cyrilzakka/clinical-trials huggingface dataset:
Querying Stroke Unit Nursing Interventions in the Emergency Department

The aim of the study is to monitor if specialized stroke nurses as team partners in the ED can reduce hospital acquired infections. The study is designed as pre- post-intervention study in which specialized SU nurses partner with ED nursing staff to asses and screen stroke admissions in the ED.

An intervention study comprised of 1) a primary registry database component and 2) a secondary questionnaire based quantitative evaluation . The intervention study includes a 3-month baseline observational period followed by a 7-month baseline data collection period, a 2-month intervention implementation phase, and a 3-month intervention observational period followed by 7-month intervention data collection period.

An intervention, where dedicated stroke nurses handle acute care of stroke and TIA patient in the ED prior to admission to a dedicated stroke unit will take place in the timeframe of 11-19:00 hrs, 7 days a week. Notably, the intervention is set to be integrated into clinical practice on a permanent basis after end of study.

Data for all stroke patients admitted to the ED at HGH are collected during the 3-month baseline and intervention observational periods. Fulfilment of Danish Stroke Quality Program (DAP) quality indicators is monitored as follows - use of dysphagia screen (GUSS), mobilization within day of ED admission and transfer to SU. Additional nursing interventions monitored in the ED are: Use of nasogastric catheter, use of bladder scan and intermittent catheterization, frequency of temperature monitoring and use of anti-pyretics, acute phase monitoring of blood-pressure every 2 hours, use of Scandinavian Stroke Scale (SSS) score.

Outcomes are monitored in hospital and at visits to the out patient clinic, as well as by registry.

Eligibility Criteria:
Inclusion Criteria:

* patients referred to the ED at Herlev Hospital with a diagnosis of stroke or TIA from 11 Am to 7 PM
* patients fulfilling one of the following ICD-10 codes at discharge: ICH: I61, cerebral infarction; I63, unspecified: I64, TIA: G45 and a scheduled follow-up appointment at the outpatient clinic Herlev Hospital

Exclusion criteria:

* Patients transferred from other hospitals or stroke units
* Patients elegible for thrombolysis or thrombectomy at time of admission
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy

The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have focal epilepsy diagnosed on clinical grounds and as applicable supported by electroencephalogram findings \[Scheffer 2017\] and brain imaging. Participants with multifocal epilepsy may be included if all other entry criteria are met.
* Must have a drug-resistant epilepsy defined as failure of adequate trials of 2 (or more) tolerated and appropriately chosen and used AEDs (whether as monotherapies or in combination) \[Kwan 2010\].
* Experiences 6 or more seizures during the 6-week prospective baseline period and is not seizure free for more than 21 consecutive days during the prospective baseline period

Key Exclusion Criteria:

* Focal aware seizures without motor signs are the only seizure type.
* Diagnosis of generalized, combined generalized and focal, or unknown epilepsy
* Known progressive structural CNS lesion.
* History of seizures occurring in predominantly clustered patterns, as determined by the Investigator, over the 12 months prior to the Screening Visit (Week -6) or during the 6-week prospective baseline period, where individual seizures cannot be counted.
* History of status epilepticus within the previous 6 months.
* Known history or presence of non-epileptic seizures.

NOTE; Other protocol defined Inclusion/Exclusion criteria may apply
Comparison of Device Based Inspiratory Muscle Training and Thera-band Resistive Training in Healthy Adults

This study aims to evaluate the impact of inspiratory muscle training and Thera-band resistive training on pulmonary function and diaphragmatic strength of healthy adults. This trail investigate whether IMT can improve pulmonary function and diaphragmatic strength of healthy adults as well as overall respiratory health.

Inspiratory Muscle Training(IMT) has been shown to improve respiratory muscle strength and endurance in various conditions. This study aims to explore the effects of IMT specifically in healthy young adults. To assess whether a structured IMT program improves diaphragmatic strength and pulmonary function in healthy adults. A randomized control trail involving 56 competitive young healthy adults will be conducted. The study duration will be 8 weeks, with assessments conducted at baseline , mid-point, and at the end of intervention. The IMT group participate in 20 minutes of training session, 4 to 5 times per week, using power-breathe device. Thera-band resistive training group participate in 15 minutes of training session, 3 times per week, using different colors of thera-band. This study aims to provide robust evidence on the benefits of IMT for young healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female participants.
* 20 to 35 years
* FEV1/FVC ratio above 60%
* Non-smokers

Exclusion Criteria:

* Acute illness within last 2 weeks
* Obese patients whose BMI greater than 30kg
* Patient with history of chronic airflow limitation or any diagnosed disease.
* Patient with acute infection.
Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle

It is generally assumed that the major causes of in vitro fertilization (IVF) failure in women with endometriosis are diminished ovarian reserve, impaired endometrial receptivity and low quality of embryos. The use of prolonged courses of hormone therapy may play an important role in the strategy of overcoming endometriosis-related infertility. The aim of this study was to evaluate the use of dienogest (DNG) before an IVF cycle in women with endometriosis undergone a previous IVF failed cycle

The primary outcomes of the study are clinical pregnancy rate and live birth rate after reaching 24 week's gestation.

