cyrilzakka/clinical-trials huggingface dataset:
Change of Inspiratory Peak Flow in COPD

Chronic obstructive bronchitis and emphysema (COPD) are pathophysiologically characterized by inflammatory and structural changes in the lung. These changes lead to a reduction in elastic recoil as well as reduction in lung parenchyma. As a consequence collapse of the small airway occurs during expiration leading to expiratory flow limitation. In severe cases this flow limitation occurs even during resting condition. This expiratory collapse is suspected to mask changes in bronchial smooth muscle tone, especially if these changes in bronchial smooth muscle tone are assessed using expiratory manoeuvres. This might leave the impression of non-reversible airway obstruction und ineffectiveness of treatment with bronchodilators. Several studies suggest that in patients with COPD symptomatic changes following application of a bronchodilating compound do not correlate with changes in forced expiratory volumes. In contrast inspiratory lung function parameters (especially forced inspiratory volume in one second (FIV1)) is much more associated with symptomatic changes in patients with COPD. Comparable effects were also detected regarding peak inspiratory flow (PIF) values.Changes in inspiratory parameters following administration of a bronchodilator in patients with COPD and asthma are reproducible. PIF can easily be measured by inspiratory peak flow meters. So far no data exists on the usability of these devices following bronchodilation in patients with COPD. Formoterol is a rapid acting bronchodilator, which has been proven save in asthma and COPD

N=40 patients with moderate to severe COPD (30 \< FEV1 \< 70 % pred.), no further significant lung disease; current smokers or ex-smokers; no exacerbation in the last 2 month.

Baseline visit Physical examination Dsypnea score (Borg-Scale, TDI) Lung function (Bodyplethysmography, CO-diffusion capacity)

Before each study day the following medication will be withheld:

Short-acting bronchodilators \> 6 hours Long-acting b2-adrenoceptor agonist \> 24 hours Tiotropium \> 24 hours

Study day 1 Bodyplethysmography including FEV1, PEF, FIV1 and PIF and assessment of PIF using an inspiratory Peak Flow Meter in randomized order.

Dysnpea Scores 30 minute break Assessment of change in dyspnea (visual analogue scale) Bodyplethysmography including FEV1, PEF, FIV1 and PIF. Assessment of PIF using an inspiratory Peak Flow Meter in randomized order Administration of 12 µg formoterol 30 minute break Assessment of change in dyspnea (visual analogue scale) Bodyplethysmography including FEV1, PEF, FIV1 and PIF. Assessment of PIF using an inspiratory Peak Flow Meter in randomized order.

Study day 2 Three to 14 days following study day 1. Schedule like day 1 with change in the order of lung function testing depending on randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with COPD of moderate to severe degree according to GOLD guidelines
2. current or ex-smokers, no history of atopy, stable clinical condition, age of \>40 years.

Exclusion Criteria:

1. Significant lung disease other than COPD, unstable clinical condition
2. acute exacerbation in the last 2 month
Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment in People With Diabetic Neuropathy

The main objective of this trial is to investigate the effect of an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.

A randomized controlled trial will be performed with 48 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform exercises at home, three times a week, through the booklet for 8-weeks.

The subjects will be evaluated in 3 different times to access the effect of the intervention: baseline and 8weeks, for all outcomes; and 16 weeks, for follow-up reasons for all outcomes.

The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the neuropathy severity, (3) tactile and vibration sensititivity (10-g monofilament and tuning fork), (4) foot-ankle kinematics and ankle kinetics during gait (infrared cameras and inverse dynamics, respectively), (5) foot isometric strength (by a pressure plate measurement), (6) functional balance reach test, (7) foot health and functionality by the Foot Health Status Questionnaire, (8) plantar pressure distribution during gait.

The hypothesis of this study is that the intervention will increase the perception of the tactile and vibratory sensitivity of the foot, reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, increase the functional balance score, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, promote a more physiological foot rollover with a redistribution of plantar pressure during gait, as well as increase foot-ankle mobility after 08-weeks of intervention. There will be also beneficial biomechanical changes during gait, such as: (1) increase in the ankle extensor moment and ankle concentric power in the propulsion phase and (3) increase in the ankle flexor moment and ankle eccentric power in the load phase.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 1 or 2;
* Moderate or severe neuropathy confirmed with the fuzzy software;
* Ability to walk independently in the laboratory

Exclusion Criteria:

* Hallux amputation or total amputation of the foot;
* History of surgical procedure in the knee, ankle or hip;
* History of arthroplasty and / or lower limb orthosis or indication of lower limb arthroplasty throughout the intervention period;
* Neurological and / or rheumatologic diseases diagnosed;
* Inability to provide consistent information;
* Perform physiotherapy intervention throughout the intervention period;
* Receiving any physiotherapy intervention or offloading devices;
* Major vascular complications;
* Severe retinopathy;
* Ulceration not healed for at least 6 months and / or active ulcer;
* Score between 12-21 (Probable Depression) from the Hospital Anxiety and Depression Scale (HADS).
Cross-sectional Study of COVID-19 Infection in Hospital Health Personnel

The objective of the study is to determine the percentage of past SARS-CoV-2 infections in hospital health personnel involved in the care of people with COVID-19 in HUGTiP and in Badalona Serveis Assistencials de Badalona.

