cyrilzakka/clinical-trials huggingface dataset:
The Clinical Effect of Adaptive Posture-balance Cardiac Rehabilitation Exercise on Cardiovascular Diseases

The whole experiment included one-month APBCRE therapy and two assessments. The one-month APBCRE consisted of twelve exercise sessions, evenly three times per week. At baseline and after rehabilitation, participants underwent one assessment, including car-diopulmonary exercise testing (CPET), resting metabolic rate (RMR) detection, and quality of life questionnaire (QoL). The primary outcomes were exercise capacity measured by function parameters at anaerobic threshold (AT) and other CPET physiological indexes. The secondary endpoints were the RMR level and QoL score.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 90 years
* With cardiovascular diseases

Exclusion Criteria:

* abnormal blood pressure response
* unstable angina pectoris
* acute heart failure
* congenital heart disease
* severe musculoskeletal diseases
Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study

Inhalation drugs are essential in the treatment of COPD, in controlling symptoms and preventing exacerbations. The aim of this pilot study is to collect data necessary for the planning of future efficacy trials. We plan to assess the value of providing training in inhalation technique to hospitalized COPD patients. Data on rehospitalizations will be collected from the hospital's medical records and from the National Patient Registry . The inhalation technique of all recruited patients will de assessed at baseline. The patients will then be randomised 1:1 to the intervention or standard care group. The intervention consists of a drug counselling, focusing on inhalation technique. In addition patients in the intervention group will have their medicines personally delivered from the hospital pharmacy at discharge (discharge service). Patients will be asked to fill in questionnaires evaluating the inhalation training and the discharge service


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the pulmonary ward, the Medical Department, Oslo University Hospital, Oslo, Norway

Exclusion Criteria:

Patients

* previously included to the study
* usually not administering their inhalation drugs themselves
* using nebulizer chamber with their drug
* who are contagious, thus restricting accessibility of personnel
* who are not able to provide informed consent
An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds

An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds

The overall objective of this post market clinical follow-up (PMCF) investigation is to confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds, with Mepilex Border Flex as the secondary dressing, when used in accordance with the Instructions for Use.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form
2. Patient aged ≥18 years old
3. Patient with moderate to high exuding chronic wound (PU (stage II-IV), VLU or DFU)
4. Patient with target wound that is a shallow to deep wound or cavity
5. Patient with target wound that is ≥ 4 weeks in age
6. Patient with target wound that is ≥ 8 cm2

Exclusion Criteria:

1. Patient is contraindicated for the dressing according to product labeling
2. Known allergy/hypersensitivity to any of the components of the investigation products
3. Pregnancy/lactating female
4. Patient with spreading soft tissue infection/cellulitis in the wound (as judged by the Investigator)
5. Patient with known immunodeficiency
6. Patient taking systemic antibiotics
7. Patient with the target wound located on an infected limb and/or interfered by minimal blood flow in the opinion of the Investigator.
8. Patient with the target wound with an unexplored enteric fistula
9. Patient requiring treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide
10. Patient who, in the opinion of the Investigator, is not expected to comply with the investigation due to physical and/or mental conditions
11. Patient who was previously enrolled in this investigation
12. Patient participating in other investigations that would preclude the subject from participating in this investigation as judged by the Investigator
13. Patient involved in the planning and conduct of the clinical investigation (applies to all Mölnlycke staff, investigational site staff, and third party vendor)
Unilateral GPi vs Unilateral STN DBS in the Same Patient With PD

The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two main targets in the deep brain stimulation (DBS) treatment for Parkinson's disease (PD). Large randomized controlled trials, in which patients of comparable clinical and demographics were randomized to either GPi DBS or STN DBS, have demonstrated equal effects of both targets in motor symptom improvement, the superiority of STN DBS in the medication reduction and the potential advantage of GPi DBS for cognitive, psychiatric and axial aspects. Unfortunately, in such a highly heterogeneous disease of PD, many of these randomized controlled trials didn't include sufficient subjects and thereby yielded inconsistent results. Moreover, most studies are investigating the difference between GPi and STN in different patients.