Secondary outcomes of the study are: changes in the diameter and volume of the largest endometrioma, total gonadotropin dose administered, number of mature oocytes collected, number of two-pronuclear (2PN) embryos, number of blastocysts.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of endometriosis at magnetic resonance imaging or transvaginal ultrasonography;
* one failed previous IVF cycle (including failure of frozen embryo transfer);
* basal FSH \< 14.0 IU/L;
* antimullerian hormone (AMH) blood level \>= 0.5 g/mL;
* normal thyroid-stimulating hormone and prolactin.

Exclusion Criteria:

* history of surgery for endometriosis;
* history of uterine or adnexal surgery;
* use of hormonal therapies for the treatment of endometriosis related pain within 6 months before IVF;
* adenomyosis (magnetic resonance imaging or transvaginal ultrasonography);
* hydrosalpinx;
* submucosal fibroids;
* body mass index (BMI) ≥ 30 kg/m2;
* severe male factor infertility (\< 5 million total motile sperm count).
Development of Tuberculosis Diagnostic Kit

Pulmonary tuberculosis is one of the most important infectious diseases in human with high mortality.

Early diagnosis followed by antibiotic treatment is the only way for control of the disease. However, most of commercial tuberculosis diagnostic kits are of moderate sensitivity. Oncoprobe Inc. recently developed a tuberculosis diagnostic kit (HR-103) based on detection of antibody against Mycobacterium tuberculosis in serum. The main purpose of this project is to evaluate the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine, pleura and serum samples.Capilia TB assay and another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be tried to detection tuberculous disease.

Sputum samples from 200 patients with chest or respiratory problems will be collected. Presence of M.

tuberculosis in the samples will be checked by acid-fast stain and bacterial culture and identification methods.

At the same time, saliva, urine, and serum samples from these 200 patients and 50 healthy volunteers will be collected. The tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc. or capilia TB assay or another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be used to detect tuberculosis disease from these samples. By comparing the results with the stain and identification results of sputum samples from the 200 patients, the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine,pleura and serum samples, as well as from combination of these samples, will be obtained. In addition to pulmonary tuberculosis, M. tuberculosis causes pleural tuberculosis. Diagnosis of pleural tuberculosis involves determination of activities of adenosine deaminase and interferon-gamma in pleural effusion, which is tedious. We also plan to collect pleural effusion samples from 100 patients, and examined by the tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc. By comparing the results with the adenosine deaminase and interferon-gamma activities of the same samples, the sensitivity and specificity of the kit in detection of pleural tuberculosis from pleural effusion samples will be obtained.

Eligibility Criteria:
Inclusion Criteria: clinical suspicious of tuberculosis

-

Exclusion Criteria:

* HIV
Severe Asthma Network Italy

The goal of this registry is collecting data of severe asthma patients, recruited by specialized centers, in a real life setting, homogeneously placed on a database management system to follow them over the time.

The information recorded will provide:

1. The collection of homogeneous clinical, functional and biologic data of patients with severe asthma in a real life setting.
2. The evaluation of adherence to treatment in real life.
3. The clinical eligibility of patients treated with biologics.
4. The evaluation of patients' clinical response to each treatment.
5. The monitoring of tolerability and safety.
6. The long-term follow up of patients with severe asthma.


Eligibility Criteria:
Inclusion Criteria:

1. signed informed consent and privacy disclaimer;
2. age \> 12 years;
3. diagnosis of severe asthma according to the ERS/ATS criteria:

   1. During treatment with:

      * High-dose ICS + at least one addistional controller (LABA, montelukast, or theophylline) or
      * Oral corticosteroids \>6 months/year
   2. at least one of the following occurs or would occur if treatment would be reduced:

      * ACT \<20 or ACQ\>1.5
      * At least 2 exacerbations in the last 12 months
      * At least 1 exacerbation treated in hospital or requiring mechanical ventilation in the last 12 months
      * FEV1 \<80% (if FEV1/FVC below the lower limit of normal)

Exclusion Criteria have not been considered in order to have a realistic view of severe asthma in real life.
Autonomic Dysfunction and Spinal Cord Stimulation in Complex Regional Pain Syndrome

To demonstrate that spinal cord stimulator has an effect on sympathetic function (the one that give us the fight and flight response). Therefore, if the spinal cord stimulator has an effect on sympathetic function, the responses from CRPS patients to different stimuli will differ significantly pre and post SCS implant.

