratory pressure ≤10 cmH2O)
* stable cardiovascular system (resting heart rate ≤130 bpm or no use of high-dose vasopressor of more than 0.2 μg kg-1 min-1)

Exclusion Criteria:

* predicted mortality within the next 24 hours
* palliative care
* consistent increase of intracranial pressure (\>20 mmHg)
* pregnancy
* uncontrolled seizure
* active bleeding
* ruptured or leaking aortic aneurysm
* development of acute myocardial infarction during ICU stay
* rapid development of degenerative neuromuscular diseases
* contraindication for early walking
Pharmacokinetics of Micafungin in Patients Intensive Care Unit

In this trial, our goal is to determine the pharmacokinetics of micafungin in a non-selected cohort of patients with suspected or proven invasive fungal infections. Patients will receive micafungin for the period necessary to achieve clinical and / or mycological cure. An attempt will be made to have 2 PK curves, one full and one limited sampling on days 3 (n=9) and 7 (n=5). Furthermore, we will be able to determine intra-individual variability. On non-PK days, trough samples will be taken to determine the time to steady state. All samples will be taken just prior to the morning dose of micafungin. All infusion rates will be according to the SPC label information. Patients are considered to be evaluable if at least the first PK curve has been completed. Two moments of PK analysis will enable us to determine whether there is an increase over time in exposure if steady state has not been reached.

Whilst micafungin (Mycamine®) has much to offer, little is known about its pharmacokinetic profile in ICU patients with specific co-morbidities such as obesity, hypoalbumenia, and severe liverfunction disturbances. Also, ICU patients are known to experience changes in pharmacokinetics (PK) due to changes in hemodynamics, extracorporeal elimination techniques, interacting comedication, etc. Based on criteria outlined below, micafungin may prove to be the drug of choice in this cohort of patients. Therefore it seems prudent to conduct a trial in a cohort of patients who receive micafungin but with co-variates that may be of influence to the pharmacokinetic profile. To build a valid pharmacokinetic model, all patients on micafungin will be included in the analysis and used for model building. Co-variates that will be explored are at least: obesitas, liverfunction, albumin, creatinin-clearance. Simulations will be performed to determine if adequate exposure is reached under different patho-physiological conditions.

In conclusion: this trial is on determining the PK of micafungin in a non-selected cohort of patients with suspected or proven invasive fungal infections. Most important covariates will be modelled using advanced mathematical techniques. Micafungin may prove to be beneficial over the other two echinocandins in terms of limited factors that impact PK. This has to be proven in a prospective trial.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is admitted to an ICU
2. Subject is at least 18 years of age on the day of the first dosing
3. If subject is female: neither pregnant nor able to become pregnant and is not nursing an infant
4. Subject has been treated with micafungin for a maximum of two days before enrolment in this trial
5. Is managed with a central venous catheter or an arterial catheter

Exclusion Criteria:

1. Is known to be hypersensitive to echinocandin antifungal agents
2. Documented history of sensitivity to excipients similar to those found in the micafungin preparation
3. Known of positive HIV test or positive hepatitis B or C test in history
4. History of or current abuse of drugs, alcohol or solvents
5. Has previously participated in this trial
Can You Reduce Problematic Smartphone Use Through a Group Intervention: A Single Case Experimental Design

This study will develop and conduct an initial, single-case, mixed-methods evaluation of a brief group intervention for mild and moderate problematic phone use.


Eligibility Criteria:
Inclusion Criteria:

-Self-identifies as struggling with problematic smart phone use

Exclusion Criteria:

* Actively experiencing suicidal or self-injurious thoughts, or have experienced these within the past year
* Already in a psychological therapy/intervention
* Planning a change of psychotropic medication during the research project.
* No access to video calling and/or slow internet connection speed
* A mental health condition that is not currently well managed/stable and therefore other interventions are likely to be more appropriate
* Does not own a smartphone that can record screen time
* Is not living in the UK, with access to services within the UK
The Development of Allergic Rhinitis in Children Previously Diagnosed as Nonallergic Rhinitis

The purpose of this study is to evaluate development of allergic rhinitis in children with nonallergic rhinitis.