In order to address the problem, an intra-patient comparison will be made by investigating the acute turning-on effects of unilateral STN stimulation versus unilateral GPi stimulation on axial symptoms, cognition and also cardinal symptoms within each individual patient who received the treatment of combined unilateral STN and contralateral GPi DBS. Axial symptoms including gait, balance and posture, motor symptoms and cognition are comprehensively assessed under two treatment conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic Parkinson's disease
* Aged between 55 and 75 years, both male and female
* Patients who have undergone combined unilateral STN and contralateral GPi DBS for more than 6 months
* A Hoehn-Yahr (H-Y) stage of less than 4 in the off-medication state
* A left-extremity to right-extremity ratio of less than 0.15 on the Unified Parkinson's Disease Rating Scale part Ⅲ (UPDRS-Ⅲ) in the both off-medication and on-medication states

Exclusion Criteria:

* History of serious psychosis
* History of intractable epilepsy (i.e., seizures)
* Diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions
* Dementia (A Mini-Mental State Examination (MMSE) score of \< 24), inability to comprehend the experimental protocol or voluntarily provide informed consent
* Lack of cooperation
* Additional reasons for exclusion at the discretion of the clinical investigator
* Poorly controlled depression or anxiety
* Past history of suicidal attempt
BIP in Jämtland Härjedalen: Increased Access to CBT Within Regular Health Care in Northern Sweden

The purpose of this study is to test internet-delivered cognitive behavior therapy for children and adolescents with anxiety disorders and obsessive-compulsive disorder in a routine clinical setting in a rural part of Sweden.

Aim The aim of this study is to conduct a pragmatic evaluation of ICBT for children and adolescents with anxiety disorders and OCD within routine health care in a rural area.

Research questions

* Is ICBT an acceptable method for the patient group?
* Is ICBT effective in a clinical setting?
* Is further treatment needed after ICBT?
* What are the long-term effects of ICBT?
* What predicts treatment outcome?
* How does ICBT work in a clincal setting? (time spent, negative effects etc)?

Design This is a uncontrolled intervention study where included families and children will be recruited consecutively during two years from a routine care CAMHS unit. All participants will be offered ICBT and assessed pre- and post-treatment, and at three-month follow-up through clinician ratings and self-report measures. The primary outcome measure is clinician rated severity of principal disorder at three-month follow-up. Long-term results will be assessed through study of medical records two years after completed ICBT.

Eligibility Criteria:
Inclusion Criteria:

* Fulfills diagnostic criteria for an anxiety disorder or OCD
* Access to a computer and internet connection
* Read and speak Swedish

Exclusion Criteria:

* ICBT is currently not assessed to be a suitable treatment
* Acute psychiatric problem (eg. severe depression or suicidality)
* Current psychosocial problems in the family (i.e substance abuse, abuse, neglect)
Supernormal Oxygen Delivery for Patients With Severe Burns

This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the goal-directed fluid therapy group to further evaluate significant differences in rate of complications during burn surgery.

This is a randomized double-blinded study to investigate the effect of control group and the goal-directed fluid therapy group on complications during surgery of the burn patients. The groups are designated as the control group and the oal-directed fluid therapy group to further evaluate significant differences in complications during the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Severe burn patients

Exclusion Criteria:

* Patients or families refuse to sign consent
Cicatrix Cream in Post Surgical Scars and Epidermic Burn

The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of epidermic burns or post surgical scars. The duration of this phase 2 clinical trial will be two months.


Eligibility Criteria:
Inclusion Criteria:

* Patient with lesions characteristic of the investigated illness.
* Signed informed consent

Exclusion Criteria:

* Patient that refer manifestations of high sensibility to the medication or to some of the components of the product
* Patient that don't want to participate in the study
* Patient not very cooperative
* Family responsible not very cooperative
Zepatier in Patients with Substance Use

The goal of this study is to assess hepatitis C virus (HCV) treatment with Zepatier (elbasvir/grazoprevir) in HCV monoinfected and human immunodeficiency virus (HIV)-HCV co-infected, HCV treatment-naïve or peginterferon/ribavirin-experienced patients with HCV genotype 1a, without baseline NS5A resistance, 1b, or 4 and substance use in urban, multidisciplinary specialty clinics.