Health personnel, especially hospital workers, have been a group especially affected by the COVID-19 epidemic. According to data from the Ministry of Health, in Spain 26% of health personnel have been infected by COVID-19, for a total of 31,053 professionals, representing up to 18.5% of all infections in the Spanish state, with variations between the different autonomous communities.1 In Italy it was estimated that up to 20% of health workers who responded to the epidemic would have been infected within a month.

There are no unified guidelines at the state level to determine infection prevention strategies in health personnel in order to validate them, beyond the use of Personal Protective Equipment (PPE) in personnel and general strategies for isolation and prevention of transmission.

There are no approved drug prevention strategies for primary prophylaxis against COVID-19.

Currently, there are no universal mass screening strategies (virological or immunological) to estimate the actual number of health personnel with an asymptomatic infection, as well as to determine the percentage of personnel who have already passed the infection asymptomatically or to determine the percentage of personnel A healthcare provider who has developed some form of immunity following a confirmed COVID-19 infection.

The HUGTiP, like the rest of Catalan hospitals, has suffered a massive avalanche accumulated in the time of admission by COVID-19, which has forced it to adopt different innovative strategies to visit them in emergencies, enter them in conventional hospitalization in a conventional plant, or attend them in the intensive care units that had to be created de novo against the clock. As of April 20, 2020, 1,000 hospital discharges have been granted to patients admitted by COVID-19 in conventional hospitalization plants and 170 more discharges from those admitted to intensive care units at HUGTiP. Likewise, the Municipal Hospital of Badalona has given a total of 300 discharges of patients with COVID-19, and they have also reported about 180 infections in their health personnel in this period.

Due to the high transmission rate of SARS-CoV-2 and its potential severity, several healthcare workers at HUGTiP decided on their own to take empirical primary prophylaxis with oral hydroxychloroquine individually as prevention of SARS-CoV-2 infection.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age\> 18 years) who have worked during the epidemic period (March and April 2020) in the Infectious Diseases, Pneumology, Emergencies, ICU and Internal Medicine departments of HUGTiP, or in the Internal Medicine or Emergency departments of the Badalona Municipal Hospital.

Exclusion Criteria:

* Participation will be voluntary and no exclusion criteria are established
The Swiss Venous Thromboembolism Cohort 65+

The purpose of this prospective multicenter cohort study is to examine long-term medical outcomes, quality of life, and medical resource utilization in elderly patients (\>= 65 years) with acute venous thromboembolism (i.e., acute pulmonary embolism and/or deep vein thrombosis)


Eligibility Criteria:
Inclusion Criteria:

* Objectively confirmed acute pulmonary embolism and/or deep vein thrombosis
* Age \>=65 years

Exclusion Criteria:

* Thrombosis at a different site than lower limb
* Catheter-related thrombosis
* Insufficient spoken language ability in German or French
* Follow-up not possible (e.g., terminally ill patients)
* Informed consent not possible (e.g., severe dementia)
* Prior enrolment in the study
Multidisciplinary Support Program in Chronic Hepatitis C

Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (recruited 2002-2004, n= 147), MSP-pilot group (recruited 2005-2006, n=131), and MSP-validation group (recruited 2007-2009, n=169).

Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (follow-up 2002-2004, n= 147), MSP-pilot group (follow-up 2005-2006, n=131), and MSP-validation group (follow-up 2007-2009, n=169).A cost-effectiveness analysis was performed using a Markov model.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis C eligible to receive antiviral treatment.

Exclusion Criteria:

* Patients who had undergone previous antiviral treatment, those with human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection, and individuals included in other treatment protocols.
Dose Effect of Limicol on (LDL)-Cholesterol Levels

The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.