Rhinitis is a common condition associated with significant effects on quality of life. Rhinitis may be divided into two groups, those with concurrent allergy (allergic rhinitis, AR) and those without allergy but who still suffer from nasal symptoms (nonallergic rhinitis, NAR).

Evidence indicated that adult with NAR can have de novo sensitization to aeroallergen (24%), suggesting that patients with NAR might evolve to AR. Thus the purpose of this study is to evaluate development of allergic rhinitis in children with nonallergic rhinitis.

Eligibility Criteria:
Inclusion Criteria:

* Children between the age of 1 year and 15 years with the diagnosis of nonallergic rhinitis who are attending the pediatric allergy clinic during Jan 2005 - Dec 2007.

Exclusion Criteria:

* Patients who have allergic rhinitis and underlying disease eg.chronic renal disease, liver disease, heart disease, cancer.
Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment

The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* Adequately diagnosed and treated Stage I-IIIa early breast cancer
* Oestrogen receptor and/or progesterone receptor positive breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Hormone replacement therapy (HRT) must be discontinued at least 2 weeks prior to registration
* Any prior tamoxifen taken for a total of 8 weeks or less
* Any prior anastrozole taken for a total of 4 weeks or less
* Anastrozole is clinically indicated to be the best adjuvant strategy
* Signed written informed consent

Exclusion Criteria:

* Clinical or radiological evidence of distant spread of disease
* Prior treatment with bisphosphonates within the past 12 months
* Prior treatment with continuous systemic corticosteroids within the past 12 months
* Prior use of parathyroid hormone for more than 1 week
* Prior use of systemic sodium fluoride for \> 3 months during the past 2 years
* Currently treated with any drugs known to affect the skeleton
* Abnormal renal function (serum creatinine greater than or equal to 265.2 mmol/L)
* History of diseases with influence on bone metabolism. Patients with lactose intolerance are also excluded
* Delayed oesophageal emptying such as stricture or achalasia
* Hypersensitivity to alendronate or anastrozole
* Previous or concomitant malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
* AST/SGOT and/or ALT/SGPT \> 3 x ULN in combination with other laboratory and clinical abnormalities indicating liver insufficiency
* Fracture due to minimal trauma, demonstrated radiologically
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Olanzapine Orally Disintegrating 5mg Tablets Under Fasting Condition

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets (Reference formulation; Eli Lilly and Company, USA). Dosing periods were separated by a washout period during fasted study.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

* Sex: male.
* Age: 18 - 45 years.
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Biomechanical Changes During Menstrual Cycle

The aim of the work is to assess the effect of the menstrual cycle on the biomechanical properties of the muscles. The study will be conducted among young women aged 20-25 with a regular menstrual cycle. During the test, muscle strength and muscle flexibility as well as activation times will be performed. The study will assess the effect of the stretching of the hamstring muscles on the biomechanical properties of the muscles in the different phases of the menstrual cycle.


Eligibility Criteria:
Inclusion Criteria:

* Regular menstrual cycle lasting 28 days (+/- 5 days)
* A menstrual cycle that has been present for at least 2 years
* No hormonal contraception
* Lack of pain in the lower spine
* No restriction of mobility in the hip joint

Exclusion Criteria:

* Irregular menstrual cycle
* BMI value below 18.5 and above 25
* Orthopedic disorders in the lower limb
* Neurological disorders
* Normal flexibility of the hamstring muscles
Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia

Study the role of oxidative stress in methotrexate induced hepatic damage, and the possible protective effect of OMEGA-3 fatty acids against methotrexate hepatotoxicity using clinical and biochemical parameters.

The patients were divided into two groups :Group I: control group, included pediatric patients with standard risk acute lymphoblastic leukemia in maintenance phase day 0 and receiving oral Methotrexate (20 mg / m2) weekly without any supplementation .

Group II: study group, included standard risk ALL pediatric patients who were supplemented with oral omega-3 capsule (one capsule / day) .