If CRPS patients exhibit autonomic, CRPS patients could be stratified according to their sympathetic function pre-implant. It is expected that patients with a moderate/mild form of autonomic dysfunction will have better outcomes with the SCS.

Currently the mechanisms of Complex Regional Pain Syndrome (CRPS) are poorly understood and stratification of either diagnosis or therapy is very weak. . There is a great need to develop and validate more objective methods to characterize and stratify CRPS that better diagnostic and therapeutic approaches are available. Spinal Cord Stimulation (SCS) has been used as the last resource to alleviate pain and re-establish function in CRPS patients. However, there is a disagreement over how it works. An underlying concept is that it works by modulating autonomic nervous system (ANS) activity. Therefore, ANS parameters could be useful to stratify patients. Our preliminary studies indicated that SCS has also an effect on blood pressure regulation and improves the CRPS patients' response to Valsalva maneuver -a test of autonomic function. The Autonomic Nervous System function in adult CRPS patients has not yet been studied. The only existing study of CRPS and autonomic function showed that 15% of the patients suffer from syncope and increased heart rate during upright position similar to same aged patients with postural tachycardia syndrome - a syndrome of autonomic dysfunction. It is unclear if autonomic dysfunction is present in CRPS patients because ANS activity is altered by chronic pain or whether or not ANS activity contributes to CRPS. Therefore, we proposed to study the autonomic function in CRPS patients by standardized autonomic function and to evaluate the effect of the SCS on autonomic function in CRPS patients before and after spinal cord stimulator implant. This is a 24 months study.

Eligibility Criteria:
Inclusion Criteria:

* CRPS patients meeting the inclusion criteria according to the International Association for the Study of pain task Force will be included in the study.
* Age: 18 to 65.
* Disease duration of at least 6 months.
* History of unsuccessful long lasting therapies: physical therapy, transcutaneous electrical stimulation and medication.

Exclusion Criteria:

* Presence of current or past pulmonary, hepatic, renal disease, arthritis, hematopoietic, and neurological diseases not related to CRPS.
* Anticoagulant therapy, cardiac pacemaker used.
* Pregnancy test for females is positive.
Methamphetamine Isomer Pharmacology in Humans

This study is being done to understand the metabolism and impairment profile of methamphetamine (meth). Meth exists as two chemical structures that are mirror images of each other: R-meth and S-meth. S-meth is a strong central nervous system stimulant and used to treat attention deficit disorder (ADD). R-meth is not a strong central nervous system stimulant and is available over-the-counter in nasal decongestant sprays.17 healthy participants will be enrolled for 3 study visits and on study for up to 12 weeks.

Double-blind crossover study design. Healthy volunteers will attend three study drug administration visits, at least 7 days apart, in which methamphetamine isomer pharmacology will be assessed following intravenous administration of (1) S-(+)-methamphetamine, (2) R(-)-methamphetamine, or (3) a (1:1) racemic mixture of R-(-)- and S-(+)-methamphetamine. The order of these interventions will be counterbalanced across participants. Serial blood samples will be drawn during each dosing visit and compared with concurrent dried blood spots from a finger stick, oral fluid collections, and pooled urine specimens.

Primary Objective

* Characterize the pharmacokinetics of acute S-(+)-methamphetamine administration.
* Characterize the pharmacokinetics of acute R-(-)-methamphetamine administration.
* Characterize the pharmacokinetics of acute racemic (1:1) R-(-)- and S-(+)-methamphetamine administration.

Secondary Objectives

* Assess for evidence of stereo-selective metabolic pathways.
* Assess for evidence of subjective, cognitive, or physiological effects from acute R-(-)-methamphetamine administration.
* Assess for evidence of more than additive effects when administering racemic methamphetamine.

Correlative Objectives

* Compare biological methamphetamine and metabolite concentrations in surveyed biological matrices (i.e., plasma, whole blood, oral fluid, dried capillary blood spots, and urine) over time.
* Compare cognitive and subjective effects of acute S-(+)-methamphetamine, R-(-)-methamphetamine, and racemic methamphetamine administration.

Eligibility Criteria:
Inclusion Criteria:

* Good mental health as determined by self-reported responses to the Psychopathology Screener
* Absence of any major cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal, or hepatic disease as determined by self-reported responses to the Medical History Screener
* English-speaking (able to provide consent and complete questionnaires)
* Written Informed Consent

Exclusion Criteria:

* Any serious prior adverse response to sympathomimetic agents or amphetamine analogs
* History of or current substance use disorder as determined by self-reported responses to the Internalizing, Externalizing, and Substance Use Disorder Screener
* Pregnancy or lactation (pregnancy test, if needed)
* Use of medications that may impact cognition or metabolism (e.g., mood stabilizers, sedatives)
* Dependent on prohibited concomitant therapy that cannot be withheld for 48 hours prior to and during study visits.
Cardiovascular Evaluation of Adult PHA 1 Patients

Vascular and cardiac alterations are associated with aldosterone effects are evidenced in experimental models and aldosterone receptor blockade is of clear benefit in cardiac disease (heart failure). The study aims at assessing vascular and cardiac alterations in adults with a chronic increase in circulating aldosterone without hypertension. The investigated population will be patients with a rare disease, pseudohypoaldosteronism type 1, due to heterozygous inactivating mutations of the mineralocorticoid receptor.