Eligibility Criteria:
Inclusion Criteria:

* About 18 to 65 years (inclusive).
* Subject has a stable weight for at least three months before the start of the study.
* Subject able and willing to comply with the protocol and agreeing to give their consent in writing.
* Subject affiliated with a social security scheme.
* Subject willing to be included in the national register of volunteers who lend themselves to biomedical research.
Evaluate the Diagnostic Value of BTPNA for PPL: a Real-world Study

The study is designed as a multicenter prospective trial of BTPNA for the diagnosis of peripheral pulmonary lesions in the real world. The purpose of the study is to evaluate the safety and effectiveness of BTPNA and to explore the factors of diagnosis rate.

The study will be conducted at about 10 clinical centers. Patients will be first screened, and only after meeting all the selection criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive BTPNA to sample the target lesions. The primary endpoint is the diagnostic yield of BTPNA. The secondary endpoints include the success rate of navigation, the operation time of the bronchoscope and so on.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years old.
2. Newly diagnosed patients whose chest CT shows peripheral pulmonary lesions that have bronchus signs but are difficult to reach through the intrabronchial path, or are adjacent to the airway, or have no bronchus sign, and are suspected of malignancy which need non-surgical biopsies.
3. The diameter of the lesions is greater than or equal to 0.8cm and less than 5cm
4. The location of lesions results in the following situations where transthoracic needle aspiration (TTNA) is difficult to obtain a diagnosis or the operation is relatively risky, or have not been diagnosed by TTNA and other non-surgical biopsies in the past.
5. Lesions can be accessed by BTPNA technology in preoperative assessment.
6. Understand the research and sign the informed consent form.

Exclusion Criteria:

1. Contraindications for bronchoscopy.
2. The lesions are adjacent to the target trachea or bronchus of points of entry(POE).
3. Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery.
4. Routine bronchoscopy showed visible lesions in the lumen.
5. The investigator believes that the patient has other conditions that are not suitable for inclusion in this study.
Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery

The main objective of this study is to evaluate the effect of pre-operative Inspiratory muscle training (IMT) using an IMT Threshold device (Philips), on early postoperative lung function recovery and on the occurrence of post-operative pulmonary complications (PPC) after major cardiothoracic surgery with and without sternotomy. As frailty can affect postoperative outcome, the relation between frailty, maximal inspiratory pressure (MIP) and post-operative outcome is investigated additionally.

Patients eligible for cardiac surgery are pre-operatively randomized to standard physiotherapy or daily inspiratory muscle training for a period of 2-3 weeks. One therapy session a week is supervised by a physiotherapist in the IMT group. Post-operative physiotherapy is standardized. Pulmonary function and clinical status are evaluated pre-operatively, and during the early post-operative phase, approximately on the 3th and 6th post-operative day, or when necessary. The occurrence of postopercenterative pulmonary complications is determined using a validated scale, the Melbourne group scale, based on clinical status, chest x-ray and blood tests. Frailty is defined based on the Fried criteria. Two Belgian hospitals are involved in this study: the University Hospital Brussels and the Jessa Hospital (Hasselt), the latter mainly focussing on patients referred for minimal invasive heart surgery (minimally invasive-aortic valve replacement (mini-AVR) and Endoscopic - Atraumatic Coronary Artery Bypass (endo-ACAB).

Eligibility Criteria:
Inclusion Criteria:

* Candidates for coronary artery bypass grafting or minimally invasive valve repair/replacement

Exclusion Criteria:

* Not able to perform pre-operative standard pulmonary function tests
* No understanding of Dutch, French or English and/or no ability to understand verbal instructions regarding the inspiratory muscle training
* Patients who participate in another clinical trial
* Patients suffering from neuromuscular disorders, unstable angina, a history of non-traumatic pneumothorax, chronic obstructive pulmonary disease (COPD) in exacerbation
* Patients in need for urgent surgery (within less than 2 weeks)
Effectiveness of Microcurrents Therapy in Pressure Ulcers in Elderly People

The purpose of this study is to investigate the effect on the healing of pressure ulcers in elderly people using a care protocol plus the application of microcurrent patches during 12 hours per day compared to the effect of the same protocol plus placebo electric stimulation.

The design of this study is a multicentric, parallel, randomised, triple blind clinical trial with placebo control.

The size of the sample will be 30 participants older than 60 years old who are institutionalized in some nursing homes in Spain.They will be randomized in two groups: control or experimental.

The variables of the study will be collected at three time points: before the intervention, 14 days after the start of the intervention and at the end of the intervention.

The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two-factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with Bonferroni correction

Eligibility Criteria:
Inclusion Criteria:

* Adults over 60 institutionalized in nursing homes.
* Participants presenting pressure ulcers in phase II, III and IV according to the North American National Pressure Ulcer Advisory Panel System and the European Pressure Ulcer Advisory Panel System.
* Time of evolution of the pressure ulcer greater than 1 month and less than 24 months.
* Ulcer size greater than 1 cm2.
* Less than 14 points on the Braden scale.