Omega-3 was supplied as soft gelatin capsules in a dose of 1000 mg of omega-3 fatty acids/day . This is in addition to chemotherapy from day one of maintenance phase receiving oral Methotrexate (20 mg / m2) Weight -adjusted doses on days 8, 15, 22, 29,36,43,50,57,64,71and 78).

Both groups were followed up for six months . All patients were under free diet and were maintained on standard diet throughout the study ( 6 months). None of them were on regular vitamin supplementation before diagnosis or at time of chemotherapy administration.

Patients follow up:

The patients were followed up every three week for the whole study period for assessing the effect and compliance to both MTX and Omega-3 fatty acid and for monitoring any potential adverse effect.

Group I were asked on each visit about signs of hepatic toxicity ( fatigue , weakness , loss of appetite , vague abdominal pain , color of urine and sclera and jaundice ), their laboratory results were revised to know level of ALT as a marker of liver injury .

Group II were asked on each visit about signs of hepatotoxicity , their laboratory data were revised , any side effects resulted from use Omega-3 fatty acids:

(increased bleeding tendency, fishy smell , nausea , diarrhea , or if there is any relapses occurred , and to be sure that the patients were compliant to prescribed medication.

Investigations:

Blood samples were collected from every patient at day 0 of maintenance and after six months for estimation of Malondialdehyde (MDA), Total antioxidant capacity (TAC), super oxide dismutase ,liver function tests and uric acids . Blood was collected into heparinised tubes which were protected from light and processed immediately after sampling. At the time of collecting the blood samples, patients were free of any potentially confounding or interfering conditions, such as infections or fever.

Eligibility Criteria:
Inclusion Criteria:

* Child age: less than 17 years old.
* Taking oral methotrexate in maintenance therapy.
* Patients are at cycle one day zero.

Exclusion Criteria:

* Child infected by hepatitis B or C viruses.
* Child taking medications or having a condition causing elevation in liver enzymes level other than methotrexate.(eg:thrombosis ,antibiotic therapy, infiltrating malignancy ,auto immune manifestations or having TPN)
* Child remission.
* Child death
* Child drop out due to non compliance
Assessment and Prevention of Acute Post-herniotomy Pain

The aim of the study is the assessment and management of Acute Post-herniotomy Pain using two different therapeutical protocols per os: ketorolac versus association of acetaminophene+tramadol.

Persistent post-herniotomy pain (PPP) affects everyday activities in 5-10% of patients. Even brief intervals of acute pain can induce long-term neuronal remodeling and sensitization, chronic pain and lasting psychological distress. Chronic pain may be caused by intense acute PPP, intraoperative nerve injury and/or ongoing inflammation or mesh response with subsequence damage to nerve structures. The aim of our study is to analyze analgesic efficacy, safety and prevention of persistent postsurgical pain of two different pharmacological strategies.

Eligibility Criteria:
Inclusion Criteria:

* Males and females over 18 years, under 80 years, scheduled for elective herniotomy
* Classification American Society of Anesthesiologists (ASA) I: without systemic disease
* Classification ASA II or III (mild systemic disease or severe systemic disease that limits the activity without invalidity).
* Patients with hernia typ 2, 3a, 3b (classification NYHUS (1993))
* Signed informed consent

Exclusion Criteria:

* ASA III, IV
* Emergency surgery
* Recovery in intensive care unit after surgery
* habitual opioid consumption
* NSADs allergy
* cognitive or mental alterations
* coagulopathy
* piastrinemia \< 100.000/mm3
The Basel CardioInsightTM - 3D Mapping Study

This study is to describe the exact location of NOAF-maintaining foci and rotors after cardiac surgery identified by mapping using the non-invasive phase mapping with CardioInsightTM - 3D Mapping technology (CardioInsightTM, Medtronic Switzerland, Tolochenaz, Switzerland) and a low-dose computed tomography scan of the chest.