Previously, people who use substances and those without liver fibrosis or cirrhosis were excluded from receiving direct-acting antiviral (DAA) treatment due to Illinois Medicaid restrictions. These sobriety and staging restrictions were recently lifted. However, due to these previous stringent requirements for sobriety, many patients were not able to be treated for HCV. This created a data gap for real-world outcomes of HCV treatment in people who use substances. This study presents a unique opportunity to provide patients with hepatitis C treatment and obtain much needed data on the use of elbasvir/grazoprevir in patients with substance use and other underrepresented comorbidities. Additionally, this study will determine if our current standard of care for the treatment of HCV is effective for patients with substance use.

Eligibility Criteria:
Inclusion Criteria:

* Adults (at least 18 years of age or older)
* Chronic HCV (HCV antibody positive with detectable HCV-RNA)
* HCV genotypes 1a, without the presence of baseline NS5A resistance (specifically, polymorphisms at amino acid positions 28, 30, 31, or 93), 1b, or 4
* HCV treatment-naïve or peginterferon/ribavirin-experienced
* Managed by the UI Health Infectious Diseases Clinic or Liver Clinic
* Recent or current substance use (per self-report or electronic medical record (EMR) data within 90 days of the screening visit, with or without positive baseline urine toxicology), inclusive of one or more of the following: Opiate substitution therapy; Prescription medication misuse (including: opiates, sedatives, tranquilizers, hypnotics, and psychostimulants); Illicit substances; Injection drug use; Alcohol

Exclusion Criteria:

* Incarcerated
* Pregnant or breastfeeding
* Decompensated liver disease (Child-Pugh B or C)
* Albumin below 3 g/dL
* Platelet count below 75,000
* Unwilling to commit to treatment and/or monitoring
* Poor venous access inhibiting laboratory collection
* Any condition considered by the investigators to be a contraindication to study participation
* Hepatitis B virus (HBV) surface antigen (HBsAg) positive
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients

The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment and PSORI-CM01 Granule with moderate to severe psoriasis. Any adverse events related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after treatment.

The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment and PSORI-CM01 Granule with moderate to severe psoriasis. Any adverse events related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. moderate to severe psoriasis vulgaris ( PASI \> 10 or BSA \>10%)
2. 18 to 65 years old
3. written/signed informed consent

Exclusion Criteria:

1. guttate psoriasis, inverse psoriasis or exclusively associated with the face
2. Acute progressive psoriasis, and erythroderma tendency
3. current (or within 1 year) pregnancy or lactation
4. current significant anxiety or depression with the Self-rating Anxiety Scale (SAS) \> 50 or the Self-rating Depression Scale (SDS) \> 53, or with other psychiatric disorders
5. With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments. Those who with malignant diseases, infections, electrolyte imbalance, acid-base disturbance. Patients with clinical test results listed below: abnormal serum calcium level ( Ca2+ \> 2.9 mmol/L or \< 2 mmol/L);AST or ALT 2 times more than normal upper limit; Creatinine and cystatin C more than normal upper limit; Hemoglobin elevates 20g/L more than normal upper limit,or hemoglobin reduction to anemia; Platelet count less than 75.0\*10\^9/L; White blood cell less than 3.0\*10\^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study
6. Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction
7. allergy to anything else ever before;
8. current registration in other clinical trials or participation within a month;
9. topical treatments (i.e. corticosteroids or retinoic acid or Vitamin D analogs ) within 2 weeks; systemic therapy or phototherapy (ultraviolet radiation B,UVB) and psoralen combined with ultraviolet A (PUVA) within 4 weeks; biological therapy within 12 weeks;
10. medical conditions assessed by investigators, that are not suitable for this clinical study.
LVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial

This is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures.

Lung volume reduction surgery (LVRS) as well as bronchoscopic lung volume reduction (BLVR) provide functional improvements in selected patients with homogenous emphysema and pronounced hyperinflation. A direct comparison of LVRS and BLVR in patients with homogenous emphysema is not available, thus the study will provide important data to guide treatment selection in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* COPD III-IV
* Age ≥ 18 years
* FEV1 \< 50% predicted after bronchodilatation
* Significant hyperinflation (TLC \>100% predicted, RV \> 200% predicted, RV/TLC \> 60%)
* Non-smoker or ex-smoker for \> 3 months (documented by cotinine testing)
* 6 MWT \>150 m and ≤ 450m
* MRC dyspnea score \> 3
* Homogenous emphysema as assessed by HR-CT (\< 15% difference in emphysema destruction score between target lobe and ipsilateral lobe) \[16, 17\]
* Uni- or bilateral collateral ventilation (CV) negative result assessed fissure completeness\>95% in QCT and confirmed by a bronchoscopic procedure (Chartis©)
* Optimal medical therapy for \> 3months, sufficient rehabilitation status with no need for further training/rehabilitation or rehabilitation within 6 months prior to intervention.
* Body Mass Index (BMI) \> 18, but \< 35 kg/m2
* Daily dose of prednisone ≤ 10mg