Exclusion Criteria:

* Presence of a pacemaker or any implanted electrical device.
* Metal implants in the pressure ulcer area.
* Pressure ulcer in occipital area.
* Cancer.
* Osteomyelitis.
* 3 or more abnormal blood values at the beginning of the study that indicate a limited healing potential (anemia, iron deficiency, protein deficiency, dehydration, uncontrolled diabetes or hypothyroidism)
* Allergies to the usual cures protocol established.
* Systemic infection
* Recent history (minimum of 30 days) of treatment with growth factors or vacuum-assisted treatment.
Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functional Recovery

The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function. The main questions it aims to answer are:

* Is stimulating the vagus nerve safe and feasible after demyelinating episodes?
* Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis?

Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control.

Participants will:

* Come in for study visits over a six month period. Study visits are three times weekly for the first month, then single follow up visits at two, three, and six months.
* During study visits, participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task, specifically the grooved peg test.
* At various timepoints in the study, motor and disability tests will be administered to see if there are any changes in motor control for that participants. These tests include the timed 25 foot walk test, expanded disability scale, the upper extremity portion of the Fugl-Meyer Assessment, and the Multiple Sclerosis Impact Scale - 29.


Eligibility Criteria:
Inclusion Criteria:

* All participants ages 18-65 with diagnosis of multiple sclerosis at least 30 days from last relapse
* Baseline grooved peg test time greater than or equal to 108 seconds for completion of the task (1 standard deviation below mean multiple sclerosis score).
* Ability to sign informed consent
* expanded disability status scale score (or estimated) of 2.5 or greater OR a clinical report of upper extremity dysfunction in their dominant hand

Exclusion Criteria:

* Current uncontrolled and/or clinically significant medical condition.
* Primary progressive multiple sclerosis.
* History of seizures or epilepsy.
* Other central nervous system disease or significant brain trauma.
* Bacterial or viral infection within the prior 30 days.
* Prior treatment with total body irradiation, clemastine, bexarotene, or other experimental remyelinating agent.
* Recent suicide attempt or continued expressed suicidal ideation.
* Implanted devices, such as pacemakers, cochlear prosthesis, neuro-stimulators.
* Abnormal ear anatomy or ear infection.
* Pregnancy, lactation, or lack of use of contraception.
* Unable to walk 25 feet continuously
* Other significant disease or disorder that might impair study participation. Participants will be allowed to initiate or maintain background disease modifying therapy to reduce the risk of multiple sclerosis relapse and optimize recruitment.
The Palliative Radiotherapy And Inflammation Study - PRAIS

Radiation therapy (RT) is one of the primary treatments for bone cancer pain due to metastatic cancer disease. About 6 of 10 patients obtain pain relief from RT. There are no established predictors that can be used to select patients that respond to RT. This raises the need to identify potential clinical characteristics and biomarkers that may better select patients for RT. A similar argument can be stated for the development of cachexia; there are currently no predictors that can identify patients who will develop cachexia later in the cancer disease trajectory. Cancer symptoms can be related to inflammation. Both pain, cachexia and depression are associated with inflammation in experimental and preclinical studies . Still, the clinical data on the relationship between inflammation and pain or cachexia are sparse. This is especially true for longitudinal follow-up studies.

This study will include 1000 adult patients in a multicenter, multinational longitudinal observation study of patients who receive radiation therapy for bone cancer pain. Demographic data, clinical variables, genetic biomarkers and inflammatory substances will be assessed before start of RT. The primary analysis in the study is to identify potential predictors for pain relief from RT. During follow up the study will also explore for predictors for development of cachexia and which inflammatory substances that are associated with changes in pain intensity, depression and development of cachexia.


Eligibility Criteria:
Inclusion criteria:

* Verified cancer diagnosis (based on radiological, histological, cytological or operative evidence). Those with hematological malignancies are also eligible.
* Bone metastasis verified either by bone x-ray, bone scan, computer tomography (CT) or magnetic resonance imaging (MRI)
* Patients that are about to undergo radiotherapy with palliative intent for painful bone metastasis
* Radiotherapy should be administered within one week after baseline observations are obtained
* Age ≥18 years
* Patient is able to comply with trial procedures.

Exclusion criteria:

* Pathological fracture in long bones (e.g femora or humeral shaft fractures)
* Patients not consenting to participate in the study
* On-going RT or RT administered within the last 4 weeks
* Patients who are not able to follow the trial procedures
* Previous participation in this study