The study includes adult patients with mineralocorticoid receptor mutation as compared with not affected relatives. It includes also relatives of adult relative of patients with PHA1 in whom no mutation was found. Cardiovascular evaluation is conducted with cardiac and vascular ultrasound assessment and cardiac NMR, ambulatory blood pressure measurement.

Protocol duration is 2 days . Detailed genetic study is conducted in family without identified mutation in MINERALORECEPTOR.

Eligibility Criteria:
Inclusion criteria:

* Age over 18
* Male or female gender
* Genotype in the PHA1.NET network

Exclusion criteria:

* Not membership to a regime of Social Security or to a CMU
* Against indication in the realization of a MRI
* Cardiac NMR not possible
* Known cardiovascular disease for person not carrying MR mutation
Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants

Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron status until six months after birth, without increasing the risk of polycythaemia or other adverse events. We hypothesize that this intervention will also benefit low birth weight infants in South Africa.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant mothers with SFH measurements below the cutpoint are eligible for inclusion. We aim to include infants with a birth weight below 2500 grams, but the actual birthweight can only be assessed after birth. We therefore accept an error of 500 grams (20%) and will include newborns up to 3000 grams. Birthweight will be measured after randomisation and study treatment.

Exclusion Criteria:

1. twin pregnancy
2. history of postpartum haemorrhage (PPH)
3. (gestational) diabetes
4. pre-eclampsia
5. abruptio placentae
6. caesarian section
7. necessity of early clamping due to tight nuchal cord
8. need for resuscitation immediately after birth
9. major congenital abnormalities
Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses

The purpose of this study is to determine whether photodynamic therapy or CO2 laser therapy is superior in the treatment of actinic keratoses with respect to efficacy and side effects.

Ablative laser therapy and photodynamic therapy are widely used and accepted therapeutic methods to treat multiple actinic keratoses, yet comparative studies are rare. The purpose of this study is to compare both treatments intraindividually with respect to treatment efficacy and side effects.

Eligibility Criteria:
Inclusion Criteria:

* men and women with clinical and histological diagnosed, symmetrical distributed actinic keratoses
* at least 2 actinic keratoses, on each of both treatment areas at least one
* Patients must be 18 years or older.

Exclusion Criteria:

* Age 17 years or younger
* lack of patient's informed consent for any of the two treatments
* contraindication for Co2 therapy or for photodynamic therapy
* skin infection in the treatment area
Therapeutic Equivalence Study of HCP0910 250/50 Mcg to Seretide 250 Diskus in Asthmatic Patients

The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients.


Eligibility Criteria:
Inclusion Criteria:

* age 20 \~ 75 inclusive
* Asthmatic diagnosis in more than 12 weeks from screening day
* Shows more than 12 % increase, and 200mL increase in FEV1 measure on Visit 2

Exclusion Criteria:

* Maintain controlled asthma for more than 4 weeks before screening
* Diagnosed as a severe asthmatic patients
Paravertebral Block for Postoperative Analgesia in Thoracoscopic Surgery

To access the analgesic efficacy of patient controlled thoracic paravertebral analgesia.

The study was carried out on thirty patients who underwent video-assisted thoracic surgery.Paravertebral space was identified by loss of resistance technique under video-assisted inside thoracic space before chest close.Initiated dose of 0.3ml/kg of bupivacaine 0.125%+fentanyl 2 mcg/ml was administered then continued patient-controlled analgesia with background rate 3ml/h, bolus dose 2ml, lockout interval 10 minutes. Postoperative pain was accessed by Visual Analogue Scale at rest and on coughing; monitor the heart rate, blood pressure, respiratory rate, SpO2, arterial blood gas and spirometry in three postoperative consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery.

Exclusion Criteria:

* Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more,, allergy to any of the study drugs, patients having any contraindication to placement of PVB, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease.
Reconstruction of the Anterolateral Ligament (ALL) With Revision Anterior Cruciate Ligament (ACL) Surgery

Patients with combined Anterolateral ligament (ALL) reconstruction- Anterior cruciate ligament (ACL) revision will have a better rotational knee stability and therefore better patient reported outcome measure (PROM) scores compared to patients, who have ACL revision surgery without ALL reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ACL revision surgery indication

Exclusion Criteria:

* Patients with difficulties of understanding danish