Exclusion Criteria:

* Contraindication against either LVRS or BLVR and/or to surgery and bronchoscopy in general
* Major comorbidities limiting survival
* Age ≥ 80 years
* Nicotine abuse within 3 months (documented by cotinine testing)
* Predominance of either left or right lung of \>70% in perfusion SPECT scintigraphy
* FEV1 and/or DLCO \<20% predicted (post bronchodilatation)
* Untreated Hypoxemia (PaO2 \< 50 mmHg)
* Untreated Hypercapnia (PaCO2 \> 50 mmHg)
* Significant pulmonary fibrosis or bronchiectasis
* Destroyed/vanished lung on HR-CT
* Previous chest surgery or bronchoscopic interventions
* Pulmonary hypertension (sPAP \> 35 mmHg)
* Active waiting list for lung transplantation
* Patient is not able to understand and willing to sign a written informed consent document.
* Pregnancy
A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block

The purpose of this study is to retrospectively compare perioperative pain relief and safety in pediatric patients who have received a femoral nerve block with varying concentrations of local anesthetic.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II
* Age \< or equal to 18 years of age at time of femoral nerve block
* Femoral nerve block performed from 2010-2015

Exclusion Criteria:

* ASA physical status \> II
* Co-morbid diseases (cardiac, pulmonary, neurological disease)
* Use of adjunctive medications in femoral nerve block (except for epinephrine), such as dexamethasone
The Effects of Night Call on Intellectual Performance

The purpose of the current proposal will be to examine the clinical performance of both physicians in training as well as experienced faculty in pre and post call situations. Groups will be matched for gender, age, experience and employment duration during regular hours versus immediate post call hour.

This is a prospective study evaluating the reaction time among attending anesthesiologists, and anesthesiology residents who take night shift call and are suffering from sleep deprivation. Investigators plan to examine clinical performance by measuring reaction times using a 10 minute psychomotor vigilance test device on physicians in training as well as experienced physicians in pre and post call situations.

All subjects will be informed of the scope and purpose of the study.

1. Attending Anesthesiologists: Gender, age, years of experience, years of employment at the institution, hours of sleep and circadian rhythm will be taken into effect.
2. Residents/Fellows: Gender, age, years of experience, years of employment at the institution and circadian rhythm will be taken into effect.

All study subjects will be asked to fill a questionnaire regarding demographic data, coping strategy Index.

1. Baseline instruments; including demographics, and coping strategy indicator (CSI), will be administrated.
2. Reaction time, mood and simple cognitive test will be measured at approximately 7 am of a regular day, (when the subject is not on call).
3. Reaction time, mood and simple cognitive test will be measured at approximately 7 am of after a call night.

This proposal attempts to examine the impact of night shift on mood, cognitive and motor task performance in physicians as compared to regular hours.

Eligibility Criteria:
Inclusion Criteria:

* Staff Attending Anesthesiologist who takes night shift call
* Anesthesiology residents who take night shift call

Exclusion Criteria:

* Staff unwilling to participate
A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose

This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI 320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed following a single dose administration on the first treatment day (Day 1) and will be assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to 28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at least 5 days but no longer than 7 days after the last dose of study drug.


Eligibility Criteria:
Key Inclusion Criteria:

* Given their signed written informed consent to participate.
* Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines.
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
* Pre-bronchodilator FEV1/FVC ratio must be \<0.70 and pre-bronchodilator FEV1 must be ≥50% and \<80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations

Key Exclusion Criteria:

* Significant diseases or conditions to : other than COPD, active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease and uncontrolled sleep apnea .
* Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
* Subjects who have a history of hypersensitivity to any corticosteroid,
* β2-agonist, muscarinic anticholinergic, or any component of the MDI
* Alpha-1 antitrypsin deficiency as the cause of COPD