Atrial fibrillation (AF) is the most commonly oberserved postoperative complication after cardiac surgery. New-onset atrial fibrillation (NOAF) leads to prolonged intensive care unit (ICU) and hospital length of stay, increased early mortality and stroke along with higher treatment costs.

The exact location of structures triggering or maintaining NOAF is unknown. Identifying the exact location of NOAF- maintaining foci and rotors could allow development of preventive treatment strategies like preoperative ablation or perioperative ablation of high-risk foci. Non-invasive phase mapping with CardioInsightTM (CIT) - 3D Mapping technology (CardioInsightTM, Medtronic Switzerland, Tolochenaz, Switzerland) allows non-invasive description of AF foci and rotors with a 252-electrode vest applied to the patient's torso due to detailed mapping of NOAF-maintaining structures without invasive electrophysiological examination.

This study is to describe the exact location of NOAF-maintaining foci and rotors after cardiac surgery identified by mapping using the non-invasive phase mapping with CardioInsightTM - 3D Mapping technology (CardioInsightTM, Medtronic Switzerland, Tolochenaz, Switzerland) and a low-dose computed tomography scan of the chest.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery
* Signed informed consent by patient or next of kin

Mapping inclusion criteria

* NOAF within the first seven postoperative days (168 hours) after cardiac surgery developing on the cardiac surgery ward, intermediate care unit or the intensive care unit of the University Hospital Basel. ICU admission will be set as starting point for observation time.

General Exclusion Criteria:

Preoperative conditions:

* History of previous left atrial ablation
* History of cardioembolic stroke
* History of amiodarone treatment within three months
* Any documented history of atrial fibrillation/atrial flutter before surgery
* Left ventricular ejection fraction \<40%
* Patient included into other study with radiation exposure

Perioperative conditions

* Perioperative mechanical circulatory support (e.g., intraaortic balloon pump; extracorporeal membrane oxygenation; left ventricular assist device (e.g. Impella, Abiomed Inc., Aachen, Germany)

Mapping exclusion criteria

* Heart rate ≥ 50 bpm AND contraindication to adenosine.

Contraindications to adenosine:

* Allergy/intolerance to adenosine
* History of chronic obstructive pulmonary disease (COPD Gold IV)(28)
* History of asthma
* History of Long-QT syndrome
* Hemodynamically unstable patients (margin of discretion of the attending physician)
To Study the Effect of SC-FOS Prebiotics in Women With Polycystic Ovary Syndrome

The purpose of this study is to determine if there is a difference in the clinical characteristics of patients with polycystic ovary syndrome after the administration of SC-FOS in the enteral diet compared to patients with a standard diet.

The protocol will be discussed with the patients and/or relatives of the patients, who will understand the consequences and advantages of the study and will thus sign the consent.

Once informed consent has been obtained, the group to which each patient belongs will be randomly assigned.

Patients will be selected according to the inclusion and exclusion criteria of the population diagnosed with PCOS with useful enteral route for random assignment into two groups, one will be administered short-chain Fructooligosaccharides at a dose of 12 g every 24 hours, another group will be given saline as a placebo to the enteral diet every 24 hours for 10 days. Patients should take the solution on an empty stomach.

Once the type of intervention has been determined, the patient will be given the suspensions corresponding to group 1 or placebo, with vials in which the content cannot be visualized, numbered according to the sheet obtained by the corresponding randomization. The initial evaluation will be completed with all the clinical characteristics to be evaluated.

The patient will be told that every 24 hours he must take 1 suspension on an empty stomach, which will be prepared at a rate of 12 grams of SC-FOS in 15 cc of saline solution for the prebiotic preparation vs 15 cc of saline solution for the placebo group. The solution will be administered enterally for 10 consecutive days at a single dose per day, and a reassessment will be made on the seventh day of the clinical characteristics of the patients, to compare and evaluate the results.

Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Age 18 to 65 years
* Polycystic Ovary Syndrome diagnosed by specialist
* Useful enteral feeding

Exclusion Criteria:

* Pregnancy
* Diabetes mellitus
* Risk of intestinal